Submission for OMB; Comment Request; National Epidemiologic Survey on Alcohol and Related Conditions-III, 79385-79386 [2010-31901]
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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
currently unapproved marketed drugs?
For which drugs might this be feasible?
What attributes make published
literature of sufficient quality to
contribute to such an evaluation?
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.
B. Limiting the Use of Enforcement
Discretion
As stated previously, the Agency
acknowledges that the practice of
exercising enforcement discretion in
certain circumstances is necessary to
ensure the availability of some essential
animal drug products. This practice of
exercising enforcement discretion (i.e., a
decision on the part of the Agency to
not take enforcement action in certain
circumstances) is not only important for
managing limited Agency resources
related to compliance activities but is
also important for assuring that certain
animal drug products remain available
for addressing the health needs of
animals. However, FDA’s goal is to
limit, to the extent possible, its use of
enforcement discretion for unapproved
animal drugs.
What factors should the Agency
consider when determining which
unapproved animal drug products or
categories of products should be the
subject of enforcement discretion?
Dated: December 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
[FR Doc. 2010–31889 Filed 12–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB; Comment
Request; National Epidemiologic
Survey on Alcohol and Related
Conditions—III
In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
the National Institute on Alcohol Abuse
and Alcoholism (NIAAA), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on October 15,
2010, and allowed 60-days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
SUMMARY:
Proposed Collection: Title: National
Epidemiologic Survey on Alcohol and
Related Conditions—III. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
This study will determine the
prevalence of alcohol use patterns and
alcohol use disorders and their
associated disabilities in a
representative sample of adults in the
United States population. The primary
objectives of this study are to: (1)
Understand the relationships between
alcohol use patterns and alcohol use
disorders and their related
psychological and medical disabilities
with a view toward designing more
effective treatment, prevention and
intervention programs; (2) identify
subgroups at high risk for alcohol use
disorders that are complicated by
associated disabilities; (3) understand
treatment utilization, unmet treatment
need, barriers to treatment, health
disparities, and economic costs of
alcohol use disorders and their
associated disabilities; and (4) identify
environmental and genetic risk factors
and their interactions that are associated
with harmful consumption patterns and
alcohol use disorders and their
associated disabilities. Frequency of
Response: On occasion. Affected Public:
Individuals. Type of Respondents:
Adults.
ESTIMATED TOTAL ANNUAL BURDEN
Estimated
number of
respondents
Type of
respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated
total annual
burden hours
requested
44,900
1,700
1
2
1.0
1.7
44,900
2,890
Total ..........................................................................................................
jlentini on DSKJ8SOYB1PROD with NOTICES
Adults ...............................................................................................................
Adults ...............................................................................................................
........................
........................
........................
47,790
The annualized cost to respondents is
estimated to be $936,684.00. There are
no Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
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17:18 Dec 17, 2010
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(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
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Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
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79386
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices
Bridget Grant, Chief, Laboratory of
Epidemiology and Biometry, DICBR,
NIAAA, NIH, 5635 Fishers Lane, Room
3077, Rockville, MD 20852, or call nontoll-free number 301–443–7370 or Email your request, including your
address, to:
Bgrant@willco.niaaa.nih.gov.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: December 15, 2010.
Keith Lamirande,
Acting Executive Officer, NIAAA, National
Institutes of Health.
[FR Doc. 2010–31901 Filed 12–17–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Meeting
jlentini on DSKJ8SOYB1PROD 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 a meeting of the
National Advisory General Medical
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
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
General Medical Sciences Council.
Date: January 27–28, 2011.
Closed: January 27, 2011, 8:30 a.m. to 5
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Open: January 28, 2011, 8:30 a.m. to
ADJOURNMENT.
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Agenda: For the discussion of program
policies and issues, opening remarks, report
of the Director, NIGMS, and other business
of the Council.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Contact Person: Ann A. Hagan, PhD,
Associate Director for Extramural Activities,
NIGMS, NIH, DHHS, 45 Center Drive, Room
2AN24H, MSC 6200, Bethesda, MD 20892–
6200. (301) 594–4499.
hagana@nigms.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 taxis, 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. Information is also available on the
Institute’s/Center’s home page: https://
www.nigms.nih.gov/about/
advisory_council.html, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
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 on
Aging Special Emphasis Panel; Hormone
Therapy and Cognitive Aging.
Date: January 11, 2011.
Time: 11 a.m. to 12 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Ramesh Vemuri, PhD,
Chief, Scientific Review Office, National
Institute On Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Bethesda,
MD 20892, 301–402–7700, rv23r@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: National Institute on
Aging Special Emphasis Panel; Cell Lineage
and Tissue Homeostasis in the Aged.
Date: March 1, 2011.
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: Bita Nakhai, PhD,
Scientific Review Officer, Scientific Review
Branch, National Institute On Aging,
Gateway Bldg., 2C212, 7201 Wisconsin
Avenue, Bethesda, MD 20814, 301–402–
7701, nakhaib@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: December 14, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Dated: December 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–31859 Filed 12–17–10; 8:45 am]
[FR Doc. 2010–31857 Filed 12–17–10; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
National Institutes of Health
Federal Emergency Management
Agency
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. 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,
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[Docket ID: FEMA–2010–0057; OMB No.
1660–0072]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request, OMB No.
1660–0072; Mitigation Grants Program/
eGrants
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; extension,
without change, of a currently approved
AGENCY:
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[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79385-79386]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31901]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB; Comment Request; National Epidemiologic
Survey on Alcohol and Related Conditions--III
SUMMARY: In compliance with the requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995, the National Institute on Alcohol
Abuse and Alcoholism (NIAAA), the National Institutes of Health (NIH)
has submitted to the Office of Management and Budget (OMB) a request
for review and approval of the information collection listed below.
This proposed information collection was previously published in the
Federal Register on October 15, 2010, and allowed 60-days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. The National
Institutes of Health may not conduct or sponsor, and the respondent is
not required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a currently valid OMB control number.
Proposed Collection: Title: National Epidemiologic Survey on
Alcohol and Related Conditions--III. Type of Information Collection
Request: NEW. Need and Use of Information Collection: This study will
determine the prevalence of alcohol use patterns and alcohol use
disorders and their associated disabilities in a representative sample
of adults in the United States population. The primary objectives of
this study are to: (1) Understand the relationships between alcohol use
patterns and alcohol use disorders and their related psychological and
medical disabilities with a view toward designing more effective
treatment, prevention and intervention programs; (2) identify subgroups
at high risk for alcohol use disorders that are complicated by
associated disabilities; (3) understand treatment utilization, unmet
treatment need, barriers to treatment, health disparities, and economic
costs of alcohol use disorders and their associated disabilities; and
(4) identify environmental and genetic risk factors and their
interactions that are associated with harmful consumption patterns and
alcohol use disorders and their associated disabilities. Frequency of
Response: On occasion. Affected Public: Individuals. Type of
Respondents: Adults.
Estimated Total Annual Burden
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Adults.......................................... 44,900 1 1.0 44,900
Adults.......................................... 1,700 2 1.7 2,890
---------------------------------------------------------------
Total....................................... .............. .............. .............. 47,790
----------------------------------------------------------------------------------------------------------------
The annualized cost to respondents is estimated to be $936,684.00.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Dr.
[[Page 79386]]
Bridget Grant, Chief, Laboratory of Epidemiology and Biometry, DICBR,
NIAAA, NIH, 5635 Fishers Lane, Room 3077, Rockville, MD 20852, or call
non-toll-free number 301-443-7370 or E-mail your request, including
your address, to: Bgrant@willco.niaaa.nih.gov.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: December 15, 2010.
Keith Lamirande,
Acting Executive Officer, NIAAA, National Institutes of Health.
[FR Doc. 2010-31901 Filed 12-17-10; 8:45 am]
BILLING CODE 4140-01-P
