[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68503-68504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tropical Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on Tropical Disease Priority Review Vouchers.

DATES: Submit either electronic or written comments on the collection 
of information by January 31, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 31, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 31, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2008-D-0530 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Tropical Disease Priority Review 
Vouchers.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the

[[Page 68504]]

docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information 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 concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Tropical Disease Priority Review Vouchers

OMB Control Number 0910-0822-- Extension

    Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360n) 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 and makes 
provisions for awarding priority review vouchers for future 
applications to sponsors of tropical disease products. Section 524 of 
the FD&C Act serves to stimulate new drug development for drugs to 
treat a ``tropical disease'' (as defined in section 524(a)(3)) by 
offering additional incentives for obtaining FDA approval for 
pharmaceutical treatments for these diseases. Under section 524 of the 
FD&C Act, a sponsor of a ``tropical disease product application,'' as 
defined in section 524(a)(4), may be eligible for a voucher that can be 
used to obtain a priority review for any other application submitted 
under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or 
section 351 of the Public Health Service Act (PHS Act).
    Accordingly, we have developed the guidance for industry entitled 
``Tropical Disease Priority Review Vouchers'' (available at https://www.fda.gov/media/72569/download). The guidance explains how FDA 
implements provisions of section 524 of the FD&C Act and how sponsors 
may qualify for a priority review voucher based on eligibility criteria 
set forth in the statute, how to use priority review vouchers, and how 
priority review vouchers may be transferred to other sponsors.
    The guidance also communicates that, under the FDA Reauthorization 
Act of 2017, section 524 requires attestation by the sponsor of 
eligibility for a priority review voucher upon submission of the 
marketing application.
    Description of Respondents: Sponsors submitting applications under 
section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Priority Review Voucher Request.               4               1               4               8              32
Notifications of Intent to Use a               2               1               2               8              16
 Voucher........................
Letters Indicating the Transfer                2               1               2               8              16
 of a Voucher Letter............
Acknowledging the Receipt of a                 2               1               2               8              16
 Transferred Voucher............
Attestation of eligibility......               4               1               4               2               8
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    Total.......................  ..............  ..............  ..............  ..............              88
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our evaluation of the information collection since last 
OMB review and approval, the burden estimate decreased based on receipt 
of fewer vouchers and other information collection activities.

    Dated: November 24, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26196 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P