National Institute of Child Health and Human Development Meetings; Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings, 40011-40012 [2017-17791]
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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
human use among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission and
European Medicines Agency;
International Federation for Animal
Health—Europe; FDA; the U.S.
Department of Agriculture; the U.S.
Animal Health Institute; the Japanese
Ministry of Agriculture, Forestry, and
Fisheries; and the Japanese Veterinary
Products Association.
Six observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, one representative from the
industry in Canada, one representative
from the government of South Africa,
and one representative from the
industry in South Africa. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by HealthforAnimals.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
II. Guidance for Industry on Studies To
Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
General Approach To Establish an
Acute Reference Dose
In the Federal Register of June 1, 2015
(80 FR 31041), FDA published the
notice of availability for a draft guidance
entitled ‘‘Studies to Evaluate the Safety
of Residues of Veterinary Drugs in
Human Food: General Approach to
Establish an Acute Reference Dose’’
(VICH GL54) giving interested persons
until July 31, 2015, to comment on the
draft guidance. FDA received two
comments on the draft guidance, and
those comments, as well as those
received by other VICH member
regulatory agencies, were considered as
the guidance was finalized. The
guidance announced in this notice
finalizes the draft guidance dated June
1, 2015. The final guidance is a product
of the Safety Expert Working Group of
the VICH.
This VICH guidance document is
intended to address the nature and
types of data that can be useful in
determining a toxicological ARfD for
residues of veterinary drugs, the studies
that may generate such data, and how
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the ARfD may be calculated based on
these data.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Significance of Guidance
Food and Drug Administration
This guidance, developed under the
VICH process, is being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). For
example, the document has been
designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
FDA is using these words to describe a
statutory or regulatory requirement.
The guidance represents the current
thinking of FDA on ‘‘Studies to Evaluate
the Safety of Residues of Veterinary
Drugs in Human Food: General
Approach to Establish an Acute
Reference Dose.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This is not a
significant regulatory action subject to
Executive Order 12866.
[Docket No. FDA–2017–D–1956]
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Action of 1995 (44 U.S.C.
3501–3520). The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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Identifying Trading Partners Under the
Drug Supply Chain Security Act; Draft
Guidance for Industry; Availability
Correction
Notice document 2017–17569,
appearing on pages 39589 through
39590, in the issue of Monday, August
21, 2017, was published in error. It
should be removed.
[FR Doc. C1–2017–17569 Filed 8–22–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development Meetings; Eunice
Kennedy Shriver National Institute of
Child Health and Human Development;
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
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 of
Child Health and Human Development Initial
Review Group Health, Behavior, and Context
Subcommittee.
Date: October 16–26, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Kimberly L. Houston, MD,
Scientific Review Officer, Eunice Kennedy
Shriver National Institute of Children Health
and Human Development, 6701B Rockledge
Drive, Room 2127B, Bethesda, MD 20892,
301–827–4902, kimberly.houston@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; NICHD International
and Domestic Pediatric and Maternal HIV
and Other High Priority Infectious Diseases
Data Coordinating Center.
Date: October 18, 2017.
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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6710 B
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, 6701B Rockledge Drive, Room,
Bethesda, MD 20892, (301) 435–6680,
skandasa@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: November 06, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Kimberly Lynette Houston,
MD, Scientific Review Officer, Eunice
Kennedy Shriver National Institute of
Children Health and Human Development,
6701B Rockledge Drive, Room 2127B,
Bethesda, MD 20892, 301–827–4902,
kimberly.houston@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209 Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: August 17, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–17791 Filed 8–22–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSKBBXCHB2PROD with NOTICES
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Environmental Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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
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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 Advisory
Environmental Health Sciences Council.
Date: September 12–13, 2017.
Closed: September 12, 2017, 8:30 a.m. to
9:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Open: September 12, 2017, 9:30 a.m. to
4:30 p.m.
Agenda: Discussion of Program and Issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Open: September 13, 2017, 8:30 a.m. to
11:00 a.m.
Agenda: Discussion of Program and Issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Contact Person: Gwen W. Collman, Ph.D.,
Interim Director, Division of Extramural
Research & Training, National Institutes of
Health, Nat. Inst. of Environmental Health
Sciences, 615 Davis Dr., KEY615/3112,
Research Triangle Park, NC 27709, (919) 541–
4980, collman@niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page:
www.niehs.nih.gov/dert/c-agenda.htm, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: August 17, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–17796 Filed 8–22–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development Meetings; Eunice
Kennedy Shriver National Institute of
Child Health and Human Development;
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
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 of
Child Health and Human Development Initial
Review Group; Function, Integration, and
Rehabilitation Sciences Subcommittee.
Date: October 6, 2017.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Joanna Kubler-Kielb,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, 6710B Rockledge
Drive, Rm., Bethesda, MD 20892–7501, 301–
435–6916, kielbj@mail.nih.gov.
Population Sciences Subcommittee,
Population Sciences Committee.
Date: October 17, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Minki Chatterji, Scientific
Review Officer, Scientific Review Branch,
Eunice Kennedy Shriver National Institute of
Child Health and Human Development, NIH,
DHHS, 6710B Rockledge Drive, Rm. 2121D,
Bethesda, MD 20892–7501, 301–827–5435,
minki.chatterji@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Archiving and
Documenting Child Health and Human
Development Data Sets.
Date: October 17, 2017.
Time: 5:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Minki Chatterji, Scientific
Review Officer, Scientific Review Branch,
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[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Pages 40011-40012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17791]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development
Meetings; Eunice Kennedy Shriver National Institute of Child Health and
Human Development; 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 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 of Child Health and Human
Development Initial Review Group Health, Behavior, and Context
Subcommittee.
Date: October 16-26, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Kimberly L. Houston, MD, Scientific Review
Officer, Eunice Kennedy Shriver National Institute of Children
Health and Human Development, 6701B Rockledge Drive, Room 2127B,
Bethesda, MD 20892, 301-827-4902, kimberly.houston@nih.gov.
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; NICHD International and Domestic
Pediatric and Maternal HIV and Other High Priority Infectious
Diseases Data Coordinating Center.
Date: October 18, 2017.
[[Page 40012]]
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 6710 B Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review
Administrator, Division of Scientific Review, National Institute of
Child Health and Human Development, 6701B Rockledge Drive, Room,
Bethesda, MD 20892, (301) 435-6680, skandasa@mail.nih.gov.
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel.
Date: November 06, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD
20814.
Contact Person: Kimberly Lynette Houston, MD, Scientific Review
Officer, Eunice Kennedy Shriver National Institute of Children
Health and Human Development, 6701B Rockledge Drive, Room 2127B,
Bethesda, MD 20892, 301-827-4902, kimberly.houston@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.864,
Population Research; 93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation Research; 93.209
Contraception and Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: August 17, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-17791 Filed 8-22-17; 8:45 am]
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