Source Sought.pdf

General Information:

Document Type: Sources Sought (FDA-SSN-126594) Release Date: December 23, 2024

Response Date: January 23, 2025 at 10 A.M. EST via e-mail to Telisha.Wilson@fda.hhs.gov

Contract Information: Telisha Wilson

Contract Specialist Office of Acquisition and Grants Services U.S. Food and Drug Administration Email: Telisha.Wilson@fda.hhs.gov

Description: Access to Outpatient Longitudinal Drug Utilization Data

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, 541519 – Other Computer Related Services.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

**QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE**

Background

A vital part of the U.S. Food and Drug Administration (FDA) and Center for Drug Evaluation and Research (CDER) mission is to protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, 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.

In response to reports from the Institute of Medicine (IOM), FDA is authorized by the FDA Amendments Act (FDAAA) of 2007 to expand database resources for providing advanced analyses of drug safety data to improve the quality of post-market risk/benefit analyses and enhance the ability of FDA to make timely assessments of drug safety data.

In addition, a sub-section of FDAAA calls for enhanced authorities for access to disparate data sources, establish, and improve procedures to identify data trends and prescribing patterns for health care practitioners on a national-level in the outpatient setting .

The 21st Century Cures Act which was enacted in December 2016 also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids, which aligns with CDER’s mission. This section of the Act encourages the use of real-world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues .

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is crucial to the overall public safety. Access to outpatient prescription and patient level data will complement and strengthen the utility of FDA’s Adverse Event Reporting System (FAERS) currently in place by providing estimates of the numbers of patients exposed to drugs and the numbers of prescriptions dispensed nationwide in the outpatient setting. These data provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the outpatient setting.

Access to these data also increases the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk management plans and labeling changes on prescribing habits and usage patterns for prescription drugs. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.

FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data.

Objectives

To provide FDA personnel with:

a. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of outpatient prescriptions over time.

b. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of unique patients over time who received dispensed prescription drug products from outpatient settings.

c. Prescriptions, medical claims, and patient-level demographic information, in either the same or separate, linked resources. If separate linked data resources are proposed, all individuals in the patient-level data resource shall link directly to their dispensed prescription data.

d. The ability to use these data to characterize the duration of drug exposure to prescription drug products at the patient level and to examine concomitant use of drug products at the patient level.

e. The ability to use these data to analyze and describe national-level estimates of drug utilization patterns in the outpatient setting through the use of projection or other appropriate methodologies based on a nationally representative sample that are scientifically sound and transparent to FDA personnel.

f. Direct, unlimited, internet- or network-based access to all HIPAA-compliant data in a multi-user environment and in real-time.

g. The ability to download (or obtain in a timely manner using other means) large datasets as needed.

Period Of Performance

The period of performance for this Contract will be a five-year ordering period.

Capabilities And Technical Experience

See Attached Statement of Work

Business Status

Please provide your business size status (e.g., small business, 8(a), HUBZone, etc) and DUNS number.

Disclaimer And Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Responses to the sources sought shall be no longer than 10 pages.