[Federal Register Volume 68, Number 167 (Thursday, August 28, 2003)]
[Notices]
[Page 51790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0165]


Draft Guidance for Industry on the Current Good Manufacturing 
Practices for Medical Gases; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period on the draft guidance for industry entitled ``Current 
Good Manufacturing Practice for Medical Gases.'' The agency issued this 
draft guidance in the Federal Register of May 6, 2003 (68 FR 24005). 
The initial comment period closes on September 3, 2003. To provide 
interested persons additional time to review the draft guidance and 
submit comments, the agency has decided to extend the comment period.

DATES: Written comments on the draft guidance may be submitted by 
November 3, 2003. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Submit written comments on the draft 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 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draft guidance document.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: Duane S. Sylvia, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-9040, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is extending the comment period on the draft guidance for 
industry entitled ``Current Good Manufacturing Practice for Medical 
Gases.'' This draft guidance is intended to provide recommendations on 
how to comply with current good manufacturing practice (CGMP) 
regulations for manufacturing, filling, transfilling, cascading, and 
transferring compressed and cryogenic medical gases. The guidance 
should help manufacturers and distributors comply with the CGMP 
requirements to ensure the identity, strength, quality, and purity of 
medical gases.
    The agency issued this draft guidance on May 6, 2003. The initial 
comment period closes on September 3, 2003, but at the request of the 
medical gas industry, the agency has decided to extend the comment 
period for an additional 60 days, until November 3, 2003.

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 mailed 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

    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/ohrms/dockets/default.htm, and http://www.fda.gov/cder/dmpq/gases.htm.

    Dated: August 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-21984 Filed 8-27-03; 8:45 am]
BILLING CODE 4160-01-S