[Federal Register Volume 62, Number 108 (Thursday, June 5, 1997)]
[Notices]
[Pages 30868-30870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-97-12]


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 on (404) 639-7090.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the

[[Page 30869]]

use of automated collection techniques for other forms of information 
technology. Send comments to Wilma Johnson, CDC Reports Clearance 
Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments 
should be received within 60 days of this notice.

Proposed Projects

    1. Childbearing-age Women, Folic Acid, and the Prevention of Spina 
Bifida and Anencephaly: Interventions and Evaluation in a Managed Care 
Setting-New--Spina bifida and anencephaly are neural tube defects 
(NTDs) that are common and serious birth defects. In 1992, the Public 
Health Service (PHS) issued the recommendation that all women capable 
of becoming pregnant should consume daily 0.4 mg of folic acid to 
prevent spina bifida and anencephaly. An estimated 50% to 70% of spina 
bifida and anencephaly could be prevented with the use of 
periconceptional folic acid, but at least 70% of the 60 million U.S. 
women of childbearing age do not consume adequate folic acid to prevent 
these defects. The Division of Birth Defects and Developmental 
Disabilities (DBDDD) at the National Center for Environmental Health 
(NCEH) of the Centers for Disease Control and Prevention (CDC) promotes 
increased consumption of folic acid to prevent these birth defects, 
with a goal of increasing the number of women of childbearing age who 
consume folic acid-containing vitamins. In mounting efforts to promote 
folic acid use, there is a need to (1) improve the understanding of the 
factors that shape women's behaviors relative to folic acid supplement 
use, (2) design and carry out interventions to increase folic acid use, 
and (3) evaluate the effectiveness of these interventions using pre- 
and post-intervention assessments. This project will address these 
needs in a managed care setting, where a large proportion of 
childbearing age women receive their health care. Interventions will 
include providing folic-acid containing vitamins to child-bearing age 
women, educating members and health care providers regarding folic acid 
and prevention of neural tube defects, and raising member and provider 
awareness through campaigns. Focus groups will be used to design the 
educational and awareness campaigns (i.e., message development). At one 
site primary health care providers will participate in educational 
sessions about the link between folic acid NTDs; a subset of those 
providers primarily involved in women's health care will receive 
additional training on how to best tailor folic acid educational 
messages to women. Pre- and post-intervention telephone surveys of 
child-bearing age women members regarding their knowledge and behaviors 
relative to supplement use and the prevention of NTD defects will be 
performed to evaluate the effectiveness of the interventions. Pre- and 
post-intervention serum folate levels will also be used to evaluate the 
effectiveness of the interventions. Serum folate levels will be 
obtained from a sample of pregnant women at the time of their first 
prenatal visit. Blood drawn for other routine prenatal care purposes 
will be used, and therefore will not require an additional blood draw. 
A shorter telephone survey of a smaller sample of pregnant women after 
their first prenatal visit will be done to determine vitamin supplement 
use prevalence early in pregnancy. The total cost to respondents is 0.

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                                                                         Number of    Avg. burden/              
                      Respondents                          Number of    responses/   response  (in  Total burden
                                                          respondents   respondent       hrs.)        (in hrs.) 
----------------------------------------------------------------------------------------------------------------
Child bearing age women................................          4800             1           .20            960
Pregnant women.........................................           720             1           .083          59.7
Focus group, childbearing age women....................            40             1          1.5              60
Primary health care providers..........................           350             1          1.0             350
Primary women's health care providers..................           150             1          2.0             300
                                                        --------------------------------------------------------
    Total..............................................  ............  ............  .............        1729.7
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    2. Health Effects from Exposure to High Levels of Sulfate in 
Drinking Water-New--The Safe Drinking Water Act Amendments of August 
1996 require the Centers for Disease Control and Prevention, in 
collaboration with the U.S. Environmental Protection Agency, to conduct 
a dose-response study of the health effects of exposure of susceptible 
populations to drinking water that contains sulfate. There is concern 
that individuals who are not used to drinking water containing sulfate 
will experience diarrhea when they first drink tap water containing 
high levels of sulfate. The effect is acute and temporary. However, 
becoming acclimated, or used to, water with high levels of sulfate may 
take approximately two weeks, during which time individuals, 
particularly those who cannot control their fluid intake, i.e., 
infants, may become dehydrated. Previous studies of the effects of 
sulfate on the incidence of diarrhea have suffered from a number of 
limitations, including small sample size, failure to account for other 
causes of diarrhea, and inadequate characterization of the water 
itself. This study will analyze the incidence of diarrhea in non-
acclimated infants and adults exposed to drinking water containing a 
range of sulfate concentrations by collecting data from mothers of 
newborn infants living in areas with a range of naturally-occurring 
sulfate levels and adult volunteers who will consume drinking water 
containing specific levels of sulfate. The total cost to the 
respondents is $0.00.

                                                 Data Collection                                                
----------------------------------------------------------------------------------------------------------------
                                                                         Number of    Avg. burden/              
                      Respondents                          Number of    responses/   response  (in  Total burden
                                                          respondents   respondent       hrs.)        (in hrs.) 
----------------------------------------------------------------------------------------------------------------
Recruiting project participants........................          2500             1           0.16           400
Training for project participants: interview...........          1250             1           1             1250
Follow-up phone calls..................................          1250             3           0.2            750
Mothers with newborn infants: diary....................          1250            28           0.1           3500
Adult volunteers: questionnaire........................           100             1           0.34            34

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Adult volunteers: diary................................           100             6           0.1             60
                                                        --------------------------------------------------------
    Total..............................................  ............  ............  .............          5994
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    Dated: May 28, 1997.
Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 97-14674 Filed 6-4-97; 8:45 am]
BILLING CODE 4163-18-P