[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Page 28928-28929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 
    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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                       Number of       Annual Frequency     Total Annual        Hours per
     Activity         Respondents        per Response        Responses           Response         Total Hours
Pretest                           27                  1                 27               0.5               13.5
Screener                       6,000                  1              6,000               0.02             120

[[Page 28929]]

Survey                         2,000                  1              2,000               0.17             340
Survey (``initial                200                  1                200               0.08              16
Total                                                                                                     490
\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]