Communicable Diseases

communicable-diseases
TitleActionFR DocPublishedAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgency NameExcerptsAbstractHTMLPDF
Control of Communicable Diseases; CorrectionRule2017-1439307/10/2017Health and Human Services DepartmentThe Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces technical corrections to the final rule (82 FR 6890) published on January 19, 2017. These technical corrections remove … The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces technical corrections to the final rule (82 FR 6890) published on January 19, 2017. These technical corrections remove grammatical errors, remove a reference to reports of deaths or illness by ``radio,'' change regulatory text to match previously updated and approved language, and amend a reporting date for a retrospective review so that the date does not coincide with a Federal holiday.control-of-communicable-diseases-correctionFR-Doc-2017-14393
Control of Communicable DiseasesProposed Rule2016-1810308/15/2016Health and Human Services DepartmentThrough this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is amending its domestic (interstate) and foreign quarantine regulations … Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is amending its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments are being proposed to aid public health responses to outbreaks of communicable diseases such as the largest recorded outbreak of Ebola virus disease (Ebola) in history, the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and repeated outbreaks and responses to measles in the United States, as well as the ongoing threat of other new or re-emerging communicable diseases. The provisions contained herein provide additional clarity to various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate.control-of-communicable-diseasesFR-Doc-2016-18103
Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Technical AmendmentsRule2015-3210101/20/2016Health and Human Services DepartmentThis document contains technical amendments to HHS regulations regarding Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The regulatory content is being amended to add information t … This document contains technical amendments to HHS regulations regarding Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The regulatory content is being amended to add information that was erroneously omitted, to include updated cross-references within HHS' regulations, and to make grammatical corrections.federal-awarding-agency-regulatory-implementation-of-office-of-management-and-budgets-uniformFR-Doc-2015-32101
Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation ActRule2014-1302306/05/2014Health and Human Services DepartmentThe Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the G … The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule.establishing-a-list-of-qualifying-pathogens-under-the-food-and-drug-administration-safety-andFR-Doc-2014-13023
Turtles Intrastate and Interstate RequirementsRule2013-1775107/25/2013Health and Human Services DepartmentThe Food and Drug Administration (FDA) is amending its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches t … The Food and Drug Administration (FDA) is amending its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches to remove procedures for destruction as FDA believes it is not necessary to routinely demand this destruction to achieve the purpose of the regulations. This action will reduce the need for investigator training and the time for the care and humane destruction of these animals.turtles-intrastate-and-interstate-requirementsFR-Doc-2013-17751
Turtles Intrastate and Interstate RequirementsProposed Rule2013-1775207/25/2013Health and Human Services DepartmentThe Food and Drug Administration (FDA) is proposing to amend its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than … The Food and Drug Administration (FDA) is proposing to amend its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches to remove procedures for destruction as FDA believes it is not necessary to routinely demand this destruction to achieve the purpose of the regulations. This action would reduce the need for investigator training and the time for the care and humane destruction of these animals.turtles-intrastate-and-interstate-requirementsFR-Doc-2013-17752
Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation ActProposed Rule2013-1386506/12/2013Health and Human Services DepartmentThe Food and Drug Administration (FDA or Agency) is proposing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. The proposed rule would implement a provisio … The Food and Drug Administration (FDA or Agency) is proposing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. The proposed rule would implement a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. FDA is proposing that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule describes the factors we considered and the methodology we used to develop this list of qualifying pathogens.establishing-a-list-of-qualifying-pathogens-under-the-food-and-drug-administration-safety-andFR-Doc-2013-13865
Control of Communicable Disease; Foreign-Requirements for Importers of Nonhuman Primates (NHP)Rule2013-0306402/15/2013Health and Human Services DepartmentThe Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by extending existing requirements for … The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of Macaca fascicularis (cynomolgus), Chlorocebus aethiops (African green), and Macaca mulatta (rhesus) monkeys to all NHPs with the exception of the filovirus testing requirement. Filovirus testing will only be required for Old World NHPs in quarantine that have illness consistent with filovirus infection or that die for any reason other than trauma during quarantine. HHS/CDC is also finalizing a provision to reduce the frequency at which importers of cynomolgus, African green, and rhesus monkeys are required to renew their special permits (from every 180 days to every 2 years). HHS/CDC is incorporating existing guidelines into the regulations and adding new provisions to address the following: NHPs imported as part of an animal act; NHPs imported or transferred by zoological societies; the transfer of NHPs from approved laboratories; and non-live imported NHP products. Finally, HHS/CDC is also requiring that all NHPs be imported only through ports of entry where a HHS/CDC quarantine station is located.control-of-communicable-disease-foreign-requirements-for-importers-of-nonhuman-primates-nhpFR-Doc-2013-03064
Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver SamplesRule2013-0282502/12/2013Health and Human Services DepartmentThe Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by establishing a user fee for filov … The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by establishing a user fee for filovirus testing of all nonhuman primates that die during the HHS/CDC-required 31-day quarantine period for any reason other than trauma. We are amending the regulations to establish a filovirus testing service at HHS/CDC, because testing is no longer being offered by the only private, commercial laboratory that previously performed these tests. This testing service will be funded through user fees.establishment-of-user-fees-for-filovirus-testing-of-nonhuman-primate-liver-samplesFR-Doc-2013-02825
Foreign Quarantine; Import Regulations for Infectious Biological Agents, Infectious Substances, and VectorsRule2013-0239102/04/2013Health and Human Services DepartmentThe Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is issuing this final rule amending the regulations regarding the importation of infectious biological agents, infectious sub … The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is issuing this final rule amending the regulations regarding the importation of infectious biological agents, infectious substances, and vectors. The amendments improve HHS/CDC's ability to prevent the introduction, transmission, or spread of communicable diseases into the United States.foreign-quarantine-import-regulations-for-infectious-biological-agents-infectious-substances-andFR-Doc-2013-02391
Control of Communicable Diseases: Foreign; Scope and DefinitionsRule2012-3072312/26/2012Health and Human Services DepartmentThrough this Direct Final Rule, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is updating and reorganizing the Scope and Definitions for foreign quarantine regula … Through this Direct Final Rule, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is updating and reorganizing the Scope and Definitions for foreign quarantine regulations and add a new section to contain definitions for Importations. This Direct Final Rule (DFR) will update the scope and definitions to reflect modern terminology and plain language used globally by industry and public health partners. As part of the update, we are updating five existing definitions; adding thirteen new definitions to help clarify existing provisions; creating a new scope and definitions section for Importations under a new section by reorganizing existing definitions into this new section; and updating regulations to reflect the language used by the most recent Executive Order regarding quarantinable communicable diseases.control-of-communicable-diseases-foreign-scope-and-definitionsFR-Doc-2012-30723
Control of Communicable Diseases: Interstate; Scope and DefinitionsProposed Rule2012-3072612/26/2012Health and Human Services DepartmentIn this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update the definitions for interstate quarantine reg … In this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update the definitions for interstate quarantine regulations to reflect modern terminology and plain language used by private industry and public health partners. These updates will not affect current practices. As part of the update, we are updating two existing definitions and adding eight new definitions to clarify existing provisions, as well as updating regulations to reflect the most recent Executive Order addressing quarantinable communicable diseases.control-of-communicable-diseases-interstate-scope-and-definitionsFR-Doc-2012-30726
Control of Communicable Diseases: Foreign; Scope and DefinitionsProposed Rule2012-3072512/26/2012Health and Human Services DepartmentThrough this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update and reorganize the Scope and Defi … Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update and reorganize the Scope and Definitions for foreign quarantine regulations and add a new section to contain definitions for Importations. This NPRM proposes to update the Scope and Definitions to reflect modern terminology and plain language used globally by industry and public health partners. As part of the proposed updates, we are updating five existing definitions; adding thirteen new definitions to help clarify existing provisions; creating a new scope and definitions section for Importations under a new section by reorganizing existing definitions into this new section; and updating regulations to reflect the language used by the most recent Executive Order regarding quarantinable communicable diseases.control-of-communicable-diseases-foreign-scope-and-definitionsFR-Doc-2012-30725
Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver SamplesRule2012-1460306/15/2012Health and Human Services DepartmentOn February 10, 2012, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) published a Direct Final Rule (DFR) that solicited public comment on the establishment of user fees fo … On February 10, 2012, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) published a Direct Final Rule (DFR) that solicited public comment on the establishment of user fees for filovirus testing of all nonhuman primates that die during the HHS/CDC-required 31-day quarantine period for any reason other than trauma. That document incorrectly listed the effective date as March 12, 2012. On February 10, 2012, HHS/CDC also published in the Federal Register a companion Notice of Proposed Rulemaking (NPRM) (77 FR 7109) that proposed identical filovirus testing and user fee requirements. In both the DFR and NPRM, HHS/CDC indicated that if it did not receive any significant adverse comments by April 10, 2012, it would publish a document in the Federal Register withdrawing the NPRM and confirming the effective date of the DFR within 30 days after the end of the comment period. Because of the error in effective date the DFR took effect prior to the expiration of the comment period. Because of this error and due to receiving significant adverse public comments, HHS/CDC is amending 42 CFR 71.53 by removing paragraph (j) which will have the same effect as the withdrawal of the DFR. HHS/CDC will carefully review the comments received on the notice of proposed rulemaking published on February 10, 2012.establishment-of-user-fees-for-filovirus-testing-of-nonhuman-primate-liver-samplesFR-Doc-2012-14603
Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver SamplesRule2012-284302/10/2012Health and Human Services DepartmentThrough this Direct Final Rule, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is establishing a user fee for filovirus testing of all nonhuman primates that … Through this Direct Final Rule, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is establishing a user fee for filovirus testing of all nonhuman primates that die during HHS/CDC-required 31- day quarantine period for any reason other than trauma. We are amending regulations to establish a filovirus testing service at HHS/CDC because testing is no longer being offered by the only private, commercial laboratory that previously performed these tests. This testing service will be funded through user fees. The direct final rule does not impose any new burdens on the regulated community because the testing of non- human primates for filovirus is a long-standing requirement and the amount of the user fee is consistent with the amount previously charged commercially. HHS/CDC is therefore publishing a direct final rule because it does not expect to receive any significant adverse comment and believes that the establishment of an HHS/CDC testing program and imposition of user fees are non-controversial. However, in this Federal Register, HHS/CDC is simultaneously publishing a companion notice of proposed rulemaking that proposes identical filovirus testing and user fee requirements. If HHS/CDC does not receive any significant adverse comment on this direct final rule within the specified comment period, it will publish a notice in the Federal Register confirming the effective date of this final rule within 30 days after the comment period on the direct final rule ends and withdraw the notice of proposed rulemaking. If HHS/CDC receives any timely significant adverse comment, it will withdraw the direct final rule in part or in whole by publication of a document in the Federal Register within 30 days after the comment period ends and proceed with notice and comment under the notice of proposed rulemaking published elsewhere in this issue of the Federal Register. A significant adverse comment is one that explains: Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or why the direct final rule will be ineffective or unacceptable without a change.establishment-of-user-fees-for-filovirus-testing-of-nonhuman-primate-liver-samplesFR-Doc-2012-2843
Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver SamplesProposed Rule2012-284102/10/2012Health and Human Services DepartmentThrough this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to establish a user fee for filovirus testing of al … Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to establish a user fee for filovirus testing of all nonhuman primates that die during the HHS/ CDC-required 31-day quarantine period for any reason other than trauma. We propose to establish a filovirus testing service at HHS/CDC because testing is no longer being offered by the only private, commercial laboratory that previously performed these tests. This testing service will be funded through user fees. Elsewhere in this issue of the Federal Register, HHS/CDC is simultaneously publishing a companion direct final rule that proposes identical filovirus testing and user fee requirements in this Federal Register because it believes that these requirements are non-controversial and unlikely to generate significant adverse comment. If HHS/CDC does not receive any significant adverse comment on the direct final rule within the specified comment period, it will publish a notice in the Federal Register withdrawing this notice of proposed rulemaking and confirming the effective date of the direct final rule within 30 days after the end of the comment period on the direct final rule. If HHS/CDC receives any timely significant adverse comment, it will withdraw the direct final rule in part or in whole by publication of a notice in the Federal Register within 30 days after the comment period ends and proceed with notice and comment under this notice of proposed rulemaking. A significant adverse comment is one that explains: Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or why the direct final rule will be ineffective or unacceptable without a change.establishment-of-user-fees-for-filovirus-testing-of-nonhuman-primate-liver-samplesFR-Doc-2012-2841
Foreign Quarantine; Etiological Agents, Hosts, and VectorsProposed Rule2011-2665610/14/2011Health and Human Services DepartmentThe Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to revise the regulations that cover the importation of etiolog … The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to revise the regulations that cover the importation of etiological agents and the hosts and vectors of human disease. The changes are proposed to improve CDC's ability to prevent the introduction, transmission, or spread of communicable diseases into the United States.foreign-quarantine-etiological-agents-hosts-and-vectorsFR-Doc-2011-26656
Requirements for Importers of Nonhuman PrimatesProposed Rule2010-3292201/05/2011Health and Human Services DepartmentCDC is proposing to amend its regulations for the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of Macaca fascicularis (cynomolgus), Chlorocebus aethiops (African green), and Maca … CDC is proposing to amend its regulations for the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of Macaca fascicularis (cynomolgus), Chlorocebus aethiops (African green), and Macaca mulatta (rhesus) monkeys to all NHPs. Filovirus testing will continue to be required only for Old World NHPs. CDC also is proposing to reduce the frequency at which importers of cynomolgus, African green, and rhesus monkeys are required to renew their registrations, (from every 180 days to every two years). CDC proposes to incorporate existing guidelines into the regulations and add new provisions to address: NHPs imported as part of a trained animal act; NHPs imported or transferred by zoological societies; The transfer of NHPs from approved laboratories; and Non-live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located.requirements-for-importers-of-nonhuman-primatesFR-Doc-2010-32922
Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other AnimalsRuleE8-2077909/08/2008Health and Human Services DepartmentThe Food and Drug Administration (FDA) is removing its regulation that established restrictions on the capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals. … The Food and Drug Administration (FDA) is removing its regulation that established restrictions on the capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals. We are removing the restrictions because we believe they are no longer needed to prevent the further introduction, transmission, or spread of monkeypox, a communicable and potentially fatal disease, in the United States.https://www.federalregister.gov/documents/2008/09/08/E8-20779/control-of-communicable-diseases-restrictions-on-african-rodents-prairie-dogs-and-certain-otherFR-Doc-E8-20779
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing UseProposed RuleE7-2156511/08/2007Health and Human Services DepartmentThe Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current pr … The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.https://www.federalregister.gov/documents/2007/11/08/E7-21565/requirements-for-human-blood-and-blood-components-intended-for-transfusion-or-for-furtherFR-Doc-E7-21565
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