83 FR 13488 - Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled ``Product- Specific Guidance for Doxycycline Hyclate.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for doxycycline hyclate oral delayed-release tablets.

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13488-13490]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Product-Specific Guidance for Doxycycline Hyclate; Revised Draft 
Guidance for Industry; Availability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the availability of a revised draft guidance for industry on generic 
doxycycline hyclate oral delayed-release tablets, entitled ``Product-
Specific Guidance for Doxycycline Hyclate.'' The revised draft 
guidance, when finalized, will provide product-specific recommendations 
on, among other things, the design of bioequivalence (BE) studies to 
support abbreviated new drug applications (ANDAs) for doxycycline 
hyclate oral delayed-release tablets.

DATES: Submit either electronic or written comments on the draft 
guidance by May 29, 2018 to ensure that the Agency considers your 
comments on the draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 13489]]

     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-2007-D-0369 for ``Product-Specific Guidance for Doxycycline 
Hyclate; Revised Draft Guidancefor Industry.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' will be 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.thefederalregister.org/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 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: Xiaoqiu Tang, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 
301-796-5850.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Guidance for Industry on Bioequivalence Recommendations for Specific 
Products'' that explained the process that would be used to make 
product-specific guidances available to the public on FDA's website at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process to develop 
and disseminate product-specific guidances and to provide a meaningful 
opportunity for the public to consider and comment on the guidances. 
This notice announces the availability of a revised draft guidance for 
generic doxycycline hyclate oral delayed-release tablets.
    FDA initially approved new drug application (NDA) 050795 for DORYX 
(doxycycline hyclate oral delayed-release tablets) in May 2005. In May 
2009, FDA issued a draft guidance for industry on generic doxycycline 
hyclate oral delayed-release tablets and most recently revised that 
guidance in June 2015. On May 20, 2016, FDA approved a supplement to 
NDA 050795 for a new formulation of doxycycline hyclate delayed-release 
tablets in equivalent to (EQ) 60 milligram (mg) and EQ 120 mg strengths 
under the trade name Doryx MPC. We are now issuing another revised 
draft guidance for industry on doxycycline hyclate oral delayed-release 
tablets to include recommendations for demonstrating bioequivalence to 
these strengths.
    In November 2016, Mayne Pharma International Pty Ltd submitted a 
citizen petition requesting that FDA require certain in vitro 
dissolution criteria as part of the BE demonstration for any ANDA 
referencing DORYX MPC. FDA has reviewed the issues raised in this 
citizen petition and is responding to the citizen petition separately 
in the docket for that citizen petition (Docket No. FDA-2016-P-4047, 
available at https://www.regulations.gov).
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The revised draft 
guidance, when finalized, will represent the current thinking of FDA on 
the design of BE studies to support ANDAs for doxycycline hyclate oral 
delayed-release tablets. 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. 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.


[[Page 13490]]


    Dated: March 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06253 Filed 3-28-18; 8:45 am]
 BILLING CODE 4164-01-P