Agency Information Collection Activities: Proposed Collection; Comment Request, 30837-30838 [2010-13145]
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30837
Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices
ANNUALIZED SUMMARY TABLE—Continued
Number of
respondents
Respondents
Responses/
respondent
Total
responses
Total
annualized
hour burden
Campus Staff ...................................................................................................
152
7
152
206
Total ..........................................................................................................
132,060
49
133,890
26,444
Written comments and
recommendations concerning the
proposed information collection should
be sent by July 2, 2010 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–6974.
Dated: May 25, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–13146 Filed 6–1–10; 8:45 am]
BILLING CODE 4162–20–P
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 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: Screening, Brief
Intervention, Brief Treatment and
Referral to Treatment (SBIRT) CrossSite Evaluation—New
SAMHSA is conducting a cross-site
external evaluation of the impact of
programs of screening, brief
intervention (BI), brief treatment (BT)
and referral to treatment on patients
presenting at various health care
delivery units with a continuum of
severity of substance use. SAMHSA’s
SBIRT program is a cooperative
agreement grant program designed to
help States and Tribal Councils expand
the continuum of care available for
substance misuse and use disorders.
The program includes screening, brief
intervention, brief treatment and
referrals to treatment for persons at risk
for dependence on alcohol or drugs. The
cross-site evaluation will provide a
comprehensive assessment of the effects
of SBIRT on patient outcomes,
performance site practices, and
treatment systems. This information
will allow SAMHSA to determine the
extent to which SBIRT has met its
objectives of implementing a
comprehensive system of identification
and care to meet the needs of
individuals at all points along the
substance use continuum.
A paper and pencil survey will be
administered to practitioners in sites
where SBIRT services are being
delivered. The practitioner survey is
designed to evaluate the
implementation of proposed SBIRT
models by measuring their penetration
and practitioners’ willingness to adopt.
Furthermore, the survey will document
moderating factors related to
practitioner and health care delivery
unit characteristics.
The 93 question practitioner survey
includes collection of demographic
information as well as questions that
attempt to assess barriers to
implementation encountered by the
practitioners and to gauge the
effectiveness of the training they
received. These measures were
developed and used by Babor et al.
(2005) in their comparable study
comparing different implementation
strategies for primary care screening and
brief intervention programs for
hazardous and harmful drinkers. The
practitioner survey also includes an
instrument developed by Panzano and
Roth (2006) to measures an
organization’s willingness to adopt new
innovative practices.
TOTAL BURDEN HOURS FOR THE CROSS-SITE PATIENT SURVEY
Number of
respondents
Instrument/Activity
sroberts on DSKD5P82C1PROD with NOTICES
Practitioner Survey ...................................
VerDate Mar<15>2010
19:08 Jun 01, 2010
Jkt 220001
Responses
per
respondent
1,075
PO 00000
Frm 00068
Hours per
response
1
Fmt 4703
Sfmt 9990
Total burden
hours
.30
E:\FR\FM\02JNN1.SGM
322.5
02JNN1
Hourly wage
$32
Total
respondent
cost a
$10,320
30838
Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: May 25, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–13145 Filed 6–1–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2003–N–0196] (formerly
Docket No. 2003N–0233)
Drometrizole Trisiloxane Eligibility for
Potential Inclusion in Sunscreen
Monograph; Over-the-Counter
Sunscreen Drug Products for Human
Use; Request for Safety, Effectiveness,
and Environmental Data
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION: Notice of eligibility; request for
data and information.
SUMMARY: As part of our ongoing review
of over-the-counter (OTC) drug
products, we (Food and Drug
Administration, FDA) are announcing a
call-for-data for safety, effectiveness,
and environmental information for
drometrizole trisiloxane, in
concentrations up to 15 percent, as a
sunscreen single active ingredient and
in combination with generally
recognized as safe and effective
(GRASE) sunscreen active ingredients
found in the sunscreen monograph. We
reviewed a time and extent application
(TEA) for drometrizole trisiloxane and
determined that it is eligible to be
considered for inclusion in our OTC
drug monograph system. We will
evaluate the submitted safety and
effectiveness data and information to
determine whether drometrizole
trisiloxane can be GRASE for its
proposed OTC use. We also request data
and information to assess the projected
environmental effects of a potential
GRASE determination in order to assist
us in complying with the requirements
of the National Environmental Policy
Act of 1969 (NEPA).
DATES: Submit data, information, and
general comments by August 31, 2010.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2003–N–
0196, by any of the following methods:
Electronic Submissions
VerDate Mar<15>2010
19:08 Jun 01, 2010
Jkt 220001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
docket number. All comments received
may be posted without change to https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Anita Kumar, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5445,
Silver Spring, MD 20993, 301–796–
2090.
SUPPLEMENTARY INFORMATION:
I. Eligibility of Drometrizole Trisiloxane
In January 2009, we received a TEA
(Ref. 1) requesting that drometrizole
trisiloxane be found eligible for review
and potential inclusion in our OTC
sunscreen drug monograph (part 352 (21
CFR part 352)). After reviewing the
TEA, we believe that it includes
adequate data demonstrating that
drometrizole trisiloxane has been
marketed for the prevention of sunburn
for a material time and to a material
extent as required by § 330.14 (21 CFR
330.14) (Ref. 2). Drometrizole
trisiloxane-containing sunscreen
products indicated for the prevention of
sunburn have been marketed directly to
consumers for over 5 continuous years
in 40 countries, with over 177 million
dosage units marketed in 54 countries.
Therefore, we conclude that
drometrizole trisiloxane, in
concentrations up to 15 percent, is
eligible to be considered for potential
inclusion in the OTC sunscreen drug
monograph as a single active ingredient
and in combination with GRASE
sunscreen active ingredients found in
§ 352.10.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
II. Request for Data and Information
We invite all interested persons to
submit data and information, as
described in § 330.14(f), on the safety
and effectiveness of drometrizole
trisiloxane for use as an active
ingredient in OTC sunscreen products.
The data should be sufficient so that we
can determine whether the ingredient
can be GRASE and not misbranded
under recommended conditions of OTC
use. Interested parties may refer to 21
CFR 330.10(a)(4) regarding the evidence
necessary for establishing general
recognition of safety and effectiveness.
Because the TEA that we reviewed
did not include an official or proposed
United States Pharmacopeia-National
Formulary (USP–NF) drug monograph
for drometrizole trisiloxane, we are
asking interested parties to provide such
a monograph to us. An active ingredient
must be recognized in an official USP–
NF drug monograph that sets forth its
standards of identity, strength, quality,
and purity in order to be included in a
final OTC monograph (§ 330.14(i)).
In addition, as stated in 21 CFR 25.1,
FDA regulations must comply with
NEPA. To comply with NEPA, an
environmental assessment (EA) of
agency actions is required unless we
determine that a categorical exclusion is
warranted. Therefore, we also invite all
interested persons to either submit data
and information that would support a
determination that the potential
inclusion of drometrizole trisiloxane in
the OTC monograph for sunscreen
meets the requirements for any
categorical exclusion found in 21 CFR
25.31, or to prepare an EA, if necessary.
For additional information on the types
of information that would support our
environmental assessment, please refer
to section IV (pages 9 through 27) of the
Center for Drug Evaluation and Research
Guidance on Environmental Assessment
of Human Drug and Biologic
Applications. The guidance document
can be viewed at https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
ucm070561.pdf.
For all data and information
submitted, we request that a submitter
segregate any data or information that
the submitter believes is protected from
disclosure by 5 U.S.C. 552(b), 18 U.S.C.
1905, or 21 U.S.C. 331(j) or 360j(c). If
such data or information is included in
the submission, we request that the
submitter summarize the confidential
information, to the extent possible, so
that the summary can be publicly
disclosed (see 21 CFR 25.50 and
25.51(a); § 330.14(f)).
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[Federal Register Volume 75, Number 105 (Wednesday, June 2, 2010)]
[Notices]
[Pages 30837-30838]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13145]
-----------------------------------------------------------------------
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 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: Screening, Brief Intervention, Brief Treatment and
Referral to Treatment (SBIRT) Cross-Site Evaluation--New
SAMHSA is conducting a cross-site external evaluation of the impact
of programs of screening, brief intervention (BI), brief treatment (BT)
and referral to treatment on patients presenting at various health care
delivery units with a continuum of severity of substance use. SAMHSA's
SBIRT program is a cooperative agreement grant program designed to help
States and Tribal Councils expand the continuum of care available for
substance misuse and use disorders. The program includes screening,
brief intervention, brief treatment and referrals to treatment for
persons at risk for dependence on alcohol or drugs. The cross-site
evaluation will provide a comprehensive assessment of the effects of
SBIRT on patient outcomes, performance site practices, and treatment
systems. This information will allow SAMHSA to determine the extent to
which SBIRT has met its objectives of implementing a comprehensive
system of identification and care to meet the needs of individuals at
all points along the substance use continuum.
A paper and pencil survey will be administered to practitioners in
sites where SBIRT services are being delivered. The practitioner survey
is designed to evaluate the implementation of proposed SBIRT models by
measuring their penetration and practitioners' willingness to adopt.
Furthermore, the survey will document moderating factors related to
practitioner and health care delivery unit characteristics.
The 93 question practitioner survey includes collection of
demographic information as well as questions that attempt to assess
barriers to implementation encountered by the practitioners and to
gauge the effectiveness of the training they received. These measures
were developed and used by Babor et al. (2005) in their comparable
study comparing different implementation strategies for primary care
screening and brief intervention programs for hazardous and harmful
drinkers. The practitioner survey also includes an instrument developed
by Panzano and Roth (2006) to measures an organization's willingness to
adopt new innovative practices.
Total Burden Hours for the Cross-Site Patient Survey
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Instrument/Activity Number of Responses per Hours per Total burden Hourly wage respondent
respondents respondent response hours cost \a\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Practitioner Survey..................................... 1,075 1 .30 322.5 $32 $10,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 30838]]
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857. Written
comments should be received within 60 days of this notice.
Dated: May 25, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010-13145 Filed 6-1-10; 8:45 am]
BILLING CODE 4162-20-P
