2018-22167. Charter Renewal of the Secretary's Advisory Committee on Human Research Protections

AGENCY:

Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

The U.S. Department of Health and Human Services (HHS) is hereby giving notice that the charter for the Secretary's Advisory Committee on Human Research Protections (SACHRP) has been renewed.

FOR FURTHER INFORMATION CONTACT:

Julia Gorey, J.D., Designated Federal Official, Executive Director, SACHRP, U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: [phone]; fax: [phone]; email address: [e-mail]. Additional information is available on the SACHRP website at https://www.hhs.gov/​ohrp/​sachrp-committee/​index.html.

SUPPLEMENTARY INFORMATION:

SACHRP is a discretionary advisory committee established under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects within the authority of HHS.

SACHRP is authorized to establish subcommittees to provide assistance for accomplishing its mission and currently maintains two subcommittees. The Subpart A Subcommittee (SAS) was established by SACHRP in October 2006 and is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment. The Subcommittee on Harmonization (SOH) was established by SACHRP at its July 2009 meeting and charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination.

On September 25, 2018, the Secretary approved renewal of the Committee's charter. The new charter was effected and filed with the appropriate Congressional committees and the Library of Congress on October 1, 2018. Renewal of the Committee's charter gives the Committee authorization to operate until October 1, 2020.

A copy of the Committee's charter is available on the Committee's website at https://www.hhs.gov/​ohrp/​sachrp-committee/​charter/​index.html.

A copy of the charter can also be obtained by accessing the Federal Advisory Committee Act database that is managed by the Committee Management Secretariat under the General Services Administration. The website for the FACA database is https://facadatabase.gov.

Dated: September 28, 2018.

Julia G. Gorey,

Executive Director, Secretary's Advisory Committee on Human Research Protections.