Notices. Notice

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on Public Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory Committee, Transmissible Spongiform Encephalopathies Advisory Committee, and the Vaccines and Related Biological Products Advisory Committee in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will or may occur through December 31, 2006. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups. DATES: Because scheduled vacancies occur on various dates throughout each year, no cutoff date is established for the receipt of nominations. However, when possible, nominations should be received at least 6 months before the date of scheduled vacancies for each year, as indicated in this notice. ADDRESSES: All nominations and curricula vitae should be sent to the contact person listed in the FOR FURTHER INFORMATION CONTACT section of this document. FOR FURTHER INFORMATION CONTACT: Donald Jehn, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, e-mail: *donald.jehn@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting members with appropriate expertise for vacancies listed as follows: **Table** 1. Advisory Committee and Expertise Needed to Fill Vacancies No. of Vacancies Approximate Date Members are Needed Allergenic Products Advisory Committee—allergy, immunology, pediatrics, internal medicine, biochemistry, statistics, and related scientific fields 1 1 As soon as possible August 31, 2006 Blood Products Advisory Committee—clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, statistics, biological and physical sciences, biotechnology, computer technology, epidemiology, consumer advocacy, sociology/ethics, and other related professions 2 1 As soon as possible September 30, 2006 Cellular, Tissue, and Gene Therapies Advisory Committee—cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation including biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics 2 March 31, 2006 Transmissible Spongiform Encephalopathies Advisory Committee—clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, consumer advocacy, sociology/ethics, and other related professions 3 As soon as possible Vaccines and Related Biological Products Advisory Committee—immunology, molecular biology, rDNA, virology, bacteriology, epidemiology, biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, biochemistry, and other related scientific fields 4 As soon as possible I. Functions A. Allergenic Products Advisory Committee The committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic diseases. B. Blood Products Advisory Committee The committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood and products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases. C. Cellular, Tissue and Gene Therapies Advisory Committee The committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion, and transfer in the prevention and treatment of a broad spectrum of human diseases and in reconstruction, repair, or replacement of tissues for various conditions. D. Transmissible Spongiform Encephalopathies Advisory Committee The committee reviews and evaluates available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health. E. Vaccines and Related Biological Products Advisory Committee The committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases. II. Qualifications Persons nominated for membership on the committees shall have adequately diversified experience appropriate to the work of the committee in such fields as clinical and administrative medicine, engineering, biological and physical sciences, statistics, and other related professions. The nature of specialized training and experience necessary to qualify the nominee as an expert suitable for appointment may include experience in medical practice, teaching, and/or research relevant to the field of activity of the committee. The particular need for vacancies on each committee for the calendar year 2006 is shown in Table 1 of this document. The term of office is up to 4 years, depending on the appointment date. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on one or more of the advisory committees. Self-nominations are also accepted. Nominations shall include the name of the committee, a complete curriculum vitae of each nominee, current business address and telephone number, and shall state that the nominee is aware of the nomination, is willing to serve as a member (name of committee(s) must be specified), and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees. Dated: February 7, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-2071 Filed 2-14-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006F-0058] ARCH Chemicals, Inc.; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that ARCH Chemicals, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (iminoimidocarbonyliminoimido- carbonyliminohexamethylene) hydrochloride (CAS Reg. No. 32289-58-0) as an antimicrobial agent in the manufacture of food-contact paper and paperboard. FOR FURTHER INFORMATION CONTACT: Elizabeth R. Sanchez, Center for Food Safety and Applied Nutrition (HFS 275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1239. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 6B4764) has been filed by ARCH Chemicals, Inc., 1955 Lake Park Dr., suite 100, Smyrna, GA 30080. The petition proposes to amend the food additive regulations in § 176.170 *Components of paper and paperboard in contact with aqueous and fatty foods* and § 176.180 *Components of paper and paperboard in contact with dry food* to provide for the safe use of poly (iminoimidocarbonyliminoimido- carbonyliminohexamethylene) hydrochloride (CAS Reg. No. 32289-58-0) as an antimicrobial agent in the manufacture of food-contact paper and paperboard. The agency has determined under 21 CFR 25.32(q) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. Dated: January 25, 2006. Laura M. Tarantino, Director, Office of Food Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E6-2137 Filed 2-14-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006F-0059] Danisco USA, Inc.; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that Danisco USA, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of polydextrose as a bulking agent, formulation aid, humectant and texturizer in all foods, except meat and poultry. DATES: Submit written or electronic comments on the petitioner's environmental assessment by March 17, 2006. ADDRESSES: Submit written comments 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* . FOR FURTHER INFORMATION CONTACT: Paul C. DeLeo, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1302. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 6A4763) has been filed by Danisco USA, Inc., 440 Saw Mill River Rd., Ardsley, NY 10502-2605. The petition proposes to amend the food additive regulations in § 172.841 *Polydextrose* (21 CFR 172.841) to provide for the safe use of polydextrose as a bulking agent, formulation aid, humectant, and texturizer in all foods, except meat and poultry. The proposed amendment would consolidate all existing food use categories and permit additional uses not allowed by the existing regulation. The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management (see ADDRESSES ) for public review and comment. Interested persons may submit to the Division of Dockets Management written or electronic comments by March 17, 2006. Two copies of any written comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the **Federal Register** . If, based on its review, the agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the **Federal Register** in accordance with 21 CFR 25.51(b). Dated: January 25, 2006. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E6-2130 Filed 2-14-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0505] Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” This guidance document describes a means by which the implantable intra-aneurysm pressure measurement system may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for implantable intra-aneurysm pressure measurement systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies on a 3.5” diskette of the guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System” 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: Nelson Anderson, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8282, ext. 171. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule classifying an implantable intra-aneurysm pressure measurement system into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document will serve as the special control for implantable intra-aneurysm pressure measurement systems. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device into class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after issuance of an order classifying the device, FDA must publish a notice in the **Federal Register** announcing such classification. On August 4, 2005, FDA classified the implantable intra-aneurysm measurement system into class III, because it was not substantially equivalent to a device that was introduced into interstate commerce for commercial distribution before May 28, 1976. On August 9, 2005, CardioMEMS, Inc., submitted a petition requesting classification of the CardioMEMS EndoSensor System under section 513(f)(2) of the act to be classified into class II. After review of the information submitted in the petition, FDA determined that the CardioMEMS EndoSensor System can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device. Therefore, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA's GGPs regulation (21 CFR 10.115). The guidance represents the agency's current thinking on implantable intra-aneurysm pressure measurement systems. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access To receive “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System” by fax machine, call the Center for Devices and Radiological Health

(CDRH)Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number

(1589)followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so by using the Internet. 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. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information in this guidance document have been approved under OMB Control. No. 0910-0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 6, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-2142 Filed 2-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D-0420] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Bone Sonometers.” The draft guidance was developed to support the reclassification of bone sonometers from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the **Federal Register** , FDA is publishing a proposed rule to reclassify these devices accordingly. This draft guidance is neither final nor is it in effect at this time. DATES: Submit written or electronic comments on the draft guidance by May 16, 2006. ADDRESSES: Submit written requests for single copies on a 3.5″ diskette of the draft guidance document entitled “Class II Special Controls Guidance Document: Bone Sonometers” 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 draft 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: Robert A. Phillips, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1212, ext. 130. SUPPLEMENTARY INFORMATION: I. Background This draft guidance provides FDA's recommendations to manufacturers of bone sonometers for identifying risks to health and mitigation measures that can be taken to offset those risks. Bone sonometers are devices that transmit ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. These devices were classified into class III by statute (section 513(f)(1) of the Federal Food, Drug, and Cosmetic (the act) (21 U.S.C. 360e(f)(i))), however, FDA believes that sufficient information exists to establish special controls that, when followed and combined with the general controls of the act, would provide reasonable assurance of the safety and effectiveness of these devices. II. Significance of the Guidance This draft guidance is being issued consistent with FDA's good guidance practice regulation (21 CFR 10.115). The draft guidance, if finalized, would represent the agency's current thinking on bone sonometers. It would not create or confer any rights for or on any person and would not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information addressed in the draft guidance have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910-0120), which expires May 31, 2007. The labeling provisions addressed in the draft guidance have been approved by OMB under the PRA under OMB control number 0910-0485 and expires June 30, 2008. IV. Comments Interested persons may submit written or electronic comments on the draft guidance to the Division of Dockets Management (see ADDRESSES ). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that an individual may submit one paper copy. Identify comments with the docket number found in brackets in the heading of this document. The draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access The Center for Devices and Radiological Health

(CDRH)Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . To receive a copy of “Class II Special Controls Guidance Document: Bone Sonometers,” by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number

(1547)followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the draft guidance may also do so by using the Internet. CDRH maintains a site 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. Dated: January 17, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-2078 Filed 2-14-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D-0001] (formerly 03D-0001) Guidance for Industry on Nonclinical Safety Evaluation of Pediatric Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance for industry entitled “Nonclinical Safety Evaluation of Pediatric Drug Products.” This document provides guidance on the role and timing of animal studies in the nonclinical safety evaluation of therapeutics intended for the treatment of pediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in pediatric patients and makes recommendations on nonclinical testing. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Karen L. Davis Bruno, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3108, Silver Spring, MD 20993-0002, 301-796-2290. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled “Nonclinical Safety Evaluation of Pediatric Drug Products.” Many therapeutics marketed in the United States and used in pediatric patients lack adequate information in the labeling for use in that population. Recent FDA regulations have focused attention on current practices for evaluating drug safety in this population. Traditionally, safety data from clinical studies in adults, supported by nonclinical studies in adult animals, have been used to support the use of a drug in pediatric patients. These studies may not always assess possible drug effects on developmental processes specific to pediatric age groups. Some effects may be very difficult to detect in clinical trials or during routine postmarketing surveillance. In the **Federal Register** of February 3, 2003 (68 FR 5301), FDA announced the availability of a draft version of this guidance entitled “Nonclinical Safety Evaluation of Pediatric Drug Products.” Interested persons had the opportunity to submit comments. Based on the public comments received, changes to wording have been added for clarity and the guidance has been finalized. This document provides guidance on the role and timing of animal studies in the safety evaluation of therapeutics intended for the treatment of pediatric patients. It is intended to serve as a resource for general considerations in testing and provide specific recommendations based on available science and pragmatic considerations. The scope of this guidance is limited to safety effects that cannot be reasonably, ethically, and safely assessed in pediatric clinical trials. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on nonclinical safety evaluation of pediatric drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. 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. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: February 8, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-2139 Filed 2-14-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)), the Health Resources and Services Administration

(HRSA)will publish periodic summaries of proposed projects being developed for submission to the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper 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. Proposed Project: Assessment of the Engagement of Historically Black Colleges and Universities in Campus and Community-based Activities To Eliminate Health Disparities

(NEW)The Health Resources and Services Administration

(HRSA)plans to conduct a survey of 525 university administrators at Historically Black Colleges and Universities (HBCUs) to collect information not otherwise available about the extent to which HBCUs have engaged in health promoting activities on campus and in their surrounding communities that are designed to eliminate health disparities among African Americans. The results of this survey will be used by HRSA's Office of Minority Health and Health Disparities (OMHHD) to obtain information regarding the engagement of HBCUs in health disparities activities. The results of the survey will also permit OMHHD

(1)to describe the origins, structure, content, and intensity of such activities,

(2)to document the level of support for campus and community activities among administrative leaders at HBCUs,

(3)to document the factors that facilitate or hinder the ability of HBCUs to engage in campus and community activities to eliminate health disparities, and

(4)to determine whether there is a need among HBCUs for additional assistance that will allow them to expand their role and improve their effectiveness in addressing health disparities. The survey process will include a web-based survey to be completed by targeted respondents. Follow-up telephone calls will be conducted with respondents who do not complete the online survey. Approximately 5 administrators will be surveyed at each of the 105 recognized HBCUs. The types of administrators to be surveyed include Presidents, Deans of Faculty, Deans of Students, and staff and/or faculty that are leaders for programs that are associated with eliminating health disparities. The estimated burden of data collection is as follows: The burden estimate for this project is as follows: Form Number of respondents Average number of responses per respondent Total responses Hours per response Total burden hours Survey 525 1 525 0.50 262.5 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received within 60 days of this notice. Dated: February 9, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-2069 Filed 2-14-06; 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 In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper 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

(NHSC)Scholarship Program (OMB No. 0915-0146): Extension The National Health Service Corps

(NHSC)Scholarship Program's mission is to ensure the geographic representation of physicians and other health practitioners in the United States. Under this program, health professions students are offered scholarships in return for service in a federally designated Health Professional Shortage Area (HPSA). The Scholarship Program provides the NHSC with the health professionals it requires to carry out its mission of providing primary health care to HPSA populations in areas of greatest need. Students are supported who are well qualified to participate in the NHSC Scholarship Program and who want to assist the NHSC in its mission, both during and after their period of obligated service. Scholars are selected for these competitive awards based on the information provided in the application and during the semi-structured personal interview that is conducted by a team of two interviewers who use a structured scoring procedure. Awards are made to applicants who demonstrate a high potential for providing quality primary health care services. The estimated response burden is as follows: Form Number of respondents Responses per respondent Hours per response Total burden hours Application 1800 1 1 1800 Interview 900 1 1 900 Total 2700 2700 Written comments and recommendations concerning the proposed information collection should be sent within 60 days of this notice to: Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 10857. Dated: February 9, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-2072 Filed 2-14-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Cancer Institute Special Emphasis Panel; SBIR Topic 226 “A Clinical Decision Support Tool To Promote Evidence-Based Screening and Intervention in Tobacco Users”. *Date:* March 21, 2006. *Time:* 10:45 a.m. to 1 p.m. *Agenda:* To review and evaluate contract proposals. *Place:* National Institutes of Health, 6116 Executive Boulevard, Conference Room 611, Rockville, MD 20852. (Telephone Conference Call.) *Contact Person:* Gail J. Bryant, Medical Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, National Institute of Health, 6116 Executive Boulevard, Room 8111, MSC 8328, Bethesda, MD 20852-8328.

(301)402-0801. *gb30t@nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: February 7, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-1379 Filed 2-14-06; 8:45 am]

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