[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14018-14019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-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 404-639-5960 
and send comments to Carol E. Walker, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email 
to <a href="/cdn-cgi/l/email-protection#2946444b694a4d4a074e465f"><span class="__cf_email__" data-cfemail="2a4547486a494e49044d455c">[email protected]</span></a>.
    Comments are invited on: (1) 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; (2) the accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) the quality, utility, and clarity 
of the information to be collected; and (4) the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology. Written comments should be received within 60 days of this 
notice.

Proposed Collection

    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

[[Page 14019]]

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. There are 
no costs to respondents except for their time to participate.

                                                            Estimated Annualized Burden Table
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                                                                                                       Number of       Average burden
             Type of respondents                           Form name                 Number of       responses per   per response  (in    Annual burden
                                                                                    respondents       respondent           hours)          (in hours)
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Women 18-44, Mexican or Central American       Phase One Screener..............               320                 1             6/60                  32
 heritage; English and Spanish speakers.
Women 18-44, Mexican or Central American       Phase One Focus Group Guide.....                80                 1                1.5               120
 heritage; English and Spanish speakers.
Women 18-44 (English speakers)...............  Phase Two Screener..............               320                 1             6/60                  32
Women 18-44 (English speakers)...............  Phase Two Focus Group Guide.....                80                 1                1.5               120
                                                                                ------------------------------------------------------------------------
    Total....................................  ................................  ................  ................  .................               304
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    Dated: March 9, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2011-5922 Filed 3-14-11; 8:45 am]
BILLING CODE 4163-18-P


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