[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Page 32621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15760]
[[Page 32621]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0164]
Positron Emission Tomography Drug Products; Draft Guidance for
Industry on Content and Format of an Abbreviated New Drug Application;
Availability; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to August
27, 1997, the comment period on the agency's draft guidance entitled
``Guidance for Industry: Content and Format of an Abbreviated New Drug
Application (ANDA)--Positron Emission Tomography (PET) Drug Products.''
FDA published a notice of availability of the draft guidance in the
Federal Register of April 23, 1997 (62 FR 19767). FDA is extending the
comment period in response to a request by the Institute for Clinical
PET for additional time for the PET community to review the agency's
proposed guidance on the submission of ANDA's for PET drugs.
DATES: Written comments by August 27, 1997. General comments on agency
guidance documents are welcomed at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Peter Rickman, Center for Drug
Evaluation and Research (HFD-615), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5862.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 23, 1997,
FDA published a notice announcing the availability of a draft guidance
document entitled ``Guidance for Industry: Content and Format of an
Abbreviated New Drug Application (ANDA)--Positron Emission Tomography
(PET) Drug Products.'' The draft guidance is intended to assist
applicants who wish to submit ANDA's for Fludeoxyglucose F18 injection.
The notice invited interested persons to submit written comments on the
draft guidance by June 28, 1997.
On May 5, 1997, FDA received a letter from Ernest V. Garcia,
President of the Institute for Clinical PET, requesting that the agency
extend the comment period on the draft guidance on ANDA's for PET drug
products. FDA has considered this request and is extending the comment
period for 60 days.
Interested persons may, on or before August 27, 1997, submit to the
Dockets Management Branch (address above) written 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. The
draft guidance and received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-15760 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F
