
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7813-7815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02964]


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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Anthrax; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Anthrax: 
Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose 
of this draft guidance is to assist sponsors in the development of new 
drugs for the prophylaxis of inhalational anthrax. This draft guidance 
supersedes the draft guidance entitled ``Inhalational Anthrax (Post-
Exposure)--Developing Antimicrobial Drugs'' issued in March 2002.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the

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instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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; Draft Guidance for Industry; Availability.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this 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. 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-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational 
Anthrax.'' The purpose of this draft guidance is to assist sponsors in 
the development of new drugs to be administered to persons who have 
inhaled Bacillus anthracis spores, but who have not yet manifested 
clinical evidence of disease, to prevent the development of 
inhalational anthrax disease. We refer to this indication as 
``prophylaxis of inhalational anthrax.'' This draft guidance describes 
approaches for the designs of the animal model efficacy studies and 
recognizes that drug development for the sole indication of prophylaxis 
of inhalational anthrax is possible.
    This draft guidance supersedes the draft guidance for industry 
entitled ``Inhalational Anthrax (Post-Exposure)--Developing 
Antimicrobial Drugs'' published in March 2002 (2002 draft guidance). 
The 2002 draft guidance stated that drugs for the prophylaxis of 
inhalational anthrax would be approved under the accelerated approval 
regulations (21 CFR part 314, subpart H, for drugs and 21 CFR part 601, 
subpart E, for biological products), unless the drug already carried an 
anthrax indication. Shortly after the 2002 draft guidance issued, FDA 
amended its regulations to provide a regulatory mechanism to approve 
drugs and biological products when human efficacy studies are not 
ethical or feasible (part 314, subpart I, for drugs and part 601, 
subpart H, for biological products). These regulations are commonly 
referred to as the ``animal rule.'' \1\ This draft guidance states that 
drugs developed for prophylaxis of inhalational anthrax will be 
considered for approval under the animal rule regulations. Other 
changes from the 2002 draft guidance are incorporated into the 
appropriate sections of this guidance and are based on comments 
received to the docket for the 2002 draft guidance as well as recent 
developments in scientific information that pertain to drugs being 
developed for prophylaxis of inhalational anthrax.
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    \1\ The animal rule regulations in this guidance specifically 
refer to part 314, subpart I, for drugs and part 601, subpart H, for 
biological products. In October 2015, FDA finalized the guidance for 
industry entitled ``Product Development Under the Animal Rule'' that 
contains general information and recommendations on the development 
and approval of products under the animal rule.
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    Issuance of this draft 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 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 this topic. It 
does not establish any rights for any person and is not binding

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on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft 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 draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02964 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P


