[Federal Register Volume 72, Number 26 (Thursday, February 8, 2007)]
[Notices]
[Pages 5976-5977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0091]


Guidance for Industry on User Fee Waivers for Fixed Dose 
Combination 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 guidance for industry entitled ``User Fee Waivers for 
FDC and Co-Packaged HIV Drugs for PEPFAR.'' This guidance describes the 
circumstances under which user fees will not be assessed for certain 
applications for fixed dose combination (FDC) and co-packaged 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). The guidance 
also describes some circumstances under which most 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 agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Division of Drug Information (HFD-

[[Page 5977]]

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 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 this guidance document.

FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug 
Evaluation and Research (HFD-5), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for 
PEPFAR.'' The guidance describes the circumstances under which user 
fees will not be assessed for certain applications for FDC and co-
packaged versions of previously approved antiretroviral therapies for 
the treatment of HIV under PEPFAR. The guidance also describes some 
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.
    In May 2004, as part of PEPFAR, FDA issued 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 draft Fixed Dose Guidance described some scenarios for approval of 
FDC or co-packaged products for the treatment of HIV and provided 
examples of drug combinations considered acceptable for FDC/co-
packaging and examples of those not considered acceptable for FDC/co-
packaging. The 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 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 co-
packaged versions of previously approved antiretroviral therapies for 
the treatment of HIV. Since issuance of the draft Fixed Dose Guidance, 
several potential applicants have asked that we clarify whether 
sponsors submitting drug applications covered by the draft Fixed Dose 
Guidance and proposed for use in 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.
    In the Federal Register of April 18, 2005 (70 FR 20145), FDA 
announced the availability of a draft version of this guidance. FDA did 
not receive any comments in response to that draft guidance, and the 
agency has made only minor editorial changes to the guidance.
    This guidance describes some of the scenarios under which 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 co-packaged 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 ``other circumstances'' 
part of the barrier-to-innovation user fee waiver.
    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 waivers for FDC and co-packaged HIV PEPFAR 
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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, 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 may 
be seen 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 guidance 
document at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 1, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2124 Filed 2-7-07; 8:45 am]
BILLING CODE 4160-01-S