[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.)
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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
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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
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Number of Avg. burden/
Respondents Number of responses/ response (in Total burden
respondents respondent hrs.) (in hrs.)
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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
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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
