[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Notices]
[Pages 32625-32626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15082]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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<Copyright> 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\
----------------------------------------------------------------------------------------------------------------
                                                       Annual Frequency
         Type of Survey           No. of Respondents     per Response     Hours per Response      Total Hours
----------------------------------------------------------------------------------------------------------------
 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
                                                                                             -------------------
 Total..........................                                                                  6,500
----------------------------------------------------------------------------------------------------------------
\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