[Federal Register: April 1, 2002 (Volume 67, Number 62)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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Draft Guidance on Current Good Manufacturing Practice for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.
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availability of a draft guidance entitled ``PET Drug Products--Current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 We are making the draft guidance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DATES: A public meeting on the draft guidance will be held on May 21,
Submit written or electronic comments on the draft guidance by June
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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INFORMATION section for electronic access to the draft guidance.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.
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
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.
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
III. Electronic Access
Persons with access to the Internet may obtain the document at
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