RFP-NIAID-DMID-NIHAI2013178__-_Amendment_1.pdf

RFP-NIAID-DMID-NIHAI2013178

Amendment #1

“PHASE 1 CLINICAL TRIAL UNIT FOR THERAPEUTICS AGAINST

INFECTIOUS DISEASES”

Amendment Issue Date: January 22, 2014

Proposal Due Date/Time:

March 5, 2014 at 3:00 P.M., local time [Unchanged]

Issued By: Aileene Mitchell Ford Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY:

lucasca@niaid.nih.gov Chase A. Lucas, Contract Specialist Phone: 301-402-0461

SECONDARY:

aileene.mitchellford@nih.gov Aileene Mitchell Ford, Contracting Officer Phone: 301-496-7288

Offerors must acknowledge receipt of this Amendment on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS NOT been extended.

This amendment is to revise: ARTICLE H.4. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV, 3rd paragraph

The Contractor is the Sponsor, therefore the "Responsible Party" for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov (http://www.ClinicalTrials.gov).

Is revised to read.

The Government is the Sponsor, therefore the "Responsible Party" for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov (http://www.ClinicalTrials.gov).

RFP-NIAID-DMID-NIHAI2013178 Page 1 of 4 Amendment 1 (01/22/14) mailto:lucasca@niaid.nih.gov mailto:aileene.mitchellford@nih.gov http://www.clinicaltrials.gov/ http://www.clinicaltrials.gov/

THIS AMENDMENT ALSO PROVDIES CLARIFICATION TO VARIOUS QUESTIONS AND

COMMENTS

# RFP

Reference

RFP

Page

Question /Comment

Attachment 3 and 9

3 of and

Question: Please provide clarification for the uniform cost assumptions for the “Annual Phase I Unit meeting”:

1. Is this an all-day meeting?

2. Hosted at an NIH facility within the Washington DC Metropolitan area?

3. How many Contractor participants?

Answer:

1. This is an all-day meeting.

2. At the Contractor’s Facility.

3. 20 Participants

3 SOW , E.

Clinical Trial Analysis, Close-out, and Final Clinical Trial Reporting

9 of

Comment: Please clarify if the SDCC is an additional repository for data or if they will be responsible to the CDISC SDTM statistician for data analysis. In item 1)b), it is not clear if the SDCC will deliver CDISC compliant data sets (TLGs) to the CRO to conduct the data analysis performed by biostatisticians. Further, in item 2)c), it is not clear what the SDCC's role is in collaboration for the final study report. We are trying to clarify and understand the deliverable exchanges in and out of the DMID SDCC and assure requirements are met.

Answer: The SDCC is the clinical trial data repository and is responsible for conducting protocol data analysis and any subsequent post hoc analysis.

Article H.4 Technical Proposal

Comment: These two sections are inconsistent with respect to who is considered the “responsible party”. Please clarify this and confirm that the responsibilities of the “responsible party” are limited to registering the clinical trial.

Answer: For clarification, Page 22 discusses FDAAA compliance and Page 84 discusses Reporting Trial results. See the revision to page 22

4 SDCC

Comment: Please clarify if the SDCC will deliver the data for analysis to the protocol team (equivalent of DBL/CDISC compliant data).

Answer: The protocol team will have access to data, stored at the SDCC, to meet this requirement.

5, Task

Order A-1

All

Question: What is the Period of Performance for Task Order A-1? Is it only 1 year (12/1/2014-11/30/15), 7 years (12/1/2014-11/30/2021), or 10 years (12/1/2014-11/30/2024)?

Answer: The Period of Performance for Task Order A-1 is for 12 months and is anticipated to be issued once per year.

RFP-NIAID-DMID-NIHAI2013178 Page 2 of 4

8, Section 2.C

5 of

Comment: Offerors are instructed to develop a technical response to Task Orders B-2 and B-3 that demonstrates plans and procedures for carrying out specific tasks and functions in the TO SOW. The Offeror is then instructed to respond to 15 specific items that, in most instances, do not match the TO SOW requirements. Are offerors to respond to the TO SOW items and THEN respond to the 15 individual elements or should we respond to the SOW elements within the context of the 15 items?

Answer: Offerors should follow the instructions already contained in Attachment 8 as it pertains to their technical proposal. Furthermore, in the same paragraph that you cited, the Solicitation states the following: As appropriate for Sample Task Orders B-2 and B-3, and for the general Technical Requirements specified in the Statement of Work for Task Area B, describe plans and procedures for the following:

FAR 52.216-22.d. states, “Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after Nov 30, 2024”.

Question: Does this clause apply to Orders issued under both Task Areas A and B? If so, is the Offeror expected to provide a cost proposal for Task Order A-1 covering the possible entire 10 year period of performance through November 30, 2024?

Answer: Yes, this clause applies. Yes, the Offeror is expected to provide a cost proposal for Task Order A-1 covering the possible entire 10 year period of performance through November 30, 2024.

9 And Attachment 3, Paragraph H

Attachment 9, (p 2 of 4) Section 4.2)c.14. states, “For clinical trial insurance/self insurance a minimum aggregate limit of two (2) million dollar policy for no-fault research-related injury is required. No other insurance cost will be supported.”

Question: Please clarify that the cost of Clinical Trial Insurance shall be an allowable direct cost under the contract.

Answer: The cost of Clinical Trial Insurance is an allowable direct cost

ARTICLE

H.18

HHSAR

352.239-70, (January 2010)

27-28

ARTICLE H.18.B. Standard for Security Configurations HHSAR 352.239-70, (January 2010), paragraph a. includes the following note (emphasis added):

“Note: FDCC is applicable to all computing systems using Windows XPTM and Windows VistaTM, including desktops and laptops - regardless of function

- but not including servers.”

The above note does not mirror the latest NIST policy which provides recommended security baselines for Information Technology products widely deployed across agencies (http://usgcb.nist.gov/usgcb_faq.html#usgcbfaq_usgcbfdcc). The current guidance indicates that the United States Government Configuration Baseline (USGCB) settings have been replaced with the Federal Desktop Core Configuration (FDCC) settings. Specifically, "the platforms addressed by USGCB are Microsoft's Windows 7, Windows 7 Firewall, Windows Vista, RFP-NIAID-DMID-NIHAI2013178 Page 3 of 4

Windows Vista Firewall, Windows XP, Windows XP Firewall, Internet Explorer 7, Internet Explorer 8, and Red Hat Enterprise Linux 5. Additional platforms may be introduced at the TIS' direction. New platforms will follow the USGCB process as defined in SP800-70 Revision 2."

Comment: Please confirm that a Contractor will be expected to follow the latest directives and policies, regardless of what is stated in HHSAR 352.239-70 (January 2010).

Answer: Follow the requirements stated in ARTICLE H.18.B. Standard for Security Configurations HHSAR 352.239-70. Offerors have the option to implement the (USGCB) settings.

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