QandA_0002.pdf

RFP 75N95024R00002

Questions Answers

# RFP Document Section Page # RFP Text Question Answer

1 NA NA NA NA

Will the government consider a proposal extension to May 24, 2024?

No, the due date remains May 10, 2024, 11:00 am EDT

2 NA NA NA NA

Can the government please confirm there are no page limits or document font style/size restrictions for the proposal?

There are no page limits. There are no requirements for font style/size.

# RFP Document Section Page # RFP Text Question Answer

Solicitation Document

Section F 5

The basic requirement will be funded on a cost reimbursement, term, level-of-effort basis and will consist of a base 12-month (1 year) period of performance with four successive 12-month term Option Periods, and one 6-month term Option Period for a total potential performance period of 5 and a 1/2 years. The level-of-effort will be in accordance with the labor hours described in Article F.3 Level of Effort.

Can the government please confirm that the scope of work for the 6-month option period only includes the requirements outlined in Performance Area 6:

Transfer- out of Repository?

The scope of work for the Option Period 5 (6 months) includes preparing for and implementing a successful transfer-out of the biological samples, electronic databases, data management systems, and files of the NINDS repository. It also includes transporting/shipping sample vials and Government Furnished Property to a NINDS designated storage facility.

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Solicitation Document

Advance Understandings

Advance Understandings

Can the government please clarify how the CO will update this clause upon award and also confirm that all cost represented within an Offerors' proposal, which is selected for award, will be permitted as part of this section?

Prior to contract award, the advance understandings may include written approval by the Contracting Officer before incurrence of the cost, which will be included in this Article prior to contract award.

Solicitation Document

Provisions Applicable to Direct Costs

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer.

Can the government please clarify how this clause will be updated upon award to ensure the Offeror cost, as represented in its proposal, will be permitted under this contract? This clause makes no reference to labor cost for services nor material cost associated with the facilities.

Offerors should propose direct costs based upon their approach, which would be under Estimated Cost. This Article "Provisions Applicable to Direct Costs" referse to items that may be prohibited or restricted. If any costs are approved prior to award, they would be listed under "Advance Understandings."

# RFP Document Section Page # RFP Text Question Answer

Solicitation Document

J. HOMELAND

SECURITY

PRESIDENTIAL

DIRECTIVE (HSPD)-

12 - Roster

The Contractor (and/or any subcontractor) must submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s).

Can the government please confirm the only use of the personnel roster will be for information security requirements?

The personnel roster is required in accordance with Information Security Requirements as indicated in Sections C, F, and L.

Solicitation Document

Level of Effort 21

The labor Hours Include vacation, holiday, and sick leave.

If the Contractor is permitted to take credit for vacation, holiday or sick hours, can the government please advise how that would be represented and reported within the awarded contract?

The level of effort that is specified in Section F of the RFP is what the Government is estimating, it is up to the offeror to propose what they feel is appropriate (inclusive of vacation, holiday and sick leave). Hours are fully burdended.

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Solicitation Document

3.b. Level of Effort 22

The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor Hours specified herein are furnished.

Can the Government please provide clarity with regards to how Fixed Fee will be impacted by Level of Effort Performed:

a) Will there be an impact to Fixed Fee in the event less than 90% of the LOE is executed? If so, how will this impact fee and what formula would be used?

b) Is the Level of Effort requirement evaluated separately each Contract Period, or is the evaluation of LOE executed only calculated based on the Total Task Order LOE?

c) How is Fixed Fee to be invoiced each month and what formula is utilized?

a) 90% LOE is required.

b) The LOE will be evaluated for each contract period as well as for the total task order.

c) the offeror may propose their monthly fee and calculations.

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Solicitation Document

Indirect Cost Rates 26

"the cognizant Contracting Officer Representative responsible for negotiating provisional and/or final indirect cost rates is identified as"

Can the government please confirm this clause is not applicable to Large Business who work directly with DCAA and DCMA for negotiation and approval of billing rates, to include provisional and final indirect cost rates?

Yes.

Solicitation Document

Indirect Cost Rates 26

"These rates are hereby incorporated without further action of the Contracting Officer."

Can the government please clarify the meaning of the following statement?: "Please confirm that a Large Business would invoice in accordance with FAR 52.216-7 "Allowable Cost and Payment" and billing rates for indirect rates would be in accordance with those which the Large Business coordinates through DCMA, to include provisional billing and final indirect rates."

The provisional and or final rates negotiated with DFAS, DCAA or DCMA are incorporated as the Indirect Cost Rates.

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Solicitation Document

Section I- Contract Clauses, 1.

General Clauses

70 NA

Please confirm clauses 52.219-13 and 52.219-14 should be removed from this solicitation since this is not a small business set-aside RFP.

These clauses may be applicable to contracts resulting from this RFP. The organizational structure of the successful offeror will determine the specific general clause listing to be contained in the contract awarded from this

RFP.

Solicitation Document

Section K 84

Complete, and INCLUDE as part of your BUSINESS

PROPOSAL:

SECTION K -

REPRESENTATIONS,

CERTIFICATIONS, AND

OTHER STATEMENTS

OF OFFERORS

which is included as an Attachment in Section J-LIST OF

ATTACHMENTS,

SOLICITATION

ATTACHMENTS

of this solicitation.

Section K notes that we are to complete the Reps and Certs attachment to the RFP and include within our Business volume.

However, Section K also includes additional Reps and Certs clauses (K)(1) through K(8). Can the government please confirm if we are also to include these within our proposal, in addition to the Reps and Certs attachment contained in the RFP?

Please complete the Reps and Certs under Section K and the Reps and Certs Attachment A5. If any of the provisions or clauses are duplicated, only one needs to be completed.

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Solicitation Document

Section L 100

The Government's requirement for the work set forth in the Statement of Work of this solicitation is [TBD at time of award] direct labor hours.

Can the Government please confirm the LOE provided in this table is only the Government's "estimate" and that the Offeror is permitted to propose its own solution and level of effort and is not bound by the LOE shown within the table of Section L?

Yes.

Solicitation Document

Section L 100

The Government's requirement for the work set forth in the Statement of Work of this solicitation is [TBD at time of award] direct labor hours.

For the Quantity Options, can the government please clarify if the Offeror is required to bid 2500 hours for each Optional Quantity?

Yes.

Solicitation Document

d. Human Subjects 124

IMPORTANT NOTE TO

OFFERORS:

The following subparagraphs shall be addressed, as applicable, in a SEPARATE FILE of the Technical Proposal entitled, "HUMAN

SUBJECTS."

Can the government please confirm if this should be a separate document submitted with the proposal, or if the intent is that this is an appendix or separate section contained within the Technical Proposal?

The Human Subjects file can be either a separate document or an appendix to the Technical Proposal.

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Solicitation Document

3.c. Certified Cost or Pricing Data

131 NA

Given the subject solicitation is competitive, we assume that offerors and its subcontractors are exempt from providing Certified Cost or Pricing Data IAW FAR 15.403- 1(b)(1). Please confirm, and please consider removing this requirement from the solicitation. If the determination is that it must stay in the RFP, please advise if the signed certificate is required as part of the initial proposal submission.

There is no excemption from the Certified Cost or Pricing Data.

Certified Cost or Pricing Data is required and a signed certificate is required as a part of the proposal submission.

Solicitation Document

BUSINESS

PROPOSAL

INSTRUCTIONS

Section (b) and section (c)(a) both contain instructions for what should be within the first page of the proposal. Can the government please clarify which we should follow?

Please include information from both Sections (b) and (c)(a).

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Solicitation Document

Small Business Subcontracting Plan

HHS expects each procuring activity to establish minimum subcontracting goals for all procurements.

The anticipated minimum goals for this RFP are as follows:

Can the government please confirm the Offeror is permitted to bid its own goals as part of its proposal which are not required to meet these minimum goals within the RFP?

The anticipated minimum goals are as stated in the RFP.

Solicitation Document

b. Cost Elements

133 - 134

In addition, provide a summary of your cost analysis and a copy of certified cost or pricing data submitted by the prospective source in support of each subcontract

Can the government confirm a sealed package from Subcontractors is acceptable as opposed to requiring the Prime to include the Subcontractors cost and pricing data? Companies have deemed this information proprietary and prefer not to submit to another company.

All proposals shall be submitted through ecps by the offeror before the due date.

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Solicitation Document

NA NA

Cost-reimbursement, level of effort type contract

Throughout the Solicitation, the contract type is listed as "cost-reimbursement, level of effort type contract". Can the Government please confirm this should be corrected to "Cost Plus Fixed Fee - Level of Effort"?

FAR Clause 52.216-11 is included in Section I, which may provide for no fee. It is not required that all offerors propose a fee, therefore the contract type is listed as "cost-reimbursement, level of effort."

21 Attachment 17 Attachment 17 NA NA

Can the government please provide an updated link associated with Attachment 17 which offerors may open? Can the government please also confirm if this attachment is required as part of the proposal submission?

Offerors should download and save a copy of the attachment to access. The file "Attachment 17:

Disclosure of Lobbying Activities, OMB Form SF-LLL" is now included in the Attachments Section on sam.gov.

# RFP Document Section Page # RFP Text Question Answer

A3 SOW NINDS

Repository 2024

Performance Area 4:

Management of Electronic Data, Including Sample Data,Web-based Catalog, and Project Management System

Can the government clarify what the system and environment security requirements are (e.g., FISMA, FedRAMP, M-21- 31)?

Information Security Requirements are indicated in Sections C, F, and L.

A3 SOW NINDS

Repository 2024

Performance Area 4:

Management of Electronic Data, Including Sample Data,Web-based Catalog, and Project Management System

Can the government please clarify what existing hardware and software dependencies of the current system are able to be communicated here and which need to be preserved?

The current system is built, owned, and operated by the incumbent and hosted within the incumbent's environment. The Government does not have the authority to disclose this proprietary information. Offerors shall put forth what they feel is appropriate for their proposed solution.

A3 SOW NINDS

Repository 2024

Performance Area 4:

Management of Electronic Data, Including Sample Data,Web-based Catalog, and Project Management System

Can the government please clarify if there are existing inflight migrations, and if so, what are they?

The current system is built, owned, and operated by the incumbent and hosted within the incumbent's environment. The Government does not have the authority to disclose this proprietary information. Offerors shall put forth what they feel is appropriate for their proposed solution.

# RFP Document Section Page # RFP Text Question Answer

A3 SOW NINDS

Repository 2024

Performance Area 4:

Management of Electronic Data, Including Sample Data,Web-based Catalog, and Project Management System

Can the government clarify if the current system is hosted in the cloud, on-premises, or hybrid? Can the government please provide an architecture diagram?

The current system is built, owned, and operated by the incumbent and hosted within the incumbent's environment. The Government does not have the authority to disclose this proprietary information. Offerors shall put forth what they feel is appropriate for their proposed solution.

A3 SOW NINDS

Repository 2024

Performance Area 4:

Management of Electronic Data, Including Sample Data,Web-based Catalog, and Project Management System

Can the government provide the existing technology stack and list of software libraries? Can the government clarify if any of these are required to remain?

The current system is built, owned, and operated by the incumbent and hosted within the incumbent's environment. The Government does not have the authority to disclose this proprietary information. Offerors shall put forth what they feel is appropriate for their proposed solution.

# RFP Document Section Page # RFP Text Question Answer

A3 SOW NINDS

Repository 2024

IV.A.1 6

“The new Contractor shall provide services for: 1) pulling, verifying, and packaging each vial for shipment; 2) transporting vials and Government Furnished Property to its facility; 3) offloading, verifying, and storing each vial and Government Furnished Property;

and 4) transferring and verifying associated data.”

1) Typical large collection transfers have a validation of 10% of samples; the RFP is requesting 100% validation. Can the government confirm if this required, or can the contractor use random sample verification of 10% with inspection of anomalies?

After the samples have been transferred to a new facility, a 10% random sample verification process would be acceptable.

However, it's important to note that the statement referred to preparing for sample transfer, which involves pulling, verifying, and packaging each individual vial.

Can the government clarify if the offeror could consider only receiving freezers manufactured on or after 2020?

Offerors are not obligated to accept any Government-furnished property, but it is anticipated that they will accept those items acquired in or after 2020.

Can the government confirm if maintenance and failure records available for all government furnished property?

Yes, those records are available.

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A3 SOW NINDS

Repository 2024

IV.b.1 7

The Contractor shall provide sample collection kits, data collection instruments and return packaging at no cost to the submitting investigator. The Contractor shall also bear the transportation cost of samples submitted by the investigator

Can the government clarify if collection kits be shipped to domestic locations only, or both domestic and international?

Both domestic and international locations.

A3 SOW NINDS

Repository 2024

IV.c.1 10

Contractor shall maintain required shipping licenses and permits from federal, state, and local authorities for the safe import, storage, and distribution of biological samples, according to regulatory guidelines.

Could the government please confirm if samples from the repository will be distributed to domestic locations only, or both domestic and international?

Both domestic and international locations.

# RFP Document Section Page # RFP Text Question Answer

A3 SOW NINDS

Repository 2024

IV.c.1 10

Could the government clarify if two kit types should be created (one with two EDTA tubes only, the other with two ACD tubes only) or one kit with all 4 tubes?

One kit with two ACD tubes only for whole blood samples of adult, or two EDTA tubes only for blood samples of pediatric subject.

A3 SOW NINDS

Repository 2024

IV.b.1 6

One tube is used to extract DNA directly from whole blood, and the other tube is used to isolate and cryopreserve lymphocytes to allow future transformation

Could the government clarify many lymphocyte aliquots should be created from the two ACD tubes?

One ACD tube of blood is used to extract DNA directly from whole blood, and the other is used to isolate and cryopreserve lymphocytes. Two lymphocyte aliqouts are created from each ACD tube.

A3 SOW NINDS

Repository 2024

IV.A.1 6

Could the government clarify what size tubes are existing DNA samples, LCLs and cryopreserved lymphocytes stored in?

Cryopreserved lymphocytes and LCLs are stored in glass ampoules and cryovials that range from 1 - 2 ml; the majority of the DNA collection is stored in cryovials that range from 0.5 - 2 ml, and special DNA collections are stored in the vials shipped by the respective submitters.

# RFP Document Section Page # RFP Text Question Answer

A3 SOW NINDS

Repository 2024

IV.b.1 6

Could the government please provide the percentage of the lymphocytes samples should be estimated requiring transformation to create a lymphoblastoid cell line?

The likelihood of needing transformation to establish a lymphoblastoid cell line (LCL) is low, estimated at no more than 2% of the expected collection.

Establishing LCLs and subsequently extracting LCL DNA may only become necessary in the event of failed DNA extraction from whole blood.

A4 Govt Furnished Property

NA 1 NA

Can the government clarify if the Offeror has to take any Government furnished property? Can the Offeror choose only Freezers that meet its age requirement for maintenance?

Offerors are not obligated to accept any Government-furnished property, but it is anticipated that they will accept those items acquired in or after 2020.

A4 Govt Furnished Property

NA 1 NA

If the Offeror accepts the government furnished property, will the government share a lease rate the government will be using to fairly compare against those that use a mix of GFP and Offeror-furnished freezers?

The Offeror should propose what they deem is an appropriate lease rate in such a scenario.

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A4 Govt Furnished Property

NA 1 NA

Will the government accept a Cost per sample model for storage that includes freezer, racks, utility, overhead and maintenance?

The Offeror should propose what they deem is an appropriate cost model in meeting the requirements set forth in the RFP.

A8 Wage Rate Determination

NA

Are we required to use the Maryland Wage Determination rates included in the RFP NIH-

NINDS-75N95019R00029,

or can we use our own state Wage Determination rate?

Please use the Wage Determination Rate for your own State. The Maryland Wage Determination was provided as an example.

A21 Employee Separation Checklist

NA

Can the Government confirm whether the NIH contractor employee separation list listed under K. Contract Initiation and Expiration applies specifically to RFP

NIH-NINDS-

75N95024R00002?

Yes.

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A13 Small Business Subcontracting Plan

NA NA

Would the Government please confirm the U.S.

Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system will be updated to add this solicitation. The RFP requires that we submit our plans through the system, however, the system does not currently reflect this solicitation as being available for plan/report submissions.

The solicitation is now avaiable in the SBCX system for plan submission. Please use this link to submit your SubK Plan:

https://osdbu.hhs.gov/subcontrac ting/7318c4dc-2f21-4bc6-8c49-e4d781416b63