[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Notices]
[Page 55145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-0266]


Draft Guidance on Current Good Manufacturing Practice for 
Positron Emission Tomography Drug 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availability of a draft guidance entitled ``PET Drug Products--Current 
Good Manufacturing Practice (CGMP).'' Elsewhere in this issue of the 
Federal Register, we are issuing proposed regulations on CGMPs for 
positron emission tomography (PET) drug products. We are making the 
draft guidance available so that producers of PET drugs can better 
understand FDA's thinking on CGMP compliance if the proposed 
regulations become final after notice-and-comment rulemaking.

DATES: Submit written or electronic comments on the draft guidance by 
December 19, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Brenda Uratani, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 11919 
Rockville Pike, Rockville, MD 20852, 301-827-8941.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed the Food and Drug 
Administration Modernization Act of 1997 (Modernization Act) (Public 
Law 105-115) into law. Section 121(c)(1)(A) of the Modernization Act 
directs us to establish appropriate approval procedures and CGMP 
requirements for PET drugs. Section 121(c)(1)(B) states that, in 
adopting such requirements, we must take due account of any relevant 
differences between not-for-profit institutions that compound PET drugs 
for their patients and commercial manufacturers of the drugs. Section 
121(c)(1)(B) also directs us to consult with patient advocacy groups, 
professional associations, manufacturers, and physicians and scientists 
who make or use PET drugs as we develop PET drug CGMP requirements and 
approval procedures.
    We presented our initial tentative approach to PET drug CGMP 
requirements and responded to numerous questions and comments about 
that approach at a public meeting on February 19, 1999. In the Federal 
Register of September 22, 1999 (64 FR 51274), FDA published preliminary 
draft regulations on CGMP for PET drug products. FDA received comments 
on the preliminary draft regulations at another public meeting on the 
same subject on September 28, 1999. FDA made changes in the working 
draft in response to the public comments. In the Federal Register of 
April 1, 2002 (67 FR 15344), FDA published a preliminary draft proposed 
rule, in conjunction with the first draft guidance (67 FR 15404, April 
1, 2002). FDA received written and oral comments on the preliminary 
draft proposed rule and the first draft guidance at a public meeting on 
May 21, 2002, and written comments after the May 2002 meeting, FDA has 
taken all comments into consideration in revising the preliminary draft 
proposed rule and the draft guidance. The draft guidance provides more 
details for discussion purposes on acceptable approaches to complying 
with the proposed regulations should they be published in final form.
    Elsewhere in this issue of the Federal Register, we are publishing 
a proposed rule on CGMP for PET drug products. We are making this draft 
guidance available so that PET drug producers can better understand 
FDA's thinking on compliance with the proposed CGMP regulations if they 
become final after notice-and-comment rulemaking. We invite comments on 
whether the draft guidance would be a useful accompaniment to the 
proposed rule.

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 document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/ohrms/dockets/default.htm, or http://www.fda.gov/cder/fdama under 
``Section 121--PET (Positron Emission Tomography).''

    Dated: September 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18509 Filed 9-15-05; 8:45 am]
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