[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28928-28929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0045]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 June
18, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
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: 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--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 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.
In the Federal Register of February 18, 2004 (69 FR 7642), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Number of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
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Pretest 27 1 27 0.5 13.5
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Screener 6,000 1 6,000 0.02 120
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[[Page 28929]]
Survey 2,000 1 2,000 0.17 340
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Survey (``initial 200 1 200 0.08 16
refusers'')
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Total 490
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\1\ There are no capital costs or maintenance and operating costs for 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: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11251 Filed 5-18-04; 8:45 am]
BILLING CODE 4160-01-S