Proposed Collection; Comment Request; A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI), 55558-55559 [E9-25954]
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Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
The current CGMP regulations already
reflect the time and associated
recordkeeping costs for those bottlers
that are required to conduct
microbiological testing of their source
water, as well as total coliform testing
of their finished bottled water products.
FDA therefore concludes that any
additional burden and costs in
recordkeeping based on the new testing
requirements for source and finished
bottled water are negligible. FDA
estimates that the labor burden of
keeping records of each test is about 5
minutes per test. FDA also requires
followup testing of source water and
finished bottled water products for E.
coli when total coliform positives occur.
FDA expects that 319 bottlers that use
sources other than PWSs may find a
total coliform positive sample about 3
times per year in source testing and
about 3 times in finished product
testing, for a total of 153 hours of
recordkeeping. In addition to the 319
bottlers, about 95 bottlers that use PWSs
may find a total coliform positive
sample about 3 times per year in
finished product testing, for a total of 23
hours of recordkeeping. Upon finding a
total coliform positive sample, bottlers
will then have to conduct a followup
test for E. coli.
FDA expects that recordkeeping for
the followup test for E. coli will also
take about 5 minutes per test. As shown
in table 1 of this document, FDA
expects that 2.5 bottlers per year will
have to carry out the additional E. coli
testing, with a burden of 1 hour. These
bottlers will also have to keep records
about rectifying the source
contamination, for a burden of 2 hours.
For all expected total coliform testing, E.
coli testing, and source rectification,
FDA estimates a total burden of 179
hours. FDA bases its estimate on its
experience with the current CGMP
regulations.
Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25927 Filed 10–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; A Generic Submission for
Formative Research, Pretesting, and
Customer Satisfaction of NCI’s
Communication and Education
Resources (NCI)
SUMMARY: Under the provisions of
Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed data
collection projects, the National Cancer
Institute (NCI), the National Institutes of
Health (NIH) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: A Generic
Submission For Formative Research,
Pretesting, and Customer Satisfaction of
NCI’s Communication and Education
Resources. Type of Information
Collection Request: REVISION. Need
and Use of Information Collection: In
order to carry out NCI’s legislative
mandate to educate and disseminate
information about cancer prevention,
detection, diagnosis, and treatment to a
wide variety of audiences and
organizations (e.g., cancer patients, their
families, the general public, health
providers, the media, voluntary groups,
scientific and medical organizations), it
is beneficial for NCI, through its Office
of Communications and Education
(OCE), to pretest NCI communications
strategies, concepts, and messages while
they are under development. This
pretesting, or formative evaluation,
helps ensure that the messages,
communication materials, and
information services created by NCI
have the greatest capacity of being
received, understood, and accepted by
their target audiences. Since NCI’s OCE
also is responsible for the design,
implementation, and evaluation of
education programs over the entire
cancer continuum, and management of
NCI initiatives that address specific
challenges in cancer research and
treatment, it is also necessary to ensure
that customers are satisfied with
programs. This customer satisfaction
research helps ensure the relevance,
utility, and appropriateness of the many
educational programs and products that
OCE and NCI produce. OCE will use a
variety of qualitative (focus groups,
interviews) and quantitative (paper,
phone, in-person, and Web surveys)
methodologies to conduct this formative
and customer satisfaction research,
allowing NCI to: (1) Understand
characteristics (attitudes, beliefs, and
behaviors) of the intended target
audience and use this information in the
development of effective
communication tools and strategies; (2)
use a feedback loop to help refine,
revise, and enhance messages, materials,
products, and programs—ensuring that
they have the greatest relevance, utility,
appropriateness, and impact for/to
target audiences; and (3) expend limited
program resource dollars wisely and
effectively. This package represents the
combination of a currently approved
generic submission, ‘‘Pretesting of NCI’s
Office of Communications Messages,’’
(OMB No. 0925–0046) and a formerly
approved generic submission,
‘‘Customer Satisfaction with
Educational Programs and Products of
the NCI’’ (OMB No. 0925–0526).
Frequency of Response: On occasion.
Affected Public: Individuals or
households; Businesses or other for
profit; Not-for-profit institutions;
Federal Government; State, Local, or
Tribal Government. Type of
Respondents: Adult cancer patients;
members of the public; health care
professionals; researchers;
organizational representatives. The table
below outlines the estimated burden
hours required for a three-year approval
of this generic submission. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
TABLE 1—ESTIMATES FOR BURDEN HOURS FOR THREE YEARS
[Generic study]
Total number
of respondents
erowe on DSK5CLS3C1PROD with NOTICES
Survey method
Frequency of
response
Minutes/hour
per response
Total burden
hours
Focus Groups ..................................................................................................
Individual In-Depth Interviews (Typically longer than 15 minutes, includes
Web site usability testing) ............................................................................
Brief Interviews (Typically less than 5 minutes) ..............................................
Surveys (Web, phone, in-person, paper-and-pencil) .......................................
900
1
90/60 (1.5)
1,350.00
600
19,000
12,500
1
1
1
45/60 (.75)
10/60 (.17)
10/60 (.17)
450.00
3,166.67
2,083.33
Totals ........................................................................................................
33,000
........................
........................
7,050.00
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E:\FR\FM\28OCN1.SGM
28OCN1
Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Nina Goodman,
Senior Public Health Advisor, Office of
Communications and Education (OCE),
NCI, NIH, 6116 Executive Blvd., Suite
400, Rockville, MD 20892, call non-tollfree number 301–435–7789 or e-mail
your request, including your address to:
goodmann@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: October 21, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–25954 Filed 10–27–09; 8:45 am]
BILLING CODE 4101–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10191]
erowe on DSK5CLS3C1PROD with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
VerDate Nov<24>2008
15:34 Oct 27, 2009
Jkt 220001
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Parts
C and D Universal Audit Guide; Use:
Under the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 and implementing regulations at
42 CFR Parts 422 and 423 Medicare Part
D plan sponsors and Medicare
Advantage organizations are required to
comply with all Medicare Parts C and D
program requirements. 42 CFR 422.502
describes CMS’ regulatory authority to
evaluate, through inspection or other
means, Medicare Advantage Part C
organizations. These records include
books, contracts, medical records,
patient care documentation and other
records that pertain to any aspect of
services performed, reconciliation of
benefit liabilities, and determination of
amounts payable. 42 CFR 423.503 states
that CMS must oversee a Part D plan
sponsor’s continued compliance with
the requirements for a Part D plan
sponsor. Section 423.514 states that the
Part D plan sponsor must have an
effective procedure to develop, compile,
evaluate, and report to CMS, to its
enrollees, and to the general public, at
the times and in the manner that CMS
requires, statistics regarding areas such
as cost of operations, patterns of
utilization availability, accessibility,
and acceptability of services.
The rapid growth of these sponsoring
organizations has forced CMS to update
its current auditing strategy to ensure
we continue to obtain meaningful audit
results. As a result, CMS’ audit strategy
will reflect a move to more targeted,
data-driven and risk-based audits. CMS
will also focus on high-risk areas that
have the greatest potential for
beneficiary harm. The goal of the audits
will be the earliest possible detection
and correction of issues and
improvement in quality and
performance of Part D sponsors and
Medicare Advantage organizations.
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55559
To accomplish these goals, we have
combined all Part C and Part D audit
elements into one universal guide
which will also promote consistency,
effectiveness and reduce financial and
time burdens for both CMS and
Medicare-contracting entities. Please
refer to the crosswalk document for a
list of changes. Form Number: CMS–
10191 (OMB#: 0938–1000); Frequency:
Reporting—Yearly; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 195; Total Annual
Responses: 195; Total Annual Hours:
24,180. (For policy questions regarding
this collection contact Laura Dash at
410–786–8623. 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 November 27, 2009.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Dated: October 21, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–25993 Filed 10–27–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–09AX]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55558-55559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25954]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; A Generic Submission for
Formative Research, Pretesting, and Customer Satisfaction of NCI's
Communication and Education Resources (NCI)
SUMMARY: Under the provisions of Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, for opportunity for public comment on proposed
data collection projects, the National Cancer Institute (NCI), the
National Institutes of Health (NIH) will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Proposed Collection: Title: A Generic Submission For Formative
Research, Pretesting, and Customer Satisfaction of NCI's Communication
and Education Resources. Type of Information Collection Request:
REVISION. Need and Use of Information Collection: In order to carry out
NCI's legislative mandate to educate and disseminate information about
cancer prevention, detection, diagnosis, and treatment to a wide
variety of audiences and organizations (e.g., cancer patients, their
families, the general public, health providers, the media, voluntary
groups, scientific and medical organizations), it is beneficial for
NCI, through its Office of Communications and Education (OCE), to
pretest NCI communications strategies, concepts, and messages while
they are under development. This pretesting, or formative evaluation,
helps ensure that the messages, communication materials, and
information services created by NCI have the greatest capacity of being
received, understood, and accepted by their target audiences. Since
NCI's OCE also is responsible for the design, implementation, and
evaluation of education programs over the entire cancer continuum, and
management of NCI initiatives that address specific challenges in
cancer research and treatment, it is also necessary to ensure that
customers are satisfied with programs. This customer satisfaction
research helps ensure the relevance, utility, and appropriateness of
the many educational programs and products that OCE and NCI produce.
OCE will use a variety of qualitative (focus groups, interviews) and
quantitative (paper, phone, in-person, and Web surveys) methodologies
to conduct this formative and customer satisfaction research, allowing
NCI to: (1) Understand characteristics (attitudes, beliefs, and
behaviors) of the intended target audience and use this information in
the development of effective communication tools and strategies; (2)
use a feedback loop to help refine, revise, and enhance messages,
materials, products, and programs--ensuring that they have the greatest
relevance, utility, appropriateness, and impact for/to target
audiences; and (3) expend limited program resource dollars wisely and
effectively. This package represents the combination of a currently
approved generic submission, ``Pretesting of NCI's Office of
Communications Messages,'' (OMB No. 0925-0046) and a formerly approved
generic submission, ``Customer Satisfaction with Educational Programs
and Products of the NCI'' (OMB No. 0925-0526).
Frequency of Response: On occasion. Affected Public: Individuals or
households; Businesses or other for profit; Not-for-profit
institutions; Federal Government; State, Local, or Tribal Government.
Type of Respondents: Adult cancer patients; members of the public;
health care professionals; researchers; organizational representatives.
The table below outlines the estimated burden hours required for a
three-year approval of this generic submission. There are no Capital
Costs, Operating Costs, and/or Maintenance Costs to report.
Table 1--Estimates for Burden Hours for Three Years
[Generic study]
----------------------------------------------------------------------------------------------------------------
Total number Frequency of Minutes/hour Total burden
Survey method of respondents response per response hours
----------------------------------------------------------------------------------------------------------------
Focus Groups.................................... 900 1 90/60 (1.5) 1,350.00
Individual In-Depth Interviews (Typically longer 600 1 45/60 (.75) 450.00
than 15 minutes, includes Web site usability
testing).......................................
Brief Interviews (Typically less than 5 minutes) 19,000 1 10/60 (.17) 3,166.67
Surveys (Web, phone, in-person, paper-and- 12,500 1 10/60 (.17) 2,083.33
pencil)........................................
---------------------------------------------------------------
Totals...................................... 33,000 .............. .............. 7,050.00
----------------------------------------------------------------------------------------------------------------
[[Page 55559]]
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency'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 those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Nina Goodman, Senior Public Health Advisor, Office
of Communications and Education (OCE), NCI, NIH, 6116 Executive Blvd.,
Suite 400, Rockville, MD 20892, call non-toll-free number 301-435-7789
or e-mail your request, including your address to:
goodmann@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: October 21, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-25954 Filed 10-27-09; 8:45 am]
BILLING CODE 4101-01-P
