[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2527-2528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1334]


Opioid Use Disorder: Developing Depot Buprenorphine Products for 
Treatment; 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 final guidance for industry entitled ``Opioid Use 
Disorder: Developing Depot Buprenorphine Products for Treatment.'' This 
guidance reflects the Agency's current thinking regarding drug product 
development and trial design issues relevant to the study of depot 
buprenorphine products (i.e., modified-release products for injection 
or implantation) for the treatment of opioid use disorder. Passive-
compliance formulations such as sustained-release injectable depots and 
implants can provide effective treatment of opioid use disorder in a 
treatment paradigm that may be less subject to misuse, abuse, or 
accidental exposure compared to self-administered formulations such as 
transmucosal tablets and films. This guidance finalizes the draft 
guidance entitled ``Opioid Dependence: Developing Depot Buprenorphine 
Products for Treatment'' issued in April 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on February 7, 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:

[[Page 2528]]

     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-2018-D-1334 for ``Opioid Use Disorder: Developing Depot 
Buprenorphine Products for Treatment.'' 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 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: Silvana Borges, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3200, Silver Spring, MD 20993-0002, 301-
796-0963.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Opioid Use Disorder: Developing Depot Buprenorphine Products 
for Treatment.'' This guidance reflects the Agency's current thinking 
regarding drug product development and trial design issues relevant to 
the study of depot buprenorphine products (i.e., modified-release 
products for injection or implantation) for the treatment of opioid use 
disorder. Passive-compliance formulations such as sustained-release 
injectable depots and implants can provide effective treatment of 
opioid use disorder in a treatment paradigm that may be less subject to 
misuse, abuse, or accidental exposure compared to self-administered 
formulations such as transmucosal tablets and films. This finalizes the 
draft guidance entitled ``Opioid Dependence: Developing Depot 
Buprenorphine Products for Treatment'' issued on April 23, 2018 (83 FR 
17666). In addition to editorial changes made primarily for 
clarification, changes from the draft to the final guidance include 
replacement of opioid dependence with opioid use disorder, the addition 
of language noting that patients with moderate-severe opioid use 
disorder should be enrolled in clinical trials, and clarification of 
the cumulative responder curve efficacy analysis.
    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 ``Opioid Use Disorder: Developing Depot 
Buprenorphine Products for Treatment.'' 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 collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively. The collection of information in 21 CFR parts 50 and 56 
have been approved under OMB control numbers 0910-0755 and 0910-0130.

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: January 24, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01517 Filed 2-6-19; 8:45 am]
 BILLING CODE 4164-01-P