Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment; Guidance for Industry; Availability, 2527-2528 [2019-01517]

Download as PDF 2527 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ ADDRESSES: acf.hhs.gov. All requests should be identified by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: The Head Start Directors Wave 1 survey addresses the grantee’s organizational characteristics, how the organization defines and diffuses T/TA, T/TA received and requested in the prior program year, and overall organizational goals and reflections on T/TA efforts for the current year. The Head Start Managers/Coordinators Wave 2 survey addresses four distinct domains of Head Start activity: (1) Program management and fiscal operations; (2) education; (3) parent and family engagement; and (4) health and wellness. The Wave 2 survey addresses how these activity domains are structured and staffed with the grantee organization, the types of T/TA and resources sought and used to improve practice in each domain, perceptions of usefulness of recent T/TA received, and T/TA priorities for the next program year. Respondents: Head Start Directors, Head Start Managers/Coordinators. ANNUAL BURDEN ESTIMATES Total/annual number of respondents Instrument Wave 1 Head Start Director Survey ................................................................ Wave 2 Head Start Managers/Coordinator Survey ......................................... Estimated Total Annual Burden Hours: 1,500. Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Authority: The Statutory Authority for this data collection is: Section 640(a)(2)(D) and section 649 of the Improving Head Start for School Readiness Act of 2007. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–01428 Filed 2–6–19; 8:45 am] BILLING CODE 4184–40–P VerDate Sep<11>2014 17:23 Feb 06, 2019 Jkt 247001 1,200 800 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. 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 selfadministered 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. SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 Average burden hours per response Annual burden hours .75 .75 900 600 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: DATES: 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: E:\FR\FM\07FEN1.SGM 07FEN1 2528 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices • 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/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 VerDate Sep<11>2014 17:23 Feb 06, 2019 Jkt 247001 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 selfadministered 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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/Guidance ComplianceRegulatoryInformation/ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0032] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the regulation SUMMARY: E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[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]

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

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.

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

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

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