Federal Register / Vol. 69, No. 4 / Wednesday, January 7, 2004 / Notices 929

[FR Doc. 04–260 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–C

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0571]

Draft Guidance for Industry on Drug 

Substance; Chemistry, Manufacturing, 

and Controls Information; Availability

AGENCY: Food and Drug Administration.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Drug Substance: 

Chemistry, Manufacturing, and Controls 

Information.’’ This draft guidance 

provides recommendations on the 

chemistry, manufacturing, and controls 

(CMC) information for drug substances 

that should be submitted to support 

original new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), new animal drug applications 

(NADAs), and abbreviated new animal 

drug applications (ANADAs). The draft 

guidance is structured to facilitate the 

preparation of applications submitted in 

Common Technical Document (CTD) 

format.

DATES: Submit written or electronic 

comments on the draft guidance by July 

5, 2004. 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single copies of the draft guidance to the 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, or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed 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:

Steve Miller, Center for Drug 

Evaluation and Research (HFD–

530), Food and Drug 

Administration, 9201 Corporate 

Blvd., Rockville, MD 20850, 301–

827–2392, or

Chris Joneckis, Center for Biologics 

Evaluation and Research (HFM–1), 

Food and Drug Administration, 

8800 Rockville Pike, Bethesda, MD 

20892, 301–435–5681, or

Dennis Bensley, Center for Veterinary 

Medicine (HFV–143), Food and 

Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 301–827–

6956

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Drug Substance: Chemistry, 

Manufacturing, and Controls 

Information.’’ This draft guidance 

provides recommendations on the drug 

substance information to be submitted 

in NDAs, ANDAs, NADAs, and 

ANADAs to ensure continued drug 

substance and drug product quality (i.e., 

the identity, strength, quality, purity, 

and potency). Recommendations are 

provided on the information that should 

be included for: (1) Nomenclature, 

structure, and general drug substance 

properties, (2) manufacture, (3) 

characterization, (4) control of drug 

substance, (5) reference standards or 

materials, (6) container closure system, 

and (7) stability. The draft guidance is 

structured to facilitate the preparation of 

applications submitted in CTD format. 

The draft guidance, when finalized, will 

replace the guidance entitled 

‘‘Submitting Supporting Documentation 

in Drug Applications for the 

Manufacture of Drug Substance’’

(February 1987).

This 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 guidance was approved under OMB 

control numbers 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 


EN07JA04.003</GPH>
930 Federal Register / Vol. 69, No. 4 / Wednesday, January 7, 2004 / Notices 

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: December 30, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–259 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2002N–0276 and 2002N–0278]

Small Entity Compliance Guides on 

Registration of Food Facilities and 

Prior Notice of Imported Food; 

Correction.

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document that appeared in the Federal 

Register of December 12, 2003 (68 FR 

69408). This document is being 

republished in its entirety and will read 

as follows: The Food and Drug 

Administration (FDA) is announcing the 

availability of small entity compliance 

guides (SECGs) for the interim final 

rules on Registration of Food Facilities 

and Prior Notice of Imported Food 

issued under the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act). Both interim final rules published 

in the Federal Register of October 10, 

2003. These SECGs are intended to help 

small businesses better understand the 

registration and prior notice regulations.

DATES: Submit written or electronic 

comments on the SECGs at any time.

ADDRESSES: Submit written comments 

concerning these SECGs to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. Submit electronic comments on 

the SECGs to http://www.fda.gov/

dockets/ecomments.

Submit requests for single copies of 

one or both SECGs to the Prior Notice 

help desk by telephone at 1–800–216–

7331 (within the United States) or 301–

575–0156 (outside the United States), by 

FAX: 301–210–0247, or by e-mail: 

furls@fda.gov. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to these SECGs.

FOR FURTHER INFORMATION CONTACT:

Questions Concerning Registration: 

Nina Adler, Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–0417, FAX 301–827–

0482; or Judith Gushee, Center for Food 

Safety and Applied Nutrition (HFS–

605), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD, 20740, 301–436–2417.

Questions Concerning Prior Notice: 

Deborah Ralston, Office of Regulatory 

Affairs, Office of Regional Operations 

(HFC–100), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–443–6230.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 10, 

2003 (68 FR 58894 and 68 FR 58974), 

FDA issued two interim final rules to 

implement sections 305 (Registration of 

Food Facilities) and 307 (Prior Notice of 

Imported Food) of the Bioterrorism Act. 

The registration interim final rule 

requires domestic and foreign facilities 

that manufacture/process, pack, or hold 

food for human or animal consumption 

in the United States to register with 

FDA by December 12, 2003. The prior 

notice interim final rule requires the 

submission to FDA of prior notice of 

food, including animal feed, that is 

imported or offered for import into the 

United States beginning on December 

12, 2003.

We examined the economic 

implications of these interim rules as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612) and determined 

that they would have a significant 

economic impact on a substantial 

number of small entities.

In compliance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (Public Law 104–121), we 

are making available these SECGs that 

explain the requirements of these 

regulations.

FDA is issuing these SECGs as level 

2 guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(c)(2)). These SECGs restate, in 

simplified format and language, FDA’s 

current requirements for Registration of 

Food Facilities and Prior Notice of 

Imported Food. As guidance, these 

documents are not binding on either 

FDA or the public. FDA notes, however, 

that the regulations that serve as the 

basis for these guidance documents 

establish requirements for all covered 

activities. For this reason, FDA strongly 

recommends that affected parties 

consult the regulations at 21 CFR part 1, 

subparts H and I, in addition to reading 

these SECGs.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding these SECGs. 

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 

applicable docket number(s) 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. Electronic Access

Persons with access to the Internet 

may obtain these SECGs at http://www/

cfsan.fda.gov/guidance.html.

Dated: December 29, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–257 Filed 1–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

Secretary’s Advisory Committee on 

Xenotransplantation (SACX).