[Federal Register: April 1, 2002 (Volume 67, Number 62)]
[Notices]               
[Page 15404]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap02-42]                         


[[Page 15404]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-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Draft Guidance on Current Good Manufacturing Practice for 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availability of a draft guidance entitled ``PET Drug Products--Current 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).'' We are announcing the 
availability of preliminary draft proposed regulations elsewhere in 
this issue of the Federal Register. We are making the draft guidance 
available so that producers of positron emission tomography (PET) drugs 
will better understand FDA's thinking concerning CGMP compliance if the 
preliminary draft proposed regulations were to become final after 
notice and comment rulemaking.

DATES: A public meeting on the draft guidance will be held on May 21, 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    Submit written or electronic comments on the draft guidance by June 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

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance. Submit 
written comments to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
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 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), we published a notice of 
availability of preliminary draft regulations on CGMP for PET drug 
products. Those preliminary draft regulations were discussed at a 
subsequent public meeting on September 28, 1999.
    After considering the comments on the preliminary draft 
regulations, we have decided to make several revisions to those 
regulations. Elsewhere in this issue of the Federal Register, we are 
announcing the availability of a preliminary draft proposed rule on 
CGMP for PET drug products. We are making this draft guidance available 
now so that PET drug producers will better understand FDA's thinking 
concerning compliance with the preliminary draft proposed CGMP 
regulations if they were to become final after notice and comment 
rulemaking. We invite comments on whether the guidance would be a 
useful accompaniment to the proposed rule. The preliminary draft 
proposed rule and the draft guidance 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 draft guidance. 
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 
draft guidance and the comments submitted to the 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/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: March 25, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7729 Filed 3-29-02; 8:45 am]
BILLING CODE 4160-01-S