Sources Sought Notice.pdf

This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this sources sought synopsis is to gain knowledge of potential qualified small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code. Responses to this sources sought synopsis will be used by the Government to make appropriate determinations about potential sources. Only small business sources shall respond to this sources sought notice.

Project Title: Economic Studies of FDA Regulations

Project Description: The purpose of this project is to provide Food and Drug Administration (FDA) with accurate information, data, and analytical models for use in assessments of the economic impacts of FDA actions or contemplated actions.

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The Economics Staff of the FDA’s Office of Policy, Legislation, and International Affairs (OPLIA) has a requirement to provide accurate and timely economic assessments of FDA regulatory actions. These analyses have high public visibility and, therefore, must withstand intense scientific and technical review and scrutiny by diverse audiences including the public, regulated entities, Government agencies such as the Department of Health and Human Services and the Office of Management and Budget (OMB), the U.S.

Congress, professional economists, and the scientific and medical community. The need of the Economics Staff for support by a contractor arises from the variety and complexity of the work, the need to have access to specialized resources to rapidly gather data to meet tight deadlines, and the need for research involving direct contact with regulated entities.

The contractor will be required to perform the following:

1. Conduct baseline assessment of industry characteristics, including, but not limited to, estimating employment levels, profits, prices, competitive structure, domestic and foreign location, and industry practices (or performance), including all international effects. The baseline should include projected changes over time.

2. Develop methods and collect data to estimate the economic costs of existing or potential regulatory actions. FDA regulations may alter the expected use of a product, as well as result in higher costs of manufacture or distribution. Each component of these costs shall be identified, defined, and quantified, with all data compiled and sorted to facilitate statistical analyses.

3. Develop methods and collect data to estimate the reduction in risk attributable to existing or potential regulatory actions and assess any potentially offsetting increases in risk.

4. Develop methods and measures of the effects of regulations and other exogenous factors on innovation and productivity. Research and development (R&D) and future innovation may be either encouraged or hindered by regulatory requirements.

5. Develop methods and measures of the effects on the competitive vitality of small business in accordance with requirements of the Regulatory Flexibility Act. Many of the firms FDA regulates are small. Record keeping and reporting requirements, for example, may impose disproportionate effects on smaller businesses, because fixed costs are spread over a smaller sales base. FDA is required by law to take these effects into account and to grant regulatory relief, where possible, to small firms.

6. Develop adaptable methods and databases that can cover various regulatory alternatives.

Many new options to meet stated objectives arise during regulation development. A critical task is to develop general methods and databases that can be applied to assess the effects of these options as they are proposed or considered.

7. Develop methods and empirical measures for a section in regulatory analyses in which FDA states prospectively how it will measure the effectiveness of regulations over time.

These measures will meet the need for retrospective reviews.

8. Consult with subject matter experts in FDA-regulated industries.

Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). A copy of the company capability statement will also be accepted. The anticipated period of performance is a 5-year ordering period. After review of the responses received, a pre-solicitation synopsis and formal solicitation may be published in the Federal Business Opportunities.

Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions:

1. Is your business a small business under the NAICS code?

2. Does your firm qualify as a small disadvantaged business?

3. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small

Business Act?

4. Are you considered a certified HUBZone firm?

5. Are you considered woman-owned or operated business?

6. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business?

7. Describe ability to conduct baseline assessment of industry characteristics, including, but not limited to, estimating employment levels, profits, prices, competitive structure, domestic and foreign location, and industry practices (or performance), including all international effects.

8. Describe ability to develop methods and collect data to estimate the economic costs of existing or potential regulatory actions.

9. Describe ability to develop methods and collect data to estimate the reduction in risk attributable to existing or potential regulatory action and assess any potentially offsetting increases in risk.

10. Describe ability to develop methods and measures of the effects of regulations and other exogenous factors on innovation and productivity.

11. Describe ability to develop methods and measures of the effects on the competitive vitality of small business in accordance with requirements of the Regulatory Flexibility Act.

12. Describe ability to develop adaptable methods and databases that can cover various regulatory alternatives.

13. Describe ability to develop methods and empirical measures for a section in regulatory analyses in which FDA states prospectively how it will measure the effectiveness of regulations over time.

14. Describe ability to consult with subject matter experts in FDA-regulated industries.

15. Provide evidence to demonstrate your firm’s capabilities to perform the work described above, including details of ability to provide personnel, organizational experience, available data access, and resources.

This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this notice shall be emailed to the Contract Specialist, Telisha Wilson at Telisha.Wilson@fda.hhs.gov on or before 10AM EST on 02/23/2024.

Please Include in the subject line “Sources Sought Response-121020” when responding.

No solicitation is currently available. Responses to this sources sought synopsis will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation.

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