Laboratory of Pulmonary Pathobiology; Submission for OMB Review; Comment Request; Use of In-Home Test Kits in Dust Mite Allergen Reduction, 3309-3310 [06-513]

Download as PDF 3309 Federal Register / Vol. 71, No. 13 / Friday, January 20, 2006 / Notices Dated: January 12, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6–628 Filed 1–19–06; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Data Collection; Comment Request; National Survey of Primary Care Physicians’ Recommendations and Practice for Breast, Cervical, Colorectal, and Lung Cancer Screening SUMMARY: In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) 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: National Survey of Primary Care Physicians’ Recommendations and Practice for Breast, Cervical, Colorectal, and Lung Cancer Screening. Type of Information Collection Request: New. Need and Use of Information Collection: This study will obtain current, national data on primary care physicians’ knowledge, attitudes, recommendations, and practices related to screening for breast, cervical, colorectal, and lung cancer. There have been substantial changes in Estimated number of respondents Questionnaire guidelines and/or technologies for these types of cancer screening in recent years. The data collected in this study will support and further NCI work in monitoring and evaluating providers’ cancer control knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Two questionnaires, one covering breast and cervical cancer screening and the other colorectal and lung cancer screening, will be administered by mail or telephone to a randomly-selected national sample of primary care physicians. Frequency of Response: One Time. Affected Public: Medical practices, clinics, or other health care organizations. Type of Respondents: Primary Care Physicians. Burden estimates are as follows: Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours 1250 1250 1 1 0.333 0.333 416.25 416.25 Total .......................................................................................................... wwhite on PROD1PC65 with NOTICES Breast and cervical cancer screening ............................................................. Colorectal and lung cancer screening ............................................................. ........................ ........................ ........................ 832.5 There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (a) Whether the proposed collection of information is necessary for the performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: Send comments to Carrie N. Klabunde, Ph.D., Epidemiologist, Division of Cancer Control and Population Sciences, National Cancer Institute, Executive Plaza North 4005, 6130 Executive Boulevard, Bethesda, Maryland 20892–7344 or call non-tollfree (301) 402–3362 or E-mail: klabundc@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if VerDate Aug<31>2005 16:16 Jan 19, 2006 Jkt 208001 received within 60 days of the date of this publication. Dated: January 11, 2006. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 06–512 Filed 1–19–06; 8:45 am] BILLING CODE 4101–01–P 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 InHome 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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 Inhome 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, E:\FR\FM\20JAN1.SGM 20JAN1 3310 Federal Register / Vol. 71, No. 13 / Friday, January 20, 2006 / Notices 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 inhome 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 × 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 Number of respondents Type of data collection Hours per response Total hours 450 280 144 122 100 0.25 0.5 1.5 1.0 1.0 112.5 140.0 216.0 122.0 100.0 Total hours ............................................................................................................................ wwhite on PROD1PC65 with NOTICES Eligibility Screening ...................................................................................................................... Dust Mite Level Eligibility Screening ........................................................................................... Baseline Visit ............................................................................................................................... 6-month follow-up ........................................................................................................................ 12-month follow-up ...................................................................................................................... ........................ ........................ 690.5 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 VerDate Aug<31>2005 16:16 Jan 19, 2006 Jkt 208001 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health/National Institute of Environmental Health Sciences Proposed Collection; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome 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: Environmental Factors in the Development of Polycystic Ovary Syndrome. Type of Information Collection Request: Revision of OMB No. 0925–0483 and expiration date 3/ 31/2006. Need and Use of Information Collection: The purpose of this study is to identify a cohort of living female twin pairs in which at least one member is E:\FR\FM\20JAN1.SGM 20JAN1

Agencies

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

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
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
-----------------
Total hours................................................. .............. .............. 690.5
----------------------------------------------------------------------------------------------------------------

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

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