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, 34837-34838 [2015-14421]

Download as PDF Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Rules and Regulations 34837 EPA APPROVED NEW MEXICO REGULATIONS—Continued State approval/ effective date State citation Title/Subject 20.2.99.3 ............................................ Statutory Authority ............................ 7/11/2014 20.2.99.4 ............................................ Duration ............................................ 7/11/2014 20.2.99.5 ............................................ Effective Date ................................... 7/11/2014 20.2.99.6 ............................................ Objective ........................................... 7/11/2014 20.2.99.7 ............................................ Definitions ......................................... 7/11/2014 20.2.99.8 ............................................ Documents ........................................ 7/11/2014 20.2.99.101 ........................................ Applicability ....................................... 7/11/2014 20.2.99.102 ........................................ Consultation ...................................... 7/11/2014 20.2.99.103 ........................................ Agency Roles in Consultation .......... 7/11/2014 20.2.99.104 ........................................ Agency Responsibilities in Consultation. General Consultation Procedures .... 7/11/2014 Consultation Procedures for Specific Major Activities. Consultation Procedures for Specific Routine Activities. Notification Procedures for Routine Activities. Conflict Resolution and Appeals to the Governor. Public Consultation Procedures ....... 7/11/2014 20.2.99.105 ........................................ 20.2.99.106 ........................................ 20.2.99.107 ........................................ 20.2.99.108 ........................................ 20.2.99.109 ........................................ 20.2.99.110 ........................................ 20.2.99.111 ........................................ 20.2.99.112 ........................................ * * * * Enforceability of Design Concept and Scope and Project-Level Mitigation and Control Measures. Savings Provision ............................. * BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 8 [Docket No. 2012–29417] tkelley on DSK3SPTVN1PROD with RULES 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 Substance Abuse and Mental Health Services Administration, HHS. ACTION: Final rule; correction. AGENCY: VerDate Sep<11>2014 12:50 Jun 17, 2015 Jkt 235001 7/11/2014 7/11/2014 7/11/2014 7/11/2014 7/11/2014 7/11/2014 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 SUMMARY: [FR Doc. 2015–13948 Filed 6–17–15; 8:45 am] 7/11/2014 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 EPA Approval date 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. 6/18/2015 [Insert Citation]. Comments Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register Federal Register 6/18/2015 [Insert Federal Register Citation]. Treatment, SAMHSA, 1 Choke Cherry Road, Room 7–1028, Rockville, MD 20857, (240) 276–2700, email: Jinhee.Lee@samhsa.hhs.gov. 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 § 8.12(i)(3)(i) through (vi) was deleted. The original intention was only to revise § 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 § 8.12(i)(3)(i) through (vi). SUPPLEMENTARY INFORMATION: E:\FR\FM\18JNR1.SGM 18JNR1 34838 Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Rules and Regulations Dated: June 4, 2015. Oliver Potts, Deputy Executive Secretary, U.S. Department of Health and Human Services. List of Subjects in 42 CFR Part 8 Health professions, LevoAlphaAcetyl-Methadol (LAAM), Methadone, Reporting and recordkeeping requirements. [FR Doc. 2015–14421 Filed 6–17–15; 8:45 am] BILLING CODE P PART 8—CERTIFICATION OF OPIOID TREATMENT PROGRAMS 1. The authority citation for part 8 continues to read as follows: ■ 45 CFR Part 1 Authority: 21 U.S.C. 823; 42 U.S.C. 290bb– 2a, 290aa(d), 290dd–2, 300x–23, 300x–27(a), 300y–11. 2. In § 8.12, paragraph (i)(3) is revised to read as follows: ■ § 8.12 Federal opioid treatment standards. tkelley on DSK3SPTVN1PROD with RULES * * * * * (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 takehome medication, but must make monthly visits. * * * * * VerDate Sep<11>2014 12:50 Jun 17, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Removal of Obsolete Provisions Office of the Secretary, HHS. Direct final rule. AGENCY: ACTION: Much of the information set out in certain regulations regarding HHS’s programs and activities is obsolete. Also, electronic resources are now available that did not exist when this part was first codified. This rule removes these obsolete regulations. DATES: This action is effective August 17, 2015 without further action, unless adverse comment is received by July 20, 2015 If adverse comment is received, HHS will publish a timely cancellation of the action in the Federal Register. ADDRESSES: Interested persons are invited to submit comments concerning this action. You may submit electronic comments to https://www.regulations. gov. Follow the ‘‘Submit a comment’’ instructions. Or, you may mail paper comments as follows: Madhura Valverde, Suite 639G, 200 Independence Avenue SW., Washington, DC 20201. (Please allow sufficient time for mailed comments to be received before the close of the comment period). If you wish to deliver paper comments in person or by courier, please call (202) 690–6827 or (202) 205– 9165, to schedule the delivery with one of our staff members. FOR FURTHER INFORMATION CONTACT: Madhura Valverde, Executive Secretary, U.S. Department of Health and Human Services, Washington, DC 20201 (madhura.valverde@hhs.gov). SUPPLEMENTARY INFORMATION: The provisions of 45 CFR part 1, specifying the CFR locations of regulations for HHS’s programs and activities, and regarding the subject matter of the Office of the Secretary regulations, have not been updated since 1987. These regulations have become obsolete and inaccurate. At the time they were added to the CFR, it was felt that this material would prove helpful to the public. However, the growth of electronic accessibility to regulations through such governmental sources as: —Office of the Federal Register’s (OFR) List of CFR Subjects SUMMARY: PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 (www.archives.gov/federalrgeister/ cfr/subjects.htm); —OFR’s Electronic Code of Federal Regulations (www.ecfr.gov); —OFR’s annual CFR Æ (www.gpo.gov/fdsys/browse/ collectionCfr.action?collection Code=CFR); —HHS’s Web site (www.hhs.gov/ regulations); as well as numerous commercial web browsers, have greatly improved the public’s access to, and ability to search our regulations. Because of this increased accessibility, and in response to Executive Order 13563, Sec. 6, which urges agencies to ‘‘repeal’’ existing regulations that are ‘‘outmoded’’, HHS is removing 45 CFR part 1. Notice and comment are not required for this rule, because it affects agency organization, procedure, or practice under 5 U.S.C. 553(b)(A). Furthermore, HHS believes that there is good cause hereby to bypass notice and comment, and to proceed to a direct final rule, pursuant to 5 U.S.C. 553 (b)(B). The action is non-controversial, merely removing information from the CFR that is obsolete and inaccurate, and whose current locations are otherwise readily available. This rule posed no new substantive requirements on the public. Accordingly, HHS believes this direct final rule will not elicit any significant adverse comments, but if such comments are received HHS will publish a timely notice of withdrawal in the Federal Register. Executive Order 12866 This action does not meet the criteria for a significant regulatory action as set out under Executive Order 12866, and review by the Office of Management and Budget has accordingly not been required. Regulatory Flexibility Act This action will not have a significant economic impact on a substantial number of small entities. Therefore, the regulatory flexibility analysis provided for under the Regulatory Flexibility Act is not required. Paperwork Reduction Act This action does not impose any information collection requirements under the Paperwork Reduction Act. List of Subjects in 45 CFR Part 1 Code of Federal Regulations, Organization and functions (Government agencies). For reasons set out in the preamble, and under the authority at 5 U.S.C. 301, HHS amends 45 CFR subchapter A by removing part 1. E:\FR\FM\18JNR1.SGM 18JNR1

Agencies

[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Rules and Regulations]
[Pages 34837-34838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14421]


=======================================================================
-----------------------------------------------------------------------

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.

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

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: 
Jinhee.Lee@samhsa.hhs.gov.

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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.