Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 11113 

to date. The input provided by 

stakeholders at that meeting was useful 

in providing insight into stakeholder 

needs and in helping to improve the 

Childhood Agricultural Injury 

Prevention Initiative. 

In 2001, a Childhood Agricultural 

Injury Prevention Summit was 

organized and convened by the National 

Children’s Center for Rural and 

Agricultural Health and Safety 

(NCCRAHS), an extramurally funded 

component, five years after the 

implementation of the NIOSH 

Childhood Agricultural Injury 

Prevention Initiative. The goal of the 

summit was to conduct a five-year 

review of the 1996 National Action Plan 

and to use a consensus development 

process to generate strategies for the 

future. Specifically, participants were 

asked to consider: (a) Successes to date, 

(b) gaps and barriers in achieving 

objectives, (c) current and potential 

effective interventions not addressed in 

the National Action Plan, and (d) 

strategies for the future. To date, NIOSH 

has undertaken a number of activities, 

both intramurally and extramurally, to 

address the recommendations in the 

1996 National Action Plan and the 2001 

Childhood Agricultural Injury 

Prevention Summit. 

Status: The Document, NIOSH 

Childhood Agricultural Injury 

Prevention Initiative: Progress and 

Proposed Future Activities, will be 

available for comment by stakeholders 

and other interested members of the 

public. Written comments should be 

submitted to the NIOSH Docket Office 

as outlined in the next section. 

Docket: Written comments on the 

usefulness of the Childhood 

Agricultural Injury Prevention Initiative 

for improving childhood agricultural 

safety and suggestions for enhancing or 

improving the impact of the Initiative 

should be mailed to the NIOSH Docket 

Office, Robert A. Taft Laboratories, MS– 

C34, 4676 Columbia Parkway, 

Cincinnati, Ohio 45226, telephone (513) 

533–8303, facsimile (513) 533–8285. 

Comments may also be submitted by email to niocindocket@cdc.gov. E-mail 

attachments should be formatted in 

Microsoft Word. All materials submitted 

to the Agency should reference NIOSH 

docket number 145 and must be 

submitted by May 15, 2009 to be 

considered by the Agency. All 

electronic comments should be 

formatted as Microsoft Word. All 

information received in response to this 

notice will be available for public 

examination and copying at the NIOSH 

Docket Office, Room 111, 4676 

Columbia Parkway, Cincinnati, Ohio 

45226. After the comment period has 

closed, comments may be accessed 

electronically at http://www.cdc.gov/ 

niosh under the link to the NIOSH 

docket. As appropriate, NIOSH will post 

comments with the commenters’ names, 

affiliations, and other information, on 

the Internet. 

Contact Person for Technical 

Information: David Hard, Health 

Scientist, Analysis and Field 

Investigations Branch, Division of Safety 

Research, telephone (304) 285–6068, Email DHard@cdc.gov, facsimile (304) 

285–6235. 

Dated: March 9, 2009. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–5583 Filed 3–13–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Proposed Project 

Title: Head Start Family and Child 

Experiences Survey (FACES 2009). 

OMB No.: 0970–0151. 

Description: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services, is planning to collect data on 

a new cohort for the Head Start Family 

and Child Experiences Survey (FACES). 

FACES is a longitudinal study of a 

nationally representative sample of 

Head Start programs and children that 

will collect information for Head Start 

performance measures. Data for FACES 

will be collected annually through 

interviews with Head Start parents, 

teachers, program directors and other 

Head Start staff, as well as direct child 

assessments and observations of Head 

Start classrooms. 

Data will be collected on a sample of 

approximately 3,400 children and 

families from 60 Head Start programs. 

Data collection will include assessments 

of Head Start children, interviews with 

their parents, and ratings by their Head 

Start teachers. Site visitors will 

interview Head Start teachers in 

approximately 405 classrooms and make 

observations of the types and quality of 

classroom activities. Interviews will also 

be conducted with Head Start program 

directors and other staff. A follow-up for 

children in Kindergarten will include 

child assessments, parent interviews, 

and teacher questionnaires and child 

ratings. 

The purpose of this data collection is 

to fulfill the requirements of the 

Government Performance and Results 

Act (GPRA) of 1993 (Pub. L. 103–62), 

and by the 1994 reauthorization of the 

Head Start program (Head Start Act, as 

amended, May 18, 1994, Section 649 

(d)), which call for periodic assessments 

of Head Start’s quality and effectiveness. 

Respondents: Parents of Head Start 

Children, Head Start Children, Head 

Start Teachers, Head Start Program 

Directors and Staff, and Kindergarten 

Teachers of former Head Start enrollees. 

ANNUAL BURDEN ESTIMATES

Annual number of respondents Number of responses per 

respondent 

Average burden hour per 

response 

Estimated annual burden 

hours 

Parent Interview ............................................................................................... 3,185 1.0 .81 2,564 

Child Assessment ............................................................................................ 3,245 1.0 0.75 2,434 

Head Start Teacher Interview .......................................................................... 405 1.0 0.50 203 

Head Start Teacher Child Rating .................................................................... 405 9.0 0.17 620 

Program Director Interview .............................................................................. 20 1.0 0.50 10 

Center Director Interview ................................................................................. 40 1.0 0.50 20 

Education Coordinator Interview ..................................................................... 20 1.0 0.50 10 

Kindergarten Teacher Questionnaire .............................................................. 1,128 1.3 0.50 733 

Kindergarten Teacher Child Rating ................................................................. 1,128 1.3 0.17 249 

Total Annual Burden Hours: ..................................................................... ........................ ........................ ........................ 6,843 

11114 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: OPRE Reports 

Clearance Officer. All requests should 

be identified by the title of the 

information collection. E-mail address: 

OPREinfocollection@acf.hhs.qov. 

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 0MB 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 the 

Administration for Children and 

Families. 

Dated: March 9, 2009. 

Brendan C. Kelly, 

OPRE Reports Clearance Officer. 

[FR Doc. E9–5511 Filed 3–13–09; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0556] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Formal Meetings With 

Sponsors and Applicants for 

Prescription Drug User Fee Act 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 15, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0429. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Formal 

Meetings With Sponsors and 

Applicants for PDUFA Products (OMB 

Control Number 0910–0429)—Extension 

This information collection approval 

request is for an FDA guidance on the 

procedures for formal meetings between 

FDA and sponsors or applicants 

regarding the development and review 

of Prescription Drug User Fee Act 

(PDUFA) products. The guidance 

describes procedures for requesting, 

scheduling, conducting, and 

documenting such formal meetings. The 

guidance provides information on how 

the agency will interpret and apply 

section 119(a) of the Food and Drug 

Administration Modernization Act (the 

Modernization Act), specific PDUFA 

goals for the management of meetings 

associated with the review of human 

drug applications for PDUFA products, 

and provisions of existing regulations 

describing certain meetings (§§ 312.47 

and 312.82 (21 CFR 312.47 and 312.82)). 

The guidance describes two 

collections of information: The 

submission of a meeting request 

containing certain information and the 

submission of an information package in 

advance of the formal meeting. Agency 

regulations at § 312.47(b)(1)(ii), 

(b)(1)(iv), and (b)(2) describe 

information that should be submitted in 

support of a request for an End-of-Phase 

2 meeting and a Pre-New Drug 

Application meeting. The information 

collection provisions under § 312.47 

have been approved by OMB (OMB 

control no. 0910–0014). However, the 

guidance provides additional 

recommendations for submitting 

information to FDA in support of a 

meeting request. As a result, FDA is 

submitting additional estimates for 

OMB approval. 

I. Request for a Meeting 

Under the guidance, a sponsor or 

applicant interested in meeting with the 

Center for Drug Evaluation and Research 

(CDER) or the Center for Biologics 

Evaluation and Research (CBER) should 

submit a meeting request to the 

appropriate FDA component as an 

amendment to the underlying 

application. FDA regulations (§§ 312.23, 

314.50, and 601.2 (21 CFR 312.23, 

314.50, and 601.2)) state that 

information provided to the agency as 

part of an investigational new drug 

application (IND), new drug application 

(NDA), or biological license application 

(BLA) must be submitted with an 

appropriate cover form. Form FDA 1571 

must accompany submissions under 

INDs and Form FDA 356h must 

accompany submissions under NDAs 

and BLAs. Both forms have valid OMB 

control numbers as follows: FDA Form 

1571 (OMB control no. 0910–0014) and 

FDA Form 356h (OMB control no. 

0910–0338). 

In the guidance document, CDER and 

CBER ask that a request for a formal 

meeting be submitted as an amendment 

to the application for the underlying 

product under the requirements of 

§§ 312.23, 314.50, and 601.2; therefore, 

requests should be submitted to the 

agency with the appropriate form 

attached, either Form FDA 1571 or Form 

FDA 356h. The agency recommends that 

a request be submitted in this manner 

for two reasons: (1) To ensure that each 

request is kept in the administrative file 

with the entire underlying application 

and (2) to ensure that pertinent 

information about the request is entered 

into the appropriate tracking databases. 

Use of the information in the agency’s 

tracking databases enables the agency to 

monitor progress on the activities 

attendant to scheduling and holding a 

formal meeting and to ensure that 

appropriate steps will be taken in a 

timely manner. 

Under the guidance, the agency 

requests that sponsors and applicants 

include in meeting requests certain 

information about the proposed meeting 

as follows: 

• Information identifying and 

describing the product; 

• The type of meeting being 

requested; 

• A brief statement of the purpose of 

the meeting; 

• A list of objectives and expected 

outcomes from the meeting; 

• A preliminary proposed agenda; 

• A draft list of questions to be raised 

at the meeting; 

• A list of individuals who will 

represent the sponsor or applicant at the 

meeting;