[Federal Register: January 20, 2006 (Volume 71, Number 13)]
[Notices]
[Page 3309-3310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ja06-71]
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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
----------------------------------------------------------------------------------------------------------------
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
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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 dz20a@niehs.nih.gov.
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