[Federal Register Volume 68, Number 108 (Thursday, June 5, 2003)]
[Notices]
[Pages 33716-33717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0079]


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: Fax written comments on the information collection by July 7, 
2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, 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 (OMB Control Number 
0910-0478)--Extension

    Under section 903(d)(2) of the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 393), 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 regulated producers to determine existing practices 
and the changes in those practices likely under various policy options, 
both consumers and manufacturers to explore attitudes towards policy 
proposals, and industry experts to solicit expert opinion. 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

[[Page 33717]]

for mail and telephone surveys, and a sample of up to 3,000 respondents 
for cable or Internet surveys.
    In the Federal Register of March 12, 2003 (68 FR 11867), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. 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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                                                                     Annual
                                                        No. of     Frequency   Total Annual   Hours per    Total
                   Type of Survey                    Respondents      per        Responses    Responses    Hours
                                                                    Response
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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           .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: May 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14105 Filed 6-4-03; 8:45 am]
BILLING CODE 4160-01-S