[Federal Register Volume 66, Number 152 (Tuesday, August 7, 2001)]
[Notices]
[Pages 41245-41246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0319]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Health and Diet Survey

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a voluntary consumer survey about 
knowledge, perceptions, attitudes, and practices related to dietary 
supplements and food.

DATES: Submit written or electronic comments on the collection of 
information by October 9, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 Schlosburg, Office of 
Information Resources Management (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.

[[Page 41246]]

 ``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

    The authority for FDA to collect the information derives from the 
authority of the Commissioner of Food and Drugs, 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 will provide FDA 
information about consumers' knowledge, perceptions, attitudes, and 
practices related to dietary supplements and food. A nationally 
representative sample of 2,000 adults in the 48 contiguous States and 
the District of Columbia will be selected at random and interviewed by 
telephone. Participation will be voluntary. The survey will collect 
information about: (1) Prevalence, experience, and purposes of use of 
dietary supplements; (2) knowledge of health benefits, health risks, 
and regulation of dietary supplements; (3) sources of dietary 
supplement information; (4) perceptions of dietary supplement labels; 
(5) replacement and combination use of supplements and drugs; (6) 
adverse experience with dietary supplements; (7) children's and 
teenagers' use of dietary supplements; (8) knowledge of diet-health 
relationships; (9) dietary management practices; and (10) use of food 
labels.
    Some of the questions to be asked (items 8 through 10 listed in the 
previous paragraph) replicate the ones asked in the 1995 Health and 
Diet Survey. Responses to these questions will help FDA identify and 
measure any changes in consumer knowledge, perceptions, attitudes, and 
practices with regard to diet, health, and use of food labels. The 
information will also help the agency evaluate the effectiveness of the 
Nutrition Labeling and Education Act of 1990 in promoting the public 
health.
    The agency will use the other questions in the proposed survey to 
enhance its understanding of consumer knowledge, perceptions, 
attitudes, and practices regarding dietary supplements. Subsequent to 
the enactment of the Dietary Supplement Health and Education Act of 
1994, the consumption of dietary supplements in the United States has 
been increasing. FDA needs current, timely, and policy-relevant 
consumer information to help it identify needs for and develop consumer 
education programs and regulatory policies to ensure safe and 
appropriately labeled supplement products. The survey will help the 
agency measure prevalence and distribution of consumer knowledge, 
perceptions, attitudes, and practices. This information can be used to 
understand and describe the consumer environment that is the intended 
target of labeling and education initiatives.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table1.-- Estimated Annual Reporting Burden\1\
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                                                                           Annual Frequency      Total Annual
                      Activity                        No. of Respondents     per Response          Responses      Hours per Response      Total Hours
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Cognitive interview.................................          9                   1                   9                   1.5                13.5
Pretest.............................................          9                   1                   9                   0.5                 4.5
Screener............................................      4,200                   1               4,200                   0.02               84
Survey..............................................      2,000                   1               2,000                   0.5             1,000
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  Total.............................................                                                                                      1,102
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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 series of nine cognitive interviews and a series of 
nine pretests to ensure the quality of the survey. Cognitive interviews 
will help the agency understand respondent comprehension of the 
meanings of questions and words, and how respondents answer questions. 
Pretests will help the agency examine and reduce problems in the 
administration of the final questionnaire. The agency will use a 
screener to select an eligible adult respondent in each household to 
participate in the survey.

    Dated: August 1, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-19626 Filed 8-6-01; 8:45 am]
BILLING CODE 4160-01-S