[Federal Register Volume 71, Number 13 (Friday, January 20, 2006)]
[Notices]
[Pages 3309-3310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health/National Institute of Environmental 
Health Sciences


Laboratory of Pulmonary Pathobiology; Submission for OMB Review; 
Comment Request; Use of In-Home Test Kits in Dust Mite Allergen 
Reduction

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Environmental Health 
Sciences (NIEHS), the National Institutes of Health (NIH) has submitted 
to the Office of Management and Budget (OMB) a request to review and 
approve the information collection listed below. This proposed 
information collection was previously published in the Federal Register 
on October 21, 2004, pages 61853-61854, and allowed 60 days for public 
comment. No public comments were received although one person sent an 
e-mail expressing interest in the study and asking if she could 
participate. She was told this was a pilot study to be carried out in a 
specific location in North Carolina. The purpose of this notice is to 
allow an additional 30 days for public comment. The National Institutes 
of Health may not conduct or sponsor, and the respondent is not 
required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.
    Proposed Collection: Title: Use of In-home Test Kits in Dust Mite 
Allergen Reduction. Type of Information Collection Request: New. Need 
and Use of Information Collection: This request for OMB review and 
approval of the information collection is required by regulation 42 CFR 
part 65(a)(6). 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,

[[Page 3310]]

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 additudinal 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 f2 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 the 
two stages of eligibility screening, data will be collected at 
baseline, 6-months, and 12-months. 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 Respondent: 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 Annual Burden Hours Requested: 690.5. The annualized cost to 
respondents is estimated at: $13,810 (assuming $20 hourly wage x 690.5 
hours). There are no Capital Costs, Operating Costs and/or Maintenance 
Costs to report.

                        Calculation for Data Burden of Dust Mite Allergen Reduction Study
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                                                                     Number of       Hours per
                     Type of data collection                        respondents      response       Total hours
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Eligibility Screening...........................................             450            0.25           112.5
Dust Mite Level Eligibility Screening...........................             280             0.5           140.0
Baseline Visit..................................................             144             1.5           216.0
6-month follow-up...............................................             122             1.0           122.0
12-month follow-up..............................................             100             1.0           100.0
                                                                 -----------------
    Total hours.................................................  ..............  ..............           690.5
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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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. To request more information on 
the proposed project or to obtain a copy of the data collection plans 
and instruments, contact: Dr. Darryl Zeldin, NIEHS, Laboratory of 
Pulmonary Pathobiology, P.O. Box 12233, Research Triangle Park, NC 
27709 or call non-toll-free number (919) 541-1169 or e-mail your 
request, including your address to [email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: January 11, 2006.
Richard A. Freed,
Associate Director for Management, NIEHS, National Institutes of 
Health.
[FR Doc. 06-513 Filed 1-19-06; 8:45 am]
BILLING CODE 4140-01-M