[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24128-24129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0412]


Anthrax: Developing Drugs for Prophylaxis of Inhalational 
Anthrax; 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 guidance for industry entitled ``Anthrax: 
Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose 
of this guidance is to assist sponsors in the development of new drugs 
for the prophylaxis of inhalational anthrax. This guidance finalizes 
the draft guidance of the same name issued on February 16, 2016.

DATES: The announcement of the guidance is published in the Federal 
Register on May 24, 2018.

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

[[Page 24129]]

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-2016-D-0412 for ``Anthrax: Developing Drugs for Prophylaxis of 
Inhalational Anthrax.'' 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 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 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: Joseph G. Toerner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational 
Anthrax.'' The purpose of this guidance is to assist sponsors in the 
development of new drugs to be administered to people who have or may 
have inhaled Bacillus anthracis spores, but who have not yet manifested 
clinical evidence of disease, to prevent the development of 
inhalational anthrax. This guidance clarifies that drugs for the 
prophylaxis of inhalational anthrax are to be considered for approval 
under the animal rule regulations because human efficacy trials are not 
ethical or feasible (21 CFR part 314, subpart I, for drugs, and 21 CFR 
part 601, subpart H, for biological products).
    This guidance finalizes the draft guidance of the same name issued 
on February 16, 2016 (81 FR 7813). Changes made to the guidance took 
into consideration written and verbal comments received. In addition to 
changes primarily for clarification, the major changes are as follows: 
Clarity in defining specific populations that would receive a drug for 
prophylaxis of inhalational anthrax, for example, first responders who 
anticipate exposure to Bacillus anthracis spores and initiate drug 
therapy immediately before exposure. In addition, the guidance was 
updated to provide consistency with the guidance for industry entitled 
``Product Development Under the Animal Rule'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm399217.pdf).
    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 three guidance documents per year 
for the conduct of clinical trials with respect to antibacterial and 
antifungal drugs.
    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 prophylaxis of inhalational anthrax. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: May 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11117 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P


