[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Page 59239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22205]


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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Draft Guidance for Industry and the Food and Drug Administration; 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.

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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availability of a draft guidance for industry entitled ``Current Good 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Combination Products (HFG-3), 15800 Crabbs 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 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Submit written comments on the draft guidance to the Division of 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INFORMATION section for electronic access to the draft guidance 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: 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, e-mail: [email protected].

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    FDA is announcing the availability of a draft guidance for industry 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draft guidance document makes recommendations for achieving compliance 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 In addition, the draft 
guidance document makes recommendations for achieving compliance with 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