Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey, 1168-1169 [2011-85]
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Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
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: Revision of a currently
approved collection; Title of
Information Collection: Pre-Existing
Health Insurance Plan and Supporting
Regulations; Use: On March 23, 2010,
the President signed into law H.R. 3590,
the Patient Protection and Affordable
Care Act (Affordable Care Act), Public
Law 111–148. Section 1101 of the law
establishes a ‘‘temporary high risk health
insurance pool program’’ (which has
been named the Pre-Existing Condition
Insurance Plan, or PCIP) to provide
health insurance coverage to currently
uninsured individuals with pre-existing
conditions. The law authorizes HHS to
carry out the program directly or
through contracts with states or private,
non-profit entities.
We are requesting an extension of this
package because this information is
needed to assure that PCIP programs are
established timely and effectively. This
request is being made based on
regulations and guidance that have been
issued and contracts which have been
executed by HHS with States or an
entity on their behalf participating in
the PCIP program. PCIP is also referred
to as the temporary qualified high risk
insurance pool program, as it is called
in the Affordable Care Act, but we have
adopted the term PCIP to better describe
the program and avoid confusion with
the existing state high risk pool
programs. Form Number: CMS–10339
(OMB#: 0938–1100); Frequency:
Reporting—On occasion; Affected
Public: State governments; Number of
Respondents: 51; Total Annual
Responses: 2,652; Total Annual Hours:
36,924. (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
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
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 8, 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.
Dated: January 4, 2011.
Kenneth Cohen,
Director, Executive Secretariat & Regulatory
Affairs, Office of Consumer Information and
Insurance Oversight.
[FR Doc. 2011–140 Filed 1–6–11; 8:45 am]
BILLING CODE 4120–01–U–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0001]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Health and Diet
Survey
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
FDA’s Health and Diet Survey.
DATES: Submit either electronic or
written comments on the collection of
information by March 8, 2011.
SUMMARY:
PO 00000
Frm 00041
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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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: 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.
‘‘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,
including each proposed extension of an
existing 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.
ADDRESSES:
Health and Diet Survey (OMB Control
Number 0910–0545—Extension)
FDA is seeking extension of OMB
approval for the Health and Diet Survey,
which is a voluntary consumer survey
E:\FR\FM\07JAN1.SGM
07JAN1
1169
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
intended to gauge and track consumer
attitudes, awareness, knowledge, and
behavior regarding various topics
related to health, nutrition and physical
activity. The authority for FDA to
collect the information derives from
FDA’s Commissioner of Food and Drugs
authority provided in section 903(d)(2)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)).
The survey consists of two
independent data collection activities.
One collection, entitled ‘‘Health and
Diet Survey—General Topics,’’ tracks a
broad range of consumer attitudes,
awareness, knowledge, and self-reported
behaviors related to key diet and health
issues. The other collection, entitled
‘‘Health and Diet Survey—Dietary
Guidelines Supplement,’’ will provide
FDA with updated information about
consumer attitudes, awareness,
knowledge, and behavior regarding
various elements of nutrition and
physical activity based on the key
recommendations of the Dietary
Guidelines for Americans, which are
jointly issued by the Department of
Health and Human Services and the
U.S. Department of Agriculture every
5 years.
The information to be collected with
the Health and Diet Survey—General
Topics will include: (1) Awareness of
diet-disease relationships, (2) food and
dietary supplement label use, (3) dietary
practices including strategies to lose or
maintain weight, and (4) awareness and
knowledge of dietary fats. This survey
has been repeated approximately every
3 years over the course of the past
several years for the purpose of tracking
changes and trends in public opinions
and consumer behavior, with some new
questions added or omitted or partially
modified each iteration in response to
current events. In the next 3 years, FDA
plans to field the Health and Diet
Survey—General Topics in 2012 and
anticipates that it might have the need
for additional iterations in 2014. The
information to be collected with the
Health and Diet Survey—Dietary
Guidelines Supplement will include: (1)
Awareness and sources of information,
(2) attitudes toward diet and physical
activity, and (3) practice and knowledge
related to recommended behaviors. The
survey will also ask about perceptions
and use of Federal nutrition
information, special diet, weight status,
health status, and demographics. In the
next 3 years, FDA anticipates to field
the Health and Diet Survey—Dietary
Guidelines Supplement in 2011–2012.
FDA and other Federal Agencies will
use the information from the Health and
Diet Survey to evaluate and develop
strategies and programs to encourage
and help consumers adopt healthy
lifestyles. The information will also
help FDA and other Federal Agencies
evaluate and track consumer awareness
and behavior as outcome measures of
their achievement in improving public
health.
Description of Respondents: The
respondents are adults, age 18 and
older, drawn from the 50 States and the
District of Columbia. Participation will
be voluntary.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
General Topics: Pretest .......................................................
General Topics: Screener ....................................................
General Topics: Survey .......................................................
Dietary Guidelines Supplement: Screener ..........................
Dietary Guidelines Supplement: Survey ..............................
27
10,000
3,000
4,000
1,200
1
1
1
1
1
27
10,000
3,000
4,000
1,200
0.25
0.02
0.25
0.02
0.22
7
200
750
80
264
Total ..............................................................................
........................
........................
........................
........................
1,301
jdjones on DSK8KYBLC1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of the number
of respondents and the hours per
response on its experience with
previous Health and Diet Surveys. Prior
to the administration of the Health and
Diet Survey—General Topics, the
Agency plans to conduct a pretest to
identify and resolve potential problems.
The pretest will be conducted with 27
participants; we estimate that it will
take a respondent 15 minutes (0.25
hours) to complete the pretest, for a total
of 6.75 hours, rounded to 7. The Agency
will use a screener to select an eligible
adult respondent in each household to
participate in the survey. For the Health
and Diet Survey—General Topics data
collection activity, a total of 10,000
individuals in the 50 States and the
District of Columbia will be screened by
telephone. We estimate that it will take
a respondent 1.2 minutes (0.02 hours) to
complete the screening, for a total of 200
hours. We estimate that 3,000 eligible
adults will participate in the survey,
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
each taking 15 minutes (0.25 hours), for
a total of 750 hours. For the Health and
Diet Survey—Dietary Guidelines
Supplement data collection activity,
4,000 individuals in the 50 States and
the District of Columbia will be
screened by telephone. We estimate that
it will take a respondent 1.2 minutes
(0.02 hours) to complete the screening
questions, for a total of 80 hours. Of
these respondents, 1,200 will complete
the survey. We estimate that it will take
a respondent 13 minutes (0.22 hours) to
complete the entire survey, for a total of
264 hours. Thus, the total estimated
burden is 1,301 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
HHS.
[FR Doc. 2011–85 Filed 1–6–11; 8:45 am]
BILLING CODE 4160–01–P
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Food and Drug Administration
[Docket No. FDA–2010–N–0492]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices:
Recommended Glossary and
Educational Outreach To Support Use
of Symbols on Labels and in Labeling
of In Vitro Diagnostic Devices Intended
for Professional Use
AGENCY:
ACTION:
Food and Drug Administration,
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
SUMMARY:
E:\FR\FM\07JAN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1168-1169]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-85]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0001]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Health and Diet Survey
AGENCY: Food and Drug Administration, HHS.
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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on FDA's Health and Diet Survey.
DATES: Submit either electronic or written comments on the collection
of information by March 8, 2011.
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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: 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.
``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, including
each proposed extension of an existing 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.
Health and Diet Survey (OMB Control Number 0910-0545--Extension)
FDA is seeking extension of OMB approval for the Health and Diet
Survey, which is a voluntary consumer survey
[[Page 1169]]
intended to gauge and track consumer attitudes, awareness, knowledge,
and behavior regarding various topics related to health, nutrition and
physical activity. The authority for FDA to collect the information
derives from FDA's Commissioner of Food and Drugs authority provided in
section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 393(d)(2)).
The survey consists of two independent data collection activities.
One collection, entitled ``Health and Diet Survey--General Topics,''
tracks a broad range of consumer attitudes, awareness, knowledge, and
self-reported behaviors related to key diet and health issues. The
other collection, entitled ``Health and Diet Survey--Dietary Guidelines
Supplement,'' will provide FDA with updated information about consumer
attitudes, awareness, knowledge, and behavior regarding various
elements of nutrition and physical activity based on the key
recommendations of the Dietary Guidelines for Americans, which are
jointly issued by the Department of Health and Human Services and the
U.S. Department of Agriculture every 5 years.
The information to be collected with the Health and Diet Survey--
General Topics will include: (1) Awareness of diet-disease
relationships, (2) food and dietary supplement label use, (3) dietary
practices including strategies to lose or maintain weight, and (4)
awareness and knowledge of dietary fats. This survey has been repeated
approximately every 3 years over the course of the past several years
for the purpose of tracking changes and trends in public opinions and
consumer behavior, with some new questions added or omitted or
partially modified each iteration in response to current events. In the
next 3 years, FDA plans to field the Health and Diet Survey--General
Topics in 2012 and anticipates that it might have the need for
additional iterations in 2014. The information to be collected with the
Health and Diet Survey--Dietary Guidelines Supplement will include: (1)
Awareness and sources of information, (2) attitudes toward diet and
physical activity, and (3) practice and knowledge related to
recommended behaviors. The survey will also ask about perceptions and
use of Federal nutrition information, special diet, weight status,
health status, and demographics. In the next 3 years, FDA anticipates
to field the Health and Diet Survey--Dietary Guidelines Supplement in
2011-2012.
FDA and other Federal Agencies will use the information from the
Health and Diet Survey to evaluate and develop strategies and programs
to encourage and help consumers adopt healthy lifestyles. The
information will also help FDA and other Federal Agencies evaluate and
track consumer awareness and behavior as outcome measures of their
achievement in improving public health.
Description of Respondents: The respondents are adults, age 18 and
older, drawn from the 50 States and the District of Columbia.
Participation will be voluntary.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Activity Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
General Topics: Pretest......... 27 1 27 0.25 7
General Topics: Screener........ 10,000 1 10,000 0.02 200
General Topics: Survey.......... 3,000 1 3,000 0.25 750
Dietary Guidelines Supplement: 4,000 1 4,000 0.02 80
Screener.......................
Dietary Guidelines Supplement: 1,200 1 1,200 0.22 264
Survey.........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,301
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA bases its estimate of the number of respondents and the hours
per response on its experience with previous Health and Diet Surveys.
Prior to the administration of the Health and Diet Survey--General
Topics, the Agency plans to conduct a pretest to identify and resolve
potential problems. The pretest will be conducted with 27 participants;
we estimate that it will take a respondent 15 minutes (0.25 hours) to
complete the pretest, for a total of 6.75 hours, rounded to 7. The
Agency will use a screener to select an eligible adult respondent in
each household to participate in the survey. For the Health and Diet
Survey--General Topics data collection activity, a total of 10,000
individuals in the 50 States and the District of Columbia will be
screened by telephone. We estimate that it will take a respondent 1.2
minutes (0.02 hours) to complete the screening, for a total of 200
hours. We estimate that 3,000 eligible adults will participate in the
survey, each taking 15 minutes (0.25 hours), for a total of 750 hours.
For the Health and Diet Survey--Dietary Guidelines Supplement data
collection activity, 4,000 individuals in the 50 States and the
District of Columbia will be screened by telephone. We estimate that it
will take a respondent 1.2 minutes (0.02 hours) to complete the
screening questions, for a total of 80 hours. Of these respondents,
1,200 will complete the survey. We estimate that it will take a
respondent 13 minutes (0.22 hours) to complete the entire survey, for a
total of 264 hours. Thus, the total estimated burden is 1,301 hours.
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-85 Filed 1-6-11; 8:45 am]
BILLING CODE 4160-01-P
