Notices. Notice

8,661 words·~39 min read·/register/2006/05/19/06-4673·

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BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-262 and CMS 10196] Agency Information Collection Activities: Proposed Collection; Comment Request Agency: Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

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

(PBP)and Formulary Submission for Medicare Advantage

(MA)Plans and Prescription Drug Plans (PDPs); *Use:* Under the Medicare Modernization Act (MMA), Medicare Advantage

(MA)and Prescription Drug Plan

(PDP)organizations are required to submit plan benefit packages for all Medicare beneficiaries residing in their service area. CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval; *Form Number:* CMS-R-262 (OMB#: 0938-0763); *Frequency:* On occasion, Annually, and Other: As required by new legislation; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 553; *Total Annual Responses:* 5,807; *Total Annual Hours:* 13,272. 2. *Type of Information Collection Request:* New Collection; *Title of Information Collection:* Medicare Part C Audit Guide, Version 4.0 and Supporting Regulation contained in 42 CFR 423.502; Use: The Medicare Modernization Act provides CMS the regulatory authority to audit, evaluate, or inspect any Part C sponsors' performance related to the law in the areas including enrollment & disenrollment, marketing, benefits and beneficiary protections, quality assurance, provider relations and contracts. The information collected will be an integral resource for oversight, monitoring, compliance, and auditing activities necessary to ensure quality provision of the Part C Medicare Advantage benefit to beneficiaries. *Form Number:* CMS-10196 (OMB#: 0938-New); *Frequency:* Recordkeeping and Reporting—Annually; *Affected Public:* Business or other for-profit; *Number of Respondents:* 393; *Total Annual Responses:* 393; *Total Annual Hours:* 12,576. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on July 18, 2006. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L. Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: May 10, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-7510 Filed 5-18-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-718BP, 719BP, 720BP, 721BP, SUM, STAFFING, SC1 and SC2] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Business Proposal Forms for Quality Improvement Organizations (QIOs); *Use:* The submission of proposal information by current QIOs and other bidders, on the appropriate forms, will satisfy CMS's need for meaningful, consistent, and verifiable data with which to evaluate contract proposals. The Government will be able to compare the costs reported by the QIOs on the cost reports to the proposed costs noted on the business proposal forms. Subsequent contract and modification negotiations will be based on historic cost data. The business proposal forms will be one element of the historical cost data from which we can analyze future proposed costs. In addition, the business proposal format will standardize the cost proposing and pricing process among all QIOs. With well-defined cost centers and line items, proposals can be compared among QIOs for reasonableness and appropriateness; *Form Number:* CMS-718BP, 719BP, 720BP, 721BP, SUM, STAFFING, SC1 and SC2 (OMB#: 0938-0579); *Frequency:* Reporting—Triennially; *Affected Public:* Not-for-profit institutions, Business or other for-profit; *Number of Respondents:* 20; *Total Annual Responses:* 20; *Total Annual Hours:* 455. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503. Fax Number:

(202)395-6974. Dated: May 9, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-7511 Filed 5-18-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0180] Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy. DATES: Submit written or electronic comments on the collection of information by July 18, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. 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: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Records and Reports Concerning Experience With Approved New Animal Drugs—21 CFR 514.80—(OMB Control Number 0910-0284)—Extension Implementation of section 512(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) and 21 CFR 514.80 requires applicants of approved new animal drug applications and abbreviated new animal drug applications (NADAs) to submit product/manufacturing defects, initial and followup reports for adverse drug experiences and lack of effectiveness of new animal drugs, increased frequency 15-day alert reports, periodic drug experience reports (annually or semiannually in a specific format), and other reports (special drug experience reports, advertisement and promotional material submissions, and distributor statements.) This continuous monitoring of approved NADAs affords the primary means by which FDA obtains information regarding potential problems in safety and effectiveness of marketed animal drugs and potential manufacturing problems. Current data on file with FDA is not adequate because animal drug effects can change over time, and less apparent effects may take years to manifest themselves. Adverse reaction reports are required to be submitted by the drug manufacturer on FDA Forms 1932 or 1932a (voluntary reporting form), following complaints from animal owners or veterinarians. Also, product defects and lack of effectiveness complaints are submitted to FDA by the drug manufacturer following their own detection of a problem or complaints from product users or their veterinarians using FDA Forms 1932 and 1932a. Form FDA 2301 is used to submit the required transmittal of periodic reports and promotional material for new animal drugs. The reporting and recordkeeping burden estimates are based on the submission of reports to the Division of Surveillance, Center for Veterinary Medicine. The total annual responses are also based on the submission of reports to the Division of Surveillance, Center for Veterinary Medicine. The annual frequency of response was calculated as the total annual responses divided by the number of respondents. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section FDA Form No. No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 514.80(b)(1) 1932 190 0.50 95 1 95 514.80(b)(2)(i) 1932 190 64.65 12,283 1 12,283 514.80(b)(2)(ii) 1932 190 31.62 6,007 1 6,007 514.80(b)(3) 1932 340 2.94 1,000 1 1,000 Voluntary reporting FDA Form 1932a for public 1923a 250 1 250 1 250 514.80(b)(4) 2301 190 6.45 1,226 11 13,486 514.80(b)(5)(i) 2301 190 0.13 25 2 50 514.80(b)(5)(ii) 2301 190 4.06 772 2 1544 514.80(b)(5)(iii) 2301 530 0.11 56 2 112 Total Hours 34827 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ** Table 2.—Estimated Annual Recordkeeping BURDEN 1 ** 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 514.80(e) 2 530 36.58 19,385 0.5 9,693 514.80(e) 3 530 4.49 2,379 10.35 24,623 Total 34,316 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Recordkeeping estimates for 514.80(b)(1), (b)(2)(i), (b)(2)(ii), (b)(3), and Form FDA 1932. 3 Recordkeeping estimates for 514.80(b)(2)(iii), (b)(4), (c), (b)(5), and Form FDA 2301. Dated: May 12, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-7616 Filed 5-18-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0185] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. DATES: Submit written or electronic comments on the collection of information by July 18, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. 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: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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 board

(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 (21 CFR parts 50 and 56) apply to all clinical investigations that are regulated by FDA (see 21 CFR 50.1; 21 CFR 56.101; 21 U.S.C. 360j(g)(3)(A), and 21 U.S.C. 360j(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 one guidance document issued under the Good Guidances Practices regulation, 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. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours Total Capital Costs Total Operating and Maintenance Costs 700 1 700 4 2,800 $210,000 420,000 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 2,400 hours (700 x 4 = 2,800). FDA estimates that the cost of developing standard operating procedures for each record keeper is $300 (6 hours of work at $50/hour (h)). This results in a total cost to industry of $210,000 ($300 x 700 recordkeepers). FDA estimates that operating costs for collecting this information is $300 per record keeper (6 hours of work at $50/h). This results in a total operational and maintenance cost to industry of $210,000 ($300 x 700 recordkeepers). The total cost of this recordkeeping, capital plus operational and maintenance cost, is estimated to be $420,000. Dated: May 12, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-7617 Filed 5-18-06; 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 (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)443-1891. 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: Faculty Loan Repayment Program

(FLRP)Application (OMB No. 0915-0150)—Extension Under the Health Resources and Services Administration Faculty Loan Repayment Program, degree-trained health professionals from disadvantaged backgrounds may enter into a contract under which HRSA, with the Department of Health and Human Services, will make payments on eligible health professions educational loans in exchange for a minimum of two years of service as a full-time or part-time faculty member of an accredited health professions college or university. Applicants must complete an application and provide all other required documentation including information on all eligible health professions educational loans. The estimated response burden is as follows: Respondent Number of respondents Responses per respondent Total responses Hours per response Total burden hours Applicants 150 1 150 1 150 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: May 15, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-7666 Filed 5-18-06; 8:45 am] BILLING CODE 4165-15-P 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 (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 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 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

(d)ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Proposed Project: Enhanced Performance Measurement System for HRSA Health Professions Education and Training Program Grants: NEW Following the 1998 reauthorization, HRSA's Health Professions Education and Training Programs have been using a reporting system known as the Comprehensive Performance Management System/Uniform Progress Report (CPMS/UPR) for preparation and submission of applications for continuation grants, and for reporting program outcomes under the Government Performance and Results Act of 1993 (GPRA). Part I of the CPMS/UPR measures grantee progress toward meeting objectives, and is used for funding decisions. Part II collects information used by program officers to monitor program specific activities. Part III collects information on program results that can be aggregated across multiple programs, and is used for GPRA reporting and OMB initiated performance assessment activities. The instrument previously approved for OMB for these purposes has been revised for clarity, and modified to better capture outcome information related to Health Professions Education and Training Programs that is increasingly required for evaluating Federal policy and program performance. Some elements have been added to improve measurement capability, while others have been streamlined to reduce burden. Additional validation rules are also being added to improve the quality of the data. Portions of the instrument have also been redesigned to improve reporting consistency among programs. The proposed system will be Web-based, and is planned to include a series of preprogrammed reports to increase access to, and analysis of, the data. Estimates of annualized reporting burden are as follows: Form Number of respondents Responses per respondent Total responses Hours per respondent Total hour burden Enhanced Performance Measurement System 1,550 1 1,550 21.5 33,325 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: May 15, 2006. Tina Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-7667 Filed 5-18-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Infant Mortality; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Infant Mortality (ACIM). *Dates and Times:* July 13, 2006, 9 a.m.-5 p.m.; July 14, 2006, 8:30 a.m.-3 p.m. *Place:* Key Bridge Marriott, 1401 Lee Highway, Arlington, VA 22209,

(703)524-6400. *Status:* The meeting is open to the public with attendance limited to space availability. *Purpose:* The Committee provides advice and recommendations to the Secretary of Health and Human Services on the following: Department programs that are directed at reducing infant mortality and improving the health status of pregnant women and infants; factors affecting the continuum of care with respect to maternal and child health care, including outcomes following childbirth; strategies to coordinate the variety of Federal, State, local and private programs and efforts that are designed to deal with the health and social problems impacting on infant mortality; and the implementation of the Healthy Start program and *Healthy People 2010* infant mortality objectives. *Agenda:* Topics that will be discussed include the following: Preterm birth; Medicaid Policy; Pregnancy Weight; and the Perinatal and Patient Safety Pilot Program. Substantial time will be spent in Subcommittee and full Committee discussions aimed at formulating the ACIM issues agenda. Proposed agenda items are subject to change as priorities indicate. Time will be provided for public comments limited to five minutes each; comments are to be submitted no later than June 19, 2006. *For Further Information Contact:* Anyone requiring information regarding the Committee should contact Peter C. van Dyck, M.D., M.P.H., Executive Secretary, ACIM, Health Resources and Services Administration (HRSA), Room 18-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, Telephone:

(301)443-2170. Individuals who are submitting public comments or who have questions regarding the meeting and location should contact Michelle Loh, HRSA, Maternal and Child Health Bureau, telephone:

(301)443-0543, e-mail: *michelle.loh@hrsa.hhs.gov.* Dated: May 15, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-7662 Filed 5-18-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration

(HRSA)is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (“the Program”), as required by section 2112(b)(2) of the Public Health Service

(PHS)Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place, NW., Washington, DC 20005,

(202)357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857;

(301)443-6593. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 *et seq.* , provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that the Secretary publish in the **Federal Register** a notice of each petition filed. Set forth below is a list of petitions received by HRSA on January 1, 2006, through March 31, 2006. Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following: 1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and 2. Any allegation in a petition that the petitioner either:

(a)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Table but which was caused by” one of the vaccines referred to in the Table, or

(b)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table. This notice will also serve as the special master's invitation to all interested persons to submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three

(3)copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading For Further Information Contact ), with a copy to HRSA addressed to Director, Division of Vaccine Injury Compensation Program, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption ( *Petitioner's Name* v. *Secretary of Health and Human Services* ) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program. List of Petitions 1. Tara Turner on behalf of Joseph Turner, Trinity, North Carolina, Court of Federal Claims Number 06-0001V 2. Elizabeth Babcock, San Quentin, California, Court of Federal Claims Number 06-0003V 3. Sharlene Smith on behalf of Jacob Smith, Norton, Massachusetts, Court of Federal Claims Number 06-0012V 4. Antoinette Gumm on behalf of Alexander Gumm, Gardnerville, Nevada, Court of Federal Claims Number 06-0023V 5. Suzanne and James Cuddy on behalf of Patrick Cuddy, Cicero, New York, Court of Federal Claims Number 06-0032V 6. Lois Wright, Warren, Michigan Court of Federal Claims Number 06-0033V 7. Roxie Hobart on behalf of Mabel F. Hobart, Deceased, Molalla, Oregon, Court of Federal Claims Number 06-0038V 8. Brian Sprinkle on behalf of Jake Sprinkle, Boston, Massachusetts, Court of Federal Claims Number 06-0042V 9. Eva Wiessmann on behalf of Isabelle Wiessmann, Boston, Massachusetts, Court of Federal Claims Number 06-0043V 10. Selvam Ganesan and Bhavani Balakrishana on behalf of Shyam Selvam, Boston, Massachusetts, Court of Federal Claims Number 06-0044V 11. Stacey Gray on behalf of Hugh Gray, Boston, Massachusetts, Court of Federal Claims Number 06-0045V 12. Joanna and Ronald Berkowitz on behalf of Sophia Berkowitz, White Plains, New York, Court of Federal Claims Number 06-0048V 13. Babak and Nausheen Alvaynejad on behalf of Shariar Alvaynejad, La Mesa, California, Court of Federal Claims Number 06-0058V 14. Mabel Annette Hughes and Darryl McDonal on behalf of Jamielee Hughes McDonal, Lexington, Mississippi, Court of Federal Claims Number 06-0059V 15. Gabriela and Byron Nolen on behalf of Nicholas Nolen, Flat Rock, Michigan, Court of Federal Claims Number 06-0060V 16. Robert Greve on behalf of Robert Gabriel Greve, Oklahoma City, Oklahoma, Court of Federal Claims Number 06-0062V 17. Catherine and John Miller on behalf of Jonathon Franklin Miller, Cincinnati, Ohio, Court of Federal Claims Number 06-0063V 18. Helen Cho, New York, New York, Court of Federal Claims Number 06-0066V 19. Diane Nolte, Biloxi, Mississippi, Court of Federal Claims Number 06-0067V 20. Victor Osemobor, Riverwoods, Illinois, Court of Federal Claims Number 06-0069V 21. Patricia Cupples, Clinton Township, Michigan, Court of Federal Claims Number 06-0070V 22. Connie and D. Glen Beals on behalf of Chase Beals, Somers Point, New Jersey, Court of Federal Claims Number 06-0071V 23. Pesi and Nyree Silva on behalf of Tava'Esina Silva, Honolulu, Hawaii, Court of Federal Claims Number 06-0076V 24. Kendria and Kinjie Sutton on behalf of Kinjie Sutton, Jr., Mt. Morris, Michigan, Court of Federal Claims Number 06-0080V 25. Antonio Vanriel, Ft. Meade, Maryland, Court of Federal Claims Number 06-0083V 26. Behzad Rezaee, Norcross, Georgia, Court of Federal Claims Number 06-0085V 27. Cathy Anthony on behalf of Noah Anthony, Somers Point, New Jersey, Court of Federal Claims Number 06-0091V 28. Nancy Alspaugh and H. Read Jackson on behalf of Wyatt Read Jackson, Somers Point, New Jersey, Court of Federal Claims Number 06-0098V 29. Barbara McGreal on behalf of Daniel Rutledge, Tampa, Florida, Court of Federal Claims Number 06-0100V 30. Pamela Kattouf on behalf of Justin Kattouf, Maplewood, New Jersey, Court of Federal Claims Number 06-0102V 31. Eric Backer on behalf of Grace Backer, St. Louis, Missouri, Court of Federal Claims Number 06-0104V 32. Luna and Stuart Paul on behalf of Daniel Paul, Northbrook, Illinois, Court of Federal Claims Number 06-0106V 33. Nicole Carey on behalf of Halle Carey, Chesterland, Ohio, Court of Federal Claims Number 06-0117V 34. Michael Hudson, Laconia, New Hampshire, Court of Federal Claims Number 06-0118V 35. Todd Lee Saint, Kansas City, Kansas, Court of Federal Claims Number 06-0119V 36. Erin and Benjamin Zeller on behalf of Benjamin Zeller, Pompano Beach, Florida, Court of Federal Claims Number 06-0120V 37. Dolores Thompson, Port Charles, Florida, Court of Federal Claims Number 06-0128V 38. Genevieve McGhee, Houston, Missouri, Court of Federal Claims Number 06-0130V 39. Renee and Mark Saville on behalf of Mathew Saville, Boston, Massachusetts, Court of Federal Claims Number 06-0131V 40. Re-Ann Dinino on behalf of Anthony Dinino, Boston, Massachusetts, Court of Federal Claims Number 06-0132V 41. Thomas Lincoln on behalf of Alexander Lincoln, Boston, Massachusetts, Court of Federal Claims Number 06-0133V 42. Elizabeth and William Anthony Gore on behalf of Mason Gore, Boston, Massachusetts, Court of Federal Claims Number 06-0134V 43. Nicholas Salvi on behalf of Francesco Salvi, Boston, Massachusetts, Court of Federal Claims Number 06-0135V 44. Lara and Jarrett Johnson on behalf of Kaden Nelson Johnson, Kansas City, Missouri, Court of Federal Claims Number 06-0140V 45. Elizabeth Fields on behalf of Bryan Fields, Boston, Massachusetts, Court of Federal Claims Number 06-0142V 46. Tangela Hairston-Reeves on behalf of Joshua Hairston, Deceased, Boston, Massachusetts, Court of Federal Claims Number 06-0143V 47. Jenna and David Shook on behalf of Trent Michael Shook, Ringgold, Virginia, Court of Federal Claims Number 06-0145V 48. Sandra and Justin Meyer on behalf of Justin Meyer, Port Arthur, Texas, Court of Federal Claims Number 06-0148V 49. Holly and Joshua Winstead on behalf of Jeremy Winstead, Athens, Georgia, Court of Federal Claims Number 06-0159V 50. Randi and Michael Bryant on behalf of Kyle Bryant, Baldwinsville, New York, Court of Federal Claims Number 06-0162V 51. Tracie and Brad Childress on behalf of Nathan Childress, Sparkill, New York, Court of Federal Claims Number 06-0163V 52. Linda and Daniel Moffitt on behalf of Robert Moffitt, Orangeburg, New York, Court of Federal Claims Number 06-0164V 53. Svitlana Budzak-Jones and Laird Jones on behalf of William Oleksandr Jones, State College, Pennsylvania, Court of Federal Claims Number 06-0165V 54. Suanne and Bradley Knutson on behalf of Jack Bradley Knutson, Sioux Falls, South Dakota, Court of Federal Claims Number 06-0166V 55. Debra Ann Anderson, Sioux Falls, South Dakota, Court of Federal Claims Number 06-0168V 56. Anita Reino on behalf of Angela Reino, Thonotosassa, Florida, Court of Federal Claims Number 06-0170V 57. Meghan Bramlage on behalf of Mitchell Bramlage, Boston, Massachusetts, Court of Federal Claims Number 06-0171V 58. Jolee Carney on behalf of Jordan Custer, Deceased, Ellsworth, Washington, Court of Federal Claims Number 06-0187V 59. Sarah and Christopher Hoiberg on behalf of Caitlyn Joy Hoiberg, Jacksonville, Florida, Court of Federal Claims Number 06-0188V 60. Tamar Feld, Englewood, New Jersey, Court of Federal Claims Number 06-0190V 61. Louis Tosches, II on behalf of Louis Tosches, III, Towson, Maryland, Court of Federal Claims Number 06-0192V 62. Jessica Kuttner on behalf of Calvin Kuttner, Traverse City, Michigan, Court of Federal Claims Number 06-0195V 63. Stephanie Coleman on behalf of Lincoln Coleman, Boston, Massachusetts, Court of Federal Claims Number 06-0197V 64. James Robert Dickman on behalf of Lindsay Kathleen Dickman, Deceased, New York, New York, Court of Federal Claims Number 06-0199V 65. Roberta and Ronald Moore on behalf of Daniel Moore, Tampa, Florida, Court of Federal Claims Number 06-0200V 66. Patricia and Vincent Miller on behalf of John Miller, West Orange, New Jersey, Court of Federal Claims Number 06-0201V 67. Linda and Charles Veneman on behalf of Linda Veneman, Henderson, Nevada, Court of Federal Claims Number 06-0203V 68. Linda and Charles Veneman on behalf of Linda Veneman, Henderson, Nevada, Court of Federal Claims Number 06-0204V 69. Naomi and Emanuel Goldman on behalf of Tamara June Goldman, Deceased, West Orange, New Jersey, Court of Federal Claims Number 06-0206V 70. Bethany and Randall Loudenslager on behalf of Zachary Loudenslager, Strongsville, Ohio, Court of Federal Claims Number 06-0207V 71. Lee and William Hinton on behalf of William S. Hinton, Jr., Mountain Brook, Alabama, Court of Federal Claims Number 06-0208V 72. Lynn and Shawn Sevey on behalf of Shalyn Sevey, Folsom, California, Court of Federal Claims Number 06-0209V 73. Tamara Charles on behalf of Jeron Charles, Brooklyn, New York, Court of Federal Claims Number 06-0212V 74. Jaynna and Eric Moxley on behalf of Mary Madison Moxley, Cabot, Arkansas, Court of Federal Claims Number 06-0213V 75. Carina Dewitt-Lord and Richard Lord on behalf of Zachary Dylan Lord, Philadelphia, Pennsylvania, Court of Federal Claims Number 06-0215V 76. Lynne Paumier, Downington, Pennsylvania, Court of Federal Claims Number 06-0220V 77. Hilmi and Samar Amar on behalf of Rushia Amar, Arlington, Texas, Court of Federal Claims Number 06-0221V 78. Parivash and Saeid Mojabi on behalf of Ryan Mojabi, San Jose, California, Court of Federal Claims Number 06-0227V 79. Penny and Richard Majewski on behalf of Zachary Adam Majewski, Somers Point, New Jersey, Court of Federal Claims Number 06-0229V 80. Diane and Samuel Yellis on behalf of Sophie Yellis, Lake Success, New York, Court of Federal Claims Number 06-0234V 81. Gayle Delong and Jonathan Rose on behalf of Flora Rose, Morristown, New Jersey, Court of Federal Claims Number 06-0235V 82. Lori and Kevin Champagne on behalf of Jared Champagne, Baldwinsville, New York, Court of Federal Claims Number 06-0248V 83. Adrian Green and Nathaniel Armstrong, Jr. on behalf of Nijieh Green, Philadelphia, Pennsylvania, Court of Federal Claims Number 06-0249V 84. Geetha Srinivasarao and Cholanayakanahalli Vinayak on behalf of Praveen Vinayak, Washington, D.C., Court of Federal Claims Number 06-0250V 85. Denise and James Walker on behalf of Nicholas John Walker, East Stroudsburg, Pennsylvania, Court of Federal Claims Number 06-0252V 86. Rena DeFelice on behalf of Carson DeFelice, Katy, Texas, Court of Federal Claims Number 06-0253V 87. Heather and Adrian Aschmann on behalf of Adrian Aschmann, Estell Manor, New Jersey, Court of Federal Claims Number 06-0256V 88. Daphne and John Dunstan on behalf of William Dunstan, Philadelphia, Pennsylvania, Court of Federal Claims Number 06-0257V Dated: May 15, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-7665 Filed 5-18-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; a Process/Outcome Evaluation of Parkinson's Disease Research Centers SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Neurological Disorders and Stroke (NINDS) Office of Science Policy and Planning, the National Institute 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 December 21, 2005, pages 75823-75824, 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:* A Process/Outcome Evaluation of Parkinson's Disease Research Centers *Type of Information Collection Request:* NEW. *Need and Use of Information Collection:* This study is primarily an outcome evaluation, designed to assess the extent to which the NINDS-funded Morris K. Udall Centers for Excellence in Parkinson's Disease Research have achieved the program's short-term and long-term goals. The study also includes elements of a process evaluation in its examination of the major activities conducted by the Udall Centers, the relationship between Center activities and the achievement of program goals, and the NINDS management of the program. The results of the full-scale evaluation should be very helpful to NINDS in identifying the most relevant measures for tracking the future progress of the Centers, developing strategies to enhance the program's effectiveness, and improving program management. NINDS will also use the findings to inform its National Advisory Neurological Disorders and Stroke Council, and to address inquiries from the public regarding the impact of the Udall Centers Program. Lastly, Udall Center awardees will be able to use the evaluation results to improve the performance of their Centers; and other NIH Institutes and Centers may use the methodology and results of this evaluation to guide their own centers assessments. *Frequency of Response:* Once or twice. *Affected Public:* Researchers, Not-for-profit institutions; Federal Government; individuals or households. *Type of Respondents:* Adult professionals. The annual reporting burden is provided in the following table: Type of respondents Estimated number of respondents Estimated frequency of response Estimated average time per response Estimated annual hour burden Center Directors 13 2 1.5 39 Project/Core Directors 54 2 1.5 162 Comparison Group 54 1 1.0 54 Totals 121 255 There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address one or more of the following points:

(1)Evaluate 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)Evaluate 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)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond, including the use of appropriated automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burdenand 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. Melinda Kelley, Office of Science Policy and Planning, National Institute of Neurological Disorders and Stroke, NIH, Building 31, 31 Center Drive, Room 8A-03, Bethesda, MD 20892; call non-toll-free 301-496-9271; or E-mail your request, including your address to: *ospp@ninds.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: May 11, 2006. Story C. Landis, Director, NINDS, National Institutes of Health. [FR Doc. E6-7626 Filed 5-18-06; 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. Viral Entry or Replication Inhibition Using siRNA, Small Molecules, or Other Tec Tyrosine Kinase Inhibitors Julie Readinger and Pamela L. Schwartzberg (NHGRI). U.S. Provisional Application filed 29 Mar 2006 (HHS Reference No. E-151-2006/0-US-01). *Licensing Contact:* Susan Ano; 301/435-5515; *anos@mail.nih.gov.* The Tec family of tyrosine kinases, consisting of five family members Tec, Btk, Itk, Rlk, and BMX, are key regulators of signaling pathways of T lymphocytes. Many existing antiviral therapies rely on inhibition of viral replication, which leads to emergence or selection of resistant viruses. The current technology provides an alternative target for the prevention or treatment of viral infection through administration of a Tec tyrosine kinase inhibitor. Such inhibitors can be siRNA, small chemical compounds, antisense or antibody. The current technology describes the inhibition of Itk (also known as Emt and Tsk) and the resulting decrease in HIV infectivity, replication, and transcription for exemplary purposes. Importantly, inhibition of Itk expression does not affect the expression of HIV receptors CCR5, CXCR4, or CD4. The current technology could be used in combination with therapeutics that target multiple stages of the virus life cycle. This research is described, in part, in the following: 1. D Dombroski, R Houghtling, CM Labno, J Burkhardt, and PL Schwartzberg, “Kinase-independent functions for Itk in the regulation of Vav and the actin cytoskeleton,” J. Immunol. 174: 1385-1392, 2005. 2. A Takesono, R Horai, M Mandai, D Dombroski, and PL Schwartzberg, “Requirement for Tec family kinases in chemokine-induced migration and activation of Cdc42 and Rac,” Curr. Biol. 10:917-22, 2004. 3. E Schaeffer, G Yap, CM Lewis, M Czar, DW McVicar, AW Cheever, A Sher, and PL Schwartzberg, “Mutation of Tec family kinases alters T helper cell differentiation,” Nature Immunol. 2:1183-8, 2001. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors: The NHGRI, Genetic Disease Research Branch/Cell Signalling Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the use of Tec family kinase inhibitors as a therapeutic target for HIV and other viral infections. Please contact Claire Driscoll, Director, NHGRI Technology Transfer Office, at 301/402-2537 or *cdriscol@mail.nih* for more information. Peptide Inhibitors of HIV-1 Integrase Useful for the Treatment of Retroviral Infection and HIV Peter P. Roller et al.

(NCI)U.S. Provisional Application No. 60/534,378 filed 06 Jan 2004 (HHS Reference No. E-039-2004/0-US-01). U.S. Provisional Application No. 60/547,067 filed 25 Feb 2004 (HHS Reference No. E-039-2004/1--US-01). U.S. Provisional Application No. 60/599,856 filed 10 Aug 2004 (HHS Reference No. E-039-2004/2-US-01). PCT Application No. PCT/US2004/42726 filed 21 Dec 2004 (HHS Reference No. E-039-2004/3-PCT-01), which published as WO 2005/068492 on 29 Dec 2005. *Licensing Contact:* Sally Hu, Ph.D., M.B.A.; 301/435-5606; *hus@mail.nih.gov.* The invention describes the discovery of short peptides, derived from the natural peptide named indolicidin that have an ability to inhibit HIV-1 integrase and exhibit antiviral activity. In particular, this invention shows that synthesized derivatives of the indolicidin peptides named RIN-25 exhibit a significant higher anti-viral and anti-integrase activity when compared to the parent compound named RIN-42. HIV-1 integrase has a good potential of being the next therapeutic target since HIV-1 integrase is essential for viral replication and there is no cellular equivalent. Thus, subject invention may be used in the development of therapeutics for the treatment of retroviral infections, such as AIDS, or other retroviral-related diseases ( *i.e.* , cancer, immune disorders). In addition, the novel peptides described in this invention may also have particular value when used in combination treatments with other antiviral therapies directed at other viral targets, such as protease and reverse transcriptase. Identification of Candidate Ligands which Modulate Antigen Presenting Cells Polly Matzinger, John P. Ridge (NIAID). U.S. Patent No. 6,680,176 issued 20 Jan 2004 (HHS Reference No. E-055-1999/0-US-01). *Licensing Contact:* Cristina Thalhammer-Reyero; 301/435-4507; *thalhamc@mail.nih.gov.* Available for licensing and commercial development are novel biotechnological tools, prophylactics, therapeutics, and methods for modulating the activation state of an antigen presenting cell

(APC)and thereby modulating the activation of a killer T cell. The activation of a killer T cell can occur in a two cell complex and two sequential steps:

(a)In the first step, an APC stimulates a T helper T cell, which in turn stimulates or “superactivates” the APC to differentiate to a state where it can independently stimulate a killer T cell;

(b)In the second step, the APC encounters the killer T cell and stimulates it so that killer T cell priming is achieved in a helper independent fashion. The first step can be bypassed altogether by viral infection or an interaction with certain molecules at the cell surface of APCs, such as CD40. More specifically, the invention consists of a method of identifying a ligand as a candidate for incorporation into a pharmaceutical composition, such as a therapeutic or prophylactic product, that modulates antigen presenting cell activity, comprising contacting an APC with a candidate ligand which interacts with the APC, analyzing the activation state of the APC; and selecting ligands that activate a killer T cell in the absence of a helper T cells as the candidates for incorporation into the pharmaceutical. Also claimed are related methods where the ligand interacts with CD40 or where the APC is a dendritic cell. The embodiments have several applications in the field of immunology, and enable to manufacture novel pharmaceuticals and vaccine components for the treatment and prevention of cancer, systemic infection, and autoimmune responses. The technology is further described in JP Ridge, F Di Rosa, and P Matzinger, “A conditioned dendritic cell can be a temporal bridge between a CD4+ T-helper and a T-killer cell,” Nature 1998 Jun 4; 393(6684):474-8. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Dated: May 11, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-7627 Filed 5-18-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, June 13, 2006, 3 p.m. to June 13, 2006, 4:30 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the **Federal Register** on May 5, 2006, 71 FR 26550-26552. The meeting will be held on June 15, 2006. The meeting time and location remain the same. The meeting is closed to the public. Dated: May 11, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-4673 Filed 5-18-06; 8:45 am]

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