RFP_15DDHQ22R00000014.pdf

U. S. Department of Justice Drug Enforcement Administration www.dea.gov

Dear Prospective Offeror:

You are invited to submit a proposal for a Diversion Quota System. The applicable North American Industry Classification System (NAICS) is 541611- Administrative Management and General Management Consulting Services. The Small Business Size Standard is $21.5 million, however this FAR 15 Acquisition is being solicited on an Unrestricted Basis.

The Drug Enforcement Administration (DEA) anticipates making up to three awards as a result of this solicitation to those Offers whom are considered most advantageous to the Government based on a Best Value Trade-Off method. Nevertheless, the Government reserves the right to award one, two, or more than three contracts, or none at all. The Government intends to conduct the evaluation and selection process in two (2) steps, Phase 1 and Phase 2 as set forth in Section M of the RFP.

Instructions for the proper preparation of your proposal are set forth in Section L of the solicitation. In order to be considered, the Offer shall be clearly marked with the RFP number and title. The Offeror shall submit its Proposal in Microsoft Office compatible file format to Jeffrey.D.Saylor@dea.gov.

The Technical Proposal (Volume I) shall not exceed 35 pages. There is no page limit on the Business Proposal (Volume II). Delivery of Proposals shall be made submitted electronically in Microsoft Office compatible files to Jeffrey.D.Saylor@dea.gov. Your proposal must be submitted to the issuing office no later than 11:00 AM, Eastern Standard Time, on or before October 3, 2022 based on the timestamp on the receiver’s side of the email. Late proposals will not be considered.

This solicitation does not commit the Government to pay any costs incurred in the submission of its proposal. It is also noted that the Contracting Officer is the only individual who may legally bind the Government.

Offerors may submit any questions in writing concerning this solicitation no later than 11:00 AM Eastern Standard Time, September 13, 2022 to JeffreyD.Saylor@dea.gov. All communications concerning the solicitation, including any of a technical nature, shall be made by email through the Contracting Officer. The RFP number, 15DDHQ22R00000014, must be referenced in the subject line for all e-mail correspondence concerning this solicitation. Questions must identify the applicable section, page number and paragraph.

NOTE: An Advisory Notice will be emailed to each Offeror immediately following completion of the Phase 1 Offer evaluations. For those participating in Phase 2 Oral Presentations, additional questions may

Office of Acquisition & Relocation Management 8107 Morrissette Drive Springfield, VA 22152

RFP: 15DDHQ22R00000014

be asked prior to Phase 2 submissions pursuant to specific written instructions that will be included in the Advisory Notice All communications in reference to this RFP shall be directed to Jeffrey Saylor, preferably by e-mail at Jeffrey.D.Saylor@dea.gov or on 202-307-7777. Collect calls will not be accepted.

Sincerely, Jeffrey D. Saylor Deputy Assistant Administrator Office of Acquisition & Relocation Management

Attachment: RFP No. 15DDHQ22R00000014

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING PAGE OF PAGES

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

CODE7. ISSUED BY 8. ADDRESS OFFER TO (If other than item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and copies for furnishings the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in until local time

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR

INFORMATION

CALL:

A. NAME B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER EXTENSION

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

(X) SEC. DESCRIPTION PAGE(S) (X) SEC. PAGE(S)DESCRIPTION

A B C D E F G H

I

J

K

L

M EVALUATION FACTORS FOR AWARD

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

LIST OF ATTACHMENTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

CONTRACT CLAUSESSOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECS./WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS(%)

DATEAMENDMENT NO.AMENDMENT NO. DATE

15A. NAME AND

ADDRESS

OF OFFEROR

CODE FACILITY 16. NAME AND THE TITLE OF PERSON AUTHORIZED TO SIGN

OFFER(Type or print)

15B. TELEPHONE NUMBER

AREA CODE NUMBER EXTENSION

15C. CHECK IF REMITTANCE ADDRESS IS

DIFFERENT FROM ABOVE - ENTER SUCH

ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL OPEN COMPETITION:

10 U.S.C. 2304 (c) ( )41 U.S.C. 3304(a)

24. ADMINISTERED BY (If other than Item 7)

26. NAME OF CONTRACTING OFFICER (Type or print)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

25. PAYMENT WILL BE MADE BY

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

CODE

ITEM

STANDARD FORM 33 (REV. 6/2014)

Prescribed by GSA - FAR (48 CFR) 53.214 (c)

SEALED BID (IFB)

NEGOTIATED (RFP)

(Hour) (Date)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

15DDHQ

Drug Enforcement Administration (FA) 8701 Morrissette Drive Springfield, VA 22152

15DDHQ22R00000014

N/A 11:00AM

Jeffrey D. Saylor Jeffrey.D.Saylor@dea.gov

6-8 9-10 13-15 16-25 26-66 94-98

85-93

66-73

10/3/2022

202 3077777

76-84

08/24/2022

UNCLASSIFIED

FOR OFFICIAL USE ONLY

15DDHQ22R00000014 Page 1

DRUG ENFORCEMENT ADMINISTRATION (DEA)

OFFICE OF ACQUISITION & RELOCATION MANAGEMENT

DIVERSION QUOTA SYSTEM REQUIREMENT

REQUEST FOR PROPOSAL (RFP or “solicitation”)

15DDHQ22R00000014

TABLE OF CONTENTS

REQUEST

TABLE OF CONTENTS

PART 1 – THE SCHEDULE

SECTION A – SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 TYPE OF AGREEEMENT

B.2 TRAVEL PRICING

B.3 CONSIDERATION AND PAYMENT

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 INTRODUCTION

C.2 BACKGROUND

C.3 STATEMENT OF WORK

SECTION D – PACKAGING AND MARKING

D.1 DEA-2852.247-70 GENERAL PACKAGING AND MARKING REQUIREMENTS (MAY 2012)

D.2 MARKINGS

D.3 EQUIPMENT REMOVAL

SECTION E – INSPECTION AND ACCEPTANCE

E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

E.2 ACCEPTANCE CRITERIA

SECTION F – DELIVERIES OR PERFORMANCE

F.1 DEA-2852.211-70 PERIOD OF PERFORMANCE (BASE AND OPTIONS) (MAY 2012)

F.2 PLACES OF PERFORMANCE

F.3 DELIVERABLES

F.4 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

F.5 NOTICE OF DELAYS TO THE GOVERNMENT

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 REQUIREMENTS

G.2 TECHNICAL DIRECTION

G.3 INTERPRETATION OR MODIFICATION

G.4 DEA-2852.203-70 FORMER EMPLOYMENT OR ASSIGNMENT WITH THE DEA (SEP 2021)

G.5 DEA-2852.211-71 SCHEDULED AND UNSCHEDULED CLOSURES OF GOVERNMENT OFFICES

(JUL 2021)

G.6 DEA-2852.242-70 CONTRACTOR PERFORMANCE ASSESSMENT (MAR 2020)

G.7 DEA-2852.242-71 INVOICE REQUIREMENTS (MAY 2012)

G.8 DEA-2852.242-72 FINAL INVOICE AND RELEASE OF RESIDUAL FUNDS (MAY 2012)

G.9 DEA-2852.242-73 CONTRACTING OFFICER’S REPRESENTATIVE (COR) (MAY 2012)

G.10 DEA-2852.242-74 CONTRACT ADMINISTRATION POINTS OF CONTACT (MAY 2012)

G.11 DEA-2852.242-81 CONTRACTOR RECORDS MANAGEMENT REQUIREMENTS (SEP 2020)

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 SECURITY REQUIREMENTS

H.2 GOVERNMENT FURNISHED PROPERTY

H.3 NONPAYMENT FOR ADDITIONAL WORK

H.4 INCORPORATION OF CONTRACTOR’S PROPOSAL

H.5 DEA-2852.209-70 ORGANIZATIONAL CONFLICT OF INTEREST (SEP 2021)

H.6 DEA-2852.209-71 LIMITATIONS ON FUTURE CONTRACTING (MAY 2021)

H.7 DEA-2852.209-79 Contractor Internal Confidentiality Agreements or Statements Prohibiting or Restricting

Reporting of Waste, Fraud, and Abuse—Solicitation (Deviation 2015-02) (Sep 2015)

H.8 DEA-2852.242-76 KEY PERSONNEL (JAN 2014)

H.9 DEA-2852.231-70 TRAVEL REQUIREMENTS FOR CONTRACTORS (JANUARY 2015)

H.10 DEA-2852.203-71 REQUIREMENT FOR NOTIFICATION OF CONTRACTOR EMPLOYEES OF

WHISTLEBLOWER RIGHTS (JAN 2017)

H.11 DEA-2852.203-72 WHISTLEBLOWER INFORMATION DISTRIBUTION (OCT 2021)

H.12 DEA-2852.204-78 CONTRACTOR PERSONNEL REPORTING REQUIREMENTS (MAY 2019)

H.13 DEA-2852.204-80 CONTRACTOR RESPONSIBILITY FORM CERTIFICATION (SEP 2021)

H.14 DEA-2852.237-70 Preventing Personal Services Contracts and Performance of Inherently Government

Functions (JUN 2018)

H.15 DEA-2852.239-71 INFORMATION RESELLERS OR DATA BROKERS (MAY 2012)

H.16 DEA-2852.239-73 SECURITY OF DOJ INFORMATION AND SYSTEMS (AUG 2015)

H.17 DEA-2852.242-82 DOJ REPORTING SYSTEM FOR REPORTABLE PERSONNEL SECURITY

RELATED ACTIVITIES (NOV 2021)

H.18 DEA-2852.242-81 CONTRACTOR RECORDS MANAGEMENT REQUIREMENTS (SEP 2020)

H.19 DEA-2852.242-77 PERMITS AND LICENSES (MAY 2012)

H.20 DEA-2852.242-78 APPROVAL REQUIRED FOR ADVERTISING AND MEDIA RELEASES (MAY

2012)

PART II—CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES

I.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

I.2 CLAUSES INCORPATED BY FULL TEXT

I.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS

(NOV 2021)

I.4 52.216-18 ORDERING (OCT 1995)

I.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

I.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

I.7 52.223-99 ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL

CONTRACTORS (OCT 2021) (DEVIATION)

I.8 DEA-2852.218-70 CONTINUING CONTRACT PERFORMANCE DURING A PANDEMIC

INFLUENZA OUTBREAK OR OTHER BIOMEDICAL EMERGENCY OR CATASTROPHE (JUL 2021)

I.9 DEA-2852.242-72 FINAL INVOICE AND RELEASE OF RESIDUAL FUNDS (MAY 2012)

I.10 DEA-2852.245-70 GOVERNMENT FURNISHED RESOURCES (MAY 2012)

I.11 JAR-2852.222-71 DOMESTIC VIOLENCE, SEXUAL ASSAULT, AND STALKING (MAR 2020)

PART III—LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS

SECTION J – LIST OF EXHIBITS AND ATTACHMENTS

J.1 EXHIBITS

PART IV—REPRESENTATIONS AND INSTRUCTIONS

SECTION K – REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS ... 76

K.1 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (MAY 2022)

K.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS

(NOV 2021)

K.3 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (AUG 2020)

K.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR RESPONDENTS

L.1 COMMUNICATIONS

L.2 TIME, DATE, AND PLACE FOR SUBMISSION OFFER

L.3 INSTRUCTIONS TO OFFERORS

L.4 TECHNICAL OFFER (VOLUME I) INSTRUCTION

L.5 BUSINESS OFFER (VOLUME II) INSTRUCTIONS

SECTION M – EVALUATION OF OFFERS AND BASIS FOR AWARD

M.1 EVALUATION GENERAL

M.2 BASIS OF AWARD

M.3 BUSINESS OFFER (VOLUME I) EVALUATION (PHASE 1)

M.4 TECHNICAL OFFER (VOLUME I) EVALUATION (PHASE 1)

M.5 BUSINESS OFFER (VOLUME II) EVALUATION (PHASE 2)

EXHIBIT 1 – CONTRACTOR RESPONSIBILITIES (8 PAGES)

15DDHQ22R00000014 Page 5

PART 1 – THE SCHEDULE

SECTION A – SOLICITATION/CONTRACT FORM

[Insert Standard Form 33, Solicitation, Offer and Award]

15DDHQ22R00000014 Page 6

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 TYPE OF AGREEEMENT

This is a FAR 15 Acquisition being solicited on an Unrestricted Basis under “Administrative Management and General Management Consulting Services” NAICS code 541611 which has a $21.5 Million revenue threshold for Small Business.

B.2 TRAVEL PRICING

Although no travel is anticipated under this Contract, should that change at any time the Contractor travel in support of this contract is subject to the Federal Travel Regulations which are incorporated by reference. Travel within fifty miles of the contractor’s residence will not be reimbursed.

15DDHQ22R00000014 Page 7

B.3 CONSIDERATION AND PAYMENT

The following represents the price schedule for this contract:

• Phase 1 - The Government anticipates making up to three awards as a result of this solicitation. Each Awardee shall provide an estimate for completing Phase 1 one of this project with a maximum Fixed Price of $150,000. It is understood and agreed as a requirement of this contract that the Government will reimburse allowable, allocable, and reasonable expenses under this contract in accordance with an indirect cost rate agreement for expenses up to but not exceeding $150,000 per contract award. The contractors will make presentations to the Government at the conclusion of Phase 1 and at least one awardee will have the Option exercised for Phase 2 to this project, as described below.

The purpose of Phase 1 is to develop and propose new models, data sets, and approaches for establishing (and revising) aggregate production quotas for schedule I and II controlled substances as well as new models, data sets, and approaches for establishing (and revising) individual quotas granted to DEA-registered manufacturers in a manner which ensures and adequate supply of controlled substances while also curbing oversupply. The Contractor shall have 60 days from the Contracting Officer’s Notification to Proceed to submit its recommendations for the New Quota Model Structure.

• Phase 2 – It is anticipated that the Option for Phase 2 will be issued within 90 days of completion of Phase 1. The contractor(s) shall provide an expansion of the proposal provided to the Government under Phase 1. Developing a road map to implement those aspects of Phase 1 which the DEA determines to be acceptable. In accordance with FAR

16.601 the Contractor shall propose the labor categories (knowledge, skills and abilities associated with that labor category) associated with their effort on this contract. For price comparison purposes, each offeror should provide a staffing plan based on a not-to-exceed total effort of 2,000 billable hours. For example, one offeror may propose a two-person team to include a Senior Program Manager and a Junior Program Manager with the proposal assuming the Senior PM will bill 500 hours, and the Junior PM will bill 1,500 hours. The Government will apply a cost realism analysis to the labor categories and number of hours being proposed to ensure that the effort is reasonable and does not constitute “buying in” to the contract at an unreasonably low price.

(Next Page)

15DDHQ22R00000014 Page 8

Phase 2 – Pricing Table CLIN # Labor Hour Category Maximum

Hours Unit Unit Price Total Price

0001 $ $ 0002 $ $ 0003 $ $ 0004 $ $ Total Base Period $

Add additional CLINs and Labor Hour Categories as applicable.

• Phase 3 - It is anticipated that Phase 3 would begin within one year from the date of contract award.

Phase 3 of the contract may be exercised as a unilateral right of the Government. Phase 3 is an Optional task which will use Labor Categories from Phase 2 to provide consultation to the Government during implementation of the resulting recommendations for development of a drug diversion quota as proposed by the Contractor. This effort, if exercised, includes assisting the Government in answering questions posed to other regulatory and oversight organizations. For evaluation purposes only, the Government will apply 500 hours for each of the offeror’s three highest priced labor categories.

Phase 3 - Consultation and Analysis

CLIN # Labor Hour Category Maximum Hours

Unit Unit Price Total Price

1001 $ $ 1002 $ $ 1003 $ $ Total Phase 3 – Option One $

Phase 3- Option Consultation and Analysis (Option Year Two)

CLIN # Labor Hour Category Maximum Hours

Unit Unit Price

Total Price

2001 $ $ 2002 $ $ 2003 $ $ Total Phase 3 - Option Year Two $

(End of Section B)

15DDHQ22R00000014 Page 9

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 INTRODUCTION

The DEA has not significantly changed its procedures for establishing and adjusting aggregate production quotas (APQ) in the last 50 years. After living through the prescription opioid crisis in the United States and observing the rise in aggressive marketing practices which drove the oversupply of certain controlled substances, DEA believes it is critical to overhaul the quota process. DEA now seeks a new model for quota, to include more real-time and accurate data, new sources of data, and a better means of analyzing data.

DEA requires consultation services to recommend a new approach to setting quota. Specifically, DEA is seeking to award up to three contracts to consultants to identify new models, data sets, and approaches to DEA’s implementation of its quota program, to include ideas on better risk identification and mitigation, new quality control procedures, new models for utilization of existing data sources, identification of new data sources, identification of additional information DEA should require from manufacturers, and proposals for broad reforms in DEA’s approach to determining thresholds that ensure an adequate supply of controlled substances while also curbing oversupply.

Consultants must have expertise in supply chain economics/management and data analytics in order to make recommendations on how DEA can reform this vital regulatory program.

C.2 BACKGROUND

Each year, DEA establishes (and adjusts) the aggregate production quotas (APQ) for all schedule I and II controlled substances (approximately 300 controlled substances) as well as the Assessment of Annual Needs (AAN) for the following three (3) list I chemicals: ephedrine, pseudoephedrine and phenylpropanolamine. The APQs and AANs represent the maximum quantity (ceiling) which may be produced in the United States to meet the estimated medical, scientific, research and industrial needs of the United States, lawful exports and reserve stock requirements. DEA’s quota program is an essential function and represents an important means by which DEA fulfills a portion of its mission, by “…ensuring an adequate and uninterrupted supply [of controlled substances] for legitimate medical, commercial, and scientific needs.”

DEA’s current quota program is administered by the Diversion Control Division’s Office of Diversion Control Regulatory (DR). DR’s UN Reporting and Quota Section (DRQ) performs the day-to-day operations of the program. DRQ is staffed by scientists who are solely dedicated to fulfilling this function. Their work is governed by statute (21 U.S.C. § 826) and implementing regulations (21 CFR parts 1303 and 1315). The APQ and AAN are established using informal adjudication procedures defined further by the regulations. Once the APQ and AAN are finalized, DRQ adjudicates approximately 3,700 individual quotas throughout the year to approximately 300 DEA-registered manufacturers of schedule I and II controlled substances as well as DEA-registered manufacturers and importers of the list I chemicals: ephedrine, pseudoephedrine and phenylpropanolamine. Diversion seeks to adjudicate quota applications it receives during the quota year expeditiously but also accurately. Each quota should be scientifically accurate based on legitimate supply needs.

To strengthen the effectiveness of the quota program and help prevent diversion, Congress passed the SUPPORT Act in October 2018. That statute directed DEA to consider diversion

15DDHQ22R00000014 Page 10 when establishing the APQ for five opioid controlled substances (fentanyl, hydrocodone, hydromorphone, oxycodone and oxymorphone). DEA was directed to consider the rates of overdose deaths and abuse, and the overall public health impact, when making determinations of APQ for those five substances. In both its estimation of diversion for these substances identified in the SUPPORT Act and in its determination of APQ more generally, DEA must remain agile and innovative to keep pace with evolving technology and marketing practices. DEA seeks to identify and analyze new, real-time, and accurate data sources and develop new forecasting models for setting APQ and evaluating individual manufacturing and procurement quota requests. This contract represents a new line of effort to create a better quota system.

C.3 STATEMENT OF WORK

Phase 1 involves a high-level task of determining new models, data sets, and approaches to setting quota, building on publicly available information on how the Aggregate Production Quota (APQ) is currently developed. After completing a nondisclosure agreement, the Contractor will receive access to DEA provided data and other information that would help the contractor(s) in creating hypotheses, testing that hypotheses, and developing an approach for implementing an APQ under Phase 2. Phase 1 will set out approaches and potential models for broad reform of DEA’s quota system. Phase 1 requires completion within 60 days of the initial “kick-off” meeting.

Phase 1 (due 60 days). The Government will provide each contractor with background materials on the existing quota process and data sources and models utilized. The Contractor shall recommend innovative approaches based on new models and data sets for how DEA should establish (and adjust) the Aggregate Production Quota (APQ) and issue individual manufacturing and procurement quotas to ensure an adequate supply while preventing oversupply. The contractor shall identify challenges in consultation with the Government and propose practicable recommendations which can be implemented immediately in making any necessary adjustments to the APQs under 21 CFR 1303.13 (and individual quotas established under the APQs) in an effort to improve procedures. Proposed models shall include suggestions for new approaches to the quota program that prioritize real-time, accurate data and reliable forecasting models.

Upon completion of Phase 1 and DEA’s review of each contractor’s report, the DEA may schedule presentations of each contractor’s proposal and respond to questions about the Contractor’s proposed approach.

15DDHQ22R00000014 Page 11

SECTION D – PACKAGING AND MARKING

D.1 DEA-2852.247-70 GENERAL PACKAGING AND MARKING REQUIREMENTS

(MAY 2012)

See attachment Exhibit 1 DEA Provisions and Clauses for detailed information.

Unless otherwise specified, all items to be delivered under this contract shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier and ensure safe delivery at destination.

All initial packing, marking and storage incidental to shipping of equipment to be provided under this contract shall be at the Contractor’s expense. The Contractor shall supervise the packing of all acquired equipment furnished by the Contractor and shall supervise the unpacking of equipment to be installed.

D.2 MARKINGS

All deliverables submitted to the Contracting Officer or the designated Contracting Officer’s Representative (COR) shall be accompanied by a packing list or other suitable shipping document that shall clearly indicate the following.

• Contract Number

• CLIN Number

• Name and address of the consignor

• Name and address of the consignee

• Government bill of lading number covering the shipment (if any); and

• Description of the item/material shipped, including item number, quantity, number of containers, and package number (if any)

D.3 EQUIPMENT REMOVAL

All Contractor-owned equipment, accessories, and devices located on Government property shall be dismantled and removed from Government premises by the Contractor, at the Contractor’s expense, within 90 calendar days after contract expiration, or as mutually agreed by the Government and the Contractor.

All Government provided equipment will be returned to the Government prior to submission and payment of the contractor’s final invoice.

(End of Section D)

15DDHQ22R00000014 Page 12

SECTION E – INSPECTION AND ACCEPTANCE

E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY

REFERENCE

The following contract clauses pertinent to this section are hereby incorporated by reference in accordance with FAR clause “52.252-2, Clauses Incorporated by Reference. See Section I, for full text version of FAR clause 52.252-2 and for an internet address for electronic access to full text of FAR clauses.

FEDERAL ACQUISTION REGULATION (48 CFR CHAPTER 1)

Clause Number Title Date

52.246-4 Inspection of Services—Fixed-Price AUG 1996

52.246-15 Responsibility of Supplies APR 1984

E.2 ACCEPTANCE CRITERIA

The COR, or other persons designated by the COR, and approved by the CO, will review all draft and final deliverables to ensure accuracy, functionality, completeness, professional quality, and overall compliance with contract requirements. The Government will consider errors, misleading statements, incomplete, irrelevant information, or repetition as deficiencies and the Contractor shall make corrections at no additional cost.

The COR will review deliverables prior to acceptance. The COR shall review the deliverable for acceptance or rejection within 20 business days of receipt from the Contractor. In the event a deliverable is rejected, the CO will notify the Contractor of the reason(s) within 30 business days of receipt of the deliverables from the Contractor. The CO is the only one who may reject deliverables. The Contractor shall correct and resubmit rejected deliverables within fifteen (15) business days of receipt of rejection notification.

(End of Section E)

SECTION F – DELIVERIES OR PERFORMANCE

F.1 DEA-2852.211-70 PERIOD OF PERFORMANCE (BASE AND OPTIONS)

The period of performance of base period of this contract begins on [DATE TBD] and ends on

[DATE TBD].

Pursuant to clause 52.217-9, Option to Extend the Term of the contract, in the event that the Contracting Officer exercises an option, the period of performance for each option period shall be as follows:

The exercise of any options is subject to the availability of funding and the continuing needs of the Government.

(End of clause)

F.2 PLACES OF PERFORMANCE

Place of performance is the Contractor’s facility. If necessary, performance may occur at the DEA facility for periods not to exceed ninety (90) days at DEA Headquarters located at 600 & 700 Army Navy Drive, Arlington, Virginia in performance of the SOW.

Option Period 1:

Option Period 2:

To be Determined To be Determined

F.3 DELIVERABLES

All applicable deliverables, required delivery dates, and destination of delivery are specified in the SOW. The schedule for completion of work to be performed is specified in the SOW.

[To be Inserted based on proposal/Schedule for Deliverables/Completion of Work]

In addition to the deliverables required under the contract, additional deliverables will be identified at the task order level.

Final Phase 1 Report. The Contractor shall prepare a report at the completion of Phase 1 of this project, as follows:

1. Phase 1 Report (Due 60 days after date of notification to proceed by the Contracting Officer). The Contractor shall prepare a final report as the completion of Phase 1.

The report shall:

• Describe the methodology of how the assessment was conducted including data and sources used.

• Recommend a new model for DEA setting and adjusting the APQ and issuing individual manufacturing and procurement quotas. Support recommendations through sources and information used to include statements of value, benefit, risk mitigation, reliability and validity.

• Identify challenges and describe proposed recommendations which can be implemented immediately for APQ determinations and adjustments under 21 CFR 1303.13 (and any individual quotas granted under the APQ), as well as recommendations for longer-term reforms.

Phase 2 Report: Phase 2 shall begin with the coordination of a management plan by the Contractor based on direction provided by the Government after the conclusion of Phase 1.

Following submission and Government Acceptance of this management plan, the Contractor shall provide a monthly management report (due no later than the first week of the month) addressing the agreed upon steps and progress gained in relation to the proposed management plan. The Contractor shall include all agreed upon reviews and Government required approvals in this monthly report as steps approach and are completed.

Phase 3 Report: Phase 3 shall include ad hoc reports to include responses to queries to the Drug Enforcement Administration by organizations outside of the DEA. Ad Hoc reports are subject to receipt and acceptance by the Government.

Task When To Whom Format Content

F.4 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY

REFERENCE

The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title and Date) in accordance with the clause at FAR “52.252-2 CLAUSES INCORPORATED BY REFERENCE” in Section I of this contract. See Section I.1 for internet address to view full text of clause.

Number Title Date

52.242-15 Stop-Work Order AUG 1989

52.247-34 F.O.B. Destination NOV 1991

F.5 NOTICE OF DELAYS TO THE GOVERNMENT

Whenever the Contractor has knowledge that any actual or potential situation may delay the timely performance of this Contract, the Contractor shall immediately notify the Contracting Officer (CO) and the Contract COR in writing, giving pertinent details.

(End of Section F)

15DDHQ22R00000014 Page 16

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 REQUIREMENTS

Final Phase 1 Report. The Contractor shall prepare a report at the completion of Phase 1 of this project, as follows:

Phase 1 Report (Due 60 days after date of notification to proceed by the Contracting Officer).

The Contractor shall prepare a final report as the completion of Phase 1. The report shall:

• Describe the methodology of how the assessment was conducted including data and sources used.

• Recommend a new model for DEA setting and adjusting the APQ and issuing individual manufacturing and procurement quotas. Support recommendations through sources and information used to include statements of value, benefit, risk mitigation, reliability and validity.

• Identify challenges and describe proposed recommendations which can be implemented immediately for APQ determinations and adjustments under 21 CFR

1303.13 (and any individual quotas granted under the APQ), as well as recommendations for longer-term reforms.

Phase 2 Report: Phase 2 shall begin with the coordination of a management plan by the Contractor based on direction provided by the Government after the conclusion of Phase 1.

Following submission and Government Acceptance of this management plan, the Contractor shall provide a monthly management report (due no later than the first week of the month) addressing the agreed upon steps and progress gained in relation to the proposed management plan. The Contractor shall include all agreed upon reviews and Government required approvals in this monthly report as steps approach and are completed.

Phase 3 Report: Phase 3 shall include ad hoc reports to include responses to queries to the Drug Enforcement Administration by organizations outside of the DEA. Ad Hoc reports are subject to receipt and acceptance by the Government.

G.2 TECHNICAL DIRECTION

Technical Direction is defined to include:

• Written directions to the Contractor which fill in details, suggest possible lines of inquiry, or otherwise facilitate completion of work within the existing scope of work as defined in the statement of work.

• Review and, where required, provide written approval of technical reports, drawings, specifications, or technical, or technical information to be delivered. Technical direction must be in writing, and must be within the scope of the work as noted in Section C.

G.3 INTERPRETATION OR MODIFICATION

Any modification to a contract must be in writing. A contracting officer cannot change any expressed contract term by oral direction. All requests for interpretation or modification shall be made in writing to the Contracting Officer.

15DDHQ22R00000014 Page 17

G.4 DEA-2852.203-70 FORMER EMPLOYMENT OR ASSIGNMENT WITH THE DEA

(SEP 2021)

(a) Any offeror or contractor who intends to employ any individual who either currently works for DEA, or had been employed with DEA as a Federal employee within the previous five (5) years for work supporting a prospective or active DEA contract must notify

DEA of its intent as described in this clause.

(b) The offeror or contractor shall instruct any prospective or current employee meeting the criteria in paragraph (a), above, to complete and sign a DEA Contractor Ethics

Questionnaire. The questionnaire is available for download at https://www.dea.gov/sites/default/files/2020-06/contractor_ethics_questionnaire_jan_2020.pdf. When the intent to employ such individual is known prior to the award of a new contract or order, the contractor shall submit the employee’s completed questionnaire and résumé to DEA concurrently with its proposal. When the intent is to employ such individual under an existing contract or order, the contractor shall submit the completed questionnaire and résumé electronically to the cognizant DEA contracting officer AND ethicsFAC@dea.gov.

(c) The offeror or contractor understands that any such employees described in paragraph (a) are prohibited from appearing before, or communicating with, the Federal

Government on behalf of a contractor regarding a Government contract, investigation or other particular matter that they participated in personally and substantially as a Federal employee with the intent to influence Government officials in those matters for the lifetime of those matters.

(d) The offeror or contractor further understands that for two (2) years after leaving the Federal Government, such employees described in paragraph (a) are prohibited from appearing before, or communicating with, the Government with the intent to influence on behalf of a contractor regarding a Government contract, investigation or other particular matter that they did not participate in personally and substantially as a Federal employee, but that was under their official responsibility during their last year in the Government. For purposes of this clause, an employee is defined as one appointed under Title 5, Section 2015 or Title 21, Section 878 of the United States Code.

(e) If DEA determines after reviewing questionnaire responses or conducting other inquiries that the prospective employee is disqualified for assignment to the contract based on an unfavorable suitability and/or security determination, or may violate the post-employment restrictions described in paragraphs (c) or (d), above, or other applicable laws if allowed to work on or support the contract/task order, at DEA’s request, the offeror or contractor must not assign such employee to work under a prospective or active contract.

(f) If an offeror or contractor fails to provide a required Questionnaire, the prospective employee will not be approved to work under the DEA contract or order until such time as the Questionnaire is submitted, reviewed, and approved in accordance with established procedures.

https://www.dea.gov/sites/default/files/2020-06/contractor_ethics_questionnaire_jan_2020.pdf mailto:ethicsFAC@dea.gov

15DDHQ22R00000014 Page 18

G.5 DEA-2852.211-71 SCHEDULED AND UNSCHEDULED CLOSURES OF

GOVERNMENT OFFICES (JUL 2021)

(a) In accordance with 5 U.S.C. 6103, Federal Government offices are closed for ordinary business in observance of the following holidays:

• New Year’s Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

• Inauguration Day (Federal offices in the Washington DC metropolitan area only)

(b) Federal offices may close at other times without advance notice due to emergencies, inclement weather, interruption of utilities, or other reasons. Such closures may be declared by the President, Office of Personnel Management, Office of Management and Budget, the Administrator of the DEA, or other appropriate executive authority. The duration of such closures may range from an early closure with normal operations expected on the next business day to a period of indeterminate length.

(c) At the time that a closure is declared, appropriate information, notifications, and instructions will be provided regarding the return to normal operations. The Contractor shall comply with all directives issued in regards to such closures. The Contractor shall follow agency procedures for registering emergency contact information and shall monitor appropriate broadcast mediums for receiving emergency information.

(d) When a closure is declared, contractor personnel must vacate the facility as directed except personnel designated in accordance with agency procedures by the contracting officer to remain onsite to continue performance. Evacuated personnel will not be allowed to reenter the facility for the duration of the closure. Performance of work at alternate sites is not permissible except in accordance with the terms of the contract and written authorization by the contracting officer.

(e) Whenever it is necessary for contractor employees to continue performance during such closures, the contracting officer will provide written authorization for such work.

Such written authorization will designate the specific individuals authorized to continue performance, alternate work sites when applicable, work schedules, work dates, and special instructions and information. Telework may be authorized if permitted by the terms of the contract. Any services scheduled to be performed at Government facilities shall not be performed elsewhere unless specifically authorized in accordance with the terms of this contract.

(f) For firm fixed priced contracts, the terms for invoicing and payment in the contract will remain unchanged unless changed by a fully executed modification to the contract.

(g) For other than firm fixed priced contracts, the contractor shall invoice in accordance with the Payments and Prompt Payment clauses of the contract only for work http://uscode.house.gov/view.xhtml?req=(title:5%20section:6103%20edition:prelim)%20OR%20(granuleid:USC-prelim-title5-section6103)&f=treesort&edition=prelim&num=0&jumpTo=true

15DDHQ22R00000014 Page 19 performed. Employee compensation for the period of the closure shall be governed by corporate policy.

(h) Agency-sponsored events such as picnics or other social events are not considered to be official office closures. The Contractor shall not invoice for time spent by its employees attending or participating in such events.

(i) In no case will any compensable administrative leave, which might be approved for Federal employees in connection with official holidays or other events, extend to contractor personnel.

G.6 DEA-2852.242-70 CONTRACTOR PERFORMANCE ASSESSMENT (MAR

2020)

(a) Pursuant to FAR subpart 42.15, the Government will assess the Contractor’s performance under this contract. Performance assessment information may be used by the

Government for decision-making on exercise of options, source selection, and other purposes, and will be made available to other federal agencies for similar purposes.

(b) Performance will be assessed in the following areas:

(1) Quality of product or service;

(2) Schedule;

(3) Cost control;

(4) Business relations;

(5) Management of key personnel; and

(6) Other appropriate areas.

(c) For contracts that include the clause at 52.219-9, Small Business Subcontracting

Plan, performance assessments will consider performance against, and efforts to achieve, small business subcontracting goals set forth in the small business subcontracting plan.

(d) For any contract with a performance period exceeding 18 months, inclusive of all options, the Government will perform interim performance assessments annually and a final performance assessment upon completion of the contract.

(e) The Government will prepare contractor performance assessment reports electronically using the Contractor Performance Assessment Reporting System (CPARS).

Additional information on CPARS may be found at www.cpars.gov.

(f) The Contractor will be provided access to CPARS to review performance assessments. The Contractor shall designate a CPARS point-of-contact for each contract subject to performance assessment reporting. Upon setup of a contract in CPARS, the

Contractor’s CPARS point-of-contact will receive a system-generated e-mail with information and instructions for using CPARS. Prior to finalizing any contractor performance assessment, the Contractor shall be given 14 calendar days to review the report and submit comments, rebutting statements, or additional information. Disagreements between the Contractor and the Government performance assessment official will be resolved by a Government

Reviewing Official, whose decision on the matter will be final.

https://www.acquisition.gov/content/part-42-contract-administration-and-audit-services#i1074222 https://www.acquisition.gov/content/52219-9-small-business-subcontracting-plan http://www.cpars.gov/

15DDHQ22R00000014 Page 20

(g) The Government will also report in the Federal Awardee Performance and

Integrity Information System (FAPIIS) module of CPARS information related to:

(1) A Contracting Officer’s final determination that a contractor has submitted defective cost or pricing data;

(2) Any subsequent change to a final determination concerning defective cost or pricing data pursuant to 15.407-1(d);

(3) Any issuance of a final termination for default or cause notice; or

(4) Any subsequent withdrawal or a conversion of a termination for default to a termination for convenience.

G.7 DEA-2852.242-71 INVOICE REQUIREMENTS (MAY 2012)

The Contractor shall submit scanned or electronic images of invoice(s) to Invoice.Diversion@dea.gov including an additional copy of the invoice, clearly marked as an information copy and shall be submitted to COR Appointee.

The date of record for invoice receipt is established on the day of receipt of the email if it arrives before the end of standard business hours or the next business day if the invoice arrives outside of normal business hours.

Scanned documents with original signatures in PDF or other graphic formats attached to the email are acceptable. Digital/electronic signatures and certificates cannot be processed by DEA and will be returned.

In addition to the items specified in FAR 32.905(b), a proper invoice shall also include the following minimum additional information and/or attached documentation:

• Total/cumulative charges for the billing period for each Contract Line Item

Number (CLIN);

• Dates upon which items/services were delivered; and

• The Contractor’s Taxpayer Identification Number (TIN).

Invoices will be rejected if they are illegible or otherwise unreadable, or if they do not contain the required information or signatures.

G.8 DEA-2852.242-72 FINAL INVOICE AND RELEASE OF RESIDUAL FUNDS

(a) The Contractor shall submit a copy of the final invoice to the Contracting Officer (COR) or designee at the address listed in clause DEA-2852.242-71, Invoice Requirements. The final invoice must be marked “Informational Copy – Final Invoice.”

(b) By submission of the final invoice and upon receipt of final payment, the Contractor releases the Government from any and all claims arising under, or by virtue of, this contract. Accordingly, the Government shall not be liable for the payment of any future invoices that may be submitted under the above referenced order.

mailto:Invoice.Diversion@dea.gov

15DDHQ22R00000014 Page 21

(c) If residual funds on the contract total $100 or less after payment of the final invoice, the Government will automatically de-obligate the residual funds without further communication with the vendor.

(d) If funds greater than $100 remain on this order after payment of the final invoice, the Government will issue a bilateral modification to de-obligate the residual funds. The Contractor will have up to 30 calendar days after issuance of the modification to sign and return it. The Contractor’s signature on the modification shall constitute a release of all claims against the Government arising by virtue of this contract, other than claims, in stated amounts, that the Contractor has specifically exempted from the operation of the release. If the contractor fails to sign the modification or assert a claim within the stated period, the Government will de-obligate the residual balance and proceed with close-out of the contract.

G.9 DEA-2852.242-73 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(a) Pursuant to FAR 1.602-2, the following individual has been designated as the Contracting Officer's Representative (COR) under this contract:

[name] TBD

[title]

[organization]

[Phone]

[email]

(b) The COR has responsibility for performing contract administration, which includes, but is not limited to, the following duties: functioning as the technical liaison with the contractor; monitoring the contractor’s performance and progress of the work; receiving, inspecting, and accepting all deliverables or services provided under the contract; and reviewing all invoices/vouchers submitted for payment.

(c) The COR does not have the authority to alter the contractor's obligations under the contract, and/or modify any of the expressed terms, conditions, specifications, or cost of the agreement. If as a result of technical discussions, it is desirable to alter/change contractual obligations or the Scope of Work, the Contracting Officer shall issue such changes.

(End of Section G)

15DDHQ22R00000014 Page 22

G.10 DEA-2852.242-74 CONTRACT ADMINISTRATION POINTS OF CONTACT

The mailing address for the Contract Administration Office for this contract is:

U. S. Department of Justice

Office of Acquisition and Relocation Management (FA)

8701 Morrissette Drive

Springfield, VA 22152

Contracting Officer (CO)

TO BE COMPLETED AT TIME OF AWARD.

Name:

Title:

Agency:

Telephone:

Email:

Contracting Specialist (CS)

TO BE COMPLETED AT TIME OF AWARD

Name:

Title:

Agency:

Telephone:

Email:

G.11 DEA-2852.242-81 CONTRACTOR RECORDS MANAGEMENT

REQUIREMENTS (SEP 2020)

A. Applicability

This clause applies to all contractors whose employees create, receive, or maintain federal records as defined below in Section B.

B. Definitions

“Federal record,” 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a federal agency under federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

15DDHQ22R00000014 Page 23

DEA Federal Records include records created, received, or maintained by the contractor its employees, agents, or subcontractors pursuant to this contract; and, deliverables and documentation associated with deliverables. Personal materials are not considered federal records.

C. Requirements

1. The contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. Chapters 21, 29, 31, and 33), NARA regulations at

36 C.F.R. Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. § 552a). These policies include the preservation of all DEA records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 C.F.R. § 1222.32, all data created for government use and delivered to, or falling under the legal control of the government are federal records subject to the provisions of 44

U.S.C. Chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. § 552), as amended, and the Privacy Act of 1974 (5 U.S.C. § 552a), as amended, and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 C.F.R. § 1222.32, the contractor shall maintain all DEA records created for

DEA use or created in the course of performing this contract and/or delivered to, or under the legal control of the government, and records must be managed in accordance with federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. DEA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records shall not be destroyed except in accordance with the provisions of the agency records schedules and with concurrence of the DEA Contracting

Officer. Records may not be removed from the legal custody of DEA without the written concurrence of the Deputy Assistant Administrator, Office of Acquisition and Relocation

Management. Willful and unlawful destruction, damage, or alienation of federal records is subject to the fines and penalties imposed by 18 U.S.C. § 2701.