Agency Information Collection Activities: Proposed Collection; Comment Request, 29487-29489 [E9-14554]

Download as PDF 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
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