Amendment_1_RFP_NIAID-DAIDS-NIHAI2015049.pdf

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 1

Amendment No. 1

NIAID-DAIDS-NIHAI2015049

“NIAID/Division of AIDS: Regulatory Support Center”

Solicitation Number: NIAID-DAIDS-NIHAI2015049

Amendment Number: One (1)

Amendment Issue Date: March 14, 2016

Proposal Due Date/Time: Thursday, May 5, 2016 at 3:00 PM, Local Time (Unchanged)

Issued By: Ashley Virts

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY virtsa@mail.nih.gov Ashley Virts, Contracting Officer Phone: 240.669.5154

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 240.669.5152

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of Amendment 1 is to: (1) revise Article C.2. Reporting Requirements; (2) revise Article G.2. Key Personnel; (3) revise Section H – Special Contract Requirements;

(4) revise Article I.3. Additional Contract Clauses; (5) revise Section L – Instructions, Conditions and Notices to Offerors; (6) revise Attachment 3, Performance Work Statement;

(7) revise Attachment 4, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents; (8) revise Attachment 5, Additional Business Proposal

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 2

Instructions and Uniform Cost Assumptions; (9) revise Attachment 6, Quality Assurance Surveillance Plan; and (10) revise Attachment 8, Technical Proposal Cost Information/Summary of Labor and Direct Costs.

As a result of the above, the solicitation is hereby revised as follows:

ARTICLE C.2. REPORTING REQUIREMENTS, is hereby revised as follows:

Paragraph a.1.a. Monthly Progress Report (on page 8 of the solicitation) is hereby deleted in its entirety. As a result, the remaining Technical Progress Reports are renumbered beginning with Quarterly Progress Report as paragraph a.1.a.

Paragraph a.1.a Quarterly Progress Report (formerly paragraph a.1.b, and on page 8 of the solicitation) is hereby revised to update the due date for this Progress Report. Based on the foregoing, the last sentence is hereby revised to read as follows: Reports are due or on before 10 business days following the end of the reporting period.

Paragraph b.3.b. IT Security Plan (IT-SP) is hereby revised to remove the reference to HHSAR 352.239-72, Security Requirements for Federal Information Technology Resources. All other language and requirements that are contained in this paragraph remain unchanged.

Paragraph b.3.c. IT Risk Assessment (IT-RA) is hereby revised to remove the reference to HHSAR 352.239-72, Security Requirements for Federal Information Technology Resources. All other language and requirements that are contained in this paragraph remain unchanged.

Paragraph b.3.d. FIPS 199 Assessment is hereby revised to remove the reference to HHSAR 352.239-72, Security Requirements for Federal Information Technology Resources. All other language and requirements that are contained in this paragraph remain unchanged.

Paragraph b.3.e. IT Security Certification and Accreditation (IT-SC&A) is revised to remove the reference to HHSAR 352.239-72, Security Requirements for Federal Information Technology Resources. All other language and requirements that are contained in this paragraph remain unchanged.

Paragraph b.5. Other Deliverables Required by the Contract and Performance Work Statement (PWS), is hereby revised to update the Delivery Schedule for Items 1, 2, 3, 6 and 19 in the table, and update the title of Item 16 to “Quarterly Progress Reports”, to coincide with paragraph a.1.a. referenced above. Based on the foregoing, the Delivery Schedule for Item 1. Initial Transition Plan (Draft) is revised to read as follows: Within 10 business days of the award date of the contract; the Delivery Schedule for Item 2. Initial Transition Plan

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 3

(Final) is revised to read as follows: Upon approval by the COR/CO, implement plan within 60 calendar days of the effective date of the contract; the Delivery Schedule for Item 3.

Annual Utilization Report is revised to read as follows: Due on/before the 28th day of the month following each anniversary date of the contract; the Delivery Schedule for Item 6.

COR-approved Project Management Plan is revised to read as follows: Within 7 calendar days of receipt of COR comments, but no later than 60 calendar days of the effective date of the contract; the Deliverable (title) for Item 16. is changed from Quarterly Summary Status Reports to Quarterly Progress Reports; and the Delivery Schedule for Item 19. Final Transition Plan (Draft) is revised to read as follows: No later than 6 months prior to the completion date of the contract.

Paragraph c. Report Submission is hereby revised to update the Deliverable Item Nos.

required for the Contracting Officer and the COR as follows:

Addressee Deliverable Item No. Number of Copies Contracting Officer (CO)

OA, DEA, NIAID, NIH, DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821 a.1.a - a.1.d, b.1 – b.4, and b.5 (items 1 – 3; 16;

18 - 21)

1 electronic copy of each report

Contracting Officer’s Representative (COR) CRRB, OPCRO, Division of AIDS

NIAID, NIH, DHHS

5601 Fishers Lane, Room XXXX, MSC XXXX Bethesda, Maryland 20892-XXXX Email Address: TBD upon award a.1a. - a.1.d, b.2 – b.4, and b.5 (items 1 - 21)

1 electronic copy of each report

ARTICLE G.2., KEY PERSONNEL, HHSAR 352.242-70 (January 2006), is hereby revised to replace the HHSAR clause reference with HHSAR 352.237-75 (December 2015), and shall read as follows:

ARTICLE G.2., KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 4

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title To be specified prior to award

SECTION H – SPECIAL CONTRACT REQUIREMENTS, is hereby revised as follows:

ARTICLE H.3. NEEDLE DISTRIBUTION, is hereby deleted in its entirety.

ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH,

is hereby deleted in its entirety.

ARTICLE H.12. INFORMATION AND PHYSICAL ACCESS SECURITY, is hereby revised as follows:

Paragraph B. Standard for Security Configurations, is revised to remove the reference to HHSAR 352.239-70, (January 2010). All other language and requirements that are contained in this paragraph remain unchanged.

Paragraph C. Standard for Encryption Language, is revised to remove the reference to HHSAR 352-239-71, (January 2010). All other language and requirements that are contained in this paragraph remain unchanged.

Paragraph D. Security Requirements for Federal Information Technology Resources, is revised to remove the reference to HHSAR 352-239-72, (January 2010). All other language and requirements that are contained in this paragraph remain unchanged.

Paragraph E. Additional NIH Requirements, is revised remove the reference to HHSAR 352-239-72, (January 2010). All other language and requirements that are contained in this paragraph remain unchanged.

ARTICLE H.13. ELECTRONIC AND INFORMATION TECHNOLOGY

ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010) is hereby revised to replace the HHSAR clause reference with the most updated version, HHSAR 352.239-73 (December 2015), and shall read as follows:

ARTICLE H.13. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY,

HHSAR 352.239-73 (December 2015)

a. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 5

electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

b. Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508 . The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and standards/communications-and-it/about-the-section-508-standards .

c. The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility. In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document--in detail--whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://www.hhs.gov/web/508 . In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

d. Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

The "HHS Section 508 Product Assessment Template" is included in SECTION J - List of Attachments, of this solicitation.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 6

ARTICLE I.3., ADDITIONAL CONTRACT CLAUSES, paragraph b., item 1. HHSAR Clause 352.231-70, Salary Rate Limitation (August 2012), is hereby revised to update the clause and to read as follows:

HHSAR Clause 352.231-70, Salary Rate Limitation (December 2015)

Note: The Salary Rate Limitation is at the Executive Level II Rate.

See the following website for Executive Schedule rates of pay:

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ .

(For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

ARTICLE I.3., ADDITIONAL CONTRACT CLAUSES, paragraph b., item 2. HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences and Seminars to Persons with Disabilities (January 2001), is hereby deleted.

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, is revised as follows:

Paragraph 1. General Instructions, item e. Performance Based Acquisition (on page 51 of the solicitation), is revised to update the attachment number reference for the Quality Assurance Surveillance Plan (QASP), in the last sentence of the third paragraph, from Attachment 7 to Attachment 6.

Paragraph 2. Instructions to Offerors, subparagraph a. General Instructions, is revised as follows:

Item 13. Past Performance Information, sub-item a. (on page 58 of the solicitation) is hereby revised to update the dollar threshold cited for a “major subcontract”, from $650,000 to $700,000. All other language and requirements that are contained in this sub-item remain unchanged.

Item 14. Information and Physical Access Security, sub-item B. Standard for Security Configurations (on page 60 of the solicitation), is hereby revised to remove the reference to HHSAR 352.239-70, (January 2010). All other language and requirements that are contained in this sub-item remain unchanged.

Item 14. Information and Physical Access Security, sub-item C. Standard for Encryption language (on page 61 of the solicitation), is hereby revised to remove the reference to

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 7

HHSAR 352.239-71, (January 2010). All other language and requirements that are contained in this sub-item remain unchanged.

Item 14. Information and Physical Access Security, sub-item D. Security Requirements for Federal Information Technology Resources (on page 62 of the solicitation), is hereby revised to remove the reference to HHSAR 352.239-72, (January 2010). All other language and requirements that are contained in this sub-item remain unchanged.

Item 14. Information and Physical Access Security, sub-item E. Additional NIH Requirements (on page 65 of the solicitation), is hereby revised remove the reference to HHSAR 352-239-72, (January 2010). All other language and requirements that are contained in this sub-item remain unchanged.

Paragraph 2. Instructions to Offerors, subparagraph b. Technical Proposal Instructions, item 4. Electronic and Information Technology Accessibility, Section 508 Compliance (on pages 71-72 of the solicitation), is revised to reflect the reference and associated requirements of the updated clause (December 2015), and to read as follows:

Electronic and Information Technology Accessibility Notice, HHSAR 352.239‐73 (December 2015)

a. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

b. Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508 . The complete text of the Section 508 Final Provisions can be accessed at http://www.access‐ board.gov/guidelines‐and standards/communications‐and‐it/about‐the‐ section‐508‐standards.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 8

c. The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239‐74, Electronic and Information Technology Accessibility. In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self‐evaluate their supplies and document‐‐in detail‐‐whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues.

Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://www.hhs.gov/web/508 . In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

d. Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

The "HHS Section 508 Product Assessment Template" is included in SECTION J ‐ List of Attachments, of this solicitation.

Paragraph 2. Instructions to Offerors, subparagraph c. Business Proposal Instructions, item 5. Salary Rate Limitation in Fiscal Year 2016 (on pages 75-76 of the solicitation), is revised to remove reference to the Fiscal Year and Public Law, and shall read as follows:

Salary Rate Limitation

Offerors are advised that no NIH funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 9

of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Contractor.

This does not preclude the offeror from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The Executive Schedule, Level II* annual salary rate limitation also applies to individuals proposed under subcontracts and to consultants. LINK TO EXECUTIVE SCHEDULE RATES OF PAY:

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/

(For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

*Note to Offerors: The current Fiscal Year Executive Level II Salary Rate shall be adhered to in the preparation of your proposal. All costs associated with any resultant contract award shall be in compliance with the current Fiscal Year Executive Level II Salary rates.

Attachment 3, Performance Work Statement, is revised as follows:

Paragraph 3)O.1. (on page 9 of the attachment) is revised to correct a typo in the due date for this deliverable and shall read as follows:

Provide for overall management, integration and coordination of all contract and subcontract activities, project management and communications, tracking, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines; per a COR-approved Project Management Plan which should be implemented within 7 calendar days of receipt of COR comments, but no later than 60 calendar days of contract effective date.

Paragraph Q.1.b. (on page 10 of the attachment) is revised to correct a typo in the due date for this deliverable and shall read as follows:

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015049 10

Within ten (10) business days of the award date of the contract, the Contractor shall develop and submit to the COR and Contracting Officer for review and approval, a Draft Initial Transition Plan to ensure full assumption of all contract responsibilities and functions no later than sixty (60) calendar days following the contract effective date. The Draft Initial Transition Plan shall include the transition activities to be undertaken, timelines for the completion of each transition activity, and Contractor staff to be assigned and their roles and responsibilities. This plan shall include the acceptance and integration of all paper and electronic files and databases, the training and QA/QC plans, SOPs and all software and hardware used by the incumbent contractor.

Paragraph Q.1.c. (on page 10 of the attachment) is revised to correct a typo in the due date for this deliverable and shall read as follows:

Implement and complete the transition, per the COR and Contracting Officer approved Initial Transition Plan, no later than sixty (60) calendar days following the effective date of the contract.

Attachment 4, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, Section 3: Technical Plan/Approach, is revised to correct a typo in the numbering of the main level paragraphs for this section. Paragraph 0) General Requirements (PWS Section A) [on page 2 of the attachment] and paragraph 1) IND and other Regulatory Support (PWS Section B) [on page 3 of the attachment] are renumbered as paragraph 1) General Requirements (PWS Section A), and paragraph 2) IND and other Regulatory Support (PWS Section B), respectively.

Attachment 5, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3, paragraph 5) Government Furnished Property, is revised to correct the number of the referenced attachment, from Attachment 8 to Attachment 7.

Attachment 6, Quality Assurance Surveillance Plan, page 8, is revised to correct a typo in the second paragraph in the first row of the column entitled “Incentives” and shall read as follows:

If >90% of the students achieve a score or 80% or higher on the government approved exam for a training session conducted in an evaluation period, the contractor shall receive allowable costs incurred, base fee up to 6% of the available Award Fee Pool per Tables 5-1.

Attachment 8, Technical Proposal Cost Information/Summary of Labor and Direct Costs, is revised to correct a typo in the attachment title, so that it reads properly as: Technical Proposal Cost Information/Summary of Labor and Direct Costs.

END OF AMENDMENT NO. 1, RFP No. NIAID-DAIDS-NIHAI2015049