Establishment of Safeguards and Program Integrity Requirements for Health and Human Services-Funded Extramural Research Involving Human Fetal Tissue

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Office of the Secretary 45 CFR Parts 46 and 75 RIN 0991-AC15 AGENCY: Office of the Secretary, Department of Health and Human Services. ACTION: Notice of proposed rulemaking. SUMMARY: 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 0991-AC15. 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: I. Introduction In September 2018, the Department of Health and Human Services (HHS) terminated a contract that provided human fetal tis…