34358 Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Notices 

plans and instruments, call 404–639– 

5960 and send comments to Maryam I. 

Daneshvar, CDC Acting Reports 

Clearance Officer, 1600 Clifton Road, 

MS–D74, Atlanta, GA 30333; or send an 

e-mail to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the 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) 

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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

CDC American Recovery and 

Reinvestment Act of 2009 (ARRA) 

Performance Progress Report—New— 

Office of the Chief Operating Officer 

(OCOO), Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The American Recovery and 

Reinvestment Act of 2009 was signed 

into law on February 17, 2009, Public 

Law 111–5 (‘‘Recovery Act’’). The 

purpose of this proposed data collection 

is to collect quarterly performance 

information for all CDC grants and 

cooperative agreements funded under 

the Recovery Act. This will allow CDC 

to receive reports on recipient 

performance measures as set forth in the 

applicable Funding Opportunity 

Announcement (FOA) and Notice of 

Grant Award. This requirement is in 

addition to the reporting requirements 

of Section 1512 of the Recovery Act, set 

forth by the Office of Management and 

Budget (OMB) under the data collection 

instrument titled ‘‘Standard Data 

Elements for Reports under Section 

1512 of the American Recovery and 

Reinvestment Act of 2009, Public Law 

111–5 (Grants, Cooperative Agreements 

and Loans).’’ 

The form CDC proposes to use is a 

modified Performance Progress Report 

(SF–PPR) which was successfully 

piloted by the Administration for 

Children and Families (ACF). CDC 

intends to use this modified form for 

quarterly standard reporting of 

performance measures set forth in the 

applicable FOA and Notice of Grant 

Award for all CDC Recovery Act funded 

grants and cooperative agreements. In 

addition to allowing for uniformity of 

information collection, this format will 

support systematic electronic collection 

and submission of information. The 

form contains identifying data elements 

and a section for a performance 

narrative. 

There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

(in hours) 

Recipients using CDC ARRA Performance Progress Report ......................... 405 4 1.5 2430 

Dated: July 8, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–16772 Filed 7–14–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0283] 

Draft Guidance for Industry on 

Postmarketing Studies and Clinical 

Trials; Implementation of the Federal 

Food, Drug, and Cosmetic Act; 

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 ‘‘Postmarketing 

Studies and Clinical Trials— 

Implementation of Section 505(o) of the 

Federal Food, Drug, and Cosmetic Act.’’ 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

added new provisions to the Federal 

Food, Drug, and Cosmetic Act (the act) 

authorizing FDA to require certain 

postmarketing studies and clinical trials 

for prescription drugs and biological 

products approved under the act or the 

Public Health Service Act (the PHS Act). 

This draft guidance provides 

information on the implementation of 

the new provisions and a description of 

the types of postmarketing studies and 

clinical trials that will generally be 

required under the new legislation 

(postmarketing requirements (PMRs)) 

and the types that will generally be 

agreed-upon commitments 

(postmarketing commitments (PMCs)) 

because they do not meet the new 

statutory criteria for required 

postmarketing studies and clinical 

trials. 

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 comment 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 October 13, 2009. 

ADDRESSES: Submit written requests for 

single copies of this 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 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 draft 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send one self-addressed 

adhesive label 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: 

Nancy Clark, Center for Drug Evaluation 

and Research, Food and Drug 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Notices 34359 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6144, Silver Spring, 

MD 20993–0002, 301–796–5400; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Postmarketing Studies and Clinical 

Trials—Implementation of Section 

505(o) of the Federal Food, Drug, and 

Cosmetic Act.’’ In the past, FDA has 

used the term ‘‘PMC’’ to refer to studies 

(including clinical trials), conducted by 

an applicant after FDA has approved a 

drug for marketing or licensing, that 

were intended to further refine the 

safety, efficacy, or optimal use of a 

product, or to ensure consistency, and 

reliability of product quality. These 

commitments were either agreed upon 

by FDA and the applicant or, in certain 

circumstances, required by FDA. Prior 

to the passage of FDAAA, FDA required 

PMCs in the following situations: 

• Subpart H and subpart E 

accelerated approvals, which require 

postmarketing studies to demonstrate 

clinical benefit (21 CFR 314.510 and 

601.41); 

• Deferred pediatric studies, where 

studies are required under the Pediatric 

Research Equity Act (PREA) (21 CFR 

314.55(b) and 601.27(b)); and 

• Animal Efficacy Rule approvals, 

where studies to demonstrate safety and 

efficacy in humans are required at the 

time of use (21 CFR 314.610(b)(1) and 

601.91(b)(1)). 

Title IX, section 901 of FDAAA 

(Public Law 110–85) amended the act by 

adding new section 505(o) (21 U.S.C. 

355(o)). Section 505(o) of the act 

authorizes FDA to require certain 

postmarketing studies or clinical trials 

for prescription drug and biological 

products approved under section 505 of 

the act or section 351 of the PHS Act (42 

U.S.C. 262). Section 505(o)(3)(B) of the 

act states that postmarketing studies and 

clinical trials may be required for one of 

three purposes: 

• To assess a known serious risk 

related to the use of the drug; 

• To assess signals of serious risk 

related to the use of the drug; or 

• To identify an unexpected serious 

risk when available data indicates the 

potential for a serious risk. 

This draft guidance provides 

information on the implementation of 

new section 505(o) of the act. The draft 

guidance also describes which types of 

postmarketing studies and clinical trials 

will be required (PMRs) under section 

505(o) of the act and which types will 

be agreed-upon commitments because 

they do not meet the statutory criteria 

for required studies and trials (PMCs). 

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 implementation of section 901 of 

FDAAA on postmarketing studies and 

clinical trials. 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 provides 

information on the implementation of 

section 901 of FDAAA. The collections 

of information requested in the draft 

guidance would be submitted under 21 

CFR 314.80, 314.81, and 601.70. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520) and are approved under OMB 

control numbers 0910–0230, 0910–0001, 

and 0910–0338. Section VI of the draft 

guidance refers to procedures in the 

guidance entitled ‘‘Formal Dispute 

Resolution: Appeals Above the Division 

Level,’’ which contains collections of 

information approved under OMB 

control number 0910–0430. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: July 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16867 Filed 7–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1998–D–0021 (formerly 

Docket No. 1998D–0514)] 

Guidance for Industry on Abbreviated 

New Drug Applications: Impurities in 

Drug Substances; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘ANDAs: Impurities in Drug 

Substances,’’ which is a revision of a 

guidance for industry of the same name 

that published in November 1999. The 

guidance provides recommendations for 

applicants on what chemistry, 

manufacturing, and controls (CMC) 

information to include regarding the 

reporting, identification, and 

qualification of impurities in drug 

substances produced by chemical 

synthesis when submitting original 

abbreviated new drug applications 

(ANDAs); drug master files (DMFs), 

including type II DMFs; and ANDA 

supplements for changes in the 

synthesis or processing of a drug 

substance. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

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 guidance 

document. 


sroberts on DSKD5P82C1PROD with NOTICES