[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Notices]
[Pages 17413-17414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08349]


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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; 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 final guidance for government public health and 
emergency response stakeholders entitled ``Extending Expiration Dates 
of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This 
document provides guidance to government stakeholders on testing to 
extend the expiration date--under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act)--of stockpiled doxycycline tablets and capsules for 
public health emergency preparedness and response purposes for an 
anthrax emergency. This 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 nonemergency purpose. This guidance 
finalizes the draft guidance issued in April 2017.

DATES: The announcement of the guidance is published in the Federal 
Register on April 25, 2019.

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-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 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

[[Page 17414]]

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: Frederick Ensor, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 240-
402-2733.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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., purity and potency) beyond the manufacturer's labeled expiration 
date so the replacement of stockpiled product could be deferred. This 
document provides guidance to government stakeholders on testing to 
extend the 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.
    This guidance applies to both doxycycline monohydrate and 
doxycycline hyclate tablets and capsules equivalent to 50 milligrams 
(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 guidance finalizes the draft guidance issued in April 2017. 
Those comments received on the draft guidance did not result in any 
policy changes but in some instances did result in clarifying language 
in the final guidance document.
    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 ``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. This guidance is not subject to 
Executive Order 12866.

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

    Dated: April 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08349 Filed 4-24-19; 8:45 am]
BILLING CODE 4164-01-P


