Clinical Research, Professional, Ancillary Support Services and Facilities for NIDCD

Pre-solicitation / Notice of Intent Synopsis Solicitation Number: HHS-NIH-OD-OLAO-SS-22-002 Solicitation Type: Sole Source (Non-Competitive) Suggested Source: John Hopkins University Title: Clinical Research, Professional, Ancillary Support Services and Facilities for NIDCD NAICS / Size Standard: 541990 all professional, scientific, and Technical Services INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A SHORT-TERM CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Institutes of Health (NIH) intends to negotiate and award an Indefinite Delivery/Indefinite Quantity (IDIQ) contract on a noncompetitive basis under the authority of FAR 6.302-1(1)(2)(iii), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Under this award, the contractor will continue providing uninterrupted Clinical Research Services in collaboration with John Hopkins University. BACKGROUND: The National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health (NIH) conducts and supports biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. NIDCD accomplishes its mandate in part through the Division of Intramural Research, (DIR), located in Bethesda, Maryland. The NIDCD DIR has undertaken an expansion of an integrated laboratory and clinical research program requiring otolaryngologist-head and neck surgeon-scientists, fellowship trained otolaryngology sub-specialists, and support staff. The expanded NIDCD DIR clinical research program will develop a translational clinical research program with emphasis on genetic and acquired disorders of human communication affecting hearing, balance, voice, speech and language. Recent scientific advances in genomics, cell biology, and immunology, have created new opportunities to more rapidly translate these findings to interventions to impact the health of persons with disorders affecting human communication. Translational clinical studies represent the practical implementation of basic discoveries and critical experiments that refine and define new questions to be addressed by non-clinical investigation. As such, a synergistic relationship exists between NIDCD's basic science and clinical studies. Successful translation of basic research requires coordination of the efforts by laboratory investigators, statisticians, physician-scientists, clinicians, and other patient- care providers. Strong linkages between the bench and the Clinical Research Program enhance the likelihood of success. New clinical investigative initiatives will include several areas and related otolaryngology clinical subspecialties. Areas of emphasis for interventional trials include disorders of: Hearing and Balance (loss due to genetic and immune causes, and ototoxic chemotherapies), requiring fellowship trained neurotology sub-specialists; and Voice, Speech and Language (laryngeal/respiratory papillomatosis, head and neck cancer, and language disorders), requiring fellowship trained laryngology, head and neck oncologic/ reconstructive, and rhinologic/skull base surgeons). These studies will focus on early phase clinical trials using new targeted gene, small molecule, and immune therapies integrated with surgical and other modalities. Some patients will receive standard or conventional care and treatment in addition to research-related interventions as appropriate for the underlying disease process under study. In addition to interventional trials in these areas, the NIDCD DIR will continue to conduct normative longitudinal studies of human communication. To support the needs of this expansion, the NIDCD at the NIH is seeking to contract for a 5-year period, with an otolaryngology department of a nearby university affiliated academic medical center that optimally meets the requirements for qualified surgeon-scientists and fellowship trained subspecialists. The contractor will support development and conduct of NIDCD DIRs translational and clinical research program, and provide all otolaryngology-head and neck surgical patient care at the NIH Clinical Research Center (CRC), located in Bethesda, Maryland. PURPOSE: The purpose of this contract is to provide clinical research, professional and ancillary support and facilities to conduct translational research and to support the clinical research program of the NIDCD DIR. In addition, this contract shall provide the infrastructure for training the next generation of NIDCD clinical researchers in human communication disorders. CONTRACTOR'S TECHNICAL REQUIREMENTS: The current contractor shall demonstrate: Clinical care of increasingly complex patients from NIDCD and other institutes at the NIH CRC requires providers with training and experience in the above subspecialties for expert management of patients with sudden hearing loss (neurotology), airway emergencies (laryngology), cancers, and life threatening bleeding or infections (head and neck and rhinologic/skull base surgery). Because such life-threatening emergencies and urgent problems require response and intervention within minutes to hours, it is essential that the providers be located at the CRC and an adjacent hospital and clinics. Immediate proximity of contractors who provide clinical research and care at NIH CRC, and at an adjacent hospital and clinics providing a full range of clinical care not available at NIH CRC, is required to provide 24/7 routine and emergency care to meet the needs of NIDCD and NIH patients and research subjects. Meeting these requirements will maximize efficiency in terms of staff cost and cross training, and provide for a common support infrastructure including but not limited to clinical laboratory and trial support for the spectrum of normative human communication and interventional trials under development. In order to initiate the expanded research agenda including normative longitudinal and interventional studies, and to provide clinical care, the NIDCD initially requires 2 part time otolaryngologist-surgeon scientists and 3[VC([1] part-time otolaryngology clinicians. Support and coordination of the NIDCD Clinical Research Program will be under the Office of the Clinical Director (OCD), DIR, NIDCD. The NIDCD Clinical Director plans, manages, and supports the conduct of intramural clinical research on the cause, diagnosis, prevention, and treatment of human communication disorders and fosters the translation of advances in basic science into clinical applications. With the NIDCD Clinical Director, their designated Chief of the Otolaryngology Head and Neck Surgery Service holds the responsibility for ensuring the quality and safety of clinical trials and patient care within the Institute. The OCD: (1) provides the infrastructure needed to promote high quality clinical research and to ensure patient safety including: protocol review, clinic infrastructure, nursing and physician support, clinical informatics, data and safety management; (2) monitors and maintains quality assurance of the intramural clinical research program; (3) develops and implements clinical program priorities, allocates clinical resources; (4) integrates the established research themes and projects with clinical relevance from various DIR laboratories and branches; (5) evaluates program effectiveness and represents the DIR in management and scientific decision-making meetings within the Institute; (6) coordinates the credentialing of health care providers within the Institute; coordinates and provides clinical research training for NIDCD staff and fellows; and develops novel approaches for carrying out translational research in an efficient and cost-effective manner. The OCD oversees NIDCD Clinical Laboratories housed in the CRC, Protocol and Patient Coordinators, and Clinicians supporting critical sub-components of the clinical research program, nursing, and other testing support staff in addition to resources needed to provide the clinical research informatics and data management infrastructure. The OCD Office Manager coordinates the credentialing of Physicians and Nurse Practitioners (NPs) within the Institute, including maintenance of the original documentation and a Continuing Medical Education (CME) report of credentialed Physicians and NPs within the Institute. SPECIFIC TASKS: Independently, the Contractor shall provide all necessary personnel and ancillary services (except for those to be furnished by the Government as may be specified elsewhere in the contract) to perform the work required by the contract as set forth below. The Contractor shall perform work in support of direct patient care activities on a 24-hour per day, 365 day per year basis, except as otherwise directed by the NIDCD Project Officer. The Contractor shall prepare a recruitment and retention plan for staffing areas with particular attention to areas where clinical research and subspecialty expertise are required (neurotology, laryngology, head and neck oncologic and reconstructive, and rhinologic/skull base surgery). This document shall be due thirty (30) calendar days after the effective date of the contract. This plan shall be revised as needed with input from the NIDCD Project Officer. The Contractor shall, within fifteen (15) calendar days after the effective date of the contract, submit to the NIDCD Project Officer a proposed personnel transition plan that will allow for the retention or hiring of necessary personnel to provide clinical research support services within ninety (90) calendar days after the effective date of the contract. The NIDCD Project Officer, in coordination with the NIDCD Clinical Director (CD), will evaluate the proposal, and will discuss changes as necessary with the Contractor. The Contractor shall submit a finalized personnel transition plan, incorporating such changes, within thirty (30) calendar days after the effective date of the contract. The Contractor shall provide a record of each Contractor staff member's translational and clinical research training, experience, and scholarly accomplishments, and otolaryngology and sub-specialty certifications as required by American Board of Otolaryngology, and sub-specialty accrediting organizations. This record shall be updated and submitted annually or sooner for a particular staff member if required for protocol submission to the IRB. The first report shall cover the period consisting of the first full three calendar months following the effective date of the contract. Thereafter, the reports shall be on an annual basis. Reports are due within thirty (30) calendar days after the close of the reporting period. The Contractor will coordinate and provide a schedule with contact information for 24/7 day, night, and weekend coverage by a primary and back up otolaryngologist on call. PERIOD OF PERFORMANCE: The Government intends to negotiate one 91) fixed price contract for a base period of 12 month and four 12-month option periods. The date of award is anticipated to be around August 31, 2022. ADDITIONAL INFORMATION: This synopsis is not a request for competitive proposals. Interested firms responding to this notice must provide a capability statement demonstrating their experience, expertise, and available resources to perform the various tasks of this requirement without service disruption. Information submitted should be pertinent and specific to the technical requirements identified above. Include relevant background and project-specific experience, references to include contract numbers, dollar value, name of contact, and telephone number. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis. All capability statements must be received electronically by 10:00 a.m. EST on November 17, 2021 and must reference synopsis number HHS-NIH-OD-OLAO-SS-22-002. Responses shall be submitted electronically to the Primary and Secondary Point of Contact listed on this notice. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. - All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. Primary Point of Contact: Aseia Chaudhry, Contract Specialist Aseia.chaudhry@nih.gov Phone: 402-0716 Fax: 301-402-3407 Place of Performance Bethesda, Maryland 20892 United States [VC([1]Now 4, Mydlarz, Ramanathan, Dhillon, Galaiya