Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 10767 

demonstrated the potential for positive 

impacts. The survey also will include 

some general informational questions 

about youth in the study so that HHS, 

policy makers, and practitioners can 

have a greater understanding of the life 

circumstances of these youth and of 

some of the challenges they may face. 

The youth surveys will focus on 

measuring both attitudinal and 

behavioral changes in areas targeted by 

the MCP program including attitudes 

towards and performance in school; 

relationships with parents, peers and 

teachers; self-esteem; and engagement in 

a variety of risk behaviors, including 

alcohol and drug use and physical 

violence. They also will include 

questions about the living situations of 

youth in the study, their relationships 

with both incarcerated and nonincarcerated caregivers, and their 

relationships with other supportive 

adults in their communities. 

The administrative survey of grantees 

will include questions about the 

programmatic structure of each grantee. 

It will provide information about 

variations in program administration, 

mentor activities, and youth served. 

Respondents: Mentoring Children of 

Prisoners (MCP) grantees and non-MCP 

mentoring organizations. 

Annual Burden Estimates: 

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden 

hours per response 

Total burden 

hours 

Student Baseline Survey. ............................................................................ 625 1 .5 312 .5 

Student follow-up Survey. ............................................................................ 500 1 .5 250 

Grantee Survey ............................................................................................ 72 1 1 72 

Estimated Total Annual Burden 

Hours: 634.5. 

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: 202–395–6974, 

Attn: Desk Officer for ACF. 

Dated: March 5, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–1101 Filed 3–8–07; 8:45 am] 

BILLING CODE 4184–07–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0301] 

Guidance for Industry: Animal Drug 

User Fees; Fees Exceed Costs Waiver/ 

Reduction; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance for industry 

(#183) entitled ‘‘Guidance for Industry: 

Animal Drug User Fees; Fees Exceed 

Costs Waiver/Reduction.’’ This 

guidance explains the procedures FDA 

expects to use to evaluate waiver 

requests under the fees exceed costs 

waiver provision of the Animal Drug 

User Fee Act of 2003 (ADUFA). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

to the Communications Staff (HFV–12), 

Center for Veterinary Medicine (CVM), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the guidance document to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. Submit electronic comments to 

http:///www.fda.gov/dockets/ 

ecomments. Comments should be 

identified with the full title of the 

guidance document and the docket 

number found in the heading of this 

document. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Dave Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 17, 

2006 (71 FR 47502), FDA published the 

notice of availability of the draft 

guidance entitled ‘‘Guidance for 

Industry: Animal Drug User Fees; Fees 

Exceed Costs Waiver and Reductions’’

giving interested persons until October 

31, 2006, to submit comments. FDA 

received no comments. 

ADUFA (Public Law 108–130) 

amended the Federal Food, Drug, and 

Cosmetic Act (the act) and requires the 

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. 

This guidance explains the 

procedures FDA expects to use to 

evaluate waiver requests under the fees 

exceed costs waiver provision of 

ADUFA. These procedures may be 

modified in the future as FDA gains 

more experience with waiver requests. 

To qualify for waiver consideration, a 

written request to the agency for a 

waiver/reduction, including under the 

fees exceed costs waiver provision, must 

be submitted no later than 180 days 

after the fee is due (section 740(i) of the 

act (21 U.S.C. 379j–12(i))). 

II. Significance of Guidance 

This level 1 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 the topic. The 

document does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. 

Alternative approaches may be used as 

long as they satisfy the requirements of 

the applicable statutes and regulations. 


jlentini on PROD1PC65 with NOTICES
10768 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Notices 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in Guidance for Industry #170. 

These collections of information are 

subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520) and have been 

approved under OMB Control No. 0910–

0540. 

IV. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. 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 the 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either CVM 

home page (http://www.fda.gov/cvm) or 

the Division of Dockets Management 

Web site http://www.fda.gov/ohrms/ 

dockets/default.htm. 

Dated: March 1, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4322 Filed 3–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submissions for OMB Review; 

Comment Request; Evaluation of the 

Impact of the New Conflicts of Interest 

Regulations on the National Institutes 

of Health’s Ability to Recruit and 

Retain Staff 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of 

Human Resources (OHR), 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. The purpose of this notice 

is to allow 30 days for public comment. 

The NIH 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: Evaluation of the Impact of the 

New Conflicts of Interest regulations on 

the National Institutes of Health’s 

Ability To Recruit and Retain Staff. 

Type of Information Collection 

Request: NEW. 

Need and Use of Information 

Collection: To assess the impact of new 

Department of Health and Human 

Services (HHS) conflicts of interest 

regulations on the NIH’s ability to 

continue to attract and recruit highly 

qualified scientific personnel. Gauging 

both the immediate and long-term 

impact of these new rules is crucial to 

NIH’s ability to develop and maintain a 

world-class staff. This project will 

produce data that will help NIH and 

HHS leaders determine the impact of 

the regulations and how to minimize the 

effect of the regulations on NIH’s ability 

to recruit and retain staff. NIH intends 

to survey potential applications for NIH 

employment from scientific 

organizations from which NIH has 

traditionally drawn leading scientific 

personnel, and those senior scientists 

and administrators who have 

voluntarily left NIH since February 

2005. This will allow NIH to determine 

whether the regulations impact 

individuals’ attitudes about 

employment at NIH and the likelihood 

of their joining and/or leaving the 

agency. This proposed one-time survey 

is part of a larger study that will provide 

OHR with the high-quality data needed 

to evaluate the impact of the new rules. 

Data will be collected on respondents’

understanding of the new regulations, 

how they believe the regulations could 

impact them, and on their feelings about 

working at NIH in light of the 

regulations. Data will also be collected 

from current NIH employees and the 

combined data will be used in the 

review of the rules. The survey is 

planned to launch in early 2007 and to 

be in the field for eight weeks. 

Frequency of Response: Once. 

Affected Public: Individuals or 

households. 

Type of Respondents: Potential 

applicants for NIH positions and senior 

scientists and administrators who have 

voluntarily left NIH since February 

2005. 

The annual reporting burden is as 

follows: 

Type of respondent Number of respondents 

Frequency of 

response 

Average time 

per response 

(minutes) 

Estimated total 

annual hour 

burden 

(hours) 

Potential Applicants ......................................................................................... 400 1 15 100 

Former NIH Employees ................................................................................... 100 1 10 16.67 

TOTAL ...................................................................................................... 500 ........................ ........................ 116.67 

Total Number of Respondents: 500. 

Total Number of Responses: 500. 

Total Hours: 116.67 hours. 

The annualized cost to respondents is 

estimated at: $3,850. 

There are no capital costs, operating 

costs, and/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 Comment 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, New Executive 


jlentini on PROD1PC65 with NOTICES