[Federal Register Volume 64, Number 26 (Tuesday, February 9, 1999)]
[Notices]
[Pages 6365-6367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0698]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Survey of Consumer Attitudes Toward Potential 
Changes in Food Standards of Identity

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 (the PRA).

DATES:  Submit written comments on the collection of information by 
March 11, 1999.

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: 
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 the PRA (44 U.S.C. 3507), 
FDA has submitted the following proposed collection of information to 
OMB for review and clearance.

[[Page 6366]]

Survey of Consumer Attitudes Toward Potential Changes in Food 
Standards of Identity

    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 foods and to conduct educational and public information programs 
relating to the safety of the nation's food supply. FDA is planning to 
conduct a telephone-mail-telephone consumer survey about consumer 
attitudes towards potential changes in food standards of identity under 
this authority. A nationally representative sample of 600 adults, who 
regularly do the food shopping for their households, will be selected 
at random and asked if they would agree to complete a mail survey. 
Participation will be voluntary. Detailed information will be obtained 
about how consumers would be affected by changes to standards and what 
their preferences are for retaining, revising, or eliminating 
standards. FDA is reviewing standard of identity regulations for foods 
in order to determine which elements of those regulations are most 
important to fulfilling the goals of those regulations. The information 
to be collected will address consumer attitudes toward potential 
changes in the standards of identity for particular products. The 
products will be chosen to represent general categories of products 
that share theoretically relevant characteristics. The changes will be 
chosen to represent general types of changes that might be made to 
standards of identity. Therefore, the information collected on 
particular changes in the standards of identity for particular products 
should provide information that can be generalized to other changes and 
other products. The information collected will be used to shape FDA's 
policy on revising standards of identity.
     In the Federal Register of September 3, 1998 (63 FR 47031), the 
agency requested comments on the proposed collection of information. 
FDA received five comments. One comment noted that Table 1 in the 
September 3, 1998, notice appeared to contain a typographical error. 
According to this comment, the ``0.8'' in the ``Hours per Response'' 
column for receiving the initial recruiting telephone call should be 
``0.08'' if that number is to be consistent with the other numbers in 
that table. FDA agrees with this comment and has revised the estimate 
for the initial telephone call accordingly.
    Some comments argued the proposed survey is unnecessary because 
industry groups have already indicated how they believe FDA should 
revise the standards of identity governing their products. FDA values 
the input of industry and intends to give full consideration to 
industry recommendations on revising standards. However, the primary 
purpose of standards of identity is to assist consumers. Therefore, FDA 
believes that information on consumer attitudes toward revising 
standards is also relevant to revising standards.
    Some comments suggested that the proposed survey is unnecessary 
because similar surveys have already been done by industry groups and 
the results of those surveys have already been shared with FDA. 
According to these comments, FDA already has sufficient information on 
consumer attitudes toward revising standards of identity to proceed 
with the task of reviewing and revising standards. Although the surveys 
that have been performed by industry groups contain much information 
that is relevant to revising standards, FDA disagrees that gathering 
additional information is unnecessary. One of the issues on which FDA 
believes that additional information is necessary is consumer attitudes 
toward the tradeoffs involved in revising various types of standards of 
identity in various ways. FDA believes that this issue has not been 
adequately addressed in the surveys that have been performed by 
industry groups.
    Many comments suggested that the proposed survey will be too 
general to have any practical utility for revising standards of 
identity. According to these comments, survey results on consumer 
attitudes on changing any given standard will not be relevant to the 
determining consumer attitudes toward changing any other standard. 
These comments suggested that the surveys that have been performed by 
industry groups do not suffer from this drawback because they deal with 
particular products. FDA acknowledges the difficulties involved in 
extrapolating the results of consumer attitudes across different 
standards and products. However, FDA believes that standards and 
products can be grouped in a meaningful way and that the results of 
consumer attitudes toward a particular change in the standard governing 
a particular product will be related to consumer attitudes toward 
similar changes in the standards governing other products of that type. 
FDA agrees that it would be more straightforward to do a separate 
survey on every possible change in every standard. However, FDA has 
insufficient resources to implement such an approach. As indicated 
previously, FDA agrees that the surveys performed by industry groups on 
particular products contain much information that is relevant to 
revising those standards. However, FDA does not believe that those 
surveys provide all the information that is relevant to revising those 
standards.
    Other comments suggested that the proposed survey will have no 
practical utility because consumer attitudes toward the hypothetical 
changes to standards discussed in the survey will not be relevant to 
determining consumer attitudes toward the types of changes that FDA 
would actually make to standards. FDA disagrees with this comment. The 
types of changes discussed in the proposed survey will reflect the 
types of changes that FDA might actually make.
    Some comments argued that the proposed survey is fundamentally 
misguided because consumers are not generally familiar with standards 
of identity and will not be able to respond to questions concerning 
changes in standards of identity. FDA is aware that most consumers are 
not already familiar with standards. The survey will be written in such 
a manner that consumers are provided with the information they need to 
consider changes to standards.
    Finally, some comments noted that interpreting the results of 
consumer surveys is complicated because those results depend crucially 
on what questions are asked and on how those questions are asked. These 
comments noted that industry has considerable experience conducting 
consumer surveys and recommended that FDA elicit the input of industry 
experts when designing the survey instrument. FDA is aware of the 
issues that are involved in interpreting the results of consumer 
surveys and believes that it has access to sufficient technical 
expertise to conduct consumer surveys without the assistance of 
industry experts. In addition, FDA notes that it does not intend to 
revise standards based only on the results of this particular survey, 
but intends to also take into account the results of all other relevant 
surveys, including those sponsored by industry groups, and all other 
relevant information.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 6367]]



                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
                                      No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Receive initial recruiting
 telephone call                       600               1             600               0.08           48
Read instructions and complete
 mail survey                          600               1             600               0.59          354
Complete followup telephone
 interview                            600               1             600               0.08           48
Total                                                                                                 450
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

     The burden estimate is based on two rounds of focus groups 
conducted to test the survey instrument. The estimates for the length 
of the initial and followup interviews are based on similar studies 
that have been conducted.

    Dated: January 31, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-3015 Filed 2-8-99; 8:45 am]
BILLING CODE 4160-01-F