[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