SOLICITATION NOTICE
A -- National Institute of Allergy and Infectious Diseases (NIAID) Clinical Data and Safety Management Center (CDSMC)
- Notice Date
- 5/21/2020 8:28:52 AM
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N93020R00011
- Archive Date
- 06/06/2020
- Point of Contact
- Deborah Blyveis, Phone: 240-669-5143, Liem Nguyen, Phone: 240-669-5144
- E-Mail Address
-
blyveisd@niaid.nih.gov, liem.nguyen@nih.gov
(blyveisd@niaid.nih.gov, liem.nguyen@nih.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- Presolicitation Notice Information Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.� The NIAID, Division of Allergy, Immunology, and Transplantation (DAIT) has a requirement to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases. Description Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases.� The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research that focuses on protective immune responses and immune-mediated diseases through grants and contracts awarded to domestic and foreign organizations.� A critical component of the Division�s mission targets clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluation of the safety and efficacy of investigational products and approaches, clinical studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics/genomics and/or other �omic�, and lifetime exposures. Research encompasses a broad range of immune-mediated diseases, including: (i) allergic diseases and asthma; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; (iv) primary immune deficiency disorders;(v) and other immune system disorders and treatments to enhance immune functions. The purpose of this request for proposals is to solicit offers for a contract to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases, examples of which are listed here: Immune Tolerance Network (ITN) Asthma and Allergic Diseases Clinical Research Programs Atopic Dermatitis Research Network (ADRN).� Consortium for Food Allergy Research (CoFAR).� Inner City Asthma Consortium (ICAC) which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)� Autoimmune Diseases Clinical Research Programs Autoimmunity Centers of Excellence (ACE) Transplantation Clinical Research Programs Clinical Trials in Organ Transplantation (CTOT).� Clinical Trials in Organ Transplantation in Children (CTOT-C). Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA). Statistical & Clinical Coordinating Centers (SCCCs) Allergy & Asthma SCCC Autoimmune Diseases SCCC Transplantation SCCC Clinical Site Monitoring Center (CSMC) Regulatory Management Center (RMC) TECHNICAL EVALUATION CRITERIA CRITERIA� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � WEIGHT Technical Plan/Approach� � � � � � � � � � � � � � � � � � � � � � � � � � � �50 Scientific and Technical Personnel������������������������������� ��� 20� Project Management� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 20� Facilities, Equipment, and Other Resources�����������������10� TOTAL POSSIBLE WEIGHT (with Options)� � � � � � � � � � � � � � � � � � � � �100 NIAID anticipates making a single term, level-of-effort (LOE), severable award for the NIAID Clinical Data and Safety Management Center (CDSMC). The total performance period, comprised of the base plus optional periods, is five (5) years.� Additionally, the anticipated contract award will contain options for increased levels of effort; each LOE option exercised, the contractor shall provide an additional one (1) FTE.� This LOE option may be exercised up to five (5) times within each contract year, as needed.� The award is anticipated to be made in or around September 30, 2021. This contract shall be administered and used primarily to support NIAID DAIT initiatives, however, NIAID may use this contract to support domestic or international clinical research or clinical trials for high-priority NIAID research on a limited basis, if the work is within the scope of and aligned with the NIAID mission.� Any responsible offeror may submit a proposal which will be considered by the Agency. �This RFP will be available electronically on/about June 8, 2020, and may be accessed through betasam:�https://beta.sam.gov/.� This notice does not commit the Government to award a contract. �No collect calls will be accepted.� No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on ""How to Submit.""
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/ffcb04fb672a4067b7f10b006531422d/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05665937-F 20200523/200521230214 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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