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Attached to: Genetics of Alzheimer's Disease and Related Dementias in Latin America
Solicitation number: NIDA-RFP-75N95022R00035
Issued by: Department of Health and Human Services National Institutes of Health National Institute on Aging

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File	Type	Posted
NIDA-RFP-75N95022R00035-Questions and Answers.pdf	PDF	Jul 7, 2022
Attachment 1 - Packaging and Delivery of Proposals Revised.pdf	PDF	Jun 30, 2022
NIDA-RFP-75N95022R00035.pdf	PDF	Jun 23, 2022

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ATTACHMENT 1 PACKAGING AND DELIVERY OF PROPOSAL

June 22, 2022 Page 1 of 2

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with [Contract specialist must select either: FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition or HHSAR 352.215-70, Late Proposals and Revisions (December 18, 2015)].

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

ATTACHMENT 1 PACKAGING AND DELIVERY OF PROPOSAL

June 22, 2022 Page 2 of 2

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS: [Contract specialist must include Section II if page limitations will be used. Otherwise, Section II may be deleted].

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed ____ pages. [Contract specialist must specify a page limit].

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not exceed ____ pages. [Contract specialist may specify a page limit].

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

pg. 1 April 2022

STATEMENT OF WORK

Genetics of Alzheimer's Disease and Related Dementias in Latin America

1. INTRODUCTION AND BACKGROUND

The prevalence and incidence of dementia appears to be stable or declining in the United States, whereas Latin American countries have seen increased dementia prevalence.

This places an unprecedented burden on patients, families, and health systems. The challenges prove particularly pressing for conditions with highly specific diagnostic and management demands, such as frontotemporal dementia (FTD).

Genetic factors seem to drive dementia presentation in Latin American countries, with stronger familial aggregation of dementia compared to the US. The region has some of the largest populations of familial dementia disorders, and some populations may harbor unique genetic factors that confer greater risk of dementia. Large consortia have assessed genetic susceptibility mostly in high income countries, but other regions, including Latin American countries still remain understudied. The recent development of polygenic risk scores (PRS) to identify individuals at risk for dementia in developed countries is very promising, but they lack validation in more heterogeneous samples, as in Latin America.

The Multi-partner consortium to expand dementia research in Latin America (ReDLat) aims to identify the unique genetic factors that drive Alzheimer’s and Dementia (AD) and FTD presentation in Latin American countries relative to the US. To this end, they are establishing a cohort across ten clinical sites in multiple Latin American countries, totaling over 4,000 participants, including controls, AD patients, and FTD patients, led by world-renowned leaders in dementia research. The contractor that is awarded this contract will be integral in the coordination of efforts across the different sites and serve as a centralized hub for coordinating patient recruitment, biospecimen collection, and genetic analyses of patient data across these sites. Along with the contractor and the larger ReDLat network, the National Institute on Aging (NIA) Center for Alzheimer’s and Related Dementias (CARD) will investigate whether there are unique risk factors for AD and FTD in Latin American countries, compared to US populations. ReDLat will recruit large numbers of controls and patients across these diverse populations to provide opportunities to identify new genetic risks for AD and FTD.

First, the Contractor shall determine the genetic substructure and familial contributions to AD and FTD in Latin American countries. This will advance efforts to treat AD and FTD

Attachment 2

pg. 2 April 2022 in patients with rare mutations. Second, by assembling this large cohort, the Contractor shall work to establish a preliminary Latin American countries-specific polygenic risk score (PRS) for predicting AD and FTD risk in future samples.

2. SCOPE AND REQUIREMENTS

In the performance of the Tasks specified, the Contractor shall be responsible for properly protecting all information used, gathered, or developed as a result of the Statement of Work (SOW). The Contractor shall establish and implement appropriate administrative, technical, and physical safeguards to ensure the security and confidentiality of sensitive data, including personal protected identification.

To achieve our aim, the Contractor shall:

- Provide standardized protocols for study implementation, volunteer recruitment, eligibility criteria, informed consent, volunteer tracking, neuropsychological testing, family history, phlebotomy, and specimen shipment across the ten clinical sites.

- Coordinate collection of patient blood or DNA samples from the ten clinical research sites in Latin America. Samples will be stored at the clinical sites after collection. The Contractor will then coordinate shipment of the stored patient samples from the sites to CARD.

- Monitor patient recruitment at each of the ten clinical sites and provide patient recruitment numbers to the Government in quarterly reports.

- Identify case and control samples based on evidence of neurodegenerative diseases or lack thereof. A standardized diagnostic assessment shall be completed for each participant by the physician and entered directly into the REDCap database maintained by the Contractor.

- Coordinate shipment of patient DNA or blood samples to NIA/CARD for genetic analyses (whole genome sequencing and array genotyping, long-read sequencing on a subset of samples).

- Perform computational analyses on the raw genotyping and sequencing data for polygenic risk score (PRS), principal component analysis (PCA), case-control studies, genotype and sequence data calling, and basis quality control to ensure data quality and integrity, with consultation and oversight provided by the Government in bi-weekly virtual meetings and on an ad-hoc basis through email communications. The Government will also advise on platform-based results communication, visualization, and dissemination, once sequencing and genotyping results have been analyzed.

- Provide the analyzed data in electronic form and associated summary reports as specified under “Reporting Requirements and Deliverables”, in order to support derived analyses and publications.

pg. 3 April 2022

3. WORK TO BE PERFORMED

Independently, and not as an agent of the US Government, the Contractor shall provide all necessary personnel, facilities, supplies and services (except for those to be furnished by the US Government as specified elsewhere in this contract) to perform the work required by this contract.

A. Recruitment of Subjects and Staff

The Contractor shall coordinate with the ten clinical sites in Latin America to develop a plan to recruit subjects for an established cohort, including subjects identified by local physicians as patients warranting further investigation for dementia. Strategies for recruiting controls may include relatives of the index case or outreach to the community. The Contractor will also develop a staff plan for these efforts, including identifying staff to carry out the tasks outlined in this Statement of Work.

B. Informed consent

The Contractor shall be responsible for coordinating with the ten clinical sites in Latin America to ensure that each site obtains appropriate ethical approvals. The Contractor shall coordinate with the sites to identify, recruit, and obtain informed consent for eligible volunteers. The informed consent forms include language required for sharing of genomic data.

C. Tasks

The Contractor shall coordinate and report on the below tasks, which will be carried out by the ten local sites through subcontracted work:

1. Site coordination: The Contractor shall provide standard operating procedures for the ten clinical sites, as obtained through ethical approvals.

The sites may not modify the protocols without first obtaining an ethical approval amendment, and it is necessary to protect the health and welfare of study participants. The Contractor shall also provide data and/or specimen disposition guidelines to the sites and obtain updated enrollment reports on activities on a quarterly basis. The Contractor shall also coordinate monthly conference calls with the sites to monitor progress and provide support, as needed.

pg. 4 April 2022

2. Recruitment: The Contractor shall identify and recruit up to 1000 patients (cases and controls) each year through data from primary and secondary care clinical records, direct recruitment from primary care health workers at the local clinical sites, outreach to persons in geographic proximity to clinical sites, and unrelated persons from the index case’s social environment. The Contractor shall also provide inclusion and exclusion criteria to the sites for consistent patient recruitment efforts across the sites. Inclusion criteria will include patients with clinical diagnosis of mild/moderate AD or FTDs using standard care approaches by the site principal investor. Patients should be within 40-80 years of age and have minimum fluency in English, Spanish, or Portuguese, visual and auditory ability for cognitive testing judged by the site investigators, availability of a partner (informant) who has frequent contact with the participant, and capability of providing informed consent.

Healthy control participants will be similar in age-, sex- and education with patients but will have a Clinical Dementia Rating (CDR) of 0 and Mini-Mental State Exam (MMSE) > 25. The Contractor will also provide guidelines for follow up study visits, tracking and monitoring enrollment, and replacing lost participants.

3. Clinical Assessment: The Contractor shall determine and communicate the standardized diagnostic assessment for each participant. Essential components at enrollment include the Diagnostic Criteria, Inclusion/Exclusion Criteria, Demographics, COVID-19 questionnaire, age of onset, years after diagnosis, Frontotemporal Lobar Degeneration- Modified Clinical Dementia Rating (FTLD-CDR), MMSE, Global Deterioration Scale (GDS), Generalized Anxiety Disorder seven-item scale (GAD-7), Neuropsychiatric Inventory-Questionnaire (NPI-Q), Functional Activities Questionnaire (FAQ), Technology-Activities of Daily Living Questionnaire (T-ADLQ), loneliness scale and basic clinical data. The Contractor shall provide relevant standardized documents to site investigators. These should be obtained from clinical evaluation and entered into the REDCap database maintained by the Contractor.

4. Genealogical history: The Contractor shall provide instruction and guidance to the sites to document the genealogical history of each participant in a standardized way that will be uploaded into the Progeny database at each site. Pedigrees shall be updated every time a patient is evaluated, or a family is visited in an extramural commission. These pedigrees will inform the selection of patient samples for long-read sequencing at CARD.

5. Phlebotomy and sample processing and archiving: The Contractor shall acquire, handle, and store biospecimens according to standardized protocols for sample collection and DNA extraction provided by the

pg. 5 April 2022

Contractor. Sites will be responsible for their own logistics, compliance, and training. Briefly, blood specimens will be drawn and collected in 2-4 K2 EDTA tubes and identified with the sample ID, site ID, and date of collection.

Deoxyriboneucleic acid (DNA) will be extracted as soon as possible and ideally within 2 hours of collection, according to standard procedures outlined by the Contractor using a genomic DNA extraction kit. Sites are responsible for collecting 2-4 tubes per patient for plasma and DNA collection.

6. Shipment: Patient samples shall be sent to CARD/NIA for genotyping and sequencing. On a quarterly basis, one aliquot of isolated DNA per participant shall be delivered on dry ice to CARD for library preparation and sequencing. FedEx labels for these shipments will be provided by the coordinating site. A printed manifest should be included in the shipment and a copy should be emailed to the Government at the time of shipping.

7. Monitoring and reporting: The Contractor shall provide a written quarterly report that includes the number of participants recruited, age and sex distribution by clinical site, and any barriers to successful recruitment. The report should also include the number of controls and diagnosed cases by age, sex, and location.

8. Computational analyses: NIA will return all raw sequencing and genotyping results to the Contractor via secure file transfer. The Contractor shall then coordinate data analysis amongst researchers in the ReDLat network for PRS, PCA, case-control status, genotype and sequence data calling and basic quality control, with consultation and oversight provided by the Government. The Contractor shall then coordinate the upload of analyzed data to the Alzheimer’s Disease Data Initiative (ADDI) Workbench (whole genome sequencing and genotyping data) or Analysis Visualization and Informatics Lab-space (AnVIL) (long-read sequencing data). The Government will also advise on platform-based results communication, visualization, and dissemination, once sequencing and genotyping results have been analyzed and uploaded.

4. ANTICIPATED PERIOD OF PERFORMANCE

It is anticipated that the NIA will award a contract consisting of a base period and three consecutive option years

5. REPORTING REQUIREMENTS AND DELIVERABLES

pg. 6 April 2022

A. Reports

The Contractor shall prepare and submit the following reports as specified below. All reports shall be submitted electronically either as a Word document or PDF file or Excel file, as appropriate.

1. Quarterly reports on the progress of patient recruitment, including recruitment efforts and sources of recruitment, number of cases and controls recruited, number of samples to be sent to NIH, and any factors impeding recruitment.

2. Annual reports of activities during the reporting period. Each annual report shall include a summary of results of the entire contract work for the period covered and the activities planned for the following reporting period. The Annual Report at a minimum shall include:

a. A list of the number of participants recruited incrementally for the year and for the entire project to date. Information on age and gender breakdown shall also be included.

b. A breakdown of any missing or invalid data.

c. An indication of any current problems encountered that may impede progress and corrective actions.

d. A summary discussion of activities planned for the next year.

3. A final report shall be submitted within one month after the contract end date. This report shall include a summation of the work performed and results obtained for the entire contract. This report shall include the tasks accomplished and the results achieved, including a summary of the data. This report shall include:

a. A listing of the number of participants recruited and assessed for the entire project.

b. A list of all traits examined.

c. A breakdown of any missing or invalid data for each of the tasks.

d. A summary of results.

B. Deliverables

The Contractor shall provide up to 1000 patient DNA or blood samples per year in a recruited cohort of AD, FTD, and neurologically healthy control cases across the ten clinical sites in Latin America. The Contractor shall provide the Government with summary reports detailing the total number of patients recruited and samples collected at each of the ten clinical sites on a quarterly basis.

C. Data transfer

The Government will be responsible for the transfer of de-identified raw data to the Contractor. Data shall be transmitted electronically. The Contractor shall provide

pg. 7 April 2022 consultation on related features of manuscript preparation. All data will be de-identified with the key data connecting the participant's personal data to the study ID held by the Contractor in a secure environment.

All de-identified genetic data will be transmitted to the Contractor in updated successive full versions at least every 6 months. The data to be reported will include the coded identity of all participants and corresponding raw results from all test instruments, including sequencing and genotyping data.

6. DATA MANAGEMENT SYSTEM

The Contractor shall use the data management systems developed for the ReDLat study.

These data management systems include the use of a secure server for storage and the Alzheimer’s Disease AD Initiative (ADDI) Workbench to analyze all whole genome sequencing and genotyping data, as well as the National Human Genome Research Institute (NHGRI) Analysis Visualization and Informatics Lab-space (AnVIL) for storage and analysis of long-read sequencing data, which are secure centralized data storage analysis and access control platforms.

In addition, the system shall provide a secure point of access for authorized users only.

It shall store information for each participant, as obtained in accordance with Informed Consent from each participant, as approved by the local Ethics Committee in Latin America and entered in a standard database format. All information in the database shall be de-identified, associated only with an alphanumeric designation for each individual. A coded list relating database entries to particular individuals shall be stored securely and separately from the database, in order for the clinical site to contact participants for visits, accede to requests from participants who wish to withdraw from the study, and record deaths of participants (all in accordance with provisions of the Informed Consent for the study). Under no circumstances shall any information that can associate information with an identifiable individual be available to the NIA or any outside investigator. Database updates for de-identified participants shall be transmitted to the NIA.

7. SECTION 508 REQUIREMENTS

This language is applicable to Statements of Work (SOW) or Performance Work Statements (PWS) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or

pg. 8 April 2022 video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

•36 CFR 1194.21 (all)

References:

Attachment 2 http://www.access-board.gov/ http://www.acquisition.gov/ http://www.section508.gov/

pg. 9 April 2022

1)HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January2005): http://www.hhs.gov/od/Final_Section_508_Policy.html

2)HHS Section 508 Web site: http://508.hhs.gov/

3)HHS ASPA Web Communications Division Web site:

http://www.hhs.gov/web/policies/index.html

4)US General Services Administration (GSA) Section 508 Web site:

http://www.section508.gov/index.cfm

Attachment 2 http://www.hhs.gov/od/Final_Section_508_Policy.html http://508.hhs.gov/ http://www.hhs.gov/web/policies/index.html http://www.section508.gov/index.cfm

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

Update per FAC 2022-06 Last updated: 05/2022

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

52.204-8 Annual Representations and Certifications.

As prescribed in 4.1202(a), insert the following provision:

ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2022)

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is__________________ [insert NAICS code].

(2) The small business size standard is _____________ [insert size standard].

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition—

(i)Is set aside for small business and has a value above the simplified acquisition threshold;

(ii)Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii)Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation.

The Offeror shall indicate which option applies by checking one of the following boxes:

Attachment 3 https://www.acquisition.gov/far/4.1202#FAR_4_1202 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7

(i) □ Paragraph (d) applies.

(ii) □ Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless–

(A) The acquisition is to be made under the simplified acquisition procedures in part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that-

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(vi) 52.204-26, Covered Telecommunications Equipment or Services-Representation.

This provision applies to all solicitations.

Attachment 3 https://www.acquisition.gov/far/52.203-2#FAR_52_203_2 https://www.acquisition.gov/far/part-13#FAR_Part_13 https://www.acquisition.gov/far/52.203-11#FAR_52_203_11 https://www.acquisition.gov/far/52.203-18#FAR_52_203_18 https://www.acquisition.gov/far/52.204-3#FAR_52_204_3 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-5#FAR_52_204_5 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26

(vii) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations- Representation.

(viii) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(ix) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(x) 52.214-14, Place of Performance-Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(xi) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xii) 52.219-1, Small Business Program Representations (Basic, Alternates I, and II).

This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(C) The provision with its Alternate II applies to solicitations that will result in a multiple-award contract with more than one NAICS code assigned.

(xiii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiv) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xvi) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements.

This provision applies to solicitations when it is anticipated the contract award will exceed

Attachment 3 https://www.acquisition.gov/far/52.209-2#FAR_52_209_2 https://www.acquisition.gov/far/52.209-5#FAR_52_209_5 https://www.acquisition.gov/far/52.209-11#FAR_52_209_11 https://www.acquisition.gov/far/52.214-14#FAR_52_214_14 https://www.acquisition.gov/far/52.215-6#FAR_52_215_6 https://www.acquisition.gov/far/52.219-1#FAR_52_219_1 https://www.acquisition.gov/far/52.219-2#FAR_52_219_2 https://www.acquisition.gov/far/52.222-22#FAR_52_222_22 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-25#FAR_52_222_25 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-38#FAR_52_222_38 the simplified acquisition threshold and the contract is not for acquisition of commercial products or commercial services.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals-Representation. This provision applies to solicitations that include the clause at 52.204- 7.)

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate.

(Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(D) If the acquisition value is $92,319 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-Certification. This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certifications. This provision applies to all solicitations.

Attachment 3 https://www.acquisition.gov/far/52.223-1#FAR_52_223_1 https://www.acquisition.gov/far/52.223-2#FAR_52_223_2 https://www.acquisition.gov/far/52.223-4#FAR_52_223_4 https://www.acquisition.gov/far/52.223-22#FAR_52_223_22 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.225-2#FAR_52_225_2 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 https://www.acquisition.gov/far/52.225-4#FAR_52_225_4 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-6#FAR_52_225_6 https://www.acquisition.gov/far/52.225-5#FAR_52_225_5 https://www.acquisition.gov/far/52.225-20#FAR_52_225_20 https://www.acquisition.gov/far/52.225-25#FAR_52_225_25

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.]

__ (i) 52.204-17, Ownership or Control of Offeror.

__ (ii) 52.204-20, Predecessor of Offeror.

__ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

__ (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment- Certification.

__ (v) 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification.

__ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA–Designated Products (Alternate I only).

__ (vii) 52.227-6, Royalty Information.

__ (A) Basic.

__ (B) Alternate I.

__ (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically in SAM website accessed through https://www.sam.gov. After reviewing the SAM information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended

Attachment 3 https://www.acquisition.gov/far/52.226-2#FAR_52_226_2 https://www.acquisition.gov/far/52.204-17#FAR_52_204_17 https://www.acquisition.gov/far/52.204-20#FAR_52_204_20 https://www.acquisition.gov/far/52.222-18#FAR_52_222_18 https://www.acquisition.gov/far/52.222-48#FAR_52_222_48 https://www.acquisition.gov/far/52.222-52#FAR_52_222_52 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 https://www.acquisition.gov/far/52.227-6#FAR_52_227_6 https://www.acquisition.gov/far/52.227-15#FAR_52_227_15 https://www.sam.gov/ https://www.acquisition.gov/far/4.1201#FAR_4_1201 representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause # Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of provision)

Alternate I (SEP 2021). As prescribed in 4.1202(a), substitute the following paragraph (a) for paragraph (a) of the basic provision:

(a)(1) The North American Industry Classification System (NAICS) codes and corresponding size standards for this acquisition are as follows; the categories or portions these NAICS codes are assigned to are specified elsewhere in the solicitation:

SNAICS Code Size standard

[Contracting Officer to insert NAICS codes and size standards].

(2) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce, (i.e., nonmanufacturer), is 500 employees if the acquisition—

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

Attachment 3 https://www.acquisition.gov/far/4.1202#FAR_4_1202

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

Attachment 3

SUMMARY OF RELATED ACTIVITIES

The following specific information must be provided by the offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract.

a. Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each of the key individuals* in this proposal.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*If an individual has no obligation(s), so state.

b. Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals*.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*If no commitment of effort is intended, so state.

c. Provide a statement of the level of effort to be dedicated to any resultant contract awarded to your organization for those individuals designated and cited in this proposal.

Name Title/Position Total Proposed Effort

Summary of Related Activities Page 1 of 1 (1/2011)

Attachment 4

OMB No. 0990-0263 Approved for use through June 30, 2024

Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)

Policy: Research activities involving human subjects may not be conducted or supported by the Departments and Agencies adopting the Common Rule unless the activities are exempt from or approved in accordance with the Common Rule. The “pre-2018 Common Rule (or pre-2018 Requirements)” was originally promulgated in 1991 and amended on June 23, 2005 (70 FR 36325). The “2018 Common Rule (or 2018 Requirements)” was originally published on January 19, 2017 (82 FR 7149) and amended on January 22, 2018 (83 FR 2885) and June 19, 2018 (83 FR 28497). The categories of exempt research are provided in Section 101(b) of the pre-2018 Common Rule and Section 104(d) of the 2018 Common Rule.

The pre-2018 Common Rule requires institutions to certify that each application or proposal for research has been reviewed and approved by an Institutional Review Board (IRB) (Section 103(f)). The 2018 Common Rule requires institutions to certify that each proposed research study has been reviewed and approved by an IRB (Section 103(d)). Institutions must have an assurance of compliance that applies to the research to be conducted and should submit certification of IRB review and approval with each application or proposal, or proposed research study, unless otherwise advised by the Department or Agency.

1. Request Type

[ ] ORIGINAL

[ CONTINUATION

[ ] EXEMPTION

2. Type of Mechanism

[ ] GRANT

[ ] CONTRACT

[ ] FELLOWSHIP

[ ] COOPERATIVE

AGREEMENT

[ ] OTHER:

3. Name of Federal Department or Agency and, if known, Application or Proposal Identification No.

4. Title of Application or Activity 5. Name of Principal Investigator, Program Director, Fellow, or Other

Attachment 5

6. Assurance Status of this Project (Respond to one of the following)

[ ] This Assurance, on file with the Department of Health and Human Services, covers this activity:

Assurance Identification No. , the expiration date IRB Registration No.

[ ] This Assurance, on file with (agency/dept) , covers this activity.

Assurance No. , the expiration date IRB Registration/Identification No. (if applicable)

[ ] No assurance has been filed for this institution. This institution declares that it will provide an Assurance and Certification of IRB review and approval upon request.

[ ] Exemption Status: Human subjects are involved, but this activity qualifies for exemption under the pre-2018 Common Rule, Section 101(b), paragraph .

[ ] Exemption Status: Human subjects are involved, but this activity qualifies for exemption under the 2018 Common Rule, Section 104(d), paragraph

7. Certification of IRB Review (Respond to one of the following IF you have an Assurance on file)

[ ] This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations.

by:

[ ] Full IRB Review on (date of IRB meeting) or [ ] Expedited Review on (date)

[ ] If less than one year approval, provide expiration date

[ ] This activity contains multiple projects, some of which have not been reviewed. The IRB has granted approval on condition that all projects covered by the Common Rule will be reviewed and approved before they are initiated and that appropriate further certification will be submitted.

8. Comments

9. The official signing below certifies that the information provided above is correct and that, as required, future reviews will be

10. Name and Address of Institution performed until study closure and certification will be provided.

11. Phone No. (with area code)

12. Email:

13. Name of Official

14. Title

15. Signature

16. Date

Authorized for local Reproduction