Notices. Notice

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0327] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 24, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Blood Establishment Registration and Product Listing, Form FDA 2830—(OMB Control Number 0910-0052)—Extension Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, place of business, and all such establishments submit, among other information, a listing of all drug or device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution. In part 607 (21 CFR part 607), FDA has issued regulations implementing these requirements for manufacturers of human blood and blood products. Section 607.20(a) requires certain establishments that engage in the manufacture of blood products to register and to submit a list of blood products in commercial distribution. Section 607.21 requires the establishments entering into the manufacturing of blood products to register within 5 days after beginning such operation and to submit a blood product listing at that time. In addition, establishments are required to register annually between November 15 and December 31 and update their blood product listing every June and December of each year. Section 607.22 requires the use of Form FDA 2830, Blood Establishment Registration and Product Listing, for initial registration, for annual registration, and for blood product listing. Section 607.25 indicates the information required for establishment registration and blood product listing. Section 607.26 requires certain changes to be submitted as amendments to the establishment registration within 5 days of such changes. Section 607.30 requires establishments to update their blood product listing information every June and December, or at the discretion of the registrant at the time the change occurs. Section 607.31 requires that additional blood product listing information be provided upon FDA request. Section 607.40 requires foreign blood product establishments to register and submit the blood product listing information, the name and address of the establishment, and the name of the individual responsible for submitting blood product listing information as well as the name, address, and phone number of its U.S. agent. Among other uses, this information assists FDA in its inspections of facilities, and its collection is essential to the overall regulatory scheme designed to ensure the safety of the Nation's blood supply. Form FDA 2830 is used to collect this information. Respondents to this collection of information are human blood and plasma donor centers, blood banks, certain transfusion services, other blood product manufacturers, and independent laboratories that engage in quality control and testing for registered blood product establishments. In the **Federal Register** of August 24, 2005 (70 FR 49655), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section Form FDA 2830 No. of respondents Annual frequency per response Total annual responses Hours per response Total hours 607.20(a), 607.21, 607.22, 607.25, and 607.40 Initial registration 100 1 100 1 100 607.21, 607.22, 607.25, 607.26, 607.31, and 607.40 Reregistration 2,775 1 2,775 0.5 1,388 607.21, 607.25, 607.30, 607.31, and 607.40 Product listing update 180 1 180 0.25 45 Total 1,533 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 13, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-844 Filed 1-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0190] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for FDA Regulated Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(1)Certificate to Foreign Government (FDA 3613),

(2)Certificate of Exportability (FDA 3613a),

(3)Certificate of a Pharmaceutical Product (FDA 3613b),

(4)Non-clinical Research Use Only Certificate (FDA 3613c), Office of Cosmetics and Colors “Certificate” (Exports) Application (FDA 3613d), and Food Export Certificate Application (FDA 3613e). Table 1 of this document lists the different certificates and details their uses: **Table 1. List of FDA Export Certificates** Certificate Name Form FDA Use Issuing FDA Center Certificate to Foreign Government 3613 For the export of products that can be legally marketed in the United States. Center for Biologic Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine

(CVM)Certificate of Exportability 3613a For the export of products that cannot be legally marketed in the United States but meet the requirements of sections 801(e) or 802 of the act and may be legally exported. CBER; CDRH; CVM Certificate of a Pharmaceutical Product 3613b For use by the importing country when considering whether to license the product in question for sale in that country. Conforms to the format established by the World Health Organization. CBER; Center for Drug Evaluation and Research; CVM Non-Clinical Research Use Only Certificate 3613c For the export of non-clinical research use only product, material, component that is not intended for human use which may be marketed in, and legally exported from the United States under the act. CBER; CDRH Office of Cosmetics and Colors “Certificate” (Exports) Application 3613d For the export of products that are identified by the requester as cosmetics. Center for Food Safety and Applied Nutrition (CFSAN) Food Export Certificate Application 3613e For food products and dietary supplements that may be legally marketed in the United States. CFSAN In the **Federal Register** of June 21, 2005 (70 FR 35678), FDA published a 60-day notice requesting public comment on the information collection provisions involving export certificates. FDA received three comments; however, only one was related to the information collection. The commenter suggested that extending the “Certificate to Foreign Government” 2-year expiration date to 3, 4 or 5 years would reduce their financial burden. The export certificate expiration date is based on the agency inspection schedule. At this time FDA is not considering reevaluating the inspection schedule. FDA will continue to rely on self-certification by manufacturers for the first three types of certificates listed in Table 1 of this notice. Manufacturers are requested to self-certify that they are in compliance with all applicable requirements of the act, not only at the time that they submit their request to the appropriate center, but also at the time that they submit the certification to the foreign government. The appropriate FDA centers will review product information submitted by firms in support of their certificate and any suspected case of fraud will be referred to FDA's Office of Criminal Investigations for follow-up. Firms making or submitting to FDA false statements on any documents may constitute violations of 18 U.S.C. 1001, with penalties including up to $250,000 in fines and up to 5 years imprisonment. FDA estimates the burden of this collection of information as follows: **Table 2.—Estimated Annual Reporting Burden** 1 FDA Center No. of respondents Annual frequency per response Total annual responses Hours per response Total hours CBER 1,501 1 1,501 1 1,501 CDER 4,803 1 4,803 1 4,803 CDRH 5,674 1 5,674 2 2 11,348 CFSAN, Office of Cosmetics and Colors 730 1 730 1 730 CFSAN, Office of Plant and Dairy Foods 181 1 181 1.5 271.5 CFSAN, Office of Nutritional Products, Labeling and Dietary Supplements 660 1 660 1.5 990 CFSAN, Office of Seafood 575 1 575 1.5 862.5 CVM 664 1 664 1 664 Total 21,170 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Based on center policy that allows multiple devices to appear on one certificate. Dated: January 13, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-845 Filed 1-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0011] Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; New Proposed and Final Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of several proposed and final documents that have been prepared by Study Groups 1, 2, 3, and 4 of the Global Harmonization Task Force (GHTF). These documents are intended to provide information only and represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents. DATES: Submit written or electronic comments on any of the proposed documents by April 25, 2006. After the close of the comment period, written comments or electronic comments may be submitted at any time to the contact persons listed in this document. ADDRESSES: Submit written requests for single copies on a 3.5″ diskette of the guidance documents to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: *For Study Group 1* : Ginette Y. Michaud, Chairperson, GHTF, Study Group 1, Office of Device Evaluation, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8913, ext.143. *For Study Group 2* : Mary Brady, GHTF, Study Group 2, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (HFZ-530), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-2102. *For Study Group 3* : Kimberly Trautman, GHTF, Study Group 3, Office of Compliance, Center for Devices and Radiological Health (HFZ-340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-276-0296. *For Study Group 4* : Jacqueline Welch, GHTF, Study Group 4, Office of Compliance, Center for Devices and Radiological Health (HFZ-320), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-276-0115. SUPPLEMENTARY INFORMATION: I. Background FDA has participated in a number of activities to promote the international harmonization of regulatory requirements. In September 1992, a meeting was held in Nice, France by senior regulatory officials to evaluate international harmonization. At this time it was decided to form a GHTF to facilitate harmonization. Subsequent meetings have been held on a yearly basis in various locations throughout the world. The GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific, and North America, each of which actively regulates medical devices using their own unique regulatory framework. The objective of the GHTF is to encourage convergence at the global level of regulatory systems of medical devices in order to facilitate trade while preserving the right of participating members to address the protection of public health by regulatory means considered most suitable. One of the ways this objective is achieved is by identifying and developing areas of international cooperation in order to facilitate progressive reduction of technical and regulatory differences in systems established to regulate medical devices. In an effort to accomplish these objectives, the GHTF formed five study groups to draft documents and carry on other activities designed to facilitate global harmonization. This notice is a result of documents that have been developed by four of the study groups (1, 2, 3, and 4). Study Group 1 was initially tasked with the responsibility of identifying differences between various regulatory systems. In 1995, the group was asked to propose areas of potential harmonization for premarket device regulations and possible guidance that could help lead to harmonization. As a result of its efforts, this group has developed proposed documents SG1/(PD)N015:2005 and SG1(PD)/N040:2005 and final documents SG1/N29R16:2005, SG1/N41R9:2005, and SG1/N43:2005. SG1(PD)N015:2005 (proposed document) entitled “Principles of Medical Devices Classification” assists a manufacturer to assign its medical device to an appropriate risk class using a set of harmonized principles. This document applies to products that have a medical purpose, as described in GHTF document SG1/N29:2005 entitled “Information Document Concerning the Definition of the Term ‘Medical Device,’” except for those devices used for the in vitro examination of specimens derived from the human body. SG1/(PD)/N040:2005 (proposed document) entitled “Principles of Conformity Assessment for Medical Devices” describes the evidence and procedures that may be used by the manufacturer to demonstrate that a medical device is safe and performs as intended by the manufacturer, and the process by which a Regulatory Authority, or Conformity Assessment Body, may confirm that the procedures are properly applied by the manufacturer. This document applies to all products that fall within the definition of a medical device, as described in GHTF document SG1/N29:2005 entitled “Information Document Concerning the Definition of the Term ‘Medical Device,’” except for those devices used for the in vitro examination of specimens derived from the human body. SG1/N29R16:2005 (final document) entitled “Information Document Concerning the Definition of the Term ‘Medical Device’” describes a harmonized definition of a medical device and provides information on products that may be considered to be medical devices in some jurisdictions. This document applies to products that have a medical purpose, including those used for the in vitro examination of specimens derived from the human body. SG1/N41R9:2005 (final document) entitled “Essential Principles of Safety and Performance of Medical Devices” is a revised version of previously published guidance on the subject and describes the six general requirements of safety and performance that apply to all medical devices and provides a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. This document applies to all products that fall within the definition of a medical device that appears within the GHTF document entitled “Information Document Concerning the Definition of the Term ‘Medical Device,’” including those used for the in vitro examination of specimens derived from the human body. The new guidance is intended to supersede the previous version of the guidance. SG1/N43:2005 (final document) entitled “Labelling for Medical Devices” describes harmonized principles for the labelling of medical devices and recommends harmonized content of labeling such as the device identity and intended purpose; how to use, maintain and store a device; residual risks; warnings and contraindications. This document applies to all products that fall within the definition of a medical device that appears within the GHTF document SG1/N29:2005 entitled “Information Document Concerning the Definition of the Term ‘Medical Device,’” including those used for the in vitro examination of specimens derived from the human body. The new guidance is intended to supersede the previous version of the guidance. Study Group 2 was initially tasked with the responsibility of developing guidance documents that will be used for the exchange of adverse event reports. As a result of its efforts, this group has developed proposed documents SG2(PD)/N54R6:2005, SG2(PD)/N57R6:2005, and SG2(PD)/N79R5:2005 and final document SG2/N38R14:2005. SG2/(PD)/N54R6:2005 (proposed document) entitled “Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices” provides guidance on the type of adverse events associated with medical devices that should be reported by manufacturers to a National Competent Authority (NCA). SG2(PD)/N57R6:2005 (proposed document) entitled “Medical Devices: Post Market Surveillance: Content of Field Safety Notices” identifies elements that should be included in safety related notifications issued by the medical device manufacturer. SG2/(PD)/N79R5:2005 (proposed document) entitled “Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form” provides guidance, procedures, and forms for the exchange of reports concerning the safety of medical devices between NCA and other participants of the GHTF National Competent Authority Report

(NCAR)exchange program. SG2/N38R15:2005 (final document) entitled “Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program” describes the prerequisites and commitments required from an organization before it can participate in the NCAR exchange program founded by GHTF SG2. Study Group 3 was initially tasked with the responsibility of developing guidance documents on quality systems. As a result of its efforts, this group has developed final document SG3/N15R8:2005. SG3/N15R8:2005 (final document) entitled “Implementation of Risk Management Principles and Activities within a Quality Management System” is intended to assist medical device manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. This document assumes a basic understanding of quality management system requirements and a basic knowledge of quality management system terminology. Study Group 4 was initially tasked with the responsibility of developing guidance documents on quality systems auditing practices. As a result of its efforts, this group has developed document SG4(PD)/N30R16:2005. SG4(PD)/N30R16:2005 (proposed document) entitled “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers—Part 2: Regulatory Auditing Strategy” is intended to assist medical device regulators and auditing organizations conducting quality management system audits of medical device manufacturers based on the process approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820). II. Significance of Guidance These documents represent recommendations from the GHTF study groups and do not describe regulatory requirements. FDA is making these documents available so that industry and other members of the public may express their views and opinions. III. Electronic Access Persons interested in obtaining a copy of the guidances may also do so by using the Internet. The Center for Devices and Radiological Health

(CDRH)maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. Information on the GHTF may be accessed at *http://www.ghtf.org* . The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding these documents. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 17, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-846 Filed 1-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)-443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Maternal and Child Health Bureau Performance Measures for Discretionary Grants (OMB No. 0915-0272) The Maternal and Child Health Bureau

(MCHB)intends to continue to collect performance data for Special Projects of Regional and National Significance (SPRANS), Community Integrated Service Systems (CISS), and other grant programs administered by MCHB. The Health Resources and Services Administration

(HRSA)proposes to continue using reporting requirements for SPRANS projects, CISS projects, and other grant programs administered by MCHB, including national performance measures, previously approved by OMB, and in accordance with the “Government Performance and Results Act

(GPRA)of 1993” (Pub. L. 103-62). This Act requires the establishment of measurable goals for Federal Programs that can be reported as part of the budgetary process, thus linking funding decisions with performance. Performance measures for MCHB discretionary grants were initially approved in January 2003. Approval from OMB is being sought to continue the use of these measures. The number of measures has been reduced with the transfer of a program to the Administration for Children and Families. The remaining performance measures are unchanged from those approved in 2003. Some of these measures are specific to certain types of programs, and will not apply to all grantees. Furthermore, these measures are based primarily on existing data, thereby minimizing the response burden consistent with program administration and management needs. The estimated response burden is as follows: Form Number of respondents Responses per respondent Total responses Burden per response Total burden hours Grant Report 631 1 631 6 3,786 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: January 19, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-893 Filed 1-24-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The Health Professions Student Loan

(HPSL)and Nursing Student Loan

(NSL)Programs: Forms (OMB No. 0915-0044): Extension The HPSL Program Provides long-term, low-interest loans to students attending schools of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, and pharmacy. The NSL Program provides long-term, low-interest loans to students who attend eligible schools of nursing in programs leading to a diploma in nursing, and an associate degree, a baccalaureate degree, or a graduate degree in nursing. Participating HPSL and NSL schools are responsible for determining eligibility of applicants, making loans, and collecting monies owed by borrowers on their outstanding loans. The deferment form (HRSA form 519) provides the schools with documentation of a borrower's eligibility for deferment. The Annual Operating Report (AORHRSA form 501) provides the Federal Government with information from participating and non-participating schools (schools that are no longer granting loans but are required to report and maintain program records, student records, and repayment records until all student loans are repaid in full and all monies due the Federal Government are returned) relating to HPSL and NSL program operations and financial activities. The estimate of burden is as follows: Form Number of respondents Responses per respondent Total responses Hours per responses Total burden hours Deferment HRSA-519 3,000 1 3,000 1 10 500 AOR-HRSA-501 977 1 977 2 4 3,908 Total Burden 3,977 3,977 4,408 1 Minutes. 2 Hours. Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: January 19, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-894 Filed 1-24-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request A Survey of Estimated Glomerular Filtration Rate

(GFR)Reporting Practices of Clinical Laboratories. *Summary:* In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of 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:* A Survey of Estimated GFR Reporting Practices of Clinical Laboratories: *Type of Information Collection Request:* New. *Need and Use of Information Collection:* This study will assess the level of U.S. clinical laboratory reporting of estimated GFR as a measure of kidney function. This will be accomplished through baseline and follow-up surveys of a representative sample of clinical laboratories in the U.S. Information will be used to establish baseline data necessary to measure an anticipated increased in use of estimated GFR, following the implementation of the NKDEP's communications and Lab Working Group

(LWG)activities promoting use of estimated GFR for patients at risk for kidney disease. The LWG, whose members are experts in their field, strongly believes that routine reporting of estimated GFR will result in a significant increase in early detection of chronic kidney disease, therefore enabling treatment that can slow or prevent patients' progression to kidney failure. *Frequency of Response:* Baseline survey only. *Affected Public:* Clinical laboratory community. *Type of Respondents:* Laboratory directors. The annual reporting burden is as follow: *Estimated Number of Respondents:* Anticipate 4,126 completed surveys; *Estimated Number of Responses per Respondent:* Respondents will complete one paper-and-pencil or online survey; *Average Burden Hours Per Response:* .083 hours [5 minutes]; and *Estimated Total Annual Burden Hours Requested:* 342.46 hours. The annualized total cost to respondents is estimated at $11,759.10. ( **Note:** Completing this survey is similar to other data reporting carried out by lab directors. Since lab directors will be able to responded to the survey within their usual workday, this collection of information will not cost labs.employers additional time and money.) There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Annual total burden hours requested Clinical Laboratory Directors 4,126 1.0 .083 342.46 Total 4,126 1.0 .083 342.46 *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 responded, 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 Elisa Gladstone, MPH, Project Officer, Associate Director, National Kidney Disease Education Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Building 31, Center Dr., Room 9A06, Bethesda, MD 20892, or call non-toll free number

(301)435-8116 or e-mail your request, including your address to, *gladstonee@niddk.nih.gov.* *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: January 17, 2006. Elisa H. Gladstone, MPH, Project Officer, Associate Director, National Kidney Disease Education Program, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. [FR Doc. 06-704 Filed 1-24-06; 8:45 am]

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