[Federal Register: February 18, 2004 (Volume 69, Number 32)]
[Notices]
[Page 7642-7643]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe04-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0045]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Health and Diet Survey--2004 Supplement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 a voluntary consumer survey to
gauge consumer understanding of diet-disease relationships,
particularly those related to saturated fats, trans fatty acids, and
omega-3 fatty acids, and consumer attitudes toward diet, health, and
physical activity.
DATES: Submit written or electronic comments on the collection of
information by April 19, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 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: (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--2004 Supplement
The authority for FDA to collect the information derives from the
FDA Commissioner's authority, as specified in section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). The Health
and Diet Survey--2004 Supplement will provide FDA with information
about consumers' knowledge of dietary fats and the risk of coronary
heart disease as well as consumers' attitudes toward diet, health, and
physical activity. A total of 2,200 adults in the 50 states and the
District of Columbia will be interviewed by telephone. Participation
will be voluntary. The survey will collect information concerning the
following items: (1) Knowledge of the relationships between the risk of
heart disease and dietary fats, including
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saturated fat, trans fatty acids, hydrogenated oil, omega-3 fatty
acids, monounsaturated fats, and polyunsaturated fats; (2) attitudes
toward diet, health, and physical activity; and (3) demographics and
health status.
The agency has established specific targets to improve consumer
understanding of diet-disease relationships, and in particular, the
relationships between dietary fats and the risk of coronary heart
disease, the leading cause of death in the United States. FDA intends
to evaluate and track consumer understanding of heart-healthy and
heart-harmful fats (saturated fat, trans fatty acids, and omega-3 fatty
acids) as initial outcome measures of its achievement in improving
public health. The primary purpose of the information collected in the
survey will be to gauge current levels of consumer understanding. The
establishment of a baseline of consumer understanding will be useful
for the development of performance indicators to identify and measure
incremental improvement in consumer understanding. A secondary purpose
of the information will be to increase the agency's understanding of
consumers' attitudes toward diet, health, and physical activity. This
information will provide insight for the exploration of effective
communication strategies and messages to assist consumers in making
informed dietary and lifestyle choices.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
Activity No. of Respondents Frequency per Total Annual Hours per Response Total Hours
Response Responses
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Pretest 27 1 27 0.5 13.5
Screener 6,000 1 6,000 0.02 120
Survey 2,000 1 2,000 0.17 340
Survey 200 1 200 0.08 16
(``initi
al
refusers
'')
Total ........................ ............... ............... ........................... 490
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on FDA's experience with previous
consumer surveys. Prior to the administration of the survey, the agency
plans to conduct a pretest of the final questionnaire to examine and
reduce potential problems in survey administration The pretest will be
conducted in three waves, each with nine respondents. The agency will
use a screener to select an eligible adult respondent in each household
to participate in the survey. Target sample size of the survey is 2,000
respondents who complete the interview. The agency, as part of an
effort to increase survey participation, plans to re-contact and
complete the interview with prospective respondents who refuse to
participate at initial contacts. Two hundred of those who refuse for
the second time, defined as ``initial refusers,'' will be administered
a shorter interview about their knowledge of saturated fat, trans fatty
acids, omega-3 fatty acids, and the risk of coronary heart disease.
Dated: February 10, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3411 Filed 2-17-04; 8:45 am]
BILLING CODE 4160-01-S