Agency information collection activities: Submission for OMB review; comment request,

[Federal Register: February 9, 1999 (Volume 64, Number 26)]

[Notices]

[Page 6365-6367]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr09fe99-93]

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.

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 Burden‹SUP›1

Annual No. of Frequency per Total Annual Hours per Total Hours Respondents Response

Responses Response

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

\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. 99-3015Filed2-8-99; 8:45 am]

BILLING CODE 4160-01-F

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