[Federal Register Volume 66, Number 231 (Friday, November 30, 2001)]
[Notices]
[Pages 59794-59796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0319]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
December 31, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA

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: 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

    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

[[Page 59795]]

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 (DSHEA), 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.
    In the Federal Register of August 7, 2001 (66 FR 41245), the agency 
requested comments on the proposed collection of information.
    FDA received 11 comments in response to the Federal Register 
announcement. Comments generally supported the need of the proposed 
information collection for the proper performance of FDA's functions. 
None of the comments were on the estimated burden or ways to minimize 
the burden of the planned information collection. Issues mentioned in 
the eight comments received from eight private citizens are beyond the 
scope of the proposed information collection; these issues will not be 
discussed here.
    One comment urged FDA to include questions regarding consumers' use 
of and attitudes toward fortified foods. The comment states that the 
information on fortified foods will help FDA assess the need to revise 
and update its food fortification policy guidelines and will provide 
initial direction for the process. Examples of proposed topics of 
inquiry include: (1) Profile of fortified food users and their patterns 
of use; (2) consumer knowledge of the upper limits of intake of 
vitamins and minerals; (3) fortified food consumers' attention to the 
amounts of particular vitamin or mineral consumed from fortified foods, 
dietary supplements, and natural food sources; (4) consumer belief of 
nutritional adequacy from one or two heavily fortified foods; (5) 
levels of calcium consumption from calcium fortified foods; and (6) 
whether consumers of calcium-fortified foods consider these foods an 
adequate substitute for consuming foods naturally rich in calcium such 
as dairy foods.
    FDA notes that, although it has an inherent interest in reviewing 
and evaluating its current fortification policy, it has more immediate 
needs of current, timely, national, and policy-relevant consumer 
information on dietary supplements to carry out its statutory 
functions. FDA also notes that any inclusion of questions on fortified 
foods in the proposed instrument would require introduction and 
explanation of this novice product category that, despite the 
popularity of certain products, has not been widely recognized by 
consumers. The introduction and explanation would be needed to provide 
an appropriate context so participants could shift their attention from 
dietary-supplement topics to fortified-food topics and could understand 
the kinds of products under discussion. FDA does not believe the 
proposed instrument is capable of obtaining valid and useful 
information on both dietary supplements and fortified foods without 
significantly increasing participant burden. Thus, the agency has 
chosen to maintain the focus of the information collection on dietary 
supplements only.
    One comment stated that the proposed information collection is not 
necessary for the proper enforcement of FDA's statutory obligations 
because: (1) The information described in the Federal Register 
announcement is already available, and (2) FDA should focus on 
enforcement of the current regulations that govern dietary supplement 
products and on completion of those regulations that are still 
necessary for finalization of the implementation of the DSHEA.
    FDA has conducted a thorough literature review to identify extant, 
accessible, and similar information that could serve the agency's 
purpose. The agency has concluded that the existing information cannot 
be used for the purpose of the proposed information collection because: 
(1) Available consumer surveys have three major limitations that 
inhibit their use as a substitute for this collection of information: 
out-of-date information, limited focuses, and regional coverage; and 
(2) available focus group studies provide qualitative rather than 
quantitative information.
    FDA recognizes its enforcement role in implementing the DSHEA. Part 
of that role includes establishing regulations and guidelines, where 
appropriate, to ensure that the dietary supplements currently used by 
consumers meet the requirements of the DSHEA. The agency is making 
progress in completing those regulations that are still necessary for 
finalization of the implementation of the DSHEA. Meanwhile, in order to 
carry out its enforcement functions efficiently, the agency also needs 
current, timely, and policy-relevant consumer information that can aid 
the agency in evaluating its labeling policies and in identifying 
potentially unsafe products. The proposed collection of information can 
provide such information. The agency, however, is not aware of the 
availability of any other source of information that can be used for 
this purpose.
    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

[[Page 59796]]

 
Survey                                                    2,000                   1               2,000                   0.5             1,000
                                                                                                                                     -------------------
  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 respondent in each household to 
participate in the survey.

    Dated: November 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-29742 Filed 11-29-01; 8:45 am]
BILLING CODE 4160-01-S