Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Biological Products, 5179-5180 [2011-1862]
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Federal Register / Vol. 76, No. 19 / Friday, January 28, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10112 and CMS–
287–05]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
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) is publishing the
following summary of proposed
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 functions;
(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: Extension without change of a
currently approved collection; Title of
Information Collection: Phone Surveys
of Products and Services for Medicare
Payment Validation and Supporting
Regulations in 42 CFR 405.502. Use:
The phone surveys of products and
services for Medicare payment
validation and supporting regulations in
42 CFR 405.502 will be used to identify
specific products/services provided to
Medicare beneficiaries and the costs
associated with the provision of those
products/services. The information
collected will be used to validate the
Medicare payment amounts for those
products/services and institute revisions
of payment amounts where necessary.
The respondents will be the companies
that have provided the product/service
under review to Medicare beneficiaries.
Form Number: CMS–10112 (OMB#
0938–0939); Frequency: Occasionally;
Affected Public: Private sector—
business or other for-profit; Number of
Respondents: 4,000; Total Annual
Responses: 4,000; Total Annual Hours:
16,000. (For policy questions regarding
this collection contact Michael Rich at
410–786–6856. For all other issues call
410–786–1326.)
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AGENCY:
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2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Chain Home
Office Cost Statement and supporting
Regulations in 42 CFR 413.17 and
413.20; Use: The Form CMS–287–05 is
filed annually by Chain Home Offices to
report the information necessary for the
determination of Medicare
reimbursement to components of chain
organizations. However, where
providers are components of chain
organizations, information included in
the chain home office cost statement is
in addition to that included in the
provider cost report and is needed to
determine whether payments are
appropriate. Form Number: CMS–287–
05 (OMB# 0938–0202); Frequency:
Yearly; Affected Public: Business or
other for-profit and not-for-profit
institutions; Number of Respondents:
1,541; Total Annual Responses: 1,541;
Total Annual Hours: 718,106.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
E-mail 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.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by March 29, 2011:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–1865 Filed 1–27–11; 8:45 am]
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5179
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0464]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Testing
Communications on Biological
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
28, 2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—New and
title ‘‘Testing Communications on
Biological Products.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Johnny Vilela, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7651, Juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Testing Communications on Biological
Products—(OMB Control Number
0910—New)
FDA is authorized by section
1003(d)(2)(D) of the Federal Food Drug
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) (Attachment 2) to conduct
educational and public information
programs relating to the safety of
regulated biological products. FDA must
conduct needed research to ensure that
such programs have the highest
likelihood of being effective. FDA
expects that improving communications
about biological products including
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28JAN1
5180
Federal Register / Vol. 76, No. 19 / Friday, January 28, 2011 / Notices
vaccines and blood products will
involve many research methods,
including individual in-depth
interviews, mall-intercept interviews,
focus groups, self-administered surveys,
gatekeeper reviews, and omnibus
telephone surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about biological product use.
Knowledge of consumer and healthcare
professional decisionmaking processes
will provide the better understanding of
target audiences that FDA needs to
design effective communication
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
In the Federal Register of October 5,
2010 (75 FR 61492), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using biological products
including vaccines and blood products
by providing users with a better context
in which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
1003(d)(2)(D) .......................................................................
16,448
1
16,448
0.1739
2,860
Total ..............................................................................
........................
........................
........................
........................
2,860
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
400B, Rockville, MD 20850, 301–796–
3793.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0411]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guide To Minimize Microbial Food
Safety Hazards of Fresh-Cut Fruits and
Vegetables
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guide to Minimize Microbial Food
Safety Hazards of Fresh-Cut Fruits and
Vegetables’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
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SUMMARY:
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In the
Federal Register of October 25, 2010 (75
FR 65491), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0609. The
approval expires on January 31, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Health Resources and Services
Administration
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–1862 Filed 1–27–11; 8:45 am]
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1861 Filed 1–27–11; 8:45 am]
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National Vaccine Injury Compensation
Program: Revised Amount of the
Average Cost of a Health Insurance
Policy
The Health Resources and Services
Administration (HRSA) is publishing an
updated monetary amount of the
average cost of a health insurance policy
as it relates to the National Vaccine
Injury Compensation Program (VICP).
Section 100.2 of the VICP’s
implementing regulation (42 CFR Part
100) states that the revised amounts of
an average cost of a health insurance
policy, as determined by the Secretary,
are to be published periodically in a
notice in the Federal Register. This
figure is calculated using the most
recent Medical Expenditure Panel
Survey—Insurance Component (MEPS–
IC) data available as the baseline for the
average monthly cost of a health
insurance policy. This baseline is
adjusted by the annual percentage
increase/decrease obtained from the
most recent annual Kaiser Family
Foundation and Health Research and
Educational Trust (KFF/HRET)
Employer Health Benefits survey or
other authoritative source that may be
more accurate or appropriate.
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[Federal Register Volume 76, Number 19 (Friday, January 28, 2011)]
[Notices]
[Pages 5179-5180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1862]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0464]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Testing
Communications on Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 28, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910--New and
title ``Testing Communications on Biological Products.'' Also include
the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Testing Communications on Biological Products--(OMB Control Number
0910--New)
FDA is authorized by section 1003(d)(2)(D) of the Federal Food Drug
and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) (Attachment 2) to conduct
educational and public information programs relating to the safety of
regulated biological products. FDA must conduct needed research to
ensure that such programs have the highest likelihood of being
effective. FDA expects that improving communications about biological
products including
[[Page 5180]]
vaccines and blood products will involve many research methods,
including individual in-depth interviews, mall-intercept interviews,
focus groups, self-administered surveys, gatekeeper reviews, and
omnibus telephone surveys.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about biological
product use. Knowledge of consumer and healthcare professional
decisionmaking processes will provide the better understanding of
target audiences that FDA needs to design effective communication
strategies, messages, and labels. These communications will aim to
improve public understanding of the risks and benefits of using
biological products including vaccines and blood products by providing
users with a better context in which to place risk information more
completely.
Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents will be
asked to give their reaction to the messages in either individual or
group settings.
Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
In the Federal Register of October 5, 2010 (75 FR 61492), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
1003(d)(2)(D)................... 16,448 1 16,448 0.1739 2,860
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,860
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: January 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1862 Filed 1-27-11; 8:45 am]
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