Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices 75175 

defined by Section 510(b) of the Social 

Security Act (42 U.S.C. 710(b)) with a 

focus on those groups that are most 

likely to bear children out-of-wedlock, 

such as youth in or aging out of foster 

care. 

States are encouraged to develop 

flexible, medically accurate and 

effective abstinence-based plans 

responsive to their specific needs. These 

plans must provide abstinence 

education, and at the option of the State, 

where appropriate, mentoring, 

counseling, and adult supervision to 

promote abstinence from sexual activity, 

with a focus on those groups which are 

most likely to bear children out-ofwedlock. An expected outcome for all 

programs is to promote abstinence from 

sexual activity. 

OMB approval is requested to solicit 

comments from the public on 

paperwork reduction as it relates to 

ACYF’s receipt of the following 

documents from applicants and 

awardees: 

Application for Mandatory Formula 

Grant 

State Plan 

Performance Progress Report 

Respondents: 50 States and 9 

Territories, to include, District of 

Columbia, Puerto Rico, Virgin Islands, 

Guam, American Samoa, Northern 

Mariana Islands, the Federated States of 

Micronesia, the Marshall Islands and 

Palau. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours 

per response 

Total burden 

hours 

Application, to include program narrative ................................ 59 1 24 1,416 

Post-Award State Plan ............................................................ 59 1 40 2,360 

Performance Progress Reports ............................................... 59 2 30 3,540 

Estimated Total Annual Burden 

Hours: 7,316 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

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: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–30272 Filed 12–1–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0182] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Procedures for the Safe and Sanitary 

Processing and Importing of Fish and 

Fishery Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Procedures for the Safe and Sanitary 

Processing and Importing of Fish and 

Fishery Products’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 18, 2010 (75 FR 

34746), the Agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0354. The 

approval expires on November 30, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: November 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30277 Filed 12–1–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0603] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Animal Drug User 

Fees and Fee Waivers and Reductions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting requirements for the 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

75176 Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices 

animal drug user fees and fee waivers 

and reductions. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 31, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.regulations.

gov. Submit written comments on the 

collection of information to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, Juanmanuel.Vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Animal Drug User Fees and Fee 

Waivers and Reductions—(OMB 

Control Number 0910–0540—Extension) 

Enacted on November 18, 2003, the 

Animal Drug User Fee Act (ADUFA) 

(Pub. L. 108–130) amended the Federal 

Food, Drug, and Cosmetic Act and 

requires FDA to assess and collect user 

fees for certain applications, products, 

establishments, and sponsors. It also 

requires the Agency to grant a waiver 

from, or a reduction of those fees in 

certain circumstances. Thus, to 

implement this statutory provision of 

ADUFA, FDA developed a guidance 

entitled ‘‘Guidance for Industry: Animal 

Drug User Fees and Fee Waivers and 

Reductions.’’ It provides guidance on the 

types of fees FDA is authorized to 

collect under ADUFA, and on how to 

request waivers and reductions from 

FDA’s animal drug user fees. The 

guidance also describes the types of fees 

and fee waivers and reductions, the 

information FDA recommends 

respondents submit in support of a 

request for a fee waiver or reduction, 

how respondents may submit such a 

request, and FDA’s process for 

reviewing requests. 

Respondents to this collection of 

information are new animal drug 

sponsors. Requests for waivers or 

reductions may be submitted by a 

person paying any of the animal drug 

user fees assessed—application fees, 

product fees, establishment fees, or 

sponsor fees. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response 

Total 

hours 

740(d)(1)(A) Significant barrier to innovation ...................... 22 1 22 2 44 

740(d)(1)(B) Fees exceed cost ........................................... 0 1 0 2 0 

740(d)(1)(C) Free choice feeds .......................................... 2 1 2 2 4 

740(d)(1)(D) Minor use or minor species ........................... 52 1 52 2 104 

740(d)(1)(E) Small business ............................................... 0 1 0 0 0 

Request for reconsideration of a decision ........................... 5 1 5 2 10 

Request for review—(user fee appeal officer) ..................... 2 1 2 2 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 166 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on FDA’s database system, 

there are an estimated 250 sponsors of 

products subject to ADUFA. However, 

not all sponsors will have any 

submissions in a given year and some 

may have multiple submissions. The 

total number of waiver requests is based 

on the number of submission types 

received by FDA in fiscal year 2008. 

Dated: November 24, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30264 Filed 12–1–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Gastrointestinal Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES