National Institute of Environmental Health Sciences; Notice of Closed Meeting, 31741-31742 [E9-15689]
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Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices
patient. The numerical values generated
by susceptibility testing to determine
whether a particular microorganism is
susceptible to a particular antimicrobial
drug—the antimicrobial susceptibility
test interpretive criteria—are commonly
referred to as breakpoints. These
breakpoints are specified in the
antimicrobial drug product’s label. The
antimicrobial susceptibility test
interpretive criteria can be used to
interpret results from either manual or
automated AST devices.
On September 27, 2007, FDAAA
(Public Law 110–85) was signed into
law. Section 1111 of FDAAA requires
FDA to identify and periodically update
susceptibility test interpretive criteria
for antibacterial drug products and to
make those findings publicly available.
By enacting section 1111 of FDAAA,
Congress recognized the importance of
maintaining updated susceptibility test
interpretive criteria.
In the Federal Register of June 12,
2008 (73 FR 33438), FDA issued a draft
guidance entitled ‘‘Updating Labeling
for Susceptibility Test Information in
Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility
Testing Devices.’’ The draft guidance
described procedures for FDA, drug
application holders, and AST device
manufacturers to ensure that updated
susceptibility test information is
available to health care providers. The
draft guidance explained that where
appropriate, FDA intends to identify
susceptibility test interpretive criteria,
quality control parameters, and
susceptibility test methods by
recognizing annually, in a Federal
Register notice, standards developed by
one or more nationally or
internationally recognized standard
development organizations. The draft
guidance described, for holders of
applications for approved antibacterial
drug products, the option of relying on
such standards to update their product
labeling. The draft guidance explained
that the agency intends to make the
updated information available by
publicly posting changes to the drug
product labeling within 30 days
following approval of a supplement that
includes a change to the Microbiology
subsection of the product labeling. The
draft guidance also described, for
manufacturers of in vitro diagnostic
AST devices, the process for updating
the susceptibility test information in
their labeling to conform with updated
labeling for a relevant antibacterial drug
product.
FDA has carefully reviewed
comments received on the draft
guidance (11 comments were submitted
to the public docket). This final version
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of the guidance reflects our
consideration of these comments, as
well as our experience updating the
labeling of susceptibility test
information in systemic antibacterial
drug products and AST devices. Most of
the changes to the guidance were made
to clarify statements in the draft
guidance. The following changes in the
final version of the guidance are
noteworthy:
• The guidance clarifies that FDA is
not imposing new requirements by
recommending that drug application
holders submit revised labeling or an
explanation of why revisions are not
needed within a specific time period
after FDA recognizes a standard that is
different from the information in the
Microbiology subsection of the labeling
for the application holder’s drug
product. (See 21 CFR 201.56(a)(2).)
• The agency revised the
recommended time period for
submitting revised labeling by
extending the period from 60 days to 90
days.
Certain requests that the guidance
provide greater detail regarding the
procedures for updating in vitro AST
devices have not been addressed in this
guidance but will be addressed when
FDA updates ‘‘Class II Special Controls
Guidance Document: Antimicrobial
Susceptibility Test (AST) Systems;
Guidance for Industry and FDA.’’ This
guidance is being issued consistent with
FDA’s good guidance practices
regulation (21 CFR 10.115). The
guidance represents the agency’s current
thinking on this topic. 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
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31741
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
this guidance was approved under OMB
control number 0910-0638.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 26, 2009.
David Horowitz,
Assitant Commissioner for Policy
[FR Doc. E9–15682 Filed 7–1–09; 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 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
Environmental Health Sciences Special
Emphasis Panel; Research Conference Grants
with an Environmental Health Focus.
Date: July 30, 2009.
Time: 2 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIEHS/National Institutes of Health,
Keystone Building, 530 Davis Drive, Research
Triangle Park, NC 27709 (Telephone
Conference Call).
Contact Person: Linda K. Bass, PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research and Training, Nat. Institute
Environmental Health Sciences, P.O. Box
12233, MD EC–30, Research Triangle Park,
NC 27709. (919) 541–1307.
bass@niehs.nih.gov.
(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
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Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices
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 26, 2009.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–15689 Filed 7–1–09; 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 (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; Informatics
Training for Global Health.
Date: July 13, 2009.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Dan D. Gerendasy, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5132,
MSC 7843, Bethesda, MD 20892, 301–594–
6830, gerendad@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; Biology of
Development and Aging SBIR/STTR Review.
Date: July 13, 2009.
Time: 1 p.m. to 5 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: Dan D. Gerendasy, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
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Health, 6701 Rockledge Drive, Room 5132,
MSC 7843, Bethesda, MD 20892, 301–594–
6830, gerendad@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: Integrative Neuroscience.
Date: July 14–15, 2009.
Time: 8 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Brian Hoshaw, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181,
MSC 7844, Bethesda, MD 20892, 301–435–
1033, hoshawb@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
Conflict: Ethanol and Neurotoxicology.
Date: July 15–16, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Christine L. Melchior,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5176,
MSC 7844, Bethesda, MD 20892, (301) 435–
1713, melchioc@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;
Neurodevices and Neuroimaging.
Date: July 17, 2009.
Time: 2 p.m. to 5 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: Vilen A. Movsesyan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040M,
MSC 7806, Bethesda, MD 20892, 301–402–
7278, movsesyanv@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; Diversity
Fellowships: Division of Translational and
Clinical Sciences.
Date: July 23, 2009.
Time: 8 a.m. to 5 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: Lee Rosen, PhD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5116, MSC 7854, Bethesda, MD
20892, (301) 435–1171, rosenl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Infectious
Disease Revision Grant Applications.
Date: July 23–24, 2009.
Time: 8 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: Alexander D. Politis, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3210,
MSC 7808, Bethesda, MD 20892, (301) 435–
1150, politisa@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; OBT
Competitive Revision Applications.
Date: July 23–24, 2009.
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
(Virtual Meeting).
Contact Person: Cathleen L. Cooper, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4208,
MSC 7812, Bethesda, MD 20892, 301–435–
3566, cooperc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Chronic
Fatigue Syndrome, Fibromyalgia Syndrome,
Temporomandibular Disorders.
Date: July 28–29, 2009.
Time: 8 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: Lynn E. Luethke, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5166,
MSC 7844, Bethesda, MD 20892, (301) 435–
1018, luethkel@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Diabetes,
Obesity, Nutrition and Reproductive
Sciences.
Date: July 30–31, 2009.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Krish Krishnan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, (301) 435–
1041, krishnak@csr.nih.gov.
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Agencies
[Federal Register Volume 74, Number 126 (Thursday, July 2, 2009)]
[Notices]
[Pages 31741-31742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15689]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; 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 Environmental Health
Sciences Special Emphasis Panel; Research Conference Grants with an
Environmental Health Focus.
Date: July 30, 2009.
Time: 2 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: NIEHS/National Institutes of Health, Keystone Building,
530 Davis Drive, Research Triangle Park, NC 27709 (Telephone
Conference Call).
Contact Person: Linda K. Bass, PhD, Scientific Review
Administrator, Scientific Review Branch, Division of Extramural
Research and Training, Nat. Institute Environmental Health Sciences,
P.O. Box 12233, MD EC-30, Research Triangle Park, NC 27709. (919)
541-1307. bass@niehs.nih.gov.
(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
[[Page 31742]]
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 26, 2009.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-15689 Filed 7-1-09; 8:45 am]
BILLING CODE 4140-01-P