National Library of Medicine: Notice of Meetings, 27334-27335 [2018-12534]
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Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
viewable at https://www.regulations.gov
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information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
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the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
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You may submit comments on any
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Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Julia
Oriani, Center for Veterinary Medicine
(HFV–151), Food and Drug
FOR FURTHER INFORMATION CONTACT:
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Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0788,
julia.oriani@fda.hhs.gov.
Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–12607 Filed 6–11–18; 8:45 am]
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I. Background
In the Federal Register of July 21,
2016 (81 FR 47397), FDA published the
notice of availability for a draft revised
GFI #3 entitled ‘‘General Principles for
Evaluating the Human Food Safety of
New Animal Drugs Used in FoodProducing Animals’’ giving interested
persons until September 19, 2016, to
comment on the draft revised GFI. FDA
received several comments on the draft
revised GFI, and those comments were
considered as the guidance was
finalized. Revisions to the document
were made for accuracy and
clarification based on comments
received from the public, including
reinsertion of information specific to
endogenous sex steroids, and minor
editorial edits. The guidance announced
in this notice finalizes the draft revised
GFI dated July 2016.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘General Principles
for Evaluating the Human Food Safety
of New Animal Drugs Used in FoodProducing Animals.’’ 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
guidance is not subject to Executive
Order 12866.
III. 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 Act 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.
IV. 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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine: Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, Lister Hill National Center
for Biomedical Communications.
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 as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for review, discussion, and evaluation of
individual intramural programs and
projects conducted by the National
Library of Medicine, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, Lister Hill National Center for
Biomedical Communications.
Date: September 6–7, 2018.
Open: September 6, 2018, 9:00 a.m. to
12:00 p.m.
Agenda: Review of research and
development programs and preparation of
reports of the Lister Hill National Center for
Biomedical Communications.
Place: National Library of Medicine,
Building 38, 2nd Floor, The Lindberg Room,
8600 Rockville Pike, Bethesda, MD 20892.
Closed: September 6, 2018, 12:00 p.m. to
4:30 p.m.
Agenda: To review and evaluate personal
qualifications, performance, and competence
of individual investigators.
Place: National Library of Medicine,
Building 38, 2nd Floor, The Lindberg Room,
8600 Rockville Pike, Bethesda, MD 20892.
Closed: September 7, 2018, 9:00 a.m. to
10:00 a.m.
Agenda: To review and evaluate personal
qualifications, performance, and competence
of individual investigators.
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Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
Place: National Library of Medicine,
Building 38, 2nd Floor, The Lindberg Room,
8600 Rockville Pike, Bethesda, MD 20892.
Contact Person: Karen Steely, Program
Assistant, Lister Hill National Center for
Biomedical Communications, National
Library of Medicine, Building 38A, Room
7S707, Bethesda, MD 20892, 301–827–4385,
ksteely@mail.nih.gov.
Open: September 7, 2018, 10:00 a.m. to
11:30 a.m.
Agenda: Review of research and
development programs and preparation of
reports of the Lister Hill National Center for
Biomedical Communications.
Place: National Library of Medicine,
Building 38, 2nd Floor, The Lindberg Room,
8600 Rockville Pike, Bethesda, MD 20892.
Contact Person: Karen Steely, Program
Assistant, Lister Hill National Center for
Biomedical Communications, National
Library of Medicine, Building 38A, Room
7S707, Bethesda, MD 20892, 301–827–4385,
ksteely@mail.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.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: June 6, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–12534 Filed 6–11–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
National Library of Medicine; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
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 materials,
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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: Biomedical
Informatics, Library and Data Sciences
Review Committee.
Date: November 15–16, 2018.
Time: November 15, 2018, 8:00 a.m. to 5:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Hyatt, 1 Bethesda Metro
Center, Bethesda, MD 20814.
Time: November 16, 2018, 8:00 a.m. to 5:00
p.m.
Agenda: To review and evaluate grant
applications.
Contact Person: Zoe E. Huang, MD, Acting
Chief Scientific Review Officer, Scientific
Review Office, Extramural Programs,
National Library of Medicine, NIH, 6705
Rockledge Drive, Suite 301, Bethesda, MD
20892–7968, 301–594–4937, huangz@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: June 6, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–12536 Filed 6–11–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Planning for
Non-Communicable Diseases and Disorders
Research Training Programs in Low and
Middle Income Countries (D71).
Date: June 21, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
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27335
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Fungai Chanetsa, MPH,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3135,
MSC 7770, Bethesda, MD 20892, 301–408–
9436, fungai.chanetsa@nih.hhs.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Research on
Current Topics in Alzheimer’s Disease and
Its Related Dementias.
Date: July 2–3, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Michael Selmanoff, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5164,
MSC 7844, Bethesda, MD 20892, 301–435–
1119, selmanom@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Computational Structural Biology.
Date: July 9, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Sergei Ruvinov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4158,
MSC 7806, Bethesda, MD 20892, 301–435–
1180, ruvinser@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Cell Biology, Developmental
Biology, and Bioengineering.
Date: July 10–11, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Alexander Gubin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4196,
MSC 7812, Bethesda, MD 20892, 301–435–
2902, gubina@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group, AIDSassociated Opportunistic Infections and
Cancer Study Section.
Date: July 10, 2018.
Time: 8:00 a.m. to 6:00 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: Eduardo A. Montalvo,
Ph.D., Scientific Review Officer, Center for
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Agencies
[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)]
[Notices]
[Pages 27334-27335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Library of Medicine: Notice of Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the Board of Scientific
Counselors, Lister Hill National Center for Biomedical Communications.
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 as indicated below in
accordance with the provisions set forth in section 552b(c)(6), Title 5
U.S.C., as amended for review, discussion, and evaluation of individual
intramural programs and projects conducted by the National Library of
Medicine, including consideration of personnel qualifications and
performance, and the competence of individual investigators, the
disclosure of which would constitute a clearly unwarranted invasion of
personal privacy.
Name of Committee: Board of Scientific Counselors, Lister Hill
National Center for Biomedical Communications.
Date: September 6-7, 2018.
Open: September 6, 2018, 9:00 a.m. to 12:00 p.m.
Agenda: Review of research and development programs and
preparation of reports of the Lister Hill National Center for
Biomedical Communications.
Place: National Library of Medicine, Building 38, 2nd Floor, The
Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892.
Closed: September 6, 2018, 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate personal qualifications,
performance, and competence of individual investigators.
Place: National Library of Medicine, Building 38, 2nd Floor, The
Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892.
Closed: September 7, 2018, 9:00 a.m. to 10:00 a.m.
Agenda: To review and evaluate personal qualifications,
performance, and competence of individual investigators.
[[Page 27335]]
Place: National Library of Medicine, Building 38, 2nd Floor, The
Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892.
Contact Person: Karen Steely, Program Assistant, Lister Hill
National Center for Biomedical Communications, National Library of
Medicine, Building 38A, Room 7S707, Bethesda, MD 20892, 301-827-
4385, [email protected].
Open: September 7, 2018, 10:00 a.m. to 11:30 a.m.
Agenda: Review of research and development programs and
preparation of reports of the Lister Hill National Center for
Biomedical Communications.
Place: National Library of Medicine, Building 38, 2nd Floor, The
Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892.
Contact Person: Karen Steely, Program Assistant, Lister Hill
National Center for Biomedical Communications, National Library of
Medicine, Building 38A, Room 7S707, Bethesda, MD 20892, 301-827-
4385, [email protected].
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.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance Program No. 93.879,
Medical Library Assistance, National Institutes of Health, HHS)
Dated: June 6, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-12534 Filed 6-11-18; 8:45 am]
BILLING CODE 4140-01-P