Solicitation_Final_trl.pdf

SECTION B - Supplies or Services and Prices/Costs

B.1 BRIEF DESCRIPTION OF SERVICES

The contractor shall provide all personnel and services necessary to for an ad hoc committee which will develop a framework to evaluate existing clinical practice guidelines for prescribing opioid analgesics for medical conditions or surgical procedures associated with acute pain and recommend for which new evidence-based guidelines should be developed, and recommend a future plan/research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioid analgesics to treat acute pain where prescribing is warranted.

B.2 TYPE OF CONTRACT

Cost Reimbursable.

B.3 NONSEVERABLE SERVICES

The services specified in this contract have been determined to be nonseverable services - a specific undertaking or entire job with a defined end product of value to the Government.

B.4 CONSIDERATION AND PAYMENT

In consideration of performance of the non-severable work described in Section C, the Contractor shall be reimbursed a total amount not to exceed $TBD, for all reasonable costs, allowable costs, and allocable costs under this cost reimbursement contract. The contractor is required to provide backup detail for pricing of each of the Tasks in Section C and then a summary of each of those tasks to provide a final total price.

C. DESCRIPTION OF SERVICES TO BE PROVIDED

Food and Drug Administration

Office of Medical Products and Tobacco The National Academies of Sciences: Develop Evidence Base to Inform Opioid Prescribing

Statement of Work (SOW)

1 INTRODUCTION

BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by “ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” FDA is also responsible for “advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”1 Prescription opioid analgesics are powerful pain-reducing medications, such as oxycodone, hydrocodone, and morphine, among others. Opioid analgesics can provide benefits for patients with acute pain but also have serious potential risks. These medications can help manage pain when prescribed for the right condition and when used appropriately, but when misused or abused, they can cause serious harm, including addiction, overdose, and death.

Widespread opioid abuse and misuse have created a public health crisis. The over-prescribing of opioid analgesic products for routine medical problems is a key factor fueling this crisis. The FDA has a critical role in helping to guide more appropriate prescribing while ensuring that patients with pain are adequately treated.

1.2 OBJECTIVE

FDA is seeking to work with a broad range of stakeholders, including medical professional societies, to evaluate existing clinical practice guidelines on the appropriate prescribing of opioid analgesics for acute pain associated with different medical conditions and surgical procedures.

Key objectives of this effort will be to:

• Develop a framework that will derive and spur the generation of evidence-based clinical practice guidelines for appropriate prescribing of opioid analgesic products for specific medical conditions or surgical procedures associated with acute pain;

• Identify and prioritize specific surgical procedures and medical conditions associated with acute pain for which opioid analgesics are commonly prescribed and considered clinically necessary, (i.e., develop a diversified list not exceeding 50, of specific surgical procedures (e.g. cholecystectomy) and medical conditions (e.g. low back pain) where evidence-based clinical practice guidelines would help inform prescribing practices).

• Based on the list of identified surgical procedures and medical conditions, evaluate the available clinical practice guidelines for opioid analgesics prescribing to determine which specific surgical procedures or medical conditions have clinical practice guidelines that:

o Meet the developed framework (i.e., evidenced-based to inform prescribing, such as studies measuring adequate patient-reported pain control, minimal leftover medication, assessment of inter-individual differences in patient needs within a specific indication, etc.), or

1 See What We Do, FDA Mission, available at https://www.fda.gov/AboutFDA/WhatWeDo/.

https://www.fda.gov/AboutFDA/WhatWeDo/ o Do not meet the developed framework (i.e., require generation of data to be considered acceptable to meet the developed framework); or o Do not have existing clinical practice guidelines.

• For any surgical procedure or medical condition listed above for which no prescribing guidelines exist or for which evidence is required to support existing clinical practice guidelines, create a plan/research paper (not to exceed 10 each of surgical procedure or medical condition) that indicates deficiencies and includes what additional information is required to bring the clinical guidelines up to the standards indicated in the developed framework.

The goal is to encourage specialty organizations to develop evidence-based clinical practice guidelines for appropriate prescribing of opioid analgesic products for specific medical conditions or surgical procedures associated with acute pain to make them easily accessible to prescribers (possibly referenced in approved product labeling). Although the FDA hopes that this work will result in medical specialty organizations carrying out the recommendations issued in the form of a plan/research agenda, the primary aim of this activity is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner. However, it will be important to engage with the medical specialty organizations to ensure their buy-in and adoption (i.e., willingness to develop the needed evidence and either update or generate new evidence-based guidelines).

These guidelines will help to inform health care professionals about ways to reduce the inappropriate use of opioid analgesic products, thus reducing overall public exposure to opioids and the potential for their misuse and abuse.

2 DESCRIPTION OF WORK - SCOPE

As part of FDA’s focus on appropriate prescribing of opioid analgesics, this Statement of Work (SOW) seeks to obtain the independent, objective perspectives and expert services of the National Academies of Sciences, Engineering, and Medicine (National Academies). An ad hoc committee will develop a framework to evaluate existing clinical practice guidelines for prescribing opioid analgesics for medical conditions or surgical procedures associated with acute pain and recommend for which new evidence-based guidelines should be developed, and recommend a future plan/research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioid analgesics to treat acute pain where prescribing is warranted.

The committee will:

1. Develop a framework that could be used to support the development of clinical practice guidelines or the evaluation of existing clinical practice guidelines for opioid analgesic prescribing. This framework would articulate a threshold level of evidence that should be available to support the development of and ensure consistency among guidelines. The committee will consider the standards established in the 2011 IOM report, Clinical Practice Guidelines We Can Trust, and other well accepted standards for evidence assessment, such as GRADE2 criteria and other publicly available or FDA-provided resources.

2. Develop a consensus report that addresses the following:

a. Recommendations for how to generate easily accessible, evidence-based, trustworthy clinical practice guidelines for effectively managing acute pain with opioid analgesics for specific surgical procedures and medical conditions that FDA could use as a reference in its publicly available materials (e.g., product labeling), based on framework developed.

b. Identification of specific surgical procedures and medical conditions associated with acute pain for which opioid analgesics are prescribed and considered clinically necessary (i.e., develop a prioritized list not to exceed 50, of specific surgical procedures and medical conditions where evidence-based clinical practice guidelines would help inform prescribing practices). This list should be prioritized to identify those first which are deemed to have the greatest potential impact on public health.

c. Evaluation of the available clinical practice guidelines for opioid analgesics prescribing, in medical conditions or surgical procedures, based on above list and using framework created above, to determine which surgical procedures or medical conditions meet the framework and have either sufficient guidelines (i.e., evidenced-based to inform prescribing, such as studies measuring adequate patient-reported pain control, minimal leftover medication, assessment of inter-individual differences in patient needs within a specific indication, etc.), guidelines that do not meet the framework (i.e., require generation of evidence to be considered evidence-based) or do not have existing clinical guidelines. This will include conducting a landscape analysis to identify existing opioid analgesic prescribing guidelines for acute pain.

d. Development of a plan/research agenda (i.e., statement of needs), not to exceed 10 of each surgical procedure or medical condition for which no prescribing guidelines exist or for which evidence is required to support existing clinical practice guidelines, including the type of evidence needed.

2.1 WORK PLAN

The National Academies will appoint an ad hoc committee of approximately 12 members that will conduct activities integral to the aforementioned statement of work over the course of a 16-month period. The committee will analyze and research current scientific evidence and will communicate extensively with FDA in the committee’s information gathering process in accordance with institutional guidelines. The committee will consider and build on the past work of the National Academies through data-gathering activities integral to the task, while also taking into account changes in the scientific and policy ecosystem over the course of the period of performance.

2 GRADE: Grading of Recommendations Assessment, Development and Evaluation (A,B,C,D):

https://www.essentialevidenceplus.com/product/ebm_loe.cfm?show=grade

As part of its data-gathering activities, the committee will hold a series of meetings and public workshops. The workshops will engage a broad range of expert stakeholders, including medical specialty societies, who can contribute expert knowledge on existing guidelines and on emerging evidence or specific policy issues related to the development and availability of guidelines for opioid analgesic prescribing based on their specialty. The organizations engaged will include those with existing guidelines, as well as those representing areas for which prescribing guidelines for acute pain are lacking or insufficient. Participants will be asked to provide insights on the many complex issues related to the development of guidelines for the appropriate prescribing of opioid analgesic products for the treatment of acute pain and to help foster the development of evidence-based guidelines that meet a consistent threshold for level of evidence.

The committee will also meet via webinar as needed. Some components of the committee meetings will be open to the public, and others will be closed to the public for deliberations.

For each public workshop, with the support of National Academies’ staff, the committee will develop the agenda, select and invite speakers, discussants, and moderators. The committee’s findings and conclusions from the workshops and other information gathering activities will be reflected in the committee’s final report and recommendations.

Public workshops are to be organized as follows:

• Each public workshop will be 1-2 days long

• Each public workshop will be webcasted to allow maximum remote public access.

• Post public workshop activities will include the following:

– Finalizing the workshop transcript

– Finalizing the attendance list

– Offer opportunity for comments to be submitted for consideration by the committee

– Writing a meeting recap

– Identifying and documenting problems to be solved in preparation for the next workshop

– Posting webcast materials, including slides, webcast video, and other relevant presentation materials, on the project website in accordance with institutional policies.

Committee meetings to be organized as follows:

– Each committee meeting will include domestic travel for 12

– All committee meetings will be closed with the exception of meeting 1 (allows up to 90 minutes public interaction) 8.5 hrs total length of committee meeting 1.

– Committee Meeting 2 & 4 are 8 hours in length

– Committee Meeting 3 & 5 are 12 hours in length

To supplement the information collected through the public workshops, and other data-gathering activities such as literature reviews, the committee may seek input from groups of specialists for in-depth examination of particularly complex or contentious issues, as needed.

The committee’s final report will be subject to the National Academies’ standard report review procedures prior to transmittal to FDA and the report’s public release.

2.1.1 SUMMARY OF THE CORE TASKS

To accomplish the scope and objectives, the project will focus on the following tasks:

Task 1: Assemble and convene the ad hoc committee (meeting #1; public session and closed session ; complete initial planning activities :

• The National Academies will appoint a committee of approximately 12 domestic committee members (not including the NAS staff) with appropriate backgrounds, ensuring expertise in pain medicine, knowledge of regulatory authority, and expertise in clinical trial development. Nominees to the committee will be sought from a number of sources, including the FDA, and care will be taken to ensure a balance of experience and a broad range of perspectives.

• The first committee meeting will be conducted in-person. This first meeting will include a closed session for a discussion of bias and conflict of interest, led by National Academies staff, and committee deliberations, as well as an open, public session with FDA representatives to discuss the committee’s charge and work plan, including the timing of the public workshops.

• In conjunction with this meeting, the committee will:

– Consult with medical professional societies to conduct a landscape analysis of opioid analgesic guidelines for acute pain indications, and identify indications for which evidence-based guidelines may be needed. The committee will use these findings to inform the design and agenda of the first public workshop.

– Develop a framework that could be used to support the development of clinical practice guidelines or the evaluation of existing clinical practice guidelines for opioid analgesic prescribing. This framework would articulate a threshold level of evidence that should be available to support the development of and ensure consistency among guidelines.

The committee will consider the standards established in the 2011 IOM report, Clinical Practice Guidelines We Can Trust, and other well accepted standards for evidence assessment, such as GRADE 3 criteria and other publicly available or FDA-provided resources.

Task 2: Conduct public workshop #1, including completing preliminary and post-workshop activities; Committee Meeting #2 :

• Pre-workshop activities:

o Conference calls to discuss objectives, goals, and potential speakers. NAS staff will host pre-meeting conference calls with confirmed speakers and session chairs to answer questions and discuss presentation topics .

• Workshop 1 will meet the following objectives:

o Identification of surgical procedures and medical conditions associated with acute pain for which opioid analgesics are prescribed and considered clinically necessary (i.e., develop a list not to exceed 50 of surgical procedures and medical conditions) where evidenced-based clinical practice guidelines would help inform

3 GRADE: Grading of Recommendations Assessment, Development and Evaluation (A,B,C,D):

prescribing practices. This list should be prioritized to identify those first which are deemed to have the greatest potential impact on public health.

o From that list and the landscape analysis, identify specific indications with acute pain for which evidence-based guidelines are needed but do not currently exist.

o A framework that could be used to support the development or evaluation of the evidence base underpinning clinical practice guidelines for opioid analgesic prescribing.

This framework would create a threshold level of evidence that should be available to support the development and ensure consistency among guidelines. The committee will consider the standards established in the 2011 IOM report, Clinical Practice Guidelines We Can Trust and other well accepted standards for evidence assessment, such as GRADE criteria, other publicly available, or FDA-provided resources.

• Post-workshop activities with NAS staff:

o At the conclusion of Workshop 1, within 6 weeks, generate a summary of the meeting discussions and include deliverables related to the meeting objective (i.e., a prioritized list, not to exceed 50 of identified surgical procedures or medical conditions for which prescribers could benefit from guidelines).

• Committee Meeting #2 o In conjunction with the workshop, the 12 committee members will convene in a closed session to review information gathered and deliberate on prioritized list of 50 identified surgical procedures or medical conditions and review against the framework developed in task 1 (to be completed before the third committee meeting).

Task 3: Committee Meeting #3 (closed session,: The 12 committee members, with support of NAS staff will address the following objectives:

• Based on the list of identified surgical procedures and medical conditions, evaluate the available clinical practice guidelines for opioid analgesics prescribing to determine which specific surgical procedures or medical conditions have clinical practice guidelines that:

o Meet the developed framework (i.e., evidenced-based to inform prescribing, such as studies measuring adequate patient-reported pain control, minimal leftover medication, assessment of inter-individual differences in patient needs within a specific indication, etc.), or o Do not meet the developed framework (i.e., require generation of data to be considered acceptable to meet the developed framework); or o Do not have existing clinical practice guidelines.

Task 4: Conduct public workshop #2 , including completing preliminary and post-workshop activities; Committee Meeting #4 :

• Pre-workshop activities:

o Conference calls to discuss objectives, goals, and potential speakers. Staff will host pre-meeting conference calls with confirmed speakers and session chairs to answer questions and discuss presentation topics.

• Workshop 2 is to meet the following objectives:

o For any surgical procedure or medical condition listed above for which no prescribing guidelines exist or for which evidence is required to support existing clinical practice guidelines, the workshop goal is to assist/inform the committee members to create a plan/research paper (not to exceed 10 each of surgical procedure or medical condition) that indicates deficiencies and includes what additional information is required to bring the clinical guidelines up to the standards indicated in the developed framework.

o Inform the development of a plan/ research agenda (i.e., statement of needs), by surgical procedure or medical condition for which no prescribing guidelines exist or for which more evidence is required to support existing guidelines, including the type of evidence needed.

• Post-workshop activities:

o At the conclusion of Workshop 2, within 6 weeks, generate a summary of the meeting discussion, and include deliverables related to the meeting objectives (i.e., plan/research agenda potential research activities to strengthen the evidence base for guidelines not to exceed 10 each of surgical procedures or medical conditions.

• Committee Meeting #4 o In conjunction with the workshop, the committee will convene in closed session to:

develop recommendations for how to generate easily accessible, evidence-based, trustworthy clinical practice guidelines for effectively managing acute pain with opioid analgesics for surgical procedures and medical conditions that FDA could use as a reference in its publicly available materials (e.g., product labeling).

Review information gathered, deliberate, and develop for any surgical procedure or medical condition listed above for which no prescribing guidelines exist or for which evidence is required to support existing clinical practice guidelines, create a plan/research paper (not to exceed 10 each of surgical procedure or medical condition) that indicates deficiencies and includes the specific additional information/evidence required to bring the clinical guidelines up to the standards indicated in the developed framework.

o Task 5: Committee Meeting #5 (closed session); Deliberate and complete the draft consensus report

• The committee will convene to deliberate and complete a draft consensus report that compiles the deliverables from (Tasks 1-4) addresses the following, in preparation for external peer review:

• A framework is the prelude of the report used to support the development of clinical practice guidelines or the evaluation of existing clinical practice guidelines for opioid analgesics. This framework articulates a threshold level of evidence that should be available to support the development of and ensure consistency among guidelines. The committee will consider the standards established in the 2011 IOM report, Clinical Practice Guidelines We Can Trust, and other well accepted standards for evidence assessment, such as GRADE criteria and other publicly available or FDA-provided resources. (Developed in Task 1)

• The consensus report that addresses the following:

o Recommendations for how to generate easily accessible, evidence-based, trustworthy clinical practice guidelines for effectively managing acute pain with opioid analgesics for specific surgical procedures and medical conditions that FDA could use as a reference in its publicly available materials (e.g., product labeling), based on framework developed.

o Identification of specific surgical procedures and medical conditions associated with acute pain for which opioid analgesics are prescribed and considered clinically necessary (i.e., develop a prioritized list not to exceed 50, of specific surgical procedures and medical conditions where evidence-based clinical practice guidelines would help inform prescribing practices). This list should be prioritized to identify those first which are deemed to have the greatest potential impact on public health. (Developed in Task 2) o Evaluation of the available clinical practice guidelines for opioid analgesics prescribing, in medical conditions or surgical procedures, based on above list and using framework created above, to determine which surgical procedures or medical conditions meet the framework and have either sufficient guidelines (i.e., evidenced-based to inform prescribing, such as studies measuring adequate patient-reported pain control, minimal leftover medication, assessment of inter-individual differences in patient needs within a specific indication, etc.), guidelines that do not meet the framework (i.e., require generation of evidence to be considered evidence-based) or do not have existing clinical guidelines. This will include conducting a landscape analysis to identify existing opioid analgesic prescribing guidelines for acute pain. (Developed in Task 3) o Development of a plan/research agenda (i.e., statement of needs), not to exceed 10 of each surgical procedure or medical condition for which no prescribing guidelines exist or for which evidence is required to support existing clinical practice guidelines, including the type of evidence needed. (Developed in Task 4)

• The report, prepared by the committee with support from National Academies’ staff, will aggregate the information collected through the committee’s data-gathering activities, including the discussions from and information presented at the two workshops.

Task 6: External review and release of the final consensus report

• The capstone report will be subject to standard National Academies’ report review procedures prior to release and allow comment from medical specialty organizations to ensure their engagement and adoption

• FDA staff will be briefed prior to public release of the pre-publication report

• The final report will be published by the National Academies Press and will be available to the public as a free PDF.

Deliverables and Schedule are specified in Section 2.1 and Table 1 All deliverables as defined by this SOW will be provided to FDA in electronic form.

The Contracting Officer Representative (COR) will closely monitor contractor performance through use of measures contractually in place to be able to evaluate progress and deliverables.

Activities will include bi-monthly status reports from the Contractor, and close examination of invoices against the work performed.

Table 1: Deliverables and Schedule

Deliverables Due Date Project Kick-off Meeting Contract effective date (CED) +5 business days Bi-Monthly Status Reports Bi-Monthly, via email in Word format Publicly post the report committee slate Within 30 business days of CED Public Workshop Agenda Three days before each workshop Public Workshop Transcripts Within business 30 day of each workshop Distribute output from each public workshop Within business 45 day of each workshop, via email in Word, Excel or other MS Office formats

Task # 1 Establish and convene the committee (Meeting 1), 1.

Develop a framework for evidence based guidelines and list of indications where prescribers would benefit from guidelines and announce the public workshops

Within 60 days after award of contract

Task #2 Public Workshop 1 and Committee Meeting 2 Identification of surgical procedures and medical conditions associated with acute pain for which opioid analgesics are prescribed and considered clinically necessary (i.e., develop a list not to exceed 50

Within 150 days after award of contract

Task #3 Committee Meeting 3 Evaluate guidelines using the framework

Within 210 days after award of contract

Task #4 Public Workshop 2 and Committee Meeting 4 Create a plan/research paper (not to exceed 10 each of surgical procedure or medical condition) that indicates deficiencies and includes what additional information is required to bring the clinical guidelines up to the standards indicated in the developed framework.

within 300 days after award of contract

Deliverables Due Date Task #5:

Committee Meeting #5; Deliberate and complete the draft consensus report Aggregate information collected through the committee’s data-gathering activities, including the discussions from and information presented at the two workshops

Within 330 days after award of contract

Task #6: External review Within 360 days after ward of contract

Pre-publication documents Within 400 days of contract award Final hard-copy publication Within 430 days after award of contract All final deliverables specified in Section 2 3 days prior to the end of the PoP Project Closeout Meeting Last day of task order

DELIVERABLE DELIVERY ADDRESS

Unless otherwise specified, all deliverables will be delivered to:

FDA Office of Medical Policy and Tobacco Products ATTN: Trudy Lilly 10903 New Hampshire Avenue Bldg. 1, Room 2306 Silver Spring, MD 20904 Telephone: (301) 796-1371 Email: Trudy.lilly@fda.hhs.gov

2.1.2 Inspection and Acceptance

The government will review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the COR. Reporting Requirements/Deliverables will be submitted to the COR or government designee in accordance with the delivery schedule. The acceptance of deliverables and satisfactory work performance, required herein, will be based upon the timeliness and accuracy of the deliverables. The Contractor will share information and provide full access to documentation while delivering integrated, cohesive business and technology services. Work products developed under this contract will be considered to be owned by the government and will not be labeled ‘copyright’ or ‘proprietary’ or anything similar that might preempt the desired environment of fluid sharing and partnership.

Acceptance may be presumed, unless otherwise indicated in writing by the Contracting Officer, COR or the duly authorized representative, within 10 business days of receipt.

The Contractor will implement necessary changes within 10 business days, or a mutually agreed upon period of time, from the day of change notification.

The COR, or duly authorized representative, will perform inspection and acceptance of materials and services.

Any and all work products under this SOW, including, but not limited to, source code, executable code, scripts, batch jobs, documentation, notes and meeting materials, are the sole property of the US government. Inspection and acceptance will be performed at: 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 or any other related FDA facility.

mailto:Trudy.lilly@fda.hhs.gov

Period of Performance The expected Period of Performance (PoP) for this Task Order is September 1, 2018 – January 31, 2020. The official start date is contingent on the contract being awarded and the PoP may be changed through modifying the contract.

Place of Performance The contractor will perform its work at the following locations of The National Academies of Sciences, Engineering and Medicine:

• Main Campus: 2101 Constitution Avenue, N.W., Washington, D.C.

• Keck Building: 500 Fifth Street, NW, Washington, D.C.

Status Reporting The Contractor will prepare and deliver quarterly status reports to the COR or designated government representative in accordance to the delivery schedule.

5.1 Quarterly Summary Report

The quarterly report will contain the following:

• Brief summary of accomplishments during the reporting period and significant events regarding the task order

• Deliverables submitted or progress on deliverable products

• Any current or anticipated risks/issues

• Summary of plans/required activities for the next quarter

• The quarterly summary report will be submitted to FDA quarterly and as the project progresses.

D. PACKAGING

Packages shall be clearly marked in accordance with normal commercial practices to ensure safe delivery to their destination. In addition, all packages shall be marked as follows:

1. Name of Contractor;

2. Order Number;

3. Description of items contained therein;

4. Consignee’s name and address.

E. INSPECTION AND ACCEPTANCE

FDA review of the final report will be performed after any revision by the contractor before formal acceptance. The final report submitted (following any revisions based on Section 6(b) compliance review) will be reviewed within 7 days of receipt of the report for formal acceptance.

F. PERIOD OF PERFORMANCE/DELIVERABLE/ACTIVITY SCHEDULE

F.1. Period of Performance

As set forth in the Attached Statement of Work.

F.2. Place of Performance

As set forth in the Attached Statement of Work.

F.3. Observance of Federal Holidays

Deliverables due on a Saturday, Sunday, or the following Federal holidays shall be due on the following business day.

1. New Year’s Day 1 January

2. Martin Luther King’s Birthday 3rd Monday in January

3. President’s Day 3rd Monday in February

4. Memorial Day Last Monday in May

5. Independence Day 4 July

6. Labor Day 1st Monday in September

7. Columbus Day 2nd Monday in October

8. Veteran’s Day 11 November

9. Thanksgiving Day 4th Thursday in November

10. Christmas Day 25 December

G. CONTRACT ADMINISTRATION DATA

G.1 Method of Payment

The contractor shall use the invoicing procedures as specified in G.1.1- Invoice Procedures in the BOA, HHSP233201400020B, and detailed below:

G.1.1. Invoice Procedures

The Contractor shall submit invoices once per month. A complete invoice with all required back-up documentation shall be sent electronically, via email, to:

1. DAM mailbox: pscs.invoices@psc.hhs.gov. *

2. Financial Management Service (FMS): psc.invoices@psc.hhs.gov.*

3. COR-

4. Contract Specialist: Kristine.Zechman@psc.hhs.gov

* No other non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent to the DAM and FMS mailboxes, invoices only.

The subject line of your email invoice submission shall contain the contract number, contract line item number, the order number, if applicable, and the number of invoices. The Contractor shall send one email per contract per month. The email may have multiple invoices for the contract. Invoices must be in the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF or TIFF or Word).

Invoices shall be submitted in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc.

All calls concerning contract payment shall be directed to the COR.

In accordance with FAR 52.232-25 Prompt Payment, a proper invoice must include the following items:

(i) Name and address of the contractor.

(ii) Invoice date and invoice number. (Contractors should date invoices as close as possible to the date of mailing or transmission.)

(iii) Contract number or other authorization for supplies delivered or services performed (including order number and contract line item number).

(iv) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed.

(v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading.

(vi) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).

(vii) Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

(viii) Taxpayer Identification Number (TIN) and Dun & Bradstreet Number (DUNS).

The contractor must include its TIN and DUNS on the invoice.

(ix) Electronic funds transfer (EFT) banking information.

(A) The contractor must include EFT banking information on the invoice only if required by agency procedures.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the contractor must have submitted correct EFT banking information in accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(x) Any other information or documentation required by the contract (e.g., evidence of shipment).

In accordance with OMB Memorandum, M-11-32, Agencies shall make payments to small businesses as soon as practicable, with the goal of making payments within 15 days of receipt of a proper invoice. If a small business contractor is not paid within this (15 day) accelerated period, the contractor will not be given a late-payment interest penalty. Interest penalties, as prescribed by the Prompt Payment Act, remain unchanged by means of this memorandum. All small businesses shall label all invoices as “Small Business.”

Additionally, in accordance with OMB Memorandum, M-12-16, all prime contractors are encouraged to disburse funds received from the Federal Government to their small business subcontractors in a prompt manner. To assist prime contractors in expediting contractor payments to small business subcontractors, Agencies shall, to the full extent permitted by law, temporarily establish an earlier, accelerated date for making agency payments to all prime contractors. Consistent with OMB Memorandum M-11-32 above, Agencies shall have a goal of paying all prime contractors within 15 days of receiving proper documentation. In an effort to support small business growth, drive economic activity and job creation, the Contractor is encouraged to accelerate payments to their small business subcontractors.

In accordance with the requirements of the Debt Collection Improvement Act of 1996, all payments under this order will be made by electronic funds transfer (EFT). The Contractor shall provide financial institution information to the Finance Office designated above in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer – System for Award Management.

G.2 Minimum Cost Information for Cost Reimbursement Contracts

a. The Contractor shall provide a summary page showing the cost breakdown by element. The Contractor shall also provide a cost breakdown by element by task. The following minimum information in support of costs submitted:

i. Direct Labor - include all persons, listing the person’s name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

ii. Fringe Costs - show rate, base and total amount;

iii. Overhead or Indirect Costs - show rate, base and total amount;

iv. Consultants - include the name, number of days or hours worked, daily or hourly rate, a total amount per consultant and a total amount for this category;

v. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs include ground transportation shown separately and the per diem costs. Other travel costs shall also be listed. A total amount for this category shall be provided;

vi. Subcontractors - include, for each subcontractor, the same data as is being provided for the prime Contractor. A total amount for this category shall be provided;

vii. Data Processing - include all non-labor costs, i.e., computer time, equipment purchase, lease or rental, data tapes. A total amount for this category shall be provided;

viii. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, equipment rental, duplication, postage;

ix. G&A – show rate, base and total; and

x. Fee - show rate, base and total.

G.3 Authorities of Government Personnel

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of this task order will require maximum coordination between the Government and the Contractor. The following individuals will be the Government's points of contact during the performance of this task order:

G.3.1 Contract Administration

All communications pertaining to contractual and/or administrative matters under the task order shall be addressed to the Contract Specialist.

Contract Specialist Name: Kristine Zechman Address: Contract Specialist, Acquisition Management Services

Program Support Center U.S. Department of Health and Human Services 7700 Wisconsin Avenue Bethesda, Maryland 20857 Phone: (703) 995-9329 Email: Kristine.Zechman@psc.hhs.gov

Contracting Officer Name: Sam Layton Address: 350 Main Street Salt Lake City, Utah 84111 Phone: 385-285-7381 Email: Samuel.Layton@psc.hhs.gov

G.3.2 Contracting Officer’s Representative (COR) Authority

a. Performance of work under this contract must be subject to the technical direction of the Contracting Officer’s Representative identified in individual orders, or a representative designated in writing. The term “technical direction” includes, without limitation, filling in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

b. Technical direction must be within the scope of the specification(s)/work statement.

The Contracting Officer’s Representative does not have authority to issue technical direction that:

i. Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

ii. Constitutes a change as defined in the clause entitled “Changes”;

iii. In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

iv. Changes any of the terms, conditions, or specification(s)/work statement of the contract;

v. Interferes with the contractor's right to perform under the terms and conditions of the contract; or

vi. Directs, supervises or otherwise controls the actions of the contractor's employees.

mailto:Samuel.Layton@psc.hhs.gov

c. Technical direction may be oral or in writing. The Contracting Officer’s Representative shall confirm oral direction in writing within five workdays, with a copy to the Contracting Officer.

d. The contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officer’s Representative. If, in the opinion of the contractor, any direction of the Contracting Officer’s Representative, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government work day.

e. Failure of the contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

G.3.3 Contracting Officer’s Representative (COR):

Contracting Officer Representative

Trudy Lilly 10903 New Hampshire Blvd.

Bldg. 1, Room 2306 Silver Spring, MD Telephone: (301) 796-1371 Email: Trudy.lilly@fda.hhs.gov

Technical Lead for the SOW:

Anna Fine 10903 New Hampshire Blvd.

Bldg. 1, Room 2307 Silver Spring, MD Telephone: (240) 402-4474 Email: anna.fine@fda.hhs.gov

Technical Lead for the SOW:

Kathleen Davies 10903 New Hampshire Blvd.

Bldg. 1, Room 231-07 Silver Spring, MD Telephone: (301) 796-2205

Email: Kathleen.davies@fda.hhs.gov

G.4 Government Furnished Property, Equipment and Materials

As stated in Section C.

mailto:Trudy.lilly@fda.hhs.gov

G.5 Travel and Other Costs

The Contractor shall be reimbursed for all domestic travel as described below, incurred directly, and specifically in the performance of this contract, claimed by the Contractor, accepted by the Contracting Officer and not exceeding:

a. Cost of air travel by most direct route. “Air coach” or “Air tourist” accommodations on prop or jet aircraft constitutes the normal class of air travel, which shall be utilized.

First-class accommodations may be used if (1) less than first-class is not available providing reservation was requested within 24 hours after the traveler had knowledge of the trip; (2) less than first-class requires circuitous routing; (3) less than first-class requires travel to begin or end at unreasonable hours (i.e., if scheduled flight time is before 8:00 a.m. and schedule arrival is after 9:00 p.m.); (4) less than first-class would result in additional direct costs which would offset the transportation savings; or (5) less than first-class will not make connections with other flights or means of transportation for continuation of the journey.

b. Cost of rail travel by most direct route, first-class with lower berth or nearest equivalent.

c. Travel by motor vehicle including rented automobile shall be reimbursed on a reasonable actual expense basis, or at the Contractor’s option, on a mileage basis at the current rate shown in the GSA Federal Travel Regulation, plus any toll or ferry charges.

d. Reasonable subsistence not in excess of actual itemized expenses not to exceed the ceiling in the Federal Travel Regulations in effect at the time of incurred cost.

G.6 Contractor Performance Assessment Report

During the life of this agreement, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov. The ordering Contracting Officer will evaluate Contractor performance on each individual order.

G.7 Printing and Duplicating/Copying

The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing, CFR Title 44. The regulations can be access at http://www.gpo.gov/pdfs/customers/sfas/jcpregs.pdf.

Printing:

No printing by the Contractor or any subcontractor is authorized under this contract. All printing required hereunder must be performed by the Government Printing Office, in accordance with CFR Title 44; Public Law 102-392, as amended by H.R. 4454; and The Legislative Branch Appropriations Act 2995. The Contractor shall complete Form HHS 26 and submit it along with all camera-ready copies to the Contracting Officer’s Representative (COR).

Duplicating/Copying:

If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10-3/4 by 14-1/4 inches. This page limit is per requirement and not per contract.

All printing, as well as duplicating/copying in excess of the stated limits, shall be obtained by the COR through the Publishing Services, Program Support Center. The cost of any unauthorized printing or duplicating /copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

H. SPECIAL CONTRACT REQUIREMENTS (AS NUMBERED IN BOA)

H.1. Organizational Conflict of Interest

a. General: The Contractor shall have programs in place to identify, report, and mitigate actual and potential conflicts of interest for itself, its employees, subcontractors and consultants. The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.

b. Disclosure: The Contractor shall report all actual and potential conflicts of interest pertaining to this contract to the Contracting Officer, including those that would be caused by a contemplated modification to this contact or another contract. Such reports shall be in writing (including by email). Upon request, the Contractor shall respond to a Contracting Officer’s request for an OCI mitigation plan.

c. Resolution: In the event the Contracting Officer determines that a conflict of interest exists, based on disclosure from the Contractor or from other sources, the Contracting Officer shall take action which may include, but is not limited to, requesting a mitigation plan from the Contractor, terminating part or all of the contract, modifying the contract or obtaining a waiver in accordance with applicable law, including FAR 9.503 as applicable.

H.2 Additional Clauses

H.2.1 Reporting:

The Contractor agrees that the final report containing the results of work performed under this contract (the “Report”) shall not identify by name a manufacturer, private labeler, or particular trademark or trade name of a consumer product. Prior to any public disclosure or publication of the Report, and solely to ensure that the Report does not identify by name a manufacturer, private labeler, or particular trademark or trade name of a consumer product, the Contractor shall submit the Report to the FDA for review in accordance with FDA regulations. In connection with this review, the FDA will redact from the Report the names of specific manufacturers and private labelers and the identity of a particular trademark or trade name of a consumer product.

The FDA, however, will not comment, opine, or redact any of the scientific findings, analyses, or conclusions contained in the Report. At all times, the FDA will comply with government-wide and agency-specific scientific integrity laws, regulations and policies.

H.2.2 Contractor Compliance:

The Contractor may be reimbursed for direct and indirect costs (indirect rates are not-to-exceed the currently approved HHS rates) incurred in the performance hereof as are allowable under the provisions of Subpart 31.7 of the Federal Acquisitions in the no-to-exceed amount of $1,069,760 which is subject to the Limitations of Cost Clause. The Contractor may request monthly interim payments for costs incurred during the performance of the contract. A statement of costs incurred by the Contractor in the performance of tasks under this contract and claimed to constitute allowable costs will support each monthly interim payment request. Each monthly interim payment request will be submitted in accordance with the below invoice instructions. Prior approval of the COR is required if the Contractor wishes to use a different payment request format.

In accordance with the clause 52.232-25, “Prompt Payment,” monthly interim payments will be made by the 30th day following receipt of proper request for payment by the designated billing…