QandA_Responses_Final_0002.pdf

REQUEST FOR PROPOSAL (RFP) NUMBER: 75N95024R00124

PROJECT TITLE: NIH NEUROBIOBANK BRAIN AND TISSUE REPOSITORY

Questions and Answers

Q1 Could you clarify the margins requirement? Page 104 of the RFP solicitation states they should be no less than ½ inch. However, Attachment 1 – A2 Packaging and Delivery for eCPS states that they must be at least 1” on all sides.

A1 Section L, Page 104 of the RFP has been amended to state 1 inch.

Q2 It appears a Subcontracting Plan has not yet been created for this solicitation. Could you please let me know when you will be entering the Subcontracting Plan into the system?

A2 The U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system is now ready for offerors. The following link may be used to access this solicitation’s subcontracting plan in the SBCX system:

https://osdbu.hhs.gov/subcontracting/f86828be-1b0a-4100-943f-ccd75e4d7aaf

Q3 As I read the SOW, I understand that General Task Areas 1 through 7 are mandatory.

Should these requirements be arranged as heading in the technical proposal?

A3 Unless specifically required in the solicitation or attachments, offerors may organize their technical proposal in the manner they see fit in order to adequately respond to the technical requirements.

Q4 The question on the optional budget for task 9 is about how to allocate the costs. Is it supposed to be presented as a one-year budget or spread over all years?

A4 Task 9 is to be an optional option for the base year and each one-year option period.

Q5 The issue is administrative work – some effort is the same whether you do 1 sample or 5,000 in a year. So it’s not correct to present a single year budget and then think the same work can be spread over 5 years by dividing it by 5.

A5 See the Level of Effort Section on Page 16 of the SOW for the Government’s estimated Level of effort.

Q6 Can we have a foreign institution participating in the brain collection for this contract?

https://osdbu.hhs.gov/subcontracting/f86828be-1b0a-4100-943f-ccd75e4d7aaf

A6 Offerors may propose foreign institutions participation; however, the NBB does not currently accept foreign collection sites.

Q7 Can we subcontract with a foreign institution for the brain collection?

A7 Please see the response to Q6 above.

Q8 Is 12 pt font with 1” margins all around acceptable?

A8 See Section L, Page 104 of the RFP and Attachment 2, Packaging and Delivery of Proposal for font size and margin requirements.

Q9 Should members of the external advisory board have salary support?

A9 Yes, as necessary to complete the QMP evaluation and generate annual reports. External scientific advisors/consultants could be included as consultants to the project, depending on the estimated level of effort required for this role. Please see Q25 and A25.

Q10 Is including letters of support [for the external advisory board] agreeing to serve necessary or acceptable?

A10 See Section L, Paragraph 1(B)(3) for additional personnel requirements.

Q11 Our proposal includes specific collaborations with other individuals [at our place of employment] who will not receive salary support because their cooperation is part of their existing clinical duties, should we include (or can we include) letters of support from them as well?

A11 Please see the response to Q10 above.

Q12 If we understand correctly the option quantity, they are meant so that the offeror (us) or NIH can ask for an increase in effort up to 80% of the total budget in increments of 5% (max 16 times per year) to acquire more tissue. Please confirm if this is correct?

A12 This is correct as stated in the RFP.

Q13 Budget 1 is the budget for the Base Contract over 5 years. Please confirm if this is correct?

A13 Specific budget requirements may be found in Attachment 5 – Additional Technical and

Business Proposal Instructions.

Q14 Budget 2 contains 80% on top of Budge 1 reflecting quantity option to increase our effort by up to 80%. Please confirm if this is correct?

A14 Specific budget requirements may be found in Attachment 5 – Additional Technical and Business Proposal Instructions.

Q15 Budget 3 contains the option to transfer out the repository to a third party. Please confirm if this is correct?

A15 Specific budget requirements may be found in Attachment 5 – Additional Technical and Business Proposal Instructions.

Q16 Budget 4 is Budget 1 + 2(80% more) plus a transfer out in Y5. Please confirm if this is correct?

A16 Specific budget requirements may be found in Attachment 5 – Additional Technical and Business Proposal Instructions.

Q17 Are separate excel files (1 for each Budgets above) needed?

A17 Separate budgets are required, not separate excel files.

Q18 Do each [Budget] also need a Business and a Technical Proposal?

A18 Yes, each proposed budget will need a business and technical proposal.

Q19 If our understanding is correct, each Optional General Task Area, such as Area 8, will need to be submitted with separate submission documents (Budget, Business Proposal and Technical Proposal). Please confirm if this is correct?

A19 Yes, each optional task will need a separate budget, business proposal and technical proposal.

Q20 Please clarify whether these documents [Budget, Business Proposal and Technical Proposal] for Area 8 are to be submitted for each of the 5 years of the Base Contract or just for Contract Year 1?

A20 For the optional task areas, a budget will need to be submitted for the base period and any optional periods for which the offeror is proposing. Only one business proposal and one technical proposal would need to be submitted for the optional task areas.

Q21 When will the HHS Subcontracting Plan be created for this solicitation and when will institutions be invited to access it? Or will a link be created and sent out to applicants?

A21 Please see the response to Q2 above.

Q22 What information is required on the cover page for the technical proposal? Should this model the cover page for the business proposal? There is generic info on page 108 for a cover page. On pages 123 & 125, which is specific to the business proposal, there is slightly different information about what should be contained. Can we get clarification on what should be included for each proposal’s cover page?

A22 Cover page requirements/recommendations may be found in Section L, Paragraph 1(b)(1).

Additional specific cover page requirements may be found in Section L, Paragraph 3 et seq.

Q23 A requirement for serological testing (blood, serum) for the presence of Sars-CoV-2. To the best of our knowledge, serological testing is not suitable nor established for the detection of a Sars-CoV-2 infection.

A23 Offerors should propose methods they think are appropriate. Specifically, for Sars-CoV-2 testing, a decision will be made by the consortium on the value of testing and what tissue to test.

Q24 Please confirm that all RIN assays (RNA Integrity number) will be done at a NBB designated laboratory and not at the BTR.

A24 This is currently the plan, although it might change during the Contract.

Q25 The Statement of Work lists an External Scientific Consultant (ESC) as required Key Personnel whose effort might equal. The Quality Assurance Plan notes that the proposal will evaluate the addition of the ESC, but I haven’t found a delineation of the ESC’s role/responsibilities and how they might differ from [the employer’s] personnel. Could you provide additional information on the role and responsibilities you envision for the External Scientific Consultant?

A25 The responsibilities of the external scientific advisor (s) are to evaluate, provide oversight of General Task Area 7, and generate an annual report of findings and recommendations. The level of effort provided in the SOW are not prescriptive for any of the categories but are for guidance.

The assigned level of effort should be determined by the offeror and should depend on how many consultants/advisors are included in the application. The consultants shall function in an autonomous manner, separate from technical staff, and report results directly to the Principal Investigator (PI) and/or senior management.

Q26 In order to present a competitive and compliant response, will the government consider extending the due date by one week to November 21, 2024, at 5:00 P.M., Eastern Time?

A26 Pages one and two of the RFP have been amended to extend the due date to November 25, 2024 at 9:00 A.M. Eastern Standard Time.

Q27 The exclusion criteria mention “extended mechanical ventilation” will the government please specify the allowable duration that could be included in the inclusion criteria?

A27 We recommend eight hours, however, exceptions will be made for high value cases, such as donors who had a diagnosis of ALS.

Q28 Will the government please specify the types of drug or substance addictions that are permissible for inclusion in the criteria?

A28 None, all substance use should be documented in the clinical records and toxicology reports.

Q29 Will the government please explain if all the specified sample types be collected from each donor, or is it acceptable to gather only those that are feasible from each individual?

A29 Whatever is feasible and consented to by the legal next-of-kin. Brain and/or spinal cord are required for each donor that is included in the NBB collection.

Q30 Is it necessary to collect brain and other tissues from every donor, or is it acceptable to collect additional tissues from just one donor?

A30 Brain and/or spinal cord are required, everything else is secondary.

Q31 Are unconsented, consented, and consent-waived samples acceptable?

A31 See the General Requirements Section of the SOW, only appropriately consented samples are acceptable.

Q32 Will the government please provide the specific dimensions required for spinal cord, peripheral nerves, skin, and dura mater samples?

A32 See General Task Area 1 of the Specific Requirements Section of the SOW, collection of brain and nervous system tissues (i.e., spinal cord, peripheral nerves, cerebrospinal fluid), and peripheral tissues (skin, blood, dura, and other organs), is to be as consented to and authorized by the donor’s legal next-of-kin.

Q33 What is the exact volume required for blood and cerebrospinal fluid collection from each donor?

A33 Please see the response to Q32 above.

Q34 Are there specific requirements regarding the types of peripheral nerves that need to be collected?

A34 Please see the response to Q32 above.

Q35 For peripheral tissues (such as skin, blood, dura mater, and other organs), will the government please specify which part of the skin is needed and clarify which other organs are of interest?

A35 Skin is collected for derivation of cell lines at some sites. Blood and CSF are encouraged.

Q36 What is the maximum allowable Post-Mortem Interval (PMI) for sample collection?

A36 Optimal is up to 24 hours. NBB tries not to collect beyond 48 hours, however, exceptions can be made for certain situations depending on the time of cooling onset.

Q37 Are previously existing (banked) specimens with low PMI and associated data acceptable?

A37 Yes, high quality and appropriately consented previously banked specimens are acceptable.

Q38 Is there a specific timeframe between sample collection and when the samples should be tested in the laboratory?

A38 See General Task Area 4 of the Specific Requirements Section of the SOW, the average time interval between brain recovery and specimen listing on the NBB portal is expected to be 12-18 months.

Q39 Is the government open to accepting samples preserved when using different methods (fresh, fresh-frozen, or fixed)? If so, will the government please specify what methods are acceptable?

A39 Please refer to the methods in task area 2 in the Statement of Work for freezing or fixing specimens. The exact method of preservation is dependent on the bank’s SOP as long as tissue quality and integrity are maintained. More specificity and harmonization will be provided at the project’s kick-off time.

Q40 Are there any specific solutions or media to be used for the fresh collection of samples for preservation?

A40 Beyond the requirements in the SOW, each offeror should propose their best methods for preservation. The SOPs will be reviewed and harmonized as necessary.

Q41 Is [Phenotypic information such as cranial MRI findings (deidentified images and/or reports), other radiological reports, results of genetic tests and/or diagnostic evaluations, other clinical notes, and evaluations by specialists.] all this information mandatory for every donor, or can it be provided based on what is available for each individual?

A41 NBB encourages the collection of as much information to support the characterization of the donor and specimen.

Q42 When taking images are the 3D Scanning, 2D Scanning, and MRI imaging optional?

A42 See General Task Area 2 of the Specific Requirements Section of the SOW, 3D and 2D images are required, while MRI is optional.

Q43 Will the government please confirm if the gross inspection tests are to be performed on each tissue?

A43 Characterization is only required for central nervous system tissues.

Q44 Will the government please confirm if the Peripheral Tissue test is optional?

A44 Characterization is only required for central nervous system tissues.

Q45 Will the government please confirm if the Peripheral Nerve test is optional?

A45 Characterization is only required for central nervous system tissues.

Q46 Will the government please confirm if the Spinal Cord test is optional?

A46 Characterization is only required for central nervous system tissues

Q47 Will the government please confirm if the Cerebrospinal Fluid Postmortem Drug Screening is acceptable?

A47 CSF postmortem drug screening is acceptable for pre-existing collections to be contributed to the NBB inventory. However, brain tissue will be tested for prospective collections.

Q48 Are the other six NeuroBioBank centers all applying for competitive renewals? If so, does NIH have plans to expand the program beyond 6 sites?

A48 The Government will not disclose any offeror who has expressed an intent to submit a proposal. See page 1 and Section L, Paragraph e on page 100 of the solicitation, NIMH expects to award multiple awards from this solicitation.

Q49 Is it unlikely that two centers will be funded in close proximity to each other (i.e. in the same city/region)? Will any weight be given to this issue?

A49 See Paragraph (f) of FAR 52.215-1 Instructions to Offerors – Competitive Acquisition (NOV 2021) on page 135 of the solicitation, “The Government intends to award a contract or contracts resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and subfactors in the solicitation.”

Q50 If the PI of the grant is on NIH study section near the application due date, is there a possibility of an extension of the due date, similarly to NIH grants? Does it matter if the PI performing the NIH services is the contact PI?

A50 This solicitation is for a cost-reimbursement type contract. See the response to Q26 for the Government’s response to a request for a due date extension.

Q51 Does NIH expect whole brain/spinal cord specimen (as well as peripheral tissues) to be shared with the NIH Biobank or can donations vary in their “comprehensiveness” (ideally still with scientific justification to have representation across key brain/spinal cord areas).

A51 All donor specimens collected with NBB funding will be made available for sharing with the research community.

Q52 Will there be any priority for BTR sites to access the specimens – especially as it relates to supporting ongoing NIH studies? We know they must still request through NIH to access donated samples, but does this jeopardize existing plans to use specimens for currently funded (and/or future) projects?

A52 All tissue requests should be submitted through the NBB portal and inventory system. BTR sites do not have priority for tissue utilization but are able to request specimens for their research use.

Q53 Is there any cap on the budget?

A53 See Paragraph (f) of FAR 52.215-1 Instructions to Offerors – Competitive Acquisition (NOV 2021) on page 135 of the solicitation, “The Government intends to award a contract or contracts resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and subfactors in the solicitation.”