10-Day Letter

D EPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control and Prevention

N ational Center for Health Statistics

3311 Toledo Road

Hyattsville, Maryland 20782

July 31, 2006

Ms. Susan Schechter

Office of Management and Budget

725 17^th Street, N.W.

Room 10201

Washington, D.C.

Dear Ms. Schechter:

The staff of the National Health and Nutrition Examination Survey (NHANES), National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention, seeks approval to conduct a pilot study of a 20 minute telephone interview, part of the Flexible Consumer Behavior Survey (FCBS) as a component of the NHANES under OMB Control No. 0920-0237. The NCHS received approval from OMB for field activities for the Main Study of the NHANES 2005-2006 on November 23, 2004.

Background

The Economic Research Service of the US Department of Agriculture has proposed collecting data within NHANES. The FCBS will fill a major gap in information related to the eating habits of Americans that was left by the discontinuation of USDA’s Diet Health Knowledge Survey (DHKS) after 1996. The new survey will reinstate and continue the core function of the DHKS by gathering information about nutrition knowledge, attitudes, and beliefs. The NHANES core data on dietary intakes and nutritional biomarkers will be linked to participants’ knowledge, attitudes and perceptions related to food. Assessing such linkages in various population subgroups and how the linkages change over time will provide critical information not only to public health experts and policymakers, but to the food industry and the growing food-away-from-home sector as well. Information gathered by the FCBS will contribute to the NHANES objectives of studying the relationship between diet, nutrition and health, as well as monitoring trends in risk behaviors and the prevalence of risk factors in population subgroups.

Cognitive testing completed

Following OMB approval in March Westat conducted cognitive interviews to assist in the development of the FCBS questions. The purpose of the interviewing was to explore potential sources of response error (such as difficulties with comprehension) in the draft versions of the questions. The interviews were conducted in two phases. Both English and Spanish versions of the FCBS questions were examined in the cognitive interviews. During both phases of the testing NCHS staff observed the cognitive interviews. Paul Beatty of the NCHS’s Cognitive Methods staff participated in the planning and debriefings. Westat, NCHS and ERS staff participated in lengthy debriefings after each phase with separate debriefings for both the English and Spanish questionnaires. Changes were made to improve the understandability of the questions at each stage. A written report is available.

Proposed project

The pilot will be at one NHANES location from September 26 through November 30, 2006. NCHS estimates the telephone interview burden will increase on average 20 minutes per respondent. There will be up to 350 respondents at 20/60 per response for an additional burden of 117 hours. (The current burden will not change as burden for testing was already part of the clearance.) An additional remuneration of $30 per respondent will be given. There will be no effort to convert non-respondents to respondents during the pilot test to prevent any adverse effect on NHANES components that occur after the second dietary interview. Those components are the return of the physical activity monitor, completion of the Food Propensity Questionnaire and collection of the household Allergy Dust specimen. In 2007 all three of those components will no longer be on the survey. Additionally, the telephone interview will be conducted only with adult sample persons and in the case of families without an adult sample person the interview will be conducted with the main meal planner in the household.

The attached protocol provides detail on the pilot. The questions are found on pages 31-54.

The telephone interview that we are testing is the major portion of the FCBS. Other questions are being added to the household survey instrument for 2007. An overview of the entire FCBS and those sections of the NHANES Household questionnaire with FCBS questions are attached. The overview addresses the purpose of the FCBS questions. The FCBS questions in the attached questionnaire sections are asterisked.

Evaluation will include: (1) observation and evaluation of performance of the questions by NCHS and home office staff of the data collection contractor; (2) review of the data collected to evaluate the quality and completeness of the data and (3) evaluation of details of the protocol . NCHS and Westat staff will periodically observe data collection. Summary data will be discussed with the Economic Research Service, the NHANES FCBS questionnaire sponsor.

Individuals involved in the pilot study

The data will be collected by Westat, Inc., 1650 Research Blvd, Rockville, MD 20850 (301-251-8220) under contract to CDC/NCHS. Other individuals involved in this project include:

Centers for Disease Control and Prevention

National Center for Health Statistics, Division of Health and Nutrition Examination Studies

Clifford Johnson, Director (301-458-4292)

Vicki Burt, Chief, Planning Branch (301-458-4127)

Chia-Yih Wang, Nutritional Epidemiologist (301-458-4567)

Ana Chavez, Public Health Analyst (301-458-4227)

Jayachandran N. Variyam, Chief, Diet, Safety and Health Economics Food Economics Division, ERS (202 694-5457)

Sincerely,

Vicki L. Burt, ScM, RN

Chief, Planning Branch

Division of Health and Nutrition Examination Surveys

cc: M. Moien

R. Polson

J. Karr

S. Perryman

C. Johnson

Attachment(s):

Ethics Review Board protocol (starts on p. 1 of attachment file)

Overview of the FCBS (starts on p. 55)

Family questionnaire section(s) (starts on p. 58)

Diet and Behavior questionnaire section (starts on p. 72)

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