Notices. Notice
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/register/2007/03/07/07-1041A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 the Office of Management and Budget 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 through the use of automated collection techniques or other forms of information technology. *Proposed Project: Application for the National Health Service Corps
(NHSC)Clinician Retention Information:* New Collection The National Health Service Corps
(NHSC)of the Bureau of Health Professions (BHPr), HRSA, is committed to improving the health of the Nation's underserved by uniting communities in need with caring health professionals and by supporting communities' efforts to build better systems of care. The NHSC is responsible for collecting data on its programs to ensure compliance with legislative mandates and to report to Congress and policymakers on program accomplishments. One of the most important statistics reported to Congress and policymakers is the retention rate of NHSC supported clinicians serving in an underserved area. The following information will be collected three months prior to the completion of obligated service:
(1)Verification of current contact information;
(2)if employment is to be continued at the same NHSC site;
(3)if the clinician moved from the NHSC service site but plans to continue practicing in an underserved area, and
(4)the primary reason for stopping practice in an underserved area, if applicable. *The estimated burden is as follows:* Type of report Number of respondents Responses per respondent Hours per response Total burden hours NHSC Clinical Retention Information 1000 1 0.25 250 Send comments to Susan G. Queen, PhD, 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: February 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-3901 Filed 3-6-07; 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 through the use of automated collection techniques or other forms of information technology. *Proposed Project: Data Collection Tool for the Black Lung Clinics Program (OMB No. 0915-0292):* Revision The Office of Rural Health Policy (ORHP), Health Resources and Services Administration, conducts an annual data collection of user information for the Black Lung Clinics Program. The purpose of the Black Lung Clinics Program is to improve the health status of coal workers by providing services to minimize the effects of respiratory and pulmonary impairments of coal miners. Grantees provide specific diagnostic and treatment procedures required in the management of problems associated with black lung disease which improves the quality of life of the miner and reduces economic costs associated with morbidity and mortality arising from pulmonary diseases. The purpose of collecting this data is to provide HRSA with information on how well each grantee is meeting the needs of active and retired miners in the funded communities. Data from the annual report will provide quantitative information about the programs, specifically:
(a)The characteristics of the patients they serve (gender, age, disability level, occupation type);
(b)the characteristics of services provided (medical encounters, non-medical encounters, benefits counseling, or outreach); and
(c)the number of patients served. The annual report will be updated to include a qualitative measure on the percent of patients that show improvement in pulmonary function. This assessment will provide data useful to the program and will enable HRSA to provide data required by Congress under the Government Performance and Results Act of 1993. It will also ensure that funds are being effectively used to provide services to meet the needs of the target population. *The estimated burden is a follows:* Form name Number of respondents Responses per respondent Hours per response Total burden hours Database 15 1 10 150 Send comments to Susan G. Queen, PhD, 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: February 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-3917 Filed 3-6-07; 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 (44 U.D.C. 3506(c)(2)(A)), the Health Resources and Services Administration
(HRSA)publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on
(301)443-1129. Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(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: Data System for Organ Procurement and Transplantation Network and Associated Forms (OMB No. 0915-0157): Revision Section 372 of the Public Health Service
(PHS)Act requires that the Secretary, by contract, provide for the establishment and operation of an Organ Procurement and Transplantation Network (OPTN). The OPTN, among other responsibilities, operates and maintains a national waiting list of individuals requiring organ transplants, maintains a computerized system for matching donor organs with transplant candidates on the waiting list, and operates a 24-hour system to facilitate matching organs with individuals included in the list. Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The information is used to indicate the disease severity of transplant candidates, to monitor compliance of member organizations with OPTN rules and requirements, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country. Data are used to develop transplant, donation and allocation policies, to determine if institutional members are complying with policy, to determine member specific performance, to ensure patient safety when no alternative sources of data exist and to fulfill the requirements of the OPTN Final Rule. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of Health and Human Services, and others for evaluation, research, patient information, and other important purposes. Revisions in the 26 data collection forms are intended to implement approved reduction in data collection for candidates and recipients, to provide additional information specific to pediatric patients, and to clarify existing questions. Estimates of Annualized Hour Burden Form Number of respondents Responses per respondents Total responses Hours per response Total burden hours Deceased Donor Registration 58 215 12,470 0.4200 5,237.4000 Death referral data 58 12 696 10.0000 6,960.0000 Living Donor Registration 711 10 7,110 0.4100 2,915.1000 Living Donor Follow-up 711 18 12,798 0.3300 4,223.3400 Donor Histocompatibility 154 95 14,630 0.0600 877.8000 Recipient Histocompatibility 154 172 26,488 0.1100 2,913.6800 Heart Candidate Registration 135 23 3,105 0.2800 869.4000 Lung Candidate Registration 67 27 1,809 0.2800 506.5200 Heart/Lung Candidate Registration 59 1 59 0.2800 16.5200 Thoracic Registration 135 27 3,645 0.4400 1,603.8000 Thoracic Follow-up 135 229 30,915 0.4130 12,767.8950 Kidney Candidate Registration 250 133 33,250 0.2800 9,310.0000 Kidney Registration 250 69 17,250 0.4400 7,590.0000 Kidney Follow-up 250 544 136,000 0.3332 45,315.2000 Liver Candidate Registration 125 89 11,125 0.2800 3,115.0000 Liver Registration 125 54 6,750 0.4000 2,700.0000 Liver Follow-up 125 383 47,875 0.3336 15,971.1000 Kidney/Pancreas Candidate Registration 146 12 1,752 0.2800 490.5600 Kidney/Pancreas Registration 146 7 1,022 0.5300 541.6600 Kidney/Pancreas Follow-up 146 65 9,490 0.5027 4,770.6230 Pancreas Candidate Registration 146 7 1,022 0.2800 286.1600 Pancreas Registration 146 3 438 0.4400 192.7200 Pancreas Follow-up 146 23 3,358 0.4133 1,387.8614 Intestine Candidate Registration 45 8 360 0.2400 86.4000 Intestine Registration 45 4 180 0.5300 95.4000 Intestine Follow-up 45 17 765 0.5059 387.0135 Post Transplant Malignancy 711 6 4,266 0.0800 341.2800 Total 923 388,628 131,472.4329 Send comments to Susan G. Queen, PhD, 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: February 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-3918 Filed 3-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Practitioner Data Bank; Announcement of Proactive Disclosure Service
(PDS)Opening Date and 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 the implementation of a Proactive Disclosure Service
(PDS)Prototype. The PDS is being offered as an alternative to the periodic querying of the National Practitioner Data Bank (NPDB). It was developed in response to the growing interest of healthcare entities in on-going monitoring of practitioner credentials. Authorized Data Bank entities can choose to enroll all of their practitioners in PDS or enroll some practitioners while continuing to periodically query on others using the regular query methods. The query fee for periodic queries remains $4.75 per name. Entities with PDS enrolled practitioners will be notified within one business day of the NPDB's receipt of a report on any of their enrollees. While entities can expect to receive reports sooner with PDS, the format of and the information contained in a report, as well as the information required to be reported will remain the same. Initially, the PDS is being offered as a prototype. The annual subscription fee, during the prototype period, is $3.25 per practitioner. This rate is subject to change after the prototype period is complete. DATES: This fee will be effective April 30, 2007. 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: 1. PDS Enrollment Availability The PDS prototype will be available April 30, 2007. An invitation to enroll practitioners in the prototype has been extended first to organizations that assisted HRSA with designing and pricing, which occurred between 2003 and 2005. All NPDB registered entities have been invited to enroll their practitioners to meet a predetermined number for enrollees. Once this number is achieved, enrollment in the prototype will close. It is anticipated that the PDS prototype period will last approximately 18 to 24 months before it is opened to all authorized Data Bank entities. 2. User Fee Amount 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 related to receiving and disclosing information. Final regulations at 45 CFR part 60 set forth these 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. The Department must 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: a. 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, b. 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, c. Postage—actual cost, and d. Sending information by special methods requested by the applicant, such as express mail or electronic transfer—the actual cost of the special service.” An annual subscription fee of $3.25 per practitioner will be charged upon enrollment. This fee includes the cost of an initial query, which automatically occurs when a practitioner is first enrolled, and all reports received on the enrolled practitioner over the course of the subscription period of 1 year. The fee was determined through economic analysis of the average annual rate of queries performed by health care entities in relationship to the current query fee that is based on the actual cost for services. The Department will accept payment for the subscription fee from entities via credit card or electronic funds transfer. When the prototype period concludes, the Department may change the subscription fee. Any changes will be announced through notice in the **Federal Register** . The periodic query fee remains at $4.75 per name. The practitioner self-query fee remains at $8.00. Currently when a periodic query is 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 the information is requested. Similarly, when a PDS prototype participating entity enrolls one or more physicians, dentists or other health care practitioners, the appropriate fee will be $3.25 multiplied by the number of individuals whom are enrolled. An individual practitioner may not enroll in PDS. For examples, see the tables below. Periodic query method Fee per name in query Examples Entity query
(via)internet with electronic payment $4.75 10 names in query. 10 x $4.75 = $47.50. Practitioner Self-query 8.00 One self-query = $8.00. Proactive disclosure service
(PDS)query method Fee per name enrolled Examples Entity query
(via)internet with electronic payment $3.25 10 names in query. 10 x $3.25 = $32.50. Dated: March 1, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-3974 Filed 3-6-07; 8:45 am] BILLING CODE 4165-15-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. Novel System for HIV-1 Vaccine Development *Description of Technology:* The available technologies describe specific immunogenic peptides, peptide modifications and methods for identifying additional immunogens against HIV-1 surface proteins, gp120 and gp41. Additionally, detailed methods for use of the described immunogenic peptides in the development of vaccines and diagnostics for HIV-1 are disclosed. The current technologies further include a comprehensive system for immunogen design, comprising *in silico* design coupled to feedback from X-ray crystallography, antigenic analysis, and immunization. The described methodology demonstrates how to transplant a given HIV-1 epitope recognized by broadly neutralizing antibodies into an appropriate scaffold, while preserving its structure and antigenicity. Conservation of the three dimensional structure may lead to the generation of antibodies with broadly neutralizing characteristics, similar to the template antibody. Such epitope-transplant scaffolds may serve as valuable diagnostics to identify specific serum reactivity against the target HIV-1 epitopes. The subject scaffolding technology may be applied to any virus for which a broadly neutralizing antibody and its respective epitope has been characterized at the atomic-level. *Applications:* 1. Immunogens that elicit immune responses to HIV-1. 2. Efficient development of vaccines against HIV-1. 3. Screening tool to isolate antibodies with activities similar to identified template antibody. *Inventors:* Peter D. Kwong *et al.* (NIAID) *Publications:* 1. G Ofek, W Schief, J Guenaga, *et al.* Epitope-transplant scaffolds: Automated design, structural analysis, and antigenic characteristics. Manuscript in preparation (2007). 2. T Zhou, L Xu, B Dey, AJ Hessell, DV Ryk, SH Xiang, X Yang, MY Zhang, MB Zwick, J Arthos, DR Burton, DS Dimitrov, J Sodroski, R Wyatt, GJ Nabel, PD Kwong. Structural definition of a conserved neutralization epitope on HIV-1 gp120. Nature. 2007 Feb 15;445(7129):732-737. 3. DC Douek, PD Kwong, GJ Nabel. The rational design of an AIDS vaccine. Cell. 2006 Feb 24;124(4):677-681. 4. G Ofek, M Tang, A Sambor, H Katinger, JR Mascola, R Wyatt, PD Kwong. Structure and mechanistic analysis of the anti-HIV-1 antibody 2F5 in complex with its gp41 epitope. J Virol. 2004 Oct;78(19):10724-10737. *Patent Status:* 1. PCT Application No. PCT/US2005/016633 filed 13 May 2005, which published as WO 2005/111079 on 24 Nov 2005 (HHS Reference No. E-218-2004/0-PCT-02), and National Stage filed in the U.S. on 26 Nov 2006 (HHS Reference No. E-218-2004/0-US-03), entitled “HIV Vaccine Immunogens and Immunization Strategies to Elicit Broadly-Neutralizing Anti-HIV-1 Antibodies Against the Membrane Proximal of HIV gp41”. 2. PCT Application No. PCT/US2006/034681 filed 06 Sep 2006 (HHS Reference No. E-324-2005/3-PCT-01), entitled “Conformationally Stabilized HIV Envelope Immunogens and Triggering HIV-1 Envelope to Reveal Cryptic V3-Loop Epitopes” 3. PCT Application No. PCT/US2006/034882 filed 06 Sep 2006 (HHS Reference No. E-280-2006/1-PCT-01), entitled “HIV gp120 Crystal Structure and Its Use to Identify Immunogens” 4. U.S. Provisional Application No. 60/840,119 filed 25 Aug 2006 (HHS Reference No. E-302-2006/0-US-01), entitled “Epitope-Transplant Scaffolds and Their Use” *Licensing Availability:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov* CCR5-Specific Human Monoclonal Antibodies *Description of Technology:* The subject invention provides the composition claims related to anti-CCR5 monoclonal antibodies, their fusion protein, conjugates, derivatives, or fragments, DNA sequences encoding such antibodies, host cells containing such DNA sequences, as well as the methods to produce them recombinantly and their pharmacological composition. It has been demonstrated that the HIV co-receptor CCR5 plays an important role in virus entry. The subject antibodies exhibited neutralization activity against HIV-1 infection by binding to cell associated CCR5 in vitro. Moreover, subject antibodies have potentially lower immunogenicity and toxicity, because they are fully human antibodies. Therefore, subject anti-CCR5 antibodies have a potential as a therapeutic and/or prophylactic in combination with other HIV-1 neutralizing antibodies and anti-retroviral drugs. *Applications:* HIV treatment and prevention. *Development Status: In vitro* data is available at this time. *Inventors:* Dimiter S. Dimitrov and Mei-Yun Zhang (NCI). *Related Publications:* 1. C Pastori *et al.* Long-lasting CCR5 internalization by antibodies in a subset of long-term nonprogressors: A possible protective effect against disease progression. Blood. 2006 Jun 15;107(12):4825-4833. 2. MY Zhang, B Vu, CC Huang, I Sidirov, V Choudhly, PD Kwong, DS Dimitrov. Identification of human monoclonal antibodies specific for CCR5 from an antibody library derived from HIV-infected long-term non-progressors. Retrovirology. 2006 Dec 21;3 Suppl 1:S61. 3. DS Dimitrov. Virus entry: molecular mechanisms and biomedical applications. Nat Rev Microbiol. 2004 Feb;2(2):109-122. *Patent Status:* U.S. Provisional Application No. 60/859,401 filed 15 Nov 2006 (HHS Reference No. E-297-2006/0-US-01) *Licensing Availability:* Available for exclusive and non-exclusive licensing. *Licensing Contact:* Sally Hu, Ph.D.; 301/435-5606; *HuS@mail.nih.gov* . *Collaborative Research Opportunity:* The NCI CCR Nanobiology Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize monoclonal antibodies. Please contact John D. Hewes, Ph.D. at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Dated: February 28, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer National Institutes of Health. [FR Doc. E7-3959 Filed 3-6-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of 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 a meeting of the Advisory Committee on Research on Women's Health. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* Advisory Committee on Research on Women's Health. *Date:* March 29-30, 2007. *Time:* March 29, 2007, 9 a.m. to 5 p.m. *Agenda:* Provide advice to the Office of Research on Women's Health
(ORWH)on appropriate research activities with respect to women's health and related studies to be undertaken by the National Research Institutes; to provide recommendations regarding ORWH activities; to meet the mandates of the office; and for discussion of scientific issues. *Place:* National Institutes of Health, Building 31, 31 Center Drive, 6C/10, Bethesda, MD 20892. *Time:* March 30, 2007, 9 a.m. to 1 p.m. *Agenda:* Same as above. *Place:* National Institutes of Health, Building 31, 31 Center Drive, 6C/10, Bethesda, MD 20892. *Contact Person:* Joyce Rudick, Director, Programs & Management, Office of Research on Women's Health, Office of the Director, National Institutes of Health, Building 1, Room 201, Bethesda, MD 20892, 301/402-1770. Information is also available on the Institute's/Center's home page: *http://www4.od.nih.gov/orwh/,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiancy Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: February 28, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-1041 Filed 3-6-07; 8:45 am]
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- Pub. L. 104-13
- Pub. L. 99-660
- 45 CFR 60
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