[Federal Register Volume 64, Number 183 (Wednesday, September 22, 1999)]
[Proposed Rules]
[Pages 51274-51275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24592]
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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 Practices for Positron Emission
Tomography Drug Products; Preliminary Draft Regulations; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Availability of preliminary draft regulations.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of preliminary draft regulations on current good
manufacturing practices (CGMP's) for positron emission tomography (PET)
drug products. FDA is developing CGMP's for PET drugs in accordance
with the Food and Drug Administration Modernization Act of 1997
(Modernization Act). These preliminary draft regulations are being made
available to allow full discussion of them at an upcoming public
meeting on the regulation of PET drugs.
DATES: A public meeting on PET drug matters will be held on September
28, 1999. Submit written comments on or before October 13, 1999.
ADDRESSES: A copy of the preliminary draft regulations will be on
display at the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Copies of the preliminary draft regulations may be obtained from the
Drug Information Branch (HFD-210), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4573, and the Center for
Drug Evaluation and Research's Fax-on-Demand system at 301-827-0577 or
800-342-2722. An electronic version of the preliminary draft
regulations is available on the Internet at ``http://www.fda.gov/cder/
fdama'' under ``Section 121--PET (Positron Emission Tomography).''
Submit written comments to the Dockets Management Branch (address
above).
FOR FURTHER INFORMATION CONTACT: Tracy A. Roberts, Center for Drug
Evaluation and Research (HFD-336), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 301-594-0093.
SUPPLEMENTARY INFORMATION:
The President signed the Modernization Act (Public Law 105-115)
into law on November 21, 1997. Section 121(c)(1)(A)(ii) of the
Modernization Act directs FDA to establish within 2 years after
enactment appropriate CGMP requirements for PET drugs.
Section 121(c)(1)(B) of the Modernization Act requires FDA to
consult with patient advocacy groups, professional associations,
manufacturers, and other interested persons as the agency develops PET
drug CGMP requirements and approval procedures. To that end, the agency
has conducted public meetings on PET drug matters and has established a
public docket.
In accordance with section 121 of the Modernization Act, FDA has
developed preliminary draft CGMP requirements for PET drug products. In
accordance with 21 CFR 10.40(f)(4) and 10.80(b)(2), FDA has decided to
make available to the public these preliminary draft CGMP regulations
to facilitate discussion at the public meeting on PET drug matters to
be held on September 28, 1999, from 9 a.m. to 4 p.m., at the Holiday
Inn, Gaithersburg, MD (Goshen Room). Subsequently, FDA will issue a
proposed rule on CGMP's for PET drug
[[Page 51275]]
products and will invite comments on the proposed rule.
Interested persons may, on or before October 13, 1999, submit to
the Dockets Management Branch (address above) written comments on the
preliminary draft regulations. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments should
be identified with the docket number found in brackets in the heading
of this document. The preliminary draft regulations and received
comments may be seen in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
(Authority: 21 U.S.C. 321 et seq.)
Dated: September 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-24592 Filed 9-21-99; 8:45 am]
BILLING CODE 4160-01-F
