[Federal Register Volume 66, Number 170 (Friday, August 31, 2001)]
[Notices]
[Page 46018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0249]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 
October 1, 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: 
Wendy Taylor, 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.

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, the Regulatory 
Flexibility Act (RFA), and the Small Business Regulatory Enforcement 
Fairness Act of 1996 (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.
    In the Federal Register of June 15, 2001 (66 FR 32625), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the upper bound burden of this collection of 
information as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                      No. of       Annual Frequency     Total Annual       Hours per
                         Type of Survey                            Respondents       per Response        Responses         Response        Total Hours
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Mail questionnaire                                                  1,000                 1              1,000                3             3,000
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Phone survey                                                        1,000                 1              1,000                0.5             500
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Internet or cable survey                                            3,000                 1              3,000                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: August 24, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-22010 Filed 8-30-01; 8:45 am]
BILLING CODE 4160-01-S