Source Sought Notice_.pdf

General Information:

Document Type: Sources Sought - FDA-SSN-CDER-2023-115584

Release Date: December 6, 2022

Response Date: December 28, 2022 at 3.00 P.M. EST via e-mail to Sheila.Brown1@fda.hhs.gov

Contract Information: Sheila Brown

Contract Specialist

Office of Acquisition and Grants Services

U.S. Food and Drug Administration

Tel: 301-796-0827

Email: Sheila.Brown1@fda.hhs.gov

Description: Access to Healthcare Practitioner’s Prescribing 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, 541910, Market Research and Public Opinion Polling

($15 million).

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 Food and Drug Administration (FDA) and Center for Drug

Evaluation and Research (CDER) mission is to protect the public health. The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate post marketing drug risks and promote the safe use of drugs for 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, mailto:Sheila.Brown1@fda.hhs.gov mailto:Sheila.Brown1@fda.hhs.gov

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 (2007)1 Act 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 the Act calls for enhanced authorities for accessing 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 Act2 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. Continuous access to healthcare practitioner prescribing practice data (e.g., physician survey and e-prescribing data) will complement and strengthen the utility of FDA's Adverse

Event Reporting System (FAERS) currently in place. Access to these data also increases the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the effectiveness of product labeling in influencing prescribing behavior. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process. The funding of "Access to Data on Prescribing Practices of Health Care

Practitioners" would serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues.

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.

FDA's authority to fund research projects is outlined in section 301 of the Public Health

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

Objectives

A. The Contractor shall provide FDA personnel with access to currently existing, commercially available data resource on health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting.

B. This data source shall have the ability of providing national-level estimates of health care practitioner prescribing 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.

C. The Contractor shall provide FDA personnel with data that has a maximum of 3-month lag time, i.e., time between the date of prescriber/patient encounter and date of data availability for FDA use.

D. The Contractor shall provide FDA personnel with immediate, direct, unlimited, Internet or network-based access to all HIPAA-compliant data in a multi-user, desktop environment and in real time.

Period of Performance

The period of performance is one (1) twelve (12) month base year with four (4) twelve

(12) month option periods.

Capabilities and Technical Experience:

Provide a capability statement describing how your company would able to meet the requirements.

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.