[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Draft Guidance for Industry on User Fee Waivers for Fixed Dose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availability of a draft guidance for industry entitled ``User Fee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 This draft
guidance describes the circumstances under which certain applications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 The draft guidance also describes circumstances under which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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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access to the draft guidance document.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