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Federal Register/Vol. 86, No. 8/Wednesday, January 13, 2021

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Federal Register/Vol. 86, No. 8/Wednesday, January 13, 2021 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules 2615 DEPARTMENT OF EDUCATION ‘‘January 20, 2021’’ to read ‘‘January 21, not sufficiently assured that the contract 2021.’’ included the appropriate protections 34 CFR Part 300 [FR Doc. C1–2020–28117 Filed 1–12–21; 8:45 am] applicable to fetal tissue research or met all other procurement requirements. [Docket ID ED–2020–OSERS–0191] BILLING CODE 1301–00–D HHS subsequently initiated a Proposed Guidance; Questions and comprehensive review of all HHS Answers on Serving Children With DEPARTMENT OF HEALTH AND research involving human fetal tissue Disabilities Placed by Their Parents in HUMAN SERVICES from elective abortions to ensure Private Schools consistency with the statutes and Office of the Secretary regulations governing such research and Correction to ensure the adequacy of procedures In proposed rule document 2020– 45 CFR Parts 46 and 75 and oversight in light of the serious regulatory, moral, and ethical 27872 appearing on pages 82994–82995 RIN 0991–AC15 in the issue of Monday, December 21, considerations involved. 2020, make the following correction: Establishment of Safeguards and Promoting the dignity of human life (1) On page 82994, in the third Program Integrity Requirements for from conception to natural death is one column, in the DATES section, change Health and Human Services-Funded of the top priorities of President ‘‘January 20, 2021’’ to read ‘‘January 21, Extramural Research Involving Human Trump’s administration. The audit and 2021.’’ Fetal Tissue review informed the policy process that led to the administration’s decision, [FR Doc. C1–2020–27872 Filed 1–12–21; 8:45 am] AGENCY: Office of the Secretary, announced June 5, 2019,1 to discontinue BILLING CODE 1301–00–D Department of Health and Human National Institutes of Health (NIH) Services. intramural research—research ACTION: Notice of proposed rulemaking. conducted within NIH by NIH ENVIRONMENTAL PROTECTION researchers—involving the use of AGENCY SUMMARY: This is a notice of proposed human fetal tissue from elective rulemaking to amend certain regulatory abortion. With respect to extramural 40 CFR Part 52 provisions in order to adopt or research (research conducted outside of, [EPA–R07–OAR–2020–0620; FRL–10017– strengthen safeguards and program but funded by, NIH, e.g., at universities), 81–Region 7] integrity requirements applicable to the administration announced that, for extramural research involving human new extramural research grant Air Plan Approval; Missouri; Removal fetal tissue from elective abortions. applications or current research projects of Control of Emissions From Solvent DATES: Comments must be submitted on in the competitive renewal process Cleanup Operations or before February 12, 2021. (generally every five years) that propose to use fetal tissue from elective Correction ADDRESSES: Comments must be identified by RIN 0991–AC15. Because abortions and that are recommended for In proposed rule document 2020– of staff and resource limitations, potential funding through NIH’s two- 28121 appearing on pages 82995 comments must be submitted level external scientific review process, through 82998 in the issue of Monday, electronically to www.regulations.gov. an ethics advisory board will be December 21, 2020, make the following Follow the ‘‘Submit a comment’’ convened to review the research correction: instructions. proposal and recommend whether, in (1) On page 82995, in the second Inspection of Public Comments: All light of the ethical considerations, NIH column, in the DATES section, change comments received before the close of should fund the research project— ‘‘January 20, 2021’’ to read ‘‘January 21, the comment period are available for pursuant to a law passed by Congress 2021.’’ viewing by the public, including (42 U.S.C 289a–1). [FR Doc. C1–2020–28121 Filed 1–12–21; 8:45 am] personally identifiable or confidential In the same policy statement, HHS BILLING CODE 1301–00–D business information that is included in announced that it would also undertake a comment. Before or after the close of changes to its regulations and to NIH the comment period, the Department of grants policy to adopt or strengthen ENVIRONMENTAL PROTECTION Health and Human Services will post all safeguards and program integrity AGENCY comments that were received before the requirements applicable to extramural end of the comment period on research involving human fetal tissue 40 CFR Part 180 www.regulations.gov. Follow the search from elective abortions.2 In this notice [EPA–HQ–OPP–2020–0053; FRL–10016–93] instructions on that website to view the of proposed rulemaking, HHS proposes public comments. revisions to its Human Research Receipt of Several Pesticide Petitions FOR FURTHER INFORMATION CONTACT: Subjects Protection Regulations (45 CFR Filed for Residues of Pesticide Daniel Barry at [email protected]. part 46, subpart B, Additional Chemicals in or on Various SUPPLEMENTARY INFORMATION: Protections for Pregnant Women, Commodities (October 2020) Human Fetuses, and Neonates) and its I. Introduction Correction In September 2018, the Department of 1 See Statement from the Department of Health and Human Services, June 5, 2019, available at In proposed rule document 2020– Health and Human Services (HHS) https://www.hhs.gov/about/news/2019/06/05/ 28117 appearing on pages 82998 terminated a contract that provided statement-from-the-department-of-health-and- through 83000 in the issue of Monday, human fetal tissue from elective human-services.html. December 21, 2020, make the following abortions to the Food and Drug 2 See Statement from the Department of Health and Human Services, June 5, 2019, available at correction: Administration (FDA) for the https://www.hhs.gov/about/news/2019/06/05/ (1) On page 82998, in the second development of testing protocols. HHS statement-from-the-department-of-health-and- column, in the DATES section, change terminated the contract because it was human-services.html. VerDate Sep<11>2014 17:44 Jan 12, 2021 Jkt 253001 PO 00000 Frm 00034 Fmt 4702 Sfmt 4702 E:\FR\FM\13JAP1.SGM 13JAP1 2616 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules grants regulations (45 CFR part 75) to research is conducted in accordance Since the Common Rule was first provide additional safeguards with those principles. In 1979, the developed, the landscape of research concerning the use of such tissue in National Commission published activities has changed dramatically, HHS-funded research. This proposed ‘‘Ethical Principles and Guidelines for accompanied by a marked increase in rule would strengthen informed consent the Protection of Human Subjects of the volume of research. It is estimated requirements in Subpart B and help Research,’’ also known as the Belmont that total spending on health-related ensure compliance with the statutory Report (http://www.hhs.gov/ohrp/ research and development by the drug ban on the provision of valuable policy/belmont.html). The Belmont industry and the Federal government consideration for human fetal tissue Report identified three fundamental has more than tripled since 1990.5 through clarifying recordkeeping and ethical principles for all human subjects While traditional biomedical research maintenance requirements for the research: Respect for persons, conducted in academic medical centers acquisition of human fetal tissue for beneficence, and justice. Like the continues to flourish, many studies are research. Nuremberg Code and Helsinki now also conducted at community hospitals, outpatient clinics, or II. Background Declaration, the Belmont Report stressed the importance of obtaining physician-based practices. Clinical U.S. Federal regulations governing the informed consent before engaging in research is regularly conducted at protection of human subjects in research human subjects research. multiple institutions across the U.S. and have been in existence for more than Based on the Belmont Report and other countries. Recruitment firms, three decades. Nearly thirty years have other work of the National Commission, bioinformatics specialists, clinical trial passed since the ‘‘Common Rule’’ was HHS revised and expanded its coordinating centers, protocol adopted by 15 U.S. Federal departments regulations for the protection of human developers, data analysts, contract and agencies in an effort to promote subjects in the late 1970s and early research organizations (CROs), data and uniformity, understanding, and 1980s. The HHS regulations are codified safety monitoring boards, community- compliance with human subject at 45 CFR part 46, subparts A through based organizations, and other entities protections. (HHS adopted the Common E: have joined investigators and sponsors Rule in Subpart A of 45 CFR part 46.) • Subpart A: Basic HHS Policy for as part of the clinical research The history of contemporary human Protection of Human Research enterprise. subjects protections began in 1947 with Subjects The rapid growth and expansion of the Nuremberg Code, developed for the • Subpart B: Additional Protections for human subjects research generated Nuremberg Military Tribunal as Pregnant Women, Human Fetuses, many questions about whether the standards by which to judge the human and Neonates Involved in Research regulatory framework is adequate and experimentation conducted by the • Subpart C: Additional Protections appropriate for the protection of human 3 Nazis. The Nuremberg Code set forth Pertaining to Biomedical and subjects
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