Charter Renewal of the Secretary's Advisory Committee on Human Research Protections, 51465-51466 [2018-22167]
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51465
Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
Title of collection
New Animal Drugs for Investigational Use ..............................................................................................................
Guidance for Industry and FDA Staff, Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle .........................................................................................
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements ...
Prescription Drug Advertisements ...........................................................................................................................
Survey of the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products .................
Food and Cosmetic Export Certificate Applications Process ..................................................................................
Guidance for Industry: Medical Product Communications That are Consistent With the Food and Drug Administration Required Labeling—Questions and Answers ........................................................................................
Guidance for Industry: Drug and Device Manufacturer Communications with Payors, Formulary Committees,
and Similar Entities Questions and Answers .......................................................................................................
Guidance for Industry: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear
Pharmacies, Federal Facilities, and Certain Other Entities .................................................................................
Drug Supply Chain Security Act Pilot Program .......................................................................................................
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional and Retail Food Stores
and Facility Types (2015–2025) ..........................................................................................................................
Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22101 Filed 10–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3323]
Advisory Committee; Antimicrobial
Drugs Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Antimicrobial Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Antimicrobial
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until October 7, 2020.
DATES: Authority for the Antimicrobial
Drugs Advisory Committee will expire
on October 7, 2018, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Lauren Tesh, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
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MD 20993–0002, 301–796–9001, email:
AMDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Antimicrobial Drugs Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Antimicrobial Drugs Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of infectious
diseases and disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of infectious
disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Members will be invited to serve for
overlapping terms of up to 4 years.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The core of voting members
may include one technically qualified
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Date
approval
expires
0910–0117
8/31/2021
0910–0594
8/31/2021
0910–0608
0910–0686
0910–0744
0910–0759
0910–0793
8/31/2021
8/31/2021
8/31/2021
8/31/2021
8/31/2021
0910–0856
8/31/2021
0910–0857
8/31/2021
0910–0858
0910–0859
8/31/2021
8/31/2021
0910–0799
9/30/2021
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
Anti-InfectiveDrugsAdvisoryCommittee/
ucm094132.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22098 Filed 10–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Charter Renewal of the Secretary’s
Advisory Committee on Human
Research Protections
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
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51466
Federal Register / Vol. 83, No. 197 / Thursday, October 11, 2018 / Notices
Secretary, Department of Health and
Human Services.
ACTION: Notice.
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/sachrpcommittee/.
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/sachrpcommittee/charter/.
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Mentored Clinical and Basic Science Review
Committee.
Date: October 25–26, 2018.
Time: 10:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Crystal City, 1800 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: Keith A Mintzer, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7186, Bethesda, MD 20892–7924, 301–827–
7949, mintzerk@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: October 4, 2018.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–22087 Filed 10–10–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging, Special Emphasis Panel; NIA Clinical
Trials.
Date: November 13, 2018.
Time: 12:01 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2W200, 7201
Wisconsin Avenue, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Maurizio Grimaldi, MD,
Ph.D., Scientific Review Officer, National
Institute on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Room
2C218, Bethesda, MD 20892, 301–496–9374,
grimaldim2@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: October 4, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–22085 Filed 10–10–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
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[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Pages 51465-51466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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:
[email protected]. Additional information is available on the SACHRP
website at https://www.hhs.gov/ohrp/sachrp-committee/.
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/.
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
