[Federal Register Volume 69, Number 32 (Wednesday, February 18, 2004)]
[Notices]
[Pages 7642-7643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3411]


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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://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

[[Page 7643]]

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