SOURCES SOUGHT NOTICE 75N93020R00015.pdf

SOURCES SOUGHT NOTICE

PROJECT TITLE: NIAID/DAIT Regulatory Management Center (RMC)

RFP NUMBER 75N93020R00015

Sources Sought Reference Number: _75N93020R00015___________

Type of Requirement

New Requirement Follow-on (Contract No.: HHSN272201200002C) Other (specify): _______________

Place of Performance

Place of performance is unknown at this time Place of performance is known. Address or general location: _______________

Recompetition

PPD Development, Inc.

929 North Front Street Wilmington, NC, 28401-3331 USA 910-251-0081

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Sources Sought Notice Information

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.

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 (DAIT) supports extramural basic, nonclinical 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 in 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. Another component of NIAID’s mission focuses on the planning and implementation of research, development, and evaluation of medical countermeasures for radiation injury.

Purpose and Objectives

The purpose of this acquisition is to acquire support regulatory management activities for all clinical research, clinical trials and nonclinical research activities and trials supported by NIAID-funded networks and individual investigator-initiated cooperative agreement grants.

Examples of these requirements are:

1. Regulatory Management Support Activities

2. Examples of DAIT NIAID-funded clinical research initiatives include:

• Immune Tolerance Network (ITN)

• Asthma and Allergic Diseases Clinical Research Programs

• Autoimmune Diseases Clinical Research Programs

• Transplantation Clinical Research Programs

• Radiation and Nuclear Countermeasures Program

• DAIT NIAID-funded individual investigator-initiated cooperative agreement grants

3. Country locations of clinical sites participating in the clinical studies/trials

4. Disease/Clinical Conditions to be studied: A broad range of immune-mediated diseases

5. Study Populations

6. Investigational Products/Devices

All NIAID funded clinical research studies and trials (whether or not conducted under US IND or outside-US IND-Equivalent), must be conducted in accordance with US-federal regulations and guidelines, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines, as well as country-specific regulations and requirements. In addition, NIAID is required to provide study-specific regulatory management activities to ensure (i) compliance with the applicable regulations and (ii) integrity of study/trial data in their role as the sponsor of US Investigational New Drug Application (IND) and Investigational Device Exemption (IDE) applications as well as country-specific Regulatory Health Authority (RHA).

References:

21 CFR Parts 50, 54, 56 and 312 and 45 CFR Part 46; and ICH guidelines https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

As the sponsor of US Investigational New Drug Applications (IND) and Investigational Device Exemption (IDE) applications as well as country-specific Regulatory Health Authority (RHA) Applications for NIAID-supported clinical trials, NIAID is required to provide study-specific regulatory management activities to ensure: (i) compliance with the applicable regulations; and (ii) study/trial data integrity.

Project requirements

1. The contractor shall establish a NIAID Regulatory Management Center (RMC) that will provide regulatory management support activities for all domestic and/or international clinical trials funded by NIAID and serve as the Sponsor’s Legal Representative for RHA Applications in countries outside US where such representation is required.

2. The contractor shall establish, manage and maintain:

(i) a commercially available, validated electronic Common Technical Document (eCTD) system for all Regulatory Health Authority (RHA) submissions and correspondence; that eCTD system shall serve as the official interface for the electronic transmission of all RHA-required information from NIAID to the RHA.

(ii) a commercially available, validated electronic Trial Master File (eTMF) system that is comprised of individual protocol-specific eTMFs (holding the protocol essential clinical documents per ICH E6(R2); that eTMF system shall serve as NIAID’s official repository of protocol-specific eTMFs for all NIAID sponsored clinical trials.

3. The contractor shall be responsible for managing the writing, compilation, review, approval, and transmission of protocol-specific eCTD submissions in compliance with global electronic regulatory requirements.

4. The contractor shall be responsible the receipt, review and acceptance of the clinical essential documents in compliance with ICH E6(R2) requirements and filing in protocol specific eTMFs.

Anticipated period of performance The anticipated period of performance comprised of the base period plus optional periods is 7 years and will start in and around November 2021.

Other important considerations

Capability statement / information sought Interested respondents must submit a capability statement that delineates and documents their experience and capabilities to perform the work required by the contract.

The capability statement must address the following:

1. A summary list of prior completed projects of similar nature, identifying any that were Government contracts.

2. The professional qualifications and specific experience of staff who may be assigned to the requirement.

3. CVs for proposed key personnel, including the Principal Investigator, that reflect Education, and previous work relevant to the proposed requirement.

4. Documented 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.

5. Documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources.

6. Demonstrated ability to carry out the requirements.

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding CVs. 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:

• DUNS.

• 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) electric 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 Albert Nguyen, Contract Specialist, at nguyenal@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify 75N93020R00015. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 3:00 PM ET on July 24, 2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME

WILL NOT BE CONSIDERED.

Disclaimer and Important Notes https://www.sam.gov/index.html/#1

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).”