BNJ_FactsComparisons_Redacted.pdf

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Brand Name Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Office of Acquisition & Grant Services (OAGS) Food & Drug Administration (FDA) U.S. Department of Health & Human Services (HHS)

b. Sponsoring organization.

Office of Data, Analytics and Research (ODAR) Food & Drug Administration (FDA) U.S. Department of Health & Human Services (HHS)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The nature and purpose of this document is to delineate in writing the justification and approval of a brand name acquisition for Facts & Comparisons eAnswers subscription service in accordance with Federal Acquisition Regulations (FAR) 13.501(a)(1)(ii). The FDA intends to solicit the requirement on SAM.Gov as a total small business set-aside for Service-Disabled Veteran Owned Small Business (SDVOSB).

b. Project background.

Food and Drug Administration (FDA) researchers require an enterprise-wide site license providing access for unlimited users to content that includes the following contained in Facts & Comparisons eAnswers: Facts and Comparisons A to Z drug facts (including administration and dosing), Drug Comparisons, Drug Facts and Comparisons (including comparative charts), Drug I.D., Interaction Analysis, Facts and Comparisons Off-Label, Facts and Comparisons Risk Evaluation and Mitigation Strategy (REMS), Patient Information, Natural Products Database (along with pregnancy and lactation information), and access to detailed monographs from Briggs’ Drugs in Pregnancy and Lactation.

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FDA researchers also require access to the following information included in Facts & Comparisons eAnswers: black box warnings, pregnancy and lactation warnings, investigational drugs, manufacturer index, orphan drugs, and normal lab values and calculators.

The U.S. FDA Library requires access to these publications, which provide drug information on more than 22,000 drug products and 6,000 nonprescription and herbal products, to ensure FDA staff can perform their public health work. eAnswers provides the capability to: search and display comparative drug tables, identify potential drugs by disease/symptom, find a drug monograph using a brand or generic name, and screen for drug interactions.

These resources are highly valued and used heavily by FDA researchers in support of the Agency mission as evidenced by usage stats. The FDA Library requires online access 24/7 to these publications as it reduces the need to purchase multiple print copies of reference materials, saving the Agency research time and money.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Facts & Comparisons eAnswers Subscription

b. Project Description.

Facts & Comparisons eAnswers subscription must provide the following technical capabilities:

A site license for unlimited FDA users with 24/7 access based on IP authentication Customer service shall be available to troubleshoot website/connectivity issues via phone

(800-223-0554 option 1) or email during normal business hours (Monday – Friday, 8:00 a.m.

– 5:00 p.m. Eastern Time [E.T.]).

The Contractor shall provide usage statistics on a quarterly basis.

The Contractor shall provide a minimum of one (1) webinar per year to train FDA researchers on how to utilize the database.

The Contractor shall provide online tutorials and finding guide.

Resource shall include Dashboard to search for:

o Drug identification – Search by imprint, dosage form, shape, color, drug/product name, manufacturer/labeler, identifier o Drug Reports – Search by adverse reaction, indication, contraindication o Interactions – Search across fields for Drug, Allergies, Diseases/Conditions coupled with Pregnant, Lactating, Duplicate Drug Therapy o More Clinical Tools: Drug Comparisons – Search drugs and display in data or monograph view o Product Availability – Search by product name or code o Trissel’s IV Compatibility database

Drug Interaction Facts, including comparative charts Monographs that include off-label drug facts identified in published literature and provide administration and dosing information.

Risk evaluation and mitigation strategies (REMS) as required by FDA and manufacturer

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Medication Guides available for brand and generic products Herbal Interaction Facts Link to Review of Natural Products Boxed Warnings Interactive Tools including comparative tables, drug interaction screening, calculators Pregnancy & Lactation Warnings Orphan & Investigational Drugs Bioequivalency Codes Manufacturer Index Access to Briggs Drugs in Pregnancy and Lactation

Requirement type.

Other: Subscription Service

Type of action.

Follow-on – 75F40121P00516

Proposed contract/order type.

Firm-fixed-price

Acquisition identification number.

c. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

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UpToDate, Inc. (Doing Business As: WOLTERS KLUWER HEALTH UPTODATE)

230 3RD AVE STE 1000

Waltham, Massachusetts 02451-7560, United States

Nationwide Pharmaceutical LLC

1211 Arion Pkwy

Suite 118

San Antonio, Texas 78216 https://nationwidepharmaceutical.com

Samples Professional Healthcare Consulting, LLC

Hillsboro, TN 37342 USA philsr@pcmesllc.com

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The acquisition of Facts and Comparisons eAnswers is necessary to provide FDA staff with a reliable, evidence-based drug information database to support regulatory and scientific activities. This resource offers comprehensive, continuously updated data on prescription and nonprescription drug products, including monographs, formulation details, drug interactions, adverse effects, and comparative efficacy information. Access to this database will enhance the accuracy and efficiency of drug evaluation, labeling verification, compounding review, and policy development across FDA offices. The centralized, authoritative content will reduce redundancy and the need for multiple reference subscriptions, ensuring that reviewers and analysts have timely and consistent access to validated information. Procuring Facts and Comparisons eAnswers directly supports the FDA’s mission to protect public health by enabling informed, science-based regulatory decisions.

The Facts & Comparisons eAnswers database is the only database that offers extensive drug information, a drug interaction tool, a drug identification tool, calculators, product availability and information, a drug comparison tool, an IV compatibility tool, drug reports, patient education information on medications and natural products, and a toxicology tool. This information is critical to FDA scientific and regulatory work around the drugs FDA regulates. The platform provides critical features not found in comparable products on the market including a uniquely integrated suite of search capabilities and real-time tools that reduces the time it takes for FDA staff to find information and make decisions. This resource is highly valued and used heavily by FDA researchers in support of the Agency mission as evidenced by usage stats. The FDA Library requires online access 24/7 to these publications as it reduces the need to purchase multiple print copies of reference materials, saving the Agency research time and money. Without access to the Facts and Comparisons eAnswers database, FDA researchers would be severely affected in their ability to do research in support of the Agency mission to Protect Public Health.

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6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

This acquisition will be solicited as a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6. The acquisition will be competed on SAM.gov as a total small business set-aside for Service-Disabled Veteran- Owned Small Business (SDVOSB) concerns on a brand name basis.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

This acquisition will be competed on SAM.gov as a total small business set-aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns. An independent government cost estimate (IGCE) was developed by the program office and along with competition, will be utilized to compare proposed prices received to determine that the price received is fair and reasonable. Furthermore, historical data can be utilized as well.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research found that there are three vendors that can supply Facts and Comparisons eAnswers subscription.

UpToDate, Inc.

Nationwide Pharmaceutical, LLC.

Samples Professional Healthcare Consulting, LLC

9. Any other facts supporting the use of other than full and open competition.

No other facts.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

The following sources have expressed an interest in the acquisition:

UpToDate, Inc. 230 3RD AVE STE 1000, Waltham, Massachusetts, 02451-7560 Nationwide Pharmaceutical, LLC 1211 Arion Pkwy, STE. 118, San Antonio, TX 78216-2809 Samples Professional Healthcare Consulting, LLC 831 Henry Cove Rd., Hillsboro, TN 37342-3238

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Before any subsequent acquisitions for the required subscription services, the FDA will conduct market research to study the industry for similar subscription services that can meet the needs of the FDA to overcome barriers to competition.

12. Program office certification.