Amendment__2.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE

DATE

See Block 16C

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY

7. ADMINISTERED BY (If other than Item 5) CODE

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch 6100 EXECUTIVE BLVD., Suite 7A07, MSC 7510

BETHESDA MD 20892-7510

8. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP Code)

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION

NO.

RFP NIH-NICHD-IDD-2015-3

X

9B. DATED (SEE ITEM 11)

May 20, 2015

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

Th e a b o ve nu m b e re d s o lic ita tio n is am e n d ed a s s e t fo rth in ite m 14. Th e h ou r a nd d a te s p e c ifie d fo r re c e ip t o f Offe rs is e xtended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning __1___ copy of the amendment in your business proposal; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO FAR 52.243-2. THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract ARTICLE B.4.

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor __ is not, X is required to sign this document and return _1_ copy in your business proposal to the issuing office.

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

PURPOSE: To amend the RFP to remove the requirement for data sharing plans and to provide answers to nineteen (19) questions on RFP NIH-NICHD- IDD-2015-3 - Newborn Screening Pilot Studies.

Cut off period for questions: June 18, 2015 (unchanged)

DUE DATE: July 7, 2015 2:00 PM Local Time (unchanged)

Except as provided herein, all terms and conditions of the document referenced in item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER

Megan Gnall, Contracting Officer NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

/S/

BY

(Signature of Contracting Officer)

16C.DATE

SIGNED

06/16/2015

RFP-NIH-NICHD-IDD-2015-3

Newborn Screening Pilot Studies

The subject RFP is hereby amended to reflect the following changes:

1. Under Section C, Article C.2 Reporting Requirements, subparagraph a.

Technical Progress Reports, “Data Sharing Plans for Approval” is hereby deleted.

2. Under Section H, Article H.24 Sharing Research Data is hereby deleted in its entirety.

3. Under Section L, paragraph 5. Obtaining and Disseminating Biomedical Research Resources as shown on page 87, subparagraph a. entitled Sharing Research Data is hereby deleted in its entirety.

4. Under Attachment 3b, TO1, Statement of Work, IV Technical Requirements paragraph 10 where it states “Develop and submit data sharing plans for approval” is hereby deleted.

5. Under Attachment 4a, Technical Reporting Requirements and Deliverables, for TO1, where it states “Data Sharing Plans for approval” is hereby deleted.

Below is a list of 19 questions and answers:

Question 1: My interpretation of the RFP is NIH wants to have a list of NBS labs and associated follow-up that can be contacted to perform validation studies for new disorders added to the RUSP.

Answer 1: The selected contractors shall provide services, qualified professional and technical personnel, material, equipment, and facilities under the terms of the awarded IDIQ contract as required by the IDIQ Statement of Work. See Attachment #3a of the RFP. See also Technical Evaluation Factor (pages102 and 103 of the RFP).

Question 2: Is this RFP the only grant mechanism that has been planned for NBS pilot studies or will there be pilot studies funded by the NIH separately from this RFP in the future? For example, if a pool of contractors had been established prior to the Pompe pilot study, would labs have been selected only from the pool or would the RFP have been advertised outside the pool? While no one can predict the future, is it NIH’s intent that all pilot studies in the future will be conducted only by members of the pilot study contractor pool and you must be a member of the contractor pool to be included in pilot studies.

Answer 2: This requirement will be awarded via a contract mechanism, not a grant.

The purpose of utilizing an IDIQ contract type is to create a Newborn Screening Pilot Studies pool. Each future requirement will be competed among those successful offerors that become part of the pool. See Answer 1 provided under Amendment 1 of the RFP.

Question 3: If accepted into the pool of contractors, is it possible for a lab to decline an opportunity to validate a new test? While no lab wants to decline opportunities to improve testing, often there are complications (for example, construction of a new lab facility) that can’t be avoided which would not allow participation.

Answer 3: For future task orders competed within the Newborn Screening Pilot Studies pool, a contractor may elect not to propose on a specific task order.

Question 4: Is it possible for multi-state collaborations in this RFP? While there may be challenges for specimen sharing between states, it would seem there is an advantage to developing protocols and methods which can be demonstrated to be implemented in multiple states. Harmonized workflows and procedures should allow more efficient implementation of testing for a new disorder on a national scale.

Answer 4: While offerors can propose subcontracts on a collaborative basis with other institutions or organizations, each organization must comply with their own state regulations.

Question 5: Finally, it appears from the RFP that MPS-1 will be the first disorder to be validated using this RFP and intended start date is end of September 2015. Since discussions and assessment are currently focused on ALD, the assumption is validation of ALD may follow MPS-1.

Answer 5: MPS-1 is the first disease to be studied. It is not known at this time what the next disease will be.

Question 6: In the IDIQ SOW, Section IV, E. Please clarify if we are expected to have a proposal-specific External Advisory Committee, or if this is expected to be an Advisory Committee that serves all awardees? Note: I see in F10 that there is a condition-specific advisory committee, which is clearly proposal specific.

Answer 6: The advisory committee will be disease specific. The selected contractors who received TO1 (MPS1) shall “establish an advisory committee with expertise in clinical treatment of MPS1 disease.” See Attachment 3b of the RFP. The selected contractors that received TO2 (Core function activities) shall “assist in the establishment and coordination of an advisory committee.” See Attachment 3c of the RFP.

Question 7: Would the Government please confirm that the below requested documents are only applicable to the prime submission and are not required of proposed subcontractors? The prime Contractor maintains a federally approved purchasing system and will perform appropriate due diligence to ensure proposed subcontractors are responsible and capable of performing under Federal contracts.

-Breakdown of Proposed Estimated Costs -Other Administrative Data -Annual Financial Report

Answer 7: The Annual Financial Report is only required of the prime contractor. Please see Proposed Subcontracts required documentation on page 97 of the RFP.

Question 8: Does NIH consider the data collected to be the property of NIH? We could only give access to coded or aggregate data that has been stripped of patient identifiers.

Answer 8: Patient related data is not property of the NIH. It is understood that the contractor would only be able to give access to coded or aggregate data that has been stripped of patient identifiers. Please see Deliverables.

Question 9: On page 4 it is stated that the Contract does not include what would be research under HHS protection of human subjects regulations. But there are numerous sections that reference research. Which of these sections apply (e.g., Article 24.

Sharing Research Data)? Is this work in any way considered to be research?

Answer 9: The data sharing research requirement does not apply to this RFP, therefore, it has been removed. The statement of work for this RFP is not considered human subjects research. The requirements of the contract will not extend beyond the scope of what a state or entity would do to add any new condition to the state newborn screening panel and does not include what would be considered "research" under the HHS protection of human subjects regulations, 45 CFR Part 46.

Question 10: In the instructions for Task Order 1 (MPS-1 Pilot), Item #4 on page 2 states that the Contractor needs to provide a variety of platforms. Can a single platform (e.g., MS/MS, microfluidics) be proposed? Can contract funds be used to purchase or lease the platform(s)?

Answer 10: Yes, a single platform may be proposed. Regarding contract funds to be used to purchase or lease the platforms, this will be addressed during negotiations.

Question 11: In the instructions for Task Order 1 (MPS-1 Pilot), Item #5 on page 2 states that consent forms must be developed. If the projects are not considered to be research and an IDE is not being used, why is this necessary?

Answer 11: This will be required on an as needed basis by each individual state based on their regulations.

Question 12: In the instructions for Task Order 1 (MPS-1 Pilot), Item #10 on page 5 states that the Contractor must ensure that the technology satisfies the requirements of the FDA. We plan to assume that the microfluidics platform will be FDA approved shortly and can be used for this purpose. It is, however, highly likely that some of the assays used for other disorders will be LDTs. If during the contract period the FDA says that all LDT must be submitted to the FDA for approval/clearance, how will this affect the contract?

Answer 12: Based on the current regulations, an LDT (Laboratory Developed Test) is allowed. At this time, all offerors must follow current HHS rules and regulations.

Question 13: It seems there are 3 parts to this application - an overarching application to be part of the pool of NBS programs that will conduct pilot studies and then the two specific task orders. For the overarching piece, we cannot see that there would be specific funds tied to this and hence would not require a business proposal. We see the funds being more directly tied to the two task orders. Does that make sense or should we be looking at this differently?

Answer 13: The IDIQ is the mechanism for establishing the pool whereby the work will be done through individual task orders. The IDIQ contract will not have funds associated with it; therefore, it does not require a business proposal. (The IDIQ does require a technical proposal.) Each task order will have appropriated funds associate with it.

Question 14: For an individual task order, may the offeror propose to validate and compare two different newborn screening technologies for a single disorder?

Answer 14: The requirements of the contract will not extend beyond the scope of what a state or entity would do. Therefore, each offeror should propose according to their individual state regulations.

Question 15: According to amendment #1 and attachment #1, Task Order #1 requires two cost estimates. In addition, a cost estimate is needed for Task Order #2.

Should we complete an excel Spreadsheet of the Breakdown of Proposed Estimated Costs for each of the above with a spreadsheet consolidating the costs for the entire proposal?

Answer 15: Offerors must submit separate individual Excel Spreadsheets of the Breakdown of Proposed Estimated Costs for task order TO1 and TO2, but not a consolidated cost for the entire proposal.

Question 16: Article B.3. PROVISIONS APPLICABLE TO DIRECT COSTS (p. 5) As this Solicitation invokes IT Security Requirements, including the submission of an IT- SC&A (IT System Certification & Accreditation); what percentage of total funding amount would be considered reasonable for the implementation, maintenance and initial attainment of those IT Security Requirements?

Answer 16: Percentage of total funding will depend on the size, complexity, and security categorization of the system(s) involved.

Question 17: Does NIH-NICHD expect / accept that these funds may be bundled with the “Research” portion of the funding, or are costs / expenses directly attributable to IT Security requirements to be line itemed in the response to the solicitation?

Answer 17: The initial IT security requirements will be funded via the first issued task order (TO1 or TO2).

Question 18: ARTICLE C.2. REPORTING REQUIREMENTS, b. Other Reports/Deliverables, 2. Information Security and Physical Access Reporting Requirements, e. IT Security Certification and Accreditation (IT-SC&A) (p. 10-11)

Based on experience with similar systems of this complexity and composition, would NIH-NICHD consider extending the deadline for the IT-SC&A submission from three (3) months to five (5) months, in order to provide suitable time to remediate / mitigate vulnerabilities and other security issues found during the initial Risk Assessment prior to submitting the initial IT-SC&A, as this will greatly reduce the number of outstanding Action Items (POAMs) and greatly reduce the number of outstanding IT Security related items which must be subsequently tracked to closure?

Answer 18: Once the contract is awarded, a teleconference may be held between the NICHD Information Systems Security Officer (ISSO), Contract Officer, and Contractor, to determine if adjustments to the required deadlines are needed.

Question 19: ARTICLE H.17. INFORMATION AND PHYSICAL ACCESS SECURITY, B. Standard for Security Configurations, HHSAR 352.239-70 (p. 28), f. The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf), Homeland Security Presidential Directive12 (HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart 4.13, Personal Identity Verification.

According to the positions rating of [X] Level 1: Non-Sensitive (p.26) criteria, does the requirement for card readers on all purchased servers, desktops, and laptops still apply?

Answer 19: HSPD-12 card reader requirements are independent of the sensitivity of each position. HSPD-12 requirements do apply.