Center for Scientific Review; Notice of Closed Meeting, 3013 [2013-00615]
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Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices
and Hematology Research, National Institutes
of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 8, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
Substance Abuse and Mental Health
Services Administration
[FR Doc. 2013–00620 Filed 1–14–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
srobinson on DSK4SPTVN1PROD with
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurodevelopment and
Neuroplasticity.
Date: January 28, 2013.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Toby Behar, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4136,
MSC 7850, Bethesda, MD 20892, (301) 435–
4433, behart@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: January 9, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–00615 Filed 1–14–13; 8:45 am]
BILLING CODE 4140–01–P
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17:00 Jan 14, 2013
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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
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3013
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 on a voluntary basis
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: 5year retention by accreditation bodies of
certain records pertaining to
accreditation; 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 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.
There are no changes being made to
the forms. The reason for the reduction
in burden hours is due to more
respondents submitting information
through an online function. 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
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[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Page 3013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00615]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neurodevelopment and Neuroplasticity.
Date: January 28, 2013.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Toby Behar, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4136, MSC 7850, Bethesda, MD 20892, (301) 435-
4433, behart@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: January 9, 2013.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-00615 Filed 1-14-13; 8:45 am]
BILLING CODE 4140-01-P
