/ NIIMBL -- Project Call 1.0

The National Institute for Innovation in Manufacturing Biopharmaceuticals

Project Call 1.0

Please be advised the federal government shutdown does not affect the timeline for the NIIMBL project call. The due date for Project Call 1.0 proposals is this Friday, January 26, 2018 at 5:00 pm EST. Please contact projectcalls@niimbl.org for more information.

UPDATE: The Department of Commerce, along with 15 other federal agencies, have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the Common Rule that were scheduled to go into effect on January 19, 2018. In accordance with Section 3.2 of Project Call 1.0 RFP, NIIMBL expected to issue updated guidance in the event that these revisions went into effect. Due to the delay in the revisions, no changes to the RFP and guidance documents will be issued. For more information about the IFR, please see the following: https://www.federalregister.gov/documents/2018/01/22/2018-00997/

NIIMBL is pleased to announce Project Call 1.0 Updated 12/14/17.

About Project Call 1.0

Project Call 1.0 requests proposals for projects that address technology and/or workforce development issues in biomanufacturing. The Request for Proposals details several topic areas of interest in each of these categories. These topic areas were identified with input from Industry members.

Proposal Submission Process

Section 6 of the Request for Proposals (RFP) document provides details on the proposal submission process and required documents. Please keep in mind the following information as you prepare your proposal:

  • Only NIIMBL members may participate on proposal project teams. Organizations must provide a signed Membership Agreement by Friday, January 12, 2018 to submit a proposal or be included on a project team.
  • Proposal teams are required to send a Notice of Intent to projectcalls@niimbl.org by 5:00pm EST on Tuesday, January 16, 2018.
  • All proposal documents are due by 5:00pm EST on Friday, January 26, 2018. Late proposals will NOT be considered.
  • Only complete proposal packages will be considered.

Project Call 1.0 Webinar

NIIMBL will host a second webinar on Project Call 1.0 on Tuesday, December 12, 2017 from 3:00 pm to 5:00 pm EST. The webinar will cover information on proposal preparation and the submission process.

Please email projectcalls@niimbl.org to register.


Project Call 1.0 Request for Proposals Updated 12/14/17

Project Call 1.0 Proposal Submission Instructions

Project Call 1.0 Notice of Intent Template

Project Call 1.0 Compliance Check Sheet Updated 12/5/17

Project Call 1.0 Proposal Cover Sheet Updated 1/19/17

Project Call 1.0 Budget Template Updated 12/5/17

Project Call 1.0 Project Team Budget Summary Updated 12/5/17

Project Call 1.0 Abstract Template

Project Call 1.0 Quad Chart Template

Project Call 1.0 Work Breakdown Structure Template

NIIMBL Exempt Human Subject Activities Guidance Document

NIIMBL Manufacturing Readiness Level (MRL) Guidance Document


UPDATED 1/8/18


How does Project Call 1.0 differ from the Quick Start Project Call?

There are several ways that Project Call 1.0 differs from the Quick Start Project Call:

  1. Project Call 1.0 includes both Institute-Wide as well as Partner-Specific projects, whereas the Quick Start Project called only for Institute-Wide projects. A detailed definition of each of these project types can be found in Section 2 of the RFP.
  2. Project Call 1.0 includes both Small and Large projects which differ in funding, cost share requirements and small-to-medium enterprise (SME) participation. Details about small and large projects can be found in Section 2 of the RFP.
  3. The QSP Call requested proposals that addressed any area of biopharmaceutical manufacturing that fulfills the NIIMBL mission, while highlighting several topical areas that were of interest to the community. Project Call 1.0 still allows proposals to be submitted in any area that fulfills the NIIMBL mission, but it includes a set of priority technical and workforce topic areas developed with input from NIIMBL industry partners. While proposals for Project Call 1.0 are not limited to these Priority Funding Areas, proposals that address a Priority Funding Area have the potential to be ranked more favorably during proposal review. Additional information can be found in Sections 2 and 9 of the RFP.
  4. Exempt human subject activities will be permitted under this project call. You can find more information in section 3.2 of the RFP as well as the NIIMBL Exempt Human Subject Activities Guidance Document.

When are proposals due?

A non-binding Notice of Intent is required by 5:00pm EST on January 16, 2018. Final proposals are due by 5:00 PM EST on January 26, 2018. Late proposals will not be considered.

When will projects begin?

The earliest possible start date is April 1, 2018. But the actual project start date will depend on project award agreement negotiations.

(12/19/17) What is a deliverable? 

A deliverable is the highest level of the Work Breakdown Structure.  It is a verifiable product, result, and/or capability that serves as the outcome of the execution of the work.


Does an organization need to be a NIIMBL member to submit a proposal?

Yes, only proposals from NIIMBL members, and involving NIIMBL members, will be considered. Any proposal involving a partner who has not executed a membership agreement by January 12, 2018 will be rejected without review.

Are Tier 3 Industry Members (aka SMEs) required for participation on projects that involve workforce development only?

NIIMBL supports its SME members and encourages a collaborative effort on all project proposals. Each proposed project that involves technology development is required to have at least one SME participant if the budget request from NIIMBL is more than $200,000 per year. Projects that address workforce development only are not required to have an SME participant, although SME participation is encouraged. Please note, however, proposals which include SMEs beyond the minimum requirement will receive additional points during evaluation. Please see section 7.2 for additional information.

(12/11/17) Can the Project Manager be the Principal Investigator (PI) or co-PI?

The Project Call 1.0 RFP does not restrict a PI or co-PI from serving as the Project Manager. Section 3.3 of the RFP provides more details about the Project Manager requirements.

(12/11/17) Can a proposal be successful without including a Tier 1 company?

Proposals do not require a Tier 1 company to participate on the proposal team. Section 3 of the RFP details the proposal team composition requirements.

(12/19/17) Are consultants allowed?

Consultants are considered a professional service expense per 2 CFR 200.459.  Consultant services can be included in budgets either as a direct cost or as cost share, provided that the consultant is rendering a service to the project.

(1/8/18) We would like to develop curriculum to be taught in either community colleges or K-12 schools. Do these colleges/schools have to be NIIMBL members?

Community colleges need to be a NIIMBL member in order to participate in any aspect of the proposed project.

A public or private K-12 school needs to be a NIIMBL member if it’s representatives are substantial or significant contributors to the project’s programmatic content development, implementation and/or delivery. Please note curriculum developed at a private school needs to be eventually deliverable to the public.

Please reach out to projectcalls@niimbl.org with questions on programmatic involvement for your organization’s particular proposal.


What documents are required for proposals?

Section 6 of the RFP outlines the proposal requirements.

(12/11/17) What is considered cost-share?

Cost share refers to resources an organization dedicates to a project. Examples of allowable cost share include salaries and associated fringe benefits for staff and students participating on the project, equipment, supplies, services, travel, infrastructure modifications, analytical services, and associated overhead in support of the project. Constructions costs are not permitted. For more information on allowable cost share, please see 2 CFR 200, Subpart E and the Department of Commerce Financial Assistance Terms and Conditions.

Please see Section 3.4 of the RFP for more details on cost share requirements for Project Call 1.0.

(1/24/17) How should proposal submissions reflect cost-share dollars from states?

If a member of a proposal team plans to use state funding as cost-share, this should be indicated on the cost share tab of the budget template under State provided cost share. Cost share also needs to reflected on the Cover Sheet, Quad Chart and Compiled Budget.

I have a good idea and am looking for partners, but do not believe there is enough time to assemble the team and develop a proposal by the January 26 deadline. Any advice?

NIIMBL will release two project calls each year. Consider working out the details of your team and project and submitting in response to the next Project Call. Note that NIIMBL anticipates Project Calls to be issued at least every 6 months moving forward so teams can take their time to develop their concepts to the fullest. Keep in mind that NIIMBL is focused in the MRL 4-7 space.

Are proposals involving human subject activities permitted?

Exempt human subject activities are allowed in Project Call 1.0. Please see the Exempt Human Subject Activities Guidance Document for details.

(12/11/17) Can membership fees be used as cost share?

No, membership fees cannot be used as cost share.

(12/11/17) What instances of noncompliance can proposal teams correct after the administrative review?

Only instances of noncompliance identified by NIIMBL will be eligible for correction. These instances will be limited to corrections which can be revised and returned in a short amount of time. No corrections or revisions will be permitted on the Project Narrative or the Work Breakdown Structure. More information on the proposal review and evaluation process can be found in Section 7 of the RFP.

(12/11/17) If my team is unable to complete a proposal in time for Project Call 1.0, can I submit it for Project Call 2.0. Will Project Call 2.0 follow a similar process as Project Call 1.0?

NIIMBL plans to release Project Call 2.0 in mid-2018. Details of Project Call 2.0 are still in discussion. NIIMBL is considering the possibility that Project Call 2.0 will rely on a two-stage process (i.e. concept paper and then invited full proposals). This process has not been finalized yet and additional details about the Project Call 2.0 submission process will come out in 2018.

(12/19/17) Will no-cost extensions be allowed? 

The period of performance for Project Call 1.0 is limited to 18 months, so the scope, task, and deliverables must be developed with the intent that they be accomplished during this period.  If delays occur that prevent the scope from being fully completed in eighteen months, NIIMBL will consider no-cost extensions.

(12/19/17) Is the use of human blood an example of exempt human subjects’ activities? 

Generally, research that proposes the use of human cell lines available from a repository and/or from donors who cannot be identified is not considered human subjects research. Taking blood or other cells from living individuals for research purposes is human subjects research. The ultimate determination must be made by your local IRB based on a detailed description of the entire project. Additional guidance on working with cells can be found at: (https://humansubjects.nih.gov/human-specimens-cell-lines-data).


What types of project does NIIMBL plan to fund?

This project call allows for both Institute-Wide and Partner-Specific projects. Priority topic areas have been developed with input from NIIMBL industry members. These topics make up the Priority Funding Areas for this call. However, proposals for projects outside of these Priority Funding Areas will also be considered. You can find more information about the Priority Funding Areas for Project Call 1.0 in section 9 of the RFP.

In addition, NIIMBL will consider funding small projects (< $200,000 per year in NIIMBL funds) and large projects (> $200,000 per year in NIIMBL funding). More information can be found in Section 2 of the RFP.

(12/11/17) During the proposal review and evaluation, will a review of the Work Breakdown Structure factor into the scoring rubric?

The Work Breakdown Structure is related to the Project Significance and Merit categories.

(12/11/17) If an organization receives an award as part of the Quick Start Project call, does that limit its chances of receiving an award as part of Project Call 1.0?

All projects will be evaluated based on merit and then the GC will select a funded portfolio among the most meritorious projects.

(12/19/17) Do teams get additional points for including cost share from state agencies in their budgets? 

No.  Teams may receive additional points for cost share in excess of the minimum requirement, regardless of the source.


Section 9 of the RFP details Priority Funding Areas for Project Call 1.0.

NIIMBL Manufacturing Readiness Guidance Document

NIIMBL Human Subject Activities Guidance Document

NIIMBL Community Portal

We encourage you to use the NIIMBL Community Portal to facilitate your teaming efforts. It provides contact information, research interests, areas of expertise, facilities and equipment for NIIMBL members. Also, please be sure to complete your Community Portal profile so other members can find you for teaming opportunities. If you need access to the NIIMBL Community Portal, please contact your Program Manager or email help@NIIMBL.org.

Visit the NIIMBL Community Portal at http://niimbl.org/community.php.


If you have any questions regarding Project Call 1.0 or the proposal process, please email us at projectcalls@niimbl.org.

Copyright 2017 NIIMBL. All rights reserved.

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