Amendment 5- SF 30 NCS Vanguard 2 0.pdf

OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 4

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

05 (five) See block 16C, below N/A N/A

6. ISSUED BY CODE N/A 7. ADMINISTERED BY (If other than Item 6)

CODE N/A

National Institutes of Health The Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch, Office of Acquisitions 6100 Executive Blvd., Room 7A-07, MSC 7510 Bethesda, MD 20892-7510

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) () 9A. AMENDMENT OF SOLICITATION NO.

TO ALL PROSPECTIVE OFFERORS

NIH-NICHD-NCS-2012-14

9B. DATED (SEE ITEM 11)

May 17, 2012

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

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 one (1) copy of the amendment; (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 DATA 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 data 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: (Specify authority) 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).

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

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copy to the issuing office.

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

PURPOSE: To amend RFP NIH-NICHD-NCS-2012-14 and to provide responses to questions received regarding this

RFP.

See the amendment continuation pages.

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 (Type or print)

Fred Ettehadieh Contracting Officer, OA,NICHD, NIH, DHHS

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY __________________/S/_____________________

(Signature of Contracting Officer)

06/16/2012

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

RFP NIH-NICHD-NCS-2012-14

Amendment No. 05 (five) CONTINUATION PAGES

Solicitation PART III-LIST OF DOCUMENTS, EXHIBITS AND OTHE ATTACHMENTS, Section J-List of Attachments is amended as follows:

Attachment 3, Statement of Work and Reporting Requirements and Deliverables – IDIQ Contract, Paragraph II, Technical Requirements, is amended as follows:

Page 3, subparagraph 3 is amended to delete the third sentence. Therefore, subparagraph 3 is amended to read as follows:

A multi-faceted ROC structure shall be required in order to provide the breadth and depth of expertise, services, facilities and other resources necessary for efficient and successful study planning and implementation. The Contractor shall possess the capabilities to perform program management functional components internally, including identification, recruitment and training of field staff and long-term tracking and follow-up of participants.

Page 13, Section 3.1.1, Staffing, paragraph 3 is amended to delete the fourth sentence. Therefore, paragraph 3 is amended to read as follows:

The Project Director, Study Coordinator/Project Manager(s) and Information Management Systems Implementation and Support are key personnel. The Contractor shall provide experienced and highly skilled field staff with demonstrable ability to establish personal rapport with potential participants, gain cooperation, and convert refusals. Field staff shall also be facile with the use of technologies for data capture. Contractors shall demonstrate organizational ability and experience in recruiting, training and managing national field data collection operations.

Attachment 6, Targeted/Planned Enrollment Table, PHS-398/2590 is deleted.

The following Attachments are renumbered as a result of the above change:

Technical Proposal Attachments:

Attachment 7: Technical Proposal Cost Summary is renumbered to read Attachment 6.

Attachment 8: Summary of Related Activities is renumbered to read Attachment 7.

Attachment 9: Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310) is renumbered to read Attachment 8.

Business Proposal Attachments:

Attachment 10: Proposal Summary and Data Record, NIH-2043 is renumbered to read Attachment 9.

Attachment 11: Small Business Subcontracting Plan is renumbered to read Attachment 10.

Attachment 12: Offeror’s Points of Contact is renumbered to read Attachment 11.

Attachment 13: Disclosure of Lobbying Activities, OMB Form SF-LLL is renumbered to read Attachment 12.

Attachment 14: Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet is renumbered to read Attachment 13.

Information Attachments:

Attachment 15: Invoice/Financing Request Instructions-CR-NIH(RC)-1 is renumbered to read Attachment 14.

Attachment 16: Financial Report of Individual Project/Contract NIH 2706 is renumbered to read Attachment 15.

Attachment 17: Instructions for Completing Form NIH 2706 is renumbered to read Attachment 16.

Attachment 18: Privacy Act System of Records is renumbered to read Attachment 17.

Attachment 19: Research Patient Care Costs, NIH(RC)-11 is renumbered to read Attachment 18.

Attachment 20: Inclusion Enrollment Report is renumbered to read Attachment 19.

Attachment 21: Government Property Schedule is renumbered to read Attachment 20.

Attachment 22: Commitment to Protect Non-Public Information Contractor Agreement is renumbered to read Attachment 21.

Attachment 23: Roster of Employees Requiring Suitability Investigations is renumbered to read Attachment 22.

Attachment 24: Employee Separation Checklist is renumbered to read Attachment 23.

Attachment 25: Contract Performance Reports (EVM) is renumbered to read Attachment 24.

Attachment 26: Conference Expense Offset Worksheets is renumbered to read Attachment 25.

Responses to Questions Received Regarding this RFP

(Numbering format continued as it appears on Amendment No. four (04))

1. Contractual Questions

1.23 Question: Attachment 3, IDIQ Deliverables and Reporting Requirements, page 5, specified the delivery schedule for NCS Security Plan, Assessment, and Related Documentation as “8 weeks after effective contract date and 7 business days after update”. However, Section C, page 9, says “In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty (30) days after contract award.” There is the same issue under Task Order #1 delivery schedule (Attachment 3, Task Order No. 1, page 7). Which schedule should we use?

Response: Acknowledgment that a security plan is in process is required within 30 days. Full completed plan is expected within 8 weeks.

1.24 Question: The RFP states that the contracted Regional Operations Center (ROC) be compliant with HSPD-12 / FIPS 201 which includes the implementation of a Personal Identity Verification (PIV) card to access HHS systems and/or contracted systems. Is the ROC going to be responsible for implementation and management of the PIV cards and system?

Response: Yes, ROC will be responsible for implementing an HSPD-12 compliant system.

1.25 Question: Does the PIV system need to be operational at the time of RFP award or will a certain period of time be allowed to integrate PIV?

Response: 60 days will be allowed for integration.

1.26 Question: PIV typically applies to federated systems managed by the government – will there be expectations to integrate into the NICHD PIV and/or greater HHS PIV systems?

Response: No integration into NICDH, National Institute of Health (NIH) or Department of Health and Human Services (HHS) is required.

1.27 Question: The RFP states that all ROC personnel and any associated Study Center assigned must undergo a Position of Public Trust that would require all the personnel to undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI). This must go through the Office Management Personnel and is issued by the government. Is NICHD going to allow to onboard staff prior to an MBI and/or LBI being completed, with the understanding that they have completed an e-Quip submission and they can start pending final outcome?

Response: Yes, Staff will be allowed to onboard pending final outcome.

1.28 Question: How will NICHD handle back-log submissions for an MBI and/or LBI?

Response: Government will prioritize the MBI and/LBI in accordance with the Government’s requirements.

1.29 Question: Will the ROC be responsible for assigning a Facility Security Officer to liaison and coordinate e-Quip submissions with the government?

Response: Yes

1.30 Question: Will the government perform background checks (as stated on page 32 and 91) or will the contractor perform those (Attachment 3 page 2, item 2.1.1.)?

Response: The contractor will perform those activities.

4. Information Management Systems (IMS)

4.13 Question: In support of all FISMA requirements, will the ROC be expected to handle all related security certification and accreditation for participating study centers and subcontractors? If so, will the ROC be responsible for anticipating study center needs and provide a general approach to manage multiple NICHD tenants including DUA validations, ATO validation, Continuous Monitoring, etc.?

Response: The Prime contractor is responsible for handling all related security certification and accreditation for participating study centers and subcontractors. The National Children’s Study mission assurance team will provide assistance with all related security certification and accreditation for participating study centers and subcontractors.

4.14 Question: Is it expected that the ROC be responsible for achieving a General Support System

(GSS) certification and accreditation to support the major information system when special management attention is required?

Response: Certification and accreditation is required for the systems that are used as defined by the contract.

4.15 Question: The RFP requires the Contractor to be responsible for all configurations to information technology (IT) that is used to process information on behalf of Department of Health and Human Services (HHS).

4.15a. Question: Does this include all components, including those for the local NCS locations?

Response: Configuration responsibility is only required for those within the scope of your contract responsibility.

4.15b. Question: How are acquisitions to be handled and updated to other study location’s security plans?

Response: Security plan updates are only required for those locations within the boundaries of your contract responsibility.

4.15c. Question: Is it expected that the Contractor must provide real time monitoring through a Security Information and Event Management (SIEM) solution/tool for all those IT components?

Response: A SEIM solution for real time monitoring is not required. The real time monitoring solution is expected to be in line with the scope of the contract and data that needs protecting.