[Federal Register: June 15, 2001 (Volume 66, Number 116)]
[Notices]
[Page 32625-32626]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn01-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0249]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Consumer and Producer Surveys on Economic Issues
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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on proposed voluntary surveys of
consumers and producers in order to help FDA comply with Executive
Order 12866, the Regulatory Flexibility Act (RFA), and the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA).
DATES: Submit written or electronic comments on the collection of
information by August 14, 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, 301-827-1227.
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.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3 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, including each proposed extension of an existing
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.
Consumer and Producer Surveys on Economic Issues
Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(d)(2)), FDA is authorized to conduct research relating
to regulated articles and to collect information relating to
responsibilities of the agency. Executive Order 12866, RFA, and SBREFA
direct Federal agencies to conduct regulatory impact analysis, and to
consider flexible regulatory approaches. In order to perform the
mandatory analysis it is often necessary to survey: (1) Regulated
producers to determine existing practices and the changes in those
practices likely under various policy options, (2) both consumers and
manufacturers to explore attitudes towards policy proposals, and (3)
industry experts to solicit expert opinions. FDA is seeking OMB
clearance to conduct future surveys to implement Executive Order 12866,
RFA, and SBREFA. Participation in the surveys will be voluntary. This
request covers regulated entities, such as food processors, dietary
supplement manufacturers, health professionals or other experts, and
consumers.
FDA will use the information gathered from these surveys to
identify current business practices, expert opinion, and consumer or
manufacturer attitudes towards existing or proposed policy. FDA
projects approximately 2 to 6 surveys per year, with a sample of
between 10 and 1,000 respondents each for mail and telephone surveys,
and a sample of up to 3,000 respondents for cable or internet surveys.
FDA estimates the upper bound burden of this collection of
information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency
Type of Survey No. of Respondents per Response Hours per Response Total Hours
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Mail questionnaire............. 1,000 1 3 3,000
[[Page 32626]]
Phone survey................... 1,000 1 0.5 500
Internet or cable survey....... 3,000 1 1 3,000
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Total.......................... 6,500
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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 the expected number of respondents
necessary to obtain a statistically significant stratification of the
average to large size industries--including small business entities
covered by FDA regulations--and consumers of regulated products.
Dated: June 8, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15082 Filed 6-14-01; 8:45 am]
BILLING CODE 4160-01-S