[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Notices]
[Pages 12218-12219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6410]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97N-0083]


Abbreviated New Drug Applications; Positron Emission Tomography 
Radiopharmaceuticals; Notice of a Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop to provide information to the positron emission tomography 
(PET) radiopharmaceutical industry on submitting abbreviated new drug 
applications (ANDA's) and other regulatory issues affecting PET 
radiopharmaceutical drug products. The workshop will provide guidance 
on topics such as ANDA regulatory requirements, registration and 
listing requirements, chemistry and manufacturing controls, sterility 
assurance, bioequivalence requirements, and labeling. An agenda and 
materials to be discussed at the workshop will be available before the 
workshop.

DATES: The workshop will be held on Monday, April 28, 1997, from 8 a.m. 
to 5 p.m. Because space is limited, interested persons are encouraged 
to register as soon as possible. Preregistration will be accepted 
through April 18, 1997. There is no registration fee for the workshop. 
The administrative docket will remain open until June 27, 1997, to 
receive written comments, data, information, or views on the workshop 
and materials distributed at the workshop.

ADDRESSES: The workshop will be held at the Parklawn Bldg., 5600 
Fishers Lane, conference rm. D, Rockville, MD 20857. Persons interested 
in attending should pre-register by faxing their name, title, 
organization name if any, address, telephone and fax numbers to the 
contact person. Registrants' fax numbers should be provided, so that 
registration can be confirmed by return fax.
    Before the workshop, the agenda and materials to be discussed at 
the workshop will be available via the Internet using the World Wide 
Web (WWW). To connect to the Center for Drug Evaluation and Research 
(CDER) Home Page, type http://www.fda.gov/cder and go to the ``What's 
Happening'' section. A transcript of the workshop will be available 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, approximately 
15 business days after the workshop at a cost of 10 cents per page.
    Written comments on the workshop or materials discussed at the 
workshop can be submitted until June 27, 1997, to the Dockets 
Management Branch (HFA-305), 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857. Two copies of 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 notice. Received 
comments may be viewed at the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Susan C. Lange, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-160), 5600 
Fishers Lane, Rockville, MD 20857, 301-443-0260, FAX 301-594-0746.

SUPPLEMENTARY INFORMATION:

I. Background

    PET is a diagnostic imaging modality consisting of onsite 
production of radionuclides that are usually intravenously injected 
into patients for diagnostic purposes. The potential usefulness of a 
PET radiopharmaceutical is based upon the product's interaction with a 
biochemical process in the body.
    Over the last 20 years, there has been increasingly widespread 
commercial use of a growing number of PET radiopharmaceuticals. Having 
considered the available information, including that presented to the 
agency at a March 1993 hearing and in written materials, in the Federal 
Register of February 27, 1995 (60 FR 10593), FDA provided additional 
notice and guidance to the industry stating how the agency would apply 
its regulatory authority to PET drug products.
    Since the approval of one new drug application for F-18 FDG, PET 
drug product manufacturers have sought information on the submission of 
ANDA's. Details of the ANDA submission process will be discussed at the 
workshop. Other topics to be addressed include registration and listing 
requirements, chemistry and manufacturing controls, sterility 
assurance, bioequivalence requirements, labeling, and compliance with 
current

[[Page 12219]]

good manufacturing practice regulations and other regulatory 
requirements. Materials providing guidance on ANDA submissions and 
related topics will also be discussed at the workshop.

    Dated: March 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6410 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F