Opportunity

Solicitation75F40120R00009Notice typeCombined Synopsis/SolicitationSilver Spring, MD

Attachments

5 files

Name	Type	Posted	Actions
Amendment 1 - QandA.pdf	PDF	Jan 31, 2020	Download
RFP - Hospital Drug Data final.pdf	PDF	Jan 23, 2020	Download
Attachments 1-8.pdf	PDF	Jan 23, 2020	Download
Attachment 9 - IDIQ Pricing Worksheet.xlsx	XLSX	Jan 23, 2020	Download
Attachment 10 - TO1 SOW.pdf	PDF	Jan 23, 2020	Download

Version History

Access to Inpatient Hospital Drug Utilization Data

Combined Synopsis75F40120R00009Jan 31, 2020 · v3

Latest

Opportunity Summary

The Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) requires continued direct access to commercially available inpatient hospital drug utilization data and regulatory drug utilization services. This requirement supports the agency’s mandate under the Federal Food, Drug, and Cosmetic Act to ensure the safety and effectiveness of regulated marketed products. These data resources provide a denominator for understanding adverse event reports, modeling drug risk based on usage patterns, and calculating patient-based reporting rates for drugs used in hospital settings. Additionally, access to this information facilitates regulatory impact studies regarding drug labeling for both adult and pediatric patients, thereby accelerating the FDA's decision-making process.

This federal opportunity is a combined synopsis/solicitation issued under solicitation number 75F40120R00009. The procurement is classified under NAICS code 518210 for Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services, and PSC B537 for Special Studies/Analysis- Medical/Health. The FDA Office of Acquisition and Grant Services is the managing office for this requirement, which features a place of performance in Silver Spring, Maryland.

Responses to this solicitation are due by February 11, 2020. The notice includes five attachments: a request for proposals, two sets of additional attachments, an IDIQ pricing worksheet, a task order statement of work, and an amendment providing answers to vendor questions. Robin Goon is the designated point of contact for this requirement.

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Opportunity Summary

Opportunity Details

Response deadline: Feb 11, 2020Expired 2306 days ago
NAICS: 518210 (opens in new tab)
PSC: B537 (opens in new tab)
Set aside: —
Published: Jan 23, 2020
Updated: Jan 31, 2020
Agency: FOOD AND DRUG ADMINISTRATION (opens in new tab)
Office: FDA OFFICE OF ACQ GRANT SVCS
Department: —
Source: View on SAM.gov (opens in new tab)

Contact and place of performance

Point of contact: Robin Goon

Place of performance

Silver Spring, MD 20993

USA

Original Description

The FDA's Office of Surveillance and Epidemiology (OSE) requires access to inpatient hospital drug utilization data in order 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 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 these data complement and strengthens the utility of the passive reporting system currently in place by providing estimates of the numbers of adult and pediatric patients exposed to drugs nationwide in the hospital setting. These data resources 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 hospital setting. Access to these data also increase the FDAs ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) to better understand the usefulness of drug labeling to clinicians. This can be done by examining actual use of products in hospitals in relation to recommended labeling. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.To strengthen the Drug Utilization Program, the Food and Drug Administration (FDA) requires continual direct access to commercially available hospital drug utilization data and regulatory drug utilization services. Please see the attached solicitation for full requirement details and proposal submission instructions. The purpose of Amendment 1 is to provide responses to thesolicitation questions recieved. Please see the attached amendment.