Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38699 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

IV. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a final notice in the Federal 

Register announcing the result of our 

evaluation. 

Dated: July 27, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–16871 Filed 8–6–18; 8:45 am] 

BILLING CODE 4120–01–P 

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Draft Guidance for Industry; 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 medicationassisted 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written comments on the draft guidance 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draft guidance before it begins work on 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 MedicationAssisted 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 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, 


daltland on DSKBBV9HB2PROD with NOTICES
38700 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 

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 medicationassisted 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 medicationassisted 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/Guidance

ComplianceRegulatoryInformation/ 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[OMHA–1801–N] 

Medicare Program; Administrative Law 

Judge Hearing Program for Medicare 

Claim and Entitlement Appeals; 

Quarterly Listing of Program 

Issuances—April Through June 2018 

AGENCY: Office of Medicare Hearings 

and Appeals (OMHA), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice 

announces the reorganization and 

revision of the OMHA Case Processing 

Manual (OCPM) and lists the OCPM 

manual instructions that were published 

from April through June 2018. This 

manual standardizes the day-to-day 

procedures for carrying out adjudicative 

functions, in accordance with 

applicable statutes, regulations, and 

OMHA directives, and gives OMHA 

staff direction for processing appeals at 

the OMHA level of adjudication. 

FOR FURTHER INFORMATION CONTACT: 

Amanda Axeen, by telephone at (571) 

777–2705, or by email at 

amanda.axeen@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Office of Medicare Hearings and 

Appeals (OMHA), a staff division within 

the Office of the Secretary within the 

U.S. Department of Health and Human 

Services (HHS), administers the 

nationwide Administrative Law Judge 

hearing program for Medicare claim, 

organization and coverage 

determination, and entitlement appeals 

under sections 1869, 1155, 

1876(c)(5)(B), 1852(g)(5), and 1860D– 

4(h) of the Social Security Act (the Act). 

OMHA ensures that Medicare 

beneficiaries and the providers and 

suppliers that furnish items or services 

to Medicare beneficiaries, as well as 

Medicare Advantage Organizations 

(MAOs), Medicaid State Agencies, and 

applicable plans, have a fair and 

impartial forum to address 

disagreements with Medicare coverage 

and payment determinations made by 

Medicare contractors, MAOs, or Part D 

Plan Sponsors (PDPSs), and 

determinations related to Medicare 

eligibility and entitlement, Part B late 

enrollment penalty, and income-related 

monthly adjustment amounts (IRMAA) 

made by the Social Security 

Administration (SSA). 

The Medicare claim, organization and 

coverage determination appeals 

processes consist of four levels of 

administrative review, and a fifth level 

of review with the Federal district 

courts after administrative remedies 

under HHS regulations have been 

exhausted. The first two levels of review 

are administered by the Centers for 

Medicare & Medicaid Services (CMS) 

and conducted by Medicare contractors 

for claim appeals, by MAOs and an 

independent review entity for Part C 

organization determination appeals, or 

by PDPSs and an independent review 

entity for Part D coverage determination 

appeals. The third level of review is 

administered by OMHA and conducted 

by Administrative Law Judges and 

attorney adjudicators. The fourth level 

of review is administered by the HHS 

Departmental Appeals Board (DAB) and 

conducted by the Medicare Appeals 

Council (Council). In addition, OMHA 

and the DAB administer the second and 

third levels of appeal, respectively, for 

Medicare eligibility, entitlement, Part B 

late enrollment penalty, and IRMAA 

reconsiderations made by SSA; a fourth 

level of review with the Federal district 

courts is available after administrative 

remedies within SSA and HHS have 

been exhausted. 

Sections 1869, 1155, 1876(c)(5)(B), 

1852(g)(5), and 1860D–4(h) of the Act 

are implemented through the 

regulations at 42 CFR part 405 subparts 

I and J; part 417, subpart Q; part 422, 

subpart M; part 423, subparts M and U; 

and part 478, subpart B. As noted above, 

OMHA administers the nationwide 

Administrative Law Judge hearing 

program in accordance with these 

statutes and applicable regulations. To 

ensure nationwide consistency in that 

effort, OMHA established a manual, the 

OMHA Case Processing Manual 

(OCPM). Through the OCPM, the 

OMHA Chief Administrative Law Judge 

establishes the day-to-day procedures 

for carrying out adjudicative functions, 

in accordance with applicable statutes, 

regulations and OMHA directives. The 

OCPM provides direction for processing 

appeals at the OMHA level of 

adjudication for Medicare Part A and B 

claims; Part C organization 

determinations; Part D coverage 

determinations; and SSA eligibility and 

entitlement, Part B late enrollment 

penalty, and IRMAA determinations. 

Section 1871(c) of the Act requires 

that the Secretary publish a list of all 

Medicare manual instructions, 

interpretive rules, statements of policy, 

and guidelines of general applicability 

not issued as regulations at least every 

3 months in the Federal Register. 

II. Format for the Quarterly Issuance 

Notices 

This quarterly notice provides the 

specific updates to the OCPM that have 


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