Federal Register - January 13, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules January 20, 2021 to read January 21, 2021.
DEPARTMENT OF EDUCATION
34 CFR Part 300
FR Doc. C1202028117 Filed 11221; 8:45 am
Docket ID ED2020OSERS0191
BILLING CODE 130100D
Proposed Guidance; Questions and Answers on Serving Children With Disabilities Placed by Their Parents in Private Schools
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Correction In proposed rule document 2020
27872 appearing on pages 8299482995
in the issue of Monday, December 21, 2020, make the following correction:
1 On page 82994, in the third column, in the DATES section, change January 20, 2021 to read January 21, 2021.
FR Doc. C1202027872 Filed 11221; 8:45 am BILLING CODE 130100D
ENVIRONMENTAL PROTECTION
AGENCY
EPAR07OAR20200620; FRL10017
81Region 7
Air Plan Approval; Missouri; Removal of Control of Emissions From Solvent Cleanup Operations Correction In proposed rule document 2020
28121 appearing on pages 82995
through 82998 in the issue of Monday, December 21, 2020, make the following correction:
1 On page 82995, in the second column, in the DATES section, change January 20, 2021 to read January 21, 2021.
FR Doc. C1202028121 Filed 11221; 8:45 am BILLING CODE 130100D
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
EPAHQOPP20200053; FRL1001693
Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities October 2020
Correction In proposed rule document 2020
28117 appearing on pages 82998
through 83000 in the issue of Monday, December 21, 2020, make the following correction:
1 On page 82998, in the second column, in the DATES section, change
17:44 Jan 12, 2021
Jkt 253001
RIN 0991AC15
Establishment of Safeguards and Program Integrity Requirements for Health and Human Services-Funded Extramural Research Involving Human Fetal Tissue Office of the Secretary, Department of Health and Human Services.
ACTION: Notice of proposed rulemaking.
AGENCY:
This is a notice of proposed rulemaking to amend certain regulatory provisions in order to adopt or strengthen safeguards and program integrity requirements applicable to extramural research involving human fetal tissue from elective abortions.
DATES: Comments must be submitted on or before February 12, 2021.
ADDRESSES: Comments must be identified by RIN 0991AC15. Because of staff and resource limitations, comments must be submitted electronically to www.regulations.gov.
Follow the Submit a comment instructions.
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including personally identifiable or confidential business information that is included in a comment. Before or after the close of the comment period, the Department of Health and Human Services will post all comments that were received before the end of the comment period on www.regulations.gov. Follow the search instructions on that website to view the public comments.
FOR FURTHER INFORMATION CONTACT:
Daniel Barry at daniel.barry@hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
40 CFR Part 52
VerDate Sep<11>2014
45 CFR Parts 46 and 75
I. Introduction In September 2018, the Department of Health and Human Services HHS
terminated a contract that provided human fetal tissue from elective abortions to the Food and Drug Administration FDA for the development of testing protocols. HHS
terminated the contract because it was
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not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.
HHS subsequently initiated a comprehensive review of all HHS
research involving human fetal tissue from elective abortions to ensure consistency with the statutes and regulations governing such research and to ensure the adequacy of procedures and oversight in light of the serious regulatory, moral, and ethical considerations involved.
Promoting the dignity of human life from conception to natural death is one of the top priorities of President Trumps administration. The audit and review informed the policy process that led to the administrations decision, announced June 5, 2019,1 to discontinue National Institutes of Health NIH
intramural researchresearch conducted within NIH by NIH
researchersinvolving the use of human fetal tissue from elective abortion. With respect to extramural research research conducted outside of, but funded by, NIH, e.g., at universities, the administration announced that, for new extramural research grant applications or current research projects in the competitive renewal process generally every five years that propose to use fetal tissue from elective abortions and that are recommended for potential funding through NIHs twolevel external scientific review process, an ethics advisory board will be convened to review the research proposal and recommend whether, in light of the ethical considerations, NIH
should fund the research project pursuant to a law passed by Congress 42 U.S.C 289a1.
In the same policy statement, HHS
announced that it would also undertake changes to its regulations and to NIH
grants policy to adopt or strengthen safeguards and program integrity requirements applicable to extramural research involving human fetal tissue from elective abortions.2 In this notice of proposed rulemaking, HHS proposes revisions to its Human Research Subjects Protection Regulations 45 CFR
part 46, subpart B, Additional Protections for Pregnant Women, Human Fetuses, and Neonates and its 1 See Statement from the Department of Health and Human Services, June 5, 2019, available at https www.hhs.gov/about/news/2019/06/05/
statement-from-the-department-of-health-andhuman-services.html.
2 See Statement from the Department of Health and Human Services, June 5, 2019, available at https www.hhs.gov/about/news/2019/06/05/
statement-from-the-department-of-health-andhuman-services.html.
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