Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability, 17666-17667 [2018-08361]

Download as PDF 17666 Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices knowledgeable in the fields of arthritis, rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Further information regarding the most recent charter and other information can be found at https:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ ArthritisAdvisoryCommittee/ ucm094137.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: April 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–08358 Filed 4–20–18; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration [Docket No. FDA–2018–D–1334] Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability Food and Drug Administration, HHS. amozie on DSK30RV082PROD with NOTICES ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Opioid Dependence: Developing Depot Buprenorphine Products for Treatment.’’ This draft guidance addresses drug development and trial SUMMARY: VerDate Sep<11>2014 17:09 Apr 20, 2018 Jkt 244001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: 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: 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 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 ‘‘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/201523389.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 E:\FR\FM\23APN1.SGM 23APN1 Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices 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/ GuidanceCompliance RegulatoryInformation/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Advisory Committee on Children and Disasters and National Preparedness and Response Science Board Joint Public Teleconference Office of the Secretary, Department of Health and Human Services (HHS). ACTION: Notice. amozie on DSK30RV082PROD with NOTICES AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) and National Preparedness and Response SUMMARY: VerDate Sep<11>2014 17:09 Apr 20, 2018 Jkt 244001 Science Board (NPRSB) will hold a joint public teleconference on May 10, 2018. DATES: The NACCD and NPRSB Teleconference is May 10, 2018, from 3:00 p.m. to 4:00 p.m. Eastern Daylight Time (EDT). ADDRESSES: We encourage members of the public to attend the teleconference. To register, send an email to naccd@ hhs.gov with ‘‘NACCD Registration’’ in the subject line, or to nprsb@hhs.gov with ‘‘NPRSB Registration’’ in the subject line. Submit your comments to naccd@hhs.gov, nprsb@hhs.gov, the NPRSB Contact Form located at https:// www.phe.gov/Preparedness/legal/ boards/nprsb/Pages/ RFNBSBComments.aspx, or the NACCD Contact Form located at https:// www.phe.gov/Preparedness/legal/ boards/naccd/Pages/contact.aspx. For additional information, visit the NACCD website located at https://www.phe.gov/ naccd or the NPRSB website located at https://www.phe.gov/nprsb. SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), and section 2811A of the Public Health Service Act (42 U.S.C. 300hh–10a), as added by section 103 of the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5), the HHS Secretary, in consultation with the Secretary of the U.S. Department of Homeland Security, established the NACCD. The purpose of the NACCD is to provide advice and consultation to the HHS Secretary with respect to the medical and public health needs of children in relation to disasters. The NPRSB is authorized under Section 319M of the Public Health Service (PHS) Act (42 U.S.C. 247d–7f), as added by section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act, and by Section 222 of the PHS Act (42 U.S.C. 217a). The Board is governed by the Federal Advisory Committee Act (5 U.S.C. App.), which sets forth standards for the formation and use of advisory committees. The NPRSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Background: The May 10, 2018, NACCD and NPRSB Public Teleconference is dedicated to the presentation, deliberation, and vote on re-tasking the Assistant Secretary of PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 17667 Preparedness and Response (ASPR) Future Strategies Work Group (FSWG) as a joint task between the NACCD and NPRSB. Established under the NPRSB in 2014, the FSWG identified future strategies that can best support successful achievement of the ASPR’s and HHS’s mission for preparedness, response, and recovery. In addition, the ASPR FSWG provides prioritized recommendations for guiding current efforts toward future strategies by examining such items as ASPR’s current mission, strategic objectives, resources, and capabilities against projected futures. In 2017, the NACCD established the ASPR Future Strategies for Children Working Group with the aim of identifying future strategies to advance the ASPR’s mission as it relates to infants, children, and teens. The joint tasking of the FSWG will enable members of the NPRSB and NACCD to collaborate on areas of shared responsibility with regard to future strategies for preparedness and response. We will post modifications to the agenda on the NACCD and NPRSB May 10, 2018, teleconference websites, which are located at https:// www.phe.gov/naccd and https:// www.phe.gov/nprsb. Availability of Materials: We will post all teleconference materials prior to the teleconference on May 10, 2018, at the websites located at https:// www.phe.gov/naccd and https:// www.phe.gov/nprsb. Procedures for Providing Public Input: Members of the public may attend the teleconference via a toll-free call-in phone number, which is available on the NACCD and the NPRSB websites at https://www.phe.gov/naccd and https:// www.phe.gov/nprsb. We encourage members of the public to provide written comments that are relevant to the NACCD and NPRSB teleconference prior to May 10, 2018. Send written comments by email to naccd@hhs.gov with ‘‘NACCD Public Comment’’ in the subject line or to nprsb@hhs.gov with ‘‘NPRSB Public Comment’’ in the subject line. The NACCD and NPRSB Chairs will respond to comments received by May 9, 2018, during the teleconference. Dated: April 13, 2018. Robert P. Kadlec, Assistant Secretary for Preparedness and Response. [FR Doc. 2018–08421 Filed 4–20–18; 8:45 am] BILLING CODE P E:\FR\FM\23APN1.SGM 23APN1

Agencies

[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17666-17667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08361]


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

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.

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

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.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 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
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