[Federal Register Volume 69, Number 203 (Thursday, October 21, 2004)]
[Notices]
[Pages 61853-61854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-23560]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health/National Institute of Environmental 
Health Sciences


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

[[Page 61854]]

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 x 690.5 hours). There are no Capital Costs to report. There 
are no Operating or Maintenance Costs to report.

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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total burden
               Type of respondents                   number of     responses per     hours per         hours
                                                    respondents     respondent       response        requested
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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
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\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 (919) 541-1161 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 60 days 
of the date of this publication.

    Dated: October 8, 2004.
Rich Freed,
NIEHS, Associate Director for Management.
[FR Doc. 04-23560 Filed 10-20-04; 8:45 am]
BILLING CODE 4140-01-M