Agency Information Collection Activities: Proposed Collection; Comment Request, 48987-48988 [2012-20051]
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srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
the plans and rates associated with the
plans.
Information that is to be collected
from state high risk pools will be
collected from The National Association
of State Comprehensive Health
Insurance Plans (NASCHIP) at this time.
Updates to this information may be
submitted voluntarily. The estimated
hour burden on issuers for the Plan
Finder data collection in the first year
is estimated as 90,400 total burden
hours, or 113 hours per organization.
This estimate is based on an assumed
average of 450 individual plan issuers
and 700 small group plan issuers per
each of the four quarterly collections. It
includes 30 hours per organization for
training and communication.
Additionally, for each of the issuers it
includes 11 hours of preparation time,
one hour of login and upload time, two
hours of troubleshooting and data
review, and one half hour for attestation
per organization per quarterly refresh.
The estimated hour burden on the states
is informed by the fact that they have
already submitted the data once and
only need to update. The overall hours
estimate is 575, or 11.5 per Department
of Insurance. This is premised on 2
hours of training and communication, 8
hours for data collection, and one half
hour of submission. Form Number:
CMS–10320 (OCN: 0938–1086);
Frequency: Annually, quarterly;
Affected Public: Business or other forprofits and States; Number of
Respondents: 850; Total Annual
Responses: 3,051; Total Annual Hours:
91,225. (For policy questions regarding
this collection, contact Joe Mercer at
(301) 492–4265. 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.
Interested parties are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. To ensure
consideration of your comments and
recommendations, they must be
submitted in one of the following ways
by September 13, 2012:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
VerDate Mar<15>2010
17:49 Aug 14, 2012
Jkt 226001
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: CMS–10320/OCN 0938–
1086), Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
Dated: August 10, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–20050 Filed 8–14–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–284]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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) 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: Medicaid
Statistical Information System (MSIS).
Use: The Balanced Budget Act of 1997
mandated that states report their
Medicaid data via MSIS. MSIS is used
by states and other jurisdictions to
report fundamental statistical data on
the operation of their Medicaid
program. Data provided on eligibles,
AGENCY:
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48987
beneficiaries, payments and services are
vital to those studying and assessing
Medicaid policies and costs. Medicaid
statistical data are routinely requested
by CMS, Department agencies, the
Congress and their research offices, state
Medicaid agencies, research
organizations, social service interest
groups, universities and colleges, and
the health care industry. The data
provides the only national level
information available on enrollees,
beneficiaries, and expenditures. It also
provides the only national level
information available on Medicaid
utilization. This information is the basis
for analyses and for cost savings
estimates for the Department’s cost
sharing legislative initiatives to the
Congress. The data is also crucial to
CMS and HHS actuarial forecasts. Form
Number: CMS–R–284 (OCN 0938–0345).
Frequency: Quarterly. Affected Public:
State, Local, or Tribal Governments.
Number of Respondents: 51. Total
Annual Responses: 204. Total Annual
Hours: 2,040. (For policy questions
regarding this collection contact Kay
Spence. at 410–786–1617. 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.
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 October 15, 2012:
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: CMS–R–284 (OCN 0938–
0345), Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
E:\FR\FM\15AUN1.SGM
15AUN1
48988
Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices
Dated: August 10, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–20051 Filed 8–14–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0871]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Studies on Consumer Responses to
Nutrient Content Claims on Fortified
Foods
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
a study entitled ‘‘Experimental Studies
on Consumer Responses to Nutrient
Content Claims on Fortified Foods.’’
DATES: Submit either electronic or
written comments on the collection of
information by October 15, 2012.
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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 they conduct or sponsor.
SUPPLEMENTARY INFORMATION:
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17:49 Aug 14, 2012
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‘‘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.
Experimental Studies on Consumer
Responses to Nutrient Content Claims
on Fortified Foods (OMB Control
Number 0910–NEW)
I. Background
The Nutrition Labeling and Education
Act gave FDA the authority to
promulgate regulations which require
almost all packaged foods to bear
nutrition labeling. The law also allows
manufacturers to provide other nutrition
information on labels in the form of
various types of statements, including
claims, as long as such statements
comply with the regulatory limits that
govern the use of each type of statement.
There are three types of claims that the
food industry can voluntarily use on
food labels: (1) Health claims, (2)
nutrient content claims, and (3)
structure/function claims. All claims
must be truthful and not misleading
(Ref. 1).
The FDA’s policy on fortification (21
CFR 104.20) establishes a set of
principles that serve as a model for the
rational addition of nutrients to foods.
The FDA has an interest in the
American public achieving and
maintaining diets with optimal levels of
nutritional quality, wherein healthy
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diets are composed of foods from a
variety of nutrient sources. The FDA
does not encourage the addition of
nutrients to certain food products
(including sugars or snack foods such as
[cookies] candies, and carbonated
beverages). FDA is interested in
studying whether fortification of these
foods could cause consumers to believe
that substituting fortified snack foods
for more nutritious foods would ensure
a nutritionally sound diet.
Research suggests consumer product
perceptions and purchase decisions can
be influenced by labeling statements
and different labeling statements may
have different influences (Refs. 2
through 5). The FDA, as part of its effort
to promote public health, proposes to
conduct two related studies to explore
consumer responses to expressed and
implied nutrient content claims on the
labels of snack foods such as cookies,
carbonated beverages, and candy. Both
studies will be controlled, randomized
experiments. Study 1 will use a 15minute Web-based questionnaire to
collect information from 4,000 Englishspeaking adult members of an online
consumer panel maintained by a
contractor. Study 2 will use the same
questionnaire and draw a sample of
1,000 English-speaking adult
participants from the same online
consumer panel to test a subset of the
experimental conditions employed in
Study 1. Participants in Study 2 will
also access the survey on the Web but
will use a grocery-shopping simulation
software program to participate in the
study. Study 2 is expected to last 15
minutes as well.
The purpose for using both the regular
Web-based application and the
simulated shopping program is to be
able to compare the two modes of data
collection. One critique of experimental
studies is that they may lack external
validity—the ability to generalize the
findings beyond the study setting
because the study is very different from
real life (Ref. 6). The grocery-shopping
simulation software program may more
closely mimic consumers’ real-life
shopping experiences compared to the
regular Web-based application and
would therefore be expected to elicit
survey responses similar to real-life food
shopping. One study comparing
simulated shopping with actual
behavior concluded that consumers’
simulated purchase behaviors are highly
predictive of their actual behavior (Ref.
7). If proposed Study 1 and Study 2
results are comparable, this will lend
support to the external validity of online
experimental study results. Researchers
will endeavor to collect samples that
reflect the U.S. Census on gender,
E:\FR\FM\15AUN1.SGM
15AUN1
Agencies
[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48987-48988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-284]
Agency Information Collection Activities: Proposed Collection;
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) 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:
Medicaid Statistical Information System (MSIS). Use: The Balanced
Budget Act of 1997 mandated that states report their Medicaid data via
MSIS. MSIS is used by states and other jurisdictions to report
fundamental statistical data on the operation of their Medicaid
program. Data provided on eligibles, beneficiaries, payments and
services are vital to those studying and assessing Medicaid policies
and costs. Medicaid statistical data are routinely requested by CMS,
Department agencies, the Congress and their research offices, state
Medicaid agencies, research organizations, social service interest
groups, universities and colleges, and the health care industry. The
data provides the only national level information available on
enrollees, beneficiaries, and expenditures. It also provides the only
national level information available on Medicaid utilization. This
information is the basis for analyses and for cost savings estimates
for the Department's cost sharing legislative initiatives to the
Congress. The data is also crucial to CMS and HHS actuarial forecasts.
Form Number: CMS-R-284 (OCN 0938-0345). Frequency: Quarterly. Affected
Public: State, Local, or Tribal Governments. Number of Respondents: 51.
Total Annual Responses: 204. Total Annual Hours: 2,040. (For policy
questions regarding this collection contact Kay Spence. at 410-786-
1617. 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.
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 October 15, 2012:
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: CMS-R-284 (OCN 0938-
0345), Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland
21244-1850.
[[Page 48988]]
Dated: August 10, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-20051 Filed 8-14-12; 8:45 am]
BILLING CODE 4120-01-P