[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28354-28355]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my06-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences, Proposed
Collection; Comment Request; The Head Off Environmental Asthma in
Louisiana (HEAL) Study
SUMMARY: 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 National Institute of
Environmental Health Sciences (NIEHS), the National Institutes of
Health (NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection
Title: The Head Off Environmental Asthma in Louisiana (HEAL) Study.
Type of Information Collection Request: New collection.
Need and Use of Information Collection: The purpose of the HEAL
Study is to design, implement and evaluate a case management program to
intervene in asthma morbidity and examine the genetic and environmental
risk factors in children in post-Katrina New Orleans. Asthma is the
most common chronic disease among children in the United States; it is
the number one reason children miss school and the second leading cause
of emergency department visits after accidents and injuries. Asthma
prevalence has been increasing dramatically, especially among minority
inner-city children, where rates as high as 24% have been observed in
some urban census areas. Overall rates of asthma have also increased in
post-Katrina Louisiana children from 14% (2003) to 18% (2006) according
to results from the Louisiana Child & Family Health Study, and may be
even higher for minority and underprivileged children or children
residing in certain geographical areas that were affected by post-
Katrina flooding. For the HEAL Study, a school-based screening survey
will be given to children (5 to 12 years of age) in the public and/or
private elementary schools in New Orleans. This survey will take about
15 minutes to complete and contains questions concerning physician
diagnosed asthma, asthma morbidity, healthcare, and current housing
situation, as well as recent and planned changes in housing. The major
purpose of the school-based survey will be to identify up to 1,000
[[Page 28355]]
children with moderate to severe asthma for a tailored Asthma Counselor
case management intervention program and for an in depth examination of
the genetic and environmental risk factors associated with asthma. We
expect that about 6,000 parents or guardians will have to be
interviewed in order to identify 1,000 eligible cases.
Case management will be designed to address the unique challenges
presented to these children with asthma in post-Katrina New Orleans and
will draw upon the prior Inner City Asthma intervention programs of the
National Institutes of Health. It will also include the best components
of the locally based Step Together New Orleans (Steps) and the Open
Airways (American Lung Association) programs, among others. Each child
will undergo a baseline assessment in the form of a questionnaire
administered to their parents or guardians. This will contain questions
concerning their demographics, stress, access to care, medication use,
current and past symptoms, quality of life, knowledge and attitudes
about asthma, and environmental exposures. The questionnaire will be
administered by professional interviewers and will take about 1 hour to
complete. Each child will also undergo a baseline clinical assessment
for pulmonary function, allergen skin prick testing for indoor and
outdoor allergens including molds, and blood draws for allergen
specific IgE and genetic studies. Following the baseline assessments,
the Asthma Counselors will refer the children to selected clinics for
treatment and will monitor their progress by conducting periodic
follow-up assessments which include a phone call with standardized
questions about morbidity, treatment and exposures every two months
(about 15 min each) and 2 periodic evaluations of pulmonary function. A
final assessment will occur at the end of the year similar to the
baseline assessment and take about 1 hour to complete.
In light of the impact of environmental exposures on asthma, a
complete evaluation will also be conducted of each child's housing.
This will entail the collection of environmental samples such as
settled dust samples for potential allergens and triggers for asthma
exacerbation (dust mite, cockroach, cat, dog, mouse, and endotoxin) and
air for airborne fungal spores. The houses will be evaluated by trained
technicians for the presence of mold, mildew, evidence of smoking,
water leaks, disrepair, pests and other potential asthma triggers. The
ultimate goal of this study is to develop case management and
environmental intervention strategies for this population of post-
Katrina children to reduce their asthma morbidity and improve their
quality of life. These strategies could potentially be used to
intervene in other future disasters similar to hurricane Katrina.
Estimated Number of Respondents: The estimated number of
respondents is 40,000 which includes the parents or guardians of 1,000
children enrolled in the case management intervention and environmental
assessment programs.
Affected Public: Individuals or households.
Type of Respondents: Children with asthma 5 to 12 years of age or
their parents or guardians.
The annual reporting burden is as follows:
Estimated Number of Responses per Respondent: The table below shows
the estimated number of responses per respondent per activity over the
next two years.
Average Burden Hours per Response: 0.36; and
Estimated Total Annual Burden Hours Requested: 20,500 over 2 years.
The average annual burden hours requested is 10,250. The annualized
cost to respondents is estimated at $7.20 (assuming $20 hourly wage).
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
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Estimated Estimated Average burden Estimated total
Activity number of responses per hours per burden hours
respondents respondent response requested
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School-based eligibility screening...... 40,000 1 0.25 10,000
Enrollment interview.................... 6,000 1 0.5 3,000
Baseline QX assessment.................. 1,000 1 1.25 1,250
Baseline Medical assessment............. 1,000 1 2 2,000
Phone follow-up......................... 1,000 6 0.25 1,500
Pulmonary function assessment........... 1,000 2 1 2,000
Yearly follow-up........................ 1,000 1 2 1,000
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Total............................... ................ ................ ................ 20,750
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Request for comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function 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) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Patricia Chulada, NIEHS, P.O. Box 12233, Research
Triangle Park, NC 27709 or call non-toll-free number (919) 541-7736 or
e-mail your request, including your address to chulada@niehs.nih.gov.
Comments due date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: May 4, 2006.
Richard A. Freed,
Associate Director for Management, NIEHS.
[FR Doc. 06-4571 Filed 5-15-06; 8:45am]
BILLING CODE 4140-01-M