Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey, 53711-53712 [2014-21532]

Download as PDF 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

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