[Federal Register Volume 76, Number 142 (Monday, July 25, 2011)]
[Notices]
[Pages 44334-44336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18705]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Centers for Disease Control and Prevention



[30Day-11-11DE]




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 [email protected]. 

Send written comments to CDC Desk Officer, Office of Management and 

Budget, Washington, DC or by fax to (202) 395-5806. 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



[[Page 44335]]



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

----------------------------------------------------------------------------------------------------------------

                                                                                 Number of       Average burden

        Type of respondents               Form name            Number of       responses per   per response  (in

                                                              respondents       respondent           hours)

----------------------------------------------------------------------------------------------------------------

Women 18-44, Mexican or Central     Project One Screener.               320                 1             6/60

 American heritage; English and

 Spanish speakers.

Women 18-44, Mexican or Central     Project One Focus                    80                 1                1.5

 American heritage; English and      Group Guide.

 Spanish speakers.

Women 18-44 (English speakers)....  Project Two Screener.               320                 1             6/60

Women 18-44 (English speakers)....  Project Two Focus                    80                 1                1.5

                                     Group Guide.

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[[Page 44336]]



    Dated: July 18, 2011.

Daniel L. Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.

[FR Doc. 2011-18705 Filed 7-22-11; 8:45 am]

BILLING CODE 4163-18-P