[Federal Register: October 4, 2004 (Volume 69, Number 191)]
[Notices]
[Page 59239]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc04-74]
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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Draft Guidance for Industry and the Food and Drug Administration;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availability of a draft guidance for industry entitled ``Current Good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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Combination Products (HFG-3), 15800 Crabbs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Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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INFORMATION section for electronic access to the draft guidance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: 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FDA is announcing the availability of a draft guidance for industry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draft guidance document makes recommendations for achieving compliance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 In addition, the draft
guidance document makes recommendations for achieving compliance with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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/combination/default.htm or
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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