[Federal Register: August 7, 2001 (Volume 66, Number 152)]
[Notices]
[Page 41245-41246]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au01-96]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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