[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27616-27617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12635]


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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Drugs; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Limited 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).

DATES: Submit either electronic or written comments on the draft 
guidance by August 13, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2018-D-2032 for ``Limited Population Pathway for Antibacterial and 
Antifungal Drugs; 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 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 more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access

[[Page 27617]]

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, or 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 draft 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 draft guidance for industry 
entitled ``Limited Population Pathway for Antibacterial and Antifungal 
Drugs.'' Section 506(h)(5) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 356(h)(5)) requires FDA to issue guidance 
``describing 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, added by section 
3042 of the Cures Act. This guidance satisfies the requirements under 
section 506(h)(5) of the FD&C Act.
    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 drug products that address unmet needs of patients with 
serious bacterial and fungal infections.
    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 the LPAD 
pathway. 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

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collection 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), 
has 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 under 21 CFR 201.56 
and 201.57 has been approved under OMB control number 0910-0572. The 
submission of medication guides under 21 CFR part 208 has been approved 
under OMB control number 0910-0393. The submission of prescription drug 
advertisements under 21 CFR 202.1 has been approved under OMB control 
number 0910-0686.
    The collection of information in the draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors and Applicants 
for PDUFA Products'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf), 
including requests for pre-NDA and pre-BLA meetings and other meetings 
pertaining to the LPAD pathway, has been approved under OMB control 
number 0910-0429.
    The collection of information in the guidance for industry entitled 
``Expedited Programs for Serious Conditions--Drugs and Biologics'' 
(available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm358301.pdf), including fast track 
designation, breakthrough therapy designation, accelerated approval, 
and priority review designation has been approved under OMB control 
number 0910-0765.
    The collection of information in 21 CFR part 312, including 
submissions under subpart E, has been approved under OMB control number 
0910-0014. In accordance with the PRA, prior to publication of any 
final guidance document, FDA intends to solicit public comment and 
obtain OMB approval for any information collections recommended in this 
guidance that are new or that would represent material modifications to 
those previously approved collections of information found in FDA 
regulations or guidances.

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, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatory 
Information/Guidances/default.htm, or https://www.regulations.gov.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12635 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P


