75N95019R00006_Amendment_1.pdf

“The NIH NeuroBioBank and Tissue Repository”

AMENDMENT OF SOLICITATION NO.: RFP-75N95019R00006

AMENDMENT NO.: 1

EFFECTIVE DATE: 2/28/2019

ISSUED BY:

National Institute of Mental Health

NIDA, OA

6001 Executive Boulevard Room 8154, MSC 9559 Bethesda, Maryland 20892-9559

Point of Contact: Jeffrey E. Brown, Contracting Officer and Valerie Whipple, Contracting Officer

NAME AND ADDRESS OF CONTRACTOR: To All Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of Offers is NOT extended. Offerors must acknowledge receipt of this amendment on each copy of the offer submitted. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE

DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by updating your proposal submission in eCPS, so long as your revised proposal submission is uploaded to eCPS prior to the closing date and time.

All other terms and conditions of the RFP remain unchanged.

DESCRIPTION OF AMENDMENT (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE: To amend the RFP and to clarify the RFP requirements by responding to questions submitted under the RFP. Unless specifically noted, all specifications remain unchanged.

Part I. The RFP is amended as follows:

Attachment 4: Technical Evaluation Criteria is modified as follows to make it consistent with Attachment 3, Statement of Work:

Attachment 4, pg. 1, Section 1 a (1) is modified to remove the number 75 from the donor target range and should read as follows:

(1) New Specimens: Optimum sites can acquire well-characterized donors with a target range of at least 50 donors per year (if there is access to unique or difficult to reach populations lower accrual rates could be considered) mailto:kg25d@nih.gov

RFP 75N95019R00006

Amendment 01

Attachment 4, pg 2, Section 2 b (1), bullet point 4 is modified to remove the language in the parentheses and should read as follows:

The offeror’s ability to access unique or difficult to reach patient populations

Part II. Responses to Questions:

1. Does the inclusion of “Appendix 1 – Material Transfer Agreement (MTA)” in the Statement of Work (Attachment 3) to mean that the contractor needs to include an executed copy in its proposal.

Offerors do not need to include an executed copy of the MTA in their proposal. The MTA included in Appendix 1 is intended to serve as a reference to offerors.

2. Does the central NIH Neurobiobank executes the MTA before they ask us to ship tissue to a recipient, without any involvement on the contractor’s part.

Execution of this MTA between the NIH (on behalf of NBB BTRs) and Recipient Organizations occurs when tissue is approved for shipment to Recipient Scientists.

3. The instructions in Attachment 1 say to include all Technical Plan sections in one PDF. However, page 89 states that the Human Subjects section should be addressed in a “SEPARATE FILE” of the TP. Since there is only one place to upload the Technical Plan, should it be included as a separate section at the end of the Technical Plan PDF?

There is a separate place to upload Human Subjects within eCPS; however, the offeror can choose to instead include the Human Subjects section as part of a separate section of your technical proposal instead of uploading a separate file.

4. Number of brains expected for each year, will the contractor be expected to collect up to 150 brains for Year 1 and 2 and up to 100 brains for Year 3-5, unless Options for additional quantities are exercised. Is this correct? If so, should the budget reflect 150 brains/year for Year 1 and 2 and go down to 100 brains/year for Year 3-5 on (Attachment 3, pg.20)?

The Offeror’s Budget should reflect what the Offeror is capable of obtaining on an annual basis with a target range of at least 50 donors per year (See Part I of the Amendment). The Government may choose to exercise additional options for hours/effort within a given performance year to obtain additional donors. IN ADDITION, the Government is seeking to increase the NIH NeuroBioBank inventory of donors with opioid use and abuse disorders (see option under Opioid Use and Abuse, Attachment 3, pg. 20). Offerors MAY choose to provide evidence of their capability to acquire donor brains from individuals with history of opioid use as described. Up to 150 brains per year under the Opioid Option will be obtained across all NIH NBB BTRs.

5. Assessment of tissue quality

Attachment 3 (pg. 8) states that sites will be expected to send a small piece of brain tissue to a centralized location for standard quality metrics (RIN, 280/260 ratio, pH).

However, page 20 of Attachment 3 states “offerors should include in their proposal a plan to evaluate these measures [RIN, pH] for all specimens collected under the NBB program. Provide evidence of capability, summary of reliability measures and cost proposal”.

Should the budget and technical proposal include approach and cost for RIN measures in-house? Will serology and toxicology be centralized? Toxicology currently is but not serology.

Page 20, Attachment 3 refers to an additional task area (Assessment of Tissue Quality). If an offeror has the capabilities, expertise, and resources, they should budget to perform tissue quality assessment for all donors collected across the NIH NBB BTRs (between 550-750 donors per year for the duration of the contract).

6. Human subjects:

As required by this RFP, we are planning to gather identifiable private personal information (e.g. names, contacts), demographic and clinical information from potential donors included in our Registry. This process may be considered to fit into the definition of Human Subjects (see below). We would like to make sure that what is stated in Article H.1 doesn’t prohibit gathering information for longitudinal studies on individuals while living.

Section H: “ARTICLE H.1. HUMAN SUBJECTS “It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.”

Human Subjects Technical Proposal Instructions, 4b:

b. The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

c. Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.101(b)(1)-(6) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html .

Offerors will not be supported by this contract to collect biospecimens or other clinical data on individuals while living or to conduct longitudinal studies of living subjects. If biospecimens / clinical data are collected prior to death, the appropriate IRB approvals should be obtained and supported through other means.

7. Alternate proposals

If acceptable to submit alternate proposals, please clarify how they should be set up.

Should an alternate proposal be fully separate from main proposal, e.g. separate budget, business and technical proposals? Should an alternate proposal be added as an addendum in both the Business and Technical Proposals? How should we provide an excel budget form for an alternate proposal?

An alternate proposal should be completely separate from the main proposal. Please follow the instructions in the eCPS FAQ on how to submit an alternate proposal.

eCPS FAQ: Can I submit more than one proposal for a given solicitation?

Yes. After successful submission of your 1st proposal, you may submit other proposals by clicking ‘Submit new/alternate proposal’.

8. Quality Management Plan

Is an outside company expected to be involved in the Quality Management Plan, or is it acceptable to enroll an expert within the institution but who is not part of the HBTRC?

The QMP should be performed by an external, neutral party.

9. Electronic health records from outside sources (e.g. Hospitals):

The level of encryption of electronic health records received hospitals and other health care providers is typically not at NIH contract standards and cannot be modified by the HBTRC at the time of reception. Is it acceptable to receive them, store them, upload them on encrypted electronic HBTRC storage and then destroy them?

Regarding transfer of electronic health records from outside sources to the NIMH NeuroBioBank HBTRC contract facility the HIPAA Privacy Rule requires that covered health care providers apply reasonable safeguards when making these communications to protect the information from inappropriate use or disclosure. These safeguards may vary depending on the mode of communication used. For example:

• A hospital may fax, or communicate over the phone, a patient’s medical information.

• A hospital may deliver hard copy patient’s medical information.

• A hospital may use an encrypted portable drive to transfer a patient’s medical information.

• A hospital may use Secure File Transfer Protocol (SFTP) to communicate a patient’s medical information.

• A hospital may use encrypted email to communicate a patient’s medical information.

• Other encrypted communication method

If the level of encryption of electronic health records received by HBTRC is not up to Federal standards, HBTRC may convert the records to compatible Federal encryption standard and destroy all copies of the received version.

10. Genotyping:

Please clarify whether we should provide a plan and budget for carrying out genotyping in house. Should we provide evidence for our own ability to genotype our inventory? Please see relevant language from the RFP below.

Attachment 3 c V (5). “Genotyping or whole genome sequencing (WGS) will be conducted by an independent site for all donors (to be determined at time of award).

These data will be stored and shared following NIH genomic data sharing policies.”

Attachment 3, Option Quantities:

“Prospective contractors should provide evidence of their capability to perform large scale genomic characterization of NBB inventory. Proposals should include type of assay (i.e., targeted genotyping vs whole genome sequencing, etc. and costs). This service would be expected to manage characterization of donors from all NBB sites in efforts to enhance uniformity and reliability across sites.”

Page 20, Attachment 3 refers to an additional task area (Genotyping). If an offeror has the capabilities, expertise, and resources, they should budget to perform genotyping for all donors collected across the NIH NBB BTRs (between 550-750 donors per year for the duration of the contract).

11. The instructions indicate that we should use 12 pt for the proposal. We would like to use 10 pt for tables and budgets, as we do for our NIH grant applications in order to fit the information without extending across multiple pages. Is 10 pt for tables and budgets permissible?

You may use a 10 pt font in order to keep page consistency in tables only and the font size cannot be lower than 10 pt font. 12 pt font should still be used in the main body of the proposal.