[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Notices]
[Pages 92-93]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28654]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0059 (formerly 01D-0059)]
Guidance for Industry on Submitting Separate Marketing
Applications and Clinical Data for Purposes of Assessing User Fees;
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 a guidance for industry entitled ``Submitting Separate
Marketing Applications and Clinical Data for Purposes of Assessing User
Fees.'' The guidance describes the agency's current policy on what
should be contained in separate marketing applications and what should
be combined into one application for purposes of assessing user fees
and a definition of ``clinical data'' for user fee purposes.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. Submit written comments
on the guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Center for Drug Evaluation and Research (HFD-7),
Food and Drug Administration, 5600 Fishers Lane, or Rockville, MD
20857, 301-594-2041, FAX: 301-827-5562, or
Carla A. Vincent, Center for Biologics Evaluation and Research
(HFM-110), 1401 Rockville Pike, Rockville, MD 20852, 301-827-
[[Page 93]]
3503, FAX: 301-827-2875.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Submitting Separate Marketing Applications and Clinical Data
for Purposes of Assessing User Fees.'' The guidance document describes
FDA's thinking on what will be considered separate marketing
applications and what will constitute clinical data for purposes of
assessing user fees under sections 735 and 736 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g and 379h).
This guidance was issued in draft on February 22, 2001 (66 FR
11175) with comments due by March 26, 2001. No comments were received.
In the meantime, Congress considered reauthorization of the user fee
program. As a result, FDA delayed issuance of the guidance. Now that
the program has been reauthorized without change to the relevant
language, FDA is issuing the guidance. Other than minor editorial
changes, only two changes of note have been made to the guidance. We
have reevaluated our policy on pharmacy bulk packages and products for
prescription compounding and determined that a separate application is
no longer needed for these products unless otherwise noted in the
guidance document. Therefore, the subsection entitled ``Pharmacy Bulk
Packages and Products for Prescription Compounding'' has been removed.
In addition, the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Public Law 108-173) may require a new
application to be submitted because of a change to the reference listed
drug. Therefore, a new subsection was added to clarify the user fee
liability.
The guidance represents the agency's current thinking on this
topic. 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 requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Two copies of mailed 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
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: December 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28654 Filed 12-30-04; 8:45 am]
BILLING CODE 4160-01-S