0545 - CFSAN Justification Memo for 83C Change Request 2013 September 24

Health and Diet Survey

0910-0545

JUSTIFICATION MEMORANDUM FOR 83-C CHANGE REQUEST

The Food and Drug Administration (FDA or we) is submitting this nonmaterial/non-substantive change request (83-C) to obtain Office of Management and Budget (OMB) approval of the next Health and Diet Survey, which we plan to field in late 2013. The 2013 questionnaire is attached. As we noted in the Supporting Statement submitted in 2011, “[t]he Health and Diet Survey-General Topics questionnaire is fielded once every three years and, if events warrant, may be fielded once annually during each year of the three-year approval period, with appropriate modifications to specific portions of the questionnaire (addition and/or removal of questions). If changed, the questionnaire would be submitted to OMB for review and approval.” This nonmaterial/non-substantive change request seeks OMB review and approval of the 2013 Health and Diet Survey, which continues to collect information on the same health and diet topics approved in 2011, but contains the nonmaterial/non-substantive modifications described below.

Planned update to the methodology

Currently, the Health and Diet Survey is administered using a Computer Assisted Telephone Interviewing (CATI) system. In the 2013 Health and Diet Survey, we plan to update the telephone survey methodology to include not only landline numbers but also cell phone numbers to minimize coverage bias due to the increasing prevalence of cell phone usage in the population. To update the methodology in this way, we need to revise the questionnaire in a non-material, non-substantive way at questions SCR3-SCR5, Questionnaire pages 1-2, and questions V4a and V4b, Questionnaire page 32. See the attached questionnaire. The effect that this change in methodology has on the sampling method and sample size is described in table 1.

Table 1. – Proposed changes to the sampling method and sample size
	Previously approved	Proposed change
Respondent universe	English-speaking adults (18 years or older)	No change.
Sampling method	Sampled from a listed national landline telephone frame using the random-digit-dialing method	Sampled from a listed national landline and a cell phone frame using the random-digit-dialing method. No respondent will be excluded because of his/her telephone status (landline only, both landline and cell phone, cell phone only). Thus, the sampling frame will be an overlapping dual frame.
Target sample size	3,000 respondents, all to be contacted via landline numbers	2,000 respondents – 1,600 to be contacted via landline numbers and 400 via cell phone numbers.

Planned update to the questionnaire

The currently approved Health and Diet Survey submitted in 2011 tracks a broad range of consumer attitudes, awareness, knowledge and self-reported behaviors related to key diet and health issues, including: awareness of diet-disease relationships, food and dietary supplement label use, and dietary practices. As we noted in the Supporting Statement submitted in 2011, the Health and Diet Survey is periodically repeated to track changes in consumer awareness and practices. The Department of Health and Human Services collaborated with FDA to use the Health and Diet Survey as an evaluation mechanism at OMB’s recommendation. As we anticipated in 2011, we plan to modify the following sections of the 2013 Health and Diet Survey questionnaire to track changes in consumer awareness and practices:

• Within the general areas of diet-disease relationships and dietary practices –

  • knowledge, attitude, and practice related to sodium consumption

    • questions A10r-A10w (Questionnaire pages 19-20),

    • questions STL1-STL8 (Questionnaire pages 20-22), and

  • use of caffeinated beverages (questions ER1-ER7, Questionnaire pages 14-17),

  • knowledge of calorie intakes (question CBQ645, Questionnaire page 5),

  • self-rated diet quality (questionnaire DBA700, Questionnaire pages 5 and 22).

• Within the general area of food label use –

  • Use of nutrient amount information on the Nutrition Facts label (questions E8 and E9, Questionnaire page 25),

  • perceptions of labeling statements regarding natural, high fructose corn syrup, and added sugars (questions E12-E22, Questionnaire pages 26-29), and

  • use of the Nutrition Facts label (questions DBQ750-CBQ698y, Questionnaire pages 5-7).

We plan to conduct 18 pretests to test the modifications to the questionnaire and to examine time length of the survey. In 2011, we were approved for conducting 27 pretests.

FDA requests OMB approval of the 2013 Health and Diet Survey methodology and questionnaire as a nonmaterial/non-substantive change to the information collection approved in 2011.

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