Inactive Total Small Business Set-Aside (FAR 19.5)

Introduction Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS),... Introduction Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID DAIT mission is to conduct and support basic, preclinical, and clinical research to better understand the human immune system in health and disease, and to design and develop clinical research studies that evaluate novel prevention and treatment strategies for immune-mediated diseases that include: Asthma, food allergy, atopic dermatitis/eczema, and other allergic diseases such as rhinitis and rhinosinusitis; Autoimmune diseases, such as insulin-dependent diabetes mellitus, multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Rejection of transplanted organs, tissues, or cells; and Primary immune deficiency disorders, including more than 100 known genetically distinct primary/congenital immunodeficiency diseases are known, with many under investigational treatment via gene therapy. Collectively, these diseases affect millions of Americans, resulting in considerable morbidity, mortality, pain and suffering, and medical costs. Furthermore, these diseases cross many clinical specialties; thus, knowledge of the immune system and its role in disease is increasingly important in the daily practice of medicine. DAIT’s clinical research study portfolio includes an increasing number of investigator-initiated clinical trials and longstanding, dedicated clinical trial networks. The latter category includes the Immune Tolerance Network (ITN), Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA), Autoimmunity Centers of Excellence (ACE), Consortium for Food Allergy, Asthma and Allergic Diseases Cooperative Research Centers (CoFAR), Atopic Dermatitis Research Network (AADCRC), and Childhood Asthma in Urban Settings Research Network (CAUSE). Within the Office of the DAIT Director, the Office of Pharmaceutical Research Management (OPRM) is responsible for pharmacy and pharmaceutical oversight of national and international NIAID clinical trials to ensure product integrity, participant safety, and pharmacy, and pharmaceutical regulatory compliance. OPRM, through its quality and compliance programs provides pharmaceutical support services, including but not limited to oversight of study product manufacturing, packaging, blinding, labeling strategies, and distribution through the NIAID Clinical Products Center (CPC). Contract History In FY 2019 a 7-year contract was awarded to EMINENT Services Corporation to establish the “NIAID Division of Allergy, Immunology & Transplantation: Immune Mediated Diseases Clinical Products Center (CPC)” (Contract No. 75N93019C00003). The purpose of this contract was to continue supporting the NIAID/DAIT pharmacy and pharmaceutical oversight responsibilities of national and international NIAID DAIT-supported national and international clinical trials to ensure product integrity, participant safety, and pharmacy and pharmaceutical regulatory compliance. This contract also supported essential pharmacy and pharmaceutical support required for the conduct of NIAID/DAIT clinical trials as well as other NIAID funded clinical trials on a limited, as-needed basis. These services are study product management such as receiving from various sources (e.g., manufacturers, NIAID/DAIT Pharmaceutical Procurement Center (PPC), proper storage, shipment, blinding, repackaging, placebo manufacturing, and distribution to clinical sites. Description and Purpose The purpose of this contract is to provide support to NIAID OPRM for the pharmacy and pharmaceutical oversight responsibilities of national and international NIAID/DAIT supported clinical trials as well as other NIH funded clinical trials on an as-needed basis, to ensure study product integrity, participant safety, pharmacy and pharmaceutical regulatory compliance. This contract provides NIAID with centralized services for: 1) Study Product (i.e., IP management, procurement, receipt, storage, labeling, packaging/repackaging, blinding (i.e., over-encapsulation); placebo manufacturing, sterile product manufacturing and preparation, blister packaging, distribution to site, inventory management, accountability, disposal, and expiration dates and recall monitoring); 2) IP Regulatory Document Maintenance in the DRMC (Regulatory documents relating to shipment, receipt, disposition, return, destruction, manufacturing (placebo, food product immunotherapy, etc.), over-encapsulation (for blinding purposes), stability/sterility protocols and testing, and labeling and packaging; 3) Co-submissions of Drug Master Files (DMFs) and co-conducting product stability studies; and 4) Clinical samples repository, product sterility/stability and release testing, clinical laboratory testing such as Immunoassays, Molecular Diagnostics, DNA Sequencing, Flow Cytometry, etc. Study Products to be studied include drugs, biologics, vaccines, food immunotherapy, controlled substances, and other agents, as study interventions and services shall be provided for: DAIT funded clinical research programs to include, but not limited to, the ITN, ACE, CTOT-CA, ADRN, the Consortium of Food Allergy Research (CoFAR) and Childhood Asthma in Urban Settings (CAUSE), Asthma and Allergic Diseases, Cooperative Research Centers (AADCRC); Individual DAIT-funded clinical trials conducted under cooperative agreement grants and other funding mechanisms; Other NIH-funded clinical trials on an as-needed basis; and Support of NIAID or other NIH institutes or ICs in special circumstances such as public health emergencies for Emergency Preparedness or Public Health Emergency programs. All Contractor activities must be compliant with Federal policies and regulations to protect the integrity of study products used in NIAID-funded clinical trials, clinical research, and projects. Study products services shall be provided for, but not limited to, multiple sites in the U.S. and internationally, including sites in the Americas, Europe, Africa, Asia, and Australia. Supported studies focus on a broad range of immune-mediated diseases, including: (i) asthma and allergic diseases; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; and (iv) studies of radiation/nuclear countermeasures research. Additionally, and on an as-needed basis, clinical trials of infectious disease treatment, prevention, and vaccine studies. The following five Mandatory Qualification Criteria (MQC) must be met at the time of receipt of the Original Proposal; 1) Offerors must have a current license(s) and permit(s) as a Pharmacy, Distributor, and Research for drugs class I through 5 and be able to ship across 50 states, the District of Columbia, and U.S. territories; 2) Facility must currently possess or have possessed a license and/or permit to import and export drug, in the past 12 months; 3) Facility must be cGMP certified and registered with the FDA as a Manufacturer; 4) Facility must be registered with the FDA for Laboratory Analysis, Labeling, Packing, Re-Labeling, and Re- Packing; and 5) staff must include at least one licensed pharmacist. TECHNICAL EVALUATION CRITERIA: CRITERIA WEIGHT 1: TECHNICAL PLAN/APPROACH 40 2: FACILITIES, EQUIPMENT AND OTHER RESOURCES 30 3: SCIENTIFIC AND TECHNICAL PERSONNEL 20 4: PROJECT MANAGEMENT 10 TOTAL POSSIBLE WEIGHT: 100 It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Year 1 and Options 1-6 – Years 2 through 7) to be approximately 20,800 hours per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 5% over the base requirement which can be exercised up to 5 times per contract year. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 10/18/2024 and may be accessed through http://www.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 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."

Inactive

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding:... Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. THE NAICS CODE IS 541715 WITH A SIZE STANDARD OF 1,000 EMPLOYEES. Background Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation’s (DAIT) mission is to conduct and support basic, preclinical, and clinical research to better understand the human immune system in health and disease, and to design and develop clinical research studies that evaluate novel prevention and treatment strategies for immune-mediated diseases that include: • Asthma, food allergy, atopic dermatitis/eczema, and other allergic diseases such as rhinitis and rhinosinusitis; • Autoimmune diseases, such as insulin-dependent diabetes mellitus, multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; • Rejection of transplanted organs, tissues, or cells; and • Primary immune deficiency disorders, including more than 100 known genetically distinct primary/congenital immunodeficiency diseases are known, with many under investigational treatment via gene therapy. Collectively, these diseases affect millions of Americans, resulting in considerable morbidity, mortality, pain and suffering, and medical costs. Furthermore, these diseases cross many clinical specialties; thus, knowledge of the immune system and its role in disease is increasingly important in the daily practice of medicine. DAIT’s clinical research study portfolio includes an increasing number of investigator-initiated clinical trials and longstanding, dedicated clinical trial networks. The latter category includes the Immune Tolerance Network, Clinical Trials in Organ Transplantation in Children and Adults, Autoimmunity Centers of Excellence, Consortium for Food Allergy, Asthma and Allergic Diseases Cooperative Research Centers, Atopic Dermatitis Research Network, and Childhood Asthma in Urban Settings Research Network. Within the Office of the DAIT Director, the Office of Pharmaceutical Research Management (OPRM) is responsible for pharmacy and pharmaceutical oversight of national and international NIAID clinical trials to ensure product integrity, participant safety, and pharmacy and pharmaceutical regulatory compliance. OPRM, through its quality and compliance programs provides pharmaceutical support services, including but not limited to oversight of study product manufacturing, packaging, blinding, labeling strategies, and distribution through the NIAID Clinical Products Center (CPC). In FY 2019, a 7-year contract was awarded to EMINENT Services Corporation to establish the “NIAID Division of Allergy, Immunology & Transplantation: Immune Mediated Diseases Clinical Products Center (CPC)” (Contract No. 75N93019C00003). The purpose of this contract was to continue supporting the NIAID/DAIT pharmacy and pharmaceutical oversight responsibilities of national and international NIAID DAIT supported national and international clinical trials to ensure product integrity, participant safety, and pharmacy and pharmaceutical regulatory compliance. This contract also supported essential pharmacy and pharmaceutical support required for the conduct of NIAID/DAIT clinical trials as well as other NIAID funded clinical trials on a limited, as-needed basis. These services are study product management such as receiving from various sources (e.g., manufacturers, NIAID/DAIT Pharmaceutical Procurement Center (PPC), proper storage, shipment, blinding, repackaging, placebo manufacturing, and distribution to clinical sites. Purpose and Objectives The purpose of this contract is to provide support to NIAID OPRM for pharmacy and pharmaceutical oversight responsibilities of national and international NAID/DAIT supported clinical trials as well as other NIH funded clinical trials on an as-needed basis. The awardee will conduct study product management services such as procurement, receipt, storage, labeling, packaging/repackaging, blinding (i.e., over-encapsulation), placebo manufacturing, sterile product preparation, blister packaging, distribution to sites, inventory management, accountability, disposal, expiration dates/recall monitoring, study product regulatory document maintenance in the DAIT Regulatory Management Center (DRMC), Co-submissions of Drug Master Files (DMFs), co-conducting product stability studies, clinical samples repository, product sterility/stability and release testing, clinical laboratory testing such as Immunoassays, Molecular Diagnostics, DNA Sequencing, Flow Cytometry, etc. Project requirements It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Base Year, Year 1 and Options 1-6 – additional Years 2 through 7) to be approximately 10 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 5% over the base requirement which can be exercised up to 5 times per contract year. Anticipated period of performance The period of performance will commence in April 1, 2026 for a period of one year, with six optional annual extensions. Capability Statement / Information Sought Potential sources must demonstrate and document the following in their capability statements: The Contractor shall provide support to NIAID OPRM for the pharmacy and pharmaceutical oversight responsibilities of national and international NIAID/DAIT supported clinical trials as well as other NIH funded clinical trials on an as-needed basis to ensure study product integrity, participant safety, pharmacy and pharmaceutical regulatory compliance. This contract provides NIAID with centralized services for: 1) Study Product (i.e., investigational product (IP) management, procurement, receipt, storage, labeling, packaging/repackaging, blinding (i.e., over-encapsulation), placebo manufacturing, sterile product manufacturing and preparation, blister packaging, distribution to site, inventory management, accountability, disposal, and expiration dates and recall monitoring) and 2) IP Regulatory Document Maintenance in the DRMC (Regulatory documents relating to shipment, receipt, disposition, return, destruction, manufacturing (placebo, food product immunotherapy, etc.), over-encapsulation (for blinding purposes), stability/sterility protocol(s) and testing, labeling and packaging. 3) Co-submissions of Drug Master Files (DMFs) and co-conducting product stability studies. 4) Clinical sample repository, product sterility/stability and release testing, clinical laboratory testing such as Immunoassays, Molecular Diagnostics, DNA Sequencing, Flow Cytometry, etc. Study Products to be studied include drugs, biologics, vaccines, food immunotherapy, controlled substances, and other agents, as study interventions and services shall be provided for: DAIT-funded clinical research programs to include, but not limited to, the Immune Tolerance Network (ITN), Autoimmunity Centers of Excellence (ACE), Clinical Trials in Organ Transplantation (CTOT), Clinical Trials in Organ Transplantation in Children (CTOT-C), Atopic Dermatitis Research Network (ADRN), the Consortium of Food Allergy Research (CoFAR) and Childhood Asthma in Urban Settings (CAUSE), Asthma and Allergic Diseases, Cooperative Research Centers (AADCRC); Individual DAIT-funded clinical trials conducted under cooperative agreement grants and other funding mechanisms; Other NIH-funded clinical trials on an as-needed basis; and Support of NIAID or other NIH institutes or ICs in special circumstances such as public health emergencies for Emergency Preparedness or Public Health Emergency programs. All Contractor activities must be compliant with Federal policies and regulations to protect the integrity of study products used in NIAID-funded clinical trials, clinical research, and projects. Study products services shall be provided for, but not limited to, multiple sites in the U.S. and internationally, including sites in the Americas, Europe, Africa, Asia and Australia. Supported studies focus on a broad range of immune-mediated diseases, including: (i) asthma and allergic diseases; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; and (iv) studies of radiation/nuclear countermeasures research. Additionally, and on an as-needed basis, clinical trials of infectious disease treatment, prevention, and vaccine studies. Capability statements submitted in response to this announcement should demonstrate the offerors’ qualifications, expertise, and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. The following five Mandatory Qualification Criteria (MQC) will be required at the time of receipt of the Original Proposal and must be addressed in any capability statement received in response to this notice: 1) Offerors must have a current license(s) and permit(s) as a Pharmacy, Distributor, and Research for drugs class I through 5 and be able to ship across 50 states; 2) Facility must currently possess or have possessed a license and/or permit to import and export drug, in the past 12 months 3) Facility must be cGMP certified and registered with the FDA as a Manufacturer 4) Facility must be registered with the FDA for Laboratory Analysis, Labeling, Packing, Re-Labeling, and Re-Packing 5) staff must include at least one licensed pharmacist. All capable small business organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit a copy of their capability statement addressing each of the areas cited above via email. Written capability statements should be received by the Contracting Officer (CO) by _July 23, 2024_. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 150 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one inch on each edge of the paper. Print setup should be single sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: Unique Entity ID Company Name Company Address Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address). Number of Copies: Please submit one (1) electronic copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Deborah Blyveis, Contract Specialist, at Blyveisd@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify 75N93024R00018. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM (Eastern Time) on 7/23/2024. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).