Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey, 53711-53712 [2014-21532]
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Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Notices
On June
18, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Testing Communications on
Biological Products’’ 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 0910–0687. The
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21533 Filed 9–9–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0920]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Health and Diet
Survey
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
SUMMARY:
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 10,
2014.
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0545. Also
include the FDA 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, 8455
Colesville Road; COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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.
Health and Diet Survey as Used by the
Food and Drug Administration—(OMB
Control Number 0910–0545)—
(Revision)
We are seeking OMB approval to
revise the Health and Diet Survey,
which is a voluntary consumer survey
intended to gauge and to track consumer
attitudes, awareness, knowledge, and
behavior regarding various topics
related to health, nutrition, physical
activity, and product labeling. Currently
this collection is approved as a
traditional collection; however, the
Agency wishes to employ future
collections under the generic collection
53711
process. 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)).
We will use the Health and Diet
Survey findings to test and refine our
ideas, but will generally conduct further
research before making important
decisions such as adopting new policies
and allocating or redirecting significant
resources to support these policies.
This survey has been repeated
approximately every 3 to 5 years over
the course of the past 3 decades for the
purpose of tracking changes and trends
in public opinions and consumer
behavior, with some new questions
added or omitted or partially modified
in each iteration in response to
emerging and current events or issues.
In the next 3 years, we plan to field the
survey two to three times. We will use
the information from the Health and
Diet Survey to evaluate and develop
strategies and programs to encourage
and help consumers adopt healthy diets
and lifestyles. The information will also
help FDA 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.
In the Federal Register of July 14,
2014 (79 FR 40760), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Cognitive interview screener .................................
Cognitive interview .................................................
Pretest screener ....................................................
Pretest ...................................................................
Survey screener .....................................................
Survey ....................................................................
100
18
2,000
200
30,000
3,000
1
1
1
1
1
1
100
18
2,000
200
30,000
3,000
0.083 (5 minutes) ........
1 ...................................
0.033 (2 minutes) ........
0.25 (15 minutes) ........
0.033 (2 minutes) ........
0.25 (15 minutes) ........
8
18
66
50
990
750
Total ................................................................
........................
........................
........................
......................................
1,882
tkelley on DSK3SPTVN1PROD with NOTICES
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of respondents and the average burden
per response on our experience with
previous Health and Diet Surveys. We
will use a cognitive interview screener
VerDate Mar<15>2010
19:04 Sep 09, 2014
Jkt 232001
with 100 individuals to recruit
prospective interview participants. We
estimate that it will take a screener
respondent approximately 5 minutes
(0.083 hours) to complete the cognitive
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
interview screener, for a total of 8 hours,
rounded down from 8.3 hours. We will
conduct cognitive interviews with 18
participants. We estimate that it will
take a participant approximately 1 hour
E:\FR\FM\10SEN1.SGM
10SEN1
53712
Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Notices
to complete the interview, for a total of
18 hours. Prior to the administration of
the Health and Diet Survey, the Agency
plans to conduct a pretest to identify
and resolve potential survey
administration problems. We will use a
pretest screener with 2,000 individuals;
we estimate that it will take a
respondent approximately 2 minutes
(0.033 hours) to complete the pretest
screener, for a total of 66 hours. The
pretest will be conducted with 200
participants; we estimate that it will
take a participant 15 minutes (0.25
hours) to complete the pretest, for a total
of 50 hours. We will use a survey
screener to select an eligible adult
respondent in each household reached
by landline telephone numbers to
participate in the survey. A total of
30,000 individuals in the 50 states and
the District of Columbia will be
screened by telephone. We estimate that
it will take a respondent 2 minutes
(0.033 hours) to complete the screening,
for a total of 990 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. Thus,
the total estimated burden is 1,882
hours.
We are requesting this burden for
unplanned surveys so as not to restrict
our ability to gather information on
consumer attitudes, awareness,
knowledge, and behavior regarding
various topics related to health,
nutrition, physical activity, and product
labeling. This ability will help the
Agency identify and respond to
emerging issues in a more timely
manner.
Guide’’ for a final rule published in the
Federal Register of September 2013.
This small entity compliance guide
(SECG) intends to provide, in plain
language, the requirements of the
regulation and to help small businesses
understand and comply with the
regulation.
Food and Drug Administration
Submit either electronic or
written comments on the SECG at any
time.
ADDRESSES: Submit written requests for
single copies of the SECG entitled
‘‘Unique Device Identification System:
Small Entity Compliance Guide’’ to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002 or to the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist the office in processing
your requests.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: For
CDRH questions regarding this
document, contact UDI Regulatory
Policy Support, 301–796–5995, email:
udi@fda.hhs.gov. For CBER questions
regarding this document, contact
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2014–D–1182]
I. Background
Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21532 Filed 9–9–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Unique Device Identification System:
Small Entity Compliance Guide;
Guidance for Industry; Availability
tkelley on DSK3SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Unique Device Identification
System: Small Entity Compliance
SUMMARY:
VerDate Mar<15>2010
19:04 Sep 09, 2014
Jkt 232001
DATES:
FDA is announcing the availability of
a document entitled: ‘‘Unique Device
Identification System: Small Entity
Compliance Guide.’’
Section 226 of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) and section 614
of the Food and Drug Administration
Safety and Innovation Act (Pub. L.112–
144) amended the Federal Food, Drug,
and Cosmetic Act to add section 519(f)
(21 U.S.C. 360i(f)), which directs FDA to
issue regulations establishing a unique
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
device identification system for medical
devices.
In the Federal Register of September
24, 2013 (78 FR 58785), FDA published
a final rule establishing a unique device
identification system (the UDI Rule).
Some parts of the rule became effective
on October 24, 2013; the remaining
parts became effective on December 23,
2013. In addition, certain provisions
within the rule have later compliance
dates. In compliance with section 212 of
the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub.
L. 104–121), FDA is making available
this SECG stating in plain language the
legal requirements of the September 24,
2013, final rule.
This level 2 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR
10.115(c)(2)). The SECG represents the
Agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 801 and 830 have been
approved under OMB control number
0910–0720; the collections of
information in part 803 have been
approved under OMB control number
0910–0437; the collections of
information in part 806 have been
approved under OMB control number
0910–0359; the collections of
information in part 810 have been
approved under OMB control number
0910–0432; the collections of
information in part 814 have been
approved under 0910–0231; the
collections of information in part 821
have been approved under OMB control
number 0910–0442; and the collections
of information in part 822 have been
approved under OMB control number
0910–0449.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Notices]
[Pages 53711-53712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21532]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0920]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Health and Diet
Survey
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 October
10, 2014.
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 emailed to oirasubmission@omb.eop.gov.
All comments should be identified with the OMB control number 0910-
0545. Also include the FDA 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, 8455 Colesville Road; COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.
Health and Diet Survey as Used by the Food and Drug Administration--
(OMB Control Number 0910-0545)--(Revision)
We are seeking OMB approval to revise the Health and Diet Survey,
which is a voluntary consumer survey intended to gauge and to track
consumer attitudes, awareness, knowledge, and behavior regarding
various topics related to health, nutrition, physical activity, and
product labeling. Currently this collection is approved as a
traditional collection; however, the Agency wishes to employ future
collections under the generic collection process. 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)).
We will use the Health and Diet Survey findings to test and refine
our ideas, but will generally conduct further research before making
important decisions such as adopting new policies and allocating or
redirecting significant resources to support these policies.
This survey has been repeated approximately every 3 to 5 years over
the course of the past 3 decades for the purpose of tracking changes
and trends in public opinions and consumer behavior, with some new
questions added or omitted or partially modified in each iteration in
response to emerging and current events or issues. In the next 3 years,
we plan to field the survey two to three times. We will use the
information from the Health and Diet Survey to evaluate and develop
strategies and programs to encourage and help consumers adopt healthy
diets and lifestyles. The information will also help FDA 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.
In the Federal Register of July 14, 2014 (79 FR 40760), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate 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............... 100 1 100 0.083 (5 minutes).......................... 8
Cognitive interview........................ 18 1 18 1.......................................... 18
Pretest screener........................... 2,000 1 2,000 0.033 (2 minutes).......................... 66
Pretest.................................... 200 1 200 0.25 (15 minutes).......................... 50
Survey screener............................ 30,000 1 30,000 0.033 (2 minutes).......................... 990
Survey..................................... 3,000 1 3,000 0.25 (15 minutes).......................... 750
=================
Total.................................. .............. .............. .............. ........................................... 1,882
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number of respondents and the average
burden per response on our experience with previous Health and Diet
Surveys. We will use a cognitive interview screener with 100
individuals to recruit prospective interview participants. We estimate
that it will take a screener respondent approximately 5 minutes (0.083
hours) to complete the cognitive interview screener, for a total of 8
hours, rounded down from 8.3 hours. We will conduct cognitive
interviews with 18 participants. We estimate that it will take a
participant approximately 1 hour
[[Page 53712]]
to complete the interview, for a total of 18 hours. Prior to the
administration of the Health and Diet Survey, the Agency plans to
conduct a pretest to identify and resolve potential survey
administration problems. We will use a pretest screener with 2,000
individuals; we estimate that it will take a respondent approximately 2
minutes (0.033 hours) to complete the pretest screener, for a total of
66 hours. The pretest will be conducted with 200 participants; we
estimate that it will take a participant 15 minutes (0.25 hours) to
complete the pretest, for a total of 50 hours. We will use a survey
screener to select an eligible adult respondent in each household
reached by landline telephone numbers to participate in the survey. A
total of 30,000 individuals in the 50 states and the District of
Columbia will be screened by telephone. We estimate that it will take a
respondent 2 minutes (0.033 hours) to complete the screening, for a
total of 990 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. Thus, the total estimated burden is 1,882 hours.
We are requesting this burden for unplanned surveys so as not to
restrict our ability to gather information on consumer attitudes,
awareness, knowledge, and behavior regarding various topics related to
health, nutrition, physical activity, and product labeling. This
ability will help the Agency identify and respond to emerging issues in
a more timely manner.
Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21532 Filed 9-9-14; 8:45 am]
BILLING CODE 4164-01-P
