82_FR_19139 82 FR 19061 - Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders; Availability

82 FR 19061 - Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range19061-19062
FR Document2017-08326

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for government public health and emergency response stakeholders entitled ``Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic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 This draft guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules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.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017) 
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19061-19062]
From the Federal Register Online  [www.thefederalregister.org]
[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Strategic Stockpiles; Draft Guidance for Government Public Health and 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 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

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19061 DEPARTMENT OF HEALTH AND comment will be made public, you are https://www.regulations.gov. Submit HUMAN SERVICES solely responsible for ensuring that your both copies to the Division of Dockets comment does not include any Management. If you do not wish your Food and Drug Administration confidential information that you or a name and contact information to be [Docket No. FDA–2017–D–0762] third party may not wish to be posted, made publicly available, you can such as medical information, your or provide this information on the cover Extending Expiration Dates of anyone else’s Social Security number, or sheet and not in the body of your Doxycycline Tablets and Capsules in confidential business information, such comments and you must identify this Strategic Stockpiles; Draft Guidance as a manufacturing process. Please note information as ‘‘confidential.’’ Any for Government Public Health and that if you include your name, contact information marked as ‘‘confidential’’ Emergency Response Stakeholders; information, or other information that will not be disclosed except in Availability identifies you in the body of your accordance with 21 CFR 10.20 and other comments, that information will be applicable disclosure law. For more AGENCY: Food and Drug Administration, posted on https://www.regulations.gov. information about FDA’s posting of HHS. • If you want to submit a comment comments to public dockets, see 80 FR ACTION: Notice of availability. with confidential information that you 56469, September 18, 2015, or access do not wish to be made available to the the information at: https://www.fda.gov/ SUMMARY: The Food and Drug public, submit the comment as a regulatoryinformation/dockets/ Administration (FDA or Agency) is written/paper submission and in the default.htm. announcing the availability of a draft manner detailed (see ‘‘Written/Paper Docket: For access to the docket to guidance for government public health Submissions’’ and ‘‘Instructions’’). read background documents or the and emergency response stakeholders entitled ‘‘Extending Expiration Dates of Written/Paper Submissions electronic and written/paper comments Doxycycline Tablets and Capsules in received, go to https:// Submit written/paper submissions as www.regulations.gov and insert the Strategic Stockpiles.’’ This document, follows: docket number, found in brackets in the once finalized, will provide guidance to • Mail/Hand delivery/Courier (for government stakeholders on testing to heading of this document, into the written/paper submissions): Division of extend the shelf life (i.e., expiration ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food date) under the Federal Food, Drug, and and/or go to the Division of Dockets and Drug Administration, 5630 Fishers Cosmetic Act (the FD&C Act) of Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. stockpiled doxycycline tablets and • For written/paper comments 1061, Rockville, MD 20852. capsules for public health emergency submitted to the Division of Dockets Submit written requests for single preparedness and response purposes for Management, FDA will post your copies of the draft guidance to the an anthrax emergency. This draft comment, as well as any attachments, Division of Drug Information, Center for guidance has been prepared in response except for information submitted, Drug Evaluation and Research, Food to requests from States asking FDA what marked and identified, as confidential, and Drug Administration, 10001 New would be necessary to provide if submitted as detailed in Hampshire Ave., Hillandale Building, confidence that stockpiled doxycycline ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– tablets and capsules have retained their Instructions: All submissions received 0002. Send one self-addressed adhesive original quality beyond the must include the Docket No. FDA– label to assist that office in processing manufacturer’s labeled expiration date 2017–D–0762 for ‘‘Extending Expiration your requests. See the SUPPLEMENTARY so the replacement of stockpiled Dates of Doxycycline Tablets and INFORMATION section for electronic product could be deferred. This Capsules in Strategic Stockpiles.’’ access to the draft guidance document. guidance and any resulting expiration Received comments will be placed in FOR FURTHER INFORMATION CONTACT: date extensions authorized by FDA do the docket and, except for those Frederick Ensor, Center for Drug not apply to doxycycline available submitted as ‘‘Confidential Evaluation and Research, Food and commercially or otherwise held for any Submissions,’’ publicly viewable at Drug Administration, 10903 New other non-emergency purpose. https://www.regulations.gov or at the Hampshire Ave., Silver Spring, MD DATES: Although you can comment on Division of Dockets Management 20993–0002, 240–402–2733. any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: 10.115(g)(5)), to ensure that the Agency through Friday. • Confidential Submissions—To I. Background considers your comment on this draft guidance before it begins work on the submit a comment with confidential FDA is announcing the availability of final version of the guidance, submit information that you do not wish to be a draft guidance for government public either electronic or written comments made publicly available, submit your health and emergency response on the draft guidance by June 26, 2017. comments only as a written/paper stakeholders entitled ‘‘Extending ADDRESSES: You may submit comments submission. You should submit two Expiration Dates of Doxycycline Tablets as follows: copies total. One copy will include the and Capsules in Strategic Stockpiles.’’ A information you claim to be confidential number of government public health Electronic Submissions with a heading or cover note that states and emergency response stakeholders Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS maintain stockpiles of doxycycline asabaliauskas on DSK3SPTVN1PROD with NOTICES following way: CONFIDENTIAL INFORMATION.’’ The tablets or capsules for post-exposure • Federal eRulemaking Portal: Agency will review this copy, including prophylaxis (PEP) or treatment of https://www.regulations.gov. Follow the the claimed confidential information, in inhalational anthrax in the event of an instructions for submitting comments. its consideration of comments. The anthrax emergency. States have asked Comments submitted electronically, second copy, which will have the FDA what would be necessary to including attachments, to https:// claimed confidential information provide confidence that stockpiled www.regulations.gov will be posted to redacted/blacked out, will be available doxycycline tablets and capsules have the docket unchanged. Because your for public viewing and posted on retained their original quality (i.e., VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

19062 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices purity and potency) beyond the DEPARTMENT OF HEALTH AND systems for the detection of antibodies manufacturer’s labeled expiration date HUMAN SERVICES to T. cruzi. The use of the donor so the replacement of stockpiled screening tests are to reduce the risk of product could be deferred. This Food and Drug Administration transmission of T. cruzi infection by document, once finalized, will provide [Docket No. FDA–2013–N–0868] detecting antibodies to T. cruzi in guidance to government stakeholders on plasma and serum samples from testing to extend the shelf life (i.e., Agency Information Collection individual human donors, including expiration date) under section 564A(b) Activities; Submission for Office of donors of Whole Blood and blood of the FD&C Act (21 U.S.C. 360bbb– Management and Budget Review; components intended for transfusion. Comment Request; Guidance for The guidance recommends that 3a(b)) of stockpiled doxycycline tablets Industry: Use of Serological Tests To establishments that manufacture Whole and capsules for public health Reduce the Risk of Transmission of Blood and blood components intended emergency preparedness and response for transfusion should notify consignees purposes for an anthrax emergency. Trypanosoma cruzi Infection in Whole Blood and Blood Components for of all previously collected in-date blood The draft guidance applies to both Transfusion and blood components to quarantine doxycycline monohydrate and and return the blood components to doxycycline hyclate tablets and AGENCY: Food and Drug Administration, establishments or to destroy them capsules equivalent to 50 mg and 100 HHS. within 3 calendar days after a donor mg of doxycycline that are indicated for ACTION: Notice. tests repeatedly reactive by a licensed PEP or treatment of inhalational test for T. cruzi antibody. When anthrax. Where doxycycline is SUMMARY: The Food and Drug establishments identify a donor who is Administration (FDA or we) is repeatedly reactive by a licensed test for mentioned throughout this guidance, it announcing that a proposed collection T. cruzi antibodies and for whom there is meant to include both the hyclate and of information has been submitted to the is additional information indicating risk monohydrate forms of the drug that are Office of Management and Budget of T. cruzi infection, such as testing indicated for PEP or treatment of (OMB) for review and clearance under positive on a licensed supplemental test inhalational anthrax. the Paperwork Reduction Act of 1995 (when such test is available) or until This draft guidance is being issued (the PRA). such test is available, information that consistent with FDA’s good guidance DATES: Fax written comments on the the donor or donor’s mother resided in practices regulation (21 CFR 10.115). collection of information by May 25, an area endemic for Chagas disease The draft guidance, when finalized, will 2017. (Mexico, Central and South America) or represent the current thinking of FDA as a result of other medical diagnostic ADDRESSES: To ensure that comments on on ‘‘Extending Expiration Dates of testing of the donor indicating T. cruzi the information collection are received, Doxycycline Tablets and Capsules in infection, we recommend that the OMB recommends that written Strategic Stockpiles.’’ It does not establishment notify consignees of all comments be faxed to the Office of establish any rights for any person and previously distributed blood and blood Information and Regulatory Affairs, is not binding on FDA or the public. components collected during the OMB, Attn: FDA Desk Officer, FAX: You can use an alternative approach if lookback period and, if blood and blood 202–395–7285, or emailed to oira_ it satisfies the requirements of the components were transfused, encourage submission@omb.eop.gov. All consignees to notify the recipient’s applicable statutes and regulations. comments should be identified with the physician of record of a possible OMB control number 0910–0681. Also increased risk of T. cruzi infection. II. Paperwork Reduction Act of 1995 include the FDA docket number found Respondents to this information This guidance refers to previously in brackets in the heading of this collection are establishments that approved collections of information that document. manufacture Whole Blood and blood are subject to review by the Office of FOR FURTHER INFORMATION CONTACT: components intended for transfusion. Management and Budget (OMB) under JonnaLynn Capezzuto, Office of We believe that the information the Paperwork Reduction Act of 1995 Operations, Food and Drug collection provisions in the guidance for (44 U.S.C. 3501–3520). The collection of Administration, Three White Flint establishments to notify consignees and information has been approved under North, 10A63, 11601 Landsdown St., for consignees to notify the recipient’s OMB control number 0910–0595. North Bethesda, MD 20852, 301–796– physician of record in the guidance do 3794. not create a new burden for respondents III. Electronic Access and are part of usual and customary SUPPLEMENTARY INFORMATION: In business practices. Since the end of Persons with access to the Internet compliance with 44 U.S.C. 3507, FDA January 2007, a number of blood centers may obtain the draft guidance at either has submitted the following proposed representing a large proportion of U.S. http://www.fda.gov/Drugs/Guidance collection of information to OMB for blood collections have been testing ComplianceRegulatoryInformation/ review and clearance. donors using a licensed assay. We Guidances/default.htm or https:// Guidance for Industry: Use of believe these establishments have www.regulations.gov. Serological Tests To Reduce the Risk of already developed standard operating asabaliauskas on DSK3SPTVN1PROD with NOTICES Dated: April 19, 2017. Transmission of Trypanosoma cruzi procedures for notifying consignees and Anna K. Abram, Infection in Whole Blood and Blood for the consignees to notify the Components Intended for Transfusion recipient’s physician of record. Deputy Commissioner for Policy, Planning, The guidance also refers to previously Legislation, and Analysis. OMB Control Number 0910–0681— approved collections of information [FR Doc. 2017–08326 Filed 4–24–17; 8:45 am] Extension found in FDA regulations. The BILLING CODE 4164–01–P The guidance document implements collections of information in 21 CFR the donor screening recommendations 601.12 have been approved under OMB for the FDA-approved serological test control number 0910–0338; the VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1


Document Created: 2017-04-25 02:18:41
Document Modified: 2017-04-25 02:18:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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.
ContactFrederick Ensor, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-2733.
FR Citation82 FR 19061 
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