Notices. Notice
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/register/2006/03/10/06-2270A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration. ACTION: Notice. The Food and Drug Administration
(FDA)is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the **Federal Register** of February 1, 2006 (71 FR 5343). The amendment is being made to reflect a change in the *Date and Time* and *Agenda* portions of the document. The starting time of the meeting has been moved to 7:30 a.m. and the committee will now also hear and discuss information on cardiovascular adverse events possibly related to ADHD medications. There are no other changes. FOR FURTHER INFORMATION CONTACT: Jan N. Johannessen, Office of Science and Health Coordination (HF-33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14C-06), Rockville, MD 20857, 301-827-6687, e-mail: *Jan.Johannessen@fda.hhs.gov* , or the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of February 1, 2006, FDA announced that a meeting of the Pediatric Advisory Committee would be held on March 22, 2006, from 8 a.m. to 6 p.m., and that the committee would receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications. On page 5343, in the first column, the *Date and Time* portion of the document is amended to read as follows: *Date and Time* : The meeting will be held on March 22, 2006, from 7:30 a.m. to 6 p.m. On page 5343, in the second column, the *Agenda* portion of the document is amended to read as follows: *Agenda* : The Pediatric Advisory Committee will hear and discuss a report by the agency, as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports possibly related to clofarabine (CLOLAR), irbesartan (AVAPRO), sibutramine (MERIDIA), and the mixed salts amphetamine product (ADDERALL). In continuation of a prior committee discussion of adverse events for the class of methylphenidate products used to treat attention deficit hyperactivity disorder (ADHD), the committee will hear and discuss neuropsychiatric adverse events possibly related to other approved ADHD medications. The presentations will focus on neuropsychiatric adverse event reports and clinical trial data from approved ADHD medications. The committee will also hear and discuss information on cardiovascular adverse events possibly related to ADHD medications. The background material will become available no later than the day before the meeting and will be posted under the Pediatric Advisory Committee Docket site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* . (Click on the year 2006 and scroll down to Pediatric Advisory Committee meetings.) This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: March 3, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-3435 Filed 3-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0343] Guidance for Industry and Food and Drug Administration; Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the guidance entitled “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.” This guidance provides recommendations intended to reduce life-threatening entrapments associated with hospital bed systems. It characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, recommends dimensional criteria for bed systems, provides information about legacy beds including information to include when reporting entrapment adverse events, and provides the Hospital Bed Safety Workgroup
(HBSW)test methods for assessing gaps. 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 “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment” 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: Jay A. Rachlin, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3173. SUPPLEMENTARY INFORMATION: I. Background This guidance identifies special issues associated with hospital bed systems and provides recommendations intended to reduce life-threatening entrapments associated with these devices. Manufacturers may use this guidance to assess current hospital bed systems and to assist in the design of new beds. This guidance may be used as part of a bed safety program to help identify entrapment risks that may exist with current hospital bed systems. Previously, FDA announced the availability of a draft guidance document entitled “Hospital Bed System Dimensional Guidance to Reduce Entrapment” in the **Federal Register** of August 30, 2004 (69 FR 52907). FDA invited interested persons to comment on the guidance document by November 29, 2004. FDA received over 110 comments. FDA changed the draft guidance based on the comments received. The changes include the following:
(1)Addition of the HBSW test methods for assessing gaps and
(2)addition of the use of a test tool for assessing the potential for head and neck entrapment. II. Significance of Guidance 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 appropriate dimensional limits for, and assessment of, gaps in hospital bed systems to prevent entrapment. 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 the “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment,” you may either send a fax request to 301-443-8818 to receive a hard copy of the document, or send an e-mail request to *GWA@CDRH.FDA.GOV* to receive a hard copy or an electronic copy. Please use the document number
(1537)to identify the guidance you are requesting. 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. 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. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3369 Filed 3-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0088] Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft document entitled “Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines,” dated March 2006. The draft document is intended to provide to sponsors of pandemic influenza vaccines guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines for the prevention of disease caused by pandemic influenza viruses. The draft guidance provides recommendations for clinical data to support biologics license application
(BLA)license approval either as a supplement or as a new BLA using the accelerated approval pathway. DATES: Submit written or electronic comments on the draft guidance by June 8, 2006 to ensure their adequate consideration in preparation of the final guidance. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling the Center for Biologics Evaluation and Research at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the 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* . FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled “Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines,” dated March 2006. The draft guidance is intended to provide to sponsors of pandemic influenza vaccines guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines for the prevention of disease caused by pandemic influenza viruses. The approaches apply to “split virus” and whole virus inactivated pandemic vaccines propagated in embryonated chicken eggs, and are also applicable to cell-culture derived, recombinant hemagglutinin-based protein, and adjuvanted pandemic influenza vaccines. The draft guidance provides recommendations for clinical data to support BLA approval either as a supplement or as a new BLA using the accelerated approval. The draft guidance also addresses live attenuated influenza vaccines, but does not address influenza vaccines that do not contain a hemagglutinin component. The draft guidance does not address the nonclinical development of investigational vaccines, or the chemistry, manufacturing, control, or inspection of the manufacturing facility needed for licensure. The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the draft guidance. 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. A copy of 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. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either *http://www.fda.gov/cber/guidelines.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: March 1, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3371 Filed 3-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0083] Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft document entitled “Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines,” dated March 2006. The draft guidance document is intended to provide to sponsors of trivalent inactivated influenza vaccines guidance on the clinical data needed to support a Biologics License Application (BLA). The draft guidance summarizes clinical development approaches to facilitate and expedite the licensure of new trivalent inactivated influenza vaccines and addresses both traditional and accelerated approval. DATES: Submit written or electronic comments on the draft guidance by June 8, 2006 to ensure their adequate consideration in preparation of the final guidance. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the 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* . FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled “Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines,” dated March 2006. The draft guidance is intended to provide to sponsors of trivalent inactivated influenza vaccines guidance on the clinical data needed to support a BLA. The draft guidance summarizes clinical development approaches to facilitate and expedite the licensure of new “split virus” trivalent inactivated influenza vaccines and addresses both traditional and accelerated approval. The approaches are also applicable to vaccines made with other manufacturing processes; e.g., whole virus inactivated, cell-culture based inactivated, recombinant protein, and adjuvanted influenza vaccines. The draft guidance does not address live attenuated influenza vaccines or influenza vaccines that do not contain a hemagglutinin component. The draft guidance also does not address the nonclinical development of investigational vaccines, or the chemistry, manufacturing, control, or inspection of the manufacturing facility needed for licensure. The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The information collection provisions in this guidance for 21 CFR part 601 have been approved under OMB control number 0910-0338. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the draft guidance. 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 the brackets in the heading of this document. A copy of 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. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either *http://www.fda.gov/cber/guidelines.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: February 28, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3370 Filed 3-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Practitioner Data Bank: Change in User Fees AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), is announcing a fifty cent increase in the fee charged to entities authorized to request information from the National Practitioner Data Bank
(NPDB)for all queries. The new fee will be $4.75. There will be no change to the $8.00 self-query fee. DATES: This change will be effective May 9, 2006. FOR FURTHER INFORMATION CONTACT: Mark Pincus, Branch Chief, Practitioner Data Banks Branch, Office of Workforce Evaluation and Quality Assurance, Bureau of Health Professions, Health Resources and Services Administration, Parklawn Building, Rm 8C-103, 5600 Fishers Lane, Rockville, MD 20857, Tel: 301-443-2300, E-mail: *policyanalysis@hrsa.gov.* SUPPLEMENTARY INFORMATION: The current fee structure ($4.25 per name) was announced in the **Federal Register** on April 22, 2003 (68 FR 19837) and became effective on July 1, 2003. All entity queries are submitted and query responses received through the NPDB's Integrated Query and Reporting Service
(IQRS)and paid via an electronic funds transfer or credit card. The NPDB is authorized by the Health Care Quality Improvement Act of 1986 (the Act), Title IV of Public Law 99-660, as amended (42 U.S.C. 11101 *et seq.* ). Section 427(b)(4) of the Act authorizes the establishment of fees for the costs of processing requests for disclosure and of providing such information. Final regulations at 45 CFR part 60 set forth the criteria and procedures for information to be reported to and disclosed by the NPDB. Section 60.3 of these regulations defines the terms used in this announcement. In determining any changes in the amount of the user fee, the Department uses the criteria set forth in section 60.12(b) of the regulations, as well as allowable costs pursuant to Public Law 109-77, as amended, and Title II, Division F, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act for the Consolidated Appropriations Act, 2005, Public Law 108-447. These laws require that the Department recover the full costs of operating the Data Bank through user fees. Paragraph
(b)of the regulations states: “The amount of each fee will be determined based on the following criteria:
(1)Use of electronic data processing equipment to obtain information—the actual cost for the service, including computer search time, runs, printouts, and time of computer programmers and operators, or other employees,
(2)Photocopying or other forms of reproduction, such as magnetic tapes—actual cost of the operator's time, plus the cost of the machine time and the materials used,
(3)Postage—actual cost, and
(4)Sending information by special methods requested by the applicant, such as express mail or electronic transfer—the actual cost of the special service.” Based on analysis of the comparative costs of the various methods for filing and paying for queries, the Department is increasing all the entity query fees by $0.50 per name. The practitioner self-query fee remains at $8.00. This price increase is justified after an evaluation of the Data Bank's operational costs. At the current fee of $4.25, the Data Bank is unable to recover full costs of operation. In keeping with the Act, and pursuant to the requirements of section 60.12 of the regulations, there are not sufficient funds to recover the full costs of operating the Data Bank without a fee increase. When a query is for information on one or more physicians, dentists or other health care practitioners, the appropriate fee will be $4.75 multiplied by the number of individuals about whom information is being requested. For examples, see the table below. Query method Fee per name in query Examples Entity query (via internet with electronic payment) $4.75 10 names in query. 10 × $4.75 = $47.50. Practitioner self-query 8.00 One self-query = $8.00. The Department will continue to review the user fee periodically, and will revise it as necessary. Any changes in the fee and their effective date will be announced in the **Federal Register** . Dated: March 3, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-3323 Filed 3-9-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Healthcare Integrity and Protection Data Bank: Change in User Fees AGENCY: Office of Inspector General (OIG), HHS. ACTION: Notice. SUMMARY: In accordance with final regulations at 45 CFR part 61, implementing the Healthcare Integrity and Protection Data Bank (HIPDB), the Department is authorized to assess a fee on all requests for information, except requests from Federal agencies. In accordance with § 61.13 of the HIPDB regulations, the Department is announcing an adjustment from $4.25 to $4.75 in the fee charged for each query submitted by authorized entities. There will be no change to the current $8 self-query fee. EFFECTIVE DATE: This change will be effective May 9, 2006. FOR FURTHER INFORMATION CONTACT: Joel Schaer, Office of External Affairs,
(202)619-0089. SUPPLEMENTARY INFORMATION: User Fee Amount Section 1128E(d)(2) of the Social Security Act (the Act), as added by section 221(a) of the Health Insurance Portability and Accountability Act of 1996, specifically authorizes the establishment of fees for the costs of processing requests for disclosure and for providing information from the Healthcare Integrity and Protection Data Bank (HIPDB). Final regulations at 45 CFR part 61 set forth the criteria and procedures for information to be reported to and disclosed by the HIPDB. The Act also requires that the Department recover the full costs of operating the HIPDB through such user fees. In determining any changes in the amount of the user fee, the Department employs the criteria set forth in § 61.13(b) of the HIPDB regulations. Specifically, § 61.13(b) states that the amount of each fee will be determined based on the following criteria: • Direct and indirect personnel costs; • Physical overhead, consulting, and other indirect costs, including rent and depreciation on land, buildings, and equipment; • Agency management and supervisory costs; • Costs of enforcement, research, and establishment of regulations and guidance; • Use of electronic data processing equipment to collect and maintain information, i.e., the actual cost of the service, including computer search time, runs, and printouts; and • Any other direct or indirect costs related to the provision of services. The current fee structure of $4.25 for each separate query submitted by authorized entities was announced in a **Federal Register** notice on April 22, 2003, (68 FR 19838) and became effective on July 1, 2003. Based on the above criteria and our analysis of operational costs and the comparative costs of the various methods for filing and paying for queries, the Department is now raising the fee by $.50 cents, from $4.25 to $4.75, for each query submitted by authorized entities. The practitioner self-query fee will remain at $8 and the investigative research fee will remain at $10. When an authorized entity query is submitted for information on one or more health care practitioners, providers, or suppliers, the appropriate total fee will be $4.75 multiplied by the number of individuals or organizations about which information is being requested. To minimize administrative costs, the Department will accept queries submitted by authorized entities by credit card or electronic funds transfer. The Department will continue to accept payment for self-queries only by credit card. The HIPDB accepts Visa, MasterCard, and Discover. To submit queries, registered entities (including law enforcement agencies) must use the HIPDB Web site at *http://www.npdb-hipdb.com.* The Department will continue to review the user fee periodically and will revise it as necessary. Any future changes in the fee and its effective date will be announced through a notice in the **Federal Register** . Examples Query method Fee per name in query, by method of payment Examples Authorized entity query $4.75 10 names in query: 10 × $4.75 = $47.50. Self-query 8.00 10 self-queries: 10 × $8 = $80. Investigative research query 10.00 10 investigative research queries: 10 × $10 = $100. Dated: March 3, 2006. Daniel R. Levinson, Inspector General. [FR Doc. E6-3378 Filed 3-9-06; 8:45 am] BILLING CODE 4152-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting 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 meeting. The meeting 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 grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Cancer Institute Initial Review Group, Subcommittee C—Basic & Preclinical. *Date:* April 9-10, 2006. *Time:* 6 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Marriott Bethesda North Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. *Contact Person:* Michael B. Small, PhD, Scientific Review Administrator, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, Room 8127, Bethesda, MD 20892, 301-402-0996, *smallm@mail.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: March 3, 2006 Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-2270 Filed 3-9-06; 8:45 am]
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U.S. Code
8 references not yet in our index
- 21 CFR 14
- 44 USC 3501-3520
- 21 CFR 601
- Pub. L. 99-660
- 45 CFR 60
- Pub. L. 109-77
- Pub. L. 108-447
- 45 CFR 61
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Notices
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Cite21 CFR 14
Cite44 USC 3501-3520
Cite21 CFR 601
Pub. L.Pub. L. 99-660
Cite45 CFR 60
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