Agency Information Collection Activities: Proposed Collection; Comment Request, 29487-29489 [E9-14554]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices
Lorenzo Littles, Dallas Director,
Enterprise Community Partners, Inc.,
Dallas, Texas.
Larry Litton, Jr., President and Chief
Executive Officer, Litton Loan
Servicing, LP, Houston, Texas.
Saurabh Narain, Chief Fund Advisor,
National Community Investment
Fund, Chicago, Illinois.
Andres Navarrete, Senior Vice
President, Chief Counsel—National
Lending, Capital One Financial
Corporation, McLean, Virginia.
Jim Park, President and Chief Executive
Officer, New Vista Asset Management,
San Diego, California.
Ronald Phillips, President, Coastal
Enterprises, Inc., Wiscasset, Maine.
Kevin Rhein, Division President, Wells
Fargo Card Services, Minneapolis,
Minnesota.
Shanna Smith, President and Chief
Executive Officer, National Fair
Housing Alliance, Washington,
District of Columbia.
Jennifer Tescher, Director, Center for
Financial Services Innovation,
Chicago, Illinois.
Mary Tingerthal, President, Capital
Markets Companies, Housing
Partnership Network, St. Paul,
Minnesota.
Board of Governors of the Federal Reserve
System, June 17, 2009.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E9–14606 Filed 6–19–09; 8:45 am]
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than July 17, 2009.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Prairieland Bancorp Employee
Stock Ownership Plan and Trust,
Bushnell, Illinois; to acquire additional
voting shares, for a total of 44.62 percent
of the voting shares, of Prairieland
Bancorp, Inc., and thereby indirectly
acquire additional voting shares of
Merchants and Farmers State Bank of
Bushnell, both of Bushnell, Illinois.
Board of Governors of the Federal Reserve
System, June 17, 2009.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E9–14583 Filed 6–19–09; 8:45 am]
BILLING CODE 6210–01–S
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FEDERAL RESERVE SYSTEM
pwalker on PROD1PC71 with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR Part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
VerDate Nov<24>2008
16:55 Jun 19, 2009
Jkt 217001
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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
29487
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)
Mortality Reporting Form—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 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 developed an OTP
mortality report form to be utilized by
OTPs in response to the increasing
methadone associated mortality around
the country. This form also assists
SAMHSA with regulatory oversight of
methadone for use in opioid addiction
treatment because it is not clear whether
and to what extent the increase in
methadone-associated deaths may be
related to treatment in OTPs. A system
within SAMHSA to gather information
E:\FR\FM\22JNN1.SGM
22JNN1
29488
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices
directly relevant to the agency’s mission
of overseeing and ensuring safe and
effective treatment for patients with
opioid dependence provides an
additional layer of oversight.
SAMHSA currently has approval for
the Opioid Treatment Programs (OTPs)
Mortality Reporting Form. The data
collected from the form is used by
SAMHSA to increase understanding of
the factors contributing to these deaths,
identify preventable causes of deaths,
and ultimately, take appropriate action
to minimize risk and help improve the
quality of care. SAMHSA recently
received OMB approval for the
voluntary collection of data regarding
OTP mortality, which expires October
2011. The consolidation of the OMB
packages for the mortality form with the
regulatory forms SMA–162, SMA–163,
and SMA–168 reduces agency and staff
burden.
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
No. of
respondents
42 CFR citation
Purpose
8.3(b)(1–11) ...................................
8.3(c) ..............................................
8.3(e) ..............................................
8.3(f)(2) ..........................................
Initial approval (SMA–163) ..................
Renewal of approval (SMA–163) ........
Relinquishment notification .................
Non-renewal notification to accredited
OTPs.
Notification to SAMHSA for seriously
noncompliant OTPs.
Notification to OTP for serious noncompliance.
General documents and information to
SAMHSA upon request.
Accreditation survey to SAMHSA
upon request.
List of surveys, surveyors to SAMHSA
upon request.
Report of less than full accreditation
to SAMHSA.
Summaries of Inspections ...................
Notifications of Complaints ..................
Revocation notification to Accredited
OTPs.
Submission of 90-day corrective plan
to SAMHSA.
Notification to accredited OTPs of
Probationary Status.
8.4(b)(1)(ii) .....................................
8.4(b)(1)(iii) ....................................
8.4(d)(1) .........................................
8.4(d)(2) .........................................
8.4(d)(3) .........................................
8.4(d)(4) .........................................
8.4(d)(5) .........................................
8.4(e) ..............................................
8.6(a)(2) and (b)(3) ........................
8.6(b) ..............................................
8.6(b)(1) .........................................
TOTAL ....................................
Responses/
respondent
Hours/
response
Total
hours
1
2
1
1
1
1
1
90
6.0
1.0
0.5
0.1
6
2
0.5
9
2
2
1.0
4
2
10
1.0
20
6
5
0.5
15
6
75
0.02
9
6
6
0.2
7.2
6
5
0.5
15
6
12
1
50
6
185
0.5
0.5
0.3
150
3.6
55.5
1
1
10
10.0
1
185
0.3
55.0
6
........................
........................
361.80
..............................................................
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS
No. of
respondents
42 CFR citation
Purpose
8.11(b) ....................................
8.11(b) ....................................
8.11(e)(1) ................................
8.11(e)(2) ................................
Renewal of approval (SMA–162) ................
Relocation of Program (SMA–162) .............
Application for provisional certification .......
Application for extension of provisional certification.
Notification of sponsor or medical director
change (SMA–162).
Documentation to SAMHSA for interim
maintenance.
Request to SAMHSA for Exemption from
8.11 and 8.12 (including SMA–168).
Notification to SAMHSA Before Establishing Medication Units (SMA–162).
Notification to State Health Officer When
Patient Begins Interim Maintenance.
Contents of Appellant Request for Review
of Suspension.
Informal Review Request ............................
Appellant’s Review File and Written Statement.
Appellant’s Request for Expedited Review
Appellant Review File and Written Statement.
8.11(f)(5) .................................
8.11(g)(2) ................................
8.11(h) ....................................
8.11(i)(1) .................................
8.12(j)(2) .................................
8.24 ........................................
pwalker on PROD1PC71 with NOTICES
8.25(a) ....................................
8.26(a) ....................................
8.28(a) ....................................
8.28(c) ....................................
TOTAL ....................................
VerDate Nov<24>2008
16:55 Jun 19, 2009
.....................................................................
Jkt 217001
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Responses/
respondent
Hours/
response
Total
hours
386
35
42
30
1
1
1
1
0.15
1.17
1
0.25
57.9
40.95
42.00
7.50
60
1
0.1
6.00
1
1
1
1.00
1,200
25
0.7
2135.0
10
1
0.25
2.5
1
20
0.33
6.6
2
1
0.25
.50
2
2
1
1
1.00
5.00
2.00
10.00
2
2
1
1
1.00
5.00
2.00
10.00
1,200
........................
........................
2323.95
E:\FR\FM\22JNN1.SGM
22JNN1
29489
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Notices
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OTPS
Form name
Number of
facilities
(OTPs)
Responses
per facility
Burden/
response
(hours) to OTP
Annual burden
(hours) to
OTPs
SAMHSA OTP Mortality Form .........................................................................
1,200
2 per year
0.5
1200.00
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR MEDICAL EXAMINER (ME)
Number of ME
follow-ups
Responses
per ME
Burden/
response
(hours) for ME
Annual
burden
(hours) for ME
SAMHSA OTP mortality form ..........................................................................
pwalker on PROD1PC71 with NOTICES
Form name
230
1 per year
0.1
2.3
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.
The information requested from OTPs
on mortality report form should be
readily available to any OTP that has
met accreditation standards. The OTP
should not find any need to otherwise
analyze or synthesize new data in order
to complete this form.
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail her a
copy at summer.king@samhsa.hhs.gov.
VerDate Nov<24>2008
16:55 Jun 19, 2009
Jkt 217001
Written comments should be received
within 60 days of this notice.
Dated: June 15, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–14554 Filed 6–19–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–09–0278]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995.
To request a copy of these requests, call
the CDC Reports Clearance Officer at
(404) 639–5960 or send an e-mail to
omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
National Hospital Ambulatory
Medical Care Survey [OMB No. 0920–
0278]—Revision—National Center for
Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on ‘‘utilization of health care’’
in the United States. The National
Hospital Ambulatory Medical Care
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Survey (NHAMCS) has been conducted
annually since 1992. This revision seeks
approval to collect data for an
additional three years and to expand the
survey to include free-standing
ambulatory surgical centers. The
purpose of NHAMCS is to meet the
needs and demands for statistical
information about the provision of
ambulatory medical care services in the
United States. Ambulatory services are
rendered in a wide variety of settings,
including physicians’ offices and
hospital outpatient and emergency
departments.
The target universe of NHAMCS is inperson visits made to emergency
departments (EDs) and outpatient
departments (OPDs) of non-Federal,
short-stay hospitals (hospitals with an
average length of stay of fewer than 30
days) or those whose specialty is general
(medical or surgical) or children’s
general. In 2009, NHAMCS was
expanded to include visits to hospitalbased ambulatory surgery centers
(ASCs). NCHS seeks OMB approval to
expand NHAMCS to include freestanding ASCs in 2010. The objective of
this new collection will be to collect
data about free-standing ambulatory
surgery centers, the patients they serve,
and the services they deliver. The intent
is for NHAMCS to become the principal
source of data on ASC services in the
United States. The data to be collected
include patient characteristics,
diagnoses, surgical and nonsurgical
procedures, provider and type of
anesthesia, time in and out of surgery
and postoperative care, and discharge
disposition.
Users of NHAMCS data include, but
are not limited to, congressional offices,
Federal agencies, State and local
governments, schools of public health,
colleges and universities, private
industry, nonprofit foundations,
professional associations, clinicians,
researchers, administrators, and health
planners. There are no costs to the
respondents other than their time. The
E:\FR\FM\22JNN1.SGM
22JNN1
]]>Agencies
[Federal Register Volume 74, Number 118 (Monday, June 22, 2009)]
[Notices]
[Pages 29487-29489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14554]
=======================================================================
-----------------------------------------------------------------------
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) Mortality Reporting Form--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 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 developed an OTP mortality report form to be utilized by
OTPs in response to the increasing methadone associated mortality
around the country. This form also assists SAMHSA with regulatory
oversight of methadone for use in opioid addiction treatment because it
is not clear whether and to what extent the increase in methadone-
associated deaths may be related to treatment in OTPs. A system within
SAMHSA to gather information
[[Page 29488]]
directly relevant to the agency's mission of overseeing and ensuring
safe and effective treatment for patients with opioid dependence
provides an additional layer of oversight.
SAMHSA currently has approval for the Opioid Treatment Programs
(OTPs) Mortality Reporting Form. The data collected from the form is
used by SAMHSA to increase understanding of the factors contributing to
these deaths, identify preventable causes of deaths, and ultimately,
take appropriate action to minimize risk and help improve the quality
of care. SAMHSA recently received OMB approval for the voluntary
collection of data regarding OTP mortality, which expires October 2011.
The consolidation of the OMB packages for the mortality form with the
regulatory forms SMA-162, SMA-163, and SMA-168 reduces agency and staff
burden.
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
----------------------------------------------------------------------------------------------------------------
No. of Responses/ Hours/
42 CFR citation Purpose respondents respondent response Total hours
----------------------------------------------------------------------------------------------------------------
8.3(b)(1-11).................. Initial approval 1 1 6.0 6
(SMA-163).
8.3(c)........................ Renewal of 2 1 1.0 2
approval (SMA-
163).
8.3(e)........................ Relinquishment 1 1 0.5 0.5
notification.
8.3(f)(2)..................... Non-renewal 1 90 0.1 9
notification to
accredited OTPs.
8.4(b)(1)(ii)................. Notification to 2 2 1.0 4
SAMHSA for
seriously
noncompliant
OTPs.
8.4(b)(1)(iii)................ Notification to 2 10 1.0 20
OTP for serious
noncompliance.
8.4(d)(1)..................... General 6 5 0.5 15
documents and
information to
SAMHSA upon
request.
8.4(d)(2)..................... Accreditation 6 75 0.02 9
survey to
SAMHSA upon
request.
8.4(d)(3)..................... List of surveys, 6 6 0.2 7.2
surveyors to
SAMHSA upon
request.
8.4(d)(4)..................... Report of less 6 5 0.5 15
than full
accreditation
to SAMHSA.
8.4(d)(5)..................... Summaries of 6 50 0.5 150
Inspections.
8.4(e)........................ Notifications of 12 6 0.5 3.6
Complaints.
8.6(a)(2) and (b)(3).......... Revocation 1 185 0.3 55.5
notification to
Accredited OTPs.
8.6(b)........................ Submission of 90- 1 1 10 10.0
day corrective
plan to SAMHSA.
8.6(b)(1)..................... Notification to 1 185 0.3 55.0
accredited OTPs
of Probationary
Status.
---------------------------------------------------------------------------------
TOTAL..................... ................ 6 .............. .............. 361.80
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
No. of Responses/ Hours/
42 CFR citation Purpose respondents respondent response Total hours
----------------------------------------------------------------------------------------------------------------
8.11(b)....................... Renewal of 386 1 0.15 57.9
approval (SMA-
162).
8.11(b)....................... Relocation of 35 1 1.17 40.95
Program (SMA-
162).
8.11(e)(1).................... Application for 42 1 1 42.00
provisional
certification.
8.11(e)(2).................... Application for 30 1 0.25 7.50
extension of
provisional
certification.
8.11(f)(5).................... Notification of 60 1 0.1 6.00
sponsor or
medical
director change
(SMA-162).
8.11(g)(2).................... Documentation to 1 1 1 1.00
SAMHSA for
interim
maintenance.
8.11(h)....................... Request to 1,200 25 0.7 2135.0
SAMHSA for
Exemption from
8.11 and 8.12
(including SMA-
168).
8.11(i)(1).................... Notification to 10 1 0.25 2.5
SAMHSA Before
Establishing
Medication
Units (SMA-162).
8.12(j)(2).................... Notification to 1 20 0.33 6.6
State Health
Officer When
Patient Begins
Interim
Maintenance.
8.24.......................... Contents of 2 1 0.25 .50
Appellant
Request for
Review of
Suspension.
8.25(a)....................... Informal Review 2 1 1.00 2.00
Request.
8.26(a)....................... Appellant's 2 1 5.00 10.00
Review File and
Written
Statement.
8.28(a)....................... Appellant's 2 1 1.00 2.00
Request for
Expedited
Review.
8.28(c)....................... Appellant Review 2 1 5.00 10.00
File and
Written
Statement.
---------------------------------------------------------------------------------
TOTAL......................... ................ 1,200 .............. .............. 2323.95
----------------------------------------------------------------------------------------------------------------
[[Page 29489]]
Estimated Annual Reporting Requirement Burden for OTPs
----------------------------------------------------------------------------------------------------------------
Number of Burden/
Form name facilities Responses per response Annual burden
(OTPs) facility (hours) to OTP (hours) to OTPs
----------------------------------------------------------------------------------------------------------------
SAMHSA OTP Mortality Form................... 1,200 2 per year 0.5 1200.00
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Medical Examiner (ME)
----------------------------------------------------------------------------------------------------------------
Burden/
Form name Number of ME Responses per response Annual burden
follow-ups ME (hours) for ME (hours) for ME
----------------------------------------------------------------------------------------------------------------
SAMHSA OTP mortality form................... 230 1 per year 0.1 2.3
----------------------------------------------------------------------------------------------------------------
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;
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.
The information requested from OTPs on mortality report form should
be readily available to any OTP that has met accreditation standards.
The OTP should not find any need to otherwise analyze or synthesize new
data in order to complete this form.
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail her
a copy at summer.king@samhsa.hhs.gov. Written comments should be
received within 60 days of this notice.
Dated: June 15, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-14554 Filed 6-19-09; 8:45 am]
BILLING CODE 4162-20-P
