[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finalizes the draft guidance issued in April 2017.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