National Institute of Environmental Health Sciences, Proposed Collection; Comment Request; The Head Off Environmental Asthma in Louisiana (HEAL) Study, 28354-28355 [06-4571]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Notices]
[Pages 28354-28355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4571]


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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]
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