[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2797-2799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6880]


Material Threat Medical Countermeasure Priority Review Vouchers; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Material 
Threat Medical Countermeasure Priority Review Vouchers.'' There is 
stakeholder interest in FDA's implementation of the provision of the 
21st Century Cures Act (Cures Act) that adds a new section to the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) on priority review 
vouchers for material threat medical countermeasure applications. This 
new section of the FD&C Act makes provisions for awarding priority 
review vouchers for use with applications to sponsors of material 
threat medical countermeasure applications that meet the criteria 
specified by the FD&C Act.

[[Page 2798]]

This draft guidance explains to internal and external stakeholders how 
FDA intends to implement the provisions of the new section of the FD&C 
Act.

DATES: Submit either electronic or written comments on the draft 
guidance by March 20, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2017-D-6880 for ``Material Threat Medical Countermeasure Priority 
Review Vouchers; Draft Guidance for Industry; Availability.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the office of Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
    <bullet> 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.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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to Office 
of Counterterrorism and Emerging Threats, Office of the Commissioner, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 
4343, Silver Spring, MD 20993-0002, 301-796-8510. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Carol Drew, Office of Counterterrorism 
and Emerging Threats, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4320, Silver Spring, MD 20993-0002, 301-796-8510 
(this is not a toll free number).

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled, ``Material Threat Medical Countermeasure Priority Review 
Vouchers.'' Section 3086 of the Cures Act adds new section 565A to the 
FD&C Act. Section 565A of the FD&C Act (21 U.S.C. 360bbb-4a) was 
designed to encourage development of medical countermeasures by 
offering additional incentives for obtaining approval of new drug or 
biological medical products for the prevention and treatment of harm 
from a biological, chemical, radiological, or nuclear agent identified 
as a material threat. Under section 565A of the FD&C Act, a sponsor of 
a human drug application for a material threat medical countermeasure 
application 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 (PHS) Act (42 U.S.C. 262). 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 
represents the current thinking of FDA on obtaining a material threat 
medical countermeasure priority review voucher. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

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

[[Page 2799]]

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 comment 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 medical 
countermeasure product applications submitted under section 505(b)(1) 
of the FD&C Act and section 351 of the PHS Act may request a priority 
review voucher. Based on inquiries FDA has received on section 565A and 
related discussions with sponsors, we estimate that we will receive 
annually approximately 2 requests from 2 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 90 days 
before use. We estimate that we will receive annually approximately 2 
notifications of intent to use a voucher from 2 sponsors, and that 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 1 letter indicating the transfer of a 
voucher from 1.5 application holders, and 1 letter acknowledging the 
receipt of a transferred voucher from 1.5 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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                                                     Number of
 Reporting under Section 3086 of     Number of     responses per       Total         Hours per      Total hours
          the Cures Act             respondents     respondent       responses       response
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Priority review voucher request.               2               1               2               8              16
Notifications of intent to use a               2               1               2               8              16
 voucher........................
Letters indicating the transfer              1.5               1             1.5               8              12
 of a voucher...................
Letters acknowledging the                    1.5               1             1.5               8              12
 receipt of a transferred
 voucher........................
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    Total.......................  ..............  ..............  ..............  ..............              56
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, 
https://www.regulations.gov, or https://www.fda.gov/medicalcountermeasures.

    Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00900 Filed 1-17-18; 8:45 am]
 BILLING CODE 4164-01-P