National Institutes of Health/national Institute of Environmental Health Sciences January 2006 – Federal Register Recent Federal Regulation Documents

Proposed Collection; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome
Document Number: 06-515
Type: Notice
Date: 2006-01-20
Agency: Department of Health and Human Services, National Institutes of Health/national Institute of Environmental Health Sciences, National Institutes of Health
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 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.
Laboratory of Pulmonary Pathobiology; Submission for OMB Review; Comment Request; Use of In-Home Test Kits in Dust Mite Allergen Reduction
Document Number: 06-513
Type: Notice
Date: 2006-01-20
Agency: Department of Health and Human Services, National Institutes of Health/national Institute of Environmental Health Sciences, National Institutes of Health
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, 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.