[Federal Register Volume 70, Number 73 (Monday, April 18, 2005)]
[Notices]
[Pages 20145-20146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7729]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0091]


Draft Guidance for Industry on User Fee Waivers for Fixed Dose 
Combination Products and Co-Packaged Human Immunodeficiency Virus Drugs 
for the President's Emergency Plan for Acquired Immunodeficiency 
Syndrome Relief; 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availability of a draft guidance for industry entitled ``User Fee 
Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.'' This draft 
guidance describes the circumstances under which certain applications 
for fixed dose combination (FDC) and copackaged versions of previously 
approved antiretroviral therapies for the treatment of human 
immunodeficiency virus (HIV) under the President's Emergency Plan for 
Acquired Immunodeficiency Syndrome Relief (PEPFAR) will not be assessed 
user fees. The draft guidance also describes circumstances under which 
some of the applications that will be assessed fees may be eligible for 
a public health or a barrier-to-innovation waiver.

DATES: Submit written or electronic comments on the draft guidance by 
June 17, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers

[[Page 20146]]

Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for 
PEPFAR.'' The draft guidance describes the circumstances under which 
certain applications for FDC and copackaged versions of previously 
approved antiretroviral therapies for the treatment of HIV under PEPFAR 
will not be assessed user fees. The draft guidance also describes 
circumstances under which some of the applications that will be 
assessed fees may be eligible for a public health or a barrier-to-
innovation waiver.
    As part of PEPFAR, FDA issued in May 2004 a draft guidance entitled 
``Fixed Dose Combination and Co-Packaged Drug Products for the 
Treatment of HIV'' (Fixed Dose Guidance) (69 FR 28931, May 19, 2004). 
The Fixed Dose Guidance described some scenarios for approval of FDC or 
copackaged products for the treatment of HIV, provided examples of drug 
combinations considered acceptable for FDC/copackaging, and examples of 
those not considered acceptable for FDC/copackaging. The draft guidance 
also explained that the Federal Food, Drug, and Cosmetic Act provides 
for certain circumstances in which FDA can grant sponsors a waiver or 
reduction in fees. The draft guidance also stated that the agency was 
evaluating the circumstances under which it may grant user fee waivers 
or reductions for sponsors developing FDC and copackaged versions of 
previously approved antiretroviral therapies for the treatment of HIV. 
Since issuance of the Fixed Dose Guidance, several potential applicants 
have asked that we clarify whether sponsors submitting drug 
applications under the Fixed Dose Guidance and under the PEPFAR program 
will be required to pay user fees under the Prescription Drug User Fee 
Act (PDUFA) and if so, whether they would be eligible for a waiver of 
those fees. As explained in this draft guidance, in some of the 
scenarios described in the Fixed Dose Guidance, a sponsor could qualify 
for fee exemptions or would only be assessed a half-fee either because 
the sponsor is using an active ingredient that has already been 
approved or the application does not require clinical data for 
approval. A sponsor of an application that would be assessed either a 
full- or a half-fee may also qualify for a waiver of the application 
fee under several provisions of PDUFA.
    We expect that most of the applications, products, and 
establishments for FDC and copackaged HIV therapies proposed for use in 
the PEPFAR program will either not be assessed fees in the first 
instance or will qualify for a waiver under the special circumstances 
part of the barrier-to-innovation user fee waiver.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on waivers of 
user fees for FDC and copackaged products for the treatment of HIV 
under PEPFAR. 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 draft guidance. 
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 
draft 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: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7729 Filed 4-15-05; 8:45 am]
BILLING CODE 4160-01-S