WOMEN-OWNED SMALL

BUSINESS (WOSB)

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NUMBER 3.AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect calls)

8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

CODE

TELEPHONE NUMBER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

REQUEST

FOR QUOTE

(RFQ)

INVITATION

FOR BID

(IFB)

REQUEST

FOR

PROPOSAL

(RFP)

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Government Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 29. AWARD OF CONTRACT: REFERENCE

. YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

31b. NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NORTH AMERICAN

INDUSTRY CLASSIFICATION

STANDARD (NAICS):

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

THE DEFENSE PRIORITIES

AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4.

FAR 52.212-3 AND 52.212-5 ARE ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED.

8(A)

ECONOMICALLY

DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

DATED.

OFFER

ADDENDA

ADDENDA

75N98027Q00076

See Schedule See Schedule

National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

11/25/2026 1400 ES

JOHN JOHNSON

+1 000 000 0000

OD/OLAO-ORA

OD/OLAO

622110

$47

11/10/2026

ADMINISTERED BY:

National Institutes of Health

OD - Office of Logistics and

Acquisition Operations

Bethesda MD 20892-7511

Clinical Services and Resources for the

Continued...

STOCK RECORD (S/R)

STANDARD FORM 1449 (REV. 11/2021) BACK

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE RECEIVED (MM/DD/YYYY) 42d. TOTAL CONTAINERS

40. PAID BY

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32g. EMAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER 34. VOUCHER NUMBER 35. AMOUNT VERIFIED

CORRECT FOR

PARTIAL FINAL

37. CHECK NUMBER

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER

36. PAYMENT

COMPLETE PARTIAL FINAL

ACCEPTED,

National Institute on Drug Abuse, Intramural

Research Program (NIH/NIDA/IRP).

Period of Performance: 12/31/2026 to

01/31/2027

Document Type: Sole Source Notice

Reference No. 75N98027Q00076 Project Title: Clinical Services and Resources for the National Institute on Drug Abuse, Intramural Research Program (NIH/NIDA/IRP) Response Date: November 25, 2026, at 2PM EST.

Contracting Office Address:

NIH/OD, Hospital and Laboratory Division 6701 Rockledge Drive, Bethesda, MD 20817

Description

This is a notice of intent to award a sole source contract with Johns Hopkins Bayview Medical Center, Inc., to extend the period of performance for the clinical services and resources necessary to maintain the research operation of the NIDA IRP Clinical Research Program. The Government proposes to award an additional twelve (12) month contract with the period of performance: December 31, 2026, through January 31, 2027.

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Johns Hopkins Bayview Medical Center is the only vendor in the marketplace that can provide the services required by NIDA.

The intended source is:

Johns Hopkins University School of Medicine Edward D. Miller Research Building 733 N. Broadway, Suite 117 Baltimore, MD 21205

This notice is being published by NIH/NIDA in accordance with Federal Acquisition Regulation (FAR)

5.201. The statutory authority for this sole source modification is FAR 6.302-1, Only One Responsible Source. This notice of intent is not a request for competitive proposals. However, the Government shall consider all responses received within 15 days of this posting. Interested parties may identify their interest and capability to respond to the requirement. A determination not to compete this requirement, based upon responses to this notice, is solely at the discretion of the Government. Written responses to this synopsis shall contain sufficient documentation to establish a bona fide capability to fulfill this requirement. NIDA will not be responsible for any costs incurred by interested parties responding to this notice.

All responses must be received by the closing date and time of this announcement and must reference the reference number, 75N98027Q00076. Responses must be submitted electronically to John Johnson, Program Specialist, at johnsonjr@mail.nih.gov. U.S. Mail and Fax responses will not be accepted.

mailto:johnsonjr@mail.nih.gov.

STATEMENT OF WORK

Clinical Services and Resources for the National Institute on Drug Abuse, Intramural Research Program

(NIDA, IRP)

Background The mission of the NIDA IRP is to conduct state-of-the-art research on basic mechanisms that underlie drug use and addiction and to develop new methods for treatment. Research is supported at the molecular, cellular, and clinical levels and is conceptually integrated, highly innovative, and focused on major problems in the field of addiction.

NIDA IRP attempts to elucidate the nature of substance use disorders; to determine the potential effectiveness of new therapies for addiction, both pharmacological and psychosocial; and to decipher the long-term consequences of drugs on the development, maturation, function, and structure of the human brain and other organ systems.

Using human volunteers, the IRP clinical program conducts multidisciplinary research involving residential and nonresidential clinical addiction studies interrelating with pre-clinical laboratory investigations. In general, these studies evaluate the nature of drug use and addiction by assessing the abuse potential of drugs, investigating their underlying mechanisms, and assessing treatment modalities for substance use disorders.

Objectives The objectives of this contract are to provide the NIDA IRP with clinical care support services and resources necessary to maintain the research operation of the NIDA IRP Clinical Research Program. The Contractor shall provide the services and supplies outlined in the Statement of Work (SOW) on a cost reimbursement basis.

Schedule Period of Performance: The contract performance for this requirement will be one (1) 6-month base period with one (1) optional 6-month period.

Place of Performance (Government Site) NIDA Intramural Research Program (IRP) Biomedical Research Center 251 Bayview Boulevard, Suite 200 Baltimore, MD 21224-6825

Scope This clinical research program has developed the infrastructure needed to promote quality clinical research and to ensure research participant safety and confidentiality. The current research program, housed in the NIH Biomedical Research Center (BRC) on the campus of Johns Hopkins Bayview Medical Center includes a research participant recruitment and screening center, a 56-slot outpatient research clinic, a state-of-the-art fMRI center, and multiple specialized study rooms (including smoking chambers, mock MRI scanner, and physiological monitoring). In addition, all clinical and most research data is stored in an electronic clinical records system--Human Research Information System (HuRIS). HuRIS is located on a secure network and is accessible remotely through a virtual private network (VPN) for mobile employees or teleworkers.

The majority of IRP research participants are adults between the ages of 18 and 65. However, studies involving adolescents (under the age of 18) are occasionally performed. Additional safeguards may be required for all personnel working with minors. Each research protocol defines the number and characteristics of the research participants required. The research participant population may include active drug users or occasional users, persons with documented past history of drug dependence or use and healthy controls (such as cigarette smokers and non-users).

At maximum capacity, the clinical program can support approximately six clinical investigators and an semi-annual enrollment of approximately 250 research participants. Subsequent supplies and lab work ordered are determined by the number of research participants enrolled in an active clinical protocol as well as the needs of the protocol itself.

The clinical program does not function at maximum capacity at all times. The needs of the clinical program are dependent upon the number of clinical investigators, participant enrollment, as well as the number and type of active clinical protocols. As such, the amount of clinical services needed will fluctuate. The contractor must be flexible and understand the changing nature of research and adjust contract services according to clinical program needs.

Requirements Tasks Independently and not as an agent of the Government, the Contractor shall provide services and materials for the tasks described below.

Management of Personnel and Contract Administration-

It is the responsibility of the Contractor to ensure adequate staffing and supervision of staff as applicable. The Contractor shall ensure that the clinical staff working on this contract maintain professional licensure, including but not limited to Basic Life Support (BLS) and Advanced Life Support (ALS) training. The Contractor must maintain any other professional responsibilities and abide by a professional code of conduct. The Government may provide specialized training for contractor staff on a case-by-case basis. Contract administration staff shall oversee the performance of the contract in terms of customer satisfaction.

The Contractor shall review budgeted hours and costs versus actual expenditures, and report any or all issues to the Contracting Officer's Representative (COR). The Contractor will handle all contract financials and will provide data to the COR. This includes monitoring of hours, billing, and reconciliations. In addition, the Contractor will coordinate the timely submission of contract deliverables to the COR. The Contractor shall provide management of personnel and contract administration services from the Contractor's site.

Offerors shall designate primary contacts and alternates for billing errors, participant scheduling issues, and emergency room diversions in their written technical proposals. It is critical that these contacts or alternates respond to issues in a timely manner (e.g. billing errors-2 days; scheduling issues – 1 day;

emergency room diversion resolution- 1 hour). The Contractor’s primary contacts and alternates must be assigned for the duration of the contract and may not be replaced or removed without prior notification to the Contracting Officer. A comparable replacement must be chosen in accordance with Key Personnel, HHSAR 352.237-75.

Primary Contact or Alternate’s Responsibilities Response Time Emergency Room access and diversion concerns 1 hour Consulting appointment scheduling 1 day Billing errors 2 days Other issues 1 day

FOR PROPOSAL PURPOSES ONLY:

LEVEL OF EFFORT

Management of Personnel and Contract Administration Labor Category 6-month Professional Support (PS) 240 Administrative Support (AS) 192

Due to the critical nature of patient care, the contractor must notify the NIDA IRP 6 months in advance if they are no longer able to provide services for any reason.

Medical Consultation- These services will be acquired on a Fee for Services basis.

Approximately 250 participants are involved in one or more research protocols per year at the NIDA IRP.

The Contractor shall provide the equipment, supplies, and ancillary services necessary to conduct medical consultations and rare emergency medical care. The Contractor shall provide the following:

1. Urgent or non-routine medical consultation services for participants who are identified with a medical condition upon screening. These specialty medical consultation services may include neurology (approximately once per year), psychiatry (approximately once per year), cardiology (see below for details), and radiology (see next section). These consultations will be provided on an "as requested" basis (urgent = <48 hours, non-routine, non-urgent = <2-4 weeks-time from initial request to initial appointment). These services will be provided at the specialists' location (outpatient clinic or hospital setting). Infrequently, a research protocol may require specialty medical consultation for all participants and these services will be established in advance by the Principal Investigator, the Clinical Director and the Contractor. The Contractor must have the ability to transport and evaluate patients emergently (approximately once per year), and to provide inpatient hospitalizations as needed (approximately once per year). Emergency services must be provided at a facility within a 10-mile radius from the NIDA IRP. If participants must be diverted from the contractor’s primary emergency care facility, they must be transported to an affiliated partner’s facility.

Medical Consultation Services Response Time Emergency Room Diversions 1 hour Urgent 48 hours Non-route, Non-urgent 2-4 weeks

2. On-call cardiology consultation

A board-certified cardiologist should be available for telephonic discussion of protocol development.

Also, NIDA clinical studies often require a cardiac assessment, involving an electrocardiogram (ECG).

ECG readings are performed remotely. In the event that the ECG reading is "equivocal or abnormal", the Contractor must provide cardiology consultation - assessing the ECG, and the clinical study requirements. Approximately 200 ECGs need a cardiologist's interpretation annually. These ECGs shall be read within 1-2 business days. Some drug administration research protocols require a more urgent cardiology consultation (e.g. study safety ECG readings may require real-time readings or readings within 30 minutes of drug administration). Drug administration research protocols often require an ECG to clear the participant prior to dosing. Any abnormal ECG must be read by a board-certified cardiologist within one hour of obtaining the tracing. Approximately 20 ECGs/year require urgent/stat (one-hour return) cardiology consultation. These consultations may be required outside of usual business hours (Monday-Friday 0800--1600).

All medical consultants will be credentialed through the Contractor.

Cardiology Consultation Services Response Time Urgent/Stat ECG 1 hour Routine ECG 1-2 days Study Safety ECG Real-time or within 30 minutes of drug administration, depending on protocol requirements

Note: These consults may be required outside of usual business hours (Monday-Friday 0800--1600)

Diagnostic Laboratory and Radiology Services

The Contractor shall provide necessary diagnostic laboratory and radiology services as requested by the Office of the Clinical Director for the clinical research program. The Contractor shall provide all equipment as well as software to allow electronic transfer of laboratory data (ordering and results) between the Contractor and the NIDA IRP. The NIDA IRP maintains laboratory data in HuRIS. The Contractor’s clinical staff will be granted access to this system and will be expected to document participant and study information, as required. The clinical staff will be required to complete NIDA IRP-specific training requirements to access HuRIS. HuRIS is operated and maintained by the NIDA IRP Biomedical Informatics Section and the Contractor is not expected to provide any technical support of Human Research Information System (HuRIS). In addition, the Contractor must provide all supplies and ancillary services necessary to conduct the following tests in the Contractor's facilities:

1. Radiology - Conventional radiological studies may be required for screening purposes (e.g. chest x-ray

(CXR)). Generally, two radiological studies (either a CXR or orbital films) each month are needed.

Approximately six Stress Echo tests are needed yearly. The consultations and reports shall be sent to the NIDA IRP within a 48-hour period and will be scanned into the HuRIS database as part of the affected participant's clinical record. These studies may be performed on an urgent or routine basis, depending on the urgency of the diagnostic test. The contractor is encouraged to develop an efficient electronic mechanism to enter radiology and cardiology reports into HuRIS.

Radiology Services Response Time Urgent Consultations & Reports 48 hours Routine Consultations & Reports 72 hours

2. Neuroradiology - NIDA is mandated to obtain clinical MRIs for each participant involved in a neuroimaging study. These clinical MRIs are to be reviewed and interpreted by a board-certified neuroradiologist. The turnaround time from receipt to report should be within two business days. Based on current workload, NIDA anticipates approximately 15 reviews/month. Neuroradiology consultation may recommend additional neuroradiological studies, which will also be provided by the Contractor. NIDA anticipates approximately six additional studies per year.

Neuroradiology Services Response Time Routine Consultations & Reports 2 days

3. Laboratory - Some laboratory testing is routine during medical screening for research protocols. NIDA anticipates approximately 225 admission laboratory panels/for 6 months. However, other specialized laboratory testing may be required for clinical and/or specific research purposes. The Contractor will work with the investigators and Office of the Clinical Director to set up routine laboratory panels, etc. Lab ordering and results will be electronically exchanged between the Contractor's laboratory and HuRIS. For most routine laboratory tests, NIDA expects results to be available in HuRIS within 24 hours; results for STAT specimens must be provided within 4 hours. Additionally, the Contractor will provide all transportation of specimens.

Laboratory Services Response Time Urgent/Stat Labs 4 hours (entered in HuRIS) Routine Labs 24 hours (entered in HuRIS)

All individuals providing diagnostic and laboratory services will be credentialed through the Contractor.

Supplies & Services The Contractor will provide a mechanism to obtain necessary medical equipment, supplies and services for the clinical research program in the BRC. This includes, but is not limited to, medication, phlebotomy supplies, laboratory specimen supplies (test tubes, urinalysis supplies), IV maintenance supplies to support approximately five clinical study sessions/day that require these supplies. In addition, there may be special procedures supplies that would be pre-specified between the Contractor and the Office of the Clinical Director.

Domiciliary Oversight and Care- This service will be acquired on a Fixed Fee/month basis.

The Contractor shall provide overnight stay capability in a facility that can accommodate NIDA participants.

NIDA anticipates approximately 12 overnight stays per month; however, this can fluctuate depending on the clinical protocols currently running. The unit must be located within a ten-mile radius of the BRC. The facility must be properly secured to ensure participant safety and protocol compliance; this includes ensuring participant abstinence from drugs of abuse (and sometimes nicotine) per specified protocol requirements.

Services to be Performed The facility should include technicians and nursing staff who will be required to complete the NIDA IRP training to use HuRIS and enter the system monthly to maintain access. At times, the Contractor may be required to provide specialized nursing services for those individuals participating in protocols that require consecutive night’s accommodations. Specialized nursing services will include:

1. Administration of research drugs and/or medications as dictated by NIDA-approved study procedures.

2. Collection, processing and storage of biological specimens. Proper storage container will be provided by NIDA.

3. Collection of neuropsychological and other forms of behavioral assessments as defined by the research study design. These assessments will be performed directly into a NIDA-provided computer terminal equipped with NIDA Clinical Data Warehouse (CDW) software. NIDA will provide Clinical Research Unit (CRU) staff with training in the use of this software and assure VPN authorization by end users. Contractors must login and use the system every month to retain clinical access. Nurses must maintain login credentials.

4. Any vital signs required by the protocol will also be recorded directly into CDW software on the NIDA computer.

The facility must allow NIDA Federal medical doctors (MDs) to provide medical and/or research care. This facility must have the flexibility to allow the NIH Institutional Review Board (IRB) to be the IRB of record.

Other Specific Terms

1. A fixed-price agreement will be established for a minimum number of beds per month. The rate to be negotiated at the time of award. It is understood by both parties that this monthly cap can be adjusted. Expansion above the set number of monthly beds is acceptable provided there is bed availability and advance approval is obtained from the CRU Medical Director or his/her approved designee. Additional bed days may be purchased on a fee per service basis.

2. Each “booked bed” will be counted even if this bed is not filled for any reason by a study participant unless cancelled 48 hours or more prior to use.

3. NIDA IRP participants requesting cigarettes will require a prescription by an authorized NIDA medical official. Participants will also provide their own cigarettes.

4. If required by the clinical protocol, nurses will be authorized to dispense study, routine and PRN medications to NIDA’s participants on the CRU.

5. It is understood that the CRU does not have emergency power so if a utility outage is expected to be long term, the CRU staff will contact the NIDA principal investigator (PI) to arrange discharge. Furthermore, if a participant requests to leave the unit, the CRU staff will contact the PI who will be authorize this request and arrange for participant belongings to be properly returned.

Option Quantities The requirements for the clinical services are subject to change. Participant census can change significantly depending on the direction of the research and number or active clinical investigators. New protocol may require more medical supplies, more labs, or may utilize a new position. This impacts the labor, supplies and services requirements for clinical care. In order to accommodate changing requirements in a timely manner the contract also includes the following option quantities:

Option Task or

Quantity

Description

Maximum Quantities Per

Contract Period Estimated Effort

A Laundry Services 2 $300

The Contractor shall provide laundry services (sheets, blankets, hospital gowns, towels, wash cloths, pillowcases, bath blankets)

Deliverables Monthly Report The Contractor shall provide a monthly (an electronic file) report, to include technical and financial accounting to the Clinical Director or his/her designee, the COR and the alternate COR by the 15th of the following month. The report should include:

1. The date prepared and the date delivered;

2. A narrative summary of any specific accomplishments, changes, progress or problems overcome during the reporting period;

3. Finances: invoice concerns, billing issues;

4. Laboratory/Medical Supplies: A report of the invoices of equipment or supplies purchased by the

Contractor and passed on to the IRP as a direct line item cost, monthly itemized tally of invoiced services and supplies, track actual usage of subcontractor/consultant’s hours, number of CRU beds utilized, number of ECG evaluated by the cardiologist; and

5. Any other relevant news that could impact the work of the contract.

Final Report The Contractor shall provide an electronic copy of the Annual Report to the COR, the alternate COR, the NIDA Clinical Director and the Contracting Officer 15 days after the end of each base period or option period. The last Annual Report is due on or before the expiration date of the contract. The following information shall be included in this report:

1. Include the date the report was prepared and the date the report was delivered;

2. A narrative summary of specific accomplishments, changes, progress or problems overcome during that year, trends;

3. Any changes in personnel during that year;

4. A report of the invoices of equipment or supplies purchased by the Contractor and passed on to the

IRP as a direct line item cost;

5. A report on subcontractor/consultants: track actual usage (e.g. CRU actual bed nights, number of

Cardiology consults, number of ECGs evaluated, etc.);

6. Cumulative tally of invoiced services and supplies provided;

7. Percent of obligated funding spent to date;

8. Status of Contracting Officer Authorizations.

Privacy and Security Requirements All personnel working with human subjects are required to undergo necessary clearances, training and orientation as mandated by the Federal Government, NIH, and specific NIDA IRP clinical policies and procedures.

The NIDA IRP Clinical Research Program's research activities are guided by regulations from various federal government agencies to include, but not limited to FDA, NIH, and HHS Office of Human Research Protections. All personnel working for the NIDA IRP clinical program are required to undergo training in various areas including, but not limited to confidentiality, ethics of clinical research, Human Research, and Privacy Act. Contract staff shall be trained in necessary procedures to comply with current and future requirements mandated for human subjects' protections. The Contractor shall maintain records documenting all staff training procedures and are required to follow all NIDA IRP clinical policies.

Restricted Access The Contractor must assure that all contract staff keep Clinical areas secure and follow proper safeguards.

The DIR's Clinical facilities have controlled access and are limited to DIR and contract staff with official duties in the clinical research program. Clinical facility access is restricted to individuals who have completed the proper NIH confidentiality training and provided delivery of the completed orientation forms to the Clinical Facility Access Coordinator.

Background Investigations Pre-employment security checks must be conducted to ensure staff is suitable for federal contract employment. Individuals who will be working with minors or adolescents are required to undergo additional federal clearance requirements designed to identify individual with a criminal record in this area.

Criminal History Background Checks Criminal history background checks shall be conducted for each employee in the state of Maryland, Virginia and District of Columbia as well as any other state where the employee has resided over the past 5 years. The Contractor shall provide an alphabetical listing of prospective employees to the NIH Division of Personnel Security and Access Control (DPSAC) for the purposes of conducting a security check (Please see Section H, Information Security and/or Physical Access Security clause for more information). The full name, any aliases, address, date of birth and social security number of prospective Contractor employees shall be submitted to DPSAC prior to commencement of work on the contract (also applies for any subsequent new hires). Criminal and security background checks shall be conducted for incumbent employees before contract initiation and prior to commencing work for new hires. The Contractor shall provide the COR a written assurance statement that a criminal history background check was conducted, and names were submitted to DPSAC for each employee. Any persons deemed unacceptable by DPSAC shall not be employed on this contract.

Identification Badges, Keys and Card Keys The Government provides each employee with an NIH and Johns Hopkins Bayview identification badge, which shall always be worn while on duty. The identification card will contain a photograph of the employee, their employee name and notate Contractor. All identification cards will bear an expiration date and are laminated to prevent alterations. The Government will issue keys or card keys to Contractor employees as appropriate for each facility. All keys, card keys, access codes and parking passes will be issued to individual employees and are not transferable. The Contractor shall submit required paperwork for input into the NIH Enterprise Directory, and to request ID cards and card keys for on-site contract staff prior to the employee start date. Contractor employees shall be required to return identification badges, keys, card keys and parking passes to the Government immediately upon termination of employment with the Contractor.

The Contractor shall not invoice the Government for the employee's last pay period until identification cards, keys, card keys and parking passes are returned.

Audio and Visual Recording Devices The use of audio and visual recording devices in the in the clinical facilities is prohibited unless pre-approved by the Clinical Director or Deputy Clinical Director for NIDA or as part of an approved clinical protocol. Use of audio and visual recording device must comply with NIH Policy Manual 3047 - Trans-NIH Animal Facility Security Program: https://policymanual.nih.gov/3047.

Record Keeping Records will be kept and maintained in accordance with the NIH Policy Manual 1743 - Keeping and Destroying Records: https://policymanual.nih.gov/1743.

Training Requirements Contractor training needed for access to the NIH systems, including HuRIS, include but are not limited to:

1. NIH Computer Security Awareness and Privacy Act Training;

https://policymanual.nih.gov/3047 https://policymanual.nih.gov/1743

2. Protection of Human Research Subjects;

3. Clinical Research Computerized Training;

4. Confidentiality Web Site;

5. Ethics;

6. FBI Clearance Documents.

APPENDIX 1. Summary of Response Times for Requested Services

Primary Contact or Alternate’s Responsibilities Response Time Emergency Room access and diversion concerns 1 hour Consulting appointment scheduling 1 day Billing errors 2 days Other issues 1 day

Medical Consultation Services Response Time Emergency Room Diversions 1 hour Urgent 48 hours Non-route, Non-urgent 2-4 weeks

Cardiology Consultation Services Response Time Urgent/Stat ECG 1 hour Routine ECG 1-2 days Study Safety ECG Real-time or within 30 minutes of drug administration, depending on protocol requirements

Note: These consults may be required outside of usual business hours (Monday-Friday 0800--1600)

Radiology Services Response Time Urgent Consultations & Reports 48 hours Routine Consultations & Reports 72 hours

Neuroradiology Services Response Time Routine Consultations & Reports 2 days

Laboratory Services Response Time Urgent/Stat Labs (entered in HuRIS) 4 hours (entered in HuRIS) Routine Labs (entered in HuRIS) 24 hours (entered in HuRIS)

Attachment 2 – Contract Requirements and Clauses

SECTION A - SPECIAL CONTRACT REQUIREMENTS

ARTICLE A.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 A.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH

PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated August 25, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE A.3. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

The Contractor shall not:

Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

The Contractor is permitted to disclose only in below circumstances. The Contractor shall notify the CO minimum ten (10) calendar days prior to disclosure.

Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;

Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

Made with the consent of the individual to whom the information, document, or biospecimen pertains; or Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

In accordance with 45 CFR Part 75.303(a), the Contractor shall maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal Statutes and regulations.

The recipient of CoCs shall ensure that any company/institution/individual not funded by NIH who receives a copy of identifiable, sensitive information protected by a Certificate understand that they are also subject to the requirements of subsection 301(d) of the Public Health Service Act. The Contractor shall ensure that Subcontractors who receive funds to carry out part of the Federal award understand they are also subject to subsection 301(d) of the Public Health Service Act and the NIH Policy for Issuing CoC.

ARTICLE A.4. HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

ARTICLE A.5. NEEDLE EXCHANGE, HHSAR 352.270-12 (December 2015)

The Contractor shall not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

(End of clause)

ARTICLE A.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE A.6. CONTINUED BAN ON FUNDING ABORTION AND CONTINUED BAN ON

FUNDING OF HUMAN EMBRYO RESEARCH, HHSAR 352.270-13 (December 2015)

a. The Contractor shall not use any funds obligated under this contract for any abortion.

b. The Contractor shall not use any funds obligated under this contract for the following:

1. The creation of a human embryo or embryos for research purposes; or

2. Research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero under 45 CFR part 46 and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

c. The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR part 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes of human diploid cells.

d. The Contractor shall not use any Federal funds for the cloning of human beings.

(End of clause)

ARTICLE A.7. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF

CONTROLLED SUBSTANCES

The Contractor shall not use contract funds to support activities that promote the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established under section 202 of the Controlled Substances Act, except for normal and recognized executive-congressional communications. This limitation shall not apply when the Government determines that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

ARTICLE A.8. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE A.9. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

ARTICLE A.10. GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

ARTICLE A.11. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item; FAR Clause 52.217-8, Option to Extend Services; FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 15 days prior to the expiration date of this contract, and the estimated cost [plus fixed fee) of the contract will be increased as set forth in the ESTIMATED COST [PLUS FIXED FEE] ARTICLE Bn SECTION B of this contract.

ARTICLE A.12. NOTIFICATION OF SYSTEM OF RECORDS NOTICE, HHSAR 352.224-70 (FEB

2024) (DEVIATION).

(a) This contract provides for the design, development, or operation of a system of records about individuals from which information about an individual is retrieved by the individual’s name or by some other identifying particular assigned to the individual.

(b) The System of Records Notice(s) (SORN(s)) that is applicable to this contract is/are: 09-25-0200

(c) The System of Records design, development, or operation work the Contractor is to perform is: Human Research Information System (HuRIS)

(d) The disposition to be made of the Privacy Act records upon completion of contract performance is as follows: Upon completion of contract activities the Contractor shall relinquish all access files and data obtained from HuRIS to the Government, which is located on a secure network and is accessible remotely through a virtual private network (VPN) for mobile employees or teleworkers.

(e) Subcontract flow down. The Contractor is required to include this clause in all subcontracts at any tier performing work under the prime contract involving design, development, or operation work involving a System of Records.

(End of clause).

NOTE: The SORN describing the types of information contained in the records, the legal authority for collecting and maintaining the records, how the records are used within HHS, and the purposes (referred to as "routine uses") for which HHS may disclose the records to non-HHS parties without the individual record subject's consent is found at:

https://www.hhs.gov/foia/privacy/sorns/nih-sorns.html.

ARTICLE A.13. INFORMATION AND INFORMATION SYSTEMS SECURITY, HHSAR 352.204-71

(FEB 2024) (DEVIATION).

(a) Definitions. As used in this clause—

Breach means the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where—

(1) A person other than an authorized user accesses or potentially accesses personally identifiable information, or

(2) An authorized user accesses personally identifiable information for an other than authorized purpose.

Business associate (see 45 CFR 160.103), except as provided in paragraph (2) of this definition, business associate means, with respect to a covered entity, a person who -

(1) On behalf of such covered entity or of an organized health care arrangement (as defined in this clause) in which the covered entity participates, but other than in the capacity of a member of the workforce of such covered entity or arrangement, creates, receives, maintains, or transmits protected health information for a function or activity regulated by this contract or agreement, including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, patient safety activities listed at 42 CFR 3.20, billing, benefit management, practice management, and repricing; or

(2) Provides, other than in the capacity of a member of the workforce of such covered entity, legal, actuarial, accounting, consulting, data aggregation (as defined in 45 CFR section 164.501), management, administrative, accreditation, or financial services to or for such covered entity, or to or for an organized health care arrangement in which the covered entity participates, where the provision of the service involves the disclosure of protected health information from such covered entity or arrangement, or from another business associate of such covered entity or arrangement, to the person.

(3) A covered entity may be a business associate of another covered entity.

(4) Business associate includes the following:

(i) A Health Information Organization, E-prescribing Gateway, or other person that provides data transmission services with respect to protected health information to a covered entity and that requires access on a routine basis to such protected health information.

(ii) A person that offers a personal health record to one or more individuals on behalf of a covered entity.

(iii) A subcontractor that creates, receives, maintains, or transmits protected health information on behalf of the business associate.

(5) Business associate does not include:

(i) A health care provider, with respect to disclosures by a covered entity to the health care provider concerning the treatment of the individual.

(ii) A plan sponsor, with respect to disclosures by a group health plan (or by a health insurance issuer or HMO with respect to a group health plan) to the plan sponsor, to the extent that the requirements of 45 CFR 164.504(f) apply and are met.

(iii) A government agency, with respect to determining eligibility for, or enrollment in, a government health plan that provides public benefits and is administered by another government agency, or collecting protected health information for such purposes, to the extent such activities are authorized by law.

(iv) A covered entity participating in an organized health care arrangement that performs a function or activity as described by paragraph (1)(i) of this definition for or on behalf of such organized health care arrangement, or that provides a service as described in paragraph (1)(ii) of this definition to or for such organized health care arrangement by virtue of such activities or services.

Business associate agreement means the agreement, or other arrangement, as dictated by the HIPAA Privacy Rule (45 CFR 160), between an HHS covered entity and a business associate, which…