[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47799-47801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 This guidance finalizes the draft 
guidance of the same name issued on June 13, 2018.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

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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, 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 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.
    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, 240-402-7911.

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

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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