National Institute of Environmental Health Sciences; Notice of Meeting, 36090-36091 [E8-14261]
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36090
Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Notices
DC 20447, Attn: OPRE Reports
Clearance Officer. E-mail address:
OPREInfoCollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, FAX: 202–395–6974,
Attn: Desk Officer for ACF.
Dated: June 18, 2008.
Brendan C. Kelly,
OPRE Reports Clearance Officer.
[FR Doc. E8–14222 Filed 6–24–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0207] (formerly
Docket No. 2007D–0202)
Guidance for Industry: Microbiological
Considerations for Antimicrobial Food
Additive Submissions; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Guidance for Industry:
Microbiological Considerations for
Antimicrobial Food Additive
Submissions.’’ The guidance explains
FDA’s current thinking on a number of
microbiological issues unique to the
preparation of premarket submissions
for antimicrobial food additives.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Food Additive Safety (HFS–
200), Center for Food Safety and
Applied Nutrition, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request, or fax your request to 301–436–
2972. Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
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SUMMARY:
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MD 20852. Submit electronic comments
to https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1071.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September
25, 2007 (72 FR 54446), FDA announced
the availability of a draft guidance
entitled ‘‘Guidance for Industry:
Microbiological Considerations for
Antimicrobial Food Additive
Submissions.’’ FDA gave interested
parties an opportunity to submit
comments on the draft guidance by
November 26, 2007. The agency
considered the one received comment as
it finalized the guidance. The guidance
announced in this notice finalizes the
draft guidance dated September 2007.
FDA is issuing this guidance
document as level 1 guidance consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). The
guidance document represents FDA’s
current thinking on a number of
microbiological issues unique to the
preparation of premarket submissions
for antimicrobial food additives. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. 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 collection of information in
21 CFR 70.25, 71.1, 170.35, and 171.1
have been approved under OMB control
number 0910–0016; the collection of
information in 21 CFR 170.39 has been
approved under OMB control number
0910–0298; and the collection of
information in 21 CFR 170.101 and
170.106 have been approved under
OMB control number 0910–0495.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The guidance
document and received comments may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.cfsan.fda.gov/guidance.html.
Dated: June 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14397 Filed 6–24–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Board of Scientific Counselors, NIEHS.
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 the review, discussion, and
evaluation of individual other
conducted by the National Institute of
Environmental Health Sciences,
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.
E:\FR\FM\25JNN1.SGM
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Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
Name of Committee: Board of Scientific
Counselors, NIEHS.
Date: July 20–22, 2008. July 20, 2008, 7
p.m. to 9:30 p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Doubletree Guest Suites, 2515
Meridian Parkway, Research Triangle Park,
NC 27713.
Closed: July 21, 2008, 8:30 a.m. to 9:15 a.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Executive Conference
Room, 111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Open: July 21, 2008, 9:15 a.m. to 11:35 a.m.
Agenda: An overview of the organization
and research in the Laboratory of Structural
Biology.
Place: Nat. Inst. of Environmental Health
Sciences, South Campus, Conference Rooms
101A–C, Research Triangle Park, NC 27709.
Closed: July 21, 2008, 11:35 a.m. to 12:25
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, South Campus, Conference Rooms
101A–C, Research Triangle Park, NC 27709.
Open: July 21, 2008, 1 p.m. to 1:45 p.m.
Agenda: Poster Session.
Place: Nat. Inst. of Environmental Health
Sciences South Campus, Conference Rooms
101A–C Research Triangle Park, NC 27709.
Closed: July 21, 2008, 1:45 p.m. to 5:15
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, South Campus, Conference Rooms
101A–C, Research Triangle Park, NC 27709.
Closed: July 21, 2008, 5:15 p.m. to
Adjournment.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Doubletree Guest Suites, 2515
Meridian Parkway, Research Triangle Park,
NC 27713.
Closed: July 22, 2008, 9 a.m. to 10 a.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, South Campus, Conference Rooms
101A–C, Research Triangle Park, NC 27709.
Contact Person: Perry J. Blackshear, PhD,
MD, Acting Scientific Director, Division of
Intramural Research, National Inst. of
Environmental Health Sciences, National
Institutes of Health, PO Box 12233, Research
Triangle Park, NC 27709, (919) 541–4899,
black009@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.
(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
VerDate Aug<31>2005
21:19 Jun 24, 2008
Jkt 214001
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: June 18, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–14261 Filed 6–24–08; 8:45 am]
BILLING CODE 4140–01–M
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 5 U.S.C. Appendix 2, 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(c4)
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; Member
Conflict: Topics in Development, Aging and
Global Health.
Date: July 11, 2008.
Time: 1 p.m. to 3:30 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: Sherry L. Dupere, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5136,
MSC 7843, Bethesda, MD 20892, (301) 435–
1021, duperes@csr.nih.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; Member
Conflicts: Skeletal Muscle and Exercise
Physiology.
Date: July 16, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
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Contact Person: John P. Holden, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4211,
MSC 7814, Bethesda, MD 20892, 301–496–
8551, holdenjo@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Reference
Epigenome Mapping and Data Analysis and
Coordination Centers.
Date: July 21, 2008.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: One Washington Circle Hotel, One
Washington Circle, NW., Zenith,
Washington, DC 20037.
Contact Person: Elena Smirnova, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5187,
MSC 7840, Bethesda, MD 20892, 301–435–
1236, smirnove@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project Grant in Cell Biology.
Date: August 13–14, 2008.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: David Balasundaram, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189,
MSC 7840, Bethesda, MD 20892, 301–435–
1022, balasundaramd@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: June 18, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–14262 Filed 6–24–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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
E:\FR\FM\25JNN1.SGM
25JNN1
Agencies
[Federal Register Volume 73, Number 123 (Wednesday, June 25, 2008)]
[Notices]
[Pages 36090-36091]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14261]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; Notice of
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of
the Board of Scientific Counselors, NIEHS.
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 the review, discussion, and evaluation of
individual other conducted by the National Institute of Environmental
Health Sciences, 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.
[[Page 36091]]
Name of Committee: Board of Scientific Counselors, NIEHS.
Date: July 20-22, 2008. July 20, 2008, 7 p.m. to 9:30 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Doubletree Guest Suites, 2515 Meridian Parkway, Research
Triangle Park, NC 27713.
Closed: July 21, 2008, 8:30 a.m. to 9:15 a.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Executive Conference Room, 111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Open: July 21, 2008, 9:15 a.m. to 11:35 a.m.
Agenda: An overview of the organization and research in the
Laboratory of Structural Biology.
Place: Nat. Inst. of Environmental Health Sciences, South
Campus, Conference Rooms 101A-C, Research Triangle Park, NC 27709.
Closed: July 21, 2008, 11:35 a.m. to 12:25 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, South
Campus, Conference Rooms 101A-C, Research Triangle Park, NC 27709.
Open: July 21, 2008, 1 p.m. to 1:45 p.m.
Agenda: Poster Session.
Place: Nat. Inst. of Environmental Health Sciences South Campus,
Conference Rooms 101A-C Research Triangle Park, NC 27709.
Closed: July 21, 2008, 1:45 p.m. to 5:15 p.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, South
Campus, Conference Rooms 101A-C, Research Triangle Park, NC 27709.
Closed: July 21, 2008, 5:15 p.m. to Adjournment.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Doubletree Guest Suites, 2515 Meridian Parkway, Research
Triangle Park, NC 27713.
Closed: July 22, 2008, 9 a.m. to 10 a.m.
Agenda: To review and evaluate programmatic and personnel
issues.
Place: Nat. Inst. of Environmental Health Sciences, South
Campus, Conference Rooms 101A-C, Research Triangle Park, NC 27709.
Contact Person: Perry J. Blackshear, PhD, MD, Acting Scientific
Director, Division of Intramural Research, National Inst. of
Environmental Health Sciences, National Institutes of Health, PO Box
12233, Research Triangle Park, NC 27709, (919) 541-4899,
black009@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.
(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: June 18, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-14261 Filed 6-24-08; 8:45 am]
BILLING CODE 4140-01-M