[Federal Register Volume 67, Number 62 (Monday, April 1, 2002)]
[Proposed Rules]
[Pages 15344-15345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 212

[Docket No. 99N-4063]


Current Good Manufacturing Practice for Positron Emission 
Tomography Drug Products; Preliminary Draft Proposed Rule; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability of preliminary draft proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a preliminary draft proposed rule on current good 
manufacturing practice (CGMP) for positron emission tomography (PET) 
drug products. We are developing CGMP regulations for PET drug products 
in accordance with the Food and Drug Administration Modernization Act 
of 1997 (Modernization Act). We are making a preliminary draft of a 
proposed rule available to allow full discussion of its contents at an 
upcoming public meeting on CGMP requirements for PET drug products. We 
are announcing the availability of a companion draft guidance on CGMP 
for PET drug products elsewhere in this issue of the Federal Register.

DATES: A public meeting on the preliminary draft proposed rule will be 
held on May 21, 2002. Submit written or electronic comments on the 
preliminary draft proposed rule by June 5, 2002.

ADDRESSES: A copy of the preliminary draft proposed rule will be on 
display at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the preliminary draft 
proposed rule to the Division of Drug Information (HFD-240), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one 
self-addressed adhesive label to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the preliminary draft proposed rule. Submit written comments 
to the Dockets Management Branch (address above). Submit electronic 
comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Brenda Uratani, Center for Drug 
Evaluation and Research (HFD-325), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-594-0098.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed the 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 
such 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), we published a notice of 
availability of preliminary draft regulations on PET drug CGMP. Those 
preliminary draft regulations were discussed at a public meeting on 
September 28, 1999.
    After considering the comments on the preliminary draft 
regulations, FDA has decided to make several revisions to its approach 
to CGMP for PET drug products. In accordance with 21 CFR 10.40(f)(4) 
and 10.80(b)(2), we are making revised preliminary draft regulations 
available for comment. The preliminary draft proposed rule does not 
include sections on the economic impact of the proposed rule, 
federalism concerns, and Paperwork Reduction Act issues. We will 
include these sections when we publish a proposed rule, but we invite 
comments on these matters at this time.
    Elsewhere in this issue of the Federal Register, we are announcing 
the availability of a companion draft guidance entitled ``PET Drug 
Products--Current Good Manufacturing Practice (CGMP).'' Both the 
preliminary draft proposed rule and the draft guidance

[[Page 15345]]

will be discussed at a public meeting to be held on May 21, 2002, from 
9 a.m. to 4:30 p.m., at 5630 Fishers Lane, rm. 1066, Rockville, MD 
20852.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the preliminary draft 
proposed rule. Two copies of any 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. Electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. The preliminary draft proposed rule and the comments 
submitted to this docket may be seen in the Dockets Management Branch 
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 
http://www.fda.gov/ohrms/dockets/default.htm or www.fda.gov/cder/fdama 
under ``Section 121--PET (Positron Emission Tomography).''
    (Authority: 21 U.S.C. 321 et seq.)

    Dated: March 25, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7728 Filed 3-29-02; 8:45 am]
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