83_FR_17744 83 FR 17666 - Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability

83 FR 17666 - Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 78 (April 23, 2018)

Page Range17666-17667
FR Document2018-08361

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Dependence: Developing Depot Buprenorphine Products for Treatment.'' This draft guidance addresses drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified- release products for injection or implantation).

Federal Register, Volume 83 Issue 78 (Monday, April 23, 2018) 
[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17666-17667]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-08361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Opioid Dependence: Developing Depot Buprenorphine Products for 
Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Opioid 
Dependence: Developing Depot Buprenorphine Products for Treatment.'' 
This draft guidance addresses drug development and trial design issues 
relevant to the study of depot buprenorphine products (i.e., modified-
release products for injection or implantation).

DATES: Submit either electronic or written comments on the draft 
guidance by June 22, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-2018-D-1334 for ``Opioid Dependence: Developing Depot Buprenorphine 
Products for Treatment; Draft Guidance for Industry; Availability.'' 
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.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: Silvana Borges, Center for Drug

[[Page 17667]]

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 draft guidance for industry 
entitled ``Opioid Dependence: Developing Depot Buprenorphine Products 
for Treatment.'' This draft guidance addresses drug development and 
trial design issues relevant to the study of depot buprenorphine 
products (i.e., modified-release products for injection or 
implantation).
    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 ``Opioid 
Dependence: 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. 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 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08361 Filed 4-20-18; 8:45 am]
 BILLING CODE 4164-01-P

17666 Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices knowledgeable in the fields of arthritis, design issues relevant to the study of ‘‘Confidential Submissions,’’ publicly rheumatology, orthopedics, depot buprenorphine products (i.e., viewable at https://www.regulations.gov epidemiology or statistics, analgesics, modified-release products for injection or at the Dockets Management Staff and related specialties. Members will be or implantation). between 9 a.m. and 4 p.m., Monday invited to serve for overlapping terms of DATES: Submit either electronic or through Friday. up to 4 years. Almost all non-Federal written comments on the draft guidance • Confidential Submissions—To members of this committee serve as by June 22, 2018 to ensure that the submit a comment with confidential Special Government Employees. The Agency considers your comment on this information that you do not wish to be core of voting members may include one draft guidance before it begins work on made publicly available, submit your technically qualified member, selected the final version of the guidance. comments only as a written/paper by the Commissioner or designee, who submission. You should submit two ADDRESSES: You may submit comments is identified with consumer interests copies total. One copy will include the on any guidance at any time as follows: information you claim to be confidential and is recommended by either a consortium of consumer-oriented Electronic Submissions with a heading or cover note that states organizations or other interested ‘‘THIS DOCUMENT CONTAINS Submit electronic comments in the persons. In addition to the voting CONFIDENTIAL INFORMATION.’’ The following way: members, the Committee may include Agency will review this copy, including • Federal eRulemaking Portal: one non-voting member who is the claimed confidential information, in https://www.regulations.gov. Follow the its consideration of comments. The identified with industry interests. instructions for submitting comments. Further information regarding the second copy, which will have the Comments submitted electronically, claimed confidential information most recent charter and other including attachments, to https:// information can be found at https:// redacted/blacked out, will be available www.regulations.gov will be posted to for public viewing and posted on www.fda.gov/AdvisoryCommittees/ the docket unchanged. Because your CommitteesMeetingMaterials/Drugs/ https://www.regulations.gov. Submit comment will be made public, you are both copies to the Dockets Management ArthritisAdvisoryCommittee/ solely responsible for ensuring that your ucm094137.htm or by contacting the Staff. If you do not wish your name and comment does not include any contact information to be made publicly Designated Federal Officer (see FOR confidential information that you or a FURTHER INFORMATION CONTACT). In light available, you can provide this third party may not wish to be posted, information on the cover sheet and not of the fact that no change has been made such as medical information, your or to the committee name or description of in the body of your comments and you anyone else’s Social Security number, or must identify this information as duties, no amendment will be made to confidential business information, such 21 CFR 14.100. ‘‘confidential.’’ Any information marked as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed This document is issued under the that if you include your name, contact Federal Advisory Committee Act (5 except in accordance with 21 CFR 10.20 information, or other information that and other applicable disclosure law. For U.S.C. app.). For general information identifies you in the body of your related to FDA advisory committees, more information about FDA’s posting comments, that information will be of comments to public dockets, see 80 please check https://www.fda.gov/ posted on https://www.regulations.gov. AdvisoryCommittees/default.htm. FR 56469, September 18, 2015, or access • If you want to submit a comment the information at: https://www.gpo.gov/ Dated: April 16, 2018. with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- Leslie Kux, do not wish to be made available to the 23389.pdf. Associate Commissioner for Policy. public, submit the comment as a Docket: For access to the docket to [FR Doc. 2018–08358 Filed 4–20–18; 8:45 am] written/paper submission and in the read background documents or the BILLING CODE 4164–01–P manner detailed (see ‘‘Written/Paper electronic and written/paper comments Submissions’’ and ‘‘Instructions’’). received, go to https:// Written/Paper Submissions www.regulations.gov and insert the DEPARTMENT OF HEALTH AND docket number, found in brackets in the HUMAN SERVICES Submit written/paper submissions as heading of this document, into the follows: ‘‘Search’’ box and follow the prompts Food and Drug Administration • Mail/Hand delivery/Courier (for and/or go to the Dockets Management written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, [Docket No. FDA–2018–D–1334] Management Staff (HFA–305), Food and Rockville, MD 20852. Drug Administration, 5630 Fishers You may submit comments on any Opioid Dependence: Developing Depot Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR Buprenorphine Products for • For written/paper comments 10.115(g)(5)). Treatment; Draft Guidance for submitted to the Dockets Management Submit written requests for single Industry; Availability Staff, FDA will post your comment, as copies of the draft guidance to the AGENCY: Food and Drug Administration, well as any attachments, except for Division of Drug Information, Center for HHS. information submitted, marked and Drug Evaluation and Research, Food ACTION: Notice of availability. identified, as confidential, if submitted and Drug Administration, 10001 New as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, SUMMARY: The Food and Drug Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– amozie on DSK30RV082PROD with NOTICES Administration (FDA or Agency) is must include the Docket No. FDA– 0002. Send one self-addressed adhesive announcing the availability of a draft 2018–D–1334 for ‘‘Opioid Dependence: label to assist that office in processing guidance for industry entitled ‘‘Opioid Developing Depot Buprenorphine your requests. See the SUPPLEMENTARY Dependence: Developing Depot Products for Treatment; Draft Guidance INFORMATION section for electronic Buprenorphine Products for for Industry; Availability.’’ Received access to the draft guidance document. Treatment.’’ This draft guidance comments will be placed in the docket FOR FURTHER INFORMATION CONTACT: addresses drug development and trial and, except for those submitted as Silvana Borges, Center for Drug VerDate Sep<11>2014 17:09 Apr 20, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\23APN1.SGM 23APN1

Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices 17667 Evaluation and Research, Food and Science Board (NPRSB) will hold a joint Preparedness and Response (ASPR) Drug Administration, 10903 New public teleconference on May 10, 2018. Future Strategies Work Group (FSWG) Hampshire Ave., Bldg. 22, Rm. 3200, DATES: The NACCD and NPRSB as a joint task between the NACCD and Silver Spring, MD 20993–0002, 301– Teleconference is May 10, 2018, from NPRSB. Established under the NPRSB 796–0963. 3:00 p.m. to 4:00 p.m. Eastern Daylight in 2014, the FSWG identified future SUPPLEMENTARY INFORMATION: Time (EDT). strategies that can best support ADDRESSES: We encourage members of successful achievement of the ASPR’s I. Background the public to attend the teleconference. and HHS’s mission for preparedness, FDA is announcing the availability of To register, send an email to naccd@ response, and recovery. In addition, the a draft guidance for industry entitled hhs.gov with ‘‘NACCD Registration’’ in ASPR FSWG provides prioritized ‘‘Opioid Dependence: Developing Depot the subject line, or to nprsb@hhs.gov recommendations for guiding current Buprenorphine Products for with ‘‘NPRSB Registration’’ in the efforts toward future strategies by Treatment.’’ This draft guidance subject line. Submit your comments to examining such items as ASPR’s current addresses drug development and trial naccd@hhs.gov, nprsb@hhs.gov, the mission, strategic objectives, resources, design issues relevant to the study of NPRSB Contact Form located at https:// and capabilities against projected depot buprenorphine products (i.e., www.phe.gov/Preparedness/legal/ futures. In 2017, the NACCD established modified-release products for injection boards/nprsb/Pages/ the ASPR Future Strategies for Children or implantation). RFNBSBComments.aspx, or the NACCD Working Group with the aim of This draft guidance is being issued Contact Form located at https:// identifying future strategies to advance consistent with FDA’s good guidance www.phe.gov/Preparedness/legal/ the ASPR’s mission as it relates to practices regulation (21 CFR 10.115). boards/naccd/Pages/contact.aspx. For The draft guidance, when finalized, will additional information, visit the NACCD infants, children, and teens. The joint represent the current thinking of FDA website located at https://www.phe.gov/ tasking of the FSWG will enable on ‘‘Opioid Dependence: Developing naccd or the NPRSB website located at members of the NPRSB and NACCD to Depot Buprenorphine Products for https://www.phe.gov/nprsb. collaborate on areas of shared Treatment.’’ It does not establish any SUPPLEMENTARY INFORMATION: Pursuant responsibility with regard to future rights for any person and is not binding to the Federal Advisory Committee Act strategies for preparedness and on FDA or the public. You can use an of 1972 (5 U.S.C., Appendix, as response. We will post modifications to alternative approach if it satisfies the amended), and section 2811A of the the agenda on the NACCD and NPRSB requirements of the applicable statutes Public Health Service Act (42 U.S.C. May 10, 2018, teleconference websites, and regulations. This guidance is not 300hh–10a), as added by section 103 of which are located at https:// subject to Executive Order 12866. the Pandemic and All Hazards www.phe.gov/naccd and https:// Preparedness Reauthorization Act of www.phe.gov/nprsb. II. Electronic Access 2013 (Pub. L. 113–5), the HHS Availability of Materials: We will post Persons with access to the internet Secretary, in consultation with the all teleconference materials prior to the may obtain the draft guidance at either Secretary of the U.S. Department of teleconference on May 10, 2018, at the https://www.fda.gov/Drugs/ Homeland Security, established the websites located at https:// GuidanceCompliance NACCD. The purpose of the NACCD is www.phe.gov/naccd and https:// RegulatoryInformation/Guidances/ to provide advice and consultation to default.htm or https:// www.phe.gov/nprsb. the HHS Secretary with respect to the www.regulations.gov. medical and public health needs of Procedures for Providing Public Input: Dated: April 17, 2018. children in relation to disasters. Members of the public may attend the Leslie Kux, The NPRSB is authorized under teleconference via a toll-free call-in Section 319M of the Public Health phone number, which is available on Associate Commissioner for Policy. Service (PHS) Act (42 U.S.C. 247d–7f), the NACCD and the NPRSB websites at [FR Doc. 2018–08361 Filed 4–20–18; 8:45 am] as added by section 402 of the Pandemic https://www.phe.gov/naccd and https:// BILLING CODE 4164–01–P and All-Hazards Preparedness Act of www.phe.gov/nprsb. 2006 and amended by section 404 of the We encourage members of the public Pandemic and All-Hazards to provide written comments that are DEPARTMENT OF HEALTH AND Preparedness Reauthorization Act, and HUMAN SERVICES relevant to the NACCD and NPRSB by Section 222 of the PHS Act (42 teleconference prior to May 10, 2018. National Advisory Committee on U.S.C. 217a). The Board is governed by Send written comments by email to Children and Disasters and National the Federal Advisory Committee Act (5 U.S.C. App.), which sets forth standards naccd@hhs.gov with ‘‘NACCD Public Preparedness and Response Science Comment’’ in the subject line or to Board Joint Public Teleconference for the formation and use of advisory committees. The NPRSB provides expert nprsb@hhs.gov with ‘‘NPRSB Public AGENCY: Office of the Secretary, advice and guidance on scientific, Comment’’ in the subject line. The Department of Health and Human technical, and other matters of special NACCD and NPRSB Chairs will respond Services (HHS). interest to the Department regarding to comments received by May 9, 2018, ACTION: Notice. current and future chemical, biological, during the teleconference. nuclear, and radiological agents, Dated: April 13, 2018. amozie on DSK30RV082PROD with NOTICES SUMMARY: As stipulated by the Federal whether naturally occurring, accidental, Robert P. Kadlec, Advisory Committee Act, the or deliberate. Department of Health and Human Background: The May 10, 2018, Assistant Secretary for Preparedness and Response. Services is hereby giving notice that the NACCD and NPRSB Public National Advisory Committee on Teleconference is dedicated to the [FR Doc. 2018–08421 Filed 4–20–18; 8:45 am] Children and Disasters (NACCD) and presentation, deliberation, and vote on BILLING CODE P National Preparedness and Response re-tasking the Assistant Secretary of VerDate Sep<11>2014 17:09 Apr 20, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\23APN1.SGM 23APN1


Document Created: 2018-04-21 00:33:03
Document Modified: 2018-04-21 00:33:03
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.
DatesSubmit either electronic or written comments on the draft guidance by June 22, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactSilvana 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.
FR Citation83 FR 17666 
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