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a draft guidance for industry entitled 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This draft guidance provides 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
34360 Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Lawrence Yu, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855, 240– 

276–9310. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised guidance for industry entitled 

‘‘ANDAs: Impurities in Drug 

Substances.’’ The guidance provides 

revised recommendations on what CMC 

information to include regarding the 

reporting, identification, and 

qualification of impurities in drug 

substances produced by chemical 

synthesis when submitting: (1) Original 

ANDAs; (2) DMFs, including type II 

DMFs; and (3) ANDA supplements for 

changes in the synthesis or processing 

of a drug substance. The guidance also 

provides recommendations for 

establishing acceptance criteria for 

impurities in drug substances. 

In November 1999, FDA published 

the first version of this guidance. In 

2003, the International Conference on 

Harmonisation made changes to 

recommendations on impurities in drug 

substances for new drug applications in 

the guidance for industry entitled ‘‘Q3A 

Impurities in New Drug Substances’’ 

(Revision 1) (Q3A(R)). As a result of 

these changes, FDA began an effort to 

revise this guidance for ANDAs. FDA 

has revised the guidance to update 

information on listing impurities, 

setting acceptance criteria, and 

qualifying impurities (thresholds and 

procedures) in ANDAs to make it 

consistent with Q3A(R). 

On January 31, 2005 (70 FR 4857), 

FDA announced the availability of the 

draft revision for public comment. The 

comment period closed on May 2, 2005. 

A number of comments were received, 

which the agency considered carefully 

as it began the process of finalizing the 

guidance. 

This 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 impurities in drug 

substances for generic drugs. 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 an 

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 guidance refers to previously 

approved collections of information 

found in FDA regulations. 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). The collections of information in 

21 CFR part 314 have been approved 

under OMB Control No. 0910–0001. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: July 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16868 Filed 7–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Board of Scientific Counselors, 

Coordinating Office for Terrorism 

Preparedness and Emergency 

Response (BSC, COTPER) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC announces the 

following meeting of the 

aforementioned committee: 

Times and Dates: 12 p.m.–5:15 p.m., 

August 13, 2009; 9 a.m.–3:30 p.m., August 

14, 2009. 

Place: CDC, 1600 Clifton Road, NE., Global 

Communications Center, Building 19, 

Auditorium B3, Atlanta, Georgia 30333. 

Status: Open to the public for observation 

and comment, limited only by the space 

available. The meeting room accommodates 

approximately 50 people. Visitors to the CDC 

campus must be processed in accordance 

with established Federal policies and 

procedures and should pre-register for the 

meeting as described in Additional 

Information for visitors. Public comment 

periods are planned for both meeting days. 

Purpose: This Board is charged with 

advising the Secretary of HHS and Director 

of CDC concerning strategies and goals for 

the programs and research within COTPER, 

monitoring the strategic direction and focus 

of the Divisions, and conducting peer review 

of scientific programs. For additional 

information about the COTPER BSC, please 

visit: http://emergency.cdc.gov/cotper/ 

science/counselors.asp. 

Matters To Be Discussed: A program 

response to the Board’s recommendations 

from the external peer review of the fiscal 

allocation process; a briefing on the findings 

of the external peer review of COTPER’s 

Division of Select Agents and Toxins; status 

updates on other external peer reviews of 

COTPER programs; updates from COTPER 

activities and programs; and a discussion of 

external peer review topics for fiscal year 

2010. Agenda items are subject to change as 

priorities dictate. 

Additional Information For Visitors: All 

visitors are required to present a valid form 

of picture identification issued by a State, 

Federal or international government. To 

expedite the security clearance process for 

visitors to the CDC Roybal campus, all 

visitors must pre-register by submitting the 

following information by e-mail or phone 

(see Contact Person for More Information) no 

later than 12 noon (EDT) on Monday, July 27, 

2009: 

• Full Name, 

• Organizational Affiliation, 

• Complete Mailing Address, 

• Citizenship, and 

• Phone Number or E-mail Address. 

For foreign nationals or non-U.S. citizens, 

pre-approval is required. Please contact the 

BSC Coordinator (see Contact Person for 

More Information) in advance of the posted 

pre-registration deadline for additional 

security requirements that must be met. 

Contact Person for More Information: 

Matthew Jennings, BSC Coordinator, 

COTPER, CDC, 1600 Clifton Rd., NE., 

Mailstop D–44, Atlanta, GA 30333, 

Telephone: (404) 639–7357; Facsimile: (404) 

639–7977; E-mail: 

COTPER.BSC.Questions@cdc.gov. 

The Director, Management Analysis and 

Service Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both CDC and Agency for Toxic Substances 

and Disease Registry. 

Dated: July 7, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Service 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–16771 Filed 7–14–09; 8:45 am] 

BILLING CODE 4163–18–P 


sroberts on DSKD5P82C1PROD with NOTICES