[Federal Register Volume 62, Number 78 (Wednesday, April 23, 1997)]
[Notices]
[Pages 19767-19768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10542]


-----------------------------------------------------------------------

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Positron Emission Tomography Drug Products; Draft Guidance for 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is 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availability of a draft guidance document entitled ``Guidance for 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.'' This draft 
guidance is intended to assist applicants who wish to submit an ANDA 
for Fludeoxyglucose F18 Injection. The draft guidance is one of several 
topics to be discussed at an April 28, 1997, FDA workshop on PET 
radiopharmaceutical drug products. The agency is requesting comments on 
this draft guidance.

DATES: Written comments may be submitted on the draft guidance document 
by June 28, 1997. General comments on agency guidance documents are 
welcomed at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Drug Information Branch (HFD-210), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive 
labels to assist that office in processing your request. Submit written 
comments to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of the draft 
guidance document and received comments will be available for public 
examination in the Dockets

[[Page 19768]]

Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Peter Rickman, Center for Drug 
Evaluation and Research (HFD-615), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-0315.

SUPPLEMENTARY INFORMATION: FDA is 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draft guidance document entitled ``Guidance for Industry: Content and 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.'' PET is a medical imaging modality 
used to assess the body's biochemical processes. Radionuclides are 
manufactured into PET radiopharmaceutical drug products that are 
administered to patients for medical imaging. The images of the body's 
biochemical processes are then evaluated, generally for diagnostic 
purposes.
    Under section 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)), ANDA's may be submitted for drug products that are 
the same as a listed drug, i.e., identical in active ingredient(s), 
dosage form, strength, route of administration and conditions of use, 
except for those uses for which approval cannot be granted because of 
exclusivity, or for which an existing patent may be omitted (21 CFR 
314.92). Because a new drug application (NDA) for Fludeoxyglucose F18 
Injection (NDA 20-306) was approved on August 19, 1994, for the 
identification of regions of abnormal glucose metabolism associated 
with foci of epileptic seizures, ANDA's may be submitted for drug 
products that are the same as this reference listed drug product and 
for the same use. The purpose of the draft guidance document is to 
assist applicants who wish to submit an ANDA for Fludeoxyglucose F18 
Injection. The draft guidance is one of several issues to be discussed 
at an April 28, 1997, FDA workshop on PET radiopharmaceutical drug 
products. The workshop, which will be held in Rockville, MD, was 
announced in the Federal Register on March 14, 1997 (62 FR 12218). 
Other issues to be discussed at the workshop include: Registration and 
listing requirements, chemistry and manufacturing controls, sterility 
assurance, bioequivalence requirements, and labeling.
    This guidance document represents the agency's current thinking on 
the content and format of an ANDA for PET radiopharmaceutical drug 
products. It does not create or confer any rights for, or on, any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirement of the 
applicable statute, regulations, or both.
    Interested persons may submit written comments on the draft 
guidance document to the Dockets Management Branch (address above). 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 
document and received comments also may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    An electronic version of this draft guidance is available on the 
Internet using the World Wide Web (http://www.fda.gov/cder/
guidance.htm).

    Dated: April 18, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-10542 Filed 4-22-97; 8:45 am]
BILLING CODE 4160-01-F