[Federal Register: November 30, 2001 (Volume 66, Number 231)]
[Notices]
[Page 59794-59796]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no01-84]
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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
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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
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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 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