Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders; Availability, 19061-19062 [2017-08326]

Download as PDF 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[Docket No. FDA–2017–D–0762] Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for government public health and emergency response stakeholders entitled ‘‘Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic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 This draft guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 26, 2017.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 Fmt 4703 Sfmt 4703 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 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 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 25APN1

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]]

-----------------------------------------------------------------------

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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.