SNOTE | Q | INTERVENTIONAL RADIOLOGY RESEARCH

FBO DAILY ISSUE OF MAY 16, 2009 FBO #2728
SPECIAL NOTICE

Q -- INTERVENTIONAL RADIOLOGY RESEARCH

Notice Date: 5/14/2009
Notice Type: Special Notice
NAICS: 541690 — Other Scientific and Technical Consulting Services
Contracting Office: Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
ZIP Code: 20892-5480
Solicitation Number: P158538
Archive Date: 6/2/2009
Point of Contact: Gail Akinbinu,, Phone: 301-496-0692
E-Mail Address: gakinbinu@nih.gov
Small Business Set-Aside: N/A
Description: THE NATIONAL INSTITUTES OF HEALTH/RADIOLOGY AND IMAGING SCIENCES DEPARTMENT INTENDS TO PROCURE INTERVENTIONAL RADIOLOGY RESEARCH SERVICES FOR THE PERIOD ENDING SEPTEMBER 30, 2009. THESE SERVICES WILL BE PROCURED ON A SOLE SOURCE BASIS AS A CONTINUATION OF SERVICES ADVERTISED UNDER PRIOR SOLICITATION # P112044. PLEASE SEE STATEMENT OF WORK AND SOLE SOURCE JUSTIFICATION BELOW. Statement of Work Imaging Sciences Interventional Therapies Researcher BACKGROUND With nation-wide responsibility for improving the health and well being of all Americans, the Department of Health and Human Services oversees the biomedical research programs of the research institutes at the National Institutes of Health. The Imaging Sciences Training Program (ISTP), a research laboratory in the Imaging Sciences Program of the Warren Grant Magnuson Clinical Center, a major research component of the National Institutes of Health (NIH) and the Department of Health and Human Services, requires the research services of an interventional radiologist to join in ongoing research in the Imaging Sciences Program. The period of service will be one year, renewable up to three years, with agreement of both parties. PURPOSE The purpose of this contract is to provide interventional radiology research and clinical assistance in the pre-clinical and clinical research program of the Imaging Sciences Training Program (ISTP). REIMBURSABLE EXPENSES (TRAVEL, CONFERENCE, TRAINING, EQUIPMENT OR MATERIALS, ETC.). Travel X is required. is not required. The contractor will be required to travel to other locations in support of the tasks described in this statement of work. Prior to incurring any travel expenses, contractor personnel must obtain written authorization from the Project Officer that approves approximate travel, dates, expected duration, origin and destination, purpose, estimated costs and the number and names of personnel traveling. Contractor expense reports shall be prepared and processed in accordance with the Federal Travel Regulation (FTR). Materials and subcontracts will be reimbursed at actual cost, including allocable material handling costs, as applicable, in accordance with FAR 52.232-7 - PAYMENTS UNDER TIME-AND-MATERIALS AND LABOR-HOUR CONTRACTS. Training X is required. is not required. The contractor will be required to attend training, but is not limited to on-the-clock, on-site orientations essential to the execution of the contract; therefore, the contractor has agreed that when it is in the best interest of the Government, the contractor shall attend on-site, local, or domestic training on a space available basis. In these instances, the contractor shall be reimbursed for training expenses. Prior to incurring any training expenses, contractor personnel must obtain written authorization from the Project Officer that approves approximate training, dates, expected duration, purpose, estimated costs and the number and names of personnel attending the training. Contractor expense reports shall be prepared and processed in accordance with the Federal Travel Regulation (FTR). Materials and subcontracts will be reimbursed at actual cost, including allocable material handling costs, as applicable, in accordance with FAR 52.232-7 - PAYMENTS UNDER TIME-AND-MATERIALS AND LABOR-HOUR CONTRACTS. The contractor will be allowed up to $5,000 for travel and training expenses. EDUCATION, TRAINING AND SKILLS REQUIRED The researcher shall have an M.D. as well as residency training in Diagnostic Radiology and fellowship training in Interventional Radiology, as well as a background in cell biology and biology with relevant experience with MRI, CT, and interventional therapies, as well as an interest in biomedical engineering. The researcher shall: 1.Have expertise in CT, MR, cell biology, and clinical interventional radiology. 2.Be capable of gaining experience in large and small animal targeted therapies research which could include interventional procedures in animals. 3.Have expertise in administering targeted agents locally to organs or tumors usinmg image guided therapy techniques, which could include intra-tumoral injections, intra-arterial delivery, transcatheter arterial chemoembolization techniques in animals and study patients. 4.Have interest in tissue destruction with microwaves, high intensity focused ultrasound, cryoablation, or radiofrequency ablation. 5.Have an interest in novel minimally invasive image guided endovascular or interstitial devices and the study thereof. CONTRACT TASKS TO BE PERFORMED The researcher shall be required to perform the work set forth below: 1.Formulate and write research plans and research protocols for in vivo small (rodent), intermediate (rabbit) and large animal (swine) research. 2.Perform cell biology assays and experiments 3.Design research studies to combine smart targeted therapies with multimodality imaging guidance platforms. 4.Maintain records of all research. 5.Generate reports based on the results of the research. 6.Attend lab meetings when able, to disseminate findings and refine research plan. 7.Participate in interventional radiology procedures on patients enrolled in clinical trials. 8.Participate in call duty up to but not exceeding 18 days per 12 month period. CONTRACTOR RESPONSIBILITIES A.All on-site technician employees are required to comply with the requirements of the Code of Federal Regulations/Title 45-Public Welfare/Subtitle A-Department of Health and Human Services/Part 3-Conduct of Persons and Traffic on the National Institutes of Health Federal Enclave, Part 3 entitled Conduct of Persons and Traffic on the National Institutes of Health Enclave. Upon request the Contracting Officer will make this regulation available in full text. Also, a full text of this regulation may be accessed electronically at this address: http://www.gpoaccess.gov/cfr/index.html B.The technician is responsible for adherence to all other Federal, state, local and NIH regulations and laws. Failure of the technician to comply with any NIH local, state, or Federal regulations and laws during the performance of duties specified herein may result in the termination of this contact in accordance with all applicable Federal Acquisition Regulations. C.The Contractor will be bound by all provisions of Executive Order 10096 (See Appendix II), and any rules, regulations or the like issued there under where the National Institutes of Health determines the rights of the Government to inventions conceived or actually reduced to practice during the period of time that services shall be provided. D.Contractor agrees not to perform any duties or produce deliverables likely to generate intellectual property by Contractor. Nevertheless, Contractor understands and agrees that in the event an invention is conceived or reduced to practice by the Contractor using resources of the Federal Government, or conceived or made during working hours on Federal Government projects, or conceived or made while on Federal government property by the Contractor, or conceived or made as a consequence of any duties of the Contractor during a Federal Government project, such invention(s) shall be assigned to or owned by the Federal Government GOVERNMENT PERFORMANCE STANDARDS A.The Government reserves the right to cancel this order with two weeks prior written notification to the technician if requirement is no longer needed. The technician, upon receipt of this notification shall submit any final reports and data which may be the output of specific research, to the Government. B.The Government retains all "rights in data" as per FAR clause 52.227 - 17. (See Appendix I). The Contractor shall not have the right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in performance of this contract unless expressly waived in writing by the Government (FAR clause 52.227 - 17 (d)(1). C.The Government reserves the right to review all presentations, or submissions for publications authored by the contractor or sub-contractors utilizing data or information provided by the Government for the purpose of this contract. All documents shall be provided to allow at least 30 calendar days for review CONFLICTS OF INTEREST The contractor shall certify that, to the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational or personal conflict of interest as defined in FAR 9.5 Organizational and Consultants Conflicts of Interest, or that the contractor has disclosed such relevant information. The Contractor agrees that if an actual or potential organizational conflict of interest is discovered after the award, the Contractor shall make full disclosure in writing to the Contracting officer, along with the proposed mitigation strategy. All information provided to the contractor is considered confidential. APPENDIX I FAR 52.227 - 17 Rights in Data Clause Rights in Data-General (June 1987) (a) Definitions. "Computer software," as used in this clause, means computer programs, computer data bases, and documentation thereof. "Data," as used in this clause, means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information. "Form, fit, and function data," as used in this clause, means data relating to items, components, or processes that are sufficient to enable physical and functional interchangeability, as well as data identifying source, size, configuration, mating, and attachment characteristics, functional characteristics, and performance requirements; except that for computer software it means data identifying source, functional characteristics, and performance requirements but specifically excludes the source code, algorithm, process, formulae, and flow charts of the software. "Limited rights," as used in this clause, means the rights of the Government in limited rights data as set forth in the Limited Rights Notice of paragraph (g)(2) if included in this clause. "Limited rights data," as used in this clause, means data (other than computer software) that embody trade secrets or are commercial or financial and confidential or privileged, to the extent that such data pertain to items, components, or processes developed at private expense, including minor modifications thereof. "Restricted computer software," as used in this clause, means computer software developed at private expense and that is a trade secret; is commercial or financial and is confidential or privileged; or is published copyrighted computer software, including minor modifications of such computer software. "Restricted rights," as used in this clause, means the rights of the Government in restricted computer software, as set forth in a Restricted Rights Notice of paragraph (g)(3) if included in this clause, or as otherwise may be provided in a collateral agreement incorporated in and made part of this contract, including minor modifications of such computer software. "Technical data," as used in this clause, means data (other than computer software) which are of a scientific or technical nature. "Unlimited rights," as used in this clause, means the right of the Government to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so. (b) Allocation of rights. (1) Except as provided in paragraph (c) of this clause regarding copyright, the Government shall have unlimited rights in- (i) Data first produced in the performance of this contract; (ii) Form, fit, and function data delivered under this contract; (iii) Data delivered under this contract (except for restricted computer software) that constitute manuals or instructional and training material for installation, operation, or routine maintenance and repair of items, components, or processes delivered or furnished for use under this contract; and (iv) All other data delivered under this contract unless provided otherwise for limited rights data or restricted computer software in accordance with paragraph (g) of this clause. (2) The Contractor shall have the right to- (i) Use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, unless provided otherwise in paragraph (d) of this clause; (see publication clause above) (ii) Protect from unauthorized disclosure and use those data which are limited rights data or restricted computer software to the extent provided in paragraph (g) of this clause; (iii) Substantiate use of, add or correct limited rights, restricted rights, or copyright notices and to take other appropriate action, in accordance with paragraphs (e) and (f) of this clause; and (iv) Establish claim to copyright subsisting in data first produced in the performance of this contract to the extent provided in paragraph (c)(1) of this clause. (c) Copyright- (1) Data first produced in the performance of this contract. Unless provided otherwise in paragraph (d) of this clause, the Contractor may establish, without prior approval of the Contracting Officer, claim to copyright subsisting in scientific and technical articles based on or containing data first produced in the performance of this contract and published in academic, technical or professional journals, symposia proceedings or similar works. The prior, express written permission of the Contracting Officer is required to establish claim to copyright subsisting in all other data first produced in the performance of this contract. When claim to copyright is made, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402 and acknowledgment of Government sponsorship (including contract number) to the data when such data are delivered to the Government, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. For data other than computer software the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable worldwide license in such copyrighted data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For computer software, the Contractor grants to the Government and others acting in its behalf, a paid-up nonexclusive, irrevocable worldwide license in such copyrighted computer software to reproduce, prepare derivative works, and perform publicly and display publicly by or on behalf of the Government. (2) Data not first produced in the performance of this contract. The Contractor shall not, without prior written permission of the Contracting Officer, incorporate in data delivered under this contract any data not first produced in the performance of this contract and which contains the copyright notice of 17 U.S.C. 401 or 402, unless the Contractor identifies such data and grants to the Government, or acquires on its behalf, a license of the same scope as set forth in paragraph (c)(1) of this clause; provided, however, that if such data are computer software the Government shall acquire a copyright license as set forth in paragraph (g)(3) of this clause if included in this contract or as otherwise may be provided in a collateral agreement incorporated in or made part of this contract. (3) Removal of copyright notices. The Government agrees not to remove any copyright notices placed on data pursuant to this paragraph (c), and to include such notices on all reproductions of the data. (d) Release, publication and use of data. (1) The Contractor shall have the right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, except to the extent such data may be subject to the Federal export control or national security laws or regulations, or unless otherwise provided in this paragraph of this clause or expressly set forth in this contract. (2) The Contractor agrees that to the extent it receives or is given access to data necessary for the performance of this contract which contain restrictive markings, the Contractor shall treat the data in accordance with such markings unless otherwise specifically authorized in writing by the Contracting Officer. (e) Unauthorized marking of data. (1) Notwithstanding any other provisions of this contract concerning inspection or acceptance, if any data delivered under this contract are marked with the notices specified in paragraph (g)(2) or (g)(3) of this clause and use of such is not authorized by this clause, or if such data bears any other restrictive or limiting markings not authorized by this contract, the Contracting Officer may at any time either return the data to the Contractor, or cancel or ignore the markings. However, the following procedures shall apply prior to canceling or ignoring the markings. (i) The Contracting Officer shall make written inquiry to the Contractor affording the Contractor 30 days from receipt of the inquiry to provide written justification to substantiate the propriety of the markings; (ii) If the Contractor fails to respond or fails to provide written justification to substantiate the propriety of the markings within the 30-day period (or a longer time not exceeding 90 days approved in writing by the Contracting Officer for good cause shown), the Government shall have the right to cancel or ignore the markings at any time after said period and the data will no longer be made subject to any disclosure prohibitions. (iii) If the Contractor provides written justification to substantiate the propriety of the markings within the period set in subdivision (e)(1)(i) of this clause, the Contracting Officer shall consider such written justification and determine whether or not the markings are to be cancelled or ignored. If the Contracting Officer determines that the markings are authorized, the Contractor shall be so notified in writing. If the Contracting Officer determines, with concurrence of the head of the contracting activity, that the markings are not authorized, the Contracting Officer shall furnish the Contractor a written determination, which determination shall become the final agency decision regarding the appropriateness of the markings unless the Contractor files suit in a court of competent jurisdiction within 90 days of receipt of the Contracting Officer's decision. The Government shall continue to abide by the markings under this subdivision (e)(1)(iii) until final resolution of the matter either by the Contracting Officer's determination becoming final (in which instance the Government shall thereafter have the right to cancel or ignore the markings at any time and the data will no longer be made subject to any disclosure prohibitions), or by final disposition of the matter by court decision if suit is filed. (2) The time limits in the procedures set forth in paragraph (e)(1) of this clause may be modified in accordance with agency regulations implementing the Freedom of Information Act (5 U.S.C. 552) if necessary to respond to a request thereunder. (3) This paragraph (e) does not apply if this contract is for a major system or for support of a major system by a civilian agency other than NASA and the U.S. Coast Guard agency subject to the provisions of Title III of the Federal Property and Administrative Services Act of 1949. (4) Except to the extent the Government's action occurs as the result of final disposition of the matter by a court of competent jurisdiction, the Contractor is not precluded by this paragraph (e) from bringing a claim under the Contract Disputes Act, including pursuant to the Disputes clause of this contract, as applicable, that may arise as the result of the Government removing or ignoring authorized markings on data delivered under this contract. (f) Omitted or incorrect markings. (1) Data delivered to the Government without either the limited rights or restricted rights notice as authorized by paragraph (g) of this clause, or the copyright notice required by paragraph (c) of this clause, shall be deemed to have been furnished with unlimited rights, and the Government assumes no liability for the disclosure, use, or reproduction of such data. However, to the extent the data has not been disclosed without restriction outside the Government, the Contractor may request, within 6 months (or a longer time approved by the Contracting Officer for good cause shown) after delivery of such data, permission to have notices placed on qualifying data at the Contractor's expense, and the Contracting Officer may agree to do so if the Contractor- (i) Identifies the data to which the omitted notice is to be applied; (ii) Demonstrates that the omission of the notice was inadvertent; (iii) Establishes that the use of the proposed notice is authorized; and (iv) Acknowledges that the Government has no liability with respect to the disclosure, use, or reproduction of any such data made prior to the addition of the notice or resulting from the omission of the notice. (2) The Contracting Officer may also (i) permit correction at the Contractor's expense of incorrect notices if the Contractor identifies the data on which correction of the notice is to be made, and demonstrates that the correct notice is authorized, or (ii) correct any incorrect notices. (g) Protection of limited rights data and restricted computer software. (1) When data other than that listed in subdivisions (b)(1)(i), (ii), and (iii) of this clause are specified to be delivered under this contract and qualify as either limited rights data or restricted computer software, if the Contractor desires to continue protection of such data, the Contractor shall withhold such data and not furnish them to the Government under this contract. As a condition to this withholding, the Contractor shall identify the data being withheld and furnish form, fit, and function data in lieu thereof. Limited rights data that are formatted as a computer data base for delivery to the Government are to be treated as limited rights data and not restricted computer software. (2) [Reserved] (3) [Reserved] (h) Subcontracting. The Contractor has the responsibility to obtain from its subcontractors all data and rights therein necessary to fulfill the Contractor's obligations to the Government under this contract. If a subcontractor refuses to accept terms affording the Government such rights, the Contractor shall promptly bring such refusal to the attention of the Contracting Officer and not proceed with subcontract award without further authorization. (i) Relationship to patents. Nothing contained in this clause shall imply a license to the Government under any patent or be construed as affecting the scope of any license or other right otherwise granted to the Government APPENDIX II Executive Order 10096--Providing for a uniform patent policy for the Government with respect to inventions made by Government employees and for the administration of such policy Source: The provisions of Executive Order 10096 of Jan. 23, 1950, appear at 15 FR 389, 3 CFR, 1949-1953 Comp., p. 292, unless otherwise noted. WHEREAS inventive advances in scientific and technological fields frequently result from governmental activities carried on by Government employees; and WHEREAS the Government of the United States is expending large sums of money annually for the conduct of these activities; and WHEREAS these advances constitute a vast national resource; and WHEREAS it is fitting and proper that the inventive product of functions of the Government, carried out by Government employees, should be available to the Government; and WHEREAS the rights of Government employees in their inventions should be recognized in appropriate instances; and WHEREAS the carrying out of the policy of this order requires appropriate administrative arrangements: NOW, THEREFORE, by virtue of the authority vested in me by the Constitution and statutes, and as President of the United States and Commander in Chief of the armed forces of the United States, in the interest of the establishment and operation of a uniform patent policy for the Government with respect to inventions made by Government employees, it is hereby ordered as follows: 1. The following basic policy is established for all Government agencies with respect to inventions hereafter made by any Government employee: (a) The Government shall obtain the entire right, title and interest in and to all inventions made by any Government employee (1) during working hours, or (2) with a contribution by the Government of facilities, equipment, materials, funds, or information, or of time or services of other Government employees on official duty, or (3) which bear a direct relation to or are made in consequence of the official duties of the inventor. (b) In any case where the contribution of the Government, as measured by any one or more of the criteria set forth in paragraph (a) last above, to the invention is insufficient equitably to justify a requirement of assignment to the Government of the entire right, title and interest to such invention, or in any case where the Government has insufficient interest in an invention to obtain entire right, title and interest therein (although the Government could obtain some under paragraph (a), above), the Government agency concerned, subject to the approval of the Chairman of the Government Patents Board (provided for in paragraph 3 of this order and hereinafter referred to as the Chairman), shall leave title to such invention in the employee, subject, however, to the reservation to the Government of a non-exclusive, irrevocable, royalty-free license in the invention with power to grant licenses for all governmental purposes, such reservation, in the terms thereof, to appear, where practicable, in any patent, domestic or foreign, which may issue on such invention. (c) In applying the provisions of paragraphs (a) and (b), above, to the facts and circumstances relating to the making of any particular invention, it shall be presumed that an invention made by an employee who is employed or assigned (i) to invent or improve or perfect any art, machine, manufacture, or composition of matter, (ii) to conduct or perform research, development work, or both, (iii) to supervise, direct, coordinate, or review Government financed or conducted research, development work, or both, or (iv) to act in a liaison capacity among governmental or nongovernmental agencies or individuals engaged in such work, or made by an employee included within any other category of employees specified by regulations issued pursuant to section 4(b) hereof, falls within the provisions of paragraph (a), above, and it shall be presumed that any invention made by any other employee falls within the provisions of paragraph (b), above. Either presumption may be rebutted by the facts or circumstances attendant upon the conditions under which any particular invention is made and, notwithstanding the foregoing, shall not preclude a determination that the invention falls within the provisions of paragraph (d) next below. (d) In any case wherein the Government neither (1) pursuant to the provisions of paragraph (a) above, obtains entire right, title and interest in and to an invention nor (2) pursuant to the provisions of paragraph (b) above, reserves a non-exclusive, irrevocable, royalty-free license in the invention with power to grant licenses for all governmental purposes, the Government shall leave the entire right, title and interest in and to the invention in the Government employee, subject to law. (e) Actions taken, and rights acquired, under the foregoing provisions of this section, shall be reported to the Chairman in accordance with procedures established by him. 2. Subject to considerations of national security, or public health, safety, or welfare, the following basic policy is established for the collection, and dissemination to the public, of information concerning inventions resulting from Government research and development activities: (a) When an invention is made under circumstances defined in paragraph 1(a) of this order giving the United States the right to title thereto, the Government agency concerned shall either prepare and file an application for patent therefore in the United States Patent Office or make a full disclosure of the invention promptly to the Chairman, who may, if he determines the Government interest so requires, cause application for patent to be filed or cause the invention to be fully disclosed by publication thereof: Provided, however, That, consistent with present practice of the Department of Agriculture, no application for patent shall, without the approval of the Secretary of Agriculture, be filed in respect of any variety of plant invented by any employee of that Department. (b) [Revoked] [Sec. 2(b) revoked by EO 10695 of Jan. 16, 1957, 22 FR 365, 3 CFR, 1954-1958 Comp., p. 355] 3. (a) [Revoked] (b) The Government Patents Board shall advise and confer with the Chairman concerning the operation of those aspects of the Government's patent policy which are affected by the provisions of this order or of Executive Order No. 9865, and suggest modifications or improvements where necessary. (c) [Revoked] (d) The Chairman shall establish such committees and other working groups as may be required to advise or assist him in the performance of any of his functions. (e) The Chairman of the Government Patents Board and the Chairman of the Interdepartmental Committee on Scientific Research and Development1 (provided for by Executive Order No. 9912 of December 24, 1947) shall establish and maintain such mutual consultation as will effect the proper coordination of affairs of common concern. [Sec. 3 amended by EO 10930 of Mar. 24, 1961, 26 FR 2583, 3 CFR, 1959-1963 Comp., p. 456] 4. With a view to obtaining uniform application of the policies set out in this order and uniform operations there under, the Chairman is authorized and directed: (a) To consult and advise with Government agencies concerning the application and operation of the policies outlined herein; (b) After consultation with the Government Patents Board, to formulate and submit to the President for approval such proposed rules and regulations as may be necessary or desirable to implement and effectuate the aforesaid policies, together with the recommendations of the Government Patents Board thereon; (c) To submit annually a report to the President concerning the operation of such policies, and from time to time such recommendations for modification thereof as may be deemed desirable; (d) To determine with finality any controversies or disputes between any Government agency and its employees, to the extent submitted by any party to the dispute, concerning the ownership of inventions made by such employees or rights therein; and (e) To perform such other or further functions or duties as may from time to time be prescribed by the President or by statute. 5. The functions and duties of the Secretary of Commerce and the Department of Commerce under the provisions of Executive Order No. 9865 of June 14, 1947 are hereby transferred to the Chairman and the whole or any part of such functions and duties may be delegated by him to any Government agency or officer: Provided, That said Executive Order No. 9865 shall not be deemed to be amended or affected by any provision of this Executive order other than this paragraph 5. 6. Each Government agency shall take all steps appropriate to effectuate this order, including the promulgation of necessary regulations which shall not be inconsistent with this order or with regulations issued pursuant to paragraph 4 (b) hereof. 7. As used in this Executive order, the next stated terms, in singular and plural, are defined as follows for the purposes hereof: (a) "Government agency" includes any executive department and any independent commission, board, office, agency, authority, or other establishment of the Executive Branch of the Government of the United States (including any such independent regulatory commission or board, any such wholly-owned corporation, and the Smithsonian Institution), but excludes the Atomic Energy Commission.2 (b) "Government employee" includes any officer or employee, civilian or military, of any Government agency, except such part-time consultants or employees as may be excluded by regulations promulgated pursuant to paragraph 4(b) hereof. (c) "Invention" includes any art, machine, manufacture, design or composition of matter, or any new and useful improvement thereof, or any variety of plant, which is or may be patentable under the patent laws of the United States. ________________________________________ Editorial note: Executive Order 10096 is further amended by Executive Order 10930 of Mar. 24, 1961, 26 FR 2583, 3 CFR, 1959-1963 Comp., p. 456. The provisions of Executive Order 10930 are set forth below: Section 1. The Government Patents Board, established by section 3(a) of Executive Order No. 10096 of January 23, 1950, and all positions established there under or pursuant thereto are hereby abolished. Sec. 2. All functions of the Government Patents Board and of the Chairman thereof under the said Executive Order No. 10096, except the functions of conference and consultation between the Board and the Chairman, are hereby transferred to the Secretary of Commerce, who may provide for the performance of such transferred functions by such officer, employee, or agency of the Department of Commerce as he may designate. Sec. 3. The Secretary of Commerce shall make such provision as may be necessary and consonant with law for the disposition or transfer of property, personnel, records, and funds of the Government Patents Board. Sec. 4. Except to the extent that they may be inconsistent with this order, all determinations, regulations, rules, rulings, orders, and other actions made or issued by the Government Patents Board, or by any Government agency with respect to any function transferred by this order, shall continue in full force and effect until amended, modified, or revoked by appropriate authority. Sec. 5. Subsections (a) and (c) of section 3 of Executive Order No. 10096 are hereby revoked, and all other provisions of that order are hereby amended to the extent that they are inconsistent with the provisions of this order. Sole Source Justification Imaging Sciences Interventional Radiologist MD PhD Scientist: Karun Sharma, MD PhD We are going to contract Karun Sharma to perform interventional radiology medical research and biomedical tissue engineering research studies related to formulation and implementation of animal model experiments for novel drug delivery technologies such as drug eluting beads and imageable beads as well as thrombolytic vectors for therapy. Dr. Sharma’s unique skillset and training make him highly specific and uniquely qualified to fulfill the work duties and requirements for this job. Specifically, he is in a quite rare and scarce group with MD and PhD and fellowship trained in Interventional Radiology at an ACGME-accedited center, as well as being eligible for certificate of added qualifications in Interventional Radiology from the American Board of Radiology. He has experience with drug eluting beads as well as experience with imageable beads for selective drug delivery and regional drug delivery to the liver. He also has experience with electromagnetic tracking of surgical instruments and interventiknal devices, another area of particular interest to the department. He is the only interventional radiologist in the world who has experience with micro-CT, and macro-CT and in vivo quantification and imaging of these iodinated beads, and the only MD PhD with expertise in interventional oncology, thrombolysis, and imageable beads to our knowledge, available in a timeframe and frequency conducive to meet our translational research goals. No commercial or contracting service alternative is available that could provide the immediate solution and set of skills without extensive on-site training, where the training of another similar physician without his specific expertise and skills, could even exceed the length of the contract. Karun Sharma has become an authority on the subject of drug eluting beads and imageable beads. He combines this unique skill with rare expertise in the navigation software and hardware that were jointly developed by NIH and industry over the past few years. This skill set combination is also vital and unique for the success of our ongoing research in this area. As such an expert, he provides these projects with his experience and background that are not available on the free market and justifies sole source. No commercial alternative is available and no advertising could result in her combination of skill sets. He is likewise jointly skilled in large animal research and large animal catheter manipulation requisite for large animal research on drugs + devices to be performed.
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Place of Performance: Address: NATIONAL INSTITUTES OF HEALTH, RADIOLOGY AND IMAGING SCIENCES, BLDG 10, BETHESDA, Maryland, 20892, United States; Zip Code: 20892
Record: SN01817104-W 20090516/090514220103-ec678354226eaa5bf3854ec532a6655a (fbodaily.com)
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Q -- INTERVENTIONAL RADIOLOGY RESEARCH