RFP (with attachments).pdf

Issued by:

Rob Bailey o a e

I e o o a s a a e e B a Red e o uisi o s a o al I s u e o u buse I

NIDA 3WFN MSC 6012

301 N. Stonestreet Ave.

Bet esda MD 20 2 oint o Conta t: Rob Bailey Contra n er E-Mail: rob.bailey ni . ov one: 301.451. 5 6

11 , 4:00 .M. Eastern Standard i e e Na onal Ins tute on Dru Abuse NIDA invites you to sub it a ro osal res ondin to t e re uire ents o t is RF No. 5N 5024R00045 or Analy al C e istry and Stability es n o reat ent Dru s or Substan e se Disorders .

is Re uest or ro osal is re ared in a ordan e it t e ni or Contra t For at res ribed or overn ent Wide a li a on by t e Federal A uisi on Re ula on FAR . e ni or Contra t For at is bot a Re uest or ro osal and a ontra t a ard do u ent. e resul n ontra t ill onsist o arts I, II, III o t e ni or Contra t For at.

a 1 a a a 1 a a a a a a a a a a a a a a a a a a a a a a a a a a a

Please re er to Se on M or andatory uali a on criteria. Addi onally, all o erors ust be RE IS ERED and ave an ACTIVE Syste or Award Mana e ent : www.sa . ov (www.sa . ov account at t e e an o er ro osal is sub i ed to t e overn ent. All o erors re istered in t e Syste or Award Mana e ent : www.sa . ov (www.sa . ov ust be in ull co liance wit FAR 52.204-13 Syste or Award Mana e ent Maintenance and FAR 52.207- 7 Syste or Award Mana e ent to be eli ible to sub it a ro osal. T e overn ent will not acce t ro osals ro o erors w o do not eet t e SAM re uire ent.

T IS IS S ICITED NDER . T e NAICS code a licable to t is buy is 541715. See Sec on .1.b. o t is RFP.

a

Par cularly direct your a en on to Part IV, w ic contains instruc ons, rovisions, and evalua on actors or t e sub ission and review o ro osals. T e balance o Parts I, II, and III contain rovisions, clauses, and s ecial re uire ents w ic will be ade a art o any resultant award. Review t ese arts as to t e e ects on er or ance ca ability, tec nical and cost considera ons in t e develo ent o your ro osal. Do not ll in blanks or ot erwise co lete or ons o Parts I, II, and III w ic ot erwise a ear to re uire t e inser on o data.

T e overn ent will co lete t ose Parts rior to contract award and (i ne o a ons are conducted will tailor t ose ite s t rou nal ne o a ons.

You ust ave an aut ori ed or ani a onal o cial si n your Business Pro osal. It ust contain a detailed breakdown o costs by year and individual o ons or eac cost cate ory ele ent, an e lana on o t e basis or all costs and docu enta on to su ort t ese costs. We direct s ecial a en on to t e Breakdown o Pro osed Es ated Costs ( lus ed ee w E cel S reads eet contained in t e Business Pro osal Cost In or a on, A ac ent 10.

Please rovide an electronic co y o t e s reads eet in t is or at. Do not send encry ted les. se o t e above or at will asten review and award. See Sec on .2.c. Business Pro osal Instruc ons or addi onal detail.

Please include a co leted For NI -2043, “Pro osal Su ary and Data Record” wit t e Business Pro osal. Note t at in addi on to tele one and a nu bers, you s ould include t e e- ail addresses o bot t e Princi al Inves ator and t e res onsible business re resenta ve on t e or . For at and content re uire ents o your Tec nical Pro osal are detailed in Sec on .2.b. Tec nical Pro osal Instruc ons. Also, you s ould co lete t e “Tec nical Pro osal Cover S eet” and use it as t e cover s eet or eac co y o your tec nical ro osal. It is i ortant t at you list all ro essional ersonnel and or ani a ons na ed in t e ro osal w o ave any role in t e ro osed work. T is includes your sta , subcontractors, collabora n or ani a ons, and consultants. S ow or ani a on a lia on(s or every erson na ed. You ay use extra s eets, as needed, ollowin t e or at s own in t e Tec nical Pro osal Cover S eet. We will use t is in or a on to ensure t at no con icts o interest exist wit t e selected review co i ee e bers.

T e eror ust sub it its Travel Policy, Total Co ensa on Plan and Annual Re ort wit t e ini al Business Pro osal.

I you want to receive an e- ail no ce o any a end ents to t is RFP, you s ould re ister on t e SAM. ov website. Also, NIDA will ost all a end ents, or rovide an a ro riate link, on t e SAM. ov website.

Re uests or clari ca on, addi onal in or a on, or correc on ust be ade in wri n to t e Contract S ecialist and Contrac n cer. A co leted Pro osal Intent Res onse For .

A ac ent 02 o t e RFP: Please co lete t is or and return it to t is o ce on or be ore Marc 27, 2024.

T e Co leted Pro osal Intent Res onse S eet and o eror ues ons, i any, ust be sub i ed on or be ore 4:00 P.M. Eastern Ti e on Marc 27, 2024. T e res onse s eet and o eror ues ons ust be sub i ed by e- ail to rob.bailey ni . ov wit t e sub ect line:

“ eror Intent and ues ons – 75N 5024R00045” a a

Pro osals ust be sub i ed via t e electronic Contract Pro osal Sub ission (eCPS website ( s: ec s.ni . ov no later t an 4:00 . ., Eastern Standard Ti e (EST on A ril 11, 2024.

Pro osals sub i ed by acsi ile, e- ail, or ard co y will not be acce ted. An o cial aut ori ed to bind your or ani a on ust si n t e ro osal.

erors are solely res onsible or sub i n ro osals in a ely anner. Please note t at crea n an account to sub it ay take u to t ree (3 business days. Please lan accordin ly.

a a a a a a a a 1

All no ces related to t is solicita on will be osted on SAM ( s: www.sa . ov .

In accordance wit FAR 15.306(a (3 and FAR 52.215-1, t e overn ent intends to evaluate ro osals and award a contract wit out discussions. T ere ore, your ini al ro osal s ould contain t e best ter s ro cost or rice and tec nical stand oints. T e overn ent does, owever, reserve t e ri t to conduct discussions i t e Contrac n cer deter ines t e to be necessary.

T is RFP does not co it t e overn ent to ay t e costs or t e re ara on and sub ission o a ro osal. T e Contrac n cer is t e only individual w o le ally can co it t e overn ent to t e ex enditure o ublic unds in connec on wit t is ac uisi on.

Followin your ro osal sub ission and our review, t e Contrac n cer ay seek ore in or a on. In accordance wit FAR 15.306(a (3 and FAR 52.215-1, we advise you t at t e overn ent intends to evaluate ro osals and award a contract wit out discussions (exce t clari ca ons . T ere ore, your ini al ro osal s ould contain t e best ter s ro cost or rice and tec nical stand oints. owever, we reserve t e ri t to conduct discussions i t e Contrac n cer later decides t e to be necessary.

52.232- – .

Re uests or any in or a on concernin t is RFP s ould be directed to Rob Bailey, NIDA ce o Ac uisi ons, Red Branc , w o ay be reac ed on (301 451-75 6; collect calls will not be acce ted. Discussions wit any ot er individual outside t e NIDA Contracts Mana e ent

Branc s ould not occur.

Sincerely yours, Rob Bailey, Contrac n cer Contracts Mana e ent Branc , Red E ail: rob.bailey ni . ov

Robert Bailey - S

Digitally signed by Robert Bailey -S Date: 2024.02.26 12:39:22 -05'00'

Solicitation No. 75N95024R00045 NIDA Ref. No. N01DA-24-001343

RFP TABLE OF CONTENTS

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2 ESTIMATED COST - OPTION

ARTICLE B.3. OPTION QUANTITIES

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

ARTICLE B.5. ADVANCE UNDERSTANDINGS

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

ARTICLE C.2. REPORTING REQUIREMENTS

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

ARTICLE F.2. DELIVERIES

ARTICLE F.3. LEVEL OF EFFORT

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998)

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-

40 (Nov 2021)

ARTICLE G.5. INDIRECT COST RATES

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

ARTICLE G.7. GOVERNMENT PROPERTY

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

ARTICLE H.2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY ... 22 ARTICLE H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING

FROM NIH-FUNDED RESEARCH

ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

ARTICLE H.5. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED

SUBSTANCES

ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

ARTICLE H.7. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

ARTICLE H.8. GUN CONTROL

ARTICLE H.9. OPTION PROVISION

ARTICLE H.10. SUBCONTRACTING PROVISIONS

ARTICLE H.11. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS .. 25

ARTICLE H.11.1. INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

ARTICLE H.11.2 GOVERNMENT INFORMATION PROCESSED ON GOCO OR COCO SYSTEMS

ARTICLE H.12. CONFIDENTIALITY OF INFORMATION

ARTICLE H.13. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS

OF INTEREST

ARTICLE H.14. PUBLICATION AND PUBLICITY

ARTICLE H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

ARTICLE H.16. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

ARTICLE H.17. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

ARTICLE H.18. CONSTITUTION DAY

ARTICLE H.19. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

ARTICLE H.20. USE OF FUNDS FOR PROMOTIONAL ITEMS

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1.1 GENERAL CLAUSES FOR A COST-REIMBURSEMENT CONTRACT WITH EDUCATIONAL

INSTITUTIONS

ARTICLE I.1.2 GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT

CONTRACT

ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

ARTICLE I.5. SERVICE CONTRACT LABOR STANDARDS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

SECTION M - EVALUATION FACTORS FOR AWARD

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority: P.L. 102-321 as amended

2. Request for Proposal (RFP) Number:

75N95024R00045

3. Issue Date:

February 26, 2024

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title : Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders

6. ISSUED BY:

NIDA Section Office of Acquisition National Institute on Drug Abuse c/o 3WFN MSC 6012 301 N Stonestreet Ave.

Bethesda, MD 20892

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 4:00 PM local time on April 11, 2024. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.”

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT

THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE

CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition, LOCATED IN SECTION L.1. OF

THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/ .

11. FOR INFORMATION CALL: Rob Bailey, Contracting Officer

PHONE: (301) 451-7586

e-MAIL: rob.bailey@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Rob Bailey Contracting Officer NIDA Section Contract Management Branch Red, NIDA https://www.sam.gov/SAM/

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A -

SOLICITATION/CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION

APPLICABLE TO THE CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall provide services for analytical chemistry and quality controls of drug substances and/or finished dosage forms in support of NIDA’s medication development programs. In brief, the services include: (1) development and validation of analytical methods for drug substances and/or finished dosage forms; (2) preparation of reference standards; (3) physical and chemical characterizations and quality control testing of drug substances and/or drug products; (4) determination of stability of drug substances and/or finished dosage forms according to the FDA Guidance for Industry: Q1A (R2) Stability Testing of New Drug Substances and Products; (5) provision of an adequate storage facility for the drug substances and/or finished dosage forms; (6) shipment of drug substances and dosage forms to NIDA designated sites; and (7) maintenance of a database to track the shipment and storage of the drug substances and the finished dosage forms. The NIDA Division of Therapeutics and Medical Consequences (DTMC) will use the data produced by this contract in the preparation of Drug Master File (DMF), Investigational New Drug (IND) and New Drug Application (NDA) documentation.

ARTICLE B.2 ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ ____.

b. The fixed fee for the Base Period of this contract is $ _. The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ __.

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period (Contract Year 1) Option Period 1 (Contract Year 2) Option Period 2 (Contract Year 3) Option Period 3 (Contract Year 4) Option Period 4 (Contract Year 5) Total (Base Period and Options)

ARTICLE B.3. OPTION QUANTITIES

a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE

I.3. ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

b. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Quantities specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises these options, notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The estimated cost-plus fixed fee of this contract will be increased as set forth in paragraph c., below.

c. Upon the delivery and acceptance of the Option Quantities described in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below:

Description Period Available Quantity Available

Estimated Cost per Option

Fixed Fee Per Option

Estimated Cost Plus

Fixed Fee Per Option

Option Quantity 1

– Task 1

Base Period (Contract Year 1)

Option Quantity 1

– Task 1

Option Period 1 (Contract Year 2)

Option Quantity 1

– Task 1

Option Period 2 (Contract Year 3)

Option Quantity 1

– Task 1

Option Period 3 (Contract Year 4)

Option Quantity 1

– Task 1

Option Period 4 (Contract Year 5)

Option Quantity 2

– Task 2

Base Period (Contract Year 1)

Description Period Available Quantity Available

Estimated Cost per Option

Fixed Fee Per Option

Estimated Cost Plus

Fixed Fee Per Option

Option Quantity 2

– Task 2

Option Period 1 (Contract Year 2)

Option Quantity 2

– Task 2

Option Period 2 (Contract Year 3)

Option Quantity 2

– Task 2

Option Period 3 (Contract Year 4)

Option Quantity 2

– Task 2

Option Period 4 (Contract Year 5)

Option Quantity 3

– Task 3

Base Period (Contract Year 1)

Option Quantity 3

– Task 3

Option Period 1 (Contract Year 2)

Option Quantity 3

– Task 3

Option Period 2 (Contract Year 3)

Option Quantity 3

– Task 3

Option Period 3 (Contract Year 4)

Option Quantity 3

– Task 3

Option Period 4 (Contract Year 5)

Option Quantity 4

– Task 4

Base Period (Contract Year 1)

Option Quantity 4

– Task 4

Option Period 1 (Contract Year 2)

Option Quantity 4

– Task 4

Option Period 2 (Contract Year 3)

Option Quantity 4

– Task 4

Option Period 3 (Contract Year 4)

Option Quantity 4

– Task 4

Option Period 4 (Contract Year 5)

Option Quantity 5

– Task 5

Base Period (Contract Year 1)

Option Quantity 5

– Task 5

Option Period 1 (Contract Year 2)

Option Quantity 5

– Task 5

Option Period 2 (Contract Year 3)

Option Quantity 5

– Task 5

Option Period 3 (Contract Year 4)

Option Quantity 5

– Task 5

Option Period 4 (Contract Year 5)

Option Quantity 6

– Task 6

Base Period (Contract Year 1)

Description Period Available Quantity Available

Estimated Cost per Option

Fixed Fee Per Option

Estimated Cost Plus

Fixed Fee Per Option

Option Quantity 6 – Task 6

Option Period 1 (Contract Year 2)

Option Quantity 6 – Task 6

Option Period 2 (Contract Year 3)

Option Quantity 6 – Task 6

Option Period 3 (Contract Year 4)

Option Quantity 6 – Task 6

Option Period 4 (Contract Year 5)

Option Quantity 7 – End of Contract Requirement

Prior to contract expiration

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property;

12) Printing costs; and 13) Research Funding.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports shall be submitted electronically.

These reports shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

a. Technical Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

1. Reporting Format/Procedures

The Contractor shall prepare and submit the following reports in electronic copies in Microsoft Windows compatible personal computer files using Microsoft Word for text and numerical data following the formats described below:

Front cover to contain: Date, title, study report name, drug substance/formulation identification, agency (NIDA), division (DPMC) and NIDA COR name/address/phone number, contract number (N01DA-24-8950), Contractor name and investigator names.

Main body to contain: Narrative summaries of the work accomplished, raw data, interpreted results, tables and graphs as necessary. The Contractor shall ensure that all Reports are free from spelling or grammatical errors. Study Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction.

Appendices to contain: All approved (with signatures) methods of analyses, product specifications, and protocols for testing, sampling, and stability study. All appropriate references and batch records.

https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents

2. Reporting Format/Procedures

For proposal preparation purposes only, it is estimated that electronic version(s) will be required as follows:

a) Individual Study Reports:

On Tasks 1-3 and 5-6. Within ten (10) business days after completion of a study, the Contractor shall submit one (1) electronic copy of the Study Report to the NIDA COR. The content and format of the final reports must meet FDA requirements on the Chemistry, Manufacturing and Control Section of DMF/IND/NDA submissions.

b) Monthly Progress Reports:

Within 5 business days after each month of contract work, the Contractor shall submit one electronic copy of a report on activities during the preceding month including the shipment record (Task 4) to the NIDA COR. In the monthly report, the Contractor shall briefly describe any problems encountered while performing any tasks. In addition, the Contractor shall include a list of final study reports sent to the NIDA COR during the month under the report.

The monthly report for the last month of a contract year shall be incorporated into the Annual Report.

c) Annual Progress Report:

Within 15 calendar days of the contract anniversary date, the Contractor shall submit a report on activities during the year. This report shall contain a summary of notable achievements, methods followed for each assay, results obtained, problems encountered and their solutions. One electronic copy is to be sent to the NIDA COR and one electronic copy to the Contracting Officer. The annual report for the last Contract Year shall be incorporated into the Final Report.

d) Final Report:

On or before the expiration date of the contract, the Contractor shall provide a comprehensive summary of work conducted during the entire contract period. This report shall incorporate the final annual report. One electronic copy is to be sent to the NIDA COR and one electronic copy to the Contracting Officer.

e) Individual Subcontracting Report:

Subcontracting report for individual contracts: This report is to be submitted semi annually as well as at contract completion.

3. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available at:

https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT

PROCUREMENTS

Please refer to Article F.2 and Article H.11 for HHS Security and Privacy Language for Information and IT deliverables.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

NIDA Section, Contracts Management Branch Red Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, Maryland 20892, Room 7980 https://www.ecfr.gov/current/title-45/part-94

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected.

Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer’s Representative (See Article G.1.) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute on Drug Abuse National Institutes of Health 301 N Stonestreet Ave.

Bethesda, MD 20892

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

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

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The estimated period of performance of this contract shall be from August 4, 2024 through August

3, 2025.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option Period 1 (Contract Year 2) August 4, 2025 – August 3, 2026 Option Period 2 (Contract Year 3) August 4, 2026 – August 3, 2027 Option Period 3 (Contract Year 4) August 4, 2027 – August 3, 2028 Option Period 4 (Contract Year 5) August 4, 2028 – August 3, 2029

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b.

DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule

(1) Individual Study Report 1 electronic copy – COR Within 10 business days of study completion

(2) Monthly Progress Report 1 electronic copy – COR Within 5 business days of end of contract month

(3) Annual Progress Report 1 electronic copy – COR

1 electronic copy – CO Within 15 calendar days of the contract anniversary date (if options exercised)

(4) Final Report with Summary of Salient Results

1 electronic copy – COR 1 electronic copy – CO

On or before contract expiration

(5) Individual Subcontract Report 1 electronic copy submitted to eSRS

Semi-Annually on April 30th and October 30th

(6) Summary Subcontract Report 1 electronic copy submitted to eSRS

Annually on October 30th

(7) Reporting of Financial Conflict of Interest (FCOI)

1 electronic copy – CO See Article C.2.b.1 for details

(8) System Security Plan (SSP) 1 electronic copy – COR 1 electronic copy – CO 1 electronic copy – ISSO

Within 90 calendar days after contract award and updated annually on the contract anniversary date

Item Description Quantity Delivery Schedule

(9) Security Assessment Plan (SAP) &

Security Assessment Report (SAR) 1 electronic copy – COR 1 electronic copy – CO 1 electronic copy – ISSO

Within 90 calendar days after contract award

(10) FIPS 199 Assessment 1 electronic copy – COR 1 electronic copy – CO 1 electronic copy – ISSO

Within 90 calendar days after contract award

(11) Privacy Threshold Analysis (PTA)/ Privacy Impact Assessment (PIA)

1 electronic copy – COR 1 electronic copy – CO 1 electronic copy – ISSO

See article C.2.b.2 for details

(12) Contractor Non-Disclosure Agreement (NDA)

1 electronic copy – COR 1 electronic copy – CO

See article C.2.b.2 for details

(13) Invention Report – Annual Utilization Report (if option periods are exercised)

1 electronic copy – CO Within 30 calendar days of contract anniversary date

(14) Final Invention Report 1 electronic copy – CO On or before contract expiration

b. The above items shall be addressed and delivered electronically to:

Addressee Deliverable Item No Quantity

Contracting Officer

3, 4, 7, 8, 9, 10, 11, 12, 13, and 14 1

Contracting Officer’s Representative

1, 2, 3, 4, 8, 9, 10, 11, and 12 1

Information System Security Officer (ISSO)

8, 9, 10, and 11 1

c. In accordance with FAR 4.804, following contract expiration/completion, the Contractor shall be responsible for providing the following items: Indirect cost rate proposals for all years (in which a proposal was not previously submitted); final property inventory (excluding intellectual property);

standard forms 1428 and 1429 (if applicable); settling all subcontract costs and any issues thereunder; subcontracting compliance reports for all years to the eSRS; final patent and royalty reports; Contractor's release of claims, i.e. Contractor's closing statement; the Contractor's Assignment of Refunds, Rebates and Credits; and a final invoice or completion voucher (marked final).

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide ______ direct labor hours. The labor hours exclude vacation, holiday, and sick leave. These labor hours exclude subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Hours (Base Period and Option Periods) Labor Category Year 1 Year 2 Year 3 Year 4 Year 5

Professional Professional Support Administrative Support Totals

Labor Hours (Option Quantities)

Option Quantities Labor Hours per Quantity

Maximum Quantities Per Period

Total (if all Options are exercised)

Option Quantity 1 - Task 1 Option Quantity 2 - Task 2 Option Quantity 3 - Task 3 Option Quantity 4 - Task 4 Option Quantity 5 - Task 5 Option Quantity 6 - Task 6 Option Quantity 7 Total

*Option Quantity Tasks 1-6 mat be exercised up to 3 times in each period of performance. Option Quantity Task 7 is a one-time option that can be exercised before contract expiration (See Article C.1.).

b. The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer hours than the minimum specified number of direct labor hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of hours by which the number of direct labor hours furnished is less than the number of direct labor hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998).

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989).

Alternate I (April 1984) is applicable to this contract.

52.247-35, F.o.b. Destination Within Consignees Premises (April 1984).

https://www.acquisition.gov/?q=browsefar

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

[To be specified prior to award]

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

The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule;

(4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract.

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015).

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer.

The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause).

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title To be named

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

a. Invoice Submission/Contract Financing Request, NIH(RC)-1 for NIH Cost-Reimbursement Type

Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contractor must submit invoices to the Department of Treasury's Invoice Processing

Platform (IPP) at https://www.ipp.gov with a copy of the invoice to the approving official, as directed below.

The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Official: Contracting Officer Name- TBD Email Address- TBD

Contracting Officer Representative Name- TBD Email Address- TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx .

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Section, Contract Management Branch, Red.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

https://www.ipp.gov/ mailto:ofm_customer_service@mail-cmp.niceincontact.com mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is: Analytical Chemistry and Stability Testing of Treatment Drugs for

Substance Use Disorders.

g. Contract Line Items as follows:

Line Item #

Line Item Description

1 FY 24. Base Award. August 4, 2024 – August 3, 2025. Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders. Base Period (Contract Year 1).

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-

6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (Nov 2021).

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of clause).

ARTICLE G.5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer Representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer. Go to the Indirect Cost Submission web page: https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission for electronic copies of the Branch's information package documents.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually on the contract anniversary date.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/division-of-financial-advisory-services/indirect-cost-branch/indirect-cost-submission https://www.cpars.gov

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," Appendix Q, which can be found at:

https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%2 0of%20Government%20Property-Appendix%20Q.pdf https://www.cpars.gov/ https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf https://oamp.od.nih.gov/sites/default/files/DGS/HHS%20Contracting%20Guide%20for%20Contract%20of%20Government%20Property-Appendix%20Q.pdf

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources.

This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103 , "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102 , "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. In addition, publications are expected to follow the guidance at https://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research, whether preclinical or otherwise, as appropriate.