[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59705-59706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24739]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0108]


Guidance for Industry on User Fee Waivers, Reductions, and 
Refunds for Drug and Biological Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``User Fee Waivers, 
Reductions, and Refunds for Drug and Biological Products.'' This 
guidance provides recommendations to applicants considering whether to 
request a waiver or reduction in user fees. This guidance is a revision 
of the draft guidance entitled ``Draft Interim Guidance Document for 
Waivers of and Reductions in User Fees,'' issued July 16, 1993.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of 
Communication, Outreach, and Development (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on this guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
Michael Jones, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6216, Silver 
Spring, MD 20993-0002, 301-796-3602; or
Stephen Ripley, Center for Biologics Evaluation and Research, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``User Fee Waivers, Reductions, and Refunds for Drug and 
Biological Products.'' This guidance provides recommendations for 
applicants planning to request waivers or reductions in user fees 
assessed under sections 735 and 736 of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 379g and 379h, respectively). 
This guidance describes the types of waivers and reductions permitted 
under the user fee provisions of the FD&C Act and the procedures for 
submitting requests for waivers or reductions and requests for 
reconsideration and appeal. The guidance also provides clarification on 
related issues such as user fee exemptions for orphan drugs.
    In the Federal Register of March 14, 2011 (76 FR 13629), FDA 
announced the availability of a revised draft guidance entitled ``User 
Fee Waivers, Reductions, and Refunds for Drug and Biological 
Products.'' The notice gave interested persons the opportunity to 
comment by June 13, 2011. We received no comments on the revised draft 
guidance; however, we have made minor editorial changes and a small 
clarification to the guidance document.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on user fee waivers and reductions for 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 requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control number 0910-0639. The guidance also refers to collections of 
information for filling out and submitting Form FDA 3397 (Prescription 
Drug User Fee Coversheet), previously approved under OMB control number 
0910-0297, and collections of information associated with new drug 
applications or biologics license applications approved under OMB 
control numbers 0910-0001 and 0910-0338, respectively.

[[Page 59706]]

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or at http://www.regulations.gov.

    Dated: September 21, 2001.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24739 Filed 9-26-11; 8:45 am]
BILLING CODE 4160-01-P