83 FR 51465 - Charter Renewal of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 197 (October 11, 2018)

Page Range		51465-51466
FR Document		2018-22167

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.

Federal Register, Volume 83 Issue 197 (Thursday, October 11, 2018)

[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Pages 51465-51466]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Charter Renewal of the Secretary's Advisory Committee on Human 
Research Protections

AGENCY: Office of the Assistant Secretary for Health, Office of the

[[Page 51466]]

Secretary, Department of Health and Human Services.

ACTION: Notice.

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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: 240-453-8141; fax: 240-453-6909; email address: 
SACHRP@hhs.gov. 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.
[FR Doc. 2018-22167 Filed 10-10-18; 8:45 am]
 BILLING CODE 4150-36-P

Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices 51465

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB control
Title of collection approval
number expires

New Animal Drugs for Investigational Use .............................................................................................................. 0910–0117 8/31/2021
Guidance for Industry and FDA Staff, Class II Special Controls: Automated Blood Cell Separator Device Oper-
ating by Centrifugal or Filtration Separation Principle ......................................................................................... 0910–0594 8/31/2021
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Man-
ufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements ... 0910–0608 8/31/2021
Prescription Drug Advertisements ........................................................................................................................... 0910–0686 8/31/2021
Survey of the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types 0910–0744 8/31/2021
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products ................. 0910–0759 8/31/2021
Food and Cosmetic Export Certificate Applications Process .................................................................................. 0910–0793 8/31/2021
Guidance for Industry: Medical Product Communications That are Consistent With the Food and Drug Admin-
istration Required Labeling—Questions and Answers ........................................................................................ 0910–0856 8/31/2021
Guidance for Industry: Drug and Device Manufacturer Communications with Payors, Formulary Committees,
and Similar Entities Questions and Answers ....................................................................................................... 0910–0857 8/31/2021
Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear
Pharmacies, Federal Facilities, and Certain Other Entities ................................................................................. 0910–0858 8/31/2021
Drug Supply Chain Security Act Pilot Program ....................................................................................................... 0910–0859 8/31/2021
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional and Retail Food Stores
and Facility Types (2015–2025) .......................................................................................................................... 0910–0799 9/30/2021

Dated: October 4, 2018. MD 20993–0002, 301–796–9001, email: member, selected by the Commissioner
Leslie Kux, AMDAC@fda.hhs.gov. or designee, who is identified with
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: Pursuant consumer interests and is recommended
[FR Doc. 2018–22101 Filed 10–10–18; 8:45 am] to 41 CFR 102–3.65 and approval by the by either a consortium of consumer-
BILLING CODE 4164–01–P Department of Health and Human oriented organizations or other
Services pursuant to 45 CFR part 11 and interested persons. In addition to the
by the General Services Administration, voting members, the Committee may
DEPARTMENT OF HEALTH AND FDA is announcing the renewal of the include one non-voting member who is
HUMAN SERVICES Antimicrobial Drugs Advisory identified with industry interests.
Committee. The committee is a Further information regarding the
Food and Drug Administration discretionary Federal advisory most recent charter and other
committee established to provide advice information can be found at https://
[Docket No. FDA–2018–N–3323] to the Commissioner. www.fda.gov/AdvisoryCommittees/
The Antimicrobial Drugs Advisory CommitteesMeetingMaterials/Drugs/
Advisory Committee; Antimicrobial Committee advises the Commissioner or Anti-InfectiveDrugsAdvisoryCommittee/
Drugs Advisory Committee, Renewal designee in discharging responsibilities ucm094132.htm or by contacting the
as they relate to helping to ensure safe Designated Federal Officer (see FOR
AGENCY: Food and Drug Administration,
and effective drugs for human use and, FURTHER INFORMATION CONTACT). In light
HHS.
as required, any other product for which of the fact that no change has been made
ACTION:Notice; renewal of advisory the Food and Drug Administration has to the committee name or description of
committee. regulatory responsibility. duties, no amendment will be made to
The Committee reviews and evaluates 21 CFR 14.100.
SUMMARY: The Food and Drug
available data concerning the safety and This document is issued under the
Administration (FDA) is announcing the
effectiveness of marketed and Federal Advisory Committee Act (5
renewal of the Antimicrobial Drugs
investigational human drug products for U.S.C. app.). For general information
Advisory Committee by the
use in the treatment of infectious related to FDA advisory committees,
Commissioner of Food and Drugs (the
diseases and disorders and makes please check https://www.fda.gov/
Commissioner). The Commissioner has
appropriate recommendations to the AdvisoryCommittees/default.htm.
determined that it is in the public
Commissioner of Food and Drugs. Dated: October 4, 2018.
interest to renew the Antimicrobial
The Committee shall consist of a core Leslie Kux,
Drugs Advisory Committee for an
of 13 voting members including the
additional 2 years beyond the charter Associate Commissioner for Policy.
Chair. Members and the Chair are
expiration date. The new charter will be [FR Doc. 2018–22098 Filed 10–10–18; 8:45 am]
selected by the Commissioner or
in effect until October 7, 2020. BILLING CODE 4164–01–P
designee from among authorities
DATES: Authority for the Antimicrobial knowledgeable in the fields of infectious
Drugs Advisory Committee will expire disease, internal medicine,
on October 7, 2018, unless the DEPARTMENT OF HEALTH AND
microbiology, pediatrics, epidemiology
khammond on DSK30JT082PROD with NOTICES

Commissioner formally determines that HUMAN SERVICES
or statistics, and related specialties.
renewal is in the public interest. Members will be invited to serve for Charter Renewal of the Secretary’s
FOR FURTHER INFORMATION CONTACT: overlapping terms of up to 4 years. Advisory Committee on Human
Lauren Tesh, Center for Drug Evaluation Almost all non-Federal members of this Research Protections
and Research, Food and Drug committee serve as Special Government
Administration, 10903 New Hampshire Employees. The core of voting members AGENCY: Office of the Assistant
Ave., Bldg. 31, Rm. 2417, Silver Spring, may include one technically qualified Secretary for Health, Office of the

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51466 Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices

Secretary, Department of Health and A copy of the charter can also be DEPARTMENT OF HEALTH AND
Human Services. obtained by accessing the Federal HUMAN SERVICES
ACTION: Notice. Advisory Committee Act database that
is managed by the Committee National Institutes of Health
SUMMARY: The U.S. Department of Management Secretariat under the
Health and Human Services (HHS) is General Services Administration. The National Institute on Aging; Notice of
hereby giving notice that the charter for website for the FACA database is Closed Meeting
the Secretary’s Advisory Committee on https://facadatabase.gov. Pursuant to section 10(d) of the
Human Research Protections (SACHRP)
Dated: September 28, 2018. Federal Advisory Committee Act, as
has been renewed.
Julia G. Gorey, amended, notice is hereby given of the
FOR FURTHER INFORMATION CONTACT: Julia
Executive Director, Secretary’s Advisory following meeting.
Gorey, J.D., Designated Federal Official, The meeting will be closed to the
Committee on Human Research Protections.
Executive Director, SACHRP, U.S. public in accordance with the
Department of Health and Human [FR Doc. 2018–22167 Filed 10–10–18; 8:45 am]
provisions set forth in sections
Services, 1101 Wootton Parkway, Suite BILLING CODE 4150–36–P
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
200, Rockville, Maryland 20852; as amended. The grant applications and
telephone: 240–453–8141; fax: 240– the discussions could disclose
453–6909; email address: SACHRP@ DEPARTMENT OF HEALTH AND
HUMAN SERVICES confidential trade secrets or commercial
hhs.gov. Additional information is property such as patentable material,
available on the SACHRP website at National Institutes of Health and personal information concerning
https://www.hhs.gov/ohrp/sachrp- individuals associated with the grant
committee/index.html. National Heart, Lung, and Blood applications, the disclosure of which
SUPPLEMENTARY INFORMATION: SACHRP Institute; Notice of Closed Meeting would constitute a clearly unwarranted
is a discretionary advisory committee invasion of personal privacy.
established under the authority of 42 Pursuant to section 10(d) of the
U.S.C. 217a, Section 222 of the Public Federal Advisory Committee Act, as Name of Committee: National Institute on
amended (5 U.S.C. App.), notice is Aging, Special Emphasis Panel; NIA Clinical
Health Service Act, as amended, to Trials.
provide expert advice and hereby given of the following meeting.
The meeting will be closed to the Date: November 13, 2018.
recommendations to the Secretary of Time: 12:01 p.m. to 4:00 p.m.
Health and Human Services, through public in accordance with the
Agenda: To review and evaluate grant
the Assistant Secretary for Health, on provisions set forth in sections applications.
issues and topics pertaining to or 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: National Institute on Aging,
associated with the protection of human as amended. The grant applications and Gateway Building, Suite 2W200, 7201
research subjects within the authority of the discussions could disclose Wisconsin Avenue, Bethesda, MD 20892
HHS. confidential trade secrets or commercial (Telephone Conference Call).
SACHRP is authorized to establish property such as patentable material, Contact Person: Maurizio Grimaldi, MD,
subcommittees to provide assistance for and personal information concerning Ph.D., Scientific Review Officer, National
individuals associated with the grant Institute on Aging, National Institutes of
accomplishing its mission and currently Health, 7201 Wisconsin Avenue, Room
maintains two subcommittees. The applications, the disclosure of which
2C218, Bethesda, MD 20892, 301–496–9374,
Subpart A Subcommittee (SAS) was would constitute a clearly unwarranted grimaldim2@mail.nih.gov.
established by SACHRP in October 2006 invasion of personal privacy.
(Catalogue of Federal Domestic Assistance
and is charged with developing Name of Committee: Heart, Lung, and Program Nos. 93.866, Aging Research,
recommendations for consideration by Blood Initial Review Group; NHLBI National Institutes of Health, HHS)
SACHRP regarding the application of Mentored Clinical and Basic Science Review
Committee. Dated: October 4, 2018.
subpart A of 45 CFR part 46 in the
current research environment. The Date: October 25–26, 2018. Melanie J. Pantoja,
Subcommittee on Harmonization (SOH) Time: 10:30 a.m. to 12:00 p.m. Program Analyst, Office of Federal Advisory
Agenda: To review and evaluate grant Committee Policy.
was established by SACHRP at its July applications.
2009 meeting and charged with [FR Doc. 2018–22085 Filed 10–10–18; 8:45 am]
Place: Westin Crystal City, 1800 Jefferson
identifying and prioritizing areas in Davis Highway, Arlington, VA 22202. BILLING CODE 4140–01–P
which regulations and/or guidelines for Contact Person: Keith A Mintzer, Ph.D.,
human subjects research adopted by Scientific Review Officer, Office of Scientific
various agencies or offices within HHS Review/DERA, National Heart, Lung, and DEPARTMENT OF HEALTH AND
would benefit from harmonization, Blood Institute, 6701 Rockledge Drive, Room HUMAN SERVICES
consistency, clarity, simplification and/ 7186, Bethesda, MD 20892–7924, 301–827–
7949, mintzerk@nhlbi.nih.gov. National Institutes of Health
or coordination.
On September 25, 2018, the Secretary (Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for National Institute of Mental Health;
approved renewal of the Committee’s Notice of Closed Meetings
charter. The new charter was effected Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Pursuant to section 10(d) of the
and filed with the appropriate
Diseases Research; 93.839, Blood Diseases
Congressional committees and the and Resources Research, National Institutes
Federal Advisory Committee Act, as
khammond on DSK30JT082PROD with NOTICES

Library of Congress on October 1, 2018. of Health, HHS) amended, notice is hereby given of the
Renewal of the Committee’s charter following meetings.
gives the Committee authorization to Dated: October 4, 2018. The meetings will be closed to the
operate until October 1, 2020. Ronald J. Livingston, Jr., public in accordance with the
A copy of the Committee’s charter is Program Analyst, Office of Federal Advisory provisions set forth in sections
available on the Committee’s website at Committee Policy. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
https://www.hhs.gov/ohrp/sachrp- [FR Doc. 2018–22087 Filed 10–10–18; 8:45 am] as amended. The grant applications and
committee/charter/index.html. BILLING CODE 4140–01–P the discussions could disclose

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Document Created: 2018-10-11 15:37:41
Document Modified: 2018-10-11 15:37:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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
FR Citation		83 FR 51465