04-23560. Proposed Collection; Comment Request; Dust Mite Allergen Reduction 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: Tile: Dust Mite Allergen Reduction Study. Type of Information Collection Request: New. Need and Use of Information Collection: Asthmatics and others with dust mite allergies often implement strategies to avoid dust mite exposure, but have little objective evidence that their interventions are successful in reducing dust mite populations. Recently developed in-home test kits have introduced the capability to monitor the effectiveness of allergen reduction strategies by providing an affordable, simple way to measure dust mite allergens on a regular basis. The primary objective of this study is to determine if use of in-home test kits results in decreased dust mite allergen levels in home of children sensitive or allergic to dust mites. A secondary objective is to determine if use of in-home test kits result in attitudinal and behavioral changes related to implementing and maintaining dust mite reduction strategies. This study is a randomized intervention trial designed to test the efficacy of an in-home test kit in influencing behaviors to reduce dust mite allergen levels. Households will be recruited through flyers and will be screened for eligibility through a recruitment call line and a home visit to determine baseline dust mite levels in the household. Study participants will be randomly assigned to a treatment or control group. The treatment group will receive educational materials and an in-home test kit at set intervals, while the control group will receive educational materials alone. Vacuumed dust samples will be collected and delivered to the NIEHS laboratory for ELISA-based measurements of the dust mite allergens Der f 2 and Der p 2. A questionnaire will be used to collect information on home characteristics and on dust mite reduction attitudes and behaviors. Data will be collected at baseline, 6 months and 12 months. The results from this study will be used by NIEHS to plan future primary and secondary asthma prevention trials.

Frequency of Response: After two stages of eligibility screening, data will be collected at baseline, 6-months, and 12-months. Affected Public: Individuals or households. Type of Respondents: Parents of children with dust-mite allergies. The annual reporting burden is as follows: Estimated Number of Respondents: See table below. Estimated Number of Responses per Respondents: See table below. Average Burden Hours Per Response: 0.25 hour for initial screening, 0.5 hour for dust mite eligibility screening, 1.5 hours for each baseline visit and 1 hour for each follow-up home visit (6- and 12-month); and Estimated Total Burden Hours Requested: 690.5. The average annual burden hours requested is 112.5 for the initial screening, 140 for the dust mite eligibility screening, 216 for the baseline visit, 122 for the 6-month follow-up and 100 for the 12-month follow-up visits. The annualized cost to respondents is estimated at $13,810 (assuming $20 hourly wage × 690.5 hours). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total burden hours requested
Eligibility screening	450	1	0.25	112.5
Dust mite level eligibility screening	1 280	1	0.5	140
Baseline visit	2 144	1	1.5	216
6-month follow-up	122	1	1	122
12-month follow-up	3 100	1	1	100
Total	4 1,096			690.5
1 Expect approximately 60% of the participants to satisfy the initial eligibility criteria.
2 Expect approximately 50% of the participants who met initial eligibility to satisfy the dust mite level screening eligibility criteria.
3 Expect approximately 30% attrition rate over the 12 month period.
4 Individuals who participate in each step of data collection are counted more than once, for each phase of data collection. Total number of unduplicated respondents is 450.

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: Leslie Elliott, Laboratory of Respiratory Biology, NIEHS, Building 101, A2-05, 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: October 8, 2004.

Rich Freed,

NIEHS, Associate Director for Management.