80_FR_34954 80 FR 34837 - Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment Medications; Correction

80 FR 34837 - Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment Medications; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 117 (June 18, 2015)

Page Range34837-34838
FR Document2015-14421

The Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register of December 6, 2012. The document modified the dispensing requirements buprenorphine and buprenorphine combination products approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. In particular, this rule allows opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphine after the assessment and documentation of a patient's responsibility and stability to receive opioid addiction treatment medication. However, an inadvertent removal of paragraphs was made. This correction reinstates the missing paragraphs.

Federal Register, Volume 80 Issue 117 (Thursday, June 18, 2015) 
[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Rules and Regulations]
[Pages 34837-34838]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14421]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

[Docket No. 2012-29417]
RIN 0930-AA14


Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction; Proposed Modification of Dispensing Restrictions for 
Buprenorphine and Buprenorphine Combination as Used in Approved Opioid 
Treatment Medications; Correction

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Health and Human Services Department (HHS) is correcting a 
final rule that appeared in the Federal Register of December 6, 2012. 
The document modified the dispensing requirements buprenorphine and 
buprenorphine combination products approved by the Food and Drug 
Administration (FDA) for opioid dependence and used in federally 
certified and registered opioid treatment programs. In particular, this 
rule allows opioid treatment programs more flexibility in dispensing 
take-home supplies of buprenorphine after the assessment and 
documentation of a patient's responsibility and stability to receive 
opioid addiction treatment medication. However, an inadvertent removal 
of paragraphs was made. This correction reinstates the missing 
paragraphs.

DATES: Effective June 18, 2015.

FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Division of Pharmacologic 
Therapies, Center for Substance Abuse Treatment, SAMHSA, 1 Choke Cherry 
Road, Room 7-1028, Rockville, MD 20857, (240) 276-2700, email: 
[email protected].

SUPPLEMENTARY INFORMATION: On December 6, 2012 (77 FR 72752), HHS 
published a final rule in the Federal Register modifying the dispensing 
requirements in 42 CFR 8.12 for buprenorphine and buprenorphine 
combination products approved by FDA for opioid dependence and used in 
federally certified and registered opioid treatment programs. An 
inadvertent error was made whereby Sec.  8.12(i)(3)(i) through (vi) was 
deleted. The original intention was only to revise Sec.  8.12(i)(3) 
introductory text, however, this was not made clear and thus the entire 
section following the introductory text was removed. This correction 
properly modifies the dispensing requirements in 42 CFR 8.12 as 
published in the Federal Register on December 6, 2012, without removing 
Sec.  8.12(i)(3)(i) through (vi).

[[Page 34838]]

List of Subjects in 42 CFR Part 8

    Health professions, Levo-AlphaAcetyl-Methadol (LAAM), Methadone, 
Reporting and recordkeeping requirements.

PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS

0
1. The authority citation for part 8 continues to read as follows:

    Authority: 21 U.S.C. 823; 42 U.S.C. 290bb-2a, 290aa(d), 290dd-2, 
300x-23, 300x-27(a), 300y-11.

0
2. In Sec.  8.12, paragraph (i)(3) is revised to read as follows:


Sec.  8.12  Federal opioid treatment standards.

* * * * *
    (i) * * *
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is responsible in handling opioid drugs, the 
dispensing restrictions set forth in paragraphs (i)(3)(i) through (vi) 
of this section apply. The dispensing restrictions set forth in 
paragraphs (i)(3)(i) through (vi) of this section do not apply to 
buprenorphine and buprenorphine products listed under paragraph 
(h)(2)(iii) of this section.
    (i) During the first 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) is limited to a 
single dose each week and the patient shall ingest all other doses 
under appropriate supervision as provided for under the regulations in 
this subpart.
    (ii) In the second 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) are two doses per 
week.
    (iii) In the third 90 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) are three doses per 
week.
    (iv) In the remaining months of the first year, a patient may be 
given a maximum 6-day supply of take-home medication.
    (v) After 1 year of continuous treatment, a patient may be given a 
maximum 2-week supply of take-home medication.
    (vi) After 2 years of continuous treatment, a patient may be given 
a maximum one-month supply of take-home medication, but must make 
monthly visits.
* * * * *

    Dated: June 4, 2015.
Oliver Potts,
Deputy Executive Secretary, U.S. Department of Health and Human 
Services.
[FR Doc. 2015-14421 Filed 6-17-15; 8:45 am]
BILLING CODE P

Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Rules and Regulations 34837 EPA APPROVED NEW MEXICO REGULATIONS—Continued State approval/ Com- State citation Title/Subject EPA Approval date effective ments date 20.2.99.3 ............................................ Statutory Authority ............................ 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.4 ............................................ Duration ............................................ 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.5 ............................................ Effective Date ................................... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.6 ............................................ Objective ........................................... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.7 ............................................ Definitions ......................................... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.8 ............................................ Documents ........................................ 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.101 ........................................ Applicability ....................................... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.102 ........................................ Consultation ...................................... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.103 ........................................ Agency Roles in Consultation .......... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.104 ........................................ Agency Responsibilities in Consulta- 7/11/2014 6/18/2015 [Insert Federal Register tion. Citation]. 20.2.99.105 ........................................ General Consultation Procedures .... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.106 ........................................ Consultation Procedures for Specific 7/11/2014 6/18/2015 [Insert Federal Register Major Activities. Citation]. 20.2.99.107 ........................................ Consultation Procedures for Specific 7/11/2014 6/18/2015 [Insert Federal Register Routine Activities. Citation]. 20.2.99.108 ........................................ Notification Procedures for Routine 7/11/2014 6/18/2015 [Insert Federal Register Activities. Citation]. 20.2.99.109 ........................................ Conflict Resolution and Appeals to 7/11/2014 6/18/2015 [Insert Federal Register the Governor. Citation]. 20.2.99.110 ........................................ Public Consultation Procedures ....... 7/11/2014 6/18/2015 [Insert Federal Register Citation]. 20.2.99.111 ........................................ Enforceability of Design Concept 7/11/2014 6/18/2015 [Insert Federal Register and Scope and Project-Level Miti- Citation]. gation and Control Measures. 20.2.99.112 ........................................ Savings Provision ............................. 7/11/2014 6/18/2015 [Insert Federal Register Citation]. * * * * * SUMMARY: The Health and Human Treatment, SAMHSA, 1 Choke Cherry [FR Doc. 2015–13948 Filed 6–17–15; 8:45 am] Services Department (HHS) is correcting Road, Room 7–1028, Rockville, MD BILLING CODE 6560–50–P a final rule that appeared in the Federal 20857, (240) 276–2700, email: Register of December 6, 2012. The Jinhee.Lee@samhsa.hhs.gov. document modified the dispensing requirements buprenorphine and SUPPLEMENTARY INFORMATION: On DEPARTMENT OF HEALTH AND buprenorphine combination products December 6, 2012 (77 FR 72752), HHS HUMAN SERVICES approved by the Food and Drug published a final rule in the Federal Administration (FDA) for opioid Register modifying the dispensing 42 CFR Part 8 requirements in 42 CFR 8.12 for dependence and used in federally certified and registered opioid treatment buprenorphine and buprenorphine [Docket No. 2012–29417] programs. In particular, this rule allows combination products approved by FDA RIN 0930–AA14 opioid treatment programs more for opioid dependence and used in flexibility in dispensing take-home federally certified and registered opioid Opioid Drugs in Maintenance and supplies of buprenorphine after the treatment programs. An inadvertent Detoxification Treatment of Opiate assessment and documentation of a error was made whereby § 8.12(i)(3)(i) Addiction; Proposed Modification of patient’s responsibility and stability to through (vi) was deleted. The original Dispensing Restrictions for receive opioid addiction treatment intention was only to revise § 8.12(i)(3) Buprenorphine and Buprenorphine medication. However, an inadvertent introductory text, however, this was not Combination as Used in Approved removal of paragraphs was made. This made clear and thus the entire section tkelley on DSK3SPTVN1PROD with RULES Opioid Treatment Medications; correction reinstates the missing following the introductory text was Correction paragraphs. removed. This correction properly DATES: Effective June 18, 2015. modifies the dispensing requirements in AGENCY: Substance Abuse and Mental Health Services Administration, HHS. FOR FURTHER INFORMATION CONTACT: 42 CFR 8.12 as published in the Federal Jinhee Lee, Division of Pharmacologic Register on December 6, 2012, without ACTION: Final rule; correction. Therapies, Center for Substance Abuse removing § 8.12(i)(3)(i) through (vi). VerDate Sep<11>2014 12:50 Jun 17, 2015 Jkt 235001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\18JNR1.SGM 18JNR1

34838 Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Rules and Regulations List of Subjects in 42 CFR Part 8 Dated: June 4, 2015. (www.archives.gov/federalrgeister/ Oliver Potts, cfr/subjects.htm); Health professions, Levo- Deputy Executive Secretary, U.S. Department —OFR’s Electronic Code of Federal AlphaAcetyl-Methadol (LAAM), of Health and Human Services. Regulations (www.ecfr.gov); Methadone, Reporting and [FR Doc. 2015–14421 Filed 6–17–15; 8:45 am] —OFR’s annual CFR recordkeeping requirements. Æ (www.gpo.gov/fdsys/browse/ BILLING CODE P collectionCfr.action?collection PART 8—CERTIFICATION OF OPIOID Code=CFR); TREATMENT PROGRAMS —HHS’s Web site (www.hhs.gov/ DEPARTMENT OF HEALTH AND HUMAN SERVICES regulations); ■ 1. The authority citation for part 8 as well as numerous commercial web continues to read as follows: 45 CFR Part 1 browsers, have greatly improved the Authority: 21 U.S.C. 823; 42 U.S.C. 290bb– public’s access to, and ability to search 2a, 290aa(d), 290dd–2, 300x–23, 300x–27(a), Removal of Obsolete Provisions our regulations. Because of this 300y–11. increased accessibility, and in response AGENCY: Office of the Secretary, HHS. to Executive Order 13563, Sec. 6, which ■ 2. In § 8.12, paragraph (i)(3) is revised ACTION: Direct final rule. urges agencies to ‘‘repeal’’ existing to read as follows: regulations that are ‘‘outmoded’’, HHS is SUMMARY: Much of the information set § 8.12 Federal opioid treatment standards. out in certain regulations regarding removing 45 CFR part 1. * * * * * HHS’s programs and activities is Notice and comment are not required obsolete. Also, electronic resources are for this rule, because it affects agency (i) * * * organization, procedure, or practice now available that did not exist when (3) Such determinations and the basis this part was first codified. This rule under 5 U.S.C. 553(b)(A). Furthermore, for such determinations consistent with removes these obsolete regulations. HHS believes that there is good cause the criteria outlined in paragraph (i)(2) DATES: This action is effective August hereby to bypass notice and comment, of this section shall be documented in 17, 2015 without further action, unless and to proceed to a direct final rule, the patient’s medical record. If it is adverse comment is received by July 20, pursuant to 5 U.S.C. 553 (b)(B). The determined that a patient is responsible 2015 If adverse comment is received, action is non-controversial, merely in handling opioid drugs, the HHS will publish a timely cancellation removing information from the CFR that dispensing restrictions set forth in of the action in the Federal Register. is obsolete and inaccurate, and whose paragraphs (i)(3)(i) through (vi) of this current locations are otherwise readily ADDRESSES: Interested persons are section apply. The dispensing available. This rule posed no new invited to submit comments concerning restrictions set forth in paragraphs substantive requirements on the public. this action. You may submit electronic (i)(3)(i) through (vi) of this section do Accordingly, HHS believes this direct comments to http://www.regulations. not apply to buprenorphine and final rule will not elicit any significant gov. Follow the ‘‘Submit a comment’’ buprenorphine products listed under adverse comments, but if such instructions. Or, you may mail paper paragraph (h)(2)(iii) of this section. comments are received HHS will comments as follows: Madhura (i) During the first 90 days of Valverde, Suite 639G, 200 publish a timely notice of withdrawal in treatment, the take-home supply Independence Avenue SW., the Federal Register. (beyond that of paragraph (i)(1) of this Washington, DC 20201. (Please allow Executive Order 12866 section) is limited to a single dose each sufficient time for mailed comments to week and the patient shall ingest all This action does not meet the criteria be received before the close of the other doses under appropriate for a significant regulatory action as set comment period). If you wish to deliver supervision as provided for under the out under Executive Order 12866, and paper comments in person or by courier, regulations in this subpart. review by the Office of Management and please call (202) 690–6827 or (202) 205– Budget has accordingly not been (ii) In the second 90 days of treatment, 9165, to schedule the delivery with one required. the take-home supply (beyond that of of our staff members. paragraph (i)(1) of this section) are two FOR FURTHER INFORMATION CONTACT: Regulatory Flexibility Act doses per week. Madhura Valverde, Executive Secretary, This action will not have a significant (iii) In the third 90 days of treatment, U.S. Department of Health and Human economic impact on a substantial the take-home supply (beyond that of Services, Washington, DC 20201 number of small entities. Therefore, the paragraph (i)(1) of this section) are three (madhura.valverde@hhs.gov). regulatory flexibility analysis provided doses per week. SUPPLEMENTARY INFORMATION: The for under the Regulatory Flexibility Act (iv) In the remaining months of the provisions of 45 CFR part 1, specifying is not required. first year, a patient may be given a the CFR locations of regulations for HHS’s programs and activities, and Paperwork Reduction Act maximum 6-day supply of take-home medication. regarding the subject matter of the This action does not impose any Office of the Secretary regulations, have information collection requirements (v) After 1 year of continuous under the Paperwork Reduction Act. not been updated since 1987. These treatment, a patient may be given a regulations have become obsolete and List of Subjects in 45 CFR Part 1 maximum 2-week supply of take-home inaccurate. At the time they were added medication. Code of Federal Regulations, to the CFR, it was felt that this material tkelley on DSK3SPTVN1PROD with RULES (vi) After 2 years of continuous would prove helpful to the public. Organization and functions treatment, a patient may be given a However, the growth of electronic (Government agencies). maximum one-month supply of take- accessibility to regulations through such For reasons set out in the preamble, home medication, but must make governmental sources as: and under the authority at 5 U.S.C. 301, monthly visits. —Office of the Federal Register’s (OFR) HHS amends 45 CFR subchapter A by * * * * * List of CFR Subjects removing part 1. VerDate Sep<11>2014 12:50 Jun 17, 2015 Jkt 235001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\18JNR1.SGM 18JNR1


Document Created: 2018-02-22 11:12:14
Document Modified: 2018-02-22 11:12:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; correction.
DatesEffective June 18, 2015.
ContactJinhee Lee, Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, SAMHSA, 1 Choke Cherry Road, Room 7-1028, Rockville, MD 20857, (240) 276-2700, email: [email protected]
FR Citation80 FR 34837 
RIN Number0930-AA14
CFR AssociatedHealth Professions; Levo-Alphaacetyl-Methadol (laam); Methadone and Reporting and Recordkeeping Requirements
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