National Institute of Mental Health; Notice of Closed Meeting, 68461-68462 [2013-27171]
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Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1994–D–0007]
Guidance for Industry: Studies To
Evaluate the Utility of Anti-Salmonella
Chemical Food Additives in Feeds;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Request for comments.
The Food and Drug
Administration (FDA) is considering
revising the guidance entitled
‘‘Guidance for Industry: Studies to
Evaluate the Utility of Anti-Salmonella
Chemical Food Additives in Feeds,’’
and is seeking comments on this
guidance before revisions are made.
DATES: Submit electronic or written
comments by January 13, 2014.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Xin
Li, Center for Veterinary Medicine
(HFV–222), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6863,
xin.li@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
TKELleY on DSK3SPTVN1PROD with NOTICES
I. Background
One of the key objectives of Guidance
for Industry: Studies to Evaluate the
Utility of Anti-Salmonella Chemical
Food Additives in Feeds (GFI #80) is to
help sponsors design efficacy studies to
support the submission of Food
Additive Petitions (FAPs) for food
additives intended for anti-Salmonella
use in food for animals. We would like
to revise GFI #80 because science,
technology, and FDA policy have
changed since this guidance was last
revised.
GFI #80 currently addresses only
chemical food additives intended to
maintain feeds or feed ingredients
Salmonella-negative. We intend to
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expand the scope of this guidance to
address other categories of food
additives beyond chemical food
additives, and to cover all food for
animals, including pet food.
Before we revise the content of GFI
#80 we intend to consider your answers
to the following questions:
1. What intended technical effects can
we expect to see in FAPs submitted to
FDA for anti-Salmonella use of the food
additives in food for animals?
2. How should efficacy studies be
designed for the intended technical
effects described in your response to
question 1?
3. Should experimental lots of animal
food used in both laboratory and field
studies be Salmonella-negative, but not
sterile, prior to inoculation?
4. What inoculation levels of
Salmonella are appropriate for
experimental lots of animal food used in
laboratory and field studies? Please
justify your comment with scientific
evidence.
5. What methods should be used to
inoculate experimental lots of animal
food used in laboratory and field
studies?
6. What sampling criteria should be
used to provide statistical confidence
that Salmonella will be captured among
samples collected? Please justify your
comment with scientific evidence.
7. What methods should be used to
enumerate the level(s) of Salmonella in
animal food?
8. What are the key elements for
designing field studies?
9. What are the difficulties faced by
sponsors when designing and
conducting field studies?
10. What types of facilities are
available to conduct field studies?
Electronic versions of GFI #80 are in
the docket at https://www.regulations.gov
and on FDA’s Web site at https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
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68461
Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27194 Filed 11–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel,
December 04, 2013, 01:00 p.m. to
December 04, 2013, 05:00 p.m., National
Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892 which was
published in the Federal Register on
November 05, 2013, 78 FR 214 Pg.
66371.
The meeting will start on December 3,
2013 at 12:00 p.m. and end December 3,
2013 at 5:00 p.m.
The meeting location remains the
same. The meeting is closed to the
public.
Dated: November 7, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–27172 Filed 11–13–13; 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 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: National Institute of
Mental Health Special Emphasis Panel;
Fellowships and Dissertations.
Date: December 6, 2013.
Time: 2:00 p.m. to 5:00 p.m.
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68462
Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Karen Gavin-Evans, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center,
6001 Executive Boulevard, Room 6153, MSC
9606, Bethesda, MD 20892, 301–451–2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: November 7, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–27171 Filed 11–13–13; 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
TKELleY on DSK3SPTVN1PROD with NOTICES
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 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; Brain Injury
and Neurovascular Pathologies.
Date: December 2, 2013.
Time: 1:00 p.m. to 6:00 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: Alexander Yakovlev,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206,
MSC 7846, Bethesda, MD 20892–7846, 301–
435–1254, yakovleva@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Biomedical Computing and Health
Informatics Study Section.
Date: December 10, 2013.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Melinda Jenkins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3156,
MSC 7770, Bethesda, MD 20892, 301–437–
7872, jenkinsml2@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: December 10–11, 2013.
Time: 10:00 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: Kenneth A Roebuck, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 7, 2013.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–27170 Filed 11–13–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2013–0030; OMB No.
1660–0046]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
The Federal Emergency
Management Agency (FEMA) will
submit the information collection
abstracted below to the Office of
Management and Budget for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
will describe the nature of the
information collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
the actual data collection instruments
FEMA will use.
SUMMARY:
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Comments must be submitted on
or before December 16, 2013.
ADDRESSES: Submit written comments
on the proposed information collection
to the Office of Information and
Regulatory Affairs, Office of
Management and Budget. Comments
should be addressed to the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
electronic mail to oira.submission@
omb.eop.gov or faxed to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Director, Records
Management Division, 1800 South Bell
Street, Arlington, VA 20598–3005,
facsimile number (202) 646–3347, or
email address FEMA-InformationCollections-Management@dhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Collection of Information
Title: Emergency Management
Institute (EMI) Independent Study
Course Enrollment Application.
Type of information collection:
Revision of a currently approved
information collection.
Form Titles and Numbers: FEMA
Form 064–0–9, Emergency Management
Institute (EMI) Independent Study
Course Enrollment Application.
Abstract: The EMI Independent Study
program office collects data from FEMA
Form 064–0–9 to create and update
student records and provide students
with credit for training completion. The
system also allows FEMA to track
completions and failures of course
exams. The data on the electronic form
will be encrypted and sent to the server
to be parsed into the Independent Study
database.
Affected Public: Individuals and
households, business or other for-profit,
not for profit institutions, farms, Federal
government, State, local or tribal
government.
Estimated Number of Respondents:
2,148,746.
Estimated Total Annual Burden
Hours: 4,297,492.
Estimated Cost: There are no annual
capital, start-up, and operation or
maintenance costs associated with this
collection.
Dated: November 7, 2013.
Charlene D. Myrthil,
Director, Records Management Division,
Mission Support Bureau, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. 2013–27264 Filed 11–13–13; 8:45 am]
BILLING CODE 9111–72–P
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Agencies
[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68461-68462]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27171]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; 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: National Institute of Mental Health Special
Emphasis Panel; Fellowships and Dissertations.
Date: December 6, 2013.
Time: 2:00 p.m. to 5:00 p.m.
[[Page 68462]]
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center, 6001 Executive Boulevard,
Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
Dated: November 7, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-27171 Filed 11-13-13; 8:45 am]
BILLING CODE 4140-01-P