[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]
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