[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Notices]
[Pages 24313-24314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12145]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


FDA Form 3439, Interim Form for Application to Market a New Drug, 
Biologic, or Antibiotic Drug for Human Use; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of FDA Form 3439 entitled, ``Application to Market a New 
Drug, Biologic, or Antibiotic Drug for Human Use.'' This form is 
intended for use by applicants for licenses for specified biotechnology 
and specified synthetic biological products. FDA Form 3439 has received 
interim approval from the Office of Management and Budget (OMB) for use 
by applicants pending the availability of a harmonized form for use by 
applicants requesting approval of drugs, biological products, and 
antibiotics. The development of the harmonized form and this action are 
part of FDA's continuing effort to achieve the objectives of the 
President's ``Reinventing Government'' initiatives.

EFFECTIVE DATE: The FDA Form 3439 may be used May 24, 1996.

ADDRESSES: Submit written requests for single copies of FDA Form 3439 
to Division of Congressional and Public Affairs (HFM-44), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. The 
form may also be obtained by FAX by calling the CBER Voice Information 
System at 1-800-835-4709. FDA Form 3439 is available for public 
examination in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Annette A. Ragosta, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: FDA is making available FDA Form 3439, 
Application to Market a New Drug,

[[Page 24314]]

Biologic, or Antibiotic Drug for Human Use, for use in accordance with 
part 601 (21 CFR part 601), by applicants for licenses for specified 
biotechnology and specified synthetic biological products. In the final 
rule, ``Elimination of Establishment License Application for Specified 
Biotechnology and Specified Synthetic Biological Products,'' published 
elsewhere in this issue of the Federal Register, FDA is amending 
Sec. 601.2 (a) and adding new Sec. 601.2 (c) to create a licensing 
scheme for specified biotechnology and specified synthetic biological 
products. The final rule requires an applicant seeking marketing 
approval for specified biotechnology and specified synthetic biological 
products to submit a single biologics license application to CBER. FDA 
Form 3439 has received interim approval from OMB for use by applicants 
subject to the above-referenced final rule.
    In the November 1995 report entitled, ``Reinventing the Regulation 
of Drugs Made from Biotechnology'' report, the President and Vice-
President announced a series of regulatory reform initiatives, 
including FDA's intention to use a single harmonized application form 
for all licensed biological products and all drug products. The 
harmonized form will be made available for public comment and submitted 
to OMB for review and approval. FDA also intends to develop guidance to 
assist applicants in completing the harmonized application. Once it is 
approved for use by OMB, the harmonized form will supersede FDA Form 
3439. Until that time, applicants for licenses for specified 
biotechnology and specified synthetic biological products may use the 
interim FDA Form 3439.
    Under the Paperwork Reduction Act of 1995 (Pub. L. 104-13), all 
forms requesting a collection of information on identical items from 10 
or more public respondents must be approved by OMB and must display a 
valid OMB control number and expiration date. FDA Form 3439 was 
approved under OMB control number 0910-0316. The expiration date for 
the form is December 31, 1997.

    Dated: May 9, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-12145 Filed 5-10-96; 10:13 am]
BILLING CODE 4160-01-F