Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59239

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation.

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets.

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Hilda 

Scharen at least 7 days in advance of the 

meeting.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: September 24, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–22214 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0431]

Draft Guidance for Industry and the 

Food and Drug Administration; Current 

Good Manufacturing Practices for 

Combination Products; 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availability of a draft guidance for 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 ‘‘Current Good 

Manufacturing Practices for 

Combination Products.’’ Once finalized, 

this guidance will provide guidance to 

industry and FDA staff on the 

applicability of current good 

manufacturing practices (CGMP) for 

combination products.

DATES: Submit written or electronic 

comments on the draft guidance by 

December 3, 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single copies of the draft guidance to the 

Office of Combination Products (HFG–

3), 15800 Crabbs Branch Way, suite 200, 

Rockville, MD 20855. 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:

Patricia Y. Love, Office of Combination 

Products (HFG–3), Food and Drug 

Administration, 15800 Crabbs Branch 

Way, suite 200, Rockville, MD 20855, 

301–427–1934, FAX 301–427–1935, email: patricia.love@oc.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Current Good Manufacturing Practices 

for Combination Products.’’

Combination products are defined 

under 21 CFR 3.2(e). This draft guidance 

document makes recommendations for 

achieving compliance with applicable 

CGMPs for the drug, device, or 

biological product constituent parts of a 

combination product. In addition, the 

draft guidance document makes 

recommendations for achieving 

compliance with applicable CGMPs for 

combination products where the 

constituent parts of a combination 

product are joined together. The 

applicable regulations include the 

CGMP regulations for finished 

pharmaceuticals, or drug products, and 

most biological products (21 CFR parts 

210 and 211); the biological product 

regulations for biological products (21 

CFR parts 600–680); and the quality 

system regulations for devices (21 CFR 

part 820).

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 CGMP for combination 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 on the draft guidance. Two 

paper copies of mailed comments are to 

be submitted, 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. 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 draft guidance document 

at either http://www.fda.gov/oc/

combination/default.htm or http://

www.fda.gov/ohrms/dockets/

default.htm.

Dated: September 28, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22205 Filed 9–29–04; 1:51 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0440]

Draft Guidance for Industry on 

Computerized Systems Used in 

Clinical Trials; 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 ‘‘Computerized 

Systems Used in Clinical Trials.’’ This 

document provides guidance about 

computerized systems that are used to 

create, modify, maintain, archive, 

retrieve, or transmit clinical data 

required to be maintained and/or 

submitted to FDA. This draft guidance, 

when finalized, will supercede the 

guidance of the same name issued in 

April 1999.

DATES: Submit written or electronic 

comments on the draft 

recommendations by January 3, 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 

Office of Training and Communications, 

Division of Communications 

Management, Division of Drug 

Information (HFD–240), Center for Drug 

Evaluation and Research, 5600 Fishers 

Lane, Rockville, MD 20857; 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; to the Office 

of Health and Industry Programs, 

59240 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

Division of Small Manufacturers 

Assistance (HFZ–220), Center for 

Devices and Radiological Health, 1350 

Piccard Dr., Rockville, MD 20850–4307, 

Manufacturers Assistance: 800–638–

2041 or 301–443–6597; or the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. 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:

Joseph Salewski, Center for Drug 

Evaluation and Research (HFD–45), 

Food and Drug Administration, 

7520 Standish Pl., Rockville, MD 

20855, 301–594–0020; or

Patricia Holobaugh, Center for 

Biologics Evaluation and Research 

(HFM–664), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–6347; or

John Murray, Jr., Center for Devices 

and Radiological Health (HFZ–340), 

Food and Drug Administration, 

2094 Gaither Rd., Rockville, MD 

20850, 301–594–4646, ext. 107; or

John Welsh, Center for Food Safety 

and Applied Nutrition (HFS–205), 

Food and Drug Administration, 

1110 Vermont Ave., NW, 

Washington, DC 20005, 202–418–

3057; or

Vernon Toelle, Center for Veterinary 

Medicine (HFV–234), Food and 

Drug Administration, 7519 Standish 

Pl., Rockville, MD 20835, 301–827–

0312; or

James McCormack, Office of 

Enforcement (HFC–230), Food and 

Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20857, 301–827–

0425; or

Patricia Beers Block, Good Clinical 

Practice Programs (HF–34), Food 

and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3340.

SUPPLEMENTARY INFORMATION: 

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Computerized Systems Used in 

Clinical Trials.’’ This document 

provides guidance about computerized 

systems that are used to create, modify, 

maintain, archive, retrieve, or transmit 

clinical data required to be maintained 

and/or submitted to FDA. These data 

form the basis for the agency’s decisions 

regarding the safety and effectiveness of 

new human and animal drugs, 

biological products, medical devices, 

and certain food and color additives. As 

such, these data have broad public 

health significance and are expected to 

be of the highest quality and integrity.

This draft guidance, when finalized, 

will supercede the guidance of the same 

name issued in April 1999. This draft 

guidance is being revised to make it 

consistent with agency policy as 

reflected in the guidance for industry on 

‘‘Part 11, Electronic Records; Electronic 

Signatures—Scope and Application,’’

which issued in August 2003. It also 

reflects policy consistent with regard to 

the agency’s international 

harmonization efforts.

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). This draft guidance, when 

finalized, will represent the agency’s 

current thinking on computerized 

systems used in 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 the approach 

satisfies the requirements of the 

applicable statute 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 

paper copies of any comments are to be 

submitted, 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. 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

Copies of this draft guidance for 

industry are available on the Internet at 

http://www.fda.gov/cder/guidance/

index.htm, http://www.fda.gov/cber/

guidelines.htm, http://www.fda.gov/

cvm/guidance/guidance.html, and http:/

/www.fda.gov/oc/gcp/draft.html.

Dated: September 28, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22204 Filed 9–29–04; 1:51 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0226]

Food and Drug Administration 

Modernization Act of 1997; 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

011

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 011’’ (Recognition List 

Number: 011), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices.

DATES: Submit written or electronic 

comments concerning this document at 

any time. See section VII of this 

document for the effective date of the 

recognition of standards announced in 

this document.

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

011’’ to the Division of Small 

Manufacturers Assistance, Center for 

Devices and Radiological Health (HFZ–

220), Food and Drug Administration, 

1350 Piccard Dr., Rockville, MD 20850. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

requests, or fax your request to 301–

443–8818. Submit written comments 

concerning this document, or 

recommendations for additional 

standards for recognition, to the contact 

person (see FOR FURTHER INFORMATION

CONTACT). Submit electronic comments 

by e-mail: standards@cdrh.fda.gov. This 

document may also be accessed on 

FDA’s Internet site at http://

www.fda.gov/cdrh/fedregin.html. See 

section VI of this document for 

electronic access to the searchable 

database for the current list of FDA 

recognized consensus standards, 

including Recognition List Number: 011 

modifications and other standards 

related information.

FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and 

Radiological Health (HFZ–84), Food and