06-4571. 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 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.

Activity	Estimated number of respondents	Estimated responses per respondent	Average burden hours per response	Estimated total burden hours requested
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
Total				20,750

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 [phone] or e-mail your request, including your address to [e-mail].

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.