Solicitation Questions and Responses_75N95022R00043.pdf

RFP_75N95022R00043

NNTC Clinical Sites

Solicitation Questions and Government Responses

No. RFP Section Referenced

Questions Responses

1 Packaging and Delivery of Proposal, page 57

Packaging and delivery of proposal – Pg. 57 of the RFP references needing to print hard copies but also references Attachment 1 which only states to submit electronically through the eCPS website. Can you please clarify?

Offerors must submit proposals through the eCPS website. Please refer to attachment 1- Packaging and Delivery of Proposals for instructions.

Attachment 1.B. Page limitations: The page limits are left blank. Can you clarify the page count?

There are no page limitations. Attachment 1- Packaging and Delivery of Proposals is amended for clarity. Refer to the RFP attachments.

3 Is a budget justification required or only the required budget in Excel format

Budget justifications are required.

4 Are NIH-style biosketches accepted in place of the requested resumes?

Yes – NIH Biosketches are acceptable. If biosketches will be submitted, please use NIH instructions for non-fellowships.

(https://grants.nih.gov/grants/forms/biosketch.htm)

5 Formatting: are headers and footers allowed?

Headings and footers are allowed.

6 Business Proposal: The directions state to include a copy of the organization’s most recent annual report. This is over 100pgs long.

Would a document with a link to the report suffice?

Linked documents of annual reports are acceptable.

7 Can IRB protocol be submitted as Other Considerations attachment?

The IRB is included in the Technical Proposal under section 4. Human Subjects. Please refer to the RFP, section 4. Human Subjects, pages 76-86.

IRB protocols can be submitted as other considerations attachments.

https://grants.nih.gov/grants/forms/biosketch.htm

8 Is Attachment 5: Representations, Certifications, and Other Statements required for this solicitation, and should it be directly attached to the Technical Proposal or the Business Proposal?

Yes, Offerors must complete attachment 5 and submit as a portion of the Business Proposal.

Please refer to Section K – Representations, Certification and Other Statements of Offerors on page 54 of the RFP for details.

9 Is Attachment 6: Representations Regarding Certain Telecommunications required for this solicitation, and should it be directly attached to the Technical Proposal or the Business Proposal?

Yes, Offerors must complete attachment 6 and

10 Is Attachment 7: Technical Proposal Cost Summary required for this solicitation, and should it be directly attached to the Technical Proposal or the Business Proposal?

Please refer to section (2)(a)(4) “Separation of Technical and Business Proposals” on pages 57-58 of the RFP for details. The technical proposal cost summary should be attached to the technical proposal.

11 Is Attachment 8: Summary of Related Activities required for this solicitation, and should it be directly

Yes, offerors must attachment 8 and submit as a portion of the Technical Proposal.

12 Is Attachment 11: NIH 2043 form required for this solicitation, and should it be directly attached to the Technical Proposal or the Business Proposal?

Yes, Offerors must complete attachment 11 and

13 Is Attachment 12: HHS Subcontracting Plan template required for this solicitation, and should it be directly attached to the Technical Proposal or the Business Proposal?

Per the RFP, a small business subcontracting plan is required if the proposed contract exceeds a total estimated cost of $750,000 for the entire period of performance.

Attachment 12 HHS Subcontracting Plan template should be included with the business proposal.

Please refer to the Business Proposal Instructions, section 7. Small Business Subcontracting Plan on page 95 of the RFP for details.

14 Is Attachment 14: Point of Contact Information required for this solicitation, and should it be directly

Yes, Offerors must complete attachment 14 and

15 Is Attachment 15: Certificate of Current Cost or Pricing Data required for this solicitation, and should it be directly attached to the Technical Proposal or the Business Proposal?

Yes, Offerors must complete attachment 15 and

16 Is Attachment 17: Disclosure of Lobbying Activities required for this solicitation, and should it be directly

Yes, Offerors must complete attachment 17 and

17 Is Attachment 21: NDA required for this solicitation, and should it be directly attached to the Technical Proposal or the Business Proposal?

NDAs should be attached the business proposal.

18 Is there a page limitation for the contract response?

Please refer to the answer for Question No. 2

19 Regarding HIV-negative “control” participants, are we expected to enroll all of them in the longitudinal study cohort and treat them as we do the HIV+, or just collect the brains and provide historical data?

HIV negative controls can be integrated into the longitudinal study cohort and/or used as part of the brain collection. Each site should make these determinations based on scientific needs.

20 Do you accept or request letters of support from referral sources who are not named consultants?

Letters of support may be submitted; however, the evaluation of proposals will be based on what is stated in the solicitation.

21 What are the NIH plans, if any to accommodate changes in the contract activities in the event of another COVID shutdown?

Responses to COVID and other government-required shutdowns will align with local and federal policy guidance and will be managed on a case-by-case basis.

22 Restrictions on use of contract funds for food and promotional items- does this apply to research participants as well as staff/investigators? We use these items as reminders to participants and families, and also to keep participants comfortable during the study visits.

Use of funds is prohibited for any NIH funded meetings or conferences; however please refer to Article B.3, Articles H.29, and H.30 in the solicitation.

23 Link for attachment 10 “HHS Section 508 Product Assessment Template”. Doesn’t work

A copy of Attachment 10 is included with this amendment.

24 Re: “Longitudinal structural, functional, and task-based neuroimaging assessments to comprehend alterations in neuronal circuits based on common measures for study participants assessed every 24 months” “Longitudinal Data pertaining to pathway linked biological measures such as…” “Measures of mechanistic biological signatures/targets to aid in diagnosis and for developing pre-clinical therapeutic interventions for CNS co-morbidities as appropriate”.

Are these items meant to imply that

a) the Contractors are to be responsible for providing the human tissues and data that is sufficient for future investigators or oversight committees to address these items, OR, b) do you mean for the Contractor(s) should also provide the hypotheses to be explored in their proposed contracts? If the latter, will the NIH pay for consultants to advise the contractors in developing these hypotheses?

Choice a. Contractors are not expected/required to generate hypotheses and/or conduct hypothesis-driven research. The NNTC Contractors priority role is to manage the biorepository and associated data for outside investigators’ use.

25 Regarding request for an autopsy report- will you accept a redacted report on cause of death and findings?

Redacted reports will be accepted.

26 “Neuropathologic evaluation specific to Alzheimer’s disease (AD) and Alzheimer's Disease-Related Dementias (ADRD)”. Is this expected to be performed on every brain?

Even if it’s a 19-year-old?

AD and ADRD evaluation should only be performed on age-appropriate samples and/or samples whose risk profiles indicate AD or ADRD likelihood.

27 Organ Pathology - relevant to HIV controls: unclear, what does this mean?

Are we to examine for particular syndromes?

When available, contractors should assess vital organs that are relevant to, or could further advance our understanding of NeuroHIV. Pathology protocols from prior iterations of NNTC will be made available to Contractors. Contractors are expected to have staff with scientific expertise to understand state of HIV science, and should consult with NIH program staff and scientific advisory board on relevant organ pathology needs.

28 GUID- does this apply prospectively only or retrospectively?

The GUIDs are required for both prospective and retrospective data. If some or all of the elements required to create a GUID are missing (e.g., participate date of birth), pseudoGUIDs can be used.

29 Are there any defined limits on the length of the application? Section 2 of Attachment 1 defines formatting and page limitations, but these fields are blank.

Please refer to the answer for Question No. 1

30 Is there any guidance for contractors on the potential range of appropriate costs? Understanding the potential range of funding would allow contractors to better define the scope of their proposals

It is anticipated that this contract will be a cost-reimbursement completion/level of effort type of award. The level of effort may vary from site to site.

31 Are contractors expected (or allowed) to include Letters of Support within the technical proposal beyond those required for Consultants?

Letters of support may be submitted; however, the evaluation of proposals will be based solely on what is stated in the solicitation.

32 Should contractors provide a draft QMP when submitting the application?

A draft QMP plan is not required with the application. Per the SOW, a full QMP plan will be expected 60 days after the contract.

33 What, if any, monitoring is in place for the DCC processing of resource request applications? NNTC Clinical sites only become aware of requests once they are broadcast.

NIH staff will engage with the DCC to monitor resource processing and requests. Protocols for timely sharing of information will be established within 30 days of awarding NNTC contracts.

34 If brain acquisitions in a given year are over or under expectations, how will budgets be readjusted?

The contract will be a cost-reimbursement complete/level of effort type contract.

35 How do we report for the different bins of brain acquisition? Many of the bins are non-independent. For example, a person could be COVID- 19+, have recovered >5 years from addiction, and have AD.

Brains that are double-counted or are non-independent should be clearly indicated as such in any submitted reports.

36 Are all of the contractors expected to demonstrate scientific expertise in all of the NIH HIV-related research priorities listed in Section A12 of the Statement of Work (attachment 3)?

Contractors should demonstrate some level of expertise with all priorities listed as research priorities and/or demonstrate the capacity to subcontract scientific support with relevant expertise as needed. Contractors who demonstrate exceptionally strong expertise/specialization in certain areas (and not others) will be considered although they should have the ability to support all priorities as needed.

37 RFP, Article F.3 Level of Effort, section a on page.

Page 14 of the RFP states “the Contractor shall provide ____ direct labor Hours . The labor Hours Exclude vacation, holiday, and sick leave.”

Is there a minimum number of hours required, and may they vary month to month (so long as the annual average meets the agreed upon requirement)?

The Contractor should provide enough labor hours so that they can manage the project – and the time commitment should be based on the breadth and complexity needed to complete the work at high quality.

38 Page 5 of the RFP states “The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items”.

Page 37 of the RFP “use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited” and “Contractor shall not use contract funds to purchase promotional items”. May we request funding and provide detailed justification to pay for participant related food/beverages (water, coffee, etc.), or are these items prohibited in this contract?

we make use of study-specific promotional materials (cups, pens, note pads, brain-shaped stress balls, etc.) in our recruitment of participants at city events (PRIDE, etc.) to advertise our studies and boost recruitment.

These materials have minimal value, are not given to staff, visitors, or conference attendees, but to current and potential study participants. Would we be able to submit funding requests and provide justification for these promotional items to assist with recruitment?

Please refer to the answer for question #22.

39 RFP, page 51, Section J- List of Attachments, Technical Proposal Attachments

Page 51 of the RFP has a link for Attachment 10 “HHS Section 508 Product Assessment Template”. The link led to a web page, where the template link was broken. May we receive this attachment for our files and potentially submission?

Please refer to the answer for Question No. 23

40 RFP, page 57, section (2)(a)(2).

Authorized Official and Submission of Proposal

Page 57 of the RFP requests that proposals be submitted via the instructions in Attachment 1, which calls for electronic submission only.

The RFP then goes on to address the terms of a paper submission. Is this standard boilerplate, and we can consider the submission terms met if we submit electronically, or should we plan for an electronic and paper submission?

Please refer to the answer for Question No. 1

41 RFP, page 61, section 14.

Certification Regarding Tax Matters (Oct 2020)

Page 61 of the RFP addresses the certification of tax matters. Should this certification be included in the cover letter at time of submission, or does it have a dedicated form?

If applicable, Offerors may include the Certification Regarding Tax Matters in the Business Proposal or the Cover Letter.

42 Are multiple PI applications allowed?

Can one place be primary and one w be a sub while both places will participate in the duties of the PI?

NIH allows offerors the opportunity to propose a multiple Principal Investigator (PI) model on research and development contracts.

Please refer to amendment No. 5 for details.