Proposed Collection; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome, 3310-3311 [06-515]

Download as PDF 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 3311 Federal Register / Vol. 71, No. 13 / Friday, January 20, 2006 / Notices likely to have Polycystic Ovary Syndrome (PCOS) for future study. Potential participants (∼3,700) will come from the Mid-Atlantic Twin Registry (MATR) and were chosen based on their answers to several questions (in a preliminary MATR survey) concerning irregular periods and a history of cystic ovaries. The instrument to be used here will be administered by telephone by professional interviewers at the MATR. It contains 17 simple and direct questions and will take about 10 minutes to complete. Its contents deal with the frequency of menstrual periods, a history of polycystic ovaries, obesity, excess facial hair and other evidence of hyperandrogenism. Since this is such a short telephone survey, participants will receive no prior notification. Informed consent will be asked for verbally over the phone at the time of the interview. All participants will be asked about their willingness to participate in future studies if their answers meet certain criteria. The major objectives of future studies using this cohort are to determine more reliable concordance rates for PCOS in monozygotic and dizygotic twins, establish baseline heritability estimates, and develop hypotheses concerning possible pathogenetic and/or environmental factors. The findings from this study will aid in developing: (1) Genetic tests to identify high risk women; (2) preventative strategies; and (3) more effective therapies for PCOS and related syndromes such as type 2 diabetes, obesity, idiopathic hyperandrogenism, and male pattern baldness. Frequency of Response: One time. Affected Public: Individuals or households. Type of Respondents: Adult women. The annual reporting burden is as follows: Estimated Number of Respondents: 3,700; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.167; and Estimated Total Annual Burden Hours Requested: 206 per year for 3 years. The annualized cost to respondents is estimated at $6,179.00. 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: (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 Dr. Patricia C. Chulada, Health Scientist Administrator, Program in Clinical Research, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541– 7736 or e-mail your request, including your address to: chulada@niehs.nih.gov. Comment 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: January 11, 2006. Richard A. Freed, Associate Director for Management, NIEHS, National Institutes of Health. [FR Doc. 06–515 Filed 1–19–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Survey of Non-Federal Funding Sources for Cancer CAM Research 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 Cancer Institute (NCI), the Estimated number of respondents wwhite on PROD1PC65 with NOTICES Type of respondents Estimated number of responses per respondent (annual estimate) 150 50 2 2 Sfmt 4703 E:\FR\FM\20JAN1.SGM Nonprofit organizations ............................................................ Businesses or other for-profit organizations ............................ VerDate Aug<31>2005 16:16 Jan 19, 2006 Jkt 208001 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: Survey of Non-Federal Funding Sources for Cancer Complementary and Alternative Medicine (CAM) Research. Type of Information Collection Request: NEW. Need and Use of Information Collection: The goal of this study is to collect information that will allow the NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) to develop a directory of organizations external to the Federal Government that offer funding for cancer CAM research. This study will assist OCCAM in its mission to increase the quality of cancer CAM research supported by the NCI. One of the hurdles that many cancer CAM researchers encounter is the difficulty of obtaining research funding—and in particular, the difficulty of obtaining Federal funding for foundational or exploratory research. Often, researchers must obtain their initial funding through non-Federal sources, so that they can demonstrate proof of concept, which can be a precondition of obtaining Federal funds. The funding directory that is developed through this study will provide cancer CAM researchers with a resource that they can use to identify non-Federal funding sources, and target the funding sources that are most closely aligned with their research objectives. Frequency of Response: Semiannual. Affected Public: Nonprofit organizations; Businesses or other forprofit organizations; Type of Respondents: Organizations (other than Federal Government) that offer funding for cancer CAM research and have an open grant application process. The annual reporting burden is as follows: Estimated Number of Respondents: 200; Estimated Number of Responses per Respondent: 2 per year; Average Burden Hours Per Response: .25; and Estimated Total Annual Burden Hours Requested: 100. The annualized cost to respondents is estimated at: $2000 (assumes $20 hourly rate × 100 hours). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. PO 00000 Frm 00056 Fmt 4703 Average burden hours per response .25 .25 20JAN1 Estimated total annual burden hours requested 75 25

Agencies

[Federal Register Volume 71, Number 13 (Friday, January 20, 2006)]
[Notices]
[Pages 3310-3311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-515]


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

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

[[Page 3311]]

likely to have Polycystic Ovary Syndrome (PCOS) for future study. 
Potential participants (~3,700) will come from the Mid-Atlantic Twin 
Registry (MATR) and were chosen based on their answers to several 
questions (in a preliminary MATR survey) concerning irregular periods 
and a history of cystic ovaries. The instrument to be used here will be 
administered by telephone by professional interviewers at the MATR. It 
contains 17 simple and direct questions and will take about 10 minutes 
to complete. Its contents deal with the frequency of menstrual periods, 
a history of polycystic ovaries, obesity, excess facial hair and other 
evidence of hyperandrogenism. Since this is such a short telephone 
survey, participants will receive no prior notification. Informed 
consent will be asked for verbally over the phone at the time of the 
interview. All participants will be asked about their willingness to 
participate in future studies if their answers meet certain criteria. 
The major objectives of future studies using this cohort are to 
determine more reliable concordance rates for PCOS in monozygotic and 
dizygotic twins, establish baseline heritability estimates, and develop 
hypotheses concerning possible pathogenetic and/or environmental 
factors. The findings from this study will aid in developing: (1) 
Genetic tests to identify high risk women; (2) preventative strategies; 
and (3) more effective therapies for PCOS and related syndromes such as 
type 2 diabetes, obesity, idiopathic hyperandrogenism, and male pattern 
baldness. Frequency of Response: One time. Affected Public: Individuals 
or households. Type of Respondents: Adult women. The annual reporting 
burden is as follows: Estimated Number of Respondents: 3,700; Estimated 
Number of Responses per Respondent: 1; Average Burden Hours Per 
Response: 0.167; and Estimated Total Annual Burden Hours Requested: 206 
per year for 3 years. The annualized cost to respondents is estimated 
at $6,179.00. 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: (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 Dr. Patricia C. Chulada, Health Scientist 
Administrator, Program in Clinical Research, NIEHS, P.O. Box 12233, 
Research Triangle Park, NC 27709 or call non-toll-free number (919) 
541-7736 or e-mail your request, including your address to: 
chulada@niehs.nih.gov.
    Comment 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: January 11, 2006.
Richard A. Freed,
Associate Director for Management, NIEHS, National Institutes of 
Health.
[FR Doc. 06-515 Filed 1-19-06; 8:45 am]
BILLING CODE 4140-01-M