FDA-RFP-1228764_Amendment_1.pdf

Amendment 1 - FDA-RFP-1228764

Document Type Request for Proposal-IDIQ Solicitation Number FDA-RFP-1228764 (Amendment 1) Subject Access to Over the Counter (OTC) Drug Utilization Data Post Date May 07, 2020 Questions Due May 14, 2020 at 14:00 Eastern Proposal Due June 08, 2020 at 14:00 Eastern NAICS Code 541519 Other Computer Related Services

PART I

SECTION B-SUPPLIES OR SERVICES AND PRICES/COST

B.1 SOLICITATION DESCRIPTION

To strengthen the Drug Utilization Program, the Food and Drug Administration (FDA) requires access to commercially available Over-the-Counter (OTC) drug utilization data. The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary for this requirement titled, “Access to Over-the-Counter (OTC) Drug Utilization Data/Services”.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Part 12.603. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued. This solicitation is a Request for Proposals (RFP) using FAR Part 12 and 15 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-04. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541519 - Other Computer Related Services. Its associated Small Business Size Standard is $27.5M.

This requirement is intended for full and open competition. All responsible offerors are permitted to submit a proposal as a result of this solicitation.

B.2 CONTRACT TYPE

In accordance with FAR 52.216-27, the government intends to make a single award Indefinite- Delivery, Indefinite-Quantity (IDIQ) Contract award with the issuance of Firm-Fixed, Time and Material and/or Labor Hour (or hybrid) task orders. The period of performance shall consist of one

(1) 12-month Base Period and two (2) 12-month Option Periods for a total of 36 months if all options are exercised. The quantities of services ordered under this contract shall be accomplished by the issuance of task orders that will describe the contract type, objectives, scope, period of performance, and deliverables. All task orders are subject to the terms and conditions in the IDIQ base contract. At its discretion, the Government may use any combination of contract types when issuing task orders under this IDIQ contract to meet its needs, including Firm-Fixed Price (FFP), Time and Materials and/or or Labor Hour (LH). For each Request for Task Order Proposal

(RFTOP) for activities pursuant to non-Firm-Fixed Price (FFP) CLINs, the Contractor shall prepare and submit a task order proposal addressing all the areas in the Contracting Officer’s request.

B.3 CONTRACT CEILING

The IDIQ guaranteed minimum amount shall be one (1) month of service for CLIN 0001 – OR – one (1) Quarter of service under CLIN 0002. The total contract ceiling amount shall be $4,000,000.00 over three (3) years.

B.4 COST/PRICING *Offerors shall include pricing in Attachment 11

Line Item

Description Quan tity

Unit Unit Price Amount

0001 Base Year - Firm-Fixed Price (FFP)- Monthly updates of National Level Over-the-Counter (OTC) Drug Utilization Data, Acceptable Projection or Other Appropriate Methodology (1 Lot), Current and complete Data Dictionary, including updates (1 annually), Kick Off Meeting (1 Lot), On-site training programs and training materials (2 annually), Unlimited Technical Support; to include Notification of and Unlimited Disclosure Clearance and Third Party Agreement Services, and Monthly Reports by the 30th of each month (12 monthly). (See SOW C3.1)

12 Months

0002 Base Year - Firm-Fixed Price (FFP)- Quarterly updates of National Level OTC Drug Utilization Sales data in Excel File Format, Acceptable Projection or Other Appropriate Methodology (1 Lot), Current and complete Data Dictionary, including updates (1 annually), Kick Off Meeting (1 Lot), On-site training programs and

4 Quarterly training materials (2 annually), Unlimited Technical Support; to include Notification of and Unlimited Disclosure Clearance and Third Party Agreement Services, and Monthly Reports by the 30th of each month (12 monthly). (See SOW C3.1)

0003 Base Year - Time and Materials CLIN for multiple uncategorized drug datasets and have the availability to add new datasets that are not included in the proposed data. The proposed price shall include both labor and data cost.

(SOW Section C3.2) [Not to Exceed $120,000.00 annually]

12 Months $10,000.00 $120,000.00

0004 Base Year – Labor Hour - Ad-Hoc ANALYSES/Regulatory Drug Utilization Services (related to Section C.3.2) [Not to Exceed 1000 Hours total for the following Labor Categories] (See SOW C3.2.g & h)

Project Manager/Research Director 125 Hours Sr Computer Systems Analyst 125 Hours Application Programmer 125 Hours Statistician 125 Hours Pharmacist 125 Hours Survey Scientist 125 Hours Sr Training Specialist 125 Hours Epidemiologist 125 Hours

Base Year Total Amount

1001 Option Year 1 - Firm-Fixed Price (FFP)- Monthly updates of National Level Over-the-Counter (OTC) Drug Utilization Data, Acceptable Projection or Other Appropriate Methodology (1 Lot), Current and complete Data Dictionary, including updates (1 annually), Kick Off Meeting (1 Lot), On-site training programs and training materials (2 annually), Unlimited Technical Support;, Unlimited Disclosure Clearance and Third Party Agreement Services, and Monthly Reports by the 30th of each month (12 monthly). (See SOW C3.1)

12 Months

1002 Option Year 1 - Firm-Fixed Price (FFP)- Quarterly updates of National Level OTC Drug Utilization Sales data in Excel File Format, Acceptable Projection or Other Appropriate Methodology (1 Lot), Current and complete Data Dictionary, including updates (1 annually), Kick Off Meeting (1 Lot), On-site training programs and training materials (2 annually), Unlimited Technical Support;

Unlimited Disclosure Clearance and Third Party Agreement Services, and Monthly Reports by the 30th of each month (12 monthly). (See SOW C3.1)

4 Quarterly

1003 Option Year 1 - Time and Materials CLIN for multiple uncategorized drug datasets and have the availability to add new datasets that are not included in the

12 Months $10,000.00 $120,000.00 proposed data. The proposed price shall include both labor and data cost. (SOW Section C3.2) [Not to Exceed $120,000.00 annually]

1004 Option Year 1 - Labor Hour - Ad-Hoc ANALYSES/Regulatory Drug Utilization Services (related to Section C.3.2) [Not to Exceed 1000 Hours total for

SOW C3.2.g & h

Application Programmer 125 Hours Statistician 125 Hours Pharmacist 125 Hours Survey Scientist 125 Hours Sr Training Specialist 125 Hours Epidemiologist 125 Hours

Option Year 1 Total Amount 2001 Option Year 2 - Firm-Fixed Price

(FFP)- Monthly updates of National Level (OTC) Drug Utilization Data, Acceptable Projection or Other Appropriate Methodology (1 Lot), Current and complete Data Dictionary, including updates (1 annually), Kick Off Meeting (1 Lot), On-site training programs and training materials (2 annually), Unlimited Technical Support; , Unlimited Disclosure Clearance and Third Party Agreement Services, and Monthly Reports by the 30th of each month (12 monthly). (See

SOW C3.1)

12 Months

2002 Option Year 2 - Firm-Fixed Price (FFP)- Quarterly updates of National Level OTC Drug Utilization Sales data in Excel File Format, Acceptable Projection or

4 Quarterly

Other Appropriate Methodology (1 Lot), Current and complete Data Dictionary, including updates (1 annually), Kick Off Meeting (1 Lot), On-site training programs and training materials (2 annually), Unlimited Technical Support;, Unlimited Disclosure Clearance and Third Party Agreement Services, and Monthly Reports by the 30th of each month (12 monthly). (See SOW C3.1)

2003 Option Year 2 - Time and Materials CLIN for multiple uncategorized drug datasets and have the availability to add new datasets that are not included in the proposed data. The proposed price shall include both labor and data cost.

(SOW Section C3.2) [Not to Exceed $120,000.00 annually]

12 Months $10,000.00 $120,000.00

2004 Option Year 2 – Labor Hour - Ad-Hoc ANALYSES/Regulatory Drug Utilization Services (related to Section C.3.2) [Not to Exceed 1000 Hours total for

SOW C3.2.g & h)

Application Programmer 125 Hours Statistician 125 Hours Pharmacist 125 Hours Survey Scientist 125 Hours Sr Training Specialist 125 Hours Epidemiologist 125 Hours

Option Year 2 Total Amount Total Contract Amount

SECTION C-DESCRIPTION/SPECIFICATIONS/SCOPE OF WORK

C.1 BACKGROUND

A vital part of FDA and Center for Drug Evaluation and Research (CDER’s) mission is to protect the public health. The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate drug risks and promote the safe use of drugs by the American people. 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 Office of Surveillance and Epidemiology (OSE) contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Under PDUFA (Prescription Drug User Fee Act) IV, specific provisions in Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) contains numerous provisions related to post-marketing safety and communication of safety information. A subset of those provisions calls for enhanced authorities for accessing disparate data sources, establish and improve procedures to estimate the number of patients exposed to drugs nationwide.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

In furtherance of these efforts, the recent enactment of PDUFA V in 2012 under Section XI “Enhancement and Modernization of the FDA Drug Safety System”, Part D “Information Systems and Infrastructure” authorizes the FDA to “continue the Agency’s efforts on the standards-based information systems to support how FDA obtains and analyzes post-market drug safety data and manages emerging drug safety information”. These statutory provisions provide FDA the authority to obtain and expand database resources that will enhance FDA’s post-market surveillance capabilities.

In addition, the CDER initiated efforts to address concerns about the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (Rx) products following the June 29-30, 2009, Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee meeting. These efforts include changes in the dosing of acetaminophen along with increased education for prescribers and patients on the safe use of acetaminophen. As requested by the CDER Acetaminophen Steering Committee, the metrics working group (WG) developed an acetaminophen evaluation plan that will help to determine whether the changes, once implemented, have been effective in mitigating the adverse outcomes associated with the use of acetaminophen.

The FDA plans to evaluate the effectiveness of the Acetaminophen Safe Use Initiative by monitoring relevant databases. In support of FDA’s effort, the Office of Surveillance and Epidemiology identified the metrics and the timeline for monitoring, as well as the costs to FDA to acquire these data.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is of paramount importance to the overall public safety. Continued access to OTC drug utilization data will complement and strengthen the utility of FDA Adverse Event Reporting System (FAERS) currently in place. Access to these data will also increase the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the impact of prescription to OTC drug switches, and also allow the FDA to continue to evaluate the effectiveness of the Acetaminophen Safe Use Initiative by monitoring acetaminophen utilization patterns. Finally, direct access to these data in enhances and accelerates the pace of FDA's regulatory decision-making process. The funding of "Access to Over-the-Counter (OTC) Drug Utilization Data" would serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues related to OTC drug products.

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).

C.2 PROGRAM RESEARCH GOALS AND OBJECTIVES

This requirement seeks to obtain direct access to commercially available OTC drug utilization data and obtain services that support regulatory drug utilization activities. Specifically, the objectives are to:

1. Provide Access to OTC Drug Utilization Data as follows:

a. Provide FDA personnel with access to a currently existing, commercially available data resource for OTC data

b. Provide FDA personnel with the ability to use these data to describe national patterns of OTC drug utilization through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel;

c. Provide FDA personnel with the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies.

C.3 SCOPE OF WORK

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

C 3.1 National Level Over-the-Counter (OTC) Drug Utilization Data - Data Requirements (i.e., Base Year CLINs 0001 – or – 0002) – Firm-Fixed Price (FFP)

NOTE: Offerors shall propose providing the requirements of this Section C.3.1 on both a monthly basis (i.e., CLIN 0001) -AND- on a quarterly basis (i.e., CLIN 0002) so that the Government may determine by comparison which option provides the most efficient, effective and economical solution to this SOW requirement. Offerors shall price both the monthly and quarterly CLINs independently for the full period of performance, and the Government will later determine its preference upon execution of any resulting Task Order. This optional pricing shall not obligate the Government to order a combination of either CLIN.

a. The Contractor shall provide access to de-identified HIPAA-compliant data resources on

OTC drug product sales from U.S. retail pharmacies to consumers. FDA requires access to such data to obtain national patterns of OTC drug product utilization with the capability of current and historical national-level OTC drug product utilization. The data shall have a maximum of a 6-month lag time between the date of OTC drug product purchase and date of data availability for FDA use.

b. The OTC drug-specific basic data elements shall include brand and generic drug products,; drug active ingredients; unit price code (UPC) and/or national drug code (NDC) number; strength of active ingredients; dosage form; size of drug product by milliliter (mL), number of tablets/capsules, and/or total doses available; manufacturer and/or re-packager; date of purchase; indication(s) for use or ailment(s) intended to treat or an acceptable surrogate such as therapeutic sub-categories. The Contractor shall provide the percentage of missing or incomplete data for each of these OTC drug-specific basic data elements. Of note, specific store names for store name brand products are not required but data on store name brand products, such as drug active ingredients, shall be included for analysis by the elements listed above.

c. The treatment-specific basic data elements shall describe the patient’s ailment treatment category.

d. The data resource shall include a coding system that consists of drug and ailment coding levels for FDA data analyses and the percentage of missing or incomplete information for each data element.

e. The contractor shall provide FDA staff the ability to select OTC drugs and market categories, and perform data reports at the active ingredient level, product level, (), and any other data elements that may become available.

The Contractor shall de-identify the data for FDA use, and the methods used to de-identify the data shall be described in the proposal and shall be HIPAA-compliant.

f. The Contractor shall provide national estimates using FDA approved and appropriate projection methodology. These estimates shall be comparable to estimates obtained from national benchmarks such as the U.S. National Census Data. The data resource(s) shall have raw/sample and projected numbers. The Contractor shall provide the frequency with which data are updated and methods for updates.

g. The Contractor shall provide full disclosure of data collection, construction, coding, and configuration to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology.

C3.2 Uncategorized Drug Datasets (i.e., Base Year CLIN 0003) – Time and Materials

When directed by the Contracting Officer via the issuance of Task Orders, on a Time and Materials (T&M) basis at the rates negotiated in this base IDIQ, the Contractor shall provide for configuration and inclusion of drug categories that were either not included in the dataset or not completely coded.

The performance period/delivery date(s) for services ordered shall be specified on each order. These drug categories shall include, but shall not be limited to, the following drug categories: Antismoking products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, motion sickness/anti emetic products.

C3.3 Ad-Hoc Analyses - Regulatory Drug Utilizations Services (i.e., Base Year CLIN 0004) – Labor Hour

When directed by the Contracting Officer via the issuance of Task Orders, on a Labor Hour basis at the rates negotiated in this base IDIQ, the Contractor shall provide ad-hoc Regulatory Drug Utilization Services. The performance period/delivery date(s) for services ordered shall be specified on each order. The types of task orders would include:

a. Concomitant drug reports – reports on the concomitant use of an OTC product(s) or class of products with another product(s) or class of products used to treat an ailment.

b. Feasibility studies - studies that are conducted as initial pilot studies to determine if the scope of a study is practical, achievable and likely to involve a large population size to determine a significant association or non-significance association between exposure and outcome.

c. Customized analysis – analysis of data that endeavor to answer a specific question that require additional tools beyond the current interface tool that is provided by the database (e.g. Data to include but not limited to household and/or intended/patient demographic data and patient specific data elements such as age, gender, height, weight; income level;

race/ethnicity)

d. Risk management studies – studies that endeavored to ascertain if a specific risk management program is effective to ensure that the benefits of the drug outweigh the risks.

e. Training services – training staff for a specific service. For example, training medical records abstractors on the pertinent information required for abstracting medical record data based on medical record abstraction form.

f. (NOT USED)

g. Ad Hoc Analyses – The Contractor shall provide additional hours of ad hoc data analyses or custom queries not available through the data tools.

C3.4 Key Personnel and Staffing

The Offeror shall have key personnel employed and available for duty before the commencement of contract performance. The Offeror is responsible for proposing qualified staff, including the required key personnel, that meet the requirements of the SOW. Key personnel shall be evaluated in accordance with Section M, Paragraph M.2. Any subsequent changes to key personnel must meet these criteria and be approved in writing by the Contracting Officer. The following position is designated as a Key Personnel position under this contract and is subject to HHSAR 352.237.75 – Key Personnel (Dec 2015):

1. Project Manager/Research Director (Key Personnel):

• Leads team on large projects or significant segment of large complex projects

• Analyzes new and complex project related problems and creates innovative solutions involving finance, scheduling, technology, methodology, tools, and solution components

• Project manager shall have a minimum of a master’s degree or an equivalent certification and at least 5 years of experience managing projects.

The following positions are not designated Key Personnel positions, however, the Offeror shall propose staffing meeting the qualifications and position descriptions as follows:

2. Senior Computer Analyst:

• Analyze science, engineering, business, and other data processing problems to implement and improve computer systems. Analyze user requirements, procedures, and problems to automate or improve existing systems and review computer capabilities, workflow, and scheduling limitations. May analyze or recommend commercially available software.

• The individual shall have the required certification with a minimum of 8 years of experience in the field.

3. Application Programmer:

• Devises or modifies procedures to solve complex problems considering computer equipment capacity and limitations, operating time, and form of desired results

• Designs, codes, tests, debugs, and documents

• Application programmer shall have the required certification with a minimum of 5 years of experience in the field

4. Statistician:

• At least 10 years of experience and training in economics, finance, statistics, or related areas. Demonstrated record of supporting development and delivery of presentations, publications, and reports on specific programs or technically complex subjects

• An Economist/Statistician is responsible for performing work of a technically complex nature in the areas of economics and statistics, including cost-benefit and regulatory impact analysis, financial analysis, risk assessment, statistical analysis, sampling, survey design and implementation; and for reviewing the work of other staff

5. Pharmacist:

• Dispense drugs prescribed by physicians and other health practitioners and provide information to patients about medications their use. May advise physicians and other health practitioners on the selection, dosage, interactions, and side effects of medications

• Pharmacist shall be a registered in any state with a minimum of 10 years of experience in the field

6. Survey Scientist:

• Trains personnel by conducting formal classroom courses, workshops, and seminars.

• Survey Scientist shall be a registered in any state with a minimum of 10 years of experience in the field

7. Epidemiologist:

• Epidemiologists are public health professionals who investigate patterns and causes of disease and injury in humans. They seek to reduce the risk and occurrence of negative health outcomes through research, community education, and health policy.

Epidemiologist shall be a registered in any state with a minimum of 10 years of experience in the field

8. Senior Training Specialist:

• Assesses, designs, and conceptualizes training scenarios, approaches, objectives, plans, tools, aids, curriculums, and other state of the art technologies related to training and behavioral studies

• Identifies the best approach training requirements to include, but not limited to hardware, software, simulations, course assessment and refreshment, assessment centers, oral examinations, interviews, computer assisted and adaptive testing, behavior-based assessments and performance, and team and unit assessment and measurement

• Develops and revises training courses. Prepares training catalogs and course materials

• Trains personnel by conducting formal classroom courses, workshops, and seminars

• Training Specialist Senior shall have a minimum of eight (8) years of experience in the field or in a related area.

• Educational requirement is a Bachelor's degree in a related area or equivalent.

The Contractor shall provide staffing, qualified in accordance with this section of the SOW, dedicated to delivering the services required under this contract.

C3.5 Complete Data Dictionary for OTC Drug Utilization Data Resource

The Contractor shall provide a current and complete data dictionary, including updates, and a description of their data resource(s), type of data, the data collection methodology, and the data elements demonstrating that the data resource(s) can evaluate OTC drug utilization data at the national level.

C3.6 Technical Requirements and Capabilities of the Data Resources

The Contractor shall provide OTC drug utilization data that is currently existing and commercially available. Access to the data shall be via either monthly or quarterly reports in excel format.

The FDA utilizes the virtual private network (VPN) to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. The virtual private network shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard IPSEC protocols. The Contractor shall conform to Section 508 standards (See Section H).

C3.7 Monthly Reports

The Contractor shall provide a Monthly Report by the 20th of each month for the previous month data detailing, clearances, third party agreements, number of ad hoc programming hours used and project title

a. Ad Hoc Dataset Requests shall include the number of technical support programming hours used

b. Clearance Requests shall include data submitted, project title, purpose (publication, presentation, research, or other), FDA requestor, and approval date

c. Third Party Agreement Requests shall include third party collaborator, FDA principal investigator, approval date, expiration date, and project title

d. Notifications of any circumstances resulting in loss of, or lack of data streams, or any data errors that would impact access to data from the data resource(s).

C3.8 Disclosure Clearance for Aggregated Data outside the Agency

As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and Form found in Attachments 5 and 6 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. The FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period of performance. After option year 2, the FDA shall notify the contractor of the aggregated data release and accept the Contractor’s requested revisions, but shall not require formal approval for release.

C3.9 Clearance for Third Party Collaborations

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 by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data Disclosure Clearance Procedures and form to be found in Attachments 5 and 6 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. These Procedures include terms and conditions for third party collaborations.

C.3.10 Clearance after Conclusion of Contract:

The FDA shall continue to require, after the conclusion of the contract, the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period. After Year 3 the FDA shall notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions, but shall not require formal approval for release.

C4 Technical Environment

C4.1 Security

Any client software that is required to be installed on any 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 data and data (e.g. SQL queries or similar methods) accessing the Contractor’s application data sets. Such software add-ons or plugin shall be approved prior and must be approved by the FDA IT department. The contractor is responsible for providing the needed documentations to assist in the approval process. The license shall include post-production maintenance that includes patches, upgrades, and bug fixes if required.

C4.2 Virtual Private Network (VPN)

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

C4.3 Custom programming and analytical support

The Contractor shall provide analytical and programming support, to enable FDA personnel to obtain OTC drug utilization metrics not available in the monthly/quarterly deliverables.

C4.4 Onsite Training Programs and Training Materials

The Contractor shall provide training for users of the data, as well as training for FDA personnel who will support use of the data (e.g., technical users). The Contractor shall provide a minimum of two onsite training sessions per year.

The training sessions shall include an instructor led overview of the OTC data resource to the FDA staff with the ability to project via web-based presentation. A hands-on computer-based training for a maximum of 20 FDA staff members shall be provided on the use of the data and interface tool(s).

The hands-on sessions shall include exercises with data queries with FDA content. The Contractor shall work with FDA COR to develop exercises with data queries relevant to FDA work.

The Contractor shall provide options for additional “on-demand” sessions either in person or via web-based methods, as requested. Training shall be initiated within 30 days of award and shall continue throughout the duration of the contract.

The Contractor shall provide course outlines to include a detailed training agenda (pre-approved by FDA) for the overview of the OTC data resource(s) and the hands-on computer-based training offered. Training manuals and course outlines shall be provided in hard-copy at the time of training.

C4.5 Onsite Kick-Off and Annual Meetings

The Contractor shall participate in a kick-off meeting within two weeks of award and shall conduct an annual meeting on-site at the FDA campus in Silver Spring, MD once a year. The purpose of the annual meeting is to discuss scientific issues of interest to the Agency and relevant work that the Contractor has performed, as well as discussing FDA satisfaction with all deliverables.

C4.6 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 and data.

C5 Contract Management Requirements

C5.1 Management Plan:

The contractor shall provide the FDA with a project management plan that covers the six

(6) major components of this project in the areas of an Executive Summary, Policy and Procedures, Schedules, Timeline Plans, Budget, and the Quality Assurance Surveillance Plan.

C5.2 Quality Assurance Surveillance Plan:

The Contractor shall provide a Quality Assurance Surveillance Plan (QASP) plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The QASP 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 QASP at its own discretion.

C5.3 Performance Evaluation Plan:

Performance shall be evaluated to determine whether or not it meets the threshold of the agreement. When the performance threshold is not met, the FDA Contracting Officers Representative (COR) will notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with a resolution within 15 business days of receipt. Failure to meet the Acceptable Quality Level shall be captured as non-performance and provided to the Contracting Officer for action.

Required Service Standard Acceptable Quality Level (AQL)

Method of Surveillance

The Contractor shall provide Disclosure Clearance and Third

The turnaround time for urgent clearance requests

Standard shall be fully met at 100%

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

Required Service Standard Acceptable Quality Level (AQL)

Method of Surveillance

Party Agreement Service is 24 hours; 48 hours for standard clearance requests; and 72 hours for third-party agreements

The contractor shall provide an acceptable Quality Assurance Surveillance Plan

(QASP)

The Contractor Shall provide a QASP with a description of quality control measures that will ensure access to valid data that is technically correct and conforms to contract requirements.

Standard shall be met at 100%

COR and FDA staff shall monitor adherence to acceptable QASP

The Contractor shall provide Ad-hoc Analyses: custom reporting and product customization

The Contractor shall provide the FDA ad-hoc data results within 15 business days of receipt

Standard shall be fully met at 100%

COR and FDA staff shall monitor turnaround times from the Contractor’s monthly report

The Contractor shall guarantee timely access to OTC analytical datasets

The mutually agreed upon dataset parameters (max. size, data elements) and turnaround time to be negotiated at the time of award

Standards shall be fully met for access to all analytical datasets

COR and staff review of dataset quality and turnaround times

C5.4 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 it 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.

SECTION D - PACKAGING AND MARKING:

[NOT USED]

SECTION E - 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.

All Contractor deliverables shall be submitted to the COR via email. Additionally:

• The COR or designee, will inspect and accept the services provided by the contractor to ensure that they meet all requirements detailed in each individual task order.

• The COR will accept deliverables only if they conform to all terms and conditions of the individual task order.

• The COR will reject non-conforming deliverables and the contractor shall correct any deficiencies within thirty (30) calendar days upon receipt of the COR’s rejection notice. If the contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten (10) calendar days.

SECTION F - DELIVERIES OR PERFORMANCE:

F.1 ANTICIPATED DELIVERABLES

Note: Actual deliverables, deliverable schedules, Progress Reports and Status meetings shall be established in the issuance of each individual task order. Additional Reporting Requirements may be included in each Task Order. Below represent known, recurring deliverables expected to be required on all Task Orders.

Description of Deliverables Unit Delivery Date

Monthly updates to national level Over-the-Counter (OTC) Drug Utilization Data /Services; Monthly Usage Reports (by the 30th of each month); Disclosure Clearance and Third Party Agreement Services; Technical Support; Acceptable Projection or Other Appropriate Methodology; Current and complete Data Dictionary, including updates

Monthly Initiated at time of award

Quarterly updates of National Level OTC Drug Utilization Sales data in Excel File Format, Acceptable Projection or Other Appropriate Methodology (1 Lot), Current and complete Data Dictionary, including updates (1 annually), On-site training programs and training materials (2 annually), Unlimited Technical Support, Unlimited Disclosure Clearance and Third Party Agreement Services, and Monthly Reports by the 30th of each month (12 monthly).

Quarterly Initiated at time of award

Ad hoc Analyses: custom reporting and product customization Hours As specified by the Government

Monthly reports shall be submitted electronically as a “PDF” attachment emailed to the Contracting Officer’s Representative (COR).

F.2 ORDERING PERIOD

The ordering period for this contract vehicle shall be a 3-year ordering period. Task Orders may be issued up to the final day of this contract, and the contract shall remain in force to allow for the completion of all issued task orders (See FAR 52.216-22 Indefinite Quantity Oct 1995).

F.3 PLACE OF PERFORMANCE

The place of performance shall be specified at the Task Order level, though it is anticipated that all performance shall be at the Contractor’s site. Task orders may be issued for performance in any of the United States or its territories.

SECTION G-CONTRACT ADMINISTRATION

G.1 ORDERING PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders.

All task orders issued under this contract shall conform to the provisions of the contract clauses in

Multiple uncategorized drug datasets and have the availability to add new datasets that are not included in the proposed data.

The proposed price shall include both labor and data cost.

(SOW Section C3.2)

Monthly As specified by the Government

Kick Off/On-site Annual Meeting Annual As specified by the Government

Quality Assurance Surveillance Plan Annual Initiated at time of award and updated as needed thereafter.

Program Management Plan Annual Initiated at time of award and updated as needed thereafter.

Part II, Section I entitled “Contract Clauses” (See FAR 52.216-18 and 52.216-19). The only official authorized to issue task orders is a duly warranted Contracting Officer with the FDA’s Office of Acquisitions & Grants Services.

TASK ORDER PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract.

The terms, conditions, provisions and clauses of this contract shall take precedence in the event of conflict with any task order. A task orders shall be “issued” for purposes of this contract upon the effective date of the order.

The general process for individual task orders is as follows:

NOTE: The Government may issue a Task Order for any Firm-Fixed Price (FFP) CLIN at the prices specified in the Base IDIQ at any time within the contract’s Period of Performance. No Request for Task Order Proposal (RFTOP) shall be required for the issuance of a FFP Task Order.

For all non-FFP CLINs:

a) The FDA shall prepare a statement of work. The SOW shall include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work and location to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance

4. Reporting requirements and deliverables

5. Whether the order shall be time and materials, labor hour, or a hybrid type task order.

b) A Requests for Task Order Proposal (RFTOP) may be issued for any Time and Materials or Labor Hour CLINs. RFTOPs shall only be issued by the Contracting Officer.

c) The Contractor shall prepare and submit a task order proposal addressing all areas of the requirement. The Contractor shall submit the task order proposal within the time period specified in the RFTOP and adhere to the ceiling rates established in the contract. No separate payment shall be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

G.2 CONTRACTING OFFICERS REPRESENTATIVE (COR)

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

Name: Gladys Williams Organization: FDA/CDER/Office of Surveillance and Epidemiology

Email: Gladys.Williams@fda.hhs.gov Telephone: 301-796-1305

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

G.3 CONTRACTING OFFICER (CO)

The contact information for the FDA Contracting Officer is the following:

Name: Richard Robinson Organization: FDA/OAGS Email: Richard.Robinson@fda.hhs.gov Telephone: 301-796-6508

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the FDA Contract Specialist is the following:

Name: Benjamin Golway Organization: FDA/OAGS Email: Benjamin.Golway@fda.hhs.gov Telephone: 301-837-7464

SECTION H. – SPECIAL CONTRACT REQUIREMENTS

H.1 Conformance With Applicable Laws, Regulations, Policies, And Standard

Contractor Compliance The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/ mailto:samuel.carter@fda.hhs.gov mailto:Richard.Robinson@fda.hhs.gov mailto:Benjamin.Golway@fda.hhs.gov http://www.cio.gov/ http://www.hhs.gov/oirm/

The computer programs, data management systems, databases, and other resources used or developed through this contract shall comply with data standards and procedures established by DHHS and FDA (per http://www.fda.gov/ForIndustry/DataStandards/default.htm).

H.2 FDA IT Requirements

H2.1 352.239-73 Electronic Information and Technology Accessibility Notice.

Electronic and Information Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508.

The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or http://www.fda.gov/ForIndustry/DataStandards/default.htm https://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.239-74 https://www.hhs.gov/web/508 services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

H.3 Security and Privacy

A. Baseline Security Requirements

1) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06- 16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

2) Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor.