[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55720-55722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24320]


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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 7, 2019.

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 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 7, 2019. 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 the ``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.
     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

[[Page 55721]]

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.gpo.gov/fdsys/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 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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under 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 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--Revision

    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. By enacting 
section 524 of the FD&C Act, Congress intended 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 of the FD&C Act, 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 FD&C Act (21 
U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (the 
PHS Act).
    Accordingly, we have developed the guidance document entitled, 
``Guidance for Industry (GFI): Tropical Disease Priority Review 
Vouchers.'' The guidance explains how FDA will implement the provisions 
of section 524 of the FD&C Act, how sponsors may use priority review 
vouchers, and how priority review vouchers may be transferred to other 
sponsors. The guidance also explains eligibility criteria for tropical 
disease drug product applications submitted under section 505(b)(1) of 
the FD&C Act and section 351 of the PHS Act, and provides instructions 
to sponsors on how they may:
     Request a priority review voucher; and
     notify FDA of their intent to use a priority review 
voucher, including the date on which the sponsor intends to submit the 
application.
    The guidance also explains that transfer of a priority review 
voucher from one sponsor to another is permitted and that each transfer 
should be documented with a letter of transfer. Finally, the guidance 
will be revised to include new information collection established by 
section 611 of the FDA Reauthorization Act of 2017 (FDARA). As amended, 
section 524 of the FD&C Act requires the sponsor of a tropical disease 
product application to include an attestation regarding its eligibility 
for a priority review voucher.
    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 the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
 Information collection activity     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Priority Review Voucher Request.               5               1               5               8              40
Notifications of Intent to Use a               5               1               5               8              40
 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......               5               1               5               2              10
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[[Page 55722]]

 
    Total.......................  ..............  ..............  ..............  ..............             122
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have increased our burden estimate since last approval to 
account for attestations added by FDARA; however, all other information 
collection elements remain unchanged.

    Dated: November 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24320 Filed 11-6-18; 8:45 am]
 BILLING CODE 4164-01-P