SOURCES SOUGHT NOTICE 12 21 2022 FDASS12212022.docx- FINAL.pdf

SOURCES SOUGHT NOTICE:

FDASS12212022

Direct Access to Commercially Available Over-The-Counter (OTC) Drug Utilization Data and Support Services

This is NOT a solicitation announcement. This is a Sources Sought Notice only.

The purpose of this sources sought synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled Veteran-Owned, Veteran-Owned Small Business, Women- Owned Small Business, HubZone 8(a), 8(a), HubZone, Small Business, Emerging Small Business, Small Disadvantage Business (SDB), and Large Business) relative to NAICS code 541990 (size standard of $16.5 Million) All Other Professional, Scientific and Technical Services. Responses to this sources sought notice shall not constitute responses to solicitation, which is not currently available. As stipulated in FAR 15.201, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. No solicitation exists; therefore, do not request a copy of the solicitation.

The decision to solicit for a contract shall be solely the Government's discretion.

This sources sought notice is not to be construed as a commitment by the Government, nor will the Government pay for the information submitted in response. Respondents will not be notified of the results of any government assessments. The information received will be utilized to assist in formulating the strategy for competitive procurements.

DESCRIPTION

The intent of this notice is 1) to gather industry, especially small business (including 8(a), HUBZone, small disadvantaged business, service disabled veteran-owned small business and women-owned small business) input for FDA’s procurement to provide FDA personnel with the following:

a. The Contractor shall provide access to de-identified, HIPAA-compliant data resources on OTC drug product sales from U.S. retail outlets to consumers. FDA requires access to current and historical data to obtain national patterns of 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.

(approx. between 20-25 users).

b. The OTC drug-specific basic data elements shall include brand and generic drug product names; 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. In response to the RFP and as needed during the period of performance of the contract, the Contractor shall provide the percentage of missing or incomplete data for each of these OTC drug-specific basic data elements and how it is handled. 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 marketing 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.

f. 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.

g. 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 projected numbers. The Contractor shall provide the frequency with which data are updated and methods for updates.

h. 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.

i. The Contractor shall provide OTC drug utilization data that is currently existing and commercially available. Access to the data shall be through monthly reports via an online interface and/or excel format

Ad-Hoc Analyses - Regulatory Drug Utilizations Services

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 purchases 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. 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: smoking cessation products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, and motion sickness/anti-emetic products.

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

(See “Draft” Statement of Work for further details)

RESPONSES

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar service.

Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, Unique Entity ID (SAM) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing or services.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 2:00 pm EASTERN TIME on January 25, 2023 to Howard Yablon at email howard.yablon@fda.hhs.gov. Reference: FDASS12212022.

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 SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.

mailto:howard.yablon@fda.hhs.gov