[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Notices]
[Pages 75594-75595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-23AX]


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

[[Page 75595]]

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
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                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response (in
                                                                                    respondent        hours)
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Hispanic/Latina Women of             Knowledge, Attitudes, and                81               1           90/60
 Reproductive Age (WRA).              Practices (KAPs) of
                                      Hispanic/Latina Women of
                                      Reproductive Age: Focus
                                      Group Moderator Guide
                                      (English/Spanish).
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2023-24343 Filed 11-2-23; 8:45 am]
BILLING CODE 4163-18-P