RFP 75N95023R00013 - Amendment 1.pdf

RFP 75N95023R00013 Amendment 1

Request for Proposal No.: 75N95023R00013

Title: Na�onal Ins�tute on Aging Clinical Research Support Services - CRSS

RFP Response due Date: 12 NOON Eastern on March 27, 2023 (changed)

Amendment No.: 1

Date of Issuance: 03/09/2023

Number of Pages: Thirteen (13) pages

Point of Contact:

Iris Merscher, Contracting Officer E-mail: iris.merscher@nih.gov

ISSUING OFFICE OF ACQUISITIONS

National Institute on Drug Abuse (NIDA) on behalf of the National Institute on Aging (NIA)

PURPOSE OF SOLICITATION AMENDMENT No. 1

The purpose of this amendment is to:

1) Revise Proposal Response Date

2) Revise Page Limita�on

3) Revise Travel Assump�ons – Addi�onal Business Proposal Instruc�ons

4) Revise position sensitivity designation levels

5) Revise Past Performance Evalua�on

6) Revise Technical Evalua�on Factors

7) Respond to Ques�ons received regarding the solicita�on

THE HOUR AND DATE SPECIFIED FOR RECEIPT OF OFFERS HAVE CHANGED.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full effect.

mailto:iris.merscher@nih.gov

1) PROPOSAL RESPONSE DUE DATE – RFP PAGE 1

The Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of Offers are changed to 12 NOON Eastern on March 27, 2023. Any offeror submi�ng a proposal MUST acknowledge receipt of this amendment on the face page of the proposal.

2) PAGE LIMITATION – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS – ATTACHMENT 5

Page limitation - Additional Technical Proposal Instructions (Attachment 5) page 1 - has been revised. Revisions are provided as underlined bold text.

The page limita�on of 25-pages applies to the technical response to the IDIQ SOW. The page limita�on of 10-pages is hereby incorporated and applicable to the technical response to the TO1 SOW. As a result, the technical proposal total page limita�on is changed from 25 to 35 pages.

The page limita�on for past performance is also changed from 5 to 10 pages.

3) TRAVEL - BUSINESS PROPOSAL INSTRUCTIONS – ATTACHMENT 6

Travel information - Additional Business Proposal Instructions (Attachment 6) page 2 - has been revised. Revisions are provided as underlined bold text.

Travel is not anticipated for the initial Order Base Period of the Task Order One. It is anticipated that travel will be required when onsite clinical monitoring and/or site visits are needed. The offeror should assume 12 site visits of 3 days each under Task Order One.

4) POSITION SENSITIVITY DESIGNATIONS – RFP PAGES 6, 25, 63

The posi�on sensi�vity designa�on has been revised. The revision is related to the RFP Pages 6, 25, and 63. The sensi�vity designa�on shall read Tier 2S as shown below:

POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). To determine the designation, the Position Designation Tool (PDT) discussion is found at:

https://www.ors.od.nih.gov/ser/dpsac/resources/Pages/investigation-requirements-for-your-position.aspx and the link to access the tool is found at: https://pdt.nbis.mil/.

The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Tier 5: Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility.

[ ] Tier 5SR: Reinvestigation.

[ ] Tier 4: High Risk Public Trust (HRPT).

[ ] Tier 4SR: Reinvestigation.

[ ] Tier 3: Non-Critical Sensitive, National Security, including Secret and "L" access eligibility.

[ ] Tier 3SR: Reinvestigation.

[X] Tier 2S with Subject Interview: Moderate Risk Public Trust (MRPT).

[ ] Tier 2SR: Reinvestigation.

[ ] Tier 1: Low Risk, Non-Sensitive, including HSPD-12 Credentialing.

5) PAST PERFORMANCE EVALUATION – RFP PAGE 87

Addi�onal language is hereby incorporated (bold) to the past performance evalua�on (RFP page 87). The past performance factor evalua�on shall read as follows:

6. PAST PERFORMANCE FACTOR

Offeror's past performance informa�on will be evaluated subsequent to the technical evalua�on.

However, this evalua�on will not be conducted on any offeror whose proposal is determined to be technically unacceptable.

The evalua�on will be based on informa�on obtained from references provided by the offeror, other relevant past performance informa�on obtained from other sources known to the Government, and any informa�on supplied by the offeror concerning problems encountered on the iden�fied contracts and correc�ve ac�on taken.

The government will assess the rela�ve risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisi�on requirements as indicated by that offeror’s record of past performance.

The assessment of performance risk is not intended to be a product of a mechanical or mathema�cal analysis of an offeror's performance on a list of contracts but rather the product of subjec�ve judgment by the Government a�er it considers relevant informa�on.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisi�on requirements, such as the offeror's record of performing according to specifica�ons, including standards of good workmanship; the offeror's record of controlling and forecas�ng costs; the offeror’s adherence to contract schedules, including the administra�ve aspects of performance; the offeror's reputa�on for reasonable and coopera�ve behavior and commitment to customer sa�sfac�on; and generally, the offeror’s business-like concern for the interest of the customer.

The Government will consider the currency and relevance of the informa�on, source of the informa�on, context of the data, and general trends in the offeror's performance.

The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.

Small Business U�liza�on: If the Offeror is Other than Small Business, the Government will consider the demonstrated approach to maximize small business subcontrac�ng par�cipa�on in the management and execu�on of clinical research management projects similar in nature, size, and complexity.

6) TECHNICAL EVALUATION FACTORS – RFP PAGES 85-86

The Technical Evalua�on Factors (RFP page 85-86) has been revised to remove small business evalua�on. As a result, the related language in the Atachment 5 has been removed (crossed out).

The evalua�on criterion No. 3 (RFP page 86) shall read as follows:

3. ORGANIZATIONAL EXPERIENCE (25)

Demonstrated organizational experience and expertise with the technical and research support areas described in the SOW on tasks of similar size, scope, and complexity in previous contract efforts, including but not limited to participant safety, data integrity (DSMBs/OSMBs, SOs, safety reporting, etc.), regulatory compliance, biostatistics, and recruitment and retention of under-represented populations.

Demonstrated understanding, knowledge, and experience in administrative, regulatory, logistic, and statistical support of clinical research portfolios within NIH.

Demonstrated history of successful completion of projects similar in size, scope, and complexity;

history of producing high-quality reports and other deliverables; history of staying on schedule and within budget.

Demonstrated approach to maximize small business subcontracting participation in the management and execution of clinical research management projects similar in nature, size, and complexity.

7) GENERAL SOLICITATION QUESTIONS/ANSWERS:

Ques�on 1: Atachment 1 – Packing and Delivery of Proposal - Sec�on II, Forma�ng and Page

Limita�ons, pg. 2 of 2. Can the Government please confirm if it would be acceptable to use 9-point font in tables and 8-point font in graphics?

Answer 1: The responses to the RFP and their distribution to the peer review panel will be completed via an electronic platform (eCPS). The font limitation is associated with the software platform. As noted in page 2 of Attachment 1, “Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.”

Ques�on 2: Atachment 3 – Statement of Work. Work Area 3 – Analy�cs Monitoring, pg. 4 of 7. Can the

Government please provide addi�onal guidance on the SOW statement under Work Area 3 Analy�cs Monitoring, bullet number 4, “Provide NIA with digital support for clinical research data management.” Does “digital support” mean data entry and data cura�on support for clinical research data being captured in the CROMS to reduce the burden on Program Officers using CROMS?

Answer 2: The requirement under bullet number 4, Work Area 3 is to request for data management assistance and support, such as data entry and analysis, of data collected via NIA digital platforms (e.g., CROMS) as well as to build digital templates to support clinical research.

Ques�on 3: Atachments, Sec�on b., Travel, Mee�ngs, and Conferences, pg. 2 of 3. Regarding page 2 of Atachment 6, 1. COST ASSSUMPTIONS, b. Travel, Mee�ngs, and Conferences, the RFP notes that travel is not an�cipated for the ini�al order; however, because Task Order 1 is 5 years in length, it is likely that proposed Work Area 5 (Clinical Research Opera�ons and Quality Assurance) personnel would travel to NIA-funded clinical sites for in-person data quality monitoring site visits.

Will the Government please confirm if contractors may include in-person site monitoring visit travel in Task Order 1?

If yes, can the Government provide uniform cost assump�ons for this travel line item? If not, can the Government confirm that future Task Orders will allow for site monitoring visit travel?

Answer 3: The travel assumptions of the Task Order One as noted in the Attachment 6 have been revised. The NIA conducts research at sites across the US. The offeror should assume 12 site visits of 3 days each under Task Order One. The site visits should be assumed to be distributed as follows: 4 visits to sites located on the East coast, 4 visits to sites located on the West coast and 4 visits to sites located on the Mid-West for each of the option years. No travel is anticipated for the base year of the Task Order One. (See revised Attachment 6).

Ques�on 4: Atachments, Sec�on 6, Work Area 2. Should contractors assume DSMB/OSMB mee�ngs will be virtual?

Answer 4: Yes. It is anticipated that DSMB/OSMB meetings will be conducted virtually.

Ques�on 5: RFP, Technical Evalua�on Factors, 3. Organiza�onal Experience, pg. 86. The RFP states, “Demonstrated approach to maximize small business subcontrac�ng par�cipa�on in the management and execu�on of clinical research management projects similar in nature, size, and complexity.” Please confirm that if a prime offeror meets the small business size standard for this opportunity, they will receive full evalua�on points for this proposal evalua�on subfactor since the Small Business Subcontrac�ng Plan does not apply to small businesses?

Answer 5: This section is not applicable to offerors that are small business primes. Please note changes to the RFP mentioned above.

Ques�on 6: Atachment 5 - Addi�onal Technical Proposal Instruc�ons, pg. 1 of 4. Can the Government increase the page limit for Past Performance to 10 pages?

Answer 6: The page requirement for Past Performance has been revised to reflect the total limit of 10 pages. (See revised Attachment 5).

Ques�on 7: Ar�cle H.14.1.1.b.iv - Safeguarding Informa�on and Informa�on Systems. (p.21) states that the contractor should “Report any discovered or unan�cipated threats or hazards by either the agency or contractor, or if exis�ng safeguards have ceased to func�on immediately a�er discovery, within one (1) hour or less, to the Government representa�ve(s).”

Ar�cle H.14.1.4.a - Incident Response (p.24): “The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/NIH IRT teams within 24 hours” Ar�cle H.14.1.4.b.iii - Incident Response (p.24): “Report all suspected and confirmed informa�on security and privacy incidents and breaches to the OpDiv Incident Response Team (IRT) via email at IRT@mail.nih.gov, COR, CO, OpDiv SOP (or his or her designee), and other stakeholders, including breaches involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour”.

Please confirm if the Government is willing to modify the one (1) hour no�fica�on and response requirements to a 24-hour requirement?

Answer 7: This is HHS and NIH Policy and part of requirements, and no authorization exist to accept deviations. Therefore, there is no modification to this requirement.

Ques�on 8: Ar�cle H.14.3.1.d Desktops, Laptops, and Other Compu�ng Devices Required for Use by the Contractor (p.28) outlines several configura�on standards for COCO systems.

Please confirm of the Government is willing to accept equivalent industry-accepted encryp�on standards, such as Bitlocker and Oracle TDE, and CIS configura�on/hardening, as applicable.

Answer 8: This requirement is based on the vendor using their information systems to process the required tasks that involve government data. If the vendor does provide their own equipment and information systems, specific encryption requirements vary depending on the system in question. For example, Bitlocker is acceptable on a Windows device, but not applicable on an Apple (MacOS) device. Oracle TDE can be implemented in compliance with FIPS 140-2 requirements, and CIS Configuration baselines, if implemented fully do meet some NIH hardening requirements. It is recommended that the prospective vendor outline their approach to meeting the requirements in the SOW.

Question 9: Article H.32.3.1.d.v H.14.3.1.d.v Desktops, Laptops, and Other Computing Devices Required for Use by the Contractor- (p. 28) requires the contractor to “Configuring its systems to allow for periodic HHS vulnerability and security configuration assessment scanning.”

Please confirm if the Government is willing to accept modification of this requirement to allow the Contractor to conduct/provide scans without requiring granting external access for vulnerability assessment/scanning to HHS?

See also C.2.c.g C.2.b.2.C.h – Government Access for Security Assessment (p. 8): “Contractor (and/or any subcontractor) must afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel mailto:IRT@mail.nih.gov used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit”.

See also H.14.3.1.b – Government Access for Security Assessment (p.27): “the Contractor (and/or any subcontractor) shall afford the Government access to the Contractor's … information systems…to the extent required to carry out a program of security assessment (to include vulnerability testing)”

Answer 9: No. As referenced in ARTICLE C (Government Access for Security Assessment), if the contractor's facilities, installations, operations, documentation, information systems, and personnel are used in performance of this contract, then the government is specifically reserving this right “to the extent required”.

Ques�on 10: Please clarify, is the 25-page technical proposal to respond to the IDIQ SOW, or the Task

Order 1 SOW?

Answer 10: The page limitation of 25-pages applies to the technical response to the IDIQ SOW. The page limitation of 10-pages is hereby incorporated and applicable to the technical response to the TO1 SOW. (see revised Attachment 5).

Ques�on 11: For Task Order One, please clarify the role of the contractor’s staff as it relates to atending the stated DSMB mee�ngs (~150 studies requiring a DSMB and 2 mee�ngs/year for each DSMB totaling ~300/year) as well as expecta�ons for services (e.g., note-taking and summary reports). Will a single DSMB be responsible for reviewing mul�ple studies? If so, what is the average number of studies that will be reviewed in one day?

Answer 11: Details of the contractor staff role with regards to expectations for services for DSMB are further described in Task Order One, under the section titled, “Data and Safety Monitoring Board/Observational Study Monitoring Boards (OSMB)/Safety Officers (SOs) activities, operations, support and management”. All attendance will be remote, but it is expected that contractor staff will participate in these meetings.

For most NIA trials, the DSMBs are trial specific and do not review multiple trials.

Ques�on 12: Is it an expecta�on that contractor staff is responsible for inpu�ng trial results into

ClinicalTrials.gov? If so, please provide an average number of studies per year for which this task would be required.

Answer 12: No. Contractor staff will not be inputting data into ClinicalTrials.gov.

Ques�on 13: The SOW includes the following task in Work Area 3: “Provide NIA with digital support for clinical research data management, if needed.” Can NIA clarify what is meant by “digital support”?

Answer 13: Please see the response to Question 2 above.

Ques�on 14: Does NIA intend that the scope of contractor services will include professional Regulatory

Affairs specialists to perform rou�ne document control, submission, and tracking? Will it also include Regulatory strategy consul�ng or Regulatory document genera�on, dra�ing, and version control (i.e., IND, mee�ng requests, briefing packages, etc.)?”

Answer 14: Currently, NIA does not hold any INDs. Therefore, at present, NIA does not envision any need for professional regulatory affairs support, or regulatory document drafting. However, in the future it is possible that NIA staff may need regulatory strategy support.

Ques�on 15: Does NIA intend that the scope of contractor services will include professional Safety

Monitors to perform rou�ne tasks such as Safety Management Plan crea�on and upda�ng, safety document (e.g., DSUR) genera�on and submission, and safety data review? Will it also include Clinical Development strategy consul�ng or key clinical document genera�on, dra�ing, and/or review (i.e., clinical development plans, protocols, safety sec�ons, Inves�gator Brochures, etc.)?

Answer 15: Currently, NIA does not hold any INDs. Therefore, NIA does not submit any documents to the FDA and does not anticipate requiring any assistance with safety monitoring, safety document generation, or safety data review from a Sponsor perspective. NIA does not anticipate requiring Clinical Development strategy consulting or key clinical document generation, drafting, and/or review.

NIA collects Adverse Events including Serious Adverse Events per NIH policy as well as AEs and SAE listings in preparation for DSMB meetings which contractor staff will be assisting NIA staff with.

NIA staff do have the responsibility to provide some oversight of NIA-supported trials and may need support for this clinical research oversight, such as determining reportability, etc.

of AE/SAE to the appropriate authorities, etc.

Ques�on 16: For Work Area 3, will the contractor have access to raw CROMS data? Is there a querying tool by which data may be retrieved by the contractor?

Answer 16: Yes. This access will be granted upon completion of contractor staff clearances (including

NDAs).

Ques�on 17: Atachment 3, Statement of Work-IDIQ (Atach. 3-p. 4) “Provide NIA with digital support for clinical research data management, if needed”. What does “digital support” mean in this context?

Answer 17: Please see the response to Question 2 above.

Ques�on 18: RFP SECTION A - SOLICITATION/CONTRACT FORM. (RFP page1). Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Atachment 1, "Packaging and Delivery of the Proposal," un�l 5:00PM local �me on March 20, 2023. Will the Government extend the proposal submission �me to April 3rd?

Answer 18: The hour and date specified for receipt of proposals have been changed to: 12 NOON Eastern on March 27, 2023.

Ques�on 19: Atachment 1- II. FORMATTING AND PAGE LIMITATIONS (Pg. 2 of 2): Font size must be 10 to 12 points. Will the government allow for the cover text to be larger than 12-point font?

Answer 19: Please see the response to Question 1 above.

Ques�on 20: Atachments Page 18. SECTION 2: STAFFING PLAN AND PERSONNEL QUALIFICATIONS: Can the government confirm what labor category for key personnel “Project Manager – Administrator” is aligned to as referenced in the table on page 21?

Answer 20: The number of FTEs, and suggested labor categories are for informational purposes.

Proposers can offer their own recommendations of effort and mix of labor.

Ques�on 21: Atachments Page 21. SECTION 2: STAFFING PLAN AND PERSONNEL QUALIFICATIONS: Does the government require a resume submited for each labor category as specified in the table on page 21?

Answer 21: Please submit resumes for the proposed Key Personnel - IDIQ and Task Order 1 (see RFP page 71 for additional resume requirements).

Ques�on 22: Atachments Page 21. BUSINESS PROPOSAL INSTRUCTIONS: As space is limited, would the

Government please consider removing Business Proposal Instruc�ons Atachment 6 - Proposed cost and/or price; profit or fee (as applicable); and total. This informa�on will be contained within the body of our Business Proposal instead.

Answer 22: No. In addition, there is no page limitation associated with the Business Proposal.

Ques�on 23: RFP Page 1. Would it be possible to extend the proposal submission deadline?

Answer 23: The hour and date specified for receipt of proposals have been changed to: 12 NOON Eastern on March 27, 2023.

Ques�on 24: Atachment 5- Addi�onal Technical Proposal Instruc�ons, Page 3. Please clarify whether a resume/Curriculum Vitae is required for each proposed staff member, or it is only required for proposed key personnel?

Answer 24: Please see the response to Question 21 above.

Ques�on 25: Atachment 3- Statement of Work – SOW – IDIQ, Page 4. If there is any in-person DSMB mee�ngs, will the contractor need to provide travel reimbursement support for atendees of in person DSMB mee�ngs?

Answer 25: It is anticipated that DSMB/OSMB meetings will be conducted virtually. Please see the response to Question 4 above.

Ques�on 26: RFP Page 62 and Atachment 5 - Addi�onal Technical Proposal Instruc�ons, Page 1. “Past

Performance: A list of the last 5 contracts completed during the past Five years and ALL CONTRACTS currently being performed that are similar in nature to the solicita�on work scope.” There is a 5 pages limit for the past performance sec�on, can the page limit for past performance be removed or limit the number of contracts to be provided in this sec�on?

Answer 26: The page requirement for Past Performance has been revised to reflect the total limit of 10 pages. Attachment 5 has been revised.

Ques�on 27: Atachment 3- SOW–IDIQ, page 5; Atachment 7- SOW-Task Order 1, page 5. “Provide NIA with digital support for clinical research data management”. Please clarify what is meant by "provide digital support for clinical research management"?

Answer 27: Please see the answer to Question 2 above.

Ques�on 28: Atachment 7- Statement of Work – Task Order 1 page 2. “The es�mated number of studies requiring a DSMB are: ~150 with 2 mee�ngs/year for each DSMB and es�mated number of studies requiring a safety officer are: ~200.” The RFP states ~ 200 studies with SO. Is that 200 studies with SO only, or does the 200 include SOs associated with a DSMB as well as standalone SO?

Answer 28: Yes, NIA anticipates ~200 studies with only a Safety Officer.

Ques�on 29: RFP Page 70, Personnel. “Describe the experience and qualifica�ons of personnel who will be assigned for direct work on this program. Informa�on is required which will show the composi�on of the task or work group, its general qualifica�ons, and recent experience with similar equipment or programs. Special men�on shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total �me each will be available for this program.”

Is this a requirement for resumes from all personnel who will be assigned for direct work on this program?

Answer 29: Please see the answer to Question 21 above.

Ques�on 30: Is Atachment 12, VPAT, required for any deliverables under this RFP? If so, please specify?

Answer 30: All information and communications technology (ICT), such as hardware, desktop software, web applications, mobile content, electronic documents, or other are required to accessible to anyone with a disability. Therefore, all deliverables must comply with 508 requirements.

Ques�on 31: RFP, Sec�on I.1, Contract Clauses, pg. 39. The lis�ng of FAR and HHSAR clauses is missing from Sec�on I.1. Will the Government please provide a list of the an�cipated FAR and HHSAR clauses that will be included in the contract for offerors to review prior to proposal submission?

Answer 31: As stated in Article I.1 of the solicitation, the general clauses for a cost-reimbursement research and development contract will apply to this requirement.

https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors The general clauses are listed below:

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT

CONTRACT

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically as follows: FAR Clauses at:

htp://www.acquisi�on.gov/far/ . HHSAR Clauses at:

htp://www.hhs.gov/policies/hhsar/subpart352.html .

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR

CLAUSE NO.

DATE TITLE

52.202-1 Jun 2020 Definitions (Over the Simplified Acquisition Threshold) 52.203-3 Apr 1984 Gratuities (Over the Simplified Acquisition Threshold) 52.203-5 May 2014 Covenant Against Contingent Fees (Over the Simplified Acquisition

Threshold) 52.203-6 Nov 2021 Restrictions on Subcontractor Sales to the Government (Over the

Simplified Acquisition Threshold) 52.203-7 Jun 2020 Anti-Kickback Procedures (Over $150,000) 52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper

Activity (Over the Simplified Acquisition Threshold) 52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity (Over the

Simplified Acquisition Threshold) 52.203-12 Jun 2020 Limitation on Payments to Influence Certain Federal Transactions (Over

$150,000)) 52.203-17 Jun 2020 Contractor Employee Whistleblower Rights and Requirements to

Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)

52.203-19 Jan 2017 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (Over the Simplified Acquisition Threshold)

52.204-10 Jun 2020 Reporting Executive Compensation and First-Tier Subcontract Awards 52.204-13 Oct 2018 System for Award Management Maintenance 52.204-25 Aug 2020 Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment 52.209-6 Nov 2021 Protecting the Government's Interest When Subcontracting With

Contractors Debarred, Suspended, or Proposed for Debarment 52.215-2 Jun 2020 Audit and Records - Negotiation 52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format 52.215-10 Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data (Over

$750,000) 52.215-12 Aug 2020 Subcontractor Certified Cost or Pricing Data 52.215-14 Nov 2021 Integrity of Unit Prices (Over the Simplified Acquisition Threshold) 52.215-15 Oct 2010 Pension Adjustments and Asset Reversions (Over $750,000) 52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions 52.215-19 Oct 1997 Notification of Ownership Changes http://www.acquisition.gov/far/ http://www.acquisition.gov/far/ http://www.hhs.gov/policies/hhsar/subpart352.html http://www.hhs.gov/policies/hhsar/subpart352.html

FAR

CLAUSE NO.

DATE TITLE

52.215-21 Nov 2021 Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications

52.215-23 Jun 2020 Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold)

52.216-7 Aug 2018 Allowable Cost and Payment 52.216-8 Jun 2011 Fixed Fee 52.219-8 Oct 2022 Utilization of Small Business Concerns (Over the Simplified Acquisition

Threshold) 52.219-9 Oct 2022 Small Business Subcontracting Plan (Over $750,000, $1.5 million for

Construction) 52.219-14 Oct 2022 Limitations on Subcontracting 52.219-16 Sep 2021 Liquidated Damages - Subcontracting Plan (Over $750,000, $1.5 million for Construction) 52.222-2 Jul 1990 Payment for Overtime Premium (Over the Simplified Acquisition

Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)

52.222-3 Jun 2003 Convict Labor 52.222-21 Apr 2015 Prohibition of Segregated Facilities 52.222-26 Sep 2016 Equal Opportunity 52.222-35 Jun 2020 Equal Opportunity for Veterans ($150,000 or more) 52.222-36 Jun 2020 Equal Opportunity for Workers with Disabilities 52.222-37 Jun 2020 Employment Reports on Veterans ($150,000 or more) 52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor Relations Act

(Over the Simplified Acquisition Threshold) 52.222-50 Nov 2021 Combating Trafficking in Persons 52.222-54 May 2022 Employment Eligibility Verification (Over $150,000) 52.223-6 May 2001 Drug-Free Workplace 52.223-18 Jun 2020 Encouraging Contractor Policies to Ban Text Messaging While Driving 52.225-1 Nov 2021 Buy American - Supplies 52.225-13 Feb 2021 Restrictions on Certain Foreign Purchases 52.227-1 Dec 2007 Authorization and Consent, Alternate I (Apr 1984) 52.227-2 Jun 2020 Notice and Assistance Regarding Patent and Copyright Infringement 52.227-11 May 2014 Patent Rights - Ownership by the Contractor (Note: In accordance with

FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.

52.227-14 May 2014 Rights in Data - General 52.232-9 Apr 1984 Limitation on Withholding of Payments 52.232-17 May 2014 Interest (Over the Simplified Acquisition Threshold) 52.232-20 Apr 1984 Limitation of Cost 52.232-23 May 2014 Assignment of Claims 52.232-25 Jul 2013 Prompt Payment, Alternate I (Feb 2002) 52.232-33 Oct 2018 Payment by Electronic Funds Transfer--System for Award Management 52.232-39 Jun 2013 Unenforceability of Unauthorized Obligations 52.233-1 May 2014 Disputes

FAR

CLAUSE NO.

DATE TITLE

52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985) 52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim 52.242-1 Apr 1984 Notice of Intent to Disallow Costs 52.242-3 Dec 2022 Penalties for Unallowable Costs (Over $800,000) 52.242-4 Jan 1997 Certification of Final Indirect Costs 52.242-13 Jul 1995 Bankruptcy (Over the Simplified Acquisition Threshold) 52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate V (Apr 1984) 52.244-2 Oct 2010 Subcontracts (Over the Simplified Acquisition Threshold), Alternate I

(June 2007) 52.244-5 Dec 1996 Competition in Subcontracting (Over the Simplified Acquisition

Threshold) 52.244-6 Dec 2022 Subcontracts for Commercial Products and Commercial Services 52.245-1 Jan 2017 Government Property 52.245-9 Apr 2012 Use and Charges 52.246-23 Feb 1997 Limitation of Liability (Over the Simplified Acquisition Threshold) 52.249-6 May 2004 Termination (Cost-Reimbursement) 52.249-14 Apr 1984 Excusable Delays 52.253-1 Jan 1991 Computer Generated Forms

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR

CHAPTER 3) CLAUSES:

HHSAR

CLAUSE NO.

DATE TITLE

352.203-70 Dec 2015 Anti-Lobbying 352.222-70 Dec 2015 Contractor Cooperation in Equal Employment Opportunity

Investigations 352.227-70 Dec 2015 Publications and Publicity 352.233-71 Dec 2015 Litigation and Claims 352.237-75 Dec 2015 Key Personnel

[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT- Rev. 2/2023].

End of Amendment 1

RFP 75N95023R00013 NIA Clinical Research Support Services - CRSS

Additional Technical Proposal Instructions - TPI Attachment # 05 February 2023 – rev. March 2023 Page 1 of 4

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

These additional Technical Proposal instructions reflect the requirements of the Request for Proposal (RFP). While Section L. of the RFP provides general Technical Proposal instructions, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used along with Section L. to prepare the Technical Proposal. Offerors are advised to carefully consider the Statement of Work (SOW) including any supplementary material, Technical Evaluation Criteria, and the RFP in the development of their proposals.

The Offeror’s proposal, including appendices, shall include a detailed table of contents, be formatted by sections, and be cross-referenced to the Technical Evaluation Criteria. Refer to the Attachment labeled “Packaging and Delivery of Proposals” for complete instructions on proposal submission.

The Offeror shall submit a detailed plan indicating how each aspect of the SOW is to be accomplished.

• The Technical Proposal shall include information on how the project is to be organized, staffed, and managed.

• Information should be provided to demonstrate the understanding of management of time frames for planning and accomplishing the work.

• The Technical Proposal shall be in as much detail as necessary to explain the proposed methods and rationale and should reflect a clear understanding of the nature of the work as described in the SOW.

• The Technical Proposal shall include unique arrangements, facilities, equipment, or other factors that the Offeror deems advantageous to the project.

SPECIFIC TECHNICAL PROPOSAL EVALUATION CRITERIA INSTRUCTIONS

PAGE LIMIT: Twenty-five (25) Thirty-five (35) pages for the Technical Proposal Part II (excluding Cover page, Executive Summary, Table of Contents, Demonstration of Compliance with Section 508, Appendices, and Curriculum Vitae/Resumes).

The below table shows the page limits to which offerors’ submissions must adhere.

Volume Section Page limit

Part I Proposal Title Page/Transmittal/Cover Letter 2 Executive Summary 2

Part II SECTION 1: Technical Approach and Management SECTION 2: Staffing Plan and Personnel Qualifications SECTION 3: Organizational Experience

25 = IDIQ

10 = TO1

Part III Past Performance 5 10

February 2023 – rev. March 2023 Page 2 of 4

PART I: COVER PAGES AND TABLE OF CONTENTS

PROPOSAL TITLE PAGE/TRANSMITTAL/COVER LETTER.

TABLE OF CONTENTS. Include a Table of Contents with indicated pages of proposal sections that at a minimum uses the Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion. Review table above for page limits.

PART II: TECHNICAL EVALUATION CRITERIA

Each Offeror should address the items below in the Technical Proposal. These items are cross-referenced to the appropriate Technical Evaluation Criteria, which should be used as guidance as to how proposals will be evaluated. Review table above for page limits.

SECTION 1: TECHNICAL APPROACH AND MANAGEMENT (See TEC #1)

• Offerors shall demonstrate understanding of the SOW and describe in detail the needs of NIA with respect to the SOW and how the Offeror’s organization would address them. Offerors shall leverage their knowledge from providing solutions for similar requirements, including those with NIH, in demonstrating their technical approach. The proposals that simply parrot back the SOW, without providing sufficient detail and explanation, will not be considered to meet the requirement.

• The Offerors shall provide a sufficient and detailed plan on how they will successfully perform each Work Area in the SOW, including overall strategy, methodologies, analyses, technologies, and services specific to NIH. Proposals that simply parrot back the SOW, without providing sufficient detail and explanation, will not be considered to meet the requirement.

• Provide an example of problem(s) encountered and solutions identified during the management of a contract of similar purpose, scope, size, and complexity.

• As part of your management plan, demonstrate the ability to communicate, coordinate, and function as a coherent team as well as with subcontractors, consultants and in interactions with the Government, other contractors, other researchers, and the public.

• Describe procedures for competition, selection, and oversight of any proposed subcontractors/consultants. Clearly define how any proposed arrangements would meet program needs. Discuss how subcontractor/consultant arrangements will be structured, organized, managed, and monitored.

• Describe the approach to quality control, quality assurance, and review of performance to optimize the delivery of the desired services within the negotiated schedule and budget and minimize performance risk factors.

February 2023 – rev. March 2023 Page 3 of 4

SECTION 2: STAFFING PLAN AND PERSONNEL QUALIFICATIONS (See TEC #2)

• Provide a staffing plan which details the mix of labor and level of effort required to accomplish the work and include an organizational chart indicating clear lines of authority, staff responsibilities, and a plan for organizational backup. The organizational chart should indicate key personnel and job titles for other staff/positions.

• For persons listed in the organizational chart, provide a table that documents individual training, education, experience, qualifications, and/or expertise and indicate which Work Area(s) each person will support.

• Provide a Resume/Curriculum Vitae (no more than 3 pages for each proposed staff) to document relevant training, experience, expertise, and competency including selected references for publications relevant to the scope of the project.

• Describe a recruitment and retention plan for personnel, particularly addressing those designated as key personnel.

• Key Personnel:

• Include the names for the following two key personnel:

• Project Director – Technical

The Project Director should have an advanced degree of at least a Masters, with a doctoral degree preferred, in a scientific field related to the activities described in the SOW or a combination of education and training. The proposed Project Director should have at least five years of relevant experience.

• Project Manager – Administrator The Project Manager should have an advanced degree of at least a Masters in a business profession, or the equivalent of a Project Management certification. The proposed Project Manager should have at least five years of relevant experience.

• For each key personnel:

• Describe the duties and the proposed effort and availability to the project.

• Describe the education, training, qualifications, experience, and prior accomplishments that demonstrate administrative, and management of large projects relevant and similar in scope, successfully completed on-time and within or under budget. The qualifications and experience should be described in terms of experience with clinical research, including any with NIH.

• Demonstrated ability and experience leading a cohesive team of employees, subcontractors, and consultants on projects similar in scope and complexity.

February 2023 – rev. March 2023 Page 4 of 4

SECTION 3: ORGANIZATIONAL EXPERIENCE (See TEC #3)

• Demonstrate understanding, knowledge, and relevant technical experience in support of clinical research portfolios for each specific Work Area described in the SOW. If offerors have relevant experience with NIH requirements, include details on these requirements as well.

• Discuss recent prior experience (within the last five years) in conducting projects that are similar in scope, size, and complexity to the requirements outlined in the Statement of Work. Provide a brief synopsis of each project and explain how it relates to the activities required in the SOW.

Identify areas where there is no work experience.

• Provide a brief synopsis of each project where small business subcontracting participation was utilized. Describe your approach to maximize subcontracting opportunities with small businesses for this SOW.

• Demonstrate experience in the management and execution of clinical research management projects similar in nature, size, and complexity.

Additional Business Proposal Instructions Attachment # 06 February 2023 – rev. March 2023 Page 1 of 3

ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

These additional Business Proposal instructions reflect the requirements of the Request for Proposal (RFP). While Section L. of the RFP provides general Business Proposal instructions, these instructions are tailored to the specific requirements of the RFP and provide uniform cost assumptions and business clarifications.

The business proposal shall be submitted as a separate volume from the technical proposal. The following information should be used to assist offerors in preparing the business proposal.

The Government anticipates awarding one Indefinite Delivery/Indefinite Quantity (ID/IQ) contract with a 5-years ordering period, for this requirement. It is anticipated that multiple cost reimbursement task orders will be issued during the 5-year ordering period.

Offerors shall submit a business proposal which adequately addresses all required aspects of the solicitation. Offerors should note that with award of the ID/IQ contract, the Government intends to concurrently award the Task Order One: OCR Project Management, DSMB and CROMS-related Support, which is associated with the Work Areas No. 1-6 of the IDIQ Statement of Work. The Statement of Work and the Deliverables of the Task Order One are incorporated to this solicitation.

The award of both the ID/IQ contract and the Task Order One will be made using the information provided in response to this solicitation. Cost information shall be provided in accordance with the information below. Separate costing for the ID/IQ is not required.

Although no page limit has been placed on the business proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

TASK ORDER ONE: OCR Project Management, DSMB and CROMS-related Support The Offeror shall submit cost information for the Task Order One activities as they are described in the Order SOW. The Task Order One shall be structured as a cost-plus fixed fee and shall consist of one (1) base year plus four (4) optional years to extend the task for a total possible performance period of five (5) years. Provide a detailed breakdown of costs for each year of the task, including a summary chart of all years.

1. COST ASSUMPTIONS

To estimate the total effort and costs for the Task Order One, Offerors are to anticipate a start date of December 8, 2023, and shall use the following information to develop costs for each year of the Task:

a. Labor – The Government's estimate for the work set forth in the Task Order SOW is 104 full time equivalents (FTEs) across five years. The table below provides general guidance to assist offerors

February 2023 – rev. March 2023 Page 2 of 3 in understanding the level of effort anticipated for this Task. The number of FTEs is for informational purposes and is not meant to be restrictive. Offerors may propose a different level of effort and mix of labor than those provided here.

b. Travel, Meetings, and Conferences – travel is not anticipated for the initial Order Base Period.

However, It is anticipated that travel will be required under Orders when onsite clinical monitoring and/or site visits are needed. Other travel and meeting costs may be proposed based on management of subcontracts and other task activities.

The NIA conducts research at sites across the US. The offeror should assume 12 site visits of 3 days each under Task Order One. The site visits should be assumed to be distributed as follows:

4 visits to sites located on the East coast, 4 visits to sites located on the West coast and 4 visits to sites located on the Mid-West for each of the option years.

c. Government Furnished Equipment – it is anticipated that the Government will provide a small number of laptops with VPN capability for the Contractor’s use, as needed. All other equipment shall be the responsibility of the Contractor.

Software and licenses: The Government will provide access and licenses to any government-specific software and/or applications that cannot otherwise be obtained commercially. The contractor will be responsible for obtaining and maintaining all necessary licenses and access to commercially available software.

February 2023 – rev. March 2023 Page 3 of 3

2. BUSINESS PROPOSAL FORMAT

Refer to Business Proposal Instructions, Section L of this solicitation. The Instructions contain the requirements for proper submission of cost/price data which must be adhered to. This format should be used as a guideline. It may require amending to meet the specific requirements of this solicitation.

This format must be used to submit the breakdown of all proposed estimated cost elements. List each cost element for direct costs, indirect costs, and fee, if applicable. In addition, provide detailed calculations for all items. For example:

• For all personnel, list the name, title, rate per hour and number of hours proposed. If a pool of personnel is proposed, list the composition of the pool and how the cost proposed was calculated.

List the factor used for prorating Year One and the escalation rate applied between years.

• For all materials, supplies, and other direct costs, list all unit prices, etc., to detail how the calculations were made.

• For all indirect costs, list the rates applied and the base the rate is applied to.

• For any subcontract proposed, submit a separate breakdown format.

• Justification for the need of some cost elements may be listed as an attachment, i.e., special equipment, above average consultant fees, etc.

• If the Government has provided "uniform pricing assumptions" for this solicitation, the offeror should identify each item. If a deviation from the uniform cost assumption is made, identify the deviation, and provide an explanation.

An electronic spreadsheet titled “Breakdown of Proposed Estimated Costs” is available to assist you in the preparation of your business proposal. It is in EXCEL format and has instructions for use and submission.

Use of this spreadsheet is optional but recommended. The electronic version of the spreadsheet can also be found here:

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_Dec2012.xlsx

IMPORTANT NOTE: Save this file on your computer before opening, otherwise, you will be prompted for a username and a password, and you will lose all the data you may have inserted.

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT