[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47799-47801]
[FR Doc No: 2020-17109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2032]

Limited Population Pathway for Antibacterial and Antifungal
Drugs; 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 final guidance for industry entitled ``Limited
Population Pathway for Antibacterial and Antifungal Drugs.'' This
guidance provides information on the implementation of the limited
population pathway provision of the 21st Century Cures Act (Cures Act),
which established the limited population pathway for antibacterial and
antifungal drugs (LPAD pathway). This guidance finalizes the draft
guidance of the same name issued on June 13, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on August 6, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2018-D-2032 for ``Limited Population Pathway for Antibacterial and
Antifungal Drugs.'' 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,<PHONE_NUMBER>.
     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 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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this 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; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Sarah Walinsky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 240-
402-4075; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Limited Population Pathway for Antibacterial and Antifungal
Drugs.'' Section 3042 of the Cures Act added section 506(h) to the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(h)(5))
to create the LPAD pathway. The LPAD pathway is intended to encourage
the development of certain antibacterial and antifungal drugs to help
address the critical public health and patient care concern that has
resulted from the current decline in antibacterial drug research and
development as serious antibacterial and antifungal drug-resistant
infections increase. FDA is committed to using the tools at its
disposal, including the LPAD pathway, to help encourage the development
of safe and effective drugs that address unmet needs of patients with
serious bacterial and fungal infections.
    Section 506(h)(5) of the FD&C Act requires FDA to issue guidance
that describes criteria, processes, and other general considerations
for demonstrating the safety and effectiveness of limited population
antibacterial and antifungal drugs. This guidance provides this
information and is intended to assist sponsors in the development of
certain new antibacterial and antifungal drugs for approval under the
LPAD pathway. This guidance also is intended to assist sponsors in
developing labeling, including prescribing information, patient
labeling, and carton/container labeling, that incorporates certain
statements required by section 506(h) of the FD&C Act. This guidance
satisfies the requirements under section 506(h)(5) of the FD&C Act.
    This guidance finalizes the draft guidance of the same name issued
on June 13, 2018 (83 FR 27616). Changes made to the guidance were based
on the comments submitted to the docket on the draft guidance and
public comments received during the FDA public meeting entitled
``Limited Population Pathway for Antibacterial and Antifungal Drugs,''
which was held on July 12, 2019 (84 FR 12621) (meeting transcript
available at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-limited-population-pathway-antibacterial-and-antifungal-drugs-07122019-07122019). Based on the
comments received, FDA made clarifying changes to this guidance,
included examples of labeling and explanations of the meaning of
limited population, and provided further

information about presubmission of promotional materials.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Limited Population Pathway for
Antibacterial and Antifungal Drugs.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance contains no new collection of information. Therefore,
additional clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521) is not
required.
    However, this guidance refers to previously approved FDA
collections of information. These collections of information were
reviewed by OMB under the PRA. The collections of information in 21 CFR
part 314 for the submission of new drug applications (NDAs) under the
LPAD pathway, including the submission of labeling under Sec.
314.50(e)(2)(ii) and (l)(1)(i) and advertisements and promotional
labeling under Sec.  314.81(b)(3)(i), have been approved under OMB
control number 0910-0001. The submission of biologics license
applications (BLAs) under the LPAD pathway has been approved under OMB
control number 0910-0338.
    The submission of prescription drug labeling in 21 CFR 201.56 and
201.57 has been approved under OMB control number 0910-0572. The
submission of medication guides in 21 CFR part 208 has been approved
under OMB control number 0910-0393. The submission of prescription drug
advertisements in 21 CFR 202.1 has been approved under OMB control
number 0910-0686.
    The collections of information in 21 CFR part 312, including
submissions under subpart E, have been approved under OMB control
number 0910-0014. The collections of information in FDA's draft
guidance for industry entitled ``Formal Meetings Between the FDA and
Sponsors and Applicants for PDUFA Products'' (available at https://www.fda.gov/media/109951/download), including requests for pre-NDA and
pre-BLA meetings and other meetings pertaining to the LPAD pathway,
have been approved under OMB control number 0910-0429.
    The collections of information in FDA's final guidance for industry
entitled ``Expedited Programs for Serious Conditions--Drugs and
Biologics'' (available at https://www.fda.gov/media/86377/download)
have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17109 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P