FDA-21-SOL-1249290.pdf

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FDA-21-SOL-1249290

Statement of Work

Instructor-Led Training on Pharmacoepidemiology Table of Contents

Contents

SECTION 1: BACKGROUND

SECTION 2: OBJECTIVE

SECTION 3: SCOPE OF WORK

3.1 TASK 1 - Develop Six Modules for Pharmacoepidemiologic Methods Training

Module 1: Introduction to Pharmacoepidemiologic Methods

Module 2: Biostatistical Concepts Relevant for Pharmacoepidemiology Studies

Module 3: Advanced Topics in Pharmacoepidemiology

Module 4: Administrative Databases/Repurposing of Data and Important Implications for Drug Safety Studies .. 4

Module 5: Special Topics

Module 6: Important Challenges in Drug Safety

3.2 Task 2: Instructor-led Training Requirements (A-E)

3.3 Task 3: Project Management – Kick-off Meeting and Annual Teleconferences

SECTION 4: DELIVERABLES

SECTION 5: INSPECTION AND ACCEPTANCE

SECTION 6: PLACE OF PERFORMANCE

SECTION 7: PERIOD OF PERFORMANCE

SECTION 8: LABOR CATEGORY DESCRIPTIONS

SECTION 9: CONTRACT ADMINISTRATION

SECTION 10: INVOICE SUBMISSION

SECTION 11: KEY PERSONNEL REQUIREMENTS

SECTION 12: GOVERNMENT FURNISHED PROPERTY/INFORMATION (GFP/GFI)

SECTION 13: SECTION 508 – ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY

SECTION 12: ACCESS TO NON-PUBLIC INFORMATION

SECTION 13: SECURITY AND PRIVACY REQUIREMENTS

SECTION 14: RELEVANT CLAUSES

SECTION 15: INSTRUCTIONS TO THE OFFERORS

SECTION 16: TECHNICAL EVALUATION FACTORS

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SECTION 17: EVALUATION FACTORS FOR AWARD

FAR 52.212-2 – Evaluation-Commercial Items (Oct 2014)

SECTION 1: BACKGROUND

The mission of the U.S. Food and Drug Administration is to protect the public health (www.fda.gov). The Office of Surveillance and Epidemiology (OSE) within the FDA, Center for Drug Evaluation and Research (CDER) contribute to this effort by evaluating drug risks and promoting the safe use of drugs by American consumers using a variety of tools and disciplines throughout the life cycle of the drugs.

These OSE-wide activities necessitate the development of highly skilled scientific workforce to conduct our mission of protecting and advancing the public health. In support and in alignment with the following legislation, goals and priorities, OSE is strengthening the scientific and associated workforce through the continuation of the a Pharmacoepidemiologic Instructor-led Certificate Program.

1. The 21st Century Cures Act, Section 3071, 21st Century Cures Act

To assist FDA in hiring scientific, technical, and professional personnel, Subtitle G, Improving Scientific Expertise and Outreach at FDA addresses hiring and retention authorities, with FDA submitting workforce planning reports, as outlined in the Cures Act.

2. HHS Goal/Objective, HHS Performance-Plan Goal

Goal 4: Foster Sound, Sustained Advances in the Sciences

Objective 4.2: Expand the capacity of the scientific workforce and infrastructure to support innovative research.

3. FDA Strategic Priority, FDA’s Strategic Policy Roadmap, Priority IV

Strengthen FDA’s scientific workforce and its tools for efficient risk management o Goal: Ensure FDA’s ability to bring innovative new products to consumers and use the latest science to improve public health by investing in the scientific and clinical expertise of FDA’s staff and its policies.

SECTION 2: OBJECTIVE

This acquisition will fund contracted personnel to support the development of scientific, technical, and professional personnel through the customized training in the scientific area of pharmacoepidemiologic to improve scientific expertise. The customized training services include the development and delivery of pharmacoepidemiologic content through instructor-led training.

http://www.fda.gov/ https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf https://www.hhs.gov/about/budget/fy2019/performance/performance-plan-goal-4-objective-2/index.html https://www.fda.gov/media/110587/download

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SECTION 3: SCOPE OF WORK

The Contractor shall provide trained, experienced and qualified scientific, technical and professional personnel to support the Certificate Training Program, titled, Pharmacoepidemiology, for a total of up to thirty (30) FDA staff at a time, as identified by CDER. Course development work efforts (design & content) primarily occur in the base period with marginal work efforts for scientific changes in the out years (Option Years 1,2,3,4).

3.1 TASK 1 - Develop Six Modules for Pharmacoepidemiologic Methods Training

The Contractor shall develop an outline and course content to fulfill the modules listed below:

Module 1: Introduction to Pharmacoepidemiologic Methods

• 12-hour module (4 sessions consisting of 3 hours each) shall be designed to teach the basic principles in Pharmacoepidemiologic research design. Topics shall include, but are not limited to:

o pharmacoepidemiology study designs o evaluation of drug safety vs. effectiveness studies o elements relevant for interpretation of results (e.g., p-values, confidence intervals, sample size, generalizability of results) o data or population sources (e.g., electronic healthcare databases and important considerations when using these resources, prospective collection of data) o drug exposure and patient adherence o outcome/endpoints

Module 2: Biostatistical Concepts Relevant for Pharmacoepidemiology Studies

• 18-hour module (6 sessions consisting of 3 hours each) shall be designed to provide an overview of the basic concepts of biostatistics with an emphasis on the biostatistical methods appropriate to pharmacoepidemiology. The training module shall include an overview of the biostatistical material and exercises. Topics shall include, but are not limited to:

o sampling model o incidence and effects measures o stratified analyses o power and sample size o logistic regression o Poisson regression o survival regression o proportional hazard models and their modifications o analytic handling of confounding o sensitivity analyses to evaluate robustness of results o meta-analysis

Module 3: Advanced Topics in Pharmacoepidemiology

• 18-hour (6 sessions consisting of 3 hours each) module shall be designed to teach advanced topics of Pharmacoepidemiologic research. Topics shall include, but are not limited to:

4 | P a g e o new user cohort designs, nested case-control studies, self-control design o important biases in pharmacoepidemiology (e.g., selection bias, o including healthy initiator, sick stopper, and healthy user, immortal time bias) o confounding (including by indication, and by co-morbidities) o high dimensional propensity scores o inverse probability weighting o instrumental variable analysis (IVA) o introduction to other causal inference approaches: such as marginal structural model, G-estimation o introduction to the application of machine learning, neural network, natural language processing

Module 4: Administrative Databases/Repurposing of Data and Important Implications for Drug Safety Studies

• 18-hour module (6 sessions consisting of 3 hours each) shall be designed to provide participants with the skills to design and conduct a research project using existing data. Topics shall include, but are not limited to:

o pharmacoepidemiology databases (i.e. administrative claims, electronic health records, registries, other real world data sources) o characterizing data quality in terms of reliability and relevance o use of modeling tools o strategies to link different databases for the purpose of conducting pharmacoepidemiology studies o collection of additional data on sample of patients, efficient sampling strategies and how to incorporate this information into studies o outcome validation strategies o strategies to address missing information, including lack of important confounders

Module 5: Special Topics

• 15-hour module (5 sessions consisting of 3 hours each) shall be designed to explore other special topics of interest related to drug safety research. Topics shall include, but are not limited to:

o Real World Evidence (RWE) generation for regulatory decision-making o registries o surveys o prospective post-marketing studies o meta-analysis (including network meta-analysis, individual patient data (IPD) meta- analysis) o benefit-risk analysis and consideration of patient preference information (PPI) o comparative effectiveness studies

Module 6: Important Challenges in Drug Safety

• 18-hour module (6 sessions consisting of 3 hours each) shall be designed to address various challenges in drug safety. Topics shall include, but are not limited to:

o evaluation of outcomes of delayed onset, such as cancer

5 | P a g e o evaluation of pregnancy outcomes o evaluation of outcome in special population, such as pediatrics o evaluation of rare exposure/rare outcomes o evaluation of biologics/biosimilars

3.2 Task 2: Instructor-led Training Requirements (A-E)

A. The contractor shall provide lesson background materials as follows:

o The web-based background materials shall be designed for trainees to have the necessary background information two weeks before each instructor-led training module. (FDA will maintain a SharePoint Online site).

o Course materials including books shall be provided electronically for pharmacoepidemiology and biostatistics topics.

o The contractor shall also make available to the Government all data resources necessary to develop all course materials.

o All the training modules (99 hours) shall include individual homework as appropriate, as well as group work to maximize learning.

o The contractor shall work with the COR or the Technical Lead to schedule the instructor-led portion of the training (See Task 1).

B. The contractor shall provide instructor-led training by qualified instructor(s) at FDA’s

White Oak Campus or virtually in the event of campus closure at the Government’s discretion. Each module shall be held for a period of 3 hours, no more than one day per week.

C. The contractor shall also have dedicated “office hours” either on-line or in person one hour before or after training, to accommodate students with additional learning needs. The contractor shall respond to all lesson-related e-mails from students within 48 hours of receipt (M-F).

D. The contractor shall provide course evaluation feedback using electronic web-based

Survey Monkey, or emailed forms in Adobe Acrobat or Microsoft Word compatible format to the students after each module training and participate in an after action review teleconference with the COR and/or Technical Lead to discuss participant feedback from course evaluations no later than two (2) weeks after the conclusion of each instructor-led training.

E. The contractor shall revise and update the pharmacoepidemiologic modules as mutually agreed upon with the COR for the option year renewal module trainings based on the participant feedback from course evaluations.

3.3 Task 3: Project Management – Kick-off Meeting and Annual Teleconferences

Kick-off Meeting:

The contractor shall coordinate and schedule an Onsite Kick-Off Meeting within 5 business days after

6 | P a g e contract award and meeting minutes within 2 business days of the meeting onsite at the FDA campus in Silver Spring, MD. The purpose of the kick-off meeting is to review the terms of the contract to ensure successful performance. An agenda shall be provided to the COR at least 48 hours prior to the kick-off meeting.

Annual Teleconference:

The contractor shall coordinate and schedule a Teleconference within 5 business days of each option year renewal and provide meeting minutes within 2 business days after the teleconference. The purpose of the annual teleconferences is to discuss FDA’s satisfaction with all the deliverables. An agenda shall be provided to the COR at least 48 hours prior to the Teleconference.

Monthly Status Reports:

The Contractor shall provide monthly status reports to report on the progress of the customized pharmacoepidemiologic training and activities to the Contracting Officer Representative (COR).

Within the first 30 days after contract award, the Government and the Contractor shall design and agree upon a standard reporting format that typically includes the following information at a minimum:

• Identify overall progress of the project;

• Identify and describe progress on planned deliverables;

• Account for delivered services;

• Identify action items for the following month;

• Identify current, scheduled, or future training or individual training needs;

• Provide status on office hours and student email correspondence support issues;

• Report current or anticipated problems with scheduled activities;

• Identify project risks to schedule, cost, and quality and provide risk mitigation strategies;

• Address Invoice issues or concerns;

• Identify accomplishments

SECTION 4: DELIVERABLES

Base Year - Deliverables Task 1 Format Delivery Schedule

Develop Six Modules for Pharmacoepidemiologic Methods Training Course development work efforts (design & content) primarily occur in the base period with marginal work efforts for scientific changes in the out years (options).

Electronically, Microsoft Word Compatible

Pharmacoepidemiologic Methods modules delivered 4 weeks from date of award

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Task 2 A - E A. Training background materials (as per paragraph 3.2 sub-paragraph A)

Electronically, Microsoft Word Compatible

10 business days prior to scheduled training

B. FDA onsite instructor-led pharmacoepidemiology training or virtually in the event of campus closure at the Government’s discretion

FDA onsite or virtual via access to FDA network

FDA onsite or virtual via access to FDA network

C. Office Hours and/or email correspondence with students within 48 hours

On-line or in person after training sessions

Respond to all lesson-related e-mails from students within 48 hours of receipt (M- F) or either 1 hour before or immediately after each instructor-led class module.

D. Course evaluation for each instructor-led training module and participate in and after-action review teleconference for each training module

Course Evaluation:

Electronic using web-based Survey Monkey, or emailed forms in Adobe Acrobat or compatible format.

After Action Review:

Teleconference

Course evaluation provided after completion of each instructor-led training module.

After Action Review:

Teleconference 2 weeks after each instructor-led training

E. Revise and update the pharmacoepidemiologic modules as mutually agreed upon with the COR. Based on the participant feedback from course evaluations

Electronically, Annually with option year renewal module trainings based on the participant feedback from course evaluations

Task 3 Format Delivery Schedule

- Kick-Off Meeting and

Meeting Minutes Electronically, Microsoft Word Compatible

Kick-off meeting to occur as mutually agreed with the COR after contract award and Meeting Minutes within 2 business days of the meeting

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- Annual Teleconference WebEx or similar communication tool

Teleconference within 5 business days of each option year renewal and provide meeting minutes within 2 business days after the teleconference

- Monthly Reports Electronically, Microsoft Word

Submitted monthly

Option Year 1 Deliverables Task 1 Format Delivery Schedule

Develop Six Modules for Pharmacoepidemiologic Methods Training Course development work efforts (design & content) primarily occur in the base period with marginal work efforts for scientific changes in the out years (options).

Electronically, Microsoft Word Compatible

Pharmacoepidemiologic Methods modules delivered 4 weeks from date of award

Task 2 A - E F. Training background materials (as per paragraph 3.2 sub-paragraph A)

Electronically, G. FDA onsite instructor-led training or virtually in the event of campus closure at the Government’s discretion

FDA onsite or virtual via access to FDA network

FDA onsite or virtual via access to FDA network

H. Office Hours and/or email

Respond to all lesson-related e-mails from students within 48 hours of receipt (M- F) or either 1 hour before or immediately after each instructor-led class module.

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I. Course evaluation for each instructor-led training module and participate in and after-action review teleconference for each training module

Course Evaluation:

Electronic using web-based Survey Monkey, or emailed forms in Adobe Acrobat or

Course evaluation provided after completion of each instructor-led training module.

After Action Review:

Teleconference 2 weeks after each instructor-led training

J. Revise and update the pharmacoepidemiologic modules as mutually agreed upon with the COR. Based on the participant feedback from course evaluations

Electronically, on the participant feedback from course evaluations

Task 3 Format Delivery Schedule

- Kick-Off Meeting and

Meeting Minutes Electronically, Microsoft Word Compatible

Kick-off meeting to occur as mutually agreed with the COR after contract award and Meeting Minutes within 2 business days of the meeting

- Annual Teleconference WebEx or similar communication tool

Teleconference within 5 business days of each option year renewal and provide meeting minutes within 2 business days after the teleconference

- Monthly Reports Electronically, Microsoft Word

Option Year 2 Deliverables

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Develop Six Modules for Pharmacoepidemiologic Methods Training Course development work efforts (design & content) primarily occur in the base period with marginal work efforts for scientific changes in the out years (options).

Electronically, Microsoft Word Compatible

Pharmacoepidemiologic Methods modules delivered 4 weeks from date of award

Task 2 A - E K. Training background materials (as per paragraph 3.2 sub-paragraph A)

Electronically, L. FDA onsite instructor-led training or virtually in the event of campus closure at the Government’s discretion

FDA onsite or virtual via access to FDA network

FDA onsite or virtual via access to FDA network

M. Office Hours and/or email

Respond to all lesson-related e-mails from students within 48 hours of receipt (M- F) or either 1 hour before or immediately after each instructor-led class module.

N. Course evaluation for each instructor-led training module and participate in and after-action review teleconference for each training module

Course Evaluation:

Electronic using web-based Survey Monkey, or emailed forms in Adobe Acrobat or

Course evaluation provided after completion of each instructor-led training module.

After Action Review:

Teleconference 2 weeks after each instructor-led training

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O. Revise and update the pharmacoepidemiologic modules as mutually agreed upon with the COR. Based on the participant feedback from course evaluations

Electronically, on the participant feedback from course evaluations

Task 3 Format Delivery Schedule

- Kick-Off Meeting and

Meeting Minutes Electronically, Microsoft Word Compatible

Kick-off meeting to occur as mutually agreed with the COR after contract award and Meeting Minutes within 2 business days of the meeting

- Annual Teleconference WebEx or similar communication tool

Teleconference within 5 business days of each option year renewal and provide meeting minutes within 2 business days after the teleconference

- Monthly Reports Electronically, Microsoft Word

Option Year 3 Deliverables

Develop Six Modules for Pharmacoepidemiologic Methods Training Course development work efforts (design & content) primarily occur in the base period with marginal work efforts for scientific changes in the out years (options).

Electronically, Microsoft Word Compatible

Pharmacoepidemiologic Methods modules delivered 4 weeks from date of award

Task 2 A - E

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P. Training background materials (as per paragraph 3.2 sub-paragraph A)

Electronically, Q. FDA onsite instructor-led training or virtually in the event of campus closure at the Government’s discretion

FDA onsite or virtual via access to FDA network

FDA onsite or virtual via access to FDA network

R. Office Hours and/or email

Respond to all lesson-related e-mails from students within 48 hours of receipt (M- F) or either 1 hour before or immediately after each instructor-led class module.

S. Course evaluation for each instructor-led training module and participate in and after-action review teleconference for each training module

Course Evaluation:

Electronic using web-based Survey Monkey, or emailed forms in Adobe Acrobat or

Course evaluation provided after completion of each instructor-led training module.

After Action Review:

Teleconference 2 weeks after each instructor-led training

T. Revise and update the pharmacoepidemiologic modules as mutually agreed upon with the COR. Based on the participant feedback from course evaluations

Electronically, on the participant feedback from course evaluations

Task 3 Format Delivery Schedule

- Kick-Off Meeting and

Meeting Minutes Electronically, Microsoft Word Compatible

Kick-off meeting to occur as mutually agreed with the COR after contract award and Meeting Minutes within 2 business days of the meeting

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- Annual Teleconference WebEx or similar communication tool

Teleconference within 5 business days of each option year renewal and provide meeting minutes within 2 business days after the teleconference

- Monthly Reports Electronically, Microsoft Word

Option Year 4 Deliverables

Develop Six Modules for Pharmacoepidemiologic Methods Training Course development work efforts (design & content) primarily occur in the base period with marginal work efforts for scientific changes in the out years (options).

Electronically, Microsoft Word Compatible

Pharmacoepidemiologic Methods modules delivered 4 weeks from date of award

Task 2 A - E U. Training background materials (as per paragraph 3.2 sub-paragraph A)

Electronically, V. FDA onsite instructor-led training or virtually in the event of campus closure at the Government’s discretion

FDA onsite or virtual via access to FDA network

FDA onsite or virtual via access to FDA network

W. Office Hours and/or email

Respond to all lesson-related e-mails from students within 48 hours of receipt (M- F) or either 1 hour before or immediately after each instructor-led class module.

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X. Course evaluation for each instructor-led training module and participate in and after-action review teleconference for each training module

Course Evaluation:

Electronic using web-based Survey Monkey, or emailed forms in Adobe Acrobat or

Course evaluation provided after completion of each instructor-led training module.

After Action Review:

Teleconference 2 weeks after each instructor-led training

Y. Revise and update the pharmacoepidemiologic modules as mutually agreed upon with the COR. Based on the participant feedback from course evaluations

Electronically, on the participant feedback from course evaluations

Task 3 Format Delivery Schedule

- Kick-Off Meeting and

Meeting Minutes Electronically, Microsoft Word Compatible

Kick-off meeting to occur as mutually agreed with the COR after contract award and Meeting Minutes within 2 business days of the meeting

- Annual Teleconference WebEx or similar communication tool

Teleconference within 5 business days of each option year renewal and provide meeting minutes within 2 business days after the teleconference

- Monthly Reports Electronically, Microsoft Word

SECTION 5: INSPECTION AND ACCEPTANCE

A. Contracting Officer’s Representative (COR) or duly authorized representative will perform inspection and acceptance of materials and services. For the purpose of this section, the Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer.

B. Acceptance may be presumed within 10 days of receipt, unless otherwise indicated in writing by the Contracting Officer or duly authorized representative (COR). Inspection and acceptance will be performed at the Place of Performance in Section 6.

SECTION 6: PLACE OF PERFORMANCE

The work will be conducted at the White Oak Campus, 10903 New Hampshire Avenue, Silver Spring MD, 20993 or virtually in the event of campus is closed at the Government’s discretion. No services shall be

15 | P a g e performed on Federal Government holidays unless directed by the COR.

Government Holidays Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January New Year’s Day) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) June (Juneteenth) July (Independence Day) September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving) December (Christmas Day)

Travel Expenses The Contractor shall provide an estimate of travel and lodging costs under this contract agreement.

Performance under this contract will require travel by contractor personnel to conduct instructor-led training at FDA’s White Oak Campus. The Contractor shall comply with all Federal Travel Regulations (FTR) when engaging in travel. The FTR is available at http://www.gsa.gov. Any required travel and lodging by the Contractor will be at the direction of the Government and will be reimbursed at cost in accordance with the Federal Travel Regulation. The Contractor is responsible for making all needed travel arrangements for Contractor’s personnel.

SECTION 7: PERIOD OF PERFORMANCE

The period of performance shall be effective on the date of the Contracting Officer’s signature and shall remain in effect for five (5) years. The period of performance shall include One (1) Base Year and Four (4) Option Years.

SECTION 8: LABOR CATEGORY DESCRIPTIONS

Program Director (Epidemiologist)

Conducts the program and is responsible for administrative, fiscal and scientific conduct. The Program Director will have advanced clinical, technical or professional degrees, at the MD/PhD level with a minimum of 10 years of experience in conducting Pharmacoepidemiological training and experience utilizing real world data for real world evidence generation.

Program Manager Associate management or clinical/professional/technical personnel, holding an advanced degree, at the PhD. level with a minimum of 10 years of experience in analyzing http://www.gsa.gov/

16 | P a g e pharmacoepidemiological, biomedical, social sciences, patient reported outcomes including benefit-risk assessments, or similar scientific literature, research findings and data. Experience in conducting pharmacoepidemiological training.

Statistician (Biostatistician) At least 5 years of experience and training and analyzing data from large health care systems, statistics, or related areas. Demonstrated record of supporting development and delivery of presentations, publications and reports on specific programs or technically complex subjects. A Statistician is responsible for performing work of technically complex nature in the areas of statistics, including regulatory impact analysis, benefit-risk assessment, causal inference analysis, sampling, survey design and implementation.

Must know SAS, R or other statistical software packages. Advanced degrees at the PhD level. Experience in conducting pharmacoepidemiological training.

Program Coordinator Responsible for the daily organization, coordination, and conduct of activities related to the course.

Strong attention to detail and ability to manage multiple priorities. Competency with MS Excel, MS Word, MS PowerPoint is required; familiarity with MS Access and/or Illustrator is preferred. Prior social science or medical research experience is preferred, and epidemiology and/or biostatistics exposure is a plus. A strong applicant will display the ability to communicate with multiple levels of staff and work effectively with others in a team environment. Ability to adapt to fast-paced environment, learn quickly, attention to detail, and the ability to manage multiple priorities. Also, organizational skills and the ability to use independent judgment. Excellent communication and interpersonal skills, telephone and email etiquette and teamwork and cooperation. Holding BS, MS, or PhD in health sciences such as Medicine, Pharm.D., BS Pharmacy, Nursing, Epidemiology, Preventive Medicine, or Public Health or PhD in biological sciences. The Research Assistant will have at least five (5) years of experience. Experience in conducting pharmacoepidemiological training.

SECTION 9: CONTRACT ADMINISTRATION

The Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The contact information for the COR:

Food and Drug Administration

COR: TBD

10903 New Hampshire Ave Silver Spring, MD 20993 Phone:

Email:

Contracting Officer Responsibilities The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the CO has authority to: (1) direct or negotiate any changes in the RFP; (2) modify or

17 | P a g e extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the CO is:

Kyle Smith Phone: 240-402-7553 E-Mail: kyle.smith@fda.hhs.gov

SECTION 10: INVOICE SUBMISSION

Invoice Submission The contractor shall submit invoices after each module is completed to all addresses in the manner specified below:

(I) One original and one copy to the approving official:

Food and Drug Administration Office of Acquisition and Grants Services WO32 – Second Floor Mail Hub 2145 ATTN: TBD, Contracting Specialist 5630 Fishers Lane Room 2130, HFA-500 Rockville, MD 20852 TBD@fda.hhs.gov ***Acceptable methods of delivery include:

mail, hand delivery and email.

(II) One copy to the Contracting Officer

Representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

Food and Drug Administration 10903 New Hampshire Ave, Bldg 22 Silver Spring, MD 20993-0002 Attn: Sam Carter 240-402-6122 Samuel.Carter@fda.hhs.gov ***Acceptable methods of delivery include:

mail, hand delivery and email.

Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System

18 | P a g e for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor;

(II) Invoice date and invoice number;

(III) Purchase Order/Award Number;

(IV) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination; and

(c) any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipment, including the Bill of Lading number and weight of shipment if shipped on Government Bill of Lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order or in a proper notice of assignment);

(VIII) Name, title, and phone number of person to notify in event of defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

Questions regarding invoice payments should be directed to the FDA Payment Office at telephone number provided above.

SECTION 11: KEY PERSONNEL REQUIREMENTS

Staffing and Key Personnel The key personnel specified in this contract are considered to be essential to work performance. At least 45 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify

19 | P a g e the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The Contractor shall obtain subject matter experts with expertise in the areas of Pharmacoeepidemiology. The Contractor shall ensure the subject matter experts are available throughout the duration of the project. It is the responsibility of the Instructor to verify the technical information requirements, review test questions, validate the appropriateness of visuals, and confirm the technical accuracy of all interactive elements. The Instructor shall be available by telephone and by email to discuss any content related questions posed by FDA personnel. The Instructor selected for the project shall be available to travel to the contractor’s site if determined to be necessary by the COR.

SECTION 12: GOVERNMENT FURNISHED PROPERTY/INFORMATION (GFP/GFI)

The Government provided GFP/GFI for on-site training as follows:

1. Conference room large enough to deliver the instructor-led training modules (30 students)

2. All electronic training material and necessary computer equipment for personnel to conduct instructor-led training modules (e.g., laptop, projector, etc.)

GFP/GFI will be furnished by COR and will be required for the successful completion of the project. The contractor shall have use of the GFP for the duration of this delivery order. If available, CDER will provide the contractor with applicable resource and reference material.

All items provided as GFP/GFI will be marked as such and will have the name and phone number of provider on each document or item as a reference for the developer. Upon completion of the contract, the contractor shall deliver all source code, a Train the Trainer package containing all developmental source material necessary for life cycle support and return all provided GFM to the government.

SECTION 13: SECTION 508 – ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY

Section 508 Section 508 of the Rehabilitation Act Amendments of 1998 (29 U.S.C. § 794 (d) was enacted in the Workforce Investment Act of 1998. Section 508 requires that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities. The Act required the Architectural and Transportation Barriers Compliance Board (Access Board) to create federal standards for electronic and information technology (EIT) products (goods and services) to make them more accessible by individuals with disabilities.

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The contractor shall document their level of conformance to the Agency’s Section 508 and adhere to the agency’s section 508 standards as it relates to this contract and the TASKS within and listed below.

Each Offeror will be evaluated on their conformance to the Section 508 Standards identified below as being applicable for this requirement. The conformance to these standards will be evaluated as follows:

1. Conformance at proposal submission

2. Conformance by scheduled delivery date, after insignificant or no contractor development

3. Conformance by scheduled delivery date, after significant contractor development

No allowance is given here for partial performance as gradations are difficult to verify and add complexity.

Using the following web site, Offerors can access resources for understanding and implementing the requirements of Section 508 at http://www.section508.gov and http://www.access-board.gov/508.htm

The following applications standards have been identified as being applicable for this service:

§ 1194.31 Functional performance criteria.

(a) At least one mode of operation and information retrieval that does not require user vision shall be provided, or support for assistive technology used by people who are blind or visually impaired shall be provided.

(b) At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 shall be provided in audio and enlarged print output working together or independently, or support for assistive technology used by people who are visually impaired shall be provided.

(c) At least one mode of operation and information retrieval that does not require user hearing shall be provided, or support for assistive technology used by people who are deaf or hard of hearing shall be provided.

(d) Where audio information is important for the use of a product, at least one mode of operation and information retrieval shall be provided in an enhanced auditory fashion, or support for assistive hearing devices shall be provided.

(e) At least one mode of operation and information retrieval that does not require user speech shall be provided, or support for assistive technology used by people with disabilities shall be provided.

(f) At least one mode of operation and information retrieval that does not require fine motor control or simultaneous actions and that is operable with limited reach and strength shall be provided.

§ 1194.41 Information, documentation, and support.

(a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge.

http://www.section508.gov/ http://www.access-board.gov/508.htm http://www.access-board.gov/508.htm

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(b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge.

(c) Support services for products shall accommodate the communication needs of end-users with disabilities.

The following applications standards have been determined to not be applicable for this service:

§ 1194.21 Software applications and operating systems.

§ 1194.22 Web-based intranet and internet information and applications.

§ 1194.23 Telecommunications products.

§ 1194.24 Video and multimedia products.

§ 1194.25 Self-contained, closed products.

§ 1194.26 Desktop and portable computers.

SECTION 12: ACCESS TO NON-PUBLIC INFORMATION

All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided as an attachment 5 to this contract. If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA Project Officer and the Contracting Officer. Any new contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand-deliver it to the Contracting Officer ten (10) days prior to said new employee's commencement of work on this contract. The prime contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted.

SECTION 13: SECURITY AND PRIVACY REQUIREMENTS

The Contractor provides Instructor-Led on-site Pharmacoepidemiology Training. The Contractor does not access FDA IT systems, nor has access to GFE, GFI, or an FDA badge. While at the FDA, the Contractor is escorted to a Government conference room and projects class content from his/her laptop. When the class is remote, the Contractor uses an FDA provided WebEx link to project directly from his/her laptop. The FDA Information Technology Security Representative has reviewed this SOW and has determined that “Information security is not applicable”.

SECTION 14: RELEVANT CLAUSES

52.227-14, Rights in Data—General, Alternative IV

52.227-17, Rights in Data—Special Works

52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing

22 | P a g e labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6-months. The Contracting Officer may exercise the option by written notice to the Contractor within one (1) day. (End of clause)

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within one (1) day; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least the day before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 4 years.

52.223-99 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.

ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS (OCT 2021) (DEVIATION)

(a) Definition. As used in this clause - United States or its outlying areas means—

(1) The fifty States;

(2) The District of Columbia;

(3) The commonwealths of Puerto Rico and the Northern Mariana Islands;

(4) The territories of American Samoa, Guam, and the United States Virgin Islands; and

(5) The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll.

(b) Authority. This clause implements Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors, dated September 9, 2021 (published in the Federal Register on September 14, 2021, 86 FR 50985).

(c) Compliance. The Contractor shall comply with all guidance, including guidance conveyed through Frequently Asked Questions, as amended during the performance of this contract, for contractor or subcontractor workplace locations published by the Safer Federal Workforce Task Force (Task Force Guidance) at https:/www.saferfederalworkforce.gov/contractors/.

(d) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (d), in subcontracts at any tier that exceed the simplified acquisition threshold, as defined in Federal Acquisition Regulation

2.101 on the date of subcontract award, and are for services, including construction, performed in whole or in part within the United States or its outlying areas. (End of clause)

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SECTION 15: INSTRUCTIONS TO THE OFFERORS

General Information

It is the Offeror’s responsibility to ensure the completeness of its proposal. The evaluation of proposals will be conducted on the basis of the information contained in the proposal and other sources disclosed in this solicitation. The Government will not assume that an Offeror possesses any capabilities not specified in its proposal, except as ascertained from information received under processes disclosed in this document.

Offerors that fail to provide in their initial proposal all information required by this RFP may not be further considered, especially if the Contracting Officer determines that substantial revisions or addenda to the offeror’s proposal would be required to permit initial evaluation or if the incomplete proposal appears to be due to a lack of diligence or competence of the Offeror.

Formatting

The Offerors shall submit the technical proposal electronically via e-mail to the Contracting Officer [TBD] at [TBD]. The technical proposal described below shall be limited to 25 pages, with no less than 12-point pitch, with the majority of the text double-spaced.

Proposal Composition

Proposals shall be composed of three volumes, as follows: Volume I Technical Volume, Volume II Price Volume, and Volume III Past Performance. The Offerors proposal shall present information to reflect a thorough understanding of the work requirements and detailed technical proposal for achieving the objectives of the Scope of Work. Technical proposals shall not merely paraphrase the requirements in the Scope of Work or use phrases such as “will comply” or “standard techniques will be employed.” The technical proposal shall include a detailed description of the techniques and procedures to be used in achieving the proposed end results in compliance with the requirements in the Scope of Work.

The technical proposal shall have all the following sections:

• Cover Page including name of the proposing organizations, author(s) of the proposal, the RFP number, and the title of the RFP.

• Table of Contents with sufficient detail so that all important elements of the statement of work can be readily located.

• Contractor’s cover letter/Introduction should be a one-or-two page summary outline of the proposed work the Contractor’s interest in submitting the proposal, and the importance of this effort in relation to the Contractors’ overall operation.

The cover letter shall also list the company’s name, address, DUNN’s number, TIN, point of contact name, email and phone number.

• Technical Discussion should address each Task in the statement of work and the evaluation criteria as outlined in the sections below.

Volume I – Technical Proposal

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Volume I shall be composed of four factors as listed and described below. The Offeror shall not include any price or cost data in Volume I of its proposal. Volume I shall demonstrate the Offerors understanding of the requirements and shall demonstrate the Offeror’s approach to meeting those requirements.

Volume I of the proposal shall also cover the Contractor’s Relevant Past Performance. It is important to note that all past performance that is submitted to the FDA shall be recent and relevant in nature and the Contracting office shall use any means necessary to obtain past performance reviews related to this procurement. The Past Performance submitted shall show the dollar amount, type of work and the timeframe of contract. In the event that the Contractor has no past performance that pertains to the type of work described herein, the contractor shall receive a Neutral rating.

The offeror shall also clearly outline what part of its proposal falls under

1. 52.227-14, Rights in Data—General, Alternative IV

2. 52.227-17, Rights in Data—Special Works

Volume II – Business Proposal

The offeror shall submit a business proposal fully supported by cost information adequate to determine the reasonableness of the proposed prices and to evaluate whether the proposed prices are consistent with the level of effort described in the technical proposal. The pricing data shall be submitted in both PDF and MS Excel format for verification and evaluation purposes. In addition, all pricing formula, linkages between cells, as well as basis of estimate shall be shown to support the Offeror’s derivation of their proposed pricing. Pasted pricing data shall not be accepted.

Loaded Labor Hour Rates – Proposed hourly rates shall be supported by the submission of cost and pricing data that justifies the proposed hourly rates for the contract. Loaded bill rates shall include wages, fringe benefits, overhead, general and administrative expenses, and/or profit. The estimated hours for all labor categories should not exceed 400 hours per year.

The offeror’s proposal shall indicate whether escalation rates are used. If escalation is included, the offeror shall state the percent and methodology, e.g. annual flat rate applied to a base rate as of a specific date or a midpoint rate for the period of performance. Salary increases that are anticipated during contract performance must be claimed under the contract. Plans for any additional compensation resulting from employee relations, profit sharing, pensions or health and welfare benefits shall also be included. The offeror shall also state whether an overtime premium rate is to be applied for all direct labor proposed, if overtime is required.

The offeror must indicate in its proposal whether or not it has the necessary financial capacity, working capital and other resources to perform without assistance from any outside sources (if not, the offeror must indicate the amount required and the anticipated source).

The offeror shall submit a completed Pricing Worksheet with the Business Proposal, Attachment 3.

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SECTION 16: TECHNICAL EVALUATION FACTORS

Factor 1 - Technical Approach

The offeror shall provide a narrative that demonstrates its understanding of the requirements and its overall technical approach and capabilities for performing the types of services expected under this award. For each task area, the narrative must clearly demonstrate the offeror’s understanding of the type of work to be performed and the tools and methodologies to be deployed.