Agency Information Collection Activities: Proposed Collection; Comment Request, 13545-13547 [2010-6192]
Download as PDF
<![CDATA[
pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
Additional authority for these
activities appears in Section 1154(a)(8)
of the Act, which requires that QIOs
perform such duties and functions,
assume such responsibilities, and
comply with such other requirements as
may be required by the Medicare
statute. CMS regards survey activities as
appropriate if they will directly benefit
Medicare beneficiaries. In addition,
Section 1154(a)(10) of the Act
specifically requires that the QIOs
‘‘coordinate activities, including
information exchanges, which are
consistent with economical and efficient
operation of programs among
appropriate public and private agencies
or organizations, including other public
or private review organizations as may
be appropriate.’’ CMS regards this as
specific authority for QIOs to coordinate
and operate a broad range of
collaborative and community activities
among private and public entities, as
long as the predicted outcome will
directly benefit the Medicare program.
The purpose of the study is to design
and conduct an analysis evaluating the
impact on national and regional health
care processes and outcomes of the
Ninth Scope of Work QIO Program. The
QIO Program is national in scope and
scale and affects the quality of
healthcare of 43 million elderly and
disabled Americans. CMS will conduct
an impact and process analysis using
data from multiple sources: (1) Primary
data collected via in-depth interviews,
focus groups, and surveys of QIOs,
health care providers, and other
stakeholders; (2) secondary data
reported by QIOs through CMS systems;
and (3) CMS administrative data. The
findings will be presented in a final
report as well as in other documents
and reports suitable for publication in
peer-review journals. This request
relates to the following data collections:
(1) Survey of QIO directors and theme
leaders; (2) Survey of hospital QI
directors and nursing home
administrators; (3) focus groups with
Medicare beneficiaries; and (4) inperson and telephone discussions with
QIO staff, partner organizations, health
care providers, and community health
leaders. Form Number: CMS–10294
(OMB# 0938–New); Frequency:
Occasionally; Affected Public: Business
or other for-profits, and Medicare
beneficiaries; Number of Respondents:
3,343; Total Annual Responses: 3,343;
Total Annual Hours: 1,707. (For policy
questions regarding this collection
contact Robert Kambic at 410–786–
VerDate Nov<24>2008
16:41 Mar 19, 2010
Jkt 220001
1515. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on April 21, 2010.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, E-mail:
OIRA_submission@omb.eop.gov.
Dated: March 15, 2010.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–6237 Filed 3–19–10; 8:45 am]
BILLING CODE 4120–01–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 (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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
13545
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: Assessment of the
Town Hall Meetings on Underage
Drinking Prevention—Revision
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Substance Abuse
Prevention (CSAP), is proposing a
revision to the information collection
regarding the Assessment of the Town
Hall Meetings (THMs) on Underage
Drinking (UAD) Prevention. The current
data collection has approval under OMB
#0930–0288, which expires on January
31, 2011. Revisions were made to the
Town Hall Meeting Feedback Form,
now being referred to as the Organizers
Survey; the data collection method; and
the number of respondents.
Additionally, CSAP is adding a new
data collection component titled the
Participants Survey, which is the data
collection instrument for the
participants (or attendees) of the THM
events.
Changes
Under the current approval,
SAMHSA/CSAP distributes a brief
Town Hall Meeting Feedback Form to
all CBOs participating in THM events.
This paper-and-pencil based form
includes 14 items about the THM event,
among which—
• Where, when, and who conducted
the meeting;
• Number of attendees;
• Format of the meeting;
• Participants in the presentations;
• Actions planned;
• Media coverage;
• Composition of the audience;
• Responses of the attendees;
• Materials provided;
• Indications of increased awareness;
and
• Indications of increased
involvement.
Under this revision, SAMHSA/CSAP
will provide organizers of THM events
with password-protected login
information to access the Organizers
Survey via the Internet. The Organizers
Survey includes 36 items about the
THM event. Listed below is a summary
of the revisions that were made—
E:\FR\FM\22MRN1.SGM
22MRN1
13546
Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
Reworded topics/questions
New topics/questions
Date of THM event.
Location of THM event.
Organization(s) coordinating the THM event.
Format/Features of the THM event.
Promotion of the THM event.
Participants in the THM event presentations.
Major actions planned as a result of the THM event.
Overall satisfaction with the THM event.
Sharing of any other important features of reactions to the THM
event.
• Number/Composition of THM attendees.
• Indication of whether a THM event was not held and reason why the
event was not held.
• Venue in which THM event was held.
• Characterization of the THM event location.
• Duration of the THM event (in hours and minutes).
• Youth involvement in the THM event.
• Topic of THM event, if other than underage drinking.
• Demographics of the participants (age, race, gender).
• Language of the THM event.
• Use of materials from the https://www.stopalcoholabuse.gov Web site.
• Participation in THM-related Webinars.
• Viewing of online training and requests for technical assistance (TA).
• Satisfaction with training and/or TA received.
• Improved capacity to provide effective UAD services due to training
and/or TA received.
• Implementation of training and/or TA recommendations.
• Indication of whether data were collected about the THM event and
willingness to share those data with CSAP.
•
•
•
•
•
•
•
•
•
Deleted topics/questions
•
•
•
•
•
•
Description of meeting.
Organization affiliation.
Overall response of THM event attendees.
Use of materials from the THM resource kit.
Indications of increased awareness.
Indications of increased involvement.
New Data Collection Component
SAMHSA/CSAP will provide
organizers of THM events with a unique
URL to make available to participants of
their THM event. This unique URL
provides access to the Participants
Survey. The Participants Survey
includes 17 items about the THM event,
among which—
• When and where the THM event
was held;
• Estimation of the number of
attendees at the THM event;
• Perception of increased awareness;
• Indication of reach of the underage
drinking prevention messages from the
THM event;
• Perception of increased
involvement;
• Indication of the most important
underage drinking issues facing the
community;
• Perception of how well the THM
event addressed those issues;
• Appropriateness of the THM event
in terms of length and duration;
• Overall assessment of the THM
event; and
• Demographics of the participants.
The Organizers Survey will be
completed by an estimated 3,400 THM
event organizers and will require only
one response per respondent. It will
take an average of 30 minutes (0.500
hours) to review the instructions and
complete the survey. This burden
estimate is based on comments from
several potential respondents who
reviewed the survey and provided
comments on how long it would take
them to complete it.
The Participants Survey will be
completed by an estimated nine
participants per THM event and will
require only one response per
respondent. The estimated number of
participant respondents is based on 21
percent of the average of the sum of
adult (66,519) and youth (53,554)
participants, as reported on the 2008
THM events feedback forms (1,492
forms reported adults as participants
and 1,316 forms reported youth as
participants) [(120,073/2,808 = 42.76) x
0.21 = 8.9798]. It will take an average of
10 minutes (0.167 hours) to review the
instructions and complete the survey.
This burden estimate is based on
comments from several potential
respondents who reviewed the survey
and provided comments on how long it
would take them to complete it.
Responses per
respondent
Hours per
response
Total hour
burden
Number of respondents
Organizers Survey ........................................
Participants Survey .......................................
3,400 .............................................................
30,600 (9 responses per THM event
[3,400]).
1
1
0.500
0.167
1,700.00
5,110.20
Total .......................................................
pwalker on DSK8KYBLC1PROD with NOTICES
Form name
34,000 ...........................................................
............................
........................
6,810.20
SAMHSA/CSAP intends to support
THM events every other year. The
information collected will be used by
SAMHSA/CSAP to help plan for these
biennial events, to provide technical
assistance and training to organizations
that sponsor the events, and to comply
VerDate Nov<24>2008
16:41 Mar 19, 2010
Jkt 220001
with the reporting requirements of the
Government Performance Results Act of
1993. The information collected will
also provide a descriptive picture of the
nationwide initiative, and it will
indicate how the THM events were
received by the community and factors
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
that may be associated with wellreceived events.
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail a copy
to summer.king@samhsa.hhs.gov.
E:\FR\FM\22MRN1.SGM
22MRN1
Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
Written comments should be received
within 60 days of this notice.
Dated: March 15, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010–6192 Filed 3–19–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0117]
Agency Information Collection
Activities; Proposed Collection:
Comment Request: Guidance for
Industry Entitled Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims
AGENCY:
Food and Drug Administration,
HHS.
pwalker on DSK8KYBLC1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection associated
with the guidance ‘‘Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims,’’ which
is intended to assist applicants in
developing labeling for outcome claims
for drugs that are indicated to treat
hypertension.
DATES: Submit written or electronic
comments on the collection of
information by May 21, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov
VerDate Nov<24>2008
16:41 Mar 19, 2010
Jkt 220001
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information that they conduct or
sponsor. ‘‘Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Guidance for Industry entitled
‘‘Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims’’ 21 CFR 201.56 and 201.57—
(OMB Control Number 0910—New)
This guidance is intended to assist
applicants in developing labeling for
outcome claims for drugs that are
indicated to treat hypertension. With
few exceptions, current labeling for
antihypertensive drugs includes only
the information that these drugs are
indicated to reduce blood pressure; the
labeling does not include information
on the clinical benefits related to
cardiovascular outcomes expected from
such blood pressure reduction.
However, blood pressure control is well
established as beneficial in preventing
serious cardiovascular events, and
inadequate treatment of hypertension is
acknowledged as a significant public
health problem. FDA believes that the
appropriate use of these drugs can be
encouraged by making the connection
between lower blood pressure and
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
13547
improved cardiovascular outcomes
more explicit in labeling. The intent of
the guidance is to provide common
labeling for antihypertensive drugs
except where differences are clearly
supported by clinical data. The
guidance encourages applicants to
submit labeling supplements containing
the new language.
In the Federal Register of March 13,
2008 (73 FR 13546), FDA published the
draft guidance entitled ‘‘Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims.’’ The
draft guidance contained no information
collection subject to OMB review under
the PRA. The final guidance, however,
contains two new provisions that are
subject to OMB review and approval
under the PRA, and one new provision
that would be exempt from OMB
review. Under the PRA, FDA must first
obtain OMB approval for this
information collection before we may
issue the final guidance.
(1) Section IV.C of the guidance
requests that the CLINICAL STUDIES
section of the Full Prescribing
Information of the labeling should
include a summary of placebo- or
active-controlled trials showing
evidence of the specific drug’s
effectiveness in lowering blood
pressure. If trials demonstrating
cardiovascular outcome benefits exist,
those trials also should be summarized
in this section. Table 1 in section V of
the guidance contains the specific drugs
for which the FDA has concluded that
such trials exist. If there are no
cardiovascular outcome data to cite, one
of the following two paragraphs should
appear:
‘‘There are no trials of [DRUGNAME]
or members of the [name of
pharmacologic class] pharmacologic
class demonstrating reductions in
cardiovascular risk in patients with
hypertension,’’ or ‘‘There are no trials of
[DRUGNAME] demonstrating
reductions in cardiovascular risk in
patients with hypertension, but at least
one pharmacologically similar drug has
demonstrated such benefits.’’
In the latter case, the applicant’s
submission generally should refer to
table 1 in section V of the guidance. If
the applicant believes that table 1 is
incomplete, it should submit the
clinical evidence for the additional
information to Docket No. FDA–2008–
D–0150. The labeling submission
should reference the submission to the
docket. FDA estimates that no more
than 1 submission to the docket will be
made annually from 1 company, and
that each submission will take
approximately 10 hours to prepare and
submit. Concerning the
E:\FR\FM\22MRN1.SGM
22MRN1
]]>Agencies
[Federal Register Volume 75, Number 54 (Monday, March 22, 2010)]
[Notices]
[Pages 13545-13547]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6192]
-----------------------------------------------------------------------
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: Assessment of the Town Hall Meetings on Underage
Drinking Prevention--Revision
The Substance Abuse and Mental Health Services Administration's
(SAMHSA) Center for Substance Abuse Prevention (CSAP), is proposing a
revision to the information collection regarding the Assessment of the
Town Hall Meetings (THMs) on Underage Drinking (UAD) Prevention. The
current data collection has approval under OMB 0930-0288,
which expires on January 31, 2011. Revisions were made to the Town Hall
Meeting Feedback Form, now being referred to as the Organizers Survey;
the data collection method; and the number of respondents.
Additionally, CSAP is adding a new data collection component titled the
Participants Survey, which is the data collection instrument for the
participants (or attendees) of the THM events.
Changes
Under the current approval, SAMHSA/CSAP distributes a brief Town
Hall Meeting Feedback Form to all CBOs participating in THM events.
This paper-and-pencil based form includes 14 items about the THM event,
among which--
Where, when, and who conducted the meeting;
Number of attendees;
Format of the meeting;
Participants in the presentations;
Actions planned;
Media coverage;
Composition of the audience;
Responses of the attendees;
Materials provided;
Indications of increased awareness; and
Indications of increased involvement.
Under this revision, SAMHSA/CSAP will provide organizers of THM
events with password-protected login information to access the
Organizers Survey via the Internet. The Organizers Survey includes 36
items about the THM event. Listed below is a summary of the revisions
that were made--
[[Page 13546]]
------------------------------------------------------------------------
Reworded topics/questions New topics/questions
------------------------------------------------------------------------
Date of THM event. Indication of whether a
Location of THM event. THM event was not held and reason
Organization(s) why the event was not held.
coordinating the THM event. Venue in which THM event
Format/Features of the THM was held.
event. Characterization of the
Promotion of the THM THM event location.
event. Duration of the THM event
Participants in the THM (in hours and minutes).
event presentations. Youth involvement in the
Major actions planned as a THM event.
result of the THM event. Topic of THM event, if
Overall satisfaction with other than underage drinking.
the THM event. Demographics of the
Sharing of any other participants (age, race, gender).
important features of reactions to Language of the THM event.
the THM event. Use of materials from the
Number/Composition of THM https://www.stopalcoholabuse.gov
attendees. Web site.
Participation in THM-
related Webinars.
Viewing of online training
and requests for technical
assistance (TA).
Satisfaction with training
and/or TA received.
Improved capacity to
provide effective UAD services due
to training and/or TA received.
Implementation of training
and/or TA recommendations.
Indication of whether data
were collected about the THM event
and willingness to share those
data with CSAP.
------------------------------------------------------------------------
Deleted topics/questions
------------------------------------
Description of meeting.
Organization affiliation.
Overall response of THM
event attendees.
Use of materials from the
THM resource kit.
Indications of increased
awareness.
Indications of increased
involvement.
------------------------------------------------------------------------
New Data Collection Component
SAMHSA/CSAP will provide organizers of THM events with a unique URL
to make available to participants of their THM event. This unique URL
provides access to the Participants Survey. The Participants Survey
includes 17 items about the THM event, among which--
When and where the THM event was held;
Estimation of the number of attendees at the THM event;
Perception of increased awareness;
Indication of reach of the underage drinking prevention
messages from the THM event;
Perception of increased involvement;
Indication of the most important underage drinking issues
facing the community;
Perception of how well the THM event addressed those
issues;
Appropriateness of the THM event in terms of length and
duration;
Overall assessment of the THM event; and
Demographics of the participants.
The Organizers Survey will be completed by an estimated 3,400 THM
event organizers and will require only one response per respondent. It
will take an average of 30 minutes (0.500 hours) to review the
instructions and complete the survey. This burden estimate is based on
comments from several potential respondents who reviewed the survey and
provided comments on how long it would take them to complete it.
The Participants Survey will be completed by an estimated nine
participants per THM event and will require only one response per
respondent. The estimated number of participant respondents is based on
21 percent of the average of the sum of adult (66,519) and youth
(53,554) participants, as reported on the 2008 THM events feedback
forms (1,492 forms reported adults as participants and 1,316 forms
reported youth as participants) [(120,073/2,808 = 42.76) x 0.21 =
8.9798]. It will take an average of 10 minutes (0.167 hours) to review
the instructions and complete the survey. This burden estimate is based
on comments from several potential respondents who reviewed the survey
and provided comments on how long it would take them to complete it.
----------------------------------------------------------------------------------------------------------------
Responses per Hours per Total hour
Form name Number of respondents respondent response burden
----------------------------------------------------------------------------------------------------------------
Organizers Survey.................... 3,400.................. 1 0.500 1,700.00
Participants Survey.................. 30,600 (9 responses per 1 0.167 5,110.20
THM event [3,400]).
--------------------------------------------------------------------------
Total............................ 34,000................. ................ .............. 6,810.20
----------------------------------------------------------------------------------------------------------------
SAMHSA/CSAP intends to support THM events every other year. The
information collected will be used by SAMHSA/CSAP to help plan for
these biennial events, to provide technical assistance and training to
organizations that sponsor the events, and to comply with the reporting
requirements of the Government Performance Results Act of 1993. The
information collected will also provide a descriptive picture of the
nationwide initiative, and it will indicate how the THM events were
received by the community and factors that may be associated with well-
received events.
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail a
copy to summer.king@samhsa.hhs.gov.
[[Page 13547]]
Written comments should be received within 60 days of this notice.
Dated: March 15, 2010.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. 2010-6192 Filed 3-19-10; 8:45 am]
BILLING CODE 4162-20-P
