[Federal Register Volume 73, Number 203 (Monday, October 20, 2008)]
[Notices]
[Pages 62298-62299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0530]


Draft Guidance for Industry on Tropical Disease Priority Review 
Vouchers; 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availability of a draft guidance for industry entitled ``Tropical 
Disease Priority Review Vouchers.'' There has been significant outside 
interest in FDA's interpretation of section 1102 of the Food and Drug 
Administration Amendments Act (FDAAA), which adds a new section 524 to 
the Federal Food, Drug, and Cosmetic Act (the act). Section 524 makes 
provisions for awarding priority review vouchers for future 
applications to sponsors of tropical disease product applications that 
meet the criteria specified by the act. This draft guidance explains to 
internal and external stakeholders how FDA intends to implement the 
provisions of section 524.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 19, 2008. Submit written comments on the proposed 
collection of information by December 19, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), 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. The draft guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. 
Submit written comments on the draft guidance to the Division of 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.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    David Roeder, Office of Antimicrobial Products, Center for Drug 
Evaluation and Research, Food and Drug Administration (WO-22), rm. 
6410, 0903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
0799,or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Tropical Disease Priority Review Vouchers.'' Section 1102 of 
FDAAA adds new section 524 to the act. Section 524 is designed to 
encourage development of new drug or biological products for prevention 
and treatment of certain tropical diseases affecting millions of people 
throughout the world. By enacting section 524, Congress intends to 
stimulate new drug development for drugs to treat certain tropical 
diseases for which there are no or few available treatments by offering 
additional incentives for obtaining FDA approval for pharmaceutical 
treatments for these diseases. Under section 524, a sponsor of a human 
drug application for a qualified tropical disease may be eligible for a 
voucher that can be used to obtain a priority review for any 
application submitted under section 505(b)(1) of the act or section 351 
of the Public Health Service (PHS) Act. The draft guidance also 
provides information on using the priority review vouchers and on 
transferring priority review vouchers to other sponsors.
    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 obtaining 
tropical disease priority review vouchers. 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

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information that 
they conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on the following topics: (1) 
Whether the proposed information collected is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimated burden of 
the proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Under the draft guidance, sponsors of certain tropical disease drug 
product applications submitted under section 505(b)(1) of the act and 
section 351 of the PHS Act may request a priority review voucher. Based 
on the inquiries FDA has received on section 524 and related 
discussions with sponsors, we estimate that we will receive annually 
approximately five requests from five sponsors, and that each request 
will take approximately 8 hours to prepare and submit to FDA.
    The draft guidance also states that sponsors should notify FDA of 
their intent to use a priority review voucher, including the date on 
which the sponsor intends to submit the application, at least 1 year 
before use. We estimate that we will receive annually approximately 
five notifications of intent to use a voucher from five sponsors, and 
that

[[Page 62299]]

each notification will take approximately 8 hours to prepare and submit 
to FDA.
    The draft guidance also permits the transfer of a priority review 
voucher from one sponsor to another, and states that each transfer 
should be documented with a letter of transfer. We estimate that we 
will receive approximately two letters indicating the transfer of a 
voucher from two application holders, and two letters from two new 
voucher owners acknowledging the transfer, and that it will take 
approximately 8 hours to prepare and submit each letter to FDA.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of        No. responses  per                          Hours Per
         Reporting Under Section 1102 of FDAAA             Respondents          Respondent        Total  Responses       Response         Total Hours
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Priority review voucher request                                         5                     1                  5                  8                 40
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Notifications of intent to use a voucher                                5                     1                  5                  8                 40
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Letters indicating the transfer of a voucher                            2                     1                  2                  8                 16
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Letters acknowledging the receipt of a transferred                      2                     1                  2                  8                 16
 voucher.
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Total                                                                                                                                                112
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. 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 paper copy. 
Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-24932 Filed 10-17-08; 8:45 am]
BILLING CODE 4160-01-S