Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety Survey, 65661-65663 [2013-25976]
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Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
I. Background
The Secretary of the Department of
Health and Human Services (the
Secretary) is required by section
1833(t)(9)(A) of the Social Security Act
(the Act), and section 222 of the Public
Health Service Act (PHS Act) to consult
with an expert outside advisory panel
regarding the clinical integrity of the
Ambulatory Payment Classification
(APC) groups and relative payment
weights that are components of the
Medicare Hospital Outpatient
Prospective Payment System (OPPS),
and the appropriate supervision level
for hospital outpatient services. The
Panel is governed by the provisions of
the Federal Advisory Committee Act
(FACA) (Pub. L. 92–463), as amended (5
U.S.C. Appendix 2), which sets forth
standards for the formation and use of
advisory panels. The panel may
consider data collected or developed by
entities and organizations (other than
the Department of Health and Human
Services) as part of their deliberations.
The Charter requires that the Panel
meet up to three times annually. We
consider the technical advice provided
by the Panel as we prepare the proposed
and final rules to update the OPPS for
the following calendar year.
The Panel shall consist of a chair and
up to 19 members who are full-time
employees of hospitals, hospital
systems, or other Medicare providers
that are subject to the OPPS. (For
purposes of the Panel, consultants or
independent contractors are not
considered to be full-time employees in
these organizations.)
The current Panel members are as
follows: (Note: The asterisk [*] indicates
the Panel members whose terms end
effective September 30, 2013.)
• E.L. Hambrick, M.D., J.D., Chair, a
CMS Medical Officer.
• Karen Borman, M.D.
• Ruth L. Bush, M.D., M.P.H.*
• Lanny Copeland, M.D.
• Kari S. Cornicelli, C.P.A., FHFMA
• Dawn L. Francis, M.D., M.H.S.*
• David A. Halsey, M.D.*
• Brain D. Kavanagh, M.D., M.P.H.
• Scott Manaker, M.D., Ph.D.
• John Marshall, CRA, RCC, RT
• Jim Nelson
• Leah Osbahr
• Jacqueline Phillips
• Daniel J. Pothen, M.S., RHIA, CHPS,
CPHIMS, CCS, CCS–P, CHC*
• Gregory J. Przbylski, M.D.*
• Traci Rabine
• Michael Rabovsky, M.D.
• Marianna V. Spanki-Varelas M.D.,
Ph.D., M.B.A.
• Gale Walker
• Kris Zimmer
VerDate Mar<15>2010
17:40 Oct 31, 2013
Jkt 232001
65661
Panel members serve without
compensation, according to an advance
written agreement; however, for the
meetings, CMS reimburses travel, meals,
lodging, and related expenses in
accordance with standard Government
travel regulations. CMS has a special
interest in ensuring, while taking into
account the nominee pool, that the
Panel is diverse in all respects of the
following: geography; rural or urban
practice; race, ethnicity, sex, and
disability; medical or technical
specialty; and type of hospital, hospital
health system, or other Medicare
provider subject to the OPPS.
Based upon either self-nominations or
nominations submitted by providers or
interested organizations, the Secretary,
or her designee, appoints new members
to the Panel from among those
candidates determined to have the
required expertise. New appointments
are made in a manner that ensures a
balanced membership under the FACA
guidelines.
be accepted. Each nomination must
include the following:
• Letter of Nomination stating the
reasons why the nominee should be
considered.
• Curriculum vitae or resume of the
nominee.
• Written and signed statement from
the nominee that the nominee is willing
to serve on the Panel under the
conditions described in this notice and
further specified in the Charter.
• The hospital or hospital system
name and address, or CAH name and
address, as well as all Medicare hospital
and or Medicare CAH billing numbers
of the facility where the nominee is
employee.
II. Criteria for Nominees
The Panel must be fairly balanced in
its membership in terms of the points of
view represented and the functions to
be performed. Each Panel member must
be employed full-time by a hospital,
hospital system, or other Medicare
provider subject to payment under the
OPPS. All members must have technical
expertise to enable them to participate
fully in the Panel’s work. Such expertise
encompasses hospital payment systems;
hospital medical care delivery systems;
provider billing systems; APC groups;
Current Procedural Terminology codes;
and alpha-numeric Health Care
Common Procedure Coding System
codes; and the use of, and payment for,
drugs, medical devices, and other
services in the outpatient setting, as
well as other forms of relevant expertise.
For supervision deliberations, the Panel
shall have members that represent the
interests of Critical Access Hospitals
(CAHs), who advise CMS only regarding
the level of supervision for hospital
outpatient services.
It is not necessary for a nominee to
possess expertise in all of the areas
listed, but each must have a minimum
of 5 years experience and currently have
full-time employment in his or her area
of expertise. Generally, members of the
Panel serve overlapping terms up to 4
years, based on the needs of the Panel
and contingent upon the rechartering of
the Panel. A member may serve after the
expiration of his or her term until a
successor has been sworn in.
Any interested person or organization
may nominate one or more qualified
individuals. Self-nominations will also
IV. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
III. Copies of the Charter
To obtain a copy of the Panel’s
Charter, we refer readers to our Web site
at the following: https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonAmbulatory
PaymentClassificationGroups.html.
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program).
Dated: October 29, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2013–26258 Filed 10–31–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1161]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Safety
Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
SUMMARY:
E:\FR\FM\01NON1.SGM
01NON1
65662
Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
PRA), Federal Agencies must publish a
notice in the Federal Register
concerning each proposed collection of
information, including each proposed
reinstatement of an existing collection
of information and allow 60 days for
public comment. This notice invites
comments on a voluntary consumer
survey entitled, ‘‘Food Safety Survey.’’
DATES: Submit either written or
electronic comments on the collection
of information by December 31, 2013.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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 reinstatement
of an existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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.
Food Safety Survey—(OMB Control
Number 0910–0345)—Reinstatement
I. Background
Under section 903(b)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393(b)(2)), we are authorized to conduct
research relating to foods and to
conduct educational and public
information programs relating to the
safety of the nation’s food supply. The
Food Safety Survey measures
consumers’ knowledge, attitudes, and
beliefs about food safety. Previous
versions of the survey were collected in
1988, 1993, 1998, 2001, 2006, and 2010.
Data from the previous Food Safety
Surveys and from this proposed survey
will be used to evaluate two Healthy
People 2020 objectives: (1) Increase the
proportion of consumers who follow
key food safety practices (Objective FS–
5), and (2) reduce severe allergic
reactions to food among adults with a
food allergy diagnosis (Objective FS–4)
(Ref. 1). Data from this survey will also
be used to measure progress toward the
United States Department of
Agriculture’s Food Safety Inspection
Service’s FY2011–FY2016 Strategic Plan
goal of ensuring that, ‘‘Consumers,
including vulnerable and underserved
populations, adopt food safety best
practices’’ (Ref. 2). Additionally, Food
Safety Survey data are used to measure
trends in consumer food safety habits
including hand and cutting board
washing, cooking practices, and use of
food thermometers. Finally, data are
used to evaluate educational messages
and to inform policymakers about
consumer attitudes about technologies
such as food irradiation and
biotechnology.
The proposed Food Safety Survey will
contain many of the same questions and
topics as previous Food Safety Surveys
to facilitate measuring trends in food
safety knowledge, attitudes, and
behaviors over time. The proposed
survey will also be updated to explore
emerging consumer food safety topics
and expand understanding of previously
asked topics. For example, recent papers
in both the United States (Ref. 3) and
Europe (Refs. 4 and 5) have pointed to
changing epidemiology of listeriosis
where adults over 60 years old have the
highest rates of the illness. One reason
for the increase in listeriosis rates
among those over 60 years old could be
increasing host susceptibility due to
widened use of immunocompromising
medications. We plan to include
questions on the proposed survey to
document the proportion of those over
60 years old who self-report taking a
defined list of major
immunocompromising medications. In
conjunction with our established
questions about safe food handling and
eating potentially risky foods, the
additional questions will expand our
understanding of listeriosis among those
over 60. Other new topics planned to be
covered on the survey include:
Consumer understanding of
mechanically tenderized beef,
awareness of foodborne pathogens such
as Toxoplasma gondii, and awareness of
the risks associated with eating raw
sprouts.
The methods for the proposed Food
Safety Survey will be largely the same
as those used with the previous Food
Safety Surveys. One major difference is
that, unlike the data collection mode for
previous Food Safety Surveys that used
only land telephone lines, the proposed
survey will include cell phones in
addition to landlines. A nationally
representative sample of 4,000 adults
(2,400 landline and 1,600 cell phone)
will be selected at random for the
telephone interviews. The survey will
also include an oversample of Hispanics
and Blacks to ensure a minimum of 400
each. Additionally, 50 non-respondents
will be asked to participate in a short
version of the survey from which we
will conduct a non-response analysis.
Participation in the survey will be
voluntary. Cognitive interviews and a
pre-test will be conducted prior to
fielding the survey.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Cognitive interview screener ....................................
Cognitive interview ...................................................
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17:40 Oct 31, 2013
Jkt 232001
PO 00000
Number of
responses per
respondent
75
9
Frm 00058
Fmt 4703
1
1
Sfmt 4703
Total annual
responses
75
9
E:\FR\FM\01NON1.SGM
Average
burden per
response
0.083 (5 mins.) ..........
1. (60 mins.) ..............
01NON1
Total hours
6
9
Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Notices
65663
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Pretest screener .......................................................
Pretest ......................................................................
Survey screener .......................................................
Survey ......................................................................
Non-response survey screener ................................
Non-response survey ...............................................
45
18
10,000
4,000
125
50
1
1
1
1
1
1
45
18
10,000
4,000
125
50
0.0167 (1 min.) ..........
0.33 (20 mins.) ..........
0.0167 (1 min.) ..........
0.33 (20 mins) ...........
0.0167 (1 min.) ..........
0.1 (10 mins.) ............
1
6
167
1320
2
5
Total ..................................................................
........................
........................
........................
....................................
1516
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on the
Agency’s prior experience with the
Food Safety Survey.
II. References
1. U.S. Department of Health and Human
Services, ‘‘Healthy People 2020—
Improving the Lives of Americans,’’ July
30, 2013. Available at https://
www.healthypeople.gov/2020/
default.aspx.
2. U.S. Department of Agriculture, Food
Safety Inspection Service, ‘‘Strategic
Plan FY 2011–2016,’’ April 6, 2012.
Available at https://www.fsis.usda.gov/
wps/portal/informational/aboutfsis/
strategic-planning/fy-2011-2016strategic-plan/ct_index.
3. Pouillot, R., Hoelzer, K., Jackson, K.A.,
Henao, O.L. and Silk, B.J. ‘‘Relative Risk
of Listeriosis in Foodborne Diseases
Active Surveillance Network (FoodNet)
Sites According to Age, Pregnancy, and
Ethnicity,’’ Clinical Infectious Diseases,
54(S5): S401–410, 2012.
4. Goulet, V., Hedberg, C., Le Monnier A. and
de Valk, H. ‘‘Increasing Incidence of
Listeriosis in France and other European
Countries,’’ Emerging Infectious
Diseases, 14(5): 734–740, 2008.
˜
5. Munoz, P., Rojas, L., Bunsow, E., Saez, E.,
´
´
Sanchez-Cambronero, L., Alcala, L.,
´
Rogrıguez-Creixems, M. and Bouza, E.
‘‘Listeriosis: An Emerging Public Health
Problem Especially Among the Elderly,’’
Journal of Infection, 64: 19–33, 2012.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25976 Filed 10–31–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK67QTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2013–N–1155]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
17:40 Oct 31, 2013
Jkt 232001
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 the information
collection provisions of our food
labeling regulations and on Form FDA
3570, Model Small Business Nutrition
Labeling Exemption Notice, which
small businesses may use to claim the
small business exemption from
nutrition labeling.
DATES: Submit either electronic or
written comments on the collection of
information by December 31, 2013.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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.
Food Labeling Regulations—21 CFR
Parts 101, 102, 104, and 105 (OMB
Control Number 0910–0381)—Revision
To Include Collections Previously
Approved by OMB, but Currently in
Use Without Approval
Our food labeling regulations require
food producers to disclose to consumers
and others specific information about
themselves or their products on the
label or labeling of their products.
Related regulations require that food
producers retain records establishing
the basis for the information contained
in the label or labeling of their products
and provide those records to regulatory
officials. Finally, certain regulations
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65661-65663]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25976]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1161]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Safety Survey
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the
[[Page 65662]]
PRA), Federal Agencies must publish a notice in the Federal Register
concerning each proposed collection of information, including each
proposed reinstatement of an existing collection of information and
allow 60 days for public comment. This notice invites comments on a
voluntary consumer survey entitled, ``Food Safety Survey.''
DATES: Submit either written or electronic comments on the collection
of information by December 31, 2013.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
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 reinstatement of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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.
Food Safety Survey--(OMB Control Number 0910-0345)--Reinstatement
I. Background
Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(b)(2)), we are authorized to conduct research relating
to foods and to conduct educational and public information programs
relating to the safety of the nation's food supply. The Food Safety
Survey measures consumers' knowledge, attitudes, and beliefs about food
safety. Previous versions of the survey were collected in 1988, 1993,
1998, 2001, 2006, and 2010. Data from the previous Food Safety Surveys
and from this proposed survey will be used to evaluate two Healthy
People 2020 objectives: (1) Increase the proportion of consumers who
follow key food safety practices (Objective FS-5), and (2) reduce
severe allergic reactions to food among adults with a food allergy
diagnosis (Objective FS-4) (Ref. 1). Data from this survey will also be
used to measure progress toward the United States Department of
Agriculture's Food Safety Inspection Service's FY2011-FY2016 Strategic
Plan goal of ensuring that, ``Consumers, including vulnerable and
underserved populations, adopt food safety best practices'' (Ref. 2).
Additionally, Food Safety Survey data are used to measure trends in
consumer food safety habits including hand and cutting board washing,
cooking practices, and use of food thermometers. Finally, data are used
to evaluate educational messages and to inform policymakers about
consumer attitudes about technologies such as food irradiation and
biotechnology.
The proposed Food Safety Survey will contain many of the same
questions and topics as previous Food Safety Surveys to facilitate
measuring trends in food safety knowledge, attitudes, and behaviors
over time. The proposed survey will also be updated to explore emerging
consumer food safety topics and expand understanding of previously
asked topics. For example, recent papers in both the United States
(Ref. 3) and Europe (Refs. 4 and 5) have pointed to changing
epidemiology of listeriosis where adults over 60 years old have the
highest rates of the illness. One reason for the increase in
listeriosis rates among those over 60 years old could be increasing
host susceptibility due to widened use of immunocompromising
medications. We plan to include questions on the proposed survey to
document the proportion of those over 60 years old who self-report
taking a defined list of major immunocompromising medications. In
conjunction with our established questions about safe food handling and
eating potentially risky foods, the additional questions will expand
our understanding of listeriosis among those over 60. Other new topics
planned to be covered on the survey include: Consumer understanding of
mechanically tenderized beef, awareness of foodborne pathogens such as
Toxoplasma gondii, and awareness of the risks associated with eating
raw sprouts.
The methods for the proposed Food Safety Survey will be largely the
same as those used with the previous Food Safety Surveys. One major
difference is that, unlike the data collection mode for previous Food
Safety Surveys that used only land telephone lines, the proposed survey
will include cell phones in addition to landlines. A nationally
representative sample of 4,000 adults (2,400 landline and 1,600 cell
phone) will be selected at random for the telephone interviews. The
survey will also include an oversample of Hispanics and Blacks to
ensure a minimum of 400 each. Additionally, 50 non-respondents will be
asked to participate in a short version of the survey from which we
will conduct a non-response analysis. Participation in the survey will
be voluntary. Cognitive interviews and a pre-test will be conducted
prior to fielding the survey.
FDA estimates the burden of this collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener................ 75 1 75 0.083 (5 mins.)........................... 6
Cognitive interview......................... 9 1 9 1. (60 mins.)............................. 9
[[Page 65663]]
Pretest screener............................ 45 1 45 0.0167 (1 min.)........................... 1
Pretest..................................... 18 1 18 0.33 (20 mins.)........................... 6
Survey screener............................. 10,000 1 10,000 0.0167 (1 min.)........................... 167
Survey...................................... 4,000 1 4,000 0.33 (20 mins)............................ 1320
Non-response survey screener................ 125 1 125 0.0167 (1 min.)........................... 2
Non-response survey......................... 50 1 50 0.1 (10 mins.)............................ 5
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 1516
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's burden estimate is based on the Agency's prior experience with
the Food Safety Survey.
II. References
1. U.S. Department of Health and Human Services, ``Healthy People
2020--Improving the Lives of Americans,'' July 30, 2013. Available
at https://www.healthypeople.gov/2020/default.aspx.
2. U.S. Department of Agriculture, Food Safety Inspection Service,
``Strategic Plan FY 2011-2016,'' April 6, 2012. Available at https://www.fsis.usda.gov/wps/portal/informational/aboutfsis/strategic-planning/fy-2011-2016-strategic-plan/ct_index.
3. Pouillot, R., Hoelzer, K., Jackson, K.A., Henao, O.L. and Silk,
B.J. ``Relative Risk of Listeriosis in Foodborne Diseases Active
Surveillance Network (FoodNet) Sites According to Age, Pregnancy,
and Ethnicity,'' Clinical Infectious Diseases, 54(S5): S401-410,
2012.
4. Goulet, V., Hedberg, C., Le Monnier A. and de Valk, H.
``Increasing Incidence of Listeriosis in France and other European
Countries,'' Emerging Infectious Diseases, 14(5): 734-740, 2008.
5. Mu[ntilde]oz, P., Rojas, L., Bunsow, E., Saez, E.,
S[aacute]nchez-Cambronero, L., Alcal[aacute], L., Rogr[iacute]guez-
Creixems, M. and Bouza, E. ``Listeriosis: An Emerging Public Health
Problem Especially Among the Elderly,'' Journal of Infection, 64:
19-33, 2012.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25976 Filed 10-31-13; 8:45 am]
BILLING CODE 4160-01-P
