[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19061-19062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08326]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0762]


Extending Expiration Dates of Doxycycline Tablets and Capsules in 
Strategic Stockpiles; Draft Guidance for Government Public Health and 
Emergency Response Stakeholders; 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the availability of a draft guidance for government public health and 
emergency response stakeholders entitled ``Extending Expiration Dates 
of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This 
document, once finalized, will provide guidance to government 
stakeholders on testing to extend the shelf life (i.e., expiration 
date) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) of 
stockpiled doxycycline tablets and capsules for public health emergency 
preparedness and response purposes for an anthrax emergency. This draft 
guidance has been prepared in response to requests from States asking 
FDA what would be necessary to provide confidence that stockpiled 
doxycycline tablets and capsules have retained their original quality 
beyond the manufacturer's labeled expiration date so the replacement of 
stockpiled product could be deferred. This guidance and any resulting 
expiration date extensions authorized by FDA do not apply to 
doxycycline available commercially or otherwise held for any other non-
emergency purpose.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 26, 2017.

ADDRESSES: You may submit comments 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): 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-2017-D-0762 for ``Extending Expiration Dates of Doxycycline Tablets 
and Capsules in Strategic Stockpiles.'' 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 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 https://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: https://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 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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. 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: Frederick Ensor, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-2733.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for 
government public health and emergency response stakeholders entitled 
``Extending Expiration Dates of Doxycycline Tablets and Capsules in 
Strategic Stockpiles.'' A number of government public health and 
emergency response stakeholders maintain stockpiles of doxycycline 
tablets or capsules for post-exposure prophylaxis (PEP) or treatment of 
inhalational anthrax in the event of an anthrax emergency. States have 
asked FDA what would be necessary to provide confidence that stockpiled 
doxycycline tablets and capsules have retained their original quality 
(i.e.,

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purity and potency) beyond the manufacturer's labeled expiration date 
so the replacement of stockpiled product could be deferred. This 
document, once finalized, will provide guidance to government 
stakeholders on testing to extend the shelf life (i.e., expiration 
date) under section 564A(b) of the FD&C Act (21 U.S.C. 360bbb-3a(b)) of 
stockpiled doxycycline tablets and capsules for public health emergency 
preparedness and response purposes for an anthrax emergency.
    The draft guidance applies to both doxycycline monohydrate and 
doxycycline hyclate tablets and capsules equivalent to 50 mg and 100 mg 
of doxycycline that are indicated for PEP or treatment of inhalational 
anthrax. Where doxycycline is mentioned throughout this guidance, it is 
meant to include both the hyclate and monohydrate forms of the drug 
that are indicated for PEP or treatment of inhalational anthrax.
    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 ``Extending 
Expiration Dates of Doxycycline Tablets and Capsules in Strategic 
Stockpiles.'' 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 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 collection of information has been approved under OMB 
control number 0910-0595.

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 
https://www.regulations.gov.

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08326 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P