Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79385 

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? 

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? 

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 

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. 

Dated: December 15, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31889 Filed 12–17–10; 8:45 am] 

BILLING CODE 4160–01–P 

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

Type of 

respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

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. 


jlentini on DSKJ8SOYB1PROD with NOTICES
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] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Meeting 

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. 

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: http:// 

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) 

Dated: December 14, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–31857 Filed 12–17–10; 8:45 am] 

BILLING CODE 4140–01–P 

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. 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: 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. 

[FR Doc. 2010–31859 Filed 12–17–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[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 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 30-day notice and 

request for comments; extension, 

without change, of a currently approved 


jlentini on DSKJ8SOYB1PROD with NOTICES