2023-24343. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Assessing Knowledge, Attitudes, and Practices (KAPs) of Hispanic/Latina Women of Reproductive Age (WRA) about Folic Acid Fortification and Supplementation” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on November 22, 2022, to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication.

Proposed Project

Assessing Knowledge, Attitudes, and Practices (KAPs) of Hispanic/Latina Women of Reproductive Age (WRA) about Folic Acid Fortification and Supplementation—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Consuming 400 micrograms (mcg) of folic acid daily in the periconceptional period can reduce the risk of having a pregnancy affected by a neural tube defect (NTD), a severe birth defect of the brain and spine. To increase the amount of folic acid consumed in the U.S. population, the U.S. Food and Drug Administration (FDA) mandated fortification of enriched cereal grain products with folic acid in 1998. Although strides have been made in preventing neural tube defects, ethnic disparities remain. Hispanic women in the U.S. have the highest risk of having a child affected by a NTD, with birth prevalence of approximately seven NTDs per 10,000 live births. In addition, prior studies have found that Hispanic women: (1) have lower levels of folate in their blood compared to non-Hispanic white women; (2) are more likely than non-Hispanic white and non-Hispanic black women to have the MTHFR C677T gene variant; (3) are less likely to know about the benefits of folic acid; and (4) are less likely to get folic acid from fortified foods or take a multivitamin with folic acid in it, particularly those women who primarily speak Spanish, were born outside of the United States, and have lived in the United States for a shorter period of time.

To effectively reach Hispanic women of reproductive age (WRA) and increase their knowledge and intake of folic acid for NTD prevention, a contemporary understanding of cultural factors in the decision-making process and how these women obtain information is needed. Previous research highlighted important nuances in potential cultural beliefs regarding folic acid. A study of Spanish-speaking Hispanic women in the southwest U.S. found no cultural barriers to incorporating folic-acid rich foods into their diets; however, focus groups of Mexican American women did find several cultural barriers. These included: (1) misperceptions of the term folic acid as an illegal substance, as the word “acid” is like LSD; (2) its importance for NTD prevention since their healthcare providers did not talk to them about folic acid; (3) its absence in injectable form at the pharmacy; and (4) mistaken belief that birth defects are not preventable (resulting from an act of God). Studies have found contradictory findings, suggesting that Mexican American women have increased awareness of the association between folate and birth defects compared to English-speaking women. More research is needed to determine cultural factors in the decision-making process around folic acid intake for Hispanic WRA, though several studies have examined beliefs and best practices for promoting folic acid consumption.

The purpose of this project is to conduct formative research with Hispanic/Latina women of reproductive age to examine folic acid and fortified food awareness, food and supplement use practices, as well as messaging and channels to reach Hispanic/Latina women. The resulting data are expected to be used for developing new messaging and communication products to improve knowledge, awareness, and practices regarding folic acid fortification and supplementation among Hispanic/Latina women of reproductive age. Additionally, the findings from the project will inform future intervention activities to prevent neural tube defects among Hispanic women of reproductive age.

This information collection will involve focus groups with Hispanic/Latina WRA. CDC requests OMB approval for an estimated 122 annual burden hours. There are no costs to respondents other than their time to participate.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Hispanic/Latina Women of Reproductive Age (WRA)	Knowledge, Attitudes, and Practices (KAPs) of Hispanic/Latina Women of Reproductive Age: Focus Group Moderator Guide (English/Spanish)	81	1	90/60

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.