Advisory Committees

advisory-committees
TitlePublishedFR Doc.Description
TitlePublishedFR Doc.Description
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20192018-Apr-172018-07355This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally- facilitated Exchanges and State Exchanges on the Federal platform. It finalizes changes that provide additional flexibility to States to apply the definition of essential health benefits (EHB) to their markets, enhance the role of States regarding the certification of qualified health plans (QHPs); and provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.
Legal Services Corporation -- State Advisory Councils2018-Apr-172018-07963This final rule removes the Legal Services Corporation (LSC) regulation on state advisory councils. LSC believes this action is appropriate because the state advisory councils are no longer active and their oversight functions have been replaced adequately by other offices and processes established since the regulation was promulgated. Executive Orders 13563, ``Improving Regulation and Regulatory Review,'' and 13771, ``Reducing Regulation and Controlling Regulatory Costs,'' direct agencies to review their existing regulations and repeal or revise any that are obsolete or unnecessarily burdensome. Although LSC is not an agency of the Federal government subject to either Executive order, LSC regularly reviews its regulations and has determined that this regulation can be eliminated.
Legal Services Corporation -- State Advisory Councils2018-Feb-012018-01733This proposed rulemaking would remove the Legal Services Corporation's (LSC) regulation on state advisory councils. LSC believes this action is appropriate because the state advisory councils are no longer active and their oversight functions have been replaced adequately by other offices and processes established by Congress or LSC. Executive Orders 13563, ``Improving Regulation and Regulatory Review,'' and 13771, ``Reducing Regulation and Controlling Regulatory Costs,'' direct agencies to review their existing regulations and repeal or revise any that are obsolete or unnecessarily burdensome. Although LSC is not an agency of the Federal government subject to either executive order, LSC regularly reviews its regulations and has determined that this regulation can be eliminated.
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20192017-Nov-022017-23599This proposed rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It proposes changes that would enhance the role of States as related to essential health benefits (EHB) and qualified health plan (QHP) certification; and would provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes proposed changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2017-Oct-032017-21003This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing a national emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural, non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2017-Jan-232017-00443This rule updates the Code of Federal Regulations (CFR) legal authority citations in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing an emergency declared pursuant to the International Emergency Economic Powers Act. This is a non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Commerce Department -- Amendment to the Export Administration Regulations: Removal of Special Iraq Reconstruction License2016-Dec-052016-29056In this final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by removing the Special Iraq Reconstruction License (SIRL) from the EAR. This action furthers the objectives of the Retrospective Regulatory Review Initiative that directs BIS and other federal agencies to streamline regulations and reduce unnecessary regulatory burdens on the public. Specifically, the SIRL is outdated and seldom used by exporters, who now have more efficient options for exports and reexports to Iraq and transfers (in-country) in Iraq. This rule also makes conforming changes.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2016-Nov-092016-27017This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing an emergency declared pursuant to the International Emergency Economic Powers Act. This is a non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Commerce Department -- Wassenaar Arrangement 2015 Plenary Agreements Implementation, Removal of Foreign National Review Requirements, and Information Security Updates2016-Sep-202016-21544The Bureau of Industry and Security (BIS) maintains, as part of its Export Administration Regulations (EAR), the Commerce Control List (CCL), which identifies certain items subject to Department of Commerce jurisdiction. This final rule revises the CCL, as well as corresponding parts of the EAR, to implement changes made to the Wassenaar Arrangement's List of Dual-Use Goods and Technologies (WA List) maintained and agreed to by governments participating in the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies (Wassenaar Arrangement, or WA) at the December 2015 WA Plenary Meeting (the Plenary). The Wassenaar Arrangement advocates implementation of effective export controls on strategic items with the objective of improving regional and international security and stability. This rule harmonizes the CCL with the changes made to the WA List at the Plenary by revising Export Control Classification Numbers (ECCNs) controlled for national security reasons in each category of the CCL, as well as making other associated changes to the EAR. The changes to the WA List include raising the Adjusted Peak Performance (APP) for high performance computers. The President's report for High Performance Computers was sent to Congress on June 1, 2016, to set forth the new APP in accordance with the National Defense Authorization Act (NDAA) for FY1998. This rule also makes changes to the EAR that were not agreed to at the WA Plenary. APP parameters are amended in several places in the EAR by this rule, such as APP parameters in the de minimis rules, License Exception APP, and related reporting requirements. BIS is also updating license requirements and policies associated with Category 5--Part 2, including revising Export Control Classification Numbers 5A992, 5D992 and 5E992. In addition, this rule removes the Foreign National Review requirement associated with deemed exports under License Exceptions APP and CIV.
Health and Human Services Department -- Adjustment of Civil Monetary Penalties for Inflation2016-Sep-062016-18680The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2016-Sep-012016-21031This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Health and Human Services Department -- Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment2016-Jul-142016-16637The Food and Drug Administration (FDA or Agency) is amending the Agency's regulations by removing certain regulations that include obsolete references. FDA is taking this action to improve the accuracy of the regulations.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2016-Jul-112016-16365This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite a Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act and also to remove one obsolete citation. This is a procedural rule that only updates authority paragraphs of the EAR to make them current and to avoid confusion. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Health and Human Services Department -- Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; Termination2016-Jun-092016-13705The Food and Drug Administration (FDA) is announcing the termination of the Transmissible Spongiform Encephalopathies Advisory Committee. This document removes the Transmissible Spongiform Encephalopathies Advisory Committee from the Agency's list of standing advisory committees.
Commerce Department -- Amendment to the Export Administration Regulations: Removal of Special Iraq Reconstruction License2016-Jun-072016-13397In this rule, the Bureau of Industry and Security (BIS) proposes to amend the Export Administration Regulations (EAR) to remove the Special Iraq Reconstruction License (SIRL) from the EAR. The action, if published in final form, would further the objectives of the Retrospective Regulatory Review Initiative that directs BIS and other federal agencies to streamline regulations and reduce unnecessary regulatory burdens on the public. Specifically, the SIRL is outdated and seldom used by exporters, who now have more efficient options for exports and reexports to Iraq and transfers (in-country) in Iraq. This rule also makes conforming changes.
Commerce Department -- Removal of Short Supply License Requirements on Exports of Crude Oil2016-May-122016-11047The Bureau of Industry and Security (BIS) publishes this final rule to amend the Export Administration Regulations (EAR) to remove the short supply license requirements that, prior to the entry into force of the ``Consolidated Appropriations Act, 2016'' on December 18, 2015, applied to exports of crude oil from the United States. Specifically, this rule removes the Commerce Control List (CCL) entry and the corresponding short supply provisions in the EAR that required a license from BIS to export crude oil from the United States. This rule also amends certain other EAR provisions to reflect the removal of these short supply license requirements. The changes made by this rule are intended to bring the provisions of the EAR into full compliance with the act, which mandates that, apart from certain exemptions specified therein, ``no official of the Federal Government shall impose or enforce any restriction on the export of crude oil.'' Consistent with the exceptions in the act, exports of crude oil continue to require authorization from BIS to embargoed or sanctioned countries or persons and to persons subject to a denial of export privileges.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Amendments to Special Enrollment Periods and the Consumer Operated and Oriented Plan Program2016-May-112016-11017This interim final rule with comment establishes provisions that alter the parameters of select special enrollment periods and that revise certain rules governing consumer operated and oriented plans (CO-OPs).
Health and Human Services Department -- Patient Engagement Advisory Committee2016-Mar-212016-06240The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to add the Patient Engagement Advisory Committee.
Health and Human Services Department -- Pharmaceutical Science and Clinical Pharmacology Advisory Committee2016-Mar-072016-04940The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. This action is being taken to reflect the change made to the charter for this advisory committee.
Commerce Department -- Updated Legal Authority Citations2016-Feb-292016-04324This rule updates the Code of Federal Regulations (CFR) legal authority citations in the National Security Industrial Base Regulations (NSIBR) and the Export Administration Regulations (EAR). The citation updates reflect recent editorial reclassifications within the United States Code, the repeal of certain statutory authorities, the continuation of an emergency declared in an executive order, and minor stylistic edits. This is a non-substantive rule that only updates legal authority paragraphs of the NSIBR and the EAR. It does not alter any right, obligation or prohibition that applies to any person under the NSIBR or the EAR.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2015-Dec-092015-30753This rule updates the Code of Federal Regulations (CFR) legal authority citations in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing an emergency declared pursuant to the International Emergency Economic Powers Act. This is a non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Nuclear Regulatory Commission -- Miscellaneous Corrections2015-Dec-012015-30153The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to make miscellaneous corrections. These changes include renaming the Office of Information Services, renaming the Computer Security Office and removing it as a standalone office, capitalizing the words Tribe, Tribes, and Tribal, correcting a Web site address, correcting a misspelling, removing a submission requirement, correcting an email address, correcting a room number, removing a Federal Register notice requirement, and adding missing information collection references. This document is necessary to inform the public of these non-substantive changes to the NRC's regulations.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations To Include Continuation of Emergency Declared in Executive Order 132242015-Oct-092015-25756This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing an emergency declared pursuant to the International Emergency Economic Powers Act. This is a non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations To Include August 7, 2015 Extension of Emergency Declared in Executive Order 132222015-Sep-022015-21683This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Commerce Department -- Export Administration Regulations: Removal of Special Comprehensive License Provisions2015-Aug-262015-20980In this final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by removing the Special Comprehensive License (SCL) authorization. Based on changes to the EAR as part of Export Control Reform, BIS concludes that the SCL has outlived its usefulness to the exporting public since recent changes to the EAR permit exporters to accomplish similar results using individual licenses and without undertaking the more onerous SCL application. This rule also makes conforming amendments. These changes are part of BIS's efforts to further update export controls under the EAR consistent with the Retrospective Regulatory Review Initiative that directs BIS and other federal agencies to streamline regulations and reduce unnecessary regulatory burdens on the public.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2015-May-222015-12453This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite a Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Health and Human Services Department -- Advisory Committee; Anti-Infective Drugs Advisory Committee2015-Apr-062015-07789The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Anti-Infective Drugs Advisory Committee. This action is being taken to change the name of this committee on the Agency's list of standing advisory committees.
Health and Human Services Department -- Advisory Committee; Antiviral Drugs Advisory Committee; Termination2015-Mar-202015-06425The Food and Drug Administration (FDA) is announcing the termination of the Antiviral Drugs Advisory Committee. This document removes the Antiviral Drugs Advisory Committee from the Agency's list of standing advisory committees.
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20162015-Feb-272015-03751This final rule sets forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also finalizes additional standards for the individual market annual open enrollment period for the 2016 benefit year, essential health benefits, qualified health plans, network adequacy, quality improvement strategies, the Small Business Health Options Program, guaranteed availability, guaranteed renewability, minimum essential coverage, the rate review program, the medical loss ratio program, and other related topics.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations To Include Presidential Notice of January 21, 20152015-Feb-182015-03318This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite a Presidential notice that extended an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2014-Dec-012014-28235This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20162014-Nov-262014-27858This proposed rule would set forth payment parameters and provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It would also provide additional standards for the annual open enrollment period for the individual market for benefit years beginning on or after January 1, 2016, essential health benefits, qualified health plans, network adequacy, quality improvement strategies, the Small Business Health Options Program, guaranteed availability, guaranteed renewability, minimum essential coverage, the rate review program, the medical loss ratio program, and other related topics.
Health and Human Services Department -- Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment2014-Nov-142014-26914The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Commerce Department -- Proposed Amendments to the Export Administration Regulations: Removal of Special Comprehensive License Provisions2014-Sep-302014-23078In this rule, the Bureau of Industry and Security (BIS) proposes to continue updating export controls under the Export Administration Regulations (EAR) consistent with the Retrospective Regulatory Review Initiative that directs BIS and other Federal Government Agencies to streamline regulations and reduce unnecessary regulatory burdens on the public. Specifically, in this rule, BIS proposes to amend the EAR by removing the Special Comprehensive License authorization. This rule also proposes conforming amendments.
Agriculture Department -- Process for Establishing Rates Charged for AMS Services2014-Sep-102014-21188The Agricultural Marketing Service (AMS) is proposing to amend its regulations to provide for a set of standardized formulas by which fees are calculated. The methodology used to calculate and implement the fees charged by AMS user-funded programs would be specified in the regulations. Currently, AMS publishes separate rules for each of the service fees it collects. The fees are calculated using formulas to account for all costs incurred by AMS in providing these services. Each year, fees would be announced in a notice in the Federal Register by June 1 and take effect at the start of the fiscal year, crop year, or as required by specific laws. This would provide greater transparency to the customers we serve as to how the fees are derived. The standardized formulas would be used to calculate fees that AMS charges for providing voluntary grading, inspection, certification, auditing and laboratory services for a variety of agricultural commodities including meat and poultry, fruits and vegetables, eggs, dairy products, and cotton and tobacco. The fees would also apply to those persons requesting such services including producers, handlers, processors, importers and exporters. Fees charged for inspection of fruits, vegetables, and specialty crops subject to the Agricultural Marketing Agreement Act of 1937 also would be affected by this rule. Provisions of this proposed rule would not supersede rates established by Memorandum of Understanding, Marketing Orders, or by cooperative agreements already in place. Furthermore, the cotton program would continue to consult with its industry before rates are established.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2014-Aug-292014-20674This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite the most recent Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Commerce Department -- Addition of Certain Persons to the Entity List2014-Jun-052014-13149This rule amends the Export Administration Regulations (EAR) by adding twenty-six persons under thirty-one entries to the Entity List (Supplement No. 4 to Part 744). The persons who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These persons will be listed on the Entity List under the destinations of China, Hong Kong, Lebanon and the United Arab Emirates (U.A.E.). There are thirty-one entries for twenty- six persons because five persons are listed under multiple countries, resulting in the additional five entries. Specifically, those five additional entries cover two persons in Lebanon who also have addresses in the U.A.E., and three persons in Hong Kong who also have addresses in China. In addition to the Entity List changes described above, this final rule updates the authority for part 730 (15 CFR part 730) because of the publication of the Notice of May 7, 2014, Continuation of the National Emergency With Respect to the Actions of the Government of Syria, which resulted in a change to the legal authority for part 730 of the EAR.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond2014-May-272014-11657This final rule addresses various requirements applicable to health insurance issuers, Affordable Insurance Exchanges (``Exchanges''), Navigators, non-Navigator assistance personnel, and other entities under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, the rule establishes standards related to product discontinuation and renewal, quality reporting, non-discrimination standards, minimum certification standards and responsibilities of qualified health plan (QHP) issuers, the Small Business Health Options Program, and enforcement remedies in Federally-facilitated Exchanges. It also finalizes: A modification of HHS's allocation of reinsurance collections if those collections do not meet our projections; certain changes to allowable administrative expenses in the risk corridors calculation; modifications to the way we calculate the annual limit on cost sharing so that we round this parameter down to the nearest $50 increment; an approach to index the required contribution used to determine eligibility for an exemption from the shared responsibility payment under section 5000A of the Internal Revenue Code; grounds for imposing civil money penalties on persons who provide false or fraudulent information to the Exchange and on persons who improperly use or disclose information; updated standards for the consumer assistance programs; standards related to the opt-out provisions for self-funded, non-Federal governmental plans and related to the individual market provisions under the Health Insurance Portability and Accountability Act of 1996 including excepted benefits; standards regarding how enrollees may request access to non- formulary drugs under exigent circumstances; amendments to Exchange appeals standards and coverage enrollment and termination standards; and time-limited adjustments to the standards relating to the medical loss ratio (MLR) program. The majority of the provisions in this rule are being finalized as proposed.
Health and Human Services Department -- Advisory Committee: Bone, Reproductive and Urologic Drugs Advisory Committee2014-Apr-112014-08151The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Advisory Committee for Reproductive Health Drugs. This action is being taken to reflect changes made to the charter for this advisory committee.
Commerce Department -- Proposed Revisions to the Support Document Requirements of the Export Administration Regulations in Response to Executive Order 13563 Retrospective Regulatory Review2014-Apr-092014-07918This rule proposes changes to support documents required to be submitted for license applications under the Export Administration Regulations (EAR) and changes to the Bureau of Industry and Security's (BIS's) role in issuing documents for the Import Certificate and Delivery Verification system. This proposed rule would remove the requirement to obtain an International Import Certificate or Delivery Verification in connection with license applications, require a Statement by Ultimate Consignee and Purchaser for most license applications previously requiring an International Import Certificate, and increase the license application value requirement for obtaining a Statement by Ultimate Consignee and Purchaser. In addition, BIS would cease issuing U.S. Import Certificates or Delivery Verifications for imports into the United States. Finally, this rule revises the structure and description of support document requirements to improve clarity. BIS is proposing these changes in response to public comments received in response to BIS's notice of inquiry on retrospective regulatory review being undertaken under Executive Order 13563.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond2014-Mar-212014-06134This proposed rule addresses various requirements applicable to health insurance issuers, Affordable Insurance Exchanges (``Exchanges''), Navigators, non-Navigator assistance personnel, and other entities under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, the rule proposes standards related to product discontinuation and renewal, quality reporting, non-discrimination standards, minimum certification standards and responsibilities of qualified health plan (QHP) issuers, the Small Business Health Options Program, and enforcement remedies in Federally-facilitated Exchanges. It also proposes: A modification of HHS's allocation of reinsurance contributions collected if those contributions do not meet our projections; certain changes to the ceiling on allowable administrative expenses in the risk corridors calculation; modifications to the way we calculate certain cost-sharing parameters so that we round those parameters down to the nearest $50 increment; certain approaches we are considering to index the required contribution used to determine eligibility for an exemption from the shared responsibility payment under section 5000A of the Internal Revenue Code; grounds for imposing civil money penalties on persons who provide false or fraudulent information to the Exchange and on persons who improperly use or disclose information; updated standards for the consumer assistance programs; standards related to the opt-out provisions for self-funded, non-Federal governmental plans and the individual market provisions under the Health Insurance Portability and Accountability Act of 1996; standards for recognition of certain types of foreign group health coverage as minimum essential coverage; amendments to Exchange appeals standards and coverage enrollment and termination standards; and time-limited adjustments to the standards relating to the medical loss ratio program.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Third Party Payment of Qualified Health Plan Premiums2014-Mar-192014-06031This interim final rule requires issuers of qualified health plans (QHPs), including stand-alone dental plans (SADPs), to accept premium and cost-sharing payments made on behalf of enrollees by the Ryan White HIV/AIDS Program, other Federal and State government programs that provide premium and cost sharing support for specific individuals, and Indian tribes, tribal organizations, and urban Indian organizations.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2014-Mar-192014-06030This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to cite a Presidential notice extending an emergency declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Homeland Security Department -- Removal of Federal Advisory Committee Act Regulations2014-Mar-132014-05442This final rule removes the regulations that implement the Federal Advisory Committee Act (FACA) for the Federal Emergency Management Agency (FEMA). FEMA's implementation of FACA is now governed by the rules promulgated by the General Services Administration (GSA) and by the policies issued by the Department of Homeland Security (DHS).
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20152014-Mar-112014-05052This final rule sets forth payment parameters and oversight provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also provides additional standards with respect to composite premiums, privacy and security of personally identifiable information, the annual open enrollment period for 2015, the actuarial value calculator, the annual limitation in cost sharing for stand-alone dental plans, the meaningful difference standard for qualified health plans offered through a Federally-facilitated Exchange, patient safety standards for issuers of qualified health plans, and the Small Business Health Options Program.
Health and Human Services Department -- Advisory Committee; Pharmacy Compounding Advisory Committee2014-Jan-132014-00322The Food and Drug Administration (FDA) is amending its regulations to update information regarding the Pharmacy Compounding Advisory Committee in FDA's Center for Drug Evaluation and Research in the Agency's list of standing advisory committees. This updated information regarding the Committee includes changes to its charter to reflect the recent enactment of the Drug Quality and Security Act.
Commerce Department -- Revisions to the Export Administration Regulations (EAR): Unverified List (UVL)2013-Dec-192013-30117The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) by: Requiring exporters to file an Automated Export System (AES) record for all exports subject to the EAR involving a party or parties to the transaction who are listed on the Unverified List (the ``Unverified List'' or UVL); suspending the availability of license exceptions for exports, reexports, and transfers (in-country) involving a party or parties to the transaction who are listed on the UVL; requiring exporters, reexporters, and transferors to obtain a UVL statement from a party or parties to the transaction who are listed on the UVL before proceeding with exports, reexports, and transfers (in-country) involving items subject to the EAR, but where the item does not require a license, i.e., No License Required (NLR); publishing the UVL in the EAR; and adding to the EAR the procedures to request removal or modification of a UVL entry. These changes to the UVL enhance the U.S. Government's ability to verify the bona fides of parties to exports, reexports, or transfers (in-country) of items subject to the EAR and provide the U.S. Government increased visibility into such exports, reexports, and transfers involving persons whose bona fides could not be verified.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2013-Dec-192013-30116This rule updates the Code of Federal Regulations (CFR) legal authority paragraphs in the Export Administration Regulations (EAR) to include the citations to five Presidential notices extending emergencies declared pursuant to the International Emergency Economic Powers Act. This is a procedural rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Maximizing January 1, 2014 Coverage Opportunities2013-Dec-172013-29918This interim final rule amends the date by which a qualified individual must select a qualified health plan (QHP) through any Exchange for an effective coverage date of January 1, 2014. This rule generally allows consumers to select a QHP until December 23, 2013, which is a change from the previously stated regulatory date of December 15, 2013, but permits State Exchanges to select a different date. It also establishes a related policy regarding the date by which a consumer needs to pay any applicable initial premium to ensure timely effectuation of coverage. This rule pertains to the individual market and Small Business Health Options Program in both the Federally- facilitated Exchanges and State Exchanges. This rule does not change the plan selection or premium payment dates for coverage offered outside of the Exchanges.
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20152013-Dec-022013-28610This proposed rule sets forth payment parameters and oversight provisions related to the risk adjustment, reinsurance, and risk corridors programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges. It also proposes additional standards with respect to composite rating, privacy and security of personally identifiable information, the annual open enrollment period for 2015, the actuarial value calculator, the annual limitation in cost sharing for stand-alone dental plans, the meaningful difference standard for qualified health plans offered through a Federally-facilitated Exchange, patient safety standards for issuers of qualified health plans, and the Small Business Health Options Program.
Health and Human Services Department -- Advisory Committee; Veterinary Medicine Advisory Committee; Termination2013-Nov-222013-27854The Food and Drug Administration (FDA) is announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 20142013-Oct-302013-25326This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, this final rule outlines financial integrity and oversight standards with respect to Affordable Insurance Exchanges, qualified health plan (QHP) issuers in Federally-facilitated Exchanges (FFEs), and States with regard to the operation of risk adjustment and reinsurance programs. It also establishes additional standards for special enrollment periods, survey vendors that may conduct enrollee satisfaction surveys on behalf of QHP issuers, and issuer participation in an FFE, and makes certain amendments to definitions and standards related to the market reform rules. These standards, which include financial integrity provisions and protections against fraud and abuse, are consistent with Title I of the Affordable Care Act. This final rule also amends and adopts as final interim provisions set forth in the Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 interim final rule, published in the Federal Register on March 11, 2013, related to risk corridors and cost-sharing reduction reconciliation.
Commerce Department -- Revisions to the Export Administration Regulations (EAR): Unverified List (UVL)2013-Sep-112013-21996The Bureau of Industry and Security (BIS) proposes to amend the Export Administration Regulations (EAR) by: requiring exporters to file an Automated Export System (AES) record for all exports subject to the EAR involving a party or parties to the transaction who are listed on the Unverified List (the ``Unverified List'' or UVL); suspending the availability of license exceptions for exports, reexports, and transfers (in-country) involving a party or parties to the transaction who are listed on the UVL; requiring exporters, reexporters, and transferors to obtain a UVL statement from a party or parties to the transaction who are listed on the UVL before proceeding with exports, reexports, and transfers (in-country) involving items subject to the EAR, but where the item does not require a license, i.e., No License Required (NLR); publishing the UVL in the EAR; and adding to the EAR the procedures to request removal or modification of a UVL entry. These proposed changes to the UVL enhance the U.S. Government's ability to verify the bona fides of parties to exports, reexports, or transfers (in-country) of items subject to the EAR and provide the U.S. Government increased visibility into such exports, reexports, and transfers involving persons whose bona fides could not be verified.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Program Integrity: Exchange, SHOP, and Eligibility Appeals2013-Aug-302013-21338This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, this final rule outlines Exchange standards with respect to eligibility appeals, agents and brokers, privacy and security, issuer direct enrollment, and the handling of consumer cases. It also sets forth standards with respect to a State's operation of the Exchange and Small Business Health Options Program (SHOP). It generally is finalizing previously proposed policies without change.
Transportation Department -- Advisory Committees (RRR)2013-Aug-082013-19087This final rule removes DOT's advisory committee regulations. The DOT is removing the regulations because they have been made obsolete by other laws, regulations, and agency procedures.
Health and Human Services Department -- Medicaid and Children's Health Insurance Programs: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment2013-Jul-152013-16271This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act. This final rule finalizes new Medicaid eligibility provisions; finalizes changes related to electronic Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices and delegation of appeals; modernizes and streamlines existing Medicaid eligibility rules; revises CHIP rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; and amends requirements for benchmark and benchmark- equivalent benefit packages consistent with sections 1937 of the Social Security Act (which we refer to as ``alternative benefit plans'') to ensure that these benefit packages include essential health benefits and meet certain other minimum standards. This rule also implements specific provisions including those related to authorized representatives, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also updates and simplifies the complex Medicaid premium and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities. It includes transition policies for 2014 as applicable.
Treasury Department -- Coverage of Certain Preventive Services Under the Affordable Care Act2013-Jul-022013-15866This document contains final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. These final regulations simplify and clarify the religious employer exemption. These final regulations also establish accommodations with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), as well as student health insurance coverage arranged by eligible organizations that are institutions of higher education. These regulations also finalize related amendments to regulations concerning Affordable Insurance Exchanges.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions2013-Jul-012013-15530This final rule implements certain functions of the Affordable Insurance Exchanges (``Exchanges''). These specific statutory functions include determining eligibility for and granting certificates of exemption from the individual shared responsibility payment described in section 5000A of the Internal Revenue Code. Additionally, this final rule implements the responsibilities of the Secretary of Health and Human Services, in coordination with the Secretary of the Treasury, to designate other health benefits coverage as minimum essential coverage by providing that certain coverage be designated as minimum essential coverage. It also outlines substantive and procedural requirements that other types of individual coverage must fulfill in order to be certified as minimum essential coverage.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Program Integrity: Exchange, SHOP, Premium Stabilization Programs, and Market Standards2013-Jun-192013-14540This proposed rule sets forth financial integrity and oversight standards with respect to Affordable Insurance Exchanges; Qualified Health Plan (QHP) issuers in Federally-facilitated Exchanges (FFEs); and States with regard to the operation of risk adjustment and reinsurance programs. It also proposes additional standards with respect to agents and brokers. These standards, which include financial integrity provisions and protections against fraud and abuse, are consistent with Title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program2013-Jun-042013-13149This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) related to the Small Business Health Options Program (SHOP). Specifically, this final rule amends existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and implements a transitional policy regarding employees' choice of qualified health plans (QHPs) in the SHOP.
Commerce Department -- Revisions to the Export Administration Regulations: Initial Implementation of Export Control Reform2013-Apr-162013-08352As part of the Export Control Reform (ECR) Initiative, the Bureau of Industry and Security (BIS), and the Directorate of Defense Trade Controls (DDTC), Department of State, have published multiple proposed amendments to the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR), respectively, to strengthen national security by fundamentally reforming the export control system. This final rule implements the initial ECR changes by adding a structure and related provisions to control munitions items that the President has determined no longer warrant export control on the U.S. Munitions List (USML) on the Commerce Control List (CCL), specifically aircraft, gas turbine engines, and related items. This rule is being published in conjunction with a Department of State rule that revises the USML so that upon the effective date of both rules, the USML and CCL and corresponding regulatory structures will be complementary. The revisions in this final rule are also part of Commerce's retrospective regulatory review plan under EO 13563, which Commerce completed in August 2011.
Health and Human Services Department -- Public Hearing Before a Public Advisory Committee; Technical Amendments2013-Mar-202013-06354The Food and Drug Administration (FDA) is amending its regulations regarding advisory committees to address minor technical changes and corrections to statutory citations. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program2013-Mar-112013-04952This proposed rule would implement provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) related to the Small Business Health Options Program (SHOP). Specifically, this proposed rule would amend existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and would implement a transitional policy regarding employees' choice of qualified health plans (QHPs) in the SHOP.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Amendments to the HHS Notice of Benefit and Payment Parameters for 20142013-Mar-112013-04904This interim final rule with comment builds upon standards set forth in the HHS Notice of Benefit and Payment Parameters for 2014, published elsewhere in this issue of the Federal Register. This document will adjust risk corridors calculations that would align the calculations with the single risk pool provision, and set standards permitting issuers of qualified health plans the option of using an alternate methodology for calculating the value of cost-sharing reductions provided for the purpose of reconciliation of advance payments of cost-sharing reductions.
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20142013-Mar-112013-04902This final rule provides detail and parameters related to: the risk adjustment, reinsurance, and risk corridors programs; cost-sharing reductions; user fees for Federally-facilitated Exchanges; advance payments of the premium tax credit; the Federally-facilitated Small Business Health Option Program; and the medical loss ratio program. Cost-sharing reductions and advance payments of the premium tax credit, combined with new insurance market reforms, are expected to significantly increase the number of individuals with health insurance coverage, particularly in the individual market. In addition, we expect the premium stabilization programs--risk adjustment, reinsurance, and risk corridors--to protect against the effects of adverse selection. These programs, in combination with the medical loss ratio program and market reforms extending guaranteed availability (also known as guaranteed issue) and prohibiting the use of factors such as health status, medical history, gender, and industry of employment to set premium rates, will help to ensure that every American has access to high-quality, affordable health insurance.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Health Insurance Market Rules; Rate Review2013-Feb-272013-04335This final rule implements provisions related to fair health insurance premiums, guaranteed availability, guaranteed renewability, single risk pools, and catastrophic plans, consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The final rule clarifies the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This final rule also amends the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under the federal rate review program, and revises the timeline for states to propose state- specific thresholds for review and approval by the Centers for Medicare & Medicaid Services (CMS).
Health and Human Services Department -- Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation2013-Feb-252013-04084This final rule sets forth standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this final rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This rule also finalizes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and amends regulations providing an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.
Treasury Department -- Coverage of Certain Preventive Services Under the Affordable Care Act2013-Feb-062013-02420This document proposes amendments to rules regarding coverage for certain preventive services under section 2713 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the Public Health Service Act requires coverage without cost sharing of certain preventive health services, including certain contraceptive services, in non-exempt, non-grandfathered group health plans and health insurance coverage. The proposed rules would amend the authorization to exempt group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) with respect to the requirement to cover contraceptive services. The proposed rules would also establish accommodations for group health plans established or maintained by eligible organizations (and group health insurance coverage offered in connection with such plans), including student health insurance coverage arranged by eligible organizations that are religious institutions of higher education. This document also proposes related amendments to regulations concerning excepted benefits and Affordable Insurance Exchanges.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions2013-Feb-012013-02139This proposed rule would implement certain functions of the Affordable Insurance Exchanges (``Exchanges''), consistent with title I of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These specific statutory functions include determining eligibility for and granting certificates of exemption from the shared responsibility payment for not maintaining minimum essential coverage as described in section 5000A of the Internal Revenue Code. Additionally, this proposed rule implements the responsibility of the Secretary of Health and Human Services, in coordination with the Secretary of the Treasury, to designate other health benefits coverage as minimum essential coverage by providing that certain coverage be designated as minimum essential coverage. It also outlines substantive and procedural requirements that other types of individual coverage must fulfill in order to be certified as minimum essential coverage under the Internal Revenue Code.
Health and Human Services Department -- Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 20142012-Dec-072012-29184This proposed rule provides further detail and parameters related to: the risk adjustment, reinsurance, and risk corridors programs; cost-sharing reductions; user fees for a Federally- facilitated Exchange; advance payments of the premium tax credit; a Federally-facilitated Small Business Health Option Program; and the medical loss ratio program. The cost-sharing reductions and advanced payments of the premium tax credit, combined with new insurance market reforms, will significantly increase the number of individuals with health insurance coverage, particularly in the individual market. The premium stabilization programs--risk adjustment, reinsurance, and risk corridors--will protect against adverse selection in the newly enrolled population. These programs, in combination with the medical loss ratio program and market reforms extending guaranteed availability (also known as guaranteed issue) protections and prohibiting the use of factors such as health status, medical history, gender, and industry of employment to set premium rates, will help to ensure that every American has access to high-quality, affordable health insurance.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation2012-Nov-262012-28362This proposed rule details standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this proposed rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This proposed rule also proposes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and an amendment which provides an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Health Insurance Market Rules; Rate Review2012-Nov-262012-28428This proposed rule would implement the Affordable Care Act's policies related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans. The proposed rule would clarify the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This proposed rule would also amend the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under section 2794 of the Public Health Service Act (PHS Act). It also revises the timeline for states to propose state-specific thresholds for review and approval by CMS.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2012-Sep-142012-22719This rule updates the Code of Federal Regulations legal authority citations for the Export Administration Regulations (EAR) to include the citations to the President's Notice of August 15, 2012-- Continuation of Emergency Regarding Export Control Regulations and the President's Notice of May 19, 2012--Continuation of the National Emergency With Respect to the Actions of the Government of Syria. It also adds a citation to Executive Order 13338 to the authority citations paragraph of part 746 of the EAR.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Data Collection To Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans2012-Jul-202012-17831This final rule establishes data collection standards necessary to implement aspects of section 1302 of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. This final rule also establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Data Collection To Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans2012-Jun-052012-13489This proposed rule would establish data collection standards necessary to implement aspects of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This proposed rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. A bulletin on HHS' intended benchmark approach to defining essential health benefits was published for comment on December 16, 2011, and we intend to pursue comprehensive rulemaking on essential health benefits in the future. This proposed rule would also establish a process for the recognition of accrediting entities for purposes of certification of qualified health plans.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers2012-Mar-272012-6125This final rule will implement the new Affordable Insurance Exchanges (``Exchanges''), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
Commerce Department -- Updated Statements of Legal Authority To Reflect Continuation of Emergency Declared in Executive Orders 12947 and 132242012-Feb-222012-4062This rule updates the Code of Federal Regulations (CFR) legal authority citations for the Export Administration Regulations (EAR) to replace citations to the President's Notice of January 13, 2011, Continuation of the National Emergency with Respect to Terrorists Who Threaten to Disrupt the Middle East Peace Process, with citations to the President's Notice of January 12, 2012, and add citations to the President's Notice of September 21, 2011, Continuation of the National Emergency With Respect to Persons Who Commit, Threaten to Commit, or Support Terrorism. These notices are the most recent such annual Presidential notices on those subjects. BIS is making these changes to keep the CFR's legal authority citations for the EAR current.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan (CO-OP) Program2011-Dec-132011-31864This final rule implements the Consumer Operated and Oriented Plan (CO-OP) program, which provides loans to foster the creation of consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges (Exchanges). The goal of this program is to create a new CO-OP in every State in order to expand the number of health plans available in the Exchanges with a focus on integrated care and greater plan accountability.
Commerce Department -- Updated Statements of Legal Authority To Reflect Continuation of Emergency Declared in Executive Order 129382011-Dec-092011-31687This rule updates the Code of Federal Regulations (CFR) legal authority citations for the Export Administration Regulations (EAR) to replace citations to the President's Notice of November 4, 2010, Continuation of Emergency Regarding Weapons of Mass Destruction, with citations to the President's Notice of November 9, 2011 on the same subject. BIS is making these changes to keep the CFR's legal authority citations for the EAR current.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2011-Sep-212011-24227This rule updates the Code of Federal Regulations legal authority citations for the Export Administration Regulations (EAR) to include the citation to the President's Notice of August 12, 2011-- Continuation of Emergency Regarding Export Control Regulations.
Health and Human Services Department -- Advisory Committee; Change of Name and Function; Technical Amendment2011-Aug-302011-22105The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Anesthetic and Life Support Drugs Advisory Committee. This action is being taken to reflect changes made to the charter for this advisory committee.
Health and Human Services Department -- Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment2011-Jul-292011-19064The Food and Drug Administration (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan (CO-OP) Program2011-Jul-202011-18342This proposed rule would implement the Consumer Operated and Oriented Plan (CO-OP) program, which provides loans to foster the creation of consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges (Exchanges). The purpose of this program is to create a new CO-OP in every State in order to expand the number of health plans available in the Exchanges with a focus on integrated care and greater plan accountability.
Commerce Department -- Proposed Revisions to the Export Administration Regulations (EAR): Control of Items the President Determines No Longer Warrant Control Under the United States Munitions List (USML)2011-Jul-152011-17846President Obama directed the Administration in August 2009 to conduct a broad-based review of the U.S. export control system in order to identify additional ways to enhance national security. Secretary of Defense Gates described in April 2010 the initial results of that effort and why fundamental reform of the U.S. export control system is necessary to enhance national security. The Departments of Commerce and State described in two December 2010 Advanced Notice of Proposed Rulemakings the Administration's general plans for reviewing and revising the two primary lists of controlled items--the Commerce Control List (CCL) and the United States Munitions List (USML)--to accomplish this objective by, inter alia, making the lists more ``positive,'' ``aligned,'' and ``tiered.'' This rule proposes a new regulatory construct for the transfer of items on the USML that, in accordance with section 38(f) of the Arms Export Control Act (AECA) (22 U.S.C. 2778(f)(1)), the President determines no longer warrant control under the AECA and that would be controlled under the Export Administration Regulations (EAR) once the congressional notification requirements of section 38(f) and corresponding amendments to the International Traffic in Arms Regulations (ITAR) (22 CFR parts 120-130) and its USML and the EAR and its CCL are completed. In addition to proposing a regulatory construct for transferring these items into the CCL, this rule proposes the transfer of an initial tranche of items from USML Category VII (Tanks and Military Vehicles) to the CCL. This rule also proposes amending the EAR to establish a process by which certain items moving from the USML to the CCL would be made eligible for License Exception Strategic Trade Authorization (STA), and proposes EAR amendments related to movement of USML items to the CCL, such as new definitions of relevant terms, including ``specially designed,'' ``end items,'' ``parts,'' and ``components.'' Finally, this notice proposes establishing a new holding Export Control Classification Number (ECCN) in which items that warrant a significant level of control, but are not otherwise classified on the CCL, may be temporarily placed.
Health and Human Services Department -- Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans2011-Jul-152011-17610This proposed rule would implement the new Affordable Insurance Exchanges (``Exchanges''), consistent with title I of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. A detailed Preliminary Regulatory Impact Analysis associated with this proposed rule is available at http://cciio.cms.gov under ``Regulations and Guidance.'' A summary of the aforementioned analysis is included as part of this proposed rule.
Commerce Department -- Paperwork Reduction Act: Updated List of Approved Information Collections and Removal of a Redundant Reporting Requirement2011-Jul-112011-17356This rule makes several technical amendments to the Export Administration Regulations (EAR). This rule corrects one omission of a publication date in the authority citation paragraph of part 730 of the Export Administration Regulations. It revises the address of the Bureau of Industry and Security's (BIS) Western Regional Office at two places in the EAR to reflect the recent relocation of that office. Additionally, this rule updates the table of authorized information collection control numbers in Supplement No. 1 to part 730 of the EAR to reflect consolidation of several authorizations relating to license exceptions and exclusions into a single authorization with a single control number. Finally, this rule removes a requirement to report to BIS certain exports of oil transported from the North Slope of Alaska over Federal rights-of-way granted pursuant to section 203 of the Trans-Alaska Pipeline Authorization Act because BIS can now obtain this information from the Automated Export System (AES).
Health and Human Services Department -- Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments2011-Jun-012011-13488The Food and Drug Administration (FDA) is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Commerce Department -- Implementation of Additional Changes From the Annual Review of the Entity List; Removal of Person Based on Removal Request2011-Apr-182011-9181This rule amends the Export Administration Regulations (EAR) to implement additional changes to the Entity List (Supplement No. 4 to part 744) on the basis of the annual review of the Entity List conducted by the End-User Review Committee (ERC). The ERC conducts the annual review to determine if any entities on the Entity List should be removed or modified. This rule implements the results of the annual review for entities located in Iran and the United Arab Emirates (U.A.E.). In addition to implementing changes from the annual review, this rule removes one person located in the United Kingdom (U.K.) from the Entity List. This person is being removed from the Entity List as a result of a request for removal submitted by that person, a review of information provided in the removal request in accordance with section 744.16 (Procedure for requesting removal or modification of an Entity List entity), and further review conducted by the End-User Review Committee's (ERC) member agencies. This rule makes a clarification to an existing entry located in China to accurately reflect the relationship between two aliases listed under that entry. The Entity List provides notice to the public that certain exports, reexports, and transfers (in-country) to entities identified on the Entity List require a license from the Bureau of Industry and Security and that availability of license exceptions in such transactions is limited. Lastly, this rule updates the Code of Federal Regulations (CFR) legal authority citations for parts 730 and 744 of the EAR.
Commerce Department -- Updated Statements of Legal Authority To Reflect Continuation of Emergency Declared in Executive Order 129382010-Dec-152010-31488This rule updates the Code of Federal Regulations (CFR) legal authority citations for the Export Administration Regulations (EAR) to replace citations to the President's Notice of November 6, 2009, Continuation of Emergency Regarding Weapons of Mass Destruction, with citation to the President's Notice of November 4, 2010 on the same subject. This rule also updates the authority citation for one executive order to reflect the compilation of that executive order into title 3 of the CFR. BIS is making these changes to keep the CFR's legal authority citations for the EAR current.
Health and Human Services Department -- Amendments to General Regulations of the Food and Drug Administration2010-Nov-302010-30040The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Health and Human Services Department -- Amendments to General Regulations of the Food and Drug Administration2010-Nov-302010-30039The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2010-Sep-022010-21957This rule updates the Code of Federal Regulations legal authority citations for the Export Administration Regulations (EAR) to include the citation to the President's Notice of August 12, 2010-- Continuation of Emergency Regarding Export Control Regulations.
Commerce Department -- Encryption Export Controls: Revision of License Exception ENC and Mass Market Eligibility, Submission Procedures, Reporting Requirements, License Application Requirements, and Addition of Note 4 to Category 5, Part 22010-Jun-252010-15072The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR or Regulations) to modify the requirements of License Exception ENC, ``Encryption Commodities, Software and Technology,'' and the requirements for qualifying an encryption item as mass market. BIS is also amending specific license requirements for encryption items. With respect to encryption products of lesser national security concern, this rule replaces the requirement to wait 30 days for a technical review before exporting such products and the requirement to file semi-annual post-export sales and distribution reports with a provision that allows immediate authorization to export and reexport these products after electronic submission to BIS of an encryption registration. A condition of this new authorization for less sensitive products is submission of an annual self-classification report on these commodities and software exported under License Exception ENC. With respect to most mass market encryption products, this rule similarly replaces the requirement to wait 30 days for a technical review before exporting and reexporting such products with a provision that allows immediate authorization to export and reexport these products after electronic submission to BIS of an encryption registration, subject to annual self-classification reporting for exported encryption products. Only a few categories of License Exception ENC and mass market encryption products will continue to require submission of a 30-day classification request. Encryption items that are more strictly controlled continue to be authorized for immediate export and reexport to most end-users located in close ally countries upon submission of an encryption registration and classification request to BIS. This rule also eases licensing requirements for the export and reexport of many types of technology necessary for the development and use of encryption products, except to countries subject to export or reexport license requirements for national security reasons or anti-terrorism reasons, or that are subject to embargo or sanctions. This rule also removes the requirement to file separate encryption classification requests (formerly encryption review requests) with both BIS and the ENC Encryption Request Coordinator (Ft. Meade, MD). BIS is also amending the EAR by implementing the agreements made by the Wassenaar Arrangement at the plenary meeting in December 2009 that pertained to ``information security'' items. This rule adds an overarching note to exclude particular products that use cryptography from being controlled as ``information security'' items. The addition of this note focuses ``information security'' controls on the use of encryption for computing, communications, networking and information security. This rule also makes additional changes throughout the EAR to harmonize it with the new note. This rule also replaces a note in ECCN 5A002 pertaining to personalized smart cards with a note pertaining to smart cards and smart readers/writers. As a result of this change, a definition is being removed from the EAR.
Commerce Department -- Updated Statements of Legal Authority To Reflect Continuation of Emergency Declared in Executive Order 12938 and Changes to the United States Code2009-Dec-249-30481This rule updates the Code of Federal Regulations (CFR) legal authority citations for the Export Administration Regulations (EAR) to replace citations to the President's Notice of November 10, 2008-- Continuation of Emergency Regarding Weapons of Mass Destruction with the President's Notice of November 6, 2009 on the same subject and to reflect the recodification of former 42 U.S.C app. 466c as 15 U.S.C 1824a. BIS is making these changes to keep the CFR legal authority citations for the EAR current.
Commerce Department -- Encryption Simplification Rule: Final2009-Oct-159-24697The Bureau of Industry and Security (BIS) published the interim final rule entitled ``Encryption Simplification'' on October 3, 2008 (73 FR 57495). This rule finalizes that rule, corrects errors published in the October 3, 2008 interim final rule, and resolves inconsistencies in that rule identified by the public.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2009-Sep-219-22677This rule updates the Code of Federal Regulations legal authority citations for the Export Administration Regulations (EAR) to include the citation to the President's Notice of August 13, 2009-- Continuation of Emergency Regarding Export Control Regulations.
Health and Human Services Department -- Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment2009-Aug-269-20485The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents requesting nominations for voting and non-voting membership on this committee. This document also amends the agency's regulations to add the Tobacco Products Scientific Advisory Committee (the committee) to the agency's list of standing advisory committees.
Health and Human Services Department -- Advisory Committee; Risk Communication Advisory Committee; Termination and Recharter2009-Jul-219-17218The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency's regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.
Commerce Department -- Revisions to License Requirements and License Exception Eligibility for Certain Thermal Imaging Cameras and Foreign Made Military Commodities Incorporating Such Cameras2009-May-229-11951This rule imposes a license requirement for certain exports and reexports of military commodities manufactured outside the United States that are not subject to the International Traffic in Arms Regulations, regardless of the level of U.S. origin content, if those military commodities incorporate certain thermal imaging cameras that are subject to the Export Administration Regulations. This rule also removes Commerce Control List (CCL) based export and reexport license requirements with respect to 36 destinations for certain thermal imaging cameras when they are not incorporated into military commodities and if they are not being exported or reexported to be embedded in a civil product. It imposes a semi-annual reporting requirement on the transactions from which it removes the CCL based license requirements. This rule limits use of License Exception APR for reexports of certain cameras controlled by Export Control Classification Number 6A003.b.4.b and certain foreign made military commodities incorporating such cameras. This rule imposes a license requirement for software used to increase the frame rate of certain cameras. BIS is making these changes in recognition of the emerging availability of these cameras around the world, the export licensing practices of other governments and the potential use of these cameras in military applications.
Commerce Department -- Export Administration Regulations: Authority Citations Updates and Technical Corrections2008-Dec-158-29604This rule revises the authority citation paragraphs for 14 parts of the Export Administration Regulations to include citations to the most recent presidential notices that extend authority for those parts or to remove an outdated citation or both. This rule also updates addresses, telephone numbers, procedures and a definition, removes some potentially confusing language, makes a necessary conforming change to one Export Control Classification Number (ECCN) and restores some language that was dropped during a Code of Federal Regulations compilation. BIS is making these changes to clarify the regulations and to provide accurate authority citations for the Code of Federal Regulations edition that is to be compiled as of January 1, 2009.
Commerce Department -- De Minimis U.S. Content in Foreign Made Items2008-Oct-018-23142The Department of Commerce is revising the provisions of the Export Administration Regulations (EAR) that pertain to foreign-made items that incorporate controlled U.S.-origin items, i.e., the EAR's ``de minimis'' rules. This rule amends the EAR to change the de minimis calculation for foreign produced hardware that is bundled with U.S.- origin software. This rule also clarifies the definition of `incorporate' as it is applied to the de minimis rules and to the medical statement of understanding. This rule also removes the requirement to submit a one-time report to the Bureau of Industry and Security for foreign-made software that incorporates U.S.-origin software. In addition, this rule revises the ``Steps for Using the EAR'' and General Prohibition Two with regard to the de minimis rules in order to reduce redundancies in the EAR and harmonize the provisions with other revisions made by this rule.
Commerce Department -- Authorization To Impose License Requirements for Exports or Reexports to Entities Acting Contrary to the National Security or Foreign Policy Interests of the United States2008-Aug-218-19102The Entity List (Supplement No. 4 to Part 744 of the Export Administration Regulations (EAR)) provides notice to the public that certain exports and reexports to parties identified on the Entity List require a license from the Bureau of Industry and Security (BIS) and that availability of License Exceptions in such transactions is limited. This rule expands the scope of reasons for adding parties to the Entity List. This rule also amends the EAR to state explicitly that a party listed on the Entity List has a right to request that its listing be removed or modified and sets procedures for addressing such requests.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2007-Nov-307-23249This rule updates the Code of Federal Regulations (CFR) legal authority citations for the Export Administration Regulations (EAR) to: Replace citations to the President's Notice of October 27, 2006-- Continuation of Emergency Regarding Weapons of Mass Destruction with the President's Notice of November 8, 2007 on the same subject, replace public law citations with United States Code citations, and remove outdated citations and to add one previously omitted citation. BIS is making these changes to keep the CFR legal authority citations for the EAR current and to comply with the Office of the Federal Register policy of using United States Code citations for statutory provisions that have been encoded into the United States Code. This rule makes no changes to the text of the EAR.
Commerce Department -- Updated Statements of Legal Authority for the Export Administration Regulations2007-Sep-057-17532This rule updates the Code of Federal Regulations legal authority citations for the Export Administration Regulations (EAR) to include the citation to the President's Notice of August 15, 2007-- Continuation of Emergency Regarding Export Control Regulations.
Health and Human Services Department -- Advisory Committee; Risk Communication Advisory Committee; Establishment2007-Jul-277-14498The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing advisory committees.
Commerce Department -- Updated Office Names, Office Addresses, Statements of Legal Authority and Statute Name and Citation2007-May-047-8582This rule revises office names and addresses to reflect a recent Bureau of Industry and Security (BIS) reorganization, updates the statements of legal authority for ten parts of the Export Administration Regulations (EAR), and replaces an outdated statute name and citation with the current name of that statute in one section of the EAR.
Commerce Department -- Revisions and Technical Correction to the Export Administration Regulations2007-Apr-247-7730This rule amends the Export Administration Regulations (EAR) by making a technical correction to the contact information for the Drug Enforcement Administration. In addition, this rule amends the EAR by making corrections inadvertently omitted in three rules previously published in the Federal Register: the August 31, 2006, final rule implementing the rescission of Libya's designation as a state sponsor of terrorism; the November 20, 2006, final rule imposing foreign policy controls on surreptitious communications intercepting devices; and the January 26, 2007, final rule imposing restrictions on exports and reexports of luxury goods to the Democratic People's Republic of Korea (North Korea).
Commerce Department -- Technical Corrections to the Export Administration Regulations and to the Defense Priorities and Allocations System (DPAS) Regulation2007-Jan-297-1336The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR), in Subchapter C, to remove an outdated reference to another agency's schedule that is no longer used by that other agency; to remove an outdated reference to another department's regulations and replace it with the department name and regulatory reference that is currently in use; to correct two references in the EAR that inadvertently directed the public to the wrong sections of the EAR for further information; and to correct contact information listed in the EAR for one (1) telephone number; one (1) fax number; one (1) e-mail address; and two (2) addresses to this rule adds an e-mail address, fax number, and address to clarify for the public where de minimis reports should be sent, when required by the EAR. BIS is also correcting a typographical error in a final rule published in the Federal Register on July 13, 2006 (71 FR 39526) that made administrative and technical corrections to the Defense Priorities and Allocations System (DPAS) Regulation (15 CFR part 700).
Commerce Department -- Imposition of Foreign Policy Controls on Surreptitious Communications Intercepting Devices2006-Nov-206-19509The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) by imposing new foreign policy export and reexport controls on devices primarily useful for the surreptitious interception of wire, oral, or electronic communications classified under Export Control Classification Number (ECCN) 5A980. In this rule, BIS also imposes controls on related software and technology by creating ECCNs 5D980 and 5E980. BIS is taking this action in order to prevent the unlawful interception of oral, wire, or electronic communications by terrorists and others who may put the information gained through intercepted communications to an unlawful use, to promote the protection of privacy of oral, wire, or electronic communications; and to protect against threats of terrorism around the world.
Commerce Department -- Implementation of New Formula for Calculating Computer Performance: Adjusted Peak Performance (APP) in Weighted TeraFLOPS; Bulgaria; XP and MT Controls2006-Apr-2406-3647This final rule amends the Export Administration Regulations to implement the Wassenaar Arrangement's December 2005 agreement to revise the formula for calculating computer performance from Composite Theoretical Performance (CTP) measured in Millions of Theoretical Operations Per Second (MTOPS) to Adjusted Peak Performance (APP) measured in Weighted TeraFLOPS (Trillion Floating point Operations Per Second) (WT). This rule also establishes new control levels in Category 4 of the Commerce Control List (CCL) expressed in WT. In addition, this rule renames License Exception CTP to License Exception APP (Adjusted Peak Performance) to correspond to the new formula. This rule also makes conforming changes to the EAR based on the new computer parameter, such as, revising the parameters for eligibility of License Exception APP. This rule also moves Bulgaria from Computer Tier 3 to Computer Tier 1, removes High Performance Computer (XP) and Missile Technology (MT) controls from certain Export Control Classification Numbers (ECCNs) in Category 4 of the CCL, and removes the section of the EAR dedicated to various requirements for high performance computers.
Civil Rights Commission -- Membership Requirement of State Advisory Committees2006-Feb-1706-1489This final rule revises the regulations of the United States Commission on Civil Rights to amend the State Advisory Committee membership criteria to ensure both diversity and nondiscrimination in the State Advisory Committee member appointment process.
Civil Rights Commission -- Membership Requirement of State Advisory Committees2005-Nov-0405-21986The United States Commission on Civil Rights proposes to amend its regulation on the SAC membership criteria to ensure both diversity and nondiscrimination are considered in its SAC member appointment process.
Commerce Department -- Editorial Corrections to the Export Administration Regulations2005-Mar-2205-5548This final rule amends the Export Administration Regulations to update a fax number and to update the list of information collections. The Paperwork Collection List identifies the control numbers assigned to information collection requirements under the Export Administration Regulations (EAR) by the Office of Management and Budget pursuant to the Paperwork Reduction Act. This action makes editorial corrections and updates and is not intended to have a substantive effect on the rights or obligations of the public.
Commerce Department -- Technical Corrections to the Export Administration Regulations2005-Feb-1805-3216This rule makes technical corrections to the Export Administration Regulations (EAR) by updating internal agency process matters, clarifying license exceptions, correcting citation errors and clarifying paperwork requirements. None of these technical corrections change the current interpretations or licensing requirements of the EAR.
Commerce Department -- Nomenclature Change: References to Another Agency2004-Oct-1204-22861The Export Administration Regulations (EAR) are amended to update certain references to the U.S. State Department's Directorate of Defense Trade Controls. The EAR contain references to this agency under its current name and under its former name, the Office of Defense Trade Controls. This amendment will remove the possibility that a member of the public might think that two different offices are being referenced.
Commerce Department -- Revisions and Clarifications to the Export Administration Regulations2004-Feb-0604-1737This rule amends the Export Administration Regulations (EAR) by making certain corrections and clarifications, including insertion of material inadvertently omitted from previous rules.
Commerce Department -- Export Administration Regulations: Encryption Clarifications and Revisions2003-Jun-1703-15189This rule amends the Export Administration Regulations (EAR) to clarify when encryption commodities and software may be given de minimis treatment, when short-range wireless devices incorporating encryption may be given mass market or retail treatment, and to provide guidance on when exporters are required to submit encryption review requests. It also expands the authorizations according to which travelers departing the United States may take encryption for their personal use, and clarifies that specially designed medical equipment and software are not controlled as encryption or ``information security'' items under the EAR. Finally this rule implements changes to the Wassenaar Arrangement List of dual-use items (agreed upon in the September 2002 meeting and finalized in December 2002) that eliminate from Export Control Classification Number (ECCN) 5A002 certain types of ``Personalized smart cards'' and equipment specially designed and limited to controlling access to copyright protected data.
Agriculture Department -- Flue-Cured Tobacco Advisory Committee; Amendment to Regulations2003-May-1303-11890The U.S. Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule that amended the regulations for the Flue-Cured Tobacco Advisory Committee (FCTAC) by removing the sections which specify composition of the committee. The interim final rule allowed greater flexibility in responding to changing marketing conditions.
Nuclear Regulatory Commission -- Federal Advisory Committee Act Regulations2002-Dec-3102-32954The Nuclear Regulatory Commission (NRC) is amending its regulations on the Federal Advisory Committee Act (FACA) to conform with General Services Administration regulations. In this final rule, the Commission clarifies its practices regarding Federal advisory committee exemptions from the FACA requirements.
Agriculture Department -- Tobacco Inspection; Mandatory Grading2002-Nov-1902-29031The U.S. Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule that amended the regulations to provide mandatory grading for kinds of tobacco approved by a majority of producers voting in the mandatory grading referenda and to reduce the fee for mandatory grading from $.01 per pound to $.009 per pound.
Nuclear Regulatory Commission -- NRC Public Document Room Address Change and Corrections to Information Collection Provisions2002-Nov-0402-27865The Nuclear Regulatory Commission (NRC) is amending its regulations to reflect the new address for the Public Document Room (PDR) and to correct information collection sections in the Code of Federal Regulations. These amendments are necessary to inform the public of these administrative changes to the NRC regulations.
Agriculture Department -- Flue-Cured Tobacco Advisory Committee; Amendment of Regulations2002-Oct-0102-24905The U.S. Department of Agriculture (USDA) is amending the regulations for the Flue-Cured Tobacco Advisory Committee (FCTAC) by removing the sections which specify composition of the committee. This will allow greater flexibility in responding to changing marketing conditions.
Commerce Department -- Revision to the Export Administration Regulations: Denied Persons List2002-Aug-2702-21596This rule removes references in the Export Administration Regulations (EAR) to the ``Denied Persons List'' maintained by the Bureau of Industry and Security because the list is described, but not published, in the Code of Federal Regulations, and is not intended to be legally controlling. This rule also makes a format change in the template of the standard denial order published in the EAR.
Nuclear Regulatory Commission -- Federal Advisory Committee Act Regulations2002-Aug-0802-19941The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations on the Federal Advisory Committee Act (FACA) to conform with newly issued General Services Administration regulations.
Agriculture Department -- Tobacco Inspection; Mandatory Grading2002-May-2302-12892Pursuant to the requirements of section 759 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for 2002 (Appropriations Act), referenda were conducted during the periods of March 11-15, 2002, and March 18-22, 2002, among producers of each type of tobacco eligible for price support. A majority of producers favored mandatory grading for flue-cured tobacco, types 11, 12, 13, 14; burley tobacco, type 31; Kentucky-Tennessee fire-cured tobacco, types 22 and 23; Virginia fire- cured tobacco, type 21; Virginia sun-cured tobacco, type 37; and dark air-cured tobacco, types 35 and 36. This interim final rule amends the regulations to provide mandatory grading for these types of tobacco. Producers of cigar filler and binder tobacco, types 42, 43, 44, 53, 54, and 55 did not approve mandatory grading. This rule will also reduce the fee for mandatory inspection from $0.01 per pound to $0.009 per pound.
Civil Rights Commission -- Operations, Functions, and Structure of Civil Rights Commission2002-Apr-1002-7925The United States Commission on Civil Rights proposes to revise its regulations to provide the organizational structure, procedures, and program processes of the Commission.
Agriculture Department -- Tobacco Inspection; Producer Referenda on Mandatory Grading2002-Mar-0502-5228This rule establishes procedures which the U.S. Department of Agriculture (USDA) will use in conducting a referenda among producers of each kind of tobacco that is eligible for price support to determine whether they favor mandatory grading of that kind of tobacco. Currently, tobacco that is not sold at auction is not subject to mandatory grading.
Agriculture Department -- Tobacco Inspection; Producer Referenda on Mandatory Grading2002-Feb-0102-2403This proposed rule would establish procedures for referenda among producers of each kind of tobacco that is eligible for price support to determine whether they favor the mandatory grading of that kind of tobacco. Currently, tobacco that is not sold at auction is not subject to mandatory grading.
Labor Department -- Advisory Committees2002-Jan-0702-122The Occupational Safety and Health Administration (OSHA) is amending its rules governing membership on advisory committees to clarify that the Secretary has the discretion to remove and replace an advisory committee member at any time. The advisory committee rules, including the rules dealing with the tenure of members, are rules of agency organization, practice, or procedure, for which public notice and comment are not required.
Agriculture Department -- Tobacco Inspection; Growers' Referendum Results2001-Oct-1901-26393This document contains the determination with respect to the referendum on the merger of Fairmont-Fair Bluff, North Carolina and Loris, South Carolina, to become the consolidated market of Fairmont- Fair Bluff-Loris. A mail referendum was conducted during the period of June 4-8, 2001, among tobacco growers who sold tobacco on these markets in 2000 to determine producer approval/disapproval of the designation of these markets as one consolidated market. Therefore, for the 2001 and succeeding flue-cured marketing seasons, the Fairmont-Fair Bluff, North Carolina and Loris, South Carolina, tobacco markets shall be designated as Fairmont-Fair Bluff-Loris. The regulations are amended to reflect this new designated market.
General Services Administration -- Federal Advisory Committee Management2001-Jul-1901-17350The General Services Administration (GSA) is revising Federal Property Management Regulations (FPMR) coverage on Federal advisory committee management and moving it into the Federal Management Regulation (FMR). A cross-reference is added to the FPMR to direct readers to the coverage in the FMR. The FMR coverage is written in plain language to provide agencies with updated regulatory material that is easy to read and understand. This action is necessary due to legislative and policy changes that have occurred, and judicial decisions that have been issued since the regulation was last updated. It is based also on suggestions for improvement from other Federal agencies and interested parties, and clarifies how the regulation applies or does not apply to certain situations.
Agriculture Department -- Tobacco Fees and Charges for Permissive Inspection and Certification; Fee Revisions2001-May-2301-12935This rule revises the fee structure and increases fees for domestic permissive inspection and grading of tobacco. Under the Tobacco Inspection Act, fees collected must cover, as nearly as practicable, the Department's costs for performing the inspection service, including administrative and supervisory costs. The fee for permissive inspection of tobacco at receiving points will be based upon poundage and will be set at the same rate as for mandatory inspection at auction, which is $.01 per pound. The fee for permissive inspection at redrying plants will continue to be on an hourly basis and will be increased by about 46 percent. These revisions do not affect the fee for the mandatory inspection of tobacco sold at designated auction markets or permissive export certification.
Health and Human Services Department -- Revision of Administrative Practices and Procedures; Meetings and Correspondence; Public Calendars2001-Jan-2201-1566The Food and Drug Administration (FDA) is amending its regulations relating to meetings, correspondence, and the agency's public calendar. This action makes FDA's procedures more concise and understandable to the public, minimizes confusion about publicly available information concerning agency meetings, provides for more effective disclosure of such information, and allows the FDA to reallocate resources to areas of more urgent public health need.
Health and Human Services Department -- Public Hearing Before a Public Advisory Committee; Examination of Administrative Record and Other Advisory Committee Records2001-Jan-0801-390The Food and Drug Administration (FDA) is proposing to amend its administrative regulations governing the public disclosure of written information for consideration by an advisory committee at an advisory committee meeting. This action would amend the regulations to state that written information for consideration by an advisory committee at a committee meeting is available for public disclosure, whenever practicable, before or at the time of the meeting. FDA is proposing this action to reflect current FDA policy in conformance with applicable law. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Health and Human Services Department -- Public Hearing Before a Public Advisory Committee; Examination of Administrative Record and Other Advisory Committee Records2001-Jan-0801-389The Food and Drug Administration (FDA) is amending its administrative regulations governing the public disclosure of written information for consideration by an advisory committee at an advisory committee meeting. This action amends the regulations to state that the written information for consideration by an advisory committee at a committee meeting is available for public disclosure, whenever practicable, before or at the time of the meeting. FDA is taking this action to reflect current FDA policy in conformance with applicable law. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule.
Health and Human Services Department -- Administrative Practices and Procedures; Good Guidance Practices2000-Sep-1900-23887The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The Modernization Act codified certain parts of the agency's current ``Good Guidance Practices'' (GGP's) and directed the agency to issue a regulation consistent with the act that specifies FDA's policies and procedures for the development, issuance, and use of guidance documents. The intended effect of this regulation is to make the agency's procedures for development, issuance, and use of guidance documents clear to the public.
Federal Communications Commission -- Public Safety 700 MHz Band2000-Aug-2500-21579In this Fourth Notice of Proposed Rulemaking (4thNPRM), the Commission proposes rules concerning various technical and operational issues regarding the use of interoperability frequencies in the 764-776 MHz and 794-806 MHz frequency bands (the 700 MHz band). Previously, the Commission charged the Public Safety National Coordination Committee (NCC) with preparing a report on the technical and operational standards for interoperability frequencies in the 700 MHz band. The NCC issued its report to the Commission on February 25, 2000. The Commission seeks comment on the rules proposed in response to recommendations contained in the NCC's report.
Agriculture Department -- Tobacco Inspection2000-Jul-2700-18963The Department of Agriculture (Department) is adopting as a final rule, the regulations for flue-cured tobacco to more accurately describe tobacco as it presently appears at the marketplace. The revision will add a new provision to the official grade standards for flue-cured tobacco to denote that any lot of baled tobacco that has not been opened for inspection be graded by the exterior only. Additional bale dimensions and space requirements will be established for uniform marketing display in the warehouses, and a revision will be made in the poundage adjustment for a warehouse selling in excess of the sales schedule for designated and undesignated producer tobacco.
Commerce Department -- Parties to a Transaction and Their Responsibilities, Routed Export Transactions, Shipper's Export Declarations, the Automated Export System (AES), and Export Clearance2000-Jul-1000-16894The Bureau of Export Administration is revising the Export Administration Regulations (EAR) to clarify the responsibilities of parties to export and reexport transactions, the filing and use of Shipper's Export Declarations, Destination Control Statement requirements, and other export clearance issues. In addition, this rule adds information about the scope and requirements for the Automated Export System (AES) Option 4 provision.
Commerce Department -- Easing of Export Restrictions on North Korea2000-Jun-1900-15168The Bureau of Export Administration (BXA) is amending the Export Administration Regulations (EAR) to implement the President's statement of September 17, 1999 easing sanctions against North Korea. The United States is taking this action in order to pursue improved overall relations.
Agriculture Department -- Tobacco Inspection; Subpart B-Regulations2000-Jun-1200-14730The Agricultural Marketing Service (AMS) is adopting, as a final rule, with changes, an interim final rule revising the regulations governing permissive inspection of tobacco that special tests and services be provided by AMS, as requested by the industry. This action incorporates recommendations made by the Burley Tobacco Advisory Committee and the buying segment of the tobacco industry that moisture testing be performed by AMS on all burley tobacco marketed during the 1999-2000 marketing season. The revisions will continue to provide regulatory authority to conduct moisture testing and collect fees and charges for these services.
Agriculture Department -- Tobacco Fees and Charges for Mandatory Inspection; Fee Increase2000-May-2600-13290The Tobacco Inspection Act requires the Secretary to fix and collect fees and charges for inspection and certification, and other services, including administrative and supervisory costs, at designated tobacco auction markets in all tobacco producing areas. The fees collected must, as nearly as possible, cover the Department's costs of performing these services and also maintain a reserve sufficient to cover program financial liabilities. This interim final rule will increase the fee from $.0083 to $.0100 per pound to cover the increased cost of operating the tobacco inspection program and maintain the operating reserve. The last increase in the fee was in 1995. This increase does not affect the fees for import, export, or permissive tobacco inspection.
Agriculture Department -- Tobacco Inspection; Subpart B-Regulations2000-Apr-1300-9173The Department of Agriculture (Department) is adopting as a final rule, with minor formatting changes, the provisions of an interim final rule, the regulation governing the mandatory inspection of tobacco that added the term ``purchaser'' specifically to include in the regulatory text this segment of the industry from attempting to influence, impede, or discuss any matter related to grading while the tobacco inspectors are grading tobacco on the auction warehouse floor and removed the language allowing the producer to discuss the grading of their tobacco with the inspector at the time grading is being performed. This rule incorporates recommendations made by the Flue- Cured Tobacco Advisory Committee, the Five-State Flue-Cured Tobacco Committee, and industry representatives to clarify when it is allowable for someone to communicate with the grading personnel while they are performing their actual duties. The revisions better eliminate interference, distraction, and outside influence on the grading of tobacco.
Agriculture Department -- Tobacco Inspection2000-Mar-1500-6318The Department is proposing to revise the regulations for flue-cured tobacco to more accurately describe tobacco as it presently appears at the marketplace. The revision would add a new provision to the official grade standards for flue-cured tobacco to denote that any lot of baled tobacco that has not been opened for inspection would be graded by the exterior only. Additional bale dimensions and space requirements would be established for uniform marketing display in the warehouses. To take into account the marketing of bales, a revision would also be necessary in the poundage adjustment for a warehouse selling in excess of the sales schedule and for undesignated producer tobacco.
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