2011-18705. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer at 404-639-5960 or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Communication Research on Folic Acid to Support the Division of Birth Defects and Developmental Disabilities—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Since mandatory folic acid fortification of cereal grain products was mandated in 1998, rates of folic acid-preventable neural tube defects (NTDs) have declined. Disparities in rates remain, however, with NTD prevalence being highest among Hispanic women of childbearing age. Efforts to increase consumption of vitamin supplements containing folic acid among women in this ethnic group have been ongoing, however, due to differences in diet, many of these women have not benefitted from food fortification to the extent that other race/ethnic groups have. A performance goal for NCBDDD focuses specifically on the reduction of these disparities: Reduce health disparities in the occurrence of folic acid-preventable spina bifida and anencephaly by reducing the birth prevalence of these conditions. Moreover, Healthy People 2010 objectives refer to the reduction of NTD rates and increase of folic acid consumption for all women of childbearing age: (1) Reduce the occurrence of spina bifida and other NTDs; (2) Increase the proportion of pregnancies begun with an optimum folic acid level by increasing the consumption of at least 400 mcg of folic acid each day from fortified foods or dietary supplements by nonpregnant women aged 15 to 44 and increasing the median red blood cell folate level among nonpregnant women aged 15 to 44 years. The 2009 congressional omnibus appropriations language includes reference to reducing health disparities: “There is significant concern about disparity in the rates of folic acid intake and neural tube defects, particularly in the Hispanic population. Within the funds provided for folic acid, CDC is encouraged to provide increased funding to expand the folic acid education campaign to inform more women and healthcare providers about the benefits of folic acid * * *”. Finally, CDC partners are working to develop a food additive petition that will be submitted for approval to the FDA. This petition would allow for the addition of folic acid to corn masa flour and corn masa flour products. Knowing the consumer attitudes toward this endeavor is important to the overall success of the effort. Although up to 70% of neural tube defects can be prevented if a woman consumes folic acid before and during the first weeks of pregnancy, many women are still unaware of folic acid until they are already pregnant. Because half of all pregnancies in the U.S. are unplanned, reaching women with the folic acid message prior to pregnancy is critical. NCBDDD currently has several folic acid educational brochures, tip sheets, and booklets available in both English and Spanish. Since 2000, over 12 million folic acid materials have been distributed. Providing our partners, health care providers, and the public with evidence-based information in a format that is easy to read and visually appealing is important to the mission of the Prevention Research team. We want to ensure that the materials we currently have available still meet the needs of the intended audience.

CDC, with contract support from Battelle Centers for Public Health Research and Evaluation, is conducting research to inform efforts to promote folic acid consumptions among women of child-bearing age through two closely-related data collection efforts: (1) Exploratory Research of Hispanic Women's Reactions to and Beliefs About Folic Acid Fortification of Corn Masa Flour, and (2) Exploratory Research of Childbearing Age Women's Folic Acid Awareness and Knowledge, and their Reactions to Existing CDC Folic Acid Educational Materials. The purpose of the first proposed primary data collection effort is to better understand consumer acceptance of fortifying corn masa flour, a staple product in many traditional Latino, and in particular Mexican, foods. The purpose of the second proposed primary data collection effort is to determine whether educational materials developed over 10 years ago to promote folic acid consumption continue to be appealing and resonate with the target audience today. To address these two purposes and support the folic acid education efforts of CDC, focus groups with the target audience are needed.

For the first data collection activity phase, participants will be English and Spanish-speaking women 18-44 years who self identify as Mexican or Mexican American, or Central American. Participants will be segmented into groups based on whether they consume corn masa flour less than 4 times per day or 4 or more times per day. The contractor will conduct sixteen (16) focus groups with five (5) participants in each focus group. It is estimated that 320 respondents will have to be screened in order to recruit 80 focus group participants. Each screening will take approximately 6 minutes. The estimated response burden for the screening process is 32 hours. The focus group session will be structured to identify women's general awareness and knowledge about folic acid and its role in NTD prevention, perception of their risk for having an affected pregnancy, awareness and knowledge about fortification of cereal grain products, whether fortification of corn masa flour products would change their current reported use of these products, and overall reaction to potential folic acid fortification of these products.

For the second data collection activity phase, focus group participants will be women 18-44 years of age who are not pregnant at the time of the focus groups, who do not have a child with a birth defect such as spina bifida or anencephaly. The contractor will conduct sixteen (16) focus groups with five (5) participants in each focus group. It is estimated that 320 respondents will have to be screened in order to recruit 80 focus group participants. Each screening will take approximately 6 minutes. The estimated response burden for the screening process is 32 hours. Participants will be segmented into groups based on whether they self-identify as either vitamin users (take a vitamin containing folic acid 4-7 days per week) or non-users (take a vitamin containing folic acid less than 4 days per week). The focus group session shall be structured to identify women's awareness and knowledge about folic acid, and how they would like to see folic acid information portrayed in a written format. Focus group participants shall be shown written educational materials that are currently being used and asked questions designed to address whether the materials are effective in getting the folic acid message across to the audience, whether the visual images portrayed in the materials resonate with the audience, and how the materials could be improved. Also, differences based on pregnancy contemplation status shall be explored through segmentation of the focus groups.

Sixteen focus groups will be conducted in both phase one and phase two, with a total of 80 participants in each phase. The focus groups will have five participants each. Each respondent will participate in a 1.5-hour focus group, for a total burden of 120 hours. Data collection materials will be available in both English and Spanish. This request is being submitted to obtain OMB clearance for one (1) year. The total annualized burden for this project is 304 hours. There are no costs to respondents except for their time to participate.

Estimated Annualized Burden Table

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Women 18-44, Mexican or Central American heritage; English and Spanish speakers	Project One Screener	320	1	6/60
Women 18-44, Mexican or Central American heritage; English and Spanish speakers	Project One Focus Group Guide	80	1	1.5
Women 18-44 (English speakers)	Project Two Screener	320	1	6/60
Women 18-44 (English speakers)	Project Two Focus Group Guide	80	1	1.5

Dated: July 18, 2011.

Daniel L. Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.