83 FR 38699 - Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 152 (August 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 152 (August 7, 2018)
| Page Range | 38699-38700 | |
| FR Document | 2018-16813 |
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)] [Notices] [Pages 38699-38700] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16813] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2382] Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.'' This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of drugs for medication-assisted treatment of opioid use disorder. FDA is also requesting comments on when the use of placebo or active controls is most appropriate in clinical trials for such drugs. DATES: Submit either electronic or written comments on the draft guidance by October 9, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2382 for ``Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted 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.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 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3200, [[Page 38700]] 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 Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.'' This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of drugs for medication-assisted treatment of opioid use disorder. FDA is also requesting comments on when the use of placebo or active controls is most appropriate in clinical trials for such drugs. 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 endpoints for demonstrating effectiveness of drugs for medication-assisted treatment of opioid use disorder. 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 part 312 have been approved under OMB control number 0910-0014. III. 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: August 1, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16813 Filed 8-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38699
III. Collection of Information DATES: Submit either electronic or • Confidential Submissions—To
Requirements written comments on the draft guidance submit a comment with confidential
This document does not impose by October 9, 2018 to ensure that the information that you do not wish to be
information collection requirements, Agency considers your comment on this made publicly available, submit your
that is, reporting, recordkeeping or draft guidance before it begins work on comments only as a written/paper
third-party disclosure requirements. the final version of the guidance. submission. You should submit two
Consequently, there is no need for ADDRESSES: You may submit comments copies total. One copy will include the
review by the Office of Management and on any guidance at any time as follows: information you claim to be confidential
Budget under the authority of the with a heading or cover note that states
Electronic Submissions
Paperwork Reduction Act of 1995 (44 ‘‘THIS DOCUMENT CONTAINS
U.S.C. 3501 et seq.). Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
IV. Response to Public Comments • Federal eRulemaking Portal: the claimed confidential information, in
Because of the large number of public https://www.regulations.gov. Follow the its consideration of comments. The
comments we normally receive on instructions for submitting comments. second copy, which will have the
Federal Register documents, we are not Comments submitted electronically, claimed confidential information
able to acknowledge or respond to them including attachments, to https:// redacted/blacked out, will be available
individually. We will consider all www.regulations.gov will be posted to for public viewing and posted on
comments we receive by the date and the docket unchanged. Because your https://www.regulations.gov. Submit
time specified in the DATES section of comment will be made public, you are both copies to the Dockets Management
this preamble, and, when we proceed solely responsible for ensuring that your Staff. If you do not wish your name and
with a subsequent document, we will comment does not include any contact information to be made publicly
respond to the comments in the confidential information that you or a available, you can provide this
preamble to that document. third party may not wish to be posted, information on the cover sheet and not
Upon completion of our evaluation, such as medical information, your or in the body of your comments and you
including evaluation of comments anyone else’s Social Security number, or must identify this information as
received as a result of this notice, we confidential business information, such ‘‘confidential.’’ Any information marked
will publish a final notice in the Federal as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Register announcing the result of our that if you include your name, contact except in accordance with 21 CFR 10.20
evaluation. information, or other information that and other applicable disclosure law. For
Dated: July 27, 2018. identifies you in the body of your more information about FDA’s posting
Seema Verma,
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
Administrator, Centers for Medicare & • If you want to submit a comment
Medicaid Services. the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
[FR Doc. 2018–16871 Filed 8–6–18; 8:45 am]
do not wish to be made available to the 23389.pdf.
BILLING CODE 4120–01–P
public, submit the comment as a
written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
DEPARTMENT OF HEALTH AND electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’).
HUMAN SERVICES received, go to https://
Written/Paper Submissions www.regulations.gov and insert the
Food and Drug Administration docket number, found in brackets in the
Submit written/paper submissions as
[Docket No. FDA–2018–D–2382] follows: heading of this document, into the
• Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts
Opioid Use Disorder: Endpoints for written/paper submissions): Dockets and/or go to the Dockets Management
Demonstrating Effectiveness of Drugs Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
for Medication-Assisted Treatment; Drug Administration, 5630 Fishers Rockville, MD 20852.
Draft Guidance for Industry; Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any
Availability • For written/paper comments guidance at any time (see 21 CFR
AGENCY: Food and Drug Administration, submitted to the Dockets Management 10.115(g)(5)).
HHS. Staff, FDA will post your comment, as
Submit written requests for single
ACTION: Notice of availability. well as any attachments, except for
copies of the draft guidance to the
information submitted, marked and
Division of Drug Information, Center for
SUMMARY: The Food and Drug identified, as confidential, if submitted
Drug Evaluation and Research, Food
Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’
and Drug Administration, 10001 New
announcing the availability of a draft Instructions: All submissions received
Hampshire Ave., Hillandale Building,
guidance for industry entitled ‘‘Opioid must include the Docket No. FDA–
4th Floor, Silver Spring, MD 20993–
Use Disorder: Endpoints for 2018–D–2382 for ‘‘Opioid Use Disorder:
0002. Send one self-addressed adhesive
Demonstrating Effectiveness of Drugs for Endpoints for Demonstrating
label to assist that office in processing
Medication-Assisted Treatment.’’ This Effectiveness of Drugs for Medication-
your requests. See the SUPPLEMENTARY
guidance addresses the clinical Assisted Treatment.’’ Received
daltland on DSKBBV9HB2PROD with NOTICES
INFORMATION section for electronic
endpoints acceptable to demonstrate comments will be placed in the docket
and, except for those submitted as access to the draft guidance document.
effectiveness of drugs for medication-
assisted treatment of opioid use ‘‘Confidential Submissions,’’ publicly FOR FURTHER INFORMATION CONTACT:
disorder. FDA is also requesting viewable at https://www.regulations.gov Silvana Borges, Center for Drug
comments on when the use of placebo or at the Dockets Management Staff Evaluation and Research, Food and
or active controls is most appropriate in between 9 a.m. and 4 p.m., Monday Drug Administration, 10903 New
clinical trials for such drugs. through Friday. Hampshire Ave., Bldg. 22, Rm. 3200,
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![38700 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices
Silver Spring, MD 20993–0002, 301– DEPARTMENT OF HEALTH AND of review with the Federal district
796–0963. HUMAN SERVICES courts after administrative remedies
under HHS regulations have been
SUPPLEMENTARY INFORMATION: [OMHA–1801–N] exhausted. The first two levels of review
I. Background Medicare Program; Administrative Law are administered by the Centers for
Judge Hearing Program for Medicare Medicare & Medicaid Services (CMS)
FDA is announcing the availability of and conducted by Medicare contractors
Claim and Entitlement Appeals;
a draft guidance for industry entitled for claim appeals, by MAOs and an
Quarterly Listing of Program
‘‘Opioid Use Disorder: Endpoints for independent review entity for Part C
Issuances—April Through June 2018
Demonstrating Effectiveness of Drugs for organization determination appeals, or
Medication-Assisted Treatment.’’ This AGENCY: Office of Medicare Hearings by PDPSs and an independent review
guidance addresses the clinical and Appeals (OMHA), HHS. entity for Part D coverage determination
endpoints acceptable to demonstrate ACTION: Notice. appeals. The third level of review is
effectiveness of drugs for medication- administered by OMHA and conducted
assisted treatment of opioid use SUMMARY: This quarterly notice by Administrative Law Judges and
disorder. FDA is also requesting announces the reorganization and attorney adjudicators. The fourth level
comments on when the use of placebo revision of the OMHA Case Processing of review is administered by the HHS
Manual (OCPM) and lists the OCPM Departmental Appeals Board (DAB) and
or active controls is most appropriate in
manual instructions that were published conducted by the Medicare Appeals
clinical trials for such drugs.
from April through June 2018. This Council (Council). In addition, OMHA
This draft guidance is being issued manual standardizes the day-to-day and the DAB administer the second and
consistent with FDA’s good guidance procedures for carrying out adjudicative third levels of appeal, respectively, for
practices regulation (21 CFR 10.115). functions, in accordance with Medicare eligibility, entitlement, Part B
The draft guidance, when finalized, will applicable statutes, regulations, and late enrollment penalty, and IRMAA
represent the current thinking of FDA OMHA directives, and gives OMHA reconsiderations made by SSA; a fourth
on endpoints for demonstrating staff direction for processing appeals at level of review with the Federal district
effectiveness of drugs for medication- the OMHA level of adjudication. courts is available after administrative
assisted treatment of opioid use FOR FURTHER INFORMATION CONTACT:
remedies within SSA and HHS have
disorder. It does not establish any rights Amanda Axeen, by telephone at (571) been exhausted.
for any person and is not binding on Sections 1869, 1155, 1876(c)(5)(B),
777–2705, or by email at
FDA or the public. You can use an 1852(g)(5), and 1860D–4(h) of the Act
amanda.axeen@hhs.gov.
are implemented through the
alternative approach if it satisfies the SUPPLEMENTARY INFORMATION: regulations at 42 CFR part 405 subparts
requirements of the applicable statutes I and J; part 417, subpart Q; part 422,
and regulations. This guidance is not I. Background
subpart M; part 423, subparts M and U;
subject to Executive Order 12866. The Office of Medicare Hearings and and part 478, subpart B. As noted above,
Appeals (OMHA), a staff division within OMHA administers the nationwide
II. Paperwork Reduction Act of 1995 the Office of the Secretary within the Administrative Law Judge hearing
This guidance refers to previously U.S. Department of Health and Human program in accordance with these
approved collections of information that Services (HHS), administers the statutes and applicable regulations. To
are subject to review by the Office of nationwide Administrative Law Judge ensure nationwide consistency in that
hearing program for Medicare claim, effort, OMHA established a manual, the
Management and Budget (OMB) under
organization and coverage OMHA Case Processing Manual
the Paperwork Reduction Act of 1995
determination, and entitlement appeals (OCPM). Through the OCPM, the
(44 U.S.C. 3501–3520). The collections
under sections 1869, 1155, OMHA Chief Administrative Law Judge
of information in 21 CFR part 312 have 1876(c)(5)(B), 1852(g)(5), and 1860D–
been approved under OMB control establishes the day-to-day procedures
4(h) of the Social Security Act (the Act). for carrying out adjudicative functions,
number 0910–0014. OMHA ensures that Medicare in accordance with applicable statutes,
III. Electronic Access beneficiaries and the providers and regulations and OMHA directives. The
suppliers that furnish items or services OCPM provides direction for processing
Persons with access to the internet to Medicare beneficiaries, as well as appeals at the OMHA level of
may obtain the draft guidance at either Medicare Advantage Organizations adjudication for Medicare Part A and B
https://www.fda.gov/Drugs/Guidance (MAOs), Medicaid State Agencies, and claims; Part C organization
ComplianceRegulatoryInformation/ applicable plans, have a fair and determinations; Part D coverage
Guidances/default.htm or https:// impartial forum to address determinations; and SSA eligibility and
www.regulations.gov. disagreements with Medicare coverage entitlement, Part B late enrollment
and payment determinations made by penalty, and IRMAA determinations.
Dated: August 1, 2018.
Medicare contractors, MAOs, or Part D Section 1871(c) of the Act requires
Leslie Kux, Plan Sponsors (PDPSs), and that the Secretary publish a list of all
Associate Commissioner for Policy. determinations related to Medicare Medicare manual instructions,
[FR Doc. 2018–16813 Filed 8–6–18; 8:45 am] eligibility and entitlement, Part B late interpretive rules, statements of policy,
BILLING CODE 4164–01–P enrollment penalty, and income-related and guidelines of general applicability
daltland on DSKBBV9HB2PROD with NOTICES
monthly adjustment amounts (IRMAA) not issued as regulations at least every
made by the Social Security 3 months in the Federal Register.
Administration (SSA).
The Medicare claim, organization and II. Format for the Quarterly Issuance
coverage determination appeals Notices
processes consist of four levels of This quarterly notice provides the
administrative review, and a fifth level specific updates to the OCPM that have
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Document Created: 2018-11-06 10:38:25
Document Modified: 2018-11-06 10:38:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by October 9, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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. | |
| FR Citation | 83 FR 38699 |
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