HHSF223-R-1180161.pdf

HHSF223-R-1180161 Access to Over-the-Counter (OTC) Drug Utilization Data

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2005-95.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is

HHSF223-R-1180161 and is being issued as a Request for Proposals (RFP). The NAICS Code for this solicitation is 518210 and the Small Business Size Standard is $25 Million. This will be awarded as hybrid contract type with Firm-Fixed Price (FFP) and Labor Hour (LH). This procurement will be 100% Full and Open Competitive procurement. Prospective Offerors are responsible for downloading the solicitation and any amendments from FBO. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

The Government contemplates award of a single Indefinite Delivery, Indefinite Quantity (IDIQ)

FFP contract with hybrid mix of individual Task Orders either FFP or LH resulting from this solicitation, at the discretion of the Contracting Officer (CO).

The U. S. Food and Drug Administration (FDA) has a need to procure services for real-time, immediate, direct, multi-user, desktop access to a currently existing, commercially available data resource through and existing and user-friendly interface tool for Over-the-Counter (OTC) drug utilization data that include household and/or patient/intended user demographics, drug treatment patterns, and indications or ailments intended for treatment in the outpatient setting using surveys and/or other appropriate methodologies.

A. STATEMENT OF WORK (SOW) -- SCOPE OF WORK

SEE HHSF223-R-1180161 ATTACHMENT 1 FOR SOW REQUIREMENTS AND

APPENDICES

B. PLACE OF PERFORMANCE :

Contractor’s place of business and

Food and Drug Administration

10903 New Hampshire Ave

White Oak Campus, Building 66

Silver Spring, MD 20993

C. PERIOD OF PERFORMANCE:

The period of performance for this contract shall be for a Base Period, with two (2) one year

Option Periods:

Base Period: September 25, 2017 through September 24, 2018

Option Period 1: September 25, 2018 through September 24, 2019

Option Period 2: September 25, 2019 through September 24, 2020

D. PRICING SCHEDULE:

Schedule 1

Item No. Period of Performance

Fixed-Price Total

0001 Base Period $

0002 Base Period $

1001 Option Period 1 $

1002 Option Period 1 $

2001 Option Period 2 $

2002 Option Period 2 $

Total: $

Provide a FFP in accordance with the Statement of Work identified for defined deliverables.

IDIQ Labor Rates: The hourly rates for each labor category below shall be fully burdened to include wages, fringe benefits, overhead, general and administrative expenses, and/or profit.

Total Ceiling Amount of IDIQ Items Ordered via individual Task Orders shall not exceed

$4,000,000.00 over the total period of performance (Base Period and Option Periods).

Note: All IDIQ Individual Task Orders shall be awarded on a FFP or LH basis.

Schedule 2

IDIQ ITEMS/SERVICES

Base Period of Performance: September 25, 2017 through September 24, 2018

Item No. Description of Supplies/Service Quantity Unit Price

0003 Labor Category TBD Hourly

0004 Additional Services (customized analysis) TBD Each/Hourly

0005 Configuration of user interface tool TBD Each/Hourly

0006 Ad hoc analysis: custom reporting 50 Hours Hourly

IDIQ ITEMS/SERVICES

Option Period 1 of Performance: September 25, 2018 through September 24, 2019

Item No. Description of Supplies/Service Quantity Unit Price

1003 Labor Category TBD Hourly

1004 Additional Services (customized analysis) TBD Each/Hourly

1005 Configuration of user interface tool TBD Each/Hourly

1006 Ad hoc analysis: custom reporting 50 Hours Hourly

IDIQ ITEMS/SERVICES

Option Period 2 of Performance: September 25, 2019 through September 24, 2020

Item No. Description of Supplies/Service Quantity Unit Price

2003 Labor Category TBD Hourly

2004 Additional Services (customized analysis) TBD Each/Hourly

2005 Configuration of user interface tool TBD Each/Hourly

2006 Ad hoc analysis: custom reporting 50 Hours Hourly

Below are the Labor Categories to be used throughout the life of the contract for any task order.

Schedule 3

Base Period: September 25, 2017 through September 24, 2018

Contract Labor Category Labor Hourly Rate

Project Manager/Research Director $

Sr. Computer Systems Analyst $

Application Programmer $

Statistician $

Pharmacist $

Survey Scientist $

Sr. Training Specialist $

Epidemiologist $

Option Period 1: September 25, 2018 through September 24, 2019

Sr. Computer Systems Analyst $

Application Programmer $

Statistician $

Pharmacist $

Survey Scientist $

Option Period 2: September 25, 2019 through September 24, 2020

Sr. Computer Systems Analyst $

Application Programmer $

Statistician $

Pharmacist $

Survey Scientist $

E. GENERAL INFORMATION

For all meetings, the Contractor’s personnel are required to report to the security guards at the White Oak Building 75, 10903 New Hampshire Ave, Silver Spring, MD 20903, who will contact the COR or his or her designated FDA employee.

The Contractor’s personnel must be escorted by the COR or his or her designated FDA employee at all times while working on-site under this contract.

F. GOVERNMENT HOLIDAYS

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

G. EVALUATION AND AWARD:

52.212-2 Evaluation—Commercial Items. (Oct 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the

Government, price and other factors considered. The technical evaluation criteria are listed in descending order of importance. The following factors shall be used to evaluate offers:

Factor 1: Technical Approach/Understanding the Requirement

Factor 2: Management Approach/Staffing Plan

Factor 3: Relevant Past Performance

Factor 4: Price

Technical and past performance, when combined, are significantly more important than price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

In addendum to FAR 52.212-2

The Government intends to evaluate proposals and, if necessary conduct discussions with all responsible Offerors within the competitive range. The award will be made to the Offeror whose proposal conforms to the terms and conditions of the solicitation and award may be made to other than the lowest priced or the highest technically rated offer.

Relative importance and trade-offs. The Government will base the determination of best value on performance, and the other evaluation factors identified elsewhere in this solicitation. The determination of best value also considers the relative importance of the evaluation factors.

Technical factors and past performance when combined are significantly more important than price. It is pointed out; however, should technical competence between Offerors be considered approximately the same, then price could become primary.

FDA will base its award decision using a best value analysis that results in the most advantageous acquisition for the Government. FDA’s acquisition strategy used to obtain best value may result in an award to other than the lowest priced, technically rated Offeror. Best value analysis spans a continuum from the lowest priced, technically acceptable proposal to those proposals in which tradeoffs between price, past performance, and each Offeror’s technical solution is evaluated. This tradeoff process depends on the Government’s assessment of quality factors, including but not limited to past performance, compliance with solicitation requirements, technical excellence, management capability, personnel qualifications and prior experience, technical capability (which includes technical approach/understanding the requirement, management approach/staffing plan, relevant past performance), and price.

H. INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (JAN 2017)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

The Offerors proposal response shall be submitted electronically via e-mail to the Contracting

Officer: Monifa Coleman at Monifa.Coleman@fda.hhs.gov. Label the Offerors proposal with the solicitation number and the company name. Be sure the submitted response has both

Volumes properly labeled Volume 1 Technical and Volume 2 Price.

mailto:Monifa.Coleman@fda.hhs.gov

The total number of pages for the Volume 1 Technical shall not exceed fifty (50) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12. There will be no page limit on Volume 2 Price.

VOLUME 1 Technical Proposal

The technical proposal described below shall be limited to 50 pages excluding resumes or bibliographies, key personnel information, Non-Public Information Agreements (NPI) for key personnel, cover sheets, table of contents, list of figures, list of exhibits, and tab dividers. Any and all other pages, including charts, exhibits, unmarked pages and any other narrative and attachments to the quotation shall be included in the page calculation. Any excess pages will not be considered for evaluation.

Factor 1: Technical Approach/Understanding the Requirement:

a) The Offeror shall provide a narrative that presents sufficient information to reflect a thorough understanding of the work requirements and a detailed plan for achieving the objectives in the Scope of Work.

b) The Offeror shall complete the Data Characteristics Table (Attachment 3), and shall provide a detailed description of its existing data resource(s). The description shall include information on the type of data and the collection methodology.

c) The Offeror shall provide full disclosure of data collection and projection methodology or other appropriate methodology for providing national estimates of OTC drug purchasing and utilization patterns (via survey data or other methods) and compare their data to the most recent U.S. national census data as well as the availability of confidence intervals around projected estimates and the method used to calculate. In addition, the Offeror shall provide a detailed description of the projection methodology for all of the data characteristics listed in the Data Characteristics Table (Attachment 3). The Offeror shall provide sample and projected numbers from the data under consideration. All information provided shall be the most recent date for which complete data are available

(please specify date).

d) The Offeror shall provide an existing user interface tool of the data resource(s) which shall provide FDA staff the ability to select OTC drugs and market categories, and perform data reports at the active ingredient level, generic and brand products (including store name brand products), and any other data elements that may become available. The user interface tool(s) shall provide FDA staff the ability to perform data reports without or with minimal intervention by the Contractor and download in near real-time.

e) The Offeror shall describe the coding system used, including the ailment coding levels available for FDA data analyses; the availability of data to describe and quantify the amount, frequency and duration of OTC drug products used as well as the ailment intended to treat in the outpatient setting and the percentage of missing or incomplete information for each data element.

f) The Offeror shall include information demonstrating that the data resource meets all technical requirements to include: a data dictionary; total number of years of data available on-line; amount of data available online on a standard basis; a maximum of a 6-month lag time between date of service and online availability of all types of data available; the ability to download, archive, and query data no longer on-line; data de-identification procedures; Section 508; real-time updates; and secure multi-user access through an existing user-friendly interface.

Trial Subscription:

Subfactor #1 The Offeror shall provide a trial subscription for the duration of the evaluation period of 15 days and shall include direct access to the full version of the data resource, documentation, and technical support for a maximum of six FDA researchers. 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’s technical proposal shall include an executed Trial Subscription Agreement

(Appendix H) and include a point of contact for FDA to set-up the trial subscription.

The Offeror shall provide web-based and telephone training session that lasts a maximum of

2 hours at the start of the trial subscription period. Trial subscription shall include online access (six user names and six passwords) or stand-alone access.

Factor 2: Management Approach/Staffing Plan

The Offeror shall describe their approach to managing, staffing, and performing the Scope of

Work. This shall include services for the onsite training, onsite kick-off meeting and annual meeting, and adherence to the FDA Data Disclosure Clearance Procedures and form unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA

The Offeror shall describe their business that specifically details the percentage of data committed for OTC drug utilization data.

Factor 3: Relevant Past Performance

The Offeror shall provide a narrative description of three (3) examples of experience on current and previous contracts over the past three (3) years which are relevant in terms of type, scope, complexity, and size to this Scope of Work. The Offeror shall cite examples of experience that demonstrate the Offeror’s ability to overcome difficulties encountered during performance with minimum impact to the program. Relevant experience submissions shall not exceed two pages for each experience provided. In addition to the narrative description described above, for each contract the Offeror shall provide the following:

Name of Contracting Activity (Federal Government Agency, Local Government, Commercial

Customer); Contract Number; Contract Type; Total Contract Value; Contract Work (Description of Experience, Degree of Involvement, Size of Organization, etc.); Contracting Officer

Information, Project Officer/Contracting Officer Representative Contact Information).

The Offeror shall also provide a complete bibliography of all publications using these data in the area of pharmacoepidemiology, pharmacoeconomics, or health services research. The bibliography entries may be provided from the Offeror’s records or via a literature review (e.g.

PubMed search).

VOLUME 2 Price Proposal

The Offeror shall propose FFP for Schedule 1 Items No.: 0001-2002 and fully loaded fixed hourly rates for IDIQ Items for both Schedules 2 and 3 Items No.: 0003-2006 for Other Services

Associated with the Scope of Work.

EVALUATION CRITERIA

VOLUME 1: Technical Proposal

Factor 1: Technical Approach/Understanding the Requirement

a) Adequacy, feasibility and scientific rationale of the understanding of the work requirements and a detailed plan for achieving the objectives in the Scope of Work.

b) Adequacy, feasibility, and scientific rationale of the proposal, quality of the data resource in terms and of suitability of the depth and breadth of the information provided in the Data Characteristics Table, and any information on the type of data and the collection methodology.

c) Adequacy, feasibility, and scientific rationale of the proposal in terms of data collection and projection methodology providing national estimates of OTC drug purchasing and utilization patterns and compare their data to the most recent U.S.

national census data.

d) Adequacy, flexibility and feasibility of the user interface tool to allow FDA staff the ability to conduct drug-, condition- or demographic- specific queries to meet the requirement and the capability to select OTC drugs and market categories and perform data reports at the active ingredient level, generic and brand products

(including store name brand products), and any other data elements that may be available.

e) Adequacy, feasibility, and scientific rationale to describe the coding system used, including the ailment coding levels available for FDA analyses; the availability of data to describe and quantify amount, frequency and duration of OTC drug products used as well as the ailment intended to treat in the outpatient setting and the percentage of missing or incomplete information for each data element.

f) Adequacy, flexibility and scientific rationale that the data resource has met all technical requirements to include: a data dictionary; total number of years of data available on-line; amount of data available online on a standard basis; a maximum of a 6-month lag time between date of service and online availability of all types of data available; the ability to download, archive, and query data no longer on-line; data de-identification procedures; Section 508; real-time updates; and secure multi-user access through an existing user-friendly interface.

Trial Subscription:

Subfactor #1 The trial subscription shall be evaluated in terms of transparency, flexibility, ability to accommodate multiple users, consistency in results, completeness, efficiency and ease of use. At a minimum, the ability to access OTC data with the ability to select drug products by active ingredient, generic and brand name (including store name brand), stratified by patient demographics, the ability to archive queries and results, the ability to retrieve same (dated) information over time, and the timeliness of data retrieval.

Factor 2: Management Approach/Staffing Plan

a) Adequacy and feasibility of the management and staffing for the performance of the

Scope of Work related to accessing the OTC data resource to include services for the onsite training, onsite kick-off meeting and annual meeting, and adherence to the FDA

Data Disclosure Clearance Procedures and form unless a different Data Disclosure

Clearance Procedure process proposed by the Offeror is approved in advance by the

FDA.

b) Adequacy, feasibility, and scientific rationale of their business that details the percentage of data committed for OTC drug utilization data.

Factor 3: Relevant Past Performance

The Government will evaluate the extent to which the Offeror’s relevant past performance demonstrates overall client satisfaction on current and previous contracts. No relevant past performance will result in a neutral rating.

VOLUME 2: Price Proposal

The Government will add the total for each contract period (base year and two (2) one-year option periods) to derive the evaluated price for this acquisition.

The Government will evaluate price proposals to determine fairness and reasonableness. Prices that are determined to be either unreasonably high or unrealistically low in relation to the proposed work may result in the overall proposal being considered unacceptable.

The Offeror’s proposed price will also be considered in the context of price risk and affordability. In this context, price risk is the Government’s level of confidence if the Offeror’s ability to perform as proposed based on:

a. The price information provided by the Offeror and gathered from other sources

b. The completeness of the Offeror’s price documentation and traceability to the Offeror’s proposal

c. The reasonableness and realism of the Offeror’s proposed price

d. The degree of stated or implied cost risk passed to the Government

e. The Offeror’s financial capability to execute the contract in accordance with general accounting standards and to support the requirement

The price proposal shall represent the Offeror’s response to the requirements of the solicitation.

With the exception of past performance, technical criteria shall be evaluated adjectively and categorized as Excellent, Very Good, Acceptable, and Unacceptable in relation to the evaluation factors set forth in the solicitation. Sub-criteria under any particular evaluation criterion shall be weighted equally.

Adjectively Ratings

EXCELLENT The Offeror convincingly demonstrates that the RFP requirements have been analyzed, evaluated, and synthesized into proposed approaches, plans, and techniques that, when implemented, will result in superior and efficient performance. The proposal has significant strengths, which indicate beneficial features or innovations that will substantially benefit the program. The proposal has no significant weaknesses. Any minor weaknesses are insignificant when compared to the strengths.

VERY GOOD The Offeror demonstrates that the RFP requirements have been analyzed, evaluated, and synthesized into proposed approaches, plans, and techniques that, when implemented, should result in effective and efficient performance. The proposal has significant strengths and/or several minor strengths, which indicate a proposed approach that will benefit the program. The proposal has few weaknesses, and the strengths of the proposal more than offset any weaknesses.

ACCEPTABLE The Offeror demonstrates that the RFP requirements have been analyzed, evaluated, and synthesized into proposed approaches, plans, and techniques that, when implemented, should result in adequate performance. The proposal has modest strengths. The weaknesses in the proposal are offset by the strengths.

UNACCEPTABLE The Offeror demonstrates a superficial, incomplete, or incorrect understanding of the RFP requirements, resulting in proposed approaches, plans, and techniques that are deficient and should result in poor performance when implemented. The proposal has few strengths. The proposal has significant weaknesses and/or many minor weaknesses that are not offset by strengths.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested Offerors shall submit questions electronically to

Monifa.Coleman@fda.hhs.gov no later than August 21, 2017, 10:00 a.m. Eastern Standard

Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

PROPOSAL DUE: All proposals are due, electronically via e-mail to the Contracting Officer:

Monifa Coleman at Monifa.Coleman@fda.hhs.gov no later than August 30, 2017, 10:00 a.m.

Eastern Standard Time. Label the Offerors proposal with the solicitation number and the company name in the subject line of the email.

PROVISIONS and CLAUSES:

FDA

Minimum and Maximum

The Government shall consider the issuance of the first Task Order as the minimum guaranteed amount for the life of the contract. The maximum cumulative dollar value of Task Orders placed under this contract shall not exceed the ceiling amount of $4,000,000.00.

Personnel Security Clearance Requirements

1. Background

The Office of the Assistant Secretary for Management and Budget, Department of Health and

Human Services (DHHS), requires that DHHS employees and Contractor employees (including subContractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who will be in DHHS-owned or leased space for less than thirty (30) days are exempted from the background investigation requirement. These Contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. General

The Contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

Certification that all required security form packets and a list of Contractor employees’ names for whom the requisite security information has been provided, to Division of Security Operations, Policy and Planning, and Personnel Security

Staff.

"Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee.

With the exception of costs associated with fingerprinting Contractor employees outside of the

FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, Contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the

Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation

Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk level for this contract is 1.

There are two (2) potential position risk levels, which are:

Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public

Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate

Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Project Officer for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that

Contractor’s employees being denied access to FDA property until all security processing has been completed.

3. Badging Process

The FDA Contracting Officer Representative (COR) will sponsor Contractor employees on the

FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a Contractor employee must receive a "favorable" fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints will be submitted in one of two ways, depending on where the contract will be performed:

Contractor employees who will work in the Washington D.C. metro area will, at the direction of the FDA COR or his/her designee, contact the Personnel Security

Branch to schedule a fingerprinting appointment, or

Contractor employees who will work in a field office will submit fingerprints to:

Food and Drug Administration

Fingerprinting and Personnel Security Office

10903 New Hampshire Avenue, Building 1, Room 1201

Upon the receipt of a "favorable" fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at:

http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

4. Background Investigations

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

Required background investigations may include, but not be limited to:

Review of prior Government/military personnel records;

Review of FBI records and fingerprint files;

Searches of credit bureaus;

Personal interviews; and

Written inquiries covering the subject's background.

Background investigations will be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of Contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the Contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug Administration

Badging and Credentialing Office

10903 New Hampshire Avenue, Building 1, Room 1201

The Contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The Contractor shall advise its prospective employees that all standard forms submitted to the

FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

Personnel Security Staff will resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise

Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a Contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the Contractor shall immediately notify

Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting

Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor shall notify the Contracting Officer, and the Government will make a determination whether an additional security clearance is required.

In the event that a cleared individual is replaced, the Contractor shall notify the Contracting

Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the Contracting Officer Representative (COR).

6. NON-PUBLIC DATA PROTECTION

The Contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure.

CHARTS A & B ARE APPENDED TO THIS CLAUSE

For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided:

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE

POSITIONS - LEVEL 1

FORM NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT

TO

DATE

REQUIRED

FDA Form 3391 - FDA

Security Card Access

Request

Project Officer.

Sponsorship must be provided by

FDA Project

Officer.

All positions on

DHHS property or leased space

Food and Drug Administration

Attn: Badging and Credentialing

Office

10903 New Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD 20993

**Form must be submitted by

Security Rep.

Form must be received prior to making fingerprint appointment.

Contractor’s Commitment to Protect Non-Public

Information (NPI)

Agreement form

Contracting

Officer

All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to commencement of work

Listing of all Contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair

Credit Reporting Act

Release

Contractor generated

All positions, including intermittent, per diem or temporary

*Food and Drug Administration

Attn: Badging and Credentialing

Office

10903 New Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD 20993

(301) 796-4592

Ten (10) calendar days prior to commencement of work

SF 85 - Questionnaire for

Non-Sensitive Positions

Online via

OPM’s e-QIP system

Non-Sensitive

Positions - Level 1

Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days upon request of the Contracting

Officer

FD 258 - Fingerprint

Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 827-9527

Contracting

Officer

Non-Sensitive

Positions - Level 1

Clearance

*Food and Drug Administration

Fingerprinting & Personnel

Security Office

10903 New Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD 20993

(301) 796-4607

Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the Contractor shall provide a cover letter that includes:

Contractor’s name, contract number, Contractor employees’ names, and name of Contracting Officer.

*Upon favorable fingerprint return, Contractor will be notified to respond to the badging office for their building pass.

CHART B

*Food and Drug Administration

Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.

10903 New Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD 20993

No appointment necessary

(301) 796-4592

Public Trust Positions -

Levels 5 or 6

FORM NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT

TO

DATE

REQUIRED

SF 85P - Questionnaire for

Public Trust Positions

Online via

OPM’s e-QIP system

Public Trust

Positions - Level 5 or 6 Clearance

*Submit to OPM online via the e-

QIP system

Ten (10) calendar days prior to commencement of work

FD 258 - Fingerprint

Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 827-9527

Contracting

Officer

Public Trust

Positions - Level 5 or 6 Clearance

*Food and Drug Administration

Fingerprinting & Personnel

Security Office

10903 New Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD 20993

(301) 796-4607

Ten (10) calendar days prior to commencement of work

FDA Form 3391 - FDA

Security Card Access

Request

FDA COR.

Sponsorship must be provided by

FDA COR.

All positions on

DHHS property or leased space

Food and Drug Administration

Attn: Badging and Credentialing

Office

10903 New Hampshire Avenue

Building 1, Room 1201

**Form must be submitted by

Security Rep.

Form must be received prior to making fingerprinting appointment.

Contractor’s Commitment to Protect Non-Public

Information (NPI)

Contracting

Officer

All positions with access to non-public privileged, Contracting Officer for retention Ten (10) calendar days prior to

Agreement form proprietary, or trade secret information in contract file commencement of work

Listing of all Contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair

Credit Reporting Act

Release

Contractor generated

All positions, including intermittent, per diem or temporary

*Food and Drug Administration

Attn: Badging and Credentialing

Office

10903 New Hampshire Avenue

Building 1, Room 1201

(301) 796-4592

Ten (10) calendar days prior to commencement of work

*Upon favorable fingerprint return, Contractor will be notified to respond to the badging office for their building pass.

*Food and Drug Administration

Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.

10903 New Hampshire Avenue

Building 1, Room 1201

Silver Spring, MD 20993

No appointment necessary

(301) 796-4592

*In addition to the submission of these forms, the Contractor shall provide a cover letter that includes: Contractor’s name, contract number, Contractor employees’ names, and name of Contracting Officer.

FDA Three-Way Match Invoicing

A. The Contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

Division of Payment Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

301-827-3742

FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is (TBD.)

B. Invoices submitted under this contract must comply with the requirements set forth in

FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds

Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the Contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-

Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

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

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the Contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET

30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other

Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A.

DHHS

352.227-14 Rights in Data—Exceptional Circumstances (Sept 2014)

352.237-75 Key Personnel (Dec 2015)

352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

352.233-71 Litigation and Claims (Dec 2015)

FAR

The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/

The following FAR provisions and clauses apply: FAR 52.203-3 Gratuities (APR 1984); FAR

52.203-5 Covenant Against Contingent Fees (MAY 2014); FAR 52.203-6 Restrictions on

SubContractor Sales to the Government (SEPT 2006); FAR 52.203-7 Anti-Kickback Procedures

(MAY 2014); FAR 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity (MAY 2014); FAR 52.204-10 Reporting Executive Compensation and First-

Tier Subcontract Awards (OCT 2016); FAR 52.209-6 Protecting the Government’s Interest When

Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015);

FAR 52.212-1, Instructions to Offerors Commercial Items; FAR 52.212-2, Evaluation-

Commercial Items; FAR 52.212-3 Offeror Representations and Certifications-Commercial

Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--

Commercial Items; 52.216-31 Time-and-Materials/Labor-Hour Proposal Requirements—

Commercial Item Acquisition (FEB 2007);FAR 52.217-5, Evaluation of Options; FAR 52.217-8, Option to Extend Services; 52.217-9, Option to Extend the Term of the Contract; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR

52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; FAR

52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.225-13 Restrictions on

Certain Foreign Purchases (JUNE 2008); FAR 52.227-14 Rights in Data—General. (MAY 2014) &

Alternate II and Alternate III (Dec 2007); FAR 52.232-18 Availability of Funds; FAR 52.232-33

Payment by Electronic Funds Transfer—System for Award Management; FAR 52.237-3

Continuity of Services (JAN 1991).

52.216-19 Order Limitations (OCT 1995) https://www.acquisition.gov/far/

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $ 500.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $1,000,000.00;

(2) Any order for a combination of items in excess of $4,000,000.00; or

(3) A series of orders from the same ordering office within 7 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection

52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 2 days after issuance, with written notice stating the

Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

52.216-22 Indefinite Quantity(OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the

Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after September 24, 2020.

https://www.acquisition.gov/sites/default/files/current/far/html/52_216.html#wp1115057

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror

Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.