Document ID: FDA-2009-D-0136-0022
Agency: fda
Document Type: Notice
Title: Community-Acquired Bacterial Pneumonia: Developing Drugs for
Treatment; Guidance for Industry; Availability
Posted Date: 2020-06-25T04:00Z

[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Pages 38143-38144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13746]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0136]

Community-Acquired Bacterial Pneumonia: Developing Drugs for 
Treatment; 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 ``Community-
Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' The 
purpose of this guidance is to assist sponsors in the clinical 
development of antibacterial drugs for the treatment of community-
acquired bacterial pneumonia (CABP) based on comments that were 
received and current recommendations. This guidance finalizes the draft 
guidance of the same title issued on January 10, 2014.

DATES: The announcement of the guidance is published in the Federal 
Register on June 25, 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-2009-D-0136 for ``Community-Acquired Bacterial Pneumonia: 
Developing Drugs for Treatment.'' 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

[[Page 38144]]

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.
    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. 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: Sunita Shukla, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6334, Silver Spring, MD 20993-0002, 301-
796-6406.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Community-Acquired Bacterial Pneumonia: Developing Drugs for 
Treatment.'' The purpose of this guidance is to assist sponsors in the 
clinical development of antibacterial drugs for the treatment of CABP. 
This guidance finalizes the draft guidance entitled ``Community-
Acquired Bacterial Pneumonia: Developing Drugs for Treatment'' issued 
on January 10, 2014 (79 FR 1874). FDA considered comments received on 
the draft guidance as the guidance was finalized. Revisions from the 
draft to the final guidance include clarification around the time to 
assess the primary efficacy endpoint (Day 4), updates to the CABP trial 
population based on the Pneumonia Patient Outcomes Research Team 
scores, evaluation of intravenous drug formulation, and analysis 
populations. In addition, editorial changes were made to improve 
clarity. Issuance of this guidance fulfills a portion of the 
requirements of Title VIII, section 804, of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144), which 
requires FDA to review and, as appropriate, revise not fewer than 3 
guidance documents per year for the conduct of clinical trials with 
respect to antibacterial and antifungal drugs. Issuance of this final 
guidance, which revises and finalizes the draft recommendations in the 
previously published draft guidance, fulfills a portion of the 
requirements of Public Law 112-144.
    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 ``Community-Acquired Bacterial Pneumonia: 
Developing Drugs for Treatment.'' 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 refers to previously approved FDA collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 
CFR parts 312 and 314 and in 21 CFR 201.56 and 201.57 have been 
approved under OMB control numbers 0910-0014, 0910-0001, and 0910-0572, 
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13746 Filed 6-24-20; 8:45 am]
BILLING CODE 4164-01-P