9250 Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by May 4, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 31, 2009. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–4374 Filed 3–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0095] 

Draft Guidance for Industry on the 

Clinical Pharmacology Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Clinical 

Pharmacology Section of Labeling for 

Human Prescription Drug and Biological 

Products—Content and Format.’’ This 

draft guidance is one of a series of 

guidance documents intended to assist 

applicants in complying with new FDA 

regulations on the content and format of 

labeling for human prescription drug 

and biological products. The draft 

guidance describes the recommended 

information to include in the Clinical 

pharmacology section of labeling that 

pertains to the safe and effective use of 

human prescription drug and biological 

products. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 1, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send two self-addressed 

adhesive labels to assist the office in 

processing your requests. Submit 

written comments on the draft guidance 

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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Paul Hepp, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 1270, 

Silver Spring, MD 20993–0002, 

301–796–1538; or 

Lei Zhang, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 3106, 

Silver Spring, MD 20993–0002, 

301–796–1635; or 

Stephen M. Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17),Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 24, 

2006 (71 FR 3922), FDA published a 

final rule entitled ‘‘Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and Biological 

Products,’’ to revise the agency’s 

previous regulations on labeling 

(effective June 30, 2006). The new FDA 

regulations are designed to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use, 

thereby increasing the extent to which 

practitioners rely on labeling for 

prescribing decisions. Among other 

things, the new FDA regulations require 

that the Clinical pharmacology section 

of the labeling contain the following 

subsections: Mechanism of action, 

Pharmacodynamics, and 

Pharmacokinetics(§ 201.57(c)(13)(i) (21 

CFR 201.57(c)(13)(i)). 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Clinical Pharmacology Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ The draft guidance is intended 

to assist applicants in producing the 

Clinical pharmacology section of 

labeling for human prescription drug 

and biological products that is 

consistent, understandable, organized, 

clinically useful, and in compliance 

with the new requirements of 

§ 201.57(c)(13)(i). The ultimate goal of 

the guidance is to optimize patient drug 

therapy. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the content and format of the clinical 

pharmacology section of labeling for 

human prescription drug and biological 

products. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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 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. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices 9251 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information related to the content and 

format of labeling have been approved 

under OMB control no. 0910–0572; the 

collections of information related to 

pharmacogenomic data have been 

approved under OMB control no. 0910– 

0557. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/ 

guidelines.htm, or http:// 

www.regulations.gov. 

Dated: February 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4372 Filed 3–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer on (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance 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. 

Proposed Project: HRSA Office of 

Performance Review (OPR) Leading 

Practices Data Collection Initiative— 

NEW 

HRSA conducts performance reviews 

to assure that HRSA-funded grantees are 

successfully accomplishing their 

program purposes. While the Office of 

Performance Review’s (OPR) primary 

function is to conduct performance 

reviews, another core function is to 

identify leading practices through the 

performance review process. The 

purpose of this submission is to collect 

qualitative information from diverse 

grantees across HRSA and identify a 

program component (activity, strategy, 

process, or intervention) that has been 

shown to work effectively, and produce 

successful outcomes, supported by 

objective and/or subjective data sources. 

Some characteristics of the program 

components that grantees will be asked 

to describe are their ability to be 

replicable and adaptable, ability to be 

documented, and ability to lead to 

successful program outcomes. 

In order to document and evaluate 

leading practices, grantees with 

potential leading practices will be asked 

to complete both the Data Collection 

Tool and the Narrative. The information 

collected through these documents will 

be submitted to OPR. The estimated 

annual burden is as follows: 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Data Collection Tool ............................................................ 40 1 40 3 120 

Narrative ............................................................................... 40 1 40 3 120 

Total .............................................................................. ........................ ........................ ........................ ........................ 240 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: February 24, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–4459 Filed 3–2–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Health Centers 

Patient Survey—New. 

The Health Center program supports 

Community Health Centers (CHCs), 

Migrant Health Centers (MHCs), Health 

Care for the Homeless (HCH) projects, 

and Public Housing Primary Care 

(PHPC) programs. Health Centers 

receive grants from HRSA to provide 

primary and preventive health care 

services to medically underserved 

populations. 

The proposed Patient Survey will 

collect in-depth information about 

health center patients, their health 

mstockstill on PROD1PC66 with NOTICES