Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders; Availability, 19061-19062 [2017-08326]
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Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
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Strategic Stockpiles; Draft Guidance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.
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announcing the availability of a draft
guidance for government public health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 This draft
guidance has been prepared in response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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by June 26, 2017.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:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:42 Apr 24, 2017
Jkt 241001
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
PO 00000
Frm 00046
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19061
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.,
E:\FR\FM\25APN1.SGM
25APN1
19062
Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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]
[Docket No. FDA–2013–N–0868]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Use of Serological Tests To
Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Whole
Blood and Blood Components for
Transfusion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by May 25,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0681. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance for Industry: Use of
Serological Tests To Reduce the Risk of
Transmission of Trypanosoma cruzi
Infection in Whole Blood and Blood
Components Intended for Transfusion
OMB Control Number 0910–0681—
Extension
The guidance document implements
the donor screening recommendations
for the FDA-approved serological test
BILLING CODE 4164–01–P
17:42 Apr 24, 2017
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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PO 00000
Frm 00047
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Sfmt 4703
systems for the detection of antibodies
to T. cruzi. The use of the donor
screening tests are to reduce the risk of
transmission of T. cruzi infection by
detecting antibodies to T. cruzi in
plasma and serum samples from
individual human donors, including
donors of Whole Blood and blood
components intended for transfusion.
The guidance recommends that
establishments that manufacture Whole
Blood and blood components intended
for transfusion should notify consignees
of all previously collected in-date blood
and blood components to quarantine
and return the blood components to
establishments or to destroy them
within 3 calendar days after a donor
tests repeatedly reactive by a licensed
test for T. cruzi antibody. When
establishments identify a donor who is
repeatedly reactive by a licensed test for
T. cruzi antibodies and for whom there
is additional information indicating risk
of T. cruzi infection, such as testing
positive on a licensed supplemental test
(when such test is available) or until
such test is available, information that
the donor or donor’s mother resided in
an area endemic for Chagas disease
(Mexico, Central and South America) or
as a result of other medical diagnostic
testing of the donor indicating T. cruzi
infection, we recommend that the
establishment notify consignees of all
previously distributed blood and blood
components collected during the
lookback period and, if blood and blood
components were transfused, encourage
consignees to notify the recipient’s
physician of record of a possible
increased risk of T. cruzi infection.
Respondents to this information
collection are establishments that
manufacture Whole Blood and blood
components intended for transfusion.
We believe that the information
collection provisions in the guidance for
establishments to notify consignees and
for consignees to notify the recipient’s
physician of record in the guidance do
not create a new burden for respondents
and are part of usual and customary
business practices. Since the end of
January 2007, a number of blood centers
representing a large proportion of U.S.
blood collections have been testing
donors using a licensed assay. We
believe these establishments have
already developed standard operating
procedures for notifying consignees and
for the consignees to notify the
recipient’s physician of record.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
601.12 have been approved under OMB
control number 0910–0338; the
E:\FR\FM\25APN1.SGM
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Agencies
[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]
[[Page 19061]]
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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.
-----------------------------------------------------------------------
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.,
[[Page 19062]]
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 https://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