RFQ_75F40123Q00191.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

DAO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Sheila Brown

DHHS/FDA/OAGS/DAO

CODE 16. ADMINISTERED BYCODE

X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAO

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

05/17/2023 1530 ET

04/17/2023

IAN WEISS

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40123Q00191

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 63 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Ian Weiss

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

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

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

This is a Request for Quotation (RFQ) for the National Drug Code (NDC) Level Information Data.

Offers in response to this solicitation shall be due no later than May 17, 2023, 3:30PM Eastern Time.

Questions are due no later than May 1, 2023, by 3:00 PM and must be emailed to Sheila.Brown1@fda.hhs.gov.

See attached RFQ.

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

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

IAN S. WEISS

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

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

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

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

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

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

541990

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

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

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

63 2 of

NATIONAL DRUG CODE (NDC) LEVEL INFORMATION DATA

PART 1- Description

Solicitation number FDA-RFQ- 75F40123Q00191 is issued as a Request for Quotation (RFQ).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13.5 and included in this notice. The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-96. The North American Industrial Classification System (NAICS) code for this procurement is 541990, All Other Professional, Scientific, and Technical Services.

1.2 Type of Contract

The Government intends to award a Firm-Fixed-Price, Labor Hour contract vehicle for a duration of five (5) years, consisting of one (1) base year, and four (4) twelve (12) month optional periods.

The contract maximum ceiling amount is anticipated to be $800,000.00 over five (5) years, inclusive of options. .

PART 2- SUPPLIES OR SERVICES AND PRICES/COSTS

2.1 Description of Services and Supplies

The Food and Drug Administration’s Center for Drug Evaluation and Research has a need for access to National Drug Code (NDC) Level Information Data.

BASE YEAR

CLIN Description of Supplies/Service

Qty. Unit Total Price

0001 NDC-Level Data (Unlimited Access License for 50 users

One (1) License Month

0002 Disclosure Clearance and Third- Party Agreement 1 NA

0003 Current and complete Data Dictionary including updates

Lot

0004 Virtual training programs and training materials 2 Lot

0005 Virtual Annual Meeting 1 Lot

0006 Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data

Unlimited 12 months

0007 Ad-hoc Analyses: custom reporting and product customization

Hours

0008 Optional Quantity: Ten (10) Additional Users

One (1) License 12 Months

BASE YEAR: Total Firm Fixed Price

OPTION YEAR 1

0001 NDC-Level Data (Unlimited

0005 Virtual Annual Meeting 1 Lot

0006 Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data

Unlimited 12 months

0007 Ad-hoc Analyses: custom

Option Year 1: Total Firm Fixed Price

OPTION YEAR 2

0001 NDC-Level Data (Unlimited

0005 Virtual Annual Meeting 1 Lot

0006 Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data

Unlimited 12 months

0007 Ad-hoc Analyses: custom

Option Year 2: Total Firm Fixed Price

OPTION YEAR 3

0001 NDC-Level Data (Unlimited

0005 Virtual Annual Meeting 1 Lot

0006 Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data

Unlimited 12 months

0007 Ad-hoc Analyses: custom

Option Year 3: Total Firm Fixed Price

TOTAL CONTRACT VALUE

BASE PERIOD TOTAL PRICE

OPTION YEAR 1 TOTAL PRICE

OPTION YEAR 2 TOTAL PRICE

OPTION YEAR 3 TOTAL PRICE

OPTION YEAR 4 TOTAL PRICE

TOTAL FIRM FIXED PRICE

OPTION YEAR 4

0001 NDC-Level Data (Unlimited

0005 Virtual Annual Meeting 1 Lot

0006 Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data

Unlimited 12 months

0007 Ad-hoc Analyses: custom

Option Year 4: Total Firm Fixed Price

Labor Rate Pricing Chart: Labor Category Hourly Rate Estimated # of Hours per Year

Total

Rate X #Hours

Project Manager II

Base Year $ 1040 $

Option Year 1 $ 1040 $

Option Year 2 $ 1040 $

Option Year 3 $ 1040 $

Option Year 4 $ 1040 $

Senior Computer Analyst

Base Year $ 1040 $

Option Year 1 $ 1040 $

Option Year 2 $ 1040 $

Option Year 3 $ 1040 $

Option Year 4 $ 1040 $

Application Programmer

Base Year $ 1040 $

Option Year 1 $ 1040 $

Option Year 2 $ 1040 $

Option Year 3 $ 1040 $

Option Year 4 $ 1040 $

Statistician

Base year $ 1040 $

Option Year 1 $ 1040 $

Option Year 2 $ 1040 $

Option Year 3 $ 1040 $

Option Year 4 $ 1040 $

Pharmacist

Base Year $ 1040 $

Option Year 1 $ 1040 $

Option Year 2 $ 1040 $

Option Year 3 $ 1040 $

Option Year 4 $ 1040 $

Senior Training Specialist

Base Year $ 1040 $

Option Year 1 $ 1040 $

Option Year 2 $ 1040 $

Option Year 3 $ 1040 $

Option Year 4 $ 1040 $

TOTAL PRICING

PART 3 - DESCRIPTIONS/SPECIFICATIONS/STATEMENT OF WORK

3.1 Background

A vital part of FDA and CDER’s mission is to promote and protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs by the American people. The Division of Medication Error, Prevention and Analysis (DMEPA) aims to increase the safe use of drug products by minimizing use error that is related to the naming, labeling, product design, or packaging of drug products with the goal of eliminating medication errors in the United States healthcare system.

To fulfill these missions and other program functions, CDER requires access to National Drug Code (NDC)-level data to accurately characterize each FDA-regulated product active or previously active in the U.S. marketplace, down to the level of the active ingredients, inactive ingredients, strength, dosage formulation, manufacturer, and packaging. Access to these data allows the FDA to respond to post-marketing issues related to naming, route, strength, dosage form, labeling, product design, or packaging of drug products to increase the safe use of drug products by assessing safety risks and evaluating the effectiveness of strategies to mitigate those risks.

The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products.

The ability of FDA to respond expeditiously to the increasing number of post-marketing issues is of paramount importance to the overall public safety. Access to these data complements and strengthens the utility of the passive reporting system currently in place by providing broad estimates of how drugs are sold to all types of institutions in the health system. These NDC-level data resources also provide a comprehensive dataset that FDA is not interested in developing and expects any qualified organization to own the data as well as the means to allow FDA access to these data.

FDA's authority to fund research projects is set out in section 301 of the Public Health Service Act

(PHSA 42 U.S.C. 241).

3.2 Objectives

Program Research Goals:

The Contractor shall provide FDA personnel with:

i. Real-time, unlimited, immediate, direct, multi-user, desktop access to current and previously existing, commercially available NDC-level information data.

ii. The ability to use these data to integrate into other data resources and analyses to describe product characteristics.

3.3 Scope of Work

The Contractor shall provide the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work as described below.

3.4 NDC-Level Data Requirements

For this requirement, the data resource(s) shall be sufficient to meet FDA’s need to analyze NDC-level data. The data resource(s) shall capture the following data elements

A. The company-specific data elements shall include (but are not limited to): name of corporation (parent company); name of manufacturer (marketing company).

B. The drug-specific data elements shall include for all approved and unapproved prescription and nonprescription (e.g., homeopathic medications, dietary supplements, medical foods, and other over-the-counter (OTC)) products which are assigned a primary (e.g., container that holds the product, unit of use) or secondary (packaging that holds the primary packaging, unit of sale) NDC:

• product names (U.S. proprietary and non- proprietary)

• synonyms (e.g., Vitamin C as a synonym for ascorbic acid)

• brand status (brand, generic and branded generic), Rx status (Rx, OTC)

• originator status (e.g., originator, re-packager, branded or private label, etc.)

• active ingredient(s)

• inactive ingredients

• multi-ingredient, combination (e.g., drug/device or biologic/device), and reformulated product indicators

• human or animal use indicators

• Labeled indication(s) and associated dosage ranges

• off-label indications

• application type

• application number

• marketing category (monograph, OTC, prescription, Biologics License

Application (BLA), etc.)

• therapeutic equivalent code (e.g., AB)

• therapeutic class identifier (specify which classification system, e.g., WHO, ATC, or any other proprietary classifications as applicable) and description

• Foreign drug information, where available (e.g., is the active ingredient associated with the NDC available outside the United States), both unapproved and approved drug and biological products, blood products. Some NDCs may not have foreign drug information.

• all NDCs associated with the product

• NDC data source, labeled route of administration

• dosage form

• strength

• molecular salt (if applicable)

• package details (e.g., form, strength, size, or volume)

• initial market entry date, when the NDC was first assigned or when the product was added by the data vendor

• NDC marketing status (e.g., discontinued), date the NDC was inactivated or made obsolete, if applicable, and federal controlled substance category, if applicable.

• The NDC data shall also include all human and animal NDCs and corresponding data elements.

C. FDA requires five years of obsolete NDC data for comprehensive product research purposes. Updated information on NDC shall be available at least as frequently as a weekly basis.

3.5 Technical Requirements and Capabilities

A. Access to the data shall be immediate, unlimited, direct, and in real time. Access shall include all upgrades, enhancements, and modifications to software and data.

B. The data resource(s) shall be accessible via secure Internet or network-based methods permitting simultaneous, multi-user access through user-friendly data query tool(s). The network-based methods shall not necessitate any additions to the FDA communications infrastructure. Preferred methods for access (in order of preference) are: 1) secure Internet access, and 2) firewall-to-firewall virtual private network (VPN).

C. The Contractor shall provide email notification to the FDA a minimum of 48 hours in advance of any data adjustments and corrections; notify FDA about any circumstances resulting in loss of or lack of access to data from the database;

notify FDA a minimum of 48 hours in advance of planned downtime of the database; notify FDA within 30 minutes from the onset of unplanned downtime within normal hours (Monday-Friday, 9:00 AM – 5:00 PM EST) with an estimate of time to restoration of access to the database.

D. The Contractor shall maintain continuous access to current NDC-level pharmaceutical product characterization data resource(s).

E. The contractor shall notify FDA within five (5) business days of any changes in their underlying data (e.g., data suppliers) that affect the data quality and overall data characteristics.

F. FDA shall not support or maintain Quoter’s equipment or personnel onsite at government facilities.

G. Access shall be through an interface. Minimally, the interface shall provide custom reports. Custom reports require exportability function such as Excel and CSV.

H. The Contractor shall provide the FDA with the ability to download (or obtain in a timely manner using other means) large amounts of data (i.e., for many drugs and time periods at once). These data shall be available in machine-readable formats as described in Section 12. FDA’s preference is that unrestricted access to datasets shall be available on demand and without intervention by the Contractor through its interface and exported through either a CSV or excel format.

I. Full conformance or level of conformance with Section 508 standards is required.

3.6 External Disclosure(s)

As part of its regulatory activities, FDA shall at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated and conducted for the benefit of FDA. These collaborations shall require FDA to have the ability to share project-specific aggregated or raw data (if available/allowable) with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the FDA data disclosure clearance shall be utilized.

The FDA shall continue to require, after the conclusion of the contract, the ability to release aggregated data through the Data Disclosure Clearance process for data obtained during the contract period. After Option Year 4, the FDA will notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions, but shall not require formal approval for release.

3.7 User Support

The Contractor shall provide ongoing technical, analytical, and clinical support by phone or by email, which shall be available for all certified users of the data during business hours (9:00 a.m. - 5:00 p.m. EST), Monday through Friday excluding federal holidays throughout the length of the contract in accordance with the service levels established in the contract.

3.8 Training Programs and Training Materials:

The Contractor shall provide a kick-off meeting within 2 weeks upon award of contract, and two virtual training sessions per option year. Web-based training of FDA staff shall be required for any modifications, enhancements, or upgrades to the data resource.

Written documentation related to using the data, such as a User's Manual, shall be required upon award of the contract and shall be updated upon any subsequent enhancements or upgrades. Training for users of the data, as well as training for FDA personnel who will support use of the data (e.g., technical users) shall also be required. Options for additional “on-demand” sessions via live meeting/web-based methods shall be provided.

The training shall be initiated 30 days after receipt of award and continues throughout the duration of contract and the FDA shall provide the virtual venue.

3.9 Annual Meeting:

The Contractor shall be required to provide an annual meeting (virtual) for the purposes of discussing FDA satisfaction with all deliverables and any updates or changes to the data resource(s).

3.10 Ad-Hoc Analyses: Custom Reporting and Product Customization (Labor Hours)

The Contractor shall provide additional ad hoc data analyses or custom queries or product customization not available through the data tools. The number of hours allocated in the base award will not exceed 50 hours per year.

PART 4- INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) shall, in accordance with FAR 52.212-4, perform inspection and acceptance of all the services. Inspection and acceptance shall be performed at the location identified in individual task orders. Acceptance shall be communicated within 30 days of receipt in writing.

F

PART 5- DELIVERABLES AND PERFORMANCE

Description of Qty Unit Period of Performance NDC-Level Data (Unlimited Access License for 50 users

One (1) License Months Upon Award of Contract

Disclosure Clearance and Third- Party Agreement

1 NA Length of Contract

Current and complete Data

1 Lot Within 30 days of award

Virtual training programs and training materials

2 Lot Within 30 days of award

Virtual Annual Meeting 1 Lot Annually

Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data

Unlimited

12 months Length of Contract

Ad-hoc Analyses: custom reporting and product customization

50 Hours As needed

Optional Quantity: Ten (10) Additional Users

One (1) License Twelve (12) Months

Upon Exercise of Option

PART 6- FDA TECHNICAL ENVIRONMENT

6.1: Internet Access

The FDA has direct, desktop access to the Internet. The system shall be web-based and compatible with commonly used web browsers including Internet Explorer 11 and above, Firefox 23 and above, Chrome, and Safari 4 or higher.

The Contractor’s proposal shall specify any additional software and/or hardware (name and version) necessary to access the data.

6.2: Number of Users

The FDA shall purchase a site license that shall accommodate 50 users with option(s) for up to 10 additional users within the Office of Surveillance and Epidemiology as well as other authorized users within the FDA will need to access these data as appropriate for their work.

6.3: Data Downloading

The FDA uses standard statistical and data management software, such as Excel and CSV, and shall require the ability to download data in formats that are compatible with these packages.

6.4: Local Area Network Configuration

The FDA uses a central-server network model. The configuration is a wide area network with transmission control protocol/Internet protocol (TCP/IP) running on a 10/1000 Mbps network. The FDA will not provide a diagram of the network. FDA will not support dial-in or modem- based access.

6.5: Security

Any client software installed on FDA computers for the purposes of accessing the data shall not use key-logging and/or network capturing functionality to transmit any data from the FDA system except for login information specific to the dataset and requests (e.g., SQL queries or similar methods) for accessing the Offeror’s application data sets. This client software shall also not transmit any data to the FDA system other than that needed for developing, transmitting, and reviewing the output of requests (such as documentation and a querying interface).

6.6: Virtual Private Network (VPN)

The FDA utilizes a virtual private network to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. A VPN shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard IPSEC protocols.

6.7: Technical Support

The Contractor shall provide a support package comprised of web-based written documentation that includes technical, analytical, and clinical support throughout the length of the contract.

The Contractor shall provide ongoing technical, analytical, and clinical support, by phone or by e- mail, to all certified users of the data during business hours (9:00 am to 5:00 pm, EST), throughout the length of the contract in accordance with the service levels established in the contract.

The support package shall include all upgrades, enhancements, and modifications to the software

6.8: Trial Subscription Period

The FDA requires a 30-day trial subscription. The trial subscription shall include direct access, documentation, and technical support for a maximum of seven FDA researchers on the technical evaluation panel. The FDA will not pay for this subscription as access will be used solely to evaluate the Offeror’s product, and not for any analysis, public disclosure or regulatory decision making.

The Offeror shall provide telephonic or web-based training session that lasts a maximum of 2 hours at the start of the trial subscription period. Trial subscription shall include online access (user names and passwords).

The Offeror’s proposal shall include a point of contact for FDA to call to set up the trial subscription and the Trial Subscription Agreement.

The FDA shall only use the data for the purposes of understanding the systems data resources. FDA shall not use the data, nor any analyses derived from the data, for public disclosure or regulatory decision- making.

PART 7- PERIOD OF PERFORMANCE

The period of performance for this contract vehicle shall be the effective date of contract for a base year of twelve (12) months, and four (4) option years for a total of five years.

In addition, the period of performance for the optional quantities for additional users if exercised shall only be in effect for the number of months remaining under the current period of performance not to exceed twelve months. For example, if one of these optional quantities is exercised three months into the period of performance, only nine months will be utilized under this line item. Should the Government require the additional users in future periods, each optional quantity for that period will be exercised independently.

Base Year: July 31, 2023 – July 30, 2024

Option Year #1: July 31, 2024 – July 30, 2025

Option Year #2: July 31, 2025 – July 30, 2026

Option Year #3: July 31, 2026 – July 30, 2027

Option Year #4: July 31, 2027 – July 30, 2028

PART 8- CONTRACT ADMINISTRATION DATA

8.1 Place of Performance:

The Contractor shall perform services off-site at the contractor’s facility except where the Kick-Off Meeting, Annual Meetings, and Training programs are directed by the COR to be onsite.

8.2 Hours of Operation:

Unless otherwise specified in the individual task order, Contractor staff must be available during normal FDA business hours, from 8:00 am – 5:00 pm Eastern Time (ET), Monday through Friday, except on Government Closures.

The Contractor may be required to deliver documents and records materials outside of normal FDA business hours. If working outside of normal business hours, the Contractor will have the flexibility to use management tools (i.e., swing shifts) to successfully meet individual task order requirements. Any overtime incurred must be approved in advance. Normal FDA business hours are defined as being from 8:00 am – 5:00 pm ET, Monday through Friday, with deliveries on some weekends and holidays.

8.3 Observance of Government Closures

The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure under this contract or any task orders under this contract that include labor-hour or time-and-materials contract types. In the event Contractor personnel work during a holiday observed by the Contractor other than those below, no form of holiday or premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

Recognized Federal Holidays: Contractor coverage is expected during all Federal workdays. Except for designated around-the-clock or emergency operations and after-hour courier services, Contractor personnel shall not perform on-site under this contract on Federal holidays or any other day designated as a Federal holiday for the Washington, DC area. No services or deliveries shall be performed at Federal sites on Federal holidays unless specifically requested by the Contracting Officer.

January – New Year’s Day September – Labor Day

January – Martin Luther King, Jr. Day October – Columbus Day

February – President’s Day November – Veterans Day

May – Memorial Day June – Juneteenth

July – Independence Day November – Thanksgiving Day

December – Christmas Day

Inclement Weather and other Government Closures: The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather, government closures or other emergencies. The COR will notify the Contractor of Government Closures due to inclement weather, government closure or emergencies (man-made or otherwise).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management (OPM) for any reason, the agency is closed, or the Center or FDA building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

If adverse weather conditions develop after the Federal Government has opened for normal business, upon notification of early release from OPM, the COR and/or CO will notify the Contractor of Facility closings and specify the time for a final document pickup.

Additional specific inclement weather plans may be specified at the task order level.

8.4 QUALITY CONTROL PLAN:

The Contractor shall provide a Quality Control Plan (QCP) plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The QCP shall describe the systematic methods used to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QCP at its own discretion.

Required Service

Standard

Acceptable Quality Level

(AQL)

Method of Surveillance

(FDA)

Incentive

The Contractor shall provide Disclosure

Clearance and Third Party Agreement

The turnaround time for urgent clearance requests is 24 hours;

48 hours for standard clearance requests;

and 96 hours for third-party agreements

Standard shall be fully met at 100%

COR and FDA staff shall maintain a clearance tracking log with turnaround times

Past Performance evaluation of Future Awards for Similar

Standards

The Contractor shall provide

Unlimited Direct Access to Data Resource and

Services

The Contractor shall notify the FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime

The Contractor shall notify the FDA within 30 minutes (Monday- Friday, 9:00 AM – 5:00

PM EST) from the onset of unplanned downtime with an estimate of time as to restoration of access

Standard shall be fully met at 100%

COR and FDA staff shall monitor database access, notification and restoration times

Past Performance Evaluation/

Determination of Future Awards for Similar Standards

Required

Standard

Acceptable Quality Level

(AQL)

Method of

Surveillance

(FDA)

Incentive

The contractor shall The contractor shall Standard shall COR and Past Performance provide Ad-hoc provide Ad-hoc be fully met at FDA staff Evaluation/

Determination Analyses: Data results 100% shall monitor of Future custom reporting and within 15 business turnaround Awards for Similar product customization days of receipt times from Standards the Contractor’s monthly report

The contractor shall provide a resolution plan and shall include Within five business a timeline for resolving days of Contractor’s any circumstances knowledge of the loss resulting in loss of, or or lack of access to COR and Past Performance lack of, access to data data or any data Standard shall staff review of Evaluation/

Determination or any data errors/loss errors/loss from the be fully met at data quality of Future from the database(s) database(s) and shall 100% (i.e., variance Awards for Similar be documented in the in data runs) Standards Monthly Report

8.5 Contracting Officer Representative

The following COR will represent the Government for the purpose of this contract:

(COR To be determined at the time of contract award)

Contracting Officer’s Authority: The Contracting Officer is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is, or may be, outside the scope of the contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including The surveillance and assessment of performance and recommending changes in requirements to the Contracting Officer; (2) interpreting the Statement of Work and any and all other technical performance requirements; (3) performing technical evaluations as required; (4) performing technical inspections and acceptances required by this contract;

and (5) assisting in the resolution of technical problems encountered during performance of the contract. The Government may unilaterally change its COR designation.

8.6 The contact information for the Contracting Specialist is:

Sheila Brown

OFBA/OO/OAGS

4041 Powder Mill Road

Calverton, MD 20705

E-Mail: Sheila.Brown1@fda.hhs.gov

Phone: (301) 796-0827

8.7 The contact information for the Contracting Officer is:

Ian Weiss

OFBA/OO/OAGS

4041 Powder Mill Road

Calverton, MD 20705

Phone: (301) 796-5782

Email: Ian.Weiss@fda.hhs.gov

8.8 Key Personnel

The Contractor shall provide the names and qualifications of the key personnel assigned to this contract.

The individuals cited below are key personnel.

Name Title

Project Manager _______________

If any of the personnel listed as key personnel are unable to perform because of health, resignation from the Contractor’s employ, or any other reasons, the Contractor shall promptly submit to the Contract Specialist, a detailed written explanation of the situation, the proposed substitution, complete resumes for the proposed substitute, and any other information necessary for the approval of the substitution. No substitutions shall be made without prior written approval of the Contract Specialist. No increase in contract pricing will be allowed when substitutions are authorized by the government.

mailto:Sheila.Brown1@fda.hhs.gov mailto:Ian.Weiss@fda.hhs.gov

8.9 INVOICE SUBMISSION

1. The following clauses are incorporated into the contract:

a. 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting

Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the

Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

b. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

c. (1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

(2) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

(3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(4) If your company is already registered to use IPP, you will not be required to re-register.

(5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

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

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

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

• Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(END OF CLAUSE)

PART 9- SPECIAL CONTRACT REQUIREMENTS

9.1 Advance Understanding

Notwithstanding any of the above requirements, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a federal court, or with another governmental body of competent jurisdiction. If the Government intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government shall take appropriate measures within its control in an effort to ensure that the information shall be shared in a manner intended to protect the information from public disclosure.

The Contractor shall ensure the protection of the information and data they receive under this contract from unauthorized use or disclosure and shall treat the information as confidential or otherwise privileged.

PART 10- CONTRACT CLAUSES

ORDER OF PRECEDENCE

The Contractor shall follow the terms and conditions of this contract. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212‐4.

The Contractor shall not auto‐renew any subscriptions, licenses, maintenances, and services not authorized under this contract. Any autorenewals are at the risk of the Contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

10.1 FAR CLAUSES:

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108- 78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

https://www.acquisition.gov/far/part-52#FAR_52_203_19 https://www.acquisition.gov/far/part-52#FAR_52_204_23 https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.acquisition.gov/far/part-52#FAR_52_209_10 https://www.acquisition.gov/far/part-52#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/4655

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ( 31 U.S.C. 6101 note).

X (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ( 41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ( 15 U.S.C. 657a).

X (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (13) [Reserved]

__ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-7.

X (16) 52.219-8, Utilization of Small Business Concerns (OCT 2022) ( 15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (OCT 2022) ( 15 U.S.C. 637(d)(4)).

https://www.acquisition.gov/far/part-52#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_203_15 https://www.acquisition.gov/far/part-52#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_204_14 https://www.acquisition.gov/far/part-52#FAR_52_204_15 https://www.acquisition.gov/far/part-52#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_9

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2021) of 52.219-9.

__ (18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (OCT 2022) ( 15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) ( 15 U.S.C. 657f).

X (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (OCT 2022) ( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (OCT 2022) ( 15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT 2022) ( 15 U.S.C. 637(m)).

X (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ( 15 U.S.C. 644(r)).

X (26) 52.219-33, Nonmanufacturer Rule (SEP 2021) ( 15U.S.C. 637(a)(17)).

X (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

X (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEC 2022) (E.O.13126).

X (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

X (30) (i) 52.222-26,…