Notices. Request for comments
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BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program
(NTP)Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Draft Performance Standards for the Murine Local Lymph Node Assay: Request for Comments AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for comments. SUMMARY: The Murine Local Lymph Node Assay
(LLNA)is the first alternative test method evaluated and recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). It was subsequently accepted by regulatory authorities to determine the allergic contact dermatitis potential of chemicals and products. In January 2007, the U.S. Consumer Product Safety Commission
(CSPC)submitted a nomination requesting that NICEATM and ICCVAM assess the validation status of
(1)The LLNA as a stand-alone assay for potency determination for hazard classification purposes;
(2)modified LLNA protocols;
(3)the LLNA limit test;
(4)the use of LLNA to test mixtures, aqueous solutions, and metals; and
(5)the applicability domain for LLNA. In order to facilitate the review of the modified LLNA protocols, ICCVAM proposed developing performance standards for the LLNA. In May 2007, a **Federal Register** notice was published (Vol. 72, No. 95, pages 27815-27817, May 17, 2007) requesting comments and data relevant to these nominated activities. In June 2007, the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) endorsed the nominated activities as high priorities for ICCVAM. In response to SACATM comments, along with those provided by the public in response to the previous **Federal Register** notice, ICCVAM also endorsed these activities as high priorities. ICCVAM subsequently prepared draft performance standards for the LLNA and now requests public comments on this draft document, which is available on the NICEATM/ICCVAM Web site at: ( *http://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm* ) or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below). DATES: Submit comments on or before October 29, 2007. ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709,
(fax)919-541-0947, (e-mail) *niceatm@niehs.nih.gov.* Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. Responses can be submitted electronically at the ICCVAM-NICEATM Web site: *http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm* or by e-mail, mail, or fax. FOR FURTHER INFORMATION CONTACT: Other correspondence should be directed to Dr. William S. Stokes (919-541-2384 or *niceatm@niehs.nih.gov* ). SUPPLEMENTARY INFORMATION: Background The LLNA is an alternative test method used for skin sensitization testing that reduces the number of animals needed, reduces the time required for testing, and can substantially reduce or avoid pain and distress associated with traditional guinea pig testing methods. The LLNA was the first alternative test method evaluated and recommended by ICCVAM and based on the recommendations of ICCVAM and an independent scientific peer review panel, the LLNA has been accepted by U.S. and international regulatory authorities as an alternative to the guinea pig maximization test and Buehler test for assessing allergic contact dermatitis (EPA 2003; ISO 2002; OECD 2002). Since 2003, ICCVAM has routinely developed performance standards for test methods; however, because the concept of performance standards was not developed by ICCVAM until 2003, they were not developed during the ICCVAM evaluation of the LLNA in 1998 (NIH Publication No. 99-4494, available: ( *http://iccvam.niehs.nih.gov/docs/immunotox_docs/llna/llnarep.pdf* ). In January 2007, CSPC submitted a nomination requesting that NICEATM and ICCVAM assess the validation status of
(1)The LLNA as a stand-alone assay for potency determination for classification purposes;
(2)modified LLNA protocols;
(3)the LLNA limit test;
(4)the use of LLNA to test mixtures, aqueous solutions, and metals; and
(5)the applicability domain for LLNA. ICCVAM endorsed the nomination and also decided to develop performance standards to facilitate evaluation of modified LLNA protocols to the traditional LLNA. In May 2007, a **Federal Register** notice was published requesting comments and data relevant to these activities (Vol. 72, No. 95, pages 27815-27817, May 17, 2007; available, *http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/FR/FR_E7_9544.pdf* ). In June 2007, SACATM endorsed these activities as high priorities for ICCVAM. In response to SACATM comments, along with those provided by the public in response to the previous **Federal Register** notice, ICCVAM endorsed these activities, including the development of performance standards, as high priorities. ICCVAM subsequently prepared draft performance standards for the LLNA, which are available on the NICEATM/ICCVAM Web site at: ( *http://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm* ). These draft test method performance standards are proposed to evaluate the performance of LLNA test methods that incorporate specific modifications to the measurement of lymphocyte proliferation in the traditional LLNA. These modifications focus specifically on incorporating non-radioactive procedures to evaluate lymphocyte proliferation in the draining auricular lymph nodes rather than incorporation of radioactivity (i.e., 3 H-thymidine), which is used in the traditional LLNA. Public comments received in response to the draft LLNA performance standards will be considered by ICCVAM during development of a revised draft version of this document. A public meeting is planned for early 2008 where an international, independent, peer review panel will evaluate the revised draft LLNA performance standards and review the other nominated LLNA related activities. Following this meeting, the recommendations of the peer review panel will be made available for public and SACATM comment. ICCVAM will consider the panel report and public and SACATM comments in preparing final LLNA performance standards. Request for Public Comments NICEATM invites the submission of written comments on the draft LLNA performance standards. When submitting written comments, please refer to this **Federal Register** notice and include appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, if applicable). All comments received by the deadline listed above will be placed on the NICEATM/ICCVAM Web site ( *http://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm* ) and made available to the peer review panel and ICCVAM. Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 *l* -3, available at *http://iccvam.niehs.nih.gov/about/PL106545.htm* ) establishes ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of federal agencies. Additional information about ICCVAM and NICEATM is available on the following Web site: *http://iccvam.niehs.nih.gov.* Dated: September 5, 2007. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-18011 Filed 9-11-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice. SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality
(AHRQ)to request the Office of Management and Budget
(OMB)to allow the proposed information collection project: “2008-2009 Medical Expenditure Panel Survey—Insurance Component (MEPS-IC).” In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the **Federal Register** on June 28, 2007 and allowed 60 days for public comment. Public comments were received and have been addressed in the supporting statement, available upon request. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by October 12, 2007. ADDRESSES: Written comments should be submitted to: Karen Matsuoka by fax at
(202)395-6974 (attention: AHRQ's desk officer) or by e-mail at *OIRA_submission@omb.eop.gov* (attention: AHRQ's desk officer). Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer,
(301)427-1477. SUPPLEMENTARY INFORMATION: Proposed Project 2008 and 2009 Medical Expenditure Panel Survey—Insurance Component (MEPS-IC) The MEPS-IC, an annual survey of the characteristics of employer-sponsored health insurance, was first conducted by AHRQ in 1997 for the calendar year 1996. The survey has since been conducted annually for calendar years 1997 through 2006. AHRQ proposes to continue this annual survey of establishments for calendar years 2008 and 2009. The survey data for calendar year 2008 will be collected in that year. Likewise, calendar year 2009 data will be collected in 2009. This is a change from earlier MEPS-IC collections, when survey data for a calendar year were collected in the following year (i.e., 2005 survey data were collected in 2006). This changeover means that there will be no data collected for the year 2007. However, the data for 2008 and 2009 will now be released a year earlier than would have occurred under the former collection scheme. This survey will be conducted for AHRQ by the Bureau of Census using a sample comprised of an annual sample of employers selected from Census Bureau lists of private sector employers and governments. Data to be collected from each employer will include a description of the business (e.g., size, industry) and descriptions of health insurance plans available, plan enrollments, total plan costs and costs to employees. Data Confidentiality Provisions All MEPS-IC data collected, both identifiable and non-identifiable, will be stored at the Census Bureau. Their confidentiality is protected under the U.S. Census Bureau confidentiality statute, Section 9 of Title 13, United States Code. In addition, because the Census sample lists are developed using Internal Revenue Service
(IRS)Tax Information, the data also fall under the review of the IRS which conducts regular audits of the data collection storage and use (Title 26, United States Code). The confidentiality provisions of the AHRQ statute at 42 USC 299c-3(c) apply to all data collected for research that is supported by AHRQ. All data products listed below must fully comply with the data confidentiality statute under which their raw data was collected as well as any additional confidentiality provisions that apply. Data Products Data will be produced in two forms:
(1)Files containing employer information will be available for use by researchers at the Census Bureau's Research Data Centers (all research output is reviewed by Census employees and no identifiable data may leave the Center) and
(2)a large compendium of tables of estimates, produced by Census and containing no identifiable data, will be made available on the AHRQ website. These tables will contain descriptive statistics, such as, numbers of establishments offering health insurance, average premiums, average contributions, total enrollments, numbers of self insured establishments and other related statistics for a large number of population subsets defined by firm size, state, industry and other establishment characteristics such as, age, profit/nonprofit status and union/nonunion status of the workforce. The data are intended to be used for purposes such as: • Generating National and State estimates of employer health care offerings; • Producing estimates to support the Bureau of Economic Analysis and the Center for Medicare and Medicaid Services in their production of health care expenditure estimates for the National Health Accounts and the Gross Domestic Product; • Producing National and State estimates of spending on employer-sponsored health insurance to study the results of National and State health care policies; and • Supplying data for modeling the demand for health insurance. These data provide the basis for researchers to address important questions for employers and policymakers alike. Method of Collection The data will be collected using a combination of modes. The Census Bureau's first contact with employers will be made by telephone. This contact will provide information on the availability of health insurance from that employer and essential persons to contact. Based upon this information, Census will mail a questionnaire to the employer. In order to assure high response rates, Census will follow-up with a second mailing after an interval of approximately 30 working days, followed by a telephone call to collect data from those who have not responded by mail. For larger respondents with high burdens, such as State employers and very large firms, Census may follow special procedures, as needed. These include performing personal visits and doing customized collection, such as accepting data in computerized formats and using special forms. The response rate for the most recent survey was approximately 79%. Estimated Annual Respondent Burden Survey years Annual number of respondents Estimated time per respondent in hours Estimated total annual burden hours Estimated annual cost to the Government 2008 33,262 .57 19,032 $9,650,000 2009 33,262 .57 19,032 9,950,000 Request for Comments In accordance with the above cited legislation, comments on the AHRQ information collection proposal are requested with regard to any of the following:
(a)Whether the proposed collection of information is necessary for the proper performance of functions of the Agency, including whether the information will have practical utility;
(b)the accuracy of the Agency's estimate of the burden (including hours and costs) 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 the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record. Carolyn M. Clancy, Director. [FR Doc. 07-4447 Filed 9-11-07; 8:45 am]
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- Pub. L. 104-13
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