Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61445 

Estimated Total Annual Burden 

Hours: 297. 

In compliance with the requirements 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for proper performance of the functions 

of the agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Dated: October 17, 2005. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 05–21163 Filed 10–21–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Delegation of Authority 

Notice is hereby given that, under the 

authority vested in me by the Secretary 

of Health and Human Services, I have 

redelegated to the Commissioner, 

Administration on Children, Youth and 

Families, with the authority to further 

redelegate, the authority to continue the 

administration of grants and contracts 

initially awarded in the Fiscal Years 

2002, 2003 and 2004 under the Special 

Projects of Regional and National 

Significance (SPRANS) Communitybased Abstinence Education Program, 

pursuant to Title V, section 501(a)(2) of 

the Social Security Act, as amended. 

The SPRANS Community-based 

Abstinence Education Program includes 

Community-based Abstinence 

Education grants, Abstinence Education 

Special Congressional Initiative Project 

grants, and the Abstinence Education 

Technical Assistance contract with the 

National Abstinence Clearinghouse. 

This delegation permits the 

Commissioner, Administration on 

Children, Youth and Families, to 

administer FY 2002, 2003 and FY 2004 

SPRANS abstinence education grants 

under the terms and conditions of the 

initial awards, thereby allowing the 

continuation of the existing grants 

consistent with recent appropriations 

enactments (Pub. L. 108–477). 

This delegation shall be exercised 

under the Department’s policy on 

regulations and the existing delegation 

of authority to approve and issue 

regulations. This delegation excludes 

the authority to issue reports to 

Congress, to take final action to 

withhold funds from States and to act 

under the nondiscrimination provisions 

of the Social Security Act. 

This delegation also supersedes all 

prior delegations of authority to the 

extent that they are inconsistent with 

the provisions of this delegation. 

I hereby ratify any actions taken by 

the Commission, Administration on 

Children Youth and Families, or any 

other Administration on Children, 

Youth and Families official, which, in 

effect, involved the exercise of this 

authority prior to the effective date of 

this delegation. 

This delegation is effective on the 

date of signature. 

Dated: October 6, 2005. 

Wade. F. Horn, 

Assistant Secretary for Children & Families. 

[FR Doc. 05–21162 Filed 10–21–05; 8:45am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0395] 

Agency Information Collection 

Activities: Proposed Collection; 

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 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 information collection contained in 

the guidance for industry on formal 

meetings with sponsors and applicants 

for Prescription Drug User Fee Act 

(PDUFA) products. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 23, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.fda.gov/ 

dockets/ecomments. 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: 

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482. 

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 

61446 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

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. 

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 a FDA guidance on the 

procedures for formal meetings between 

FDA and sponsors or applicants 

regarding the development and review 

of 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 NDA meeting. The 

information collection provisions of 

§ 312.47 have been approved by OMB 

(OMB control number 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. 

A. 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 number 

0910–0014, expires January 31, 2005; 

and FDA Form 356h, OMB control 

number 0910–0338, expires September 

30, 2008. 

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 the following 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. Such information includes the 

following: 

• 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; 

• A list of agency staff requested to be 

in attendance; 

•The approximate date that the 

information package will be sent to the 

agency; and 

• Suggested dates and times for the 

meeting. 

•This information will be used by the 

agency to determine the utility of the 

meeting, to identify agency staff 

necessary to discuss proposed agenda 

items, and to schedule the meeting. 

B. Information Package 

A sponsor or applicant submitting an 

information package to the agency in 

advance of a formal meeting should 

provide summary information relevant 

to the product and supplementary 

information pertaining to any issue 

raised by the sponsor, applicant, or 

agency. The agency recommends that 

information packages generally include: 

• Identifying information about the 

underlying product; 

• A brief statement of the purpose of 

the meeting; 

• A list of objectives and expected 

outcomes of the meeting; 

• A proposed agenda for the meeting; 

• A list of specific questions to be 

addressed at the meeting; 

• A summary of clinical data that will 

be discussed (as appropriate); 

• A summary of preclinical data that 

will be discussed (as appropriate); and 

•Chemistry, manufacturing, and 

controls information that may be 

discussed (as appropriate). 

The purpose of the information 

package is to provide agency staff the 

opportunity to adequately prepare for 

the meeting, including the review of 

relevant data concerning the product. 

Although FDA reviews similar 

information in the meeting request, the 

information package should provide 

updated data that reflect the most 

current and accurate information 

available to the sponsor or applicant. 

The agency finds that reviewing such 

information is critical to achieving a 

productive meeting. 

The collection of information 

described in the guidance reflects the 

current and past practice of sponsors 

and applicants to submit meeting 

requests as amendments to INDs, NDAs, 

and BLAs and to submit background 

information prior to a scheduled 

meeting. Agency regulations currently 

permit such requests and recommend 

the submission of an information 

package before an End of Phase 2 

meeting (§§ 312.47(b)(1)(ii) and 

(b)(1)(iv)) and a Pre NDA meeting 

(§ 312.47(b)(2)). 

Description of respondents: A sponsor 

or applicant for a drug or biological 

product who requests a formal meeting 

with the agency regarding the 

development and review of a PDUFA 

product. 

Burden Estimate: Provided in the 

following paragraphs is an estimate of 

the annual reporting burden for the 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61447 

submission of meeting requests and 

information packages under the 

guidance. 

C. Request For a Formal Meeting 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 713 sponsors and 

applicants (respondents) request 

approximately 1,783 formal meetings 

with CDER annually and approximately 

164 respondents request approximately 

286 formal meetings with CBER 

annually regarding the development and 

review of a PDUFA product. The hours 

per response, which is the estimated 

number of hours that a respondent 

would spend preparing the information 

to be submitted with a meeting request 

in accordance with the guidance, is 

estimated to be approximately 10 hours. 

Based on FDA’s experience, the agency 

expects it will take respondents this 

amount of time to gather and copy brief 

statements about the product and a 

description of the purpose and details of 

the meeting. 

D. Information Package 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 615 respondents 

submitted approximately 1,365 

information packages to CDER annually 

and approximately 132 respondents 

submitted approximately 208 

information packages to CBER annually 

prior to a formal meeting regarding the 

development and review of a PDUFA 

product. The hours per response, which 

is the estimated number of hours that a 

respondent would spend preparing the 

information package in accordance with 

the guidance, is estimated to be 

approximately 18 hours. Based on 

FDA’s experience, the agency expects it 

will take respondents this amount of 

time to gather and copy brief statements 

about the product, a description of the 

details for the anticipated meeting, and 

data and information that generally 

would already have been compiled for 

submission to the agency. 

As stated earlier, the guidance 

provides information on how the agency 

will interpret and apply section 119(a) 

of 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). The information 

collection provisions in § 312.47 

concerning End of Phase 2 meetings and 

Pre NDA meetings have been approved 

by OMB (OMB control number 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 for OMB 

approval these additional estimates. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

Meeting Requests and Information 

Packages 

Number of Respondents Number of Responses 

Per Respondent 

Total Annual Responses Hours Per Response Total Hours 

Meeting Requests 

CDER 713 2 .50 1,783 10 17,830 

CBER 164 1 .74 286 10 2,860 

Total 20,690 

Information Packages 

CDER 615 2 .22 1,365 18 24,570 

CBER 132 1 .58 208 18 3,744 

Total 28,314 

Grand Total 49,004 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21151 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0220] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donor Testing, Donor Notification, and 

‘‘Lookback’’

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 November 

23, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written