[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4216-4218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-7001]


Qualified Infectious Disease Product Designation Questions and 
Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Qualified 
Infectious Disease Product Designation Questions and Answers.'' The 
Food and Drug Administration Safety and Innovation Act (FDASIA) creates 
incentives for the development of antibacterial and antifungal drug 
products that treat serious or life-threatening infections. The purpose 
of this draft guidance is to provide a resource for information on 
FDA's policies and procedures related to the designation of a qualified 
infectious disease product (QIDP).

DATES: Submit either electronic or written comments on the draft 
guidance by April 2, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-2017-D-7001 for ``Qualified Infectious Disease Product Designation 
Questions and Answers; Draft Guidance for Industry.'' 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 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 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

[[Page 4217]]

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 draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1182.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Qualified Infectious Disease Product Designation Questions 
and Answers.'' Title VIII of FDASIA created the Generating Antibiotic 
Incentives Now (GAIN) provisions under section 505E of the Federal 
Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355f). GAIN offers 
incentives for the development of antibacterial and antifungal drugs 
for human use to treat serious or life-threatening infections. The 
primary incentive contained in GAIN is a 5-year extension of 
exclusivity for which a QIDP-designated application qualifies upon 
approval under the FD&C Act. QIDPs also receive fast track designation 
at the sponsor's request (21 U.S.C. 356(b)(1)) and the first marketing 
application submitted for approval of a QIDP is granted priority review 
(21 U.S.C. 360n-1).
    This draft guidance provides information on the implementation of 
GAIN and responses to common questions that might arise regarding QIDP 
designation and review of QIDP new drug applications.
    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 current thinking of FDA on qualified 
infectious disease product designation questions and answers. It does 
not establish any rights for any person and is not binding on 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 (44 U.S.C. 3501-3520) (PRA), 
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 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 on respondents, including 
through the use of automated collection techniques, when appropriate, 
and other forms of information technology.
    Title: Draft Guidance for Industry on Qualified Infectious Disease 
Product Designation Questions and Answers.
    Description: As described in the draft guidance, a sponsor may 
request a QIDP designation at any time prior to that sponsor's 
submission of a marketing application under section 505(b) of the FD&C 
Act (21 U.S.C. 355(b)) for that sponsor's drug product. A request for 
QIDP designation should be submitted either to an investigational new 
drug (IND) application or as pre-IND correspondence.
    The cover letter for the QIDP designation request should include 
the following text in bold font at the top of the page: ``Request for 
Qualified Infectious Disease Product Designation Questions and 
Answers.'' Requests for multiple indications can be combined in a 
single submission or made separately. The sponsor should clearly 
identify each indication for which it is requesting QIDP designation.
    As described further in the draft guidance, each request should 
include: (1) A discussion of the information that supports the role of 
the drug as an antibacterial or antifungal drug, for example, in vitro 
data, including any available data on mechanism of action; data from 
animal models of infection; (2) any available human data from phase 1, 
phase 2, or phase 3 studies; (3) the specific serious or life-
threatening indication(s) for which the sponsor intends (or has begun) 
to develop the drug and the rationale or suitability for developing the 
drug for the proposed serious or life-threatening infection(s); and (4) 
the request may (but is not required to) include information to 
demonstrate that the product is an antibacterial or antifungal drug 
that has the capacity to treat a serious or life-threatening infection 
caused by either of the following: resistant pathogen(s), including 
novel or emerging infectious pathogens, and qualifying pathogens listed 
in 21 CFR 317.2.
    We estimate that approximately 33 requests for QIDP designation, as 
described in the draft guidance, will be submitted annually by 
approximately 25 sponsors, and that it will take approximately 60 hours 
to prepare and submit each request.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 4218]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual      Hours per       Total hours
                                                                       respondents       respondent       responses         response
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Requests for a QIDP Designation....................................              25             1.32               33               60            1,980
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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 either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01662 Filed 1-29-18; 8:45 am]
BILLING CODE 4164-01-P