Notices. Notice

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BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0185] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Identifiable 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 October 6, 2006. ADDRESSES: 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: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. 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: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that Are Not Individually Identifiable—(OMB Control Number 0910-0582)—Extension FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety and with ethical standards. Investigators should have freedom to pursue the least burdensome means of accomplishing this goal. However, to ensure that the balance is maintained between product development and the protection of public health, safety and ethical standards, FDA has established human subject protection regulations addressing requirements for informed consent and Institutional Review Committee

(IRB)review that apply to all FDA-regulated clinical investigations involving human subjects. In particular, informed consent requirements further both safety and ethical considerations by allowing potential subjects to consider both the physical and privacy risks they face if they agree to participate in a trial. Under FDA regulations, clinical investigations using human specimens conducted in support of premarket submissions to FDA are considered human subject investigations (see 21 CFR 812.3(p)). Many investigational device studies are exempt from most provisions of part 812 (21 CFR part 812), Investigational Device Exemptions, under § 812.2(c)(3), but FDA's regulations for the protection of human subjects (parts 50 and 56 (21 CFR parts 50 and 56)) apply to all clinical investigations that are regulated by FDA (see §§ 50.1 and 56.101, 21 U.S.C. 360j(g)(3)(A) and (g)(3)(D)). FDA regulations do not contain exceptions from the requirements of informed consent on the grounds that the specimens are not identifiable or that they are remnants of human specimens collected for routine clinical care or analysis that would otherwise have been discarded. Nor do FDA regulations allow IRBs to decide whether or not to waive informed consent for research involving leftover or unidentifiable specimens. In a level 1 guidance document issued under the good guidance practices

(GGP)regulations (21 CFR 10.115), FDA outlines the circumstances in which it intends to exercise enforcement discretion as to the informed consent regulations for clinical investigators, sponsors, and IRBs. In the **Federal Register** of May 19, 2006 (71 FR 29158), FDA published a 60-day notice requesting comments on the information collection provisions. In response to this notice, no comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** No. of Recordkepers Annual Frequency per Recordkeeper Total annual Records Hours per Record Total Hours Total Capital Cost Total Operating and Maintenance Cost 700 1 700 4 2,800 $210,000 $210,000 The recommendations of this guidance impose a minimal burden on industry. FDA estimates that 700 studies will be affected annually. Each study will result in one recordkeeping per year, estimated to take 4 hours to complete. This results in a total recordkeeping burden of 2,800 hours. (700 x 4 = 2,800). FDA estimates that the cost of developing standard operating procedures ( SOPs) for each recordkeeper is $300 (6 hours of work x $50 /hour. This results in a total operational and maintenance cost to industry of $210,000 ($300 x 700 recordkeepers). The total cost of this recordkeeping (i.e., capital cost plus operational and maintenance cost) is estimated to be $420,000. Dated: August 28, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-14671 Filed 9-5-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). *Dates and Times:* September 28, 2006, 1 to 5 p.m.; September 29, 2006, 1 to 5 p.m. *Place:* Teleconference meeting. *Status:* The meeting will be open to the public. *Purpose:* The Committee will be focusing on interdisciplinary training and education, specifically examining evidence-based models/research as regards interdisciplinary training and community-based training programs. In addition, the Committee will be looking at the potential impact of interdisciplinary training programs on health service delivery networks including how such training programs address the needs of various underserved populations. The meeting will allow Committee members to discuss and finalize appropriate findings and recommendations to be included in an annual report to the Secretary and Congress regarding interdisciplinary and/or community-based training. *Agenda:* The agenda includes an overview of the Committee's general business activities and minutes of the prior meeting. The Committee will review recommendations that are being developed following the testimony provided by experts on interdisciplinary training and/or community-based training during the Advisory Committee meeting held on July 24-25, 2006. The recommendations discussed, when finalized, will be prepared as a report to the Secretary and the Congress. Agenda items are subject to change as priorities indicate. *For Further Information Contact:* Anyone requesting information regarding the Committee meeting should contact Lou Coccodrilli, Federal Official for the ACICBL, and Acting Director of the Division of State, Community & Public Health, Bureau of Health Professions, Health Resources and Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857; Telephone

(301)443-6590. Vanessa Saldanha, ASPH Fellow, can also be contacted at *vsaldanha@hrsa.gov* or via telephone at

(301)443-6529. Dated: August 29, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6-14747 Filed 9-5-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* National Advisory Council on the National Health Service Corps. *Dates and Times:* September 14, 2006, 12 p.m.-5 p.m.; September 15, 2006, 9 a.m.-5 p.m.; September 16, 2006, 9 a.m.-5 p.m.; and September 17, 2006, 9 a.m.-12 p.m. *Place:* Hyatt Regency Reston, 1800 Presidents Street, Reston, VA 20190. *Status:* The meeting will be open to the public. *Agenda:* This Council meeting is being held in conjunction with the annual NHSC Loan Repayors Conference. The Council will have the chance to meet with clinicians in the field as well as work on their report outlining some recommendations for the National Health Service Corps Program. Discussions will be focused on the impact of these recommendations on the program participants, communities served by these clinicians and in the administration of the program. *For Further Information Contact:* Tira Robinson-Patterson, Division of National Health Service Corps, Bureau of Health Professions, Health Resources and Services Administration, Parklawn Building, Room 8A-55, 5600 Fishers Lane, Rockville, MD 20857; telephone:

(301)594-4140. Dated: August 29, 2006. Cheryl Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6-14752 Filed 9-5-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority; Correction AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice; correction. SUMMARY: The Health Resources and Services Administration published a document in the **Federal Register** on August 11, 2006, concerning changes to the organization and functions of the Office of the Administrator

(RA)and the HIV/AIDS Bureau (RV). The document omitted information regarding movement of the Center for Quality and also erroneously included the Telehealth function within the HIV/AIDS Bureau, which was moved to the Office of Health Information Technology

(RT)on 12/27/05 (70 FR 76463-76465). FOR FURTHER INFORMATION CONTACT: Wendy Ponton, Director, Division of Management Services, Office of Administration and Financial Management, Health Resources and Services Administration, 5600 Fishers Lane, Room 14A-08, Rockville, Maryland 20857; telephone: 301-443-0201. Correction In the **Federal Register** issue of August 11, 2006, in FR Doc. E6-13216, on page 46237, in the second column, correct the second paragraph in the Statement of Organization, Functions and Delegations of Authority section to read: This notice reflects changes to the organization and functions of the Office of the Administrator

(RA)and the HIV/AIDS Bureau (RV). Specifically, it moves the Center for Quality function from the HIV/AIDS Bureau to the Office of the Administrator. On page 46237, in the third column, under Section RV-20, Functions, delete item (10), and renumber list accordingly. Dated: August 30, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-14748 Filed 9-5-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Preventing Motor Vehicle Crashes Among Young Drivers *Summary:* Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health

(NIH)has submitted to the Office of Management and Budget

(OMB)a request for review and approval of the information collection listed below. This proposed information collection was previously published in the **Federal Register** on June 13, 2006, page 34142, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection *Title: Preventing Motor Vehicle Crashes Among Young Drivers, OMB No. 0925-new.* *Type of Information Collection Request:* New. *Need and Use of Information Collection:* Motor vehicle crash risk is particularly elevated among novice young drivers during the first six months and 1000 miles of independent driving. Previously, researchers in the Prevention Research Branch of the NICHD have demonstrated the efficacy of the Checkpoints Program for increasing parental management of teen driving and reducing exposure to high risk driving conditions during the first 12 months after licensure. The current research seeks to test the effectiveness of providing an educational program entitled The Checkpoints Program to facilitate parental management of teen driving when delivered at motor vehicle administration offices at the time the teen obtains a permit, at the time of license, or at both permit and license. *Frequency of Response:* 3 times over two years. *Affected Public:* Individuals or households. *Type of Respondents:* Adolescents and parents/guardians. *The annual reporting burden is as follows: Estimated Number of Respondents:* 4000; *Estimated Number of Responses per Respondent:* 3; *Average Burden Hours Per Response:* 35; and *Estimated Total Annual Burden Hours Requested:* 4,200. The annualized cost to respondents is estimated at: $42,000 (based on $10 per hour). 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 Estimated total annual burden hours requested Parents/guardians 2000 3 .35 2100 Teens 2000 3 .35 2100 Total 4000 3 .35 4200 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:

(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;

(2)The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Direct Comments to OMB:* Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Bruce Simons-Morton, Chief, Prevention Research Branch, DESPR, NICHD, NIH, 6100 Executive Blvd., Rm 7B05, MSC 7510, Bethesda, MD 20892-7510;

(301)496-5674; e-mail: *mortonb@mail.nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. Dated: August 25, 2006. Paul Johnson, Project Clearance Liaison, NICHD, National Institutes of Health. [FR Doc. E6-14680 Filed 9-5-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/ 496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Ghost Native-PAGE With Colorless Compound Derived From Coomassie Brilliant Blue *Description of Technology:* Protein staining dyes such as serva blue G or Coomassie blue are used to enhance the separation of protein complexes by binding to the proteins and differentially enhancing the net charge of the complexes improving the separation of the complexes using electrophoresis procedures. However, the intense blue color of Coomassie stains interferes with immunobloting and in gel colormetric or fluorescent studies. Available for licensing and commercial development is a colorless molecule that will bind and enhance the differential surface charge on protein complexes. The molecule has been demonstrated to work as well as Coomassie blue but will not interfere in gel assays critical for most investigations. This approach provides biochemists interested in protein complexes in biological tissues with the ability to separate protein complexes and perform in gel assays saving time and resources in this important emerging field. The compound and methods of its use is for polyacrylamide gel electrophoresis

(PAGE)and related gel techniques for the analysis of protein complexes and defects in the same. Such analysis can be extended to the detection of various diseases, e.g., Alzheimer's disease or Parkinson's disease. One such compound has the following formula: EN06SE06.002 *Applications:* Alzheimer's disease diagnostics; Parkinson's disease diagnostics. *Market:* Protein-protein interaction biochemistry. *Development Status:* Early-stage. *Inventors:* Robert Balaban (NHLBI), Gary Griffiths (NHLBI), Ksenia Blinova (NHLBI), et al. *Publications* : 1. MM Camacho-Carvajal, et al. Two-dimensional Blue native/SDS gel electrophoresis of multi-protein complexes from whole cellular lysates: a proteomics approach. Mol Cell Proteomics. 2004 Feb; 3(2):176-182. 2. R Van Coster, et al. Blue native polyacrylamide gel electrophoresis: a powerful tool in diagnosis of oxidative phosphorylation defects. Pediatr Res. 2001 Nov; 50(5):658-665. 3. I Whittig and H Schagger. Advantages and limitations of clear-native PAGE. Proteomics. 2005 Nov; 5(17):4338-4346. *Patent Status:* U.S. Provisional Application No. 60/835,069 filed 03 Aug 2006 (HHS Reference No. E-218-2006/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Michael A. Shmilovich, Esq.; 301/435-5019; *shmilovm@mail.nih.gov.* In Vivo Non-Invasive Diagnostic Method Using Magnetic Resonance Spectroscopy of Aspartate Transaminase *Description of Technology:* This invention describes a method for non-invasively diagnosing various diseases using magnetic resonance spectroscopy of aspartate transaminase (AST). The diagnostic market is a multi-billion dollar market, with a need for more efficient non-invasive techniques, markers and methods of diagnosis. In particular, this is a novel non-invasive method for using carbon-13 magnetization transfer effects to determine and evaluate in vivo aspartate transaminase

(AST)activity and levels in an organ, including the brain, as a biomarker of disease and certain neurological disorders. This comprises performing in vivo magnetization transfer spectroscopy, and determining the change in magnetic resonance signal intensity of reactants in AST catalyzed reaction. AST activity is known to change as a result of tissue damage and necrosis in a variety of diseases. AST activity is routinely assessed in serum of patients as a non-invasive means of identifying and following up on disease progression. Furthermore, brain levels of AST are altered in certain diseases such as Huntington's Disease, olivopontocerebellar atrophy and epilepsy, but the blood-brain barrier prevents AST from entering serum and being readily measured. Brain AST levels in living patients can be measured by brain biopsies, which are expensive and dangerous. This invention overcomes this problem by measuring AST activity in the brain by using magnetization transfer effect. This can help diagnose or follow up on the progress of a variety of diseases, including Huntington's Disease, olivopontocerebellar atrophy, epilepsy, schizophrenia, as well as hepatitis, cirrhosis, cholangitis, Gilbert's diseases, muscular dystrophy, leukemia, kidney inflammation, cardiac infarction, or the presence of a tumor. Thus, tissue AST activity may become a novel marker of brain disorders which has been inaccessible using current clinical technologies. *Applications and Market:* Diagnosis and monitoring disease status in a variety of diseases, including Huntington's Disease, olivopontocerebellar atrophy, epilepsy, schizophrenia, as well as hepatitis, cirrhosis, cholangitis, Gilbert's diseases, muscular dystrophy, leukemia, kidney inflammation, cardiac infarction, or the presence of a tumor. The diagnostic market is a multi-billion dollar market, with a need for more efficient non-invasive techniques, markers and new methods of diagnosis. *Patent Status:* U.S. Patent Application No. 11/356,214 filed 21 Feb 2006 (HHS Reference No. E-231-2005/0-US-02). *Inventors:* Dr. Jun Shen (NIMH). *Publication:* J Shen. In vivo carbon-13 magnetization transfer effect: detection of aspartate aminotransferase reaction. Magn Reson Med. 2005 Dec; 54(6):1321-1326. *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Chekesha Clingman, Ph.D.; 301/435-5018; c *lingman@mail.nih.gov.* Dated: August 29, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 06-7439 Filed 9-5-06; 8:45 am]

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