81 FR 22999 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration Federal Register Volume 81, Issue 75 (April 19, 2016)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 81, Issue 75 (April 19, 2016)
| Page Range | 22999-23001 | |
| FR Document | 2016-09020 |
[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)] [Notices] [Pages 22999-23001] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09020] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243. Comments are invited on: (a) Whether the proposed collections of information are 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) ways to enhance 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. Proposed Project: Opioid Drugs in Maintenance and Detoxification Treatment of Opioid Dependence--42 CFR part 8 (OMB No. 0930-0206) and Opioid Treatment Programs (OTPs)--Revision 42 CFR part 8 establishes a certification program managed by SAMHSA's Center for Substance Abuse Treatment (CSAT). The regulation requires that Opioid Treatment Programs (OTPs) be certified. ``Certification'' is the process by which SAMHSA determines that an OTP is qualified to provide opioid treatment under the Federal opioid treatment standards established by the Secretary of Health and Human Services. To become certified, an OTP must be accredited by a SAMHSA- approved accreditation body. The regulation also provides standards for such services as individualized treatment planning, increased medical supervision, and assessment of patient outcomes. This submission seeks continued approval of the information collection requirements in the regulation and of the forms used in implementing the regulation. SAMHSA currently has approval for the Application for Certification to Use Opioid Drugs in a Treatment Program Under 42 CFR 8.11 (Form SMA- 162); the Application for Approval as Accreditation Body Under 42 CFR 8.3(b) (Form SMA-163); and the Exception Request and Record of Justification Under 42 CFR 8.12 (Form SMA-168), which may be used by physicians when there is a patient care situation in which the physician must make a treatment decision that differs from the treatment regimen required by the regulation. Form SMA-168 is a simplified, standardized form to facilitate the documentation, request, and approval process for exceptions. SAMHSA believes that the recordkeeping requirements in the regulation are customary and usual practices within the medical and rehabilitative communities and has not calculated a response burden for them. The recordkeeping requirements set forth in 42 CFR 8.4, 8.11, and 8.12 include maintenance of the following: 5-year retention by accreditation bodies of certain records pertaining to accreditation, and documentation by an OTP of the following: A patient's medical examination when admitted to treatment, a patient's history, a treatment plan, any prenatal support provided to the patient, justification of unusually large initial doses, changes in a patient's dosage schedule, justification of unusually large daily doses, the rationale for decreasing a patient's clinic attendance, and documentation of physiologic dependence. The rule also includes requirements that OTPs and accreditation organizations disclose information. For example, 42 CFR 8.12(e)(1) requires that a physician explain the facts concerning the use of opioid drug treatment to each patient. This type of disclosure is considered to be consistent with the common medical practice and is not considered an additional burden. Further, the rule requires, under Sec. 8.4(i)(1) that accreditation organizations shall make public their fee structure; this type of disclosure is standard business practice and is not considered a burden. A number of changes have been made to the forms. Forms have been reworded for clarification, updated with current SAMHSA mailing and web-submission information, and a few additional fields have been provided for clarity and for providers to best explain their services (e.g., expanding the former global patient census in the SMA-162 to request patient census by drug type--methadone, buprenorphine, naltrexone, or other) and the needs of their patients (e.g., including urinalysis results on the SMA-168 and adding ``weather crisis'' as a standard option for physician justification of the requested exception). Amendments also include the removal of information pertaining to faxing the forms to SAMHSA, as this is no longer an acceptable form of submission. The burden hours have increased slightly (by 28% or approximately 639 hours) due to an increase in the number of facilities accredited and certified by SAMHSA since the previous submissions of these forms. The forms are available online with a unique feature for both the SMA-162 and SMA-168 that pre-populates certain information within the form. This in turn reduces the program's time spent filling out the forms as well as the staff time spent on processing it. The tables that follow summarize the annual reporting burden associated with the regulation, including burden associated with the forms. Estimated Annual Reporting Requirement Burden for Accreditation Bodies -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Responses/ Total Hours/ 42 CFR citation Purpose respondents respondent responses response Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 8.3(b)(1-11)........................... Initial approval (SMA-163)..... 1 1 1 6.00 6.00 [[Page 23000]] 8.3(c)................................. Renewal of approval (SMA-163).. 2 1 2 1.00 2.00 8.3(e)................................. Relinquishment notification.... 1 1 1 0.50 0.50 8.3(f)(2).............................. Non-renewal notification to 1 90 90 0.10 9.00 accredited OTPs. 8.4(b)(1)(ii).......................... Notification to SAMHSA for 2 2 4 1.00 4.00 seriously noncompliant OTPs. 8.4(b)(1)(iii)......................... Notification to OTP for serious 2 10 20 1.00 20.00 noncompliance. 8.4(d)(1).............................. General documents and 6 5 30 0.50 15.00 information to SAMHSA upon request. 8.4(d)(2).............................. Accreditation survey to SAMHSA 6 75 450 0.02 9.00 upon request. 8.4(d)(3).............................. List of surveys, surveyors to 6 6 36 0.20 7.20 SAMHSA upon request. 8.4(d)(4).............................. Report of less than full 6 5 30 0.50 15.00 accreditation to SAMHSA. 8.4(d)(5).............................. Summaries of Inspections....... 6 50 300 0.50 150.00 8.4(e)................................. Notifications of Complaints.... 12 6 72 0.50 36.00 8.6(a)(2) and (b)(3)................... Revocation notification to 1 185 185 0.30 55.50 Accredited OTPs. 8.6(b)................................. Submission of 90-day corrective 1 1 1 10.00 10.00 plan to SAMHSA. 8.6(b)(1).............................. Notification to accredited OTPs 1 185 185 0.30 55.50 of Probationary Status. ------------------------------------------------------------------------------- Sub Total.......................... ............................... 54 .............. 1,407 .............. 394.70 -------------------------------------------------------------------------------------------------------------------------------------------------------- Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Responses/ Total Hours/ 42 CFR citation Purpose respondents respondent responses response Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 8.11(b)................................ Renewal of approval (SMA-162).. 386 1 386 0.15 57.90 8.11(b)................................ Relocation of Program (SMA-162) 35 1 35 1.17 40.95 8.11(e)(1)............................. Application for provisional 42 1 42 1.00 42.00 certification. 8.11(e)(2)............................. Application for extension of 30 1 30 0.25 7.50 provisional certification. 8.11(f)(5)............................. Notification of sponsor or 60 1 60 0.10 6.00 medical director change (SMA- 162). 8.11(g)(2)............................. Documentation to SAMHSA for 1 1 1 1.00 1.00 interim maintenance. 8.11(h)................................ Request to SAMHSA for Exemption 1,325 25 33,125 0.07 2,318.75 from 8.11 and 8.12 (including SMA-168). 8.11(i)(1)............................. Notification to SAMHSA Before 10 1 10 0.25 2.50 Establishing Medication Units (SMA-162). 8.12(j)(2)............................. Notification to State Health 1 20 20 0.33 6.60 Officer When Patient Begins Interim Maintenance. 8.24................................... Contents of Appellant Request 2 1 2 0.25 .50 for Review of Suspension. 8.25(a)................................ Informal Review Request........ 2 1 2 1.00 2.00 8.26(a)................................ Appellant's Review File and 2 1 2 5.00 10.00 Written Statement. 8.28(a)................................ Appellant's Request for 2 1 2 1.00 2.00 Expedited Review. 8.28(c)................................ Appellant Review File and 2 1 2 5.00 10.00 Written Statement. ------------------------------------------------------------------------------- Sub Total.......................... ............................... 1,900 .............. 33,719 .............. 2,507.70 ------------------------------------------------------------------------------- Total.......................... ............................... 1,954 .............. 35,126 .............. 2,902.40 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 23001]] Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57B, Rockville, MD 20857 or email a copy at [email protected]. Written comments should be received by June 20, 2016. Summer King, Statistician. [FR Doc. 2016-09020 Filed 4-18-16; 8:45 am] BILLING CODE 4162-20-P
![Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Notices 22999
(Catalogue of Federal Domestic Assistance Proposed Project: Opioid Drugs in treatment plan, any prenatal support
Program Nos. 93.859, Pharmacology, Maintenance and Detoxification provided to the patient, justification of
Physiology, and Biological Chemistry Treatment of Opioid Dependence—42 unusually large initial doses, changes in
Research; 93.350, B—Cooperative CFR part 8 (OMB No. 0930–0206) and a patient’s dosage schedule, justification
Agreements; 93.859, Biomedical Research Opioid Treatment Programs (OTPs)— of unusually large daily doses, the
and Research Training, National Institutes of Revision rationale for decreasing a patient’s clinic
Health, HHS) attendance, and documentation of
42 CFR part 8 establishes a
Dated: April 13, 2016. certification program managed by physiologic dependence.
David Clary, SAMHSA’s Center for Substance Abuse The rule also includes requirements
Program Analyst, Office of Federal Advisory Treatment (CSAT). The regulation that OTPs and accreditation
Committee Policy. requires that Opioid Treatment organizations disclose information. For
[FR Doc. 2016–08992 Filed 4–18–16; 8:45 am] Programs (OTPs) be certified. example, 42 CFR 8.12(e)(1) requires that
‘‘Certification’’ is the process by which a physician explain the facts concerning
BILLING CODE 4140–01–P
SAMHSA determines that an OTP is the use of opioid drug treatment to each
qualified to provide opioid treatment patient. This type of disclosure is
under the Federal opioid treatment considered to be consistent with the
DEPARTMENT OF HEALTH AND
standards established by the Secretary common medical practice and is not
HUMAN SERVICES
of Health and Human Services. To considered an additional burden.
Substance Abuse and Mental Health become certified, an OTP must be Further, the rule requires, under Sec.
accredited by a SAMHSA-approved 8.4(i)(1) that accreditation organizations
Services Administration
accreditation body. The regulation also shall make public their fee structure;
Agency Information Collection provides standards for such services as this type of disclosure is standard
Activities: Proposed Collection; individualized treatment planning, business practice and is not considered
increased medical supervision, and a burden.
Comment Request
assessment of patient outcomes. This A number of changes have been made
In compliance with section submission seeks continued approval of to the forms. Forms have been reworded
3506(c)(2)(A) of the Paperwork the information collection requirements for clarification, updated with current
in the regulation and of the forms used SAMHSA mailing and web-submission
Reduction Act of 1995 concerning
in implementing the regulation. information, and a few additional fields
opportunity for public comment on SAMHSA currently has approval for
proposed collections of information, the have been provided for clarity and for
the Application for Certification to Use
Substance Abuse and Mental Health providers to best explain their services
Opioid Drugs in a Treatment Program
Services Administration (SAMHSA) (e.g., expanding the former global
Under 42 CFR 8.11 (Form SMA–162);
will publish periodic summaries of patient census in the SMA–162 to
the Application for Approval as
proposed projects. To request more request patient census by drug type—
Accreditation Body Under 42 CFR 8.3(b)
information on the proposed projects or methadone, buprenorphine, naltrexone,
(Form SMA–163); and the Exception
to obtain a copy of the information or other) and the needs of their patients
Request and Record of Justification
Under 42 CFR 8.12 (Form SMA–168), (e.g., including urinalysis results on the
collection plans, call the SAMHSA
which may be used by physicians when SMA–168 and adding ‘‘weather crisis’’
Reports Clearance Officer on (240) 276–
there is a patient care situation in which as a standard option for physician
1243. justification of the requested exception).
the physician must make a treatment
Comments are invited on: (a) Whether Amendments also include the removal
decision that differs from the treatment
the proposed collections of information of information pertaining to faxing the
regimen required by the regulation.
are necessary for the proper Form SMA–168 is a simplified, forms to SAMHSA, as this is no longer
performance of the functions of the standardized form to facilitate the an acceptable form of submission. The
agency, including whether the documentation, request, and approval burden hours have increased slightly
information shall have practical utility; process for exceptions. (by 28% or approximately 639 hours)
(b) the accuracy of the agency’s estimate SAMHSA believes that the due to an increase in the number of
of the burden of the proposed collection recordkeeping requirements in the facilities accredited and certified by
of information; (c) ways to enhance the regulation are customary and usual SAMHSA since the previous
quality, utility, and clarity of the practices within the medical and submissions of these forms. The forms
information to be collected; and (d) rehabilitative communities and has not are available online with a unique
ways to minimize the burden of the calculated a response burden for them. feature for both the SMA–162 and
collection of information on The recordkeeping requirements set SMA–168 that pre-populates certain
respondents, including through the use forth in 42 CFR 8.4, 8.11, and 8.12 information within the form. This in
of automated collection techniques or include maintenance of the following: 5- turn reduces the program’s time spent
year retention by accreditation bodies of filling out the forms as well as the staff
other forms of information technology.
certain records pertaining to time spent on processing it.
accreditation, and documentation by an The tables that follow summarize the
OTP of the following: A patient’s annual reporting burden associated with
medical examination when admitted to the regulation, including burden
mstockstill on DSK4VPTVN1PROD with NOTICES
treatment, a patient’s history, a associated with the forms.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES
Number of Responses/ Total Hours/ Total
42 CFR citation Purpose respondents respondent responses response hours
8.3(b)(1–11) ......... Initial approval (SMA–163) ................ 1 1 1 6.00 6.00
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![Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Notices 23001
Send comments to Summer King, DEPARTMENT OF HOMELAND FOR FURTHER INFORMATION CONTACT: If
SAMHSA Reports Clearance Officer, SECURITY you have questions on this notice or
5600 Fishers Lane, Room 15E57B, wish to submit proposals for future
Rockville, MD 20857 or email a copy at Coast Guard CRADAs, contact LCDR Samuel Nassar,
summer.king@samhsa.hhs.gov. Written [Docket No. USCG–2016–0291] Project Official, C4ISR Branch, U.S.
comments should be received by June Coast Guard Research and Development
20, 2016. Cooperative Research and Center, 1 Chelsea Street, New London,
Development Agreement: Troposcatter CT 06320, telephone 860–271–2727,
Summer King,
Communications Exploratory email samuel.r.nassar@uscg.mil.
Statistician.
Development SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–09020 Filed 4–18–16; 8:45 am]
BILLING CODE 4162–20–P Coast Guard, DHS.
AGENCY: Public Participation and Request for
Notice of intent; request for
ACTION: Comments
comments. We request public comments on this
notice. Although we do not plan to
DEPARTMENT OF HOMELAND The Coast Guard announces
SUMMARY:
respond to comments in the Federal
SECURITY its intent to enter into a Cooperative
Register, we will respond directly to
Research and Development Agreement
commenters and may modify our
Coast Guard (CRADA) with Comtech Systems, Inc.,
proposal in light of comments.
to investigate the potential operational Comments should be marked with
use of troposcatter technology. The docket number USCG–2016–0291and
[Docket No. USCG–2016–0104]
research includes employment of their should provide a reason for each
Navigation and Vessel Inspection Modular Transportable Transmission suggestion or recommendation. You
Circular (NVIC) No. 02–16; Inspection System (MTTS) in northern Alaska to should provide personal contact
Guidance for Sail Rigging and Masts establish beyond line of sight (BLOS) information so that we can contact you
on Inspected Sailing Vessels network links without using existing if we have questions regarding your
infrastructure or satellite comments; but please note that all
AGENCY: Coast Guard, DHS. communications. Specifically, the comments will be posted to the online
MTTS will provide a wireless IEEE docket without change and that any
ACTION: Notice of availability.
802.3 (Ethernet) data link between two personal information you include can be
SUMMARY: The Coast Guard announces locations separated by long distances searchable online (see the Federal
the availability of NVIC 02–16. This and elevated terrain. The MTTS will be Register Privacy Act notice regarding
Circular provides guidance to vessel setup in locations with no shelter/ our public dockets, 73 FR 3316, Jan. 17,
owners, riggers, marine surveyors, other protection from the Northern Alaskan 2008). We also accept anonymous
marine service providers, and Coast environment. A Pilot Demonstration comments.
Guard marine inspectors regarding schedule has been proposed in which We encourage you to submit
inspection of sail rigging, masts, and Comtech Systems will provide their comments through the Federal
associated components for commercial MTTS to connect two points separated eRulemaking Portal at http://
sailing vessels and the use of by 68 miles with a 3000 foot elevation www.regulations.gov. If your material
in between. The Coast Guard Research cannot be submitted using http://
preventative maintenance as a good
and Development Center (R&D Center) www.regulations.gov, contact the Coast
marine practice. It provides guidance for
will prepare a Pilot Demonstration Guard (see FOR FURTHER INFORMATION
the purpose of assisting vessel owners
Assessment Plan and Comtech Systems CONTACT). Documents mentioned in this
and operators, and U.S. Coast Guard
will operate the equipment for notice and all public comments, are in
personnel with the inspection and
exploratory development over a one our online docket at http://
recommended documentation of
week period to collect information on www.regulations.gov and can be viewed
maintenance for sail rigging and masts
suitability, reliability, maintenance by following that Web site’s
on inspected sailing vessels. It is
requirements, and ease of use. While the instructions. Additionally, if you go to
intended to enhance consistency with
Coast Guard is currently considering the online docket and sign up for email
the Coast Guard inspection process for
partnering with Comtech Systems, Inc., alerts, you will be notified when
the commercial sailing fleet.
the agency is soliciting public comment comments are posted or a final rule is
DATES: NVIC 02–16 is available on April on the possible nature of and
published.
13, 2016. participation of other parties in the Do not submit detailed proposals for
ADDRESSES: This NVIC is available at the proposed CRADA. In addition, the Coast future CRADAs to the Docket
following Coast Guard Web site: http:// Guard also invites other potential non- Management Facility. Instead, submit
www.uscg.mil/hq/cg5/nvic/. Federal participants to propose similar them directly to the Coast Guard (see
CRADAs. FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: If
DATES: Comments must be submitted to
you have questions on this notice, call Discussion
LCDR James T. Fogle, Office of the online docket via http://
www.regulations.gov, or reach the CRADAs are authorized under 15
Commercial Vessel Compliance, Coast
U.S.C. 3710(a).1 A CRADA promotes the
Guard, telephone 202—372–1216, email Docket Management Facility, on or
transfer of technology to the private
mstockstill on DSK4VPTVN1PROD with NOTICES
James.T.Fogle@uscg.mil. before May 19, 2016.
Synopses of proposals regarding sector for commercial use, as well as
Dated: April 13, 2016. future CRADAs must reach the Coast specified research or development
Paul F. Thomas, Guard (see FOR FURTHER INFORMATION
USCG, Assistant Commandant for Prevention CONTACT) on or before May 19, 2016. 1 The statute confers this authority on the head of
Policy. each Federal agency. The Secretary of DHS’s
ADDRESSES: Submit comments online at
authority is delegated to the Coast Guard and other
[FR Doc. 2016–09022 Filed 4–18–16; 8:45 am] http://www.regulations.gov in DHS organizational elements by DHS Delegation
BILLING CODE 9110–04–P accordance with Web site instructions. No. 0160.1, para. II.B.34.
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Document Created: 2016-04-19 00:16:11
Document Modified: 2016-04-19 00:16:11
| 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 | |
| FR Citation | 81 FR 22999 |
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