June 30, 2003
[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
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.
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are announcing the availability of a companion draft guidance on CGMP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.
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
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
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. 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 the FDA website under ``Section 121--PET (Positron Emission Tomography).''
(Authority: 21 U.S.C. 321 et seq.)