SOURCES SOUGHT
B -- Economic Staff Support
- Notice Date
- 10/30/2018
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-18-1197774
- Archive Date
- 11/29/2018
- Point of Contact
- Christopher R. McGucken, Phone: (240) 402-7566
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice: Economic Staff Support MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The Economics Staff of the Food and Drug Administration's (FDA) Office of Planning (OPl) 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, 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 FDA is seeking sources capable of performing work on the following activities: Methods - While the economic impact of certain FDA regulatory actions can be analyzed via established methods, other FDA initiatives will require novel analytical approaches to evaluate potential effects. For example, estimating the societal effects of initiatives to modernize FDA's regulatory oversight of product safety and efficacy may require innovative approaches to collect or generate data, such as Internet panels, laboratory or field experiments, expert elicitations, contingent valuation, and data-based simulations. Baseline Measurement - The FDA needs data on the economic characteristics of regulated industries, so that changes in regulatory policies can be empirically examined. This data will include, for example, the number, size, and location (domestic or foreign) of firms and their employment, sales, and number of stock keeping units (labels). In some instances, industry profile studies require supporting documentation for OMB survey clearance procedures. Estimating Effects of Potential Regulatory Actions. The agency's planned regulatory agenda includes numerous potential regulations that would have economic consequences. The FDA requires data and models that can be used to estimate the effects likely to be associated with many different policies and provisions that could become regulations. These effects include the distribution of behavioral changes of consumers and producers in response to potential agency actions and the changes in risk that would result. This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government will award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Capabilities Required: To be determined as a potentially capable source for this requirement, responses to this notice shall outline the firm's capability to perform the following work: A.Analyses and Evaluations: 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. 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. B.Areas of Analyses: The following list illustrates the kind of economic research that will be requested. The contractor shall demonstrate the ability to conduct analyses for both quick response and long range studies. 1.FDA may implement new initiatives to strengthen the review of medical products throughout their life-cycle, to reduce medical product errors and to further protect the safety or integrity of food, human and veterinary drug products, biological products and medical and radiation emitting devices. Evaluating these actions may require surveying the industry (including domestic and foreign producers) to describe baseline conditions, collecting baseline risk information, assessing the potential of various interventions to reduce risk, and assessing the potential of various interventions to have unintended consequences that increase risks. 2.FDA regulates many retail products. To better assess baseline conditions in the markets for these products, FDA may need data on the number of products in one or more of these categories, including OTC drugs, retail medical devices, and traditional and non-traditional tobacco products. 3.FDA is interested in assessing the validity of the growing number of cost effectiveness analyses prepared by pharmaceutical companies. The contractor would assist in the development of appropriate methodologies. 4.FDA is interested in assessing the effects of requiring informational or warning labels on consumer labeling. The contractor would assess the behavioral responses of consumers and domestic and foreign industry to different proposed labels for the different product categories regulated by FDA. 5.The products and components of many products regulated by FDA are imported. FDA regulations apply equally to imported and domestically manufactured or processed goods. The behavioral responses of foreign firms to FDA regulations, however, may differ greatly from the responses of domestic firms. The contractor would design a model that would incorporate FDA data on foreign firms while predicting the response of foreign firms and imports to regulations that increase costs of production. The contractor would illustrate and validate the model for an existing FDA-regulated product or products. 6.Medical scientists are developing more sophisticated tools and novel technologies that might be used to produce or evaluate FDA regulated products. Such technologies include using pharmacogenomics in drug discovery and development or using advances in biotechnology to develop medical products. The contractor would assist in evaluating the costs and risks associated with regulating novel technologies. Capability Statements: Responses to this sources sought shall unequivocally demonstrate the respondent's capabilities to perform the work above; and may include (but are not limited to) details of their ability to provide personnel, organizational experience, available data access and resources.. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following: 1.Business name and bio, DUNS 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. 2.Past Performance information shall include date of services, description, dollar value, client name, 3.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 company (to include DUNS number and size status) if not the respondent. 4.Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing. 5.If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Response Instructions: Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 PM Eastern Time on November 14th, 2018 to Christopher.mcgucken@fda.hhs.gov. 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. Confidentiality: 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).
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