42 CFR 71.2 - Penalties.
(a) Persons in violation of this part are subject to a fine of no more than $100,000 if the violation does not result in a death or one year in jail, or both, or a fine of no more than $250,000 if the violation results in a death or one year in jail, or both, or as otherwise provided by law. (b) Violations by organizations are subject to a fine of no more than $200,000 per event if the violation does not result in a death or $500,000 per event if the violation results in a death or as otherwise provided by law.
Title 42 published on 14-Sep-2017 03:57
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 71 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-14393 RIN 0920-AA63 Docket No. CDC-2016-0068 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule; correcting amendments. These correcting amendments are effective July 10, 2017. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-03042 RIN 0920-AA63 Docket No. CDC-2016-0068 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule; delay of effective date. The effective date of the final rule amending 42 CFR parts 70 and 71 published January 19, 2017 (82 FR 6890) is delayed to March 21, 2017. 42 CFR Parts 70 and 71 The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces a change in the effective date of the final rule titled “Control of Communicable Diseases” that was published on January 19, 2017. This action is undertaken in accordance with the memorandum of January 20, 2017 from the Assistant to the President and Chief of Staff entitled “Regulatory Freeze Pending Review.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-00615 RIN 0920-AA63 CDC Docket No. CDC-2016-0068 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule. This rule is effective February 21, 2017. 42 CFR Parts 70 and 71 The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments have been made to aid public health responses to outbreaks of new or re-emerging communicable diseases and to accord due process to individuals subject to Federal public health orders. In response to public comment received, the updated provisions in this final rule clarify various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate.
GPO FDSys XML | Text type regulations.gov FR Doc. 2016-18103 RIN 0920-AA63 CDC Docket No. CDC-2016-0068 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Notice of Proposed Rulemaking (NPRM). Written or electronic comments on the NPRM must be received by October 14, 2016. Paperwork Reduction Act Public Comments: Submit written or electronic comments by October 14, 2016. Please see the Paperwork Reduction Act section for instructions on how to submit comments. 42 CFR Parts 70 and 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-04136 RIN 0920-AA12 Docket No. CDC-2012-0017 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (HHS/CDC) Confirmation of effective date of direct final rule. The Direct Final Rule published at 77 FR 75939, December, 26, 2012, becomes effective on February 25, 2013. 42 CFR Part 71 The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on December 26, 2012 (77 FR 75939).
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-04131 RIN 0920-AA12 Docket No. CDC-2012-0017 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (HHS/CDC) Notice of proposed rulemaking; withdrawal. The Notice of Proposed Rulemaking published at 77 FR 75939, December 26, 2012, is withdrawn, effective immediately. 42 CFR Part 71 The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that solicited public comment on updates to the Scope and Definitions for its regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-03064 RIN 0920-AA23 Docket No. HHS/CDC-2011-0001 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule. This final rule is effective April 16, 2013. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-02825 RIN 0920-AA47 Docket No. CDC-2012-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule. This final rule is effective on March 14, 2013. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-02391 RIN 0920-AA37 Docket No. CDC-2011-0007 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Final rule. The final rule is effective April 5, 2013. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-30723 RIN 0920-AA12 Docket No. CDC-2012-0017 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (HHS/CDC) Direct Final Rule and request for comments. The direct final rule is effective on February 25, 2013 unless significant adverse comment is received by January 25, 2013. If we receive no significant adverse comments within the specified comment period, we intend to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this DFR ends. If we receive any timely significant adverse comment, we will withdraw this final rule in part or in whole by publication of a document in the Federal Register within 30 days after the comment period ends. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-30725 RIN 0920-AA12 Docket No. CDC-2012-0017 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (HHS/CDC) Notice of Proposed Rulemaking and request for comments. Submit written or electronic comments by January 25, 2013. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-14603 RIN 0920-AA47 Docket No. CDC-2012-0003 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (HHS/CDC) Correcting amendment. This action is effective June 15, 2012. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-2843 RIN 0920-AA47 Docket No. CDC-2012-0003 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Direct final rule and request for comments. The direct final rule is effective on March 12, 2012 unless significant adverse comment is received by April 10, 2012. If we receive no significant adverse comment within the specified comment period, we intend to publish a notice confirming the effective date of the final rule in the Federal Register within 30 days after the end of the comment period on this direct final rule. If we receive any timely significant adverse comment, we will withdraw this final rule in part or in whole by publication of a notice in the Federal Register within 30 days after the comment period ends. 42 CFR Part 71 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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-2841 RIN 0920-AA47 Docket No. CDC-2012-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC) Notice of Proposed Rulemaking and request for comments. Submit written or electronic comments by April 10, 2012. 42 CFR Part 71 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.