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Notice2015-150342015-06-18

Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV

Health and Human Services Department, National Institutes of Health

Abstract

The HOPE Act requires the Secretary of Health and Human Services (the Secretary) to develop and publish criteria for research involving transplantation of HIV-infected (HIV+) donor organs in HIV+ recipients. The goals of these criteria are, first, to ensure that research using organs from HIV+ donors is conducted under conditions protecting the safety of research participants and the general public; and second, that the results of this research provide a basis for evaluating the safety of solid organ transplantation (SOT) from HIV+ donors to HIV+ recipients. The National Institutes of Health (NIH), U.S. Department of Health and Human Services, invites the public to submit comments regarding the proposed HOPE Act criteria.

Action & Dates

Action
Notice of availability and request for comments.
Dates
To ensure that comments will be considered, comments must be received no later than 5:00 p.m. on August 17, 2015.

Public Comment

Comments Close
2015-08-17

Document Excerpt

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 National Institutes of Health AGENCY: National Institutes of Health, Department of Health and Human Services. ACTION: Notice of availability and request for comments. SUMMARY: The HOPE Act requires the Secretary of Health and Human Services (the Secretary) to develop and publish criteria for research involving transplantation of HIV-infected (HIV+) donor organs in HIV+ recipients. The goals of these criteria are, first, to ensure that research using organs from HIV+ donors is conducted under conditions protecting the safety of research participants and the general public; and second, that the results of this research provide a basis for evaluating the safety of solid organ transplantation (SOT) from HIV+ donors to HIV+ recipients. The National Institutes of Health (NIH), U.S. Department of Health and Human Services, invites the public to submit comments regarding the proposed HOPE Act criteria. DATES: To ensure that comments will be considered, comments must be received no later than 5:00 p.m. on August 17, 2015. ADDRESSES: Comments may be submitted by any of the following methods: Email: HOPEAct@mail.nih.gov . Fax: 301-451-5671. Regular Mail: Dr. Jonah Odim, 5601 Fishers Lane, Room 6B21, MSC 9827, Bethesda, MD 20892-9827. Hand Delivery, Overnight Mail, FedEx, and UPS: Dr. Jonah Odim, 5601 Fishers Lane, Room 6B21, MSC 9827, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Dr. Jonah Odim, 240-627-3540. SUPPLEMENTARY INFORMATION: The

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Full Document

Citation: 80 FR 34912