Agency Information Collection Activities: Proposed Collection; Comment Request, 200 [07-6254]
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Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices
found in brackets in the heading of this
document. The draft guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that in January 2008, the
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management system. After the transition
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announcing that date.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.cfsan.fda.gov/guidance.html.
Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–6266 Filed 12–27–07; 3:08 pm]
BILLING CODE 4160–01–S
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 Treatment
Programs (OTPs) Mortality Reporting
Form—NEW
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Substance Abuse
Treatment (CSAT), has developed a
voluntary reporting form for Opioid
Treatment Programs (OTPs) to report
mortality data on patients who at the
time of death, were enrolled in the
Programs that were certified to operate
by SAMHSA.
Methadone is a Schedule II controlled
substance approved by the Food and
Drug Administration for the treatment of
opioid dependence and pain. Although
it has proven safe and effective, it must
be carefully administered and for that
reason, treatment of opioid dependence
with methadone is provided only
through specialized and Federally
regulated and accredited clinics, the
OTPs. Buprenorphine, a Schedule III
controlled ssubstance, is also used in
the treatment of opioid addiction by
OTPs and office-based physicians.
In recent years, methadone has been
associated with an increasing number of
deaths around the country.
Simultaneously, the use of methadone
for pain has increased significantly over
the last 5 to 10 years. While the Food
and Drug Administration (FDA)
maintains oversight of methadone for
use in pain, SAMHSA provides
oversight of methadone for use in opioid
addiction treatment. Currently, there is
no national database that tracks
mortality among patients receiving
methadone in OTPs and as a result, it
is not clear whether and to what extent
the increase in methadone-associated
deaths may be related to treatment in
OTPs. MedWatch, a voluntary reporting
system maintained by FDA, provides
information relevant to its role in its
more general oversight of medication
and device safety. A similar system is
needed within SAMHSA to gather
information directly relevant to the
agency’s mission of overseeing and
ensuring safe and effective treatment for
patients with opioid dependence.
In order to more accurately
understand potential methadoneassociated deaths at the OTP level, it is
necessary to examine all patient deaths,
including those related to
buprenorphine. Understanding the
actual cause of death of patients
enrolled in OTPs can be a challenging
task for many reasons, including
inconsistencies in methods of reporting
causes of deaths across different
localities and officials; patients’ use of
other drugs, including illicit, over-thecounter, and prescription products; and
other aspects of the patient’s physical
and mental condition. The standardized
terminology to be used for reporting in
the proposed system will contribute to
a more precise and relevant analysis of
individual cases and higher-level
trends. The data will be 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. Importantly, better data
will enable the agency to more
proactively manage the oversight of
treatment.
The information requested from OTPs
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.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS
Number of
facilities
(OTPs)
Form
pwalker on PROD1PC71 with NOTICES
SAMHSA OTP Mortality Report .......................................................................
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 Aug<31>2005
19:07 Dec 31, 2007
Jkt 214001
1,150
Written comments should be received
within 60 days of this notice.
PO 00000
Burden
responses
(hours)
Responses
per facility
2
Fmt 4703
Sfmt 4703
1,150
Dated: December 31, 2007.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. 07–6254 Filed 12–31–07; 8:45 am]
BILLING CODE 4162–20–M
Frm 00054
0.5
Annual
burden
(hours)
E:\FR\FM\02JAN1.SGM
02JAN1
]]>Agencies
[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Page 200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-6254]
-----------------------------------------------------------------------
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 Treatment Programs (OTPs) Mortality Reporting
Form--NEW
The Substance Abuse and Mental Health Services Administration
(SAMHSA), Center for Substance Abuse Treatment (CSAT), has developed a
voluntary reporting form for Opioid Treatment Programs (OTPs) to report
mortality data on patients who at the time of death, were enrolled in
the Programs that were certified to operate by SAMHSA.
Methadone is a Schedule II controlled substance approved by the
Food and Drug Administration for the treatment of opioid dependence and
pain. Although it has proven safe and effective, it must be carefully
administered and for that reason, treatment of opioid dependence with
methadone is provided only through specialized and Federally regulated
and accredited clinics, the OTPs. Buprenorphine, a Schedule III
controlled ssubstance, is also used in the treatment of opioid
addiction by OTPs and office-based physicians.
In recent years, methadone has been associated with an increasing
number of deaths around the country. Simultaneously, the use of
methadone for pain has increased significantly over the last 5 to 10
years. While the Food and Drug Administration (FDA) maintains oversight
of methadone for use in pain, SAMHSA provides oversight of methadone
for use in opioid addiction treatment. Currently, there is no national
database that tracks mortality among patients receiving methadone in
OTPs and as a result, it is not clear whether and to what extent the
increase in methadone-associated deaths may be related to treatment in
OTPs. MedWatch, a voluntary reporting system maintained by FDA,
provides information relevant to its role in its more general oversight
of medication and device safety. A similar system is needed within
SAMHSA to gather information directly relevant to the agency's mission
of overseeing and ensuring safe and effective treatment for patients
with opioid dependence.
In order to more accurately understand potential methadone-
associated deaths at the OTP level, it is necessary to examine all
patient deaths, including those related to buprenorphine. Understanding
the actual cause of death of patients enrolled in OTPs can be a
challenging task for many reasons, including inconsistencies in methods
of reporting causes of deaths across different localities and
officials; patients' use of other drugs, including illicit, over-the-
counter, and prescription products; and other aspects of the patient's
physical and mental condition. The standardized terminology to be used
for reporting in the proposed system will contribute to a more precise
and relevant analysis of individual cases and higher-level trends. The
data will be 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. Importantly, better data will enable the
agency to more proactively manage the oversight of treatment.
The information requested from OTPs 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.
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
Number of Burden
Form facilities Responses per responses Annual burden
(OTPs) facility (hours) (hours)
----------------------------------------------------------------------------------------------------------------
SAMHSA OTP Mortality Report..................... 1,150 2 0.5 1,150
----------------------------------------------------------------------------------------------------------------
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: December 31, 2007.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. 07-6254 Filed 12-31-07; 8:45 am]
BILLING CODE 4162-20-M
