Federal Register / Vol. 70, No. 19 / Monday, January 31, 2005 / Notices 4857

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

21 CFR Section; 

[FDA Form Number] No. of Respondents No. of Responses per Respondent 

Total Annual Responses Hours Per Response Total Hours 

314.107(c)(4), 

314.107(e)(2)(iv), 

and 314.107(f) 3 2 6 1 6

314.110(a)(5) 41 1.26 52 .50 26

314.120(a)(5) 12 1.16 14 .50 7

314.420 403 1.72 694 61 42,334

Total 2,372,556

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: January 25, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–1814 Filed 1–27–05; 12:53 pm]

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D–0514]

Draft Guidance for Industry on 

Abbreviated New Drug Applications: 

Impurities in Drug Substances; 

Chemistry, Manufacturing, and 

Controls Information; 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availability of a draft guidance for 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 ‘‘ANDAs: Impurities in 

Drug Substances; Chemistry, 

Manufacturing, and Controls 

Information.’’ This draft guidance 

provides recommendations on what 

chemistry, manufacturing, and controls 

information to include regarding the 

reporting, identification, and 

qualification of impurities in drug 

substances produced by chemical 

synthesis when submitting 

documentation for an abbreviated new 

drug application (ANDA), drug master 

file (DMF), or a supplement to support 

changes in drug substance synthesis or 

process.

DATES: Submit written or electronic 

comments on the draft guidance May 2, 

2005. General comments on agency 

guidance documents are welcome at any 

time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

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.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Scott Furness, Center for Drug 

Evaluation and Research (HFD–640), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5849.

SUPPLEMENTARY INFORMATION:

I. Background

On December 3, 1999, FDA published 

in the Federal Register (64 FR 67917) 

the guidance for industry entitled 

‘‘ANDA’s: Impurities in Drug 

Substances.’’ The guidance provided 

recommendations for including 

information in ANDAs and supporting 

DMFs on the content and qualification 

of impurities in drug substances 

produced by chemical syntheses.

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘ANDAs: Impurities in Drug 

Substances,’’ which revises the 

December 3, 1999, guidance. The 

guidance is being revised to update 

information on listing of impurities, 

setting acceptance criteria, and 

qualifying impurities in conformance 

with the revision of the guidance for 

industry entitled ‘‘Q3A Impurities in 

New Drug Substances’’ (Q3A(R), 

published in February 2003). The 

guidance is also being revised to remove 

sections of the guidance containing 

recommendations that are no longer 

needed because they are addressed in 

the more recent Q3A(R).

This draft guidance contains 

information collection provisions that 

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 collection of 

information in this draft guidance was 

approved under OMB Control Nos. 

0910–0001 and 0910–0032.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

agency’s current thinking on these 

topics. 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 on the draft guidance. Two 

copies of any comments 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. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at http://

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

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: January 24, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–1752 Filed 1–28–05; 8:45 am]

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