SOLICITATION NOTICE
R -- Medical advisory medical physician services for participants of the resveratrol study at the National Institute on Aging (NIA)
- Notice Date
- 11/14/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-CSS-2015-014
- Archive Date
- 12/16/2014
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-2015-014 and the solicitation is issued as a Request For Quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-76, dated 25 JULY 2014. The North American Industry Classification System (NAICS) code for this procurement is 541990 and the Small Business Size Standard is 15 million dollars; All Other Professional, Scientific and Technical Services. This requirement is released on a restricted set-aside basis to Small Business concerns. Statement of Objectives The goal of this procurement will be to obtain health care services of a physician by a non-personal services contract, including full time services from a board certified physician in internal medicine serving as the Medical Advisory Investigator (MAI) on an Intramural Research Board (IRB)- approved study conducted at Harbor Hospital in Baltimore, MD. The study supports research protocol number 13-AG-N0378 on the NIH clinical trial number NCT01842399, "Resveratrol and Cardiovascular Health in the Elderly." Background NIA research protocol number 13-AG-N0378 (i.e. the Resveratrol Study) involves studying the effect of a low and high dose of Resveratrol on vascular markers in non-hospitalized volunteer participants over a one year period. Resveratrol is a nutraceutical and has no known side effects at the dose to be used. Resveratrol is found in the leaves and skin of grapes and studies have shown that resveratrol affects key cellular pathways and molecular targets with a range of biological effects on the aging process. The NIA is beginning a new clinical research trial number NCT01842399 to test the effects of different dose levels of Resveratrol on heart and blood vessel health among healthy overweight nonsmoking volunteers at least 50 years of age. Information and reference material for the NIH Clinical Trial, "Resveratrol and Cardiovascular Health in the Elderly," is located on ClinicalTrials.gov at the following website: http://clinicaltrials.gov/ct2/show/NCT01842399?term=01842399&rank=1 The study will involve one screening visit and four study visits by research participants. The following is a list of procedures that participants will undergo. Screening: Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Participants will be given a list of foods that they should avoid eating while on the study. Participants will be assigned into one of three groups: two groups will take different dose levels of the study drug, and the third group will take a placebo. First study visit: participants will stay in the NIH clinical center overnight for 2 days of tests. They will provide blood and urine samples, have body scans to measure fat and muscle mass and will have exercise testing be performed. Muscle biopsy will also be performed. Receive initial dose of the study drug, and will continue to take this dose for as long as they are on the study. Second visit: The second visit will be 16 weeks after the first one. It will take only 2 hours, and repeat most of the tests from the screening visit. Third visit: The third visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the second visit will be repeated. Fourth visit: The fourth and final visit will be 16 weeks later. It will involve an overnight stay. Most of the tests from the initial study visit (including the scans and the exercise tests) will be repeated. Statement of Work: With the goal of acquiring the services of a physician to serve as the Medical Advisory Investigator (MAI) on the NIA protocol #13-AG-N0378, services from the MAI Contractor will include: screening participants, performing physical exams, conducting history analyses of participants, evaluating and analyzing data, and performing follow-up visits. Additionally it involves reviewing inclusion and exclusion criteria, and being available to answer questions from participants. The total number of participants to be enrolled in this new study is 90 (30 on low dose and 30 on high dose of Resveratrol, 30 on placebo). Specific tasks to be performed: Contractor work requirements shall include the following tasks. • Conduct screening of participants recruited for the study; • Determine if the participants meet the study inclusion criteria for participating in the protocol study, in collaboration with the Clinical Research Coordinator; • Evaluate participants during the second, third, and fourth follow up visits • Maintain all paperwork as required by the NIH Institutional Review Board (IRB). • Provide medical coverage for protocols at the NIA clinical unit. Work shall be performed in close collaboration with the NIA Principal Investigator (PI), currently the NIA Scientific Director, the NIA Clinical Nurse Manager, the NIA Clinical Research Coordinator (CRC), and the NIA Clinical Recruiter. The contractor shall perform the work as directed by the NIA Clinical Director. This The following is a list of mandatory requirements that the MAI contractor will be required to possess, or have the ability to obtain, prior to award or within the time limits specified herein. • Clearance for Position Sensitivity Designation on the subject research protocol following NIH guidelines for a "Level 5: Public Trust - Moderate Risk" contractor. Contractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI). More information can be found at the website: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Pages/table2.aspx • Credentialed at Harbor Hospital in Baltimore, MD. For more information on applying for privileges, contact the Harbor Hospital Medical Staff Services department at 410-350-3477, or go to their website at: https://www.medstarhealth.org/physicians/Pages/Credentialing/MedStar-Harbor.aspx. • Malpractice insurance. (Contractor must provide documented evidence of having current malpractice insurance within 15 days of contract award) Anticipated period of performance: The anticipated period of performance of any resulting contract is one base year, to be effective on or around December 1, 2014, including the option to exercise two (2) additional one-year periods of performance. The government estimates that full time work, or 2080 hours annually, will be necessary to accomplish this Statement of Work. Contractor is expected to work during regular office hours 40 hours per week, approximately 7:00 AM to 3:30 PM. The place of performance will include the NIA Clinical Unit at Harbor Hospital located in Baltimore, MD. Contract Type: The contract type is a fixed price level of effort type of contract. Deliverables and Reporting requirements: The contractor will be required to provide data to the investigators in electronic format on an ad hoc or as needed basis regarding any of the tasks listed in the Contractor's requirements and tasks to be performed. In addition, the contractor will be required to provide the NIA Principal Investigator and NIA Clinical Director with monthly updates of participant recruitment and unanticipated events, concerns or issues. Updates and adverse events may be requested in verbal or written format. Government's responsibilities: The NIA will grant the contractor access to the work site located at the NIA Clinical Unit, Harbor Hospital, 3001 S. Hanover Street, 5th floor, Baltimore, MD 21225. The government will provide the equipment, the clinical and office space required for the contractor to achieve the statement of work. The NIA will grant the contractor access to the NIH network and applicable IT systems upon approval of the Position Sensitivity Designation clearance. The NIA will conduct the following pre-employment testing services prior to contract award in order to fulfill MedStar Harbor Hospital pre-employment requirements: • 2 step PPD (TB skin test), annual thereafter; • MMRV (measles, mumps and rubella) titers; • Mandatory annual influenza vaccine Sept-April; • Negative Urine drug screen. Contracting Officer's Representative The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract: To be determined at time of award. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. No travel will be reimbursable or required outside of normal commuting. The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned. To be determined at time of award. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference into the contract. The Government may unilaterally change its COR designation at any time throughout the performance period of this contract. Post Award evaluation of Contractor Performance a)Contractor Performance Evaluations Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted at the time of the annual evaluation. Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations Contractor responses and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. b)Electronic Access to Contractor Performance evaluations Contractors that have internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address: hhtp://oamp.od.nih./OD/CPS/cps.asp. The registration process requires the Contractor to identify an individual that will serve as a primary point of contact and who will be authorized access to the evaluations for review and comment. In addition, the Contractor will be required to identify an alternate contact that will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame. INSTRUCTIONS TO OFFERORS/EVALUATION The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Responses from Offerors will be evaluated on showing an Understanding of the Requirements. The Offeror's technical approach shall indicate compliance with Contractor Requirements, and describe an essential understanding of the requirements involved in accomplishing the work. The following factors shall be used to evaluate offers: • Documented experience and ability in screening and evaluating research participants • Educational background and qualifications • Availability of proposed personnel • Documented successful past performance reflecting knowledge of work performed in the last 2 years similar to this requirement. Experience and ability shall also include: Documentation of board certification in Internal Medicine; clinical privileges or the ability to obtain such privileges at Harbor Hospital; and the ability to obtain malpractice insurance within fifteen days upon contract award. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment). Basic Cost/Price Information The business offer must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services. Offerors shall propose a fixed-hourly rate included in their business proposal response. The hourly rate must be a fully loaded labor rate inclusive of all direct costs, indirect cost, overhead, and profit or fee. Offeror must also include a breakdown of how the fully loaded hourly rate was determined. The Offeror must submit with its proposal: either complete FAR 52.212-3, Offerors Representation and Certifications - Commercial Items (Aug 2009) or provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management Applications (www.SAM.gov) with their technical/business proposal submission. Responses to this RFQ must be submitted in Microsoft Word or searchable PDF format in a font size of 11 or 12 point and font type of Arial or Times New Romans. Margins must be 1-inch wide (top, bottom, left, and right). The technical proposal must not exceed 20 pages in length and the pages must be sequentially numbered regardless of the section or part, and must contain a header or footer to include the name of the contractor and the RFQ number. Pages in excess of the specified page limit will not be considered or evaluated. Resumes of personnel qualifications must not exceed 3 pages in length and are not counted in the page limit. The following FAR provisions shall apply to this solicitation: 52.212-1, Instructions to Offerors--Commercial Items, 52.212-2, Evaluation--Commercial Items. Evaluation factors that will be used to evaluate the offer most advantageous to the Government, price and other factors considered, include ability to meet the technical requirements stated in this pre-solicitation and on basis of best value to the government. Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, or provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror's cover sheet. The Clause at 52.212-4, Contract Terms and Conditions Commercial Items, applies to this acquisition and the Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items applies to this acquisition. FAR clause 52.227-14, "Rights in Data-General," is applicable to this solicitation and will be incorporated into the contract. The NIA shall have unlimited rights to and ownership of all deliverables provided under this Professional Service Contract, including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic Professional Service Contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clauses 52.224-1, Privacy Act Notification, and 52.224-2, Privacy Act, are applicable to this solicitation and shall be included in any contract resulting from this solicitation. FAR clause at 52.237-7, Indemnification and Medical Liability Insurance, is applicable to this solicitation and will be included in any resulting contract. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All responses must be received no later than December 1, 2014, 12:00 pm, Eastern Time as specified in this announcement. Late responses will not be accepted. All responses must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-2015-014. Responses must be submitted electronically to hunter.tjugum@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, contact Hunter Tjugum by email at hunter.tjugum@nih.gov or by phone at 301-435-8780.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-CSS-2015-014/listing.html)
- Place of Performance
- Address: Harbor Hospital, NIA Clinical Unit, 3001 S. Hanover Street, Baltimore, Maryland, 21225, United States
- Zip Code: 21225
- Zip Code: 21225
- Record
- SN03573320-W 20141116/141114234331-71539245e11786b1325e9c6da68a2aef (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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