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U.S. Department of Health and Human Services

Drugs

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Economic Assistance and Incentives for Drug Development

Economic assistance is available in the pre-approval period of drug development for the conduct of clinical trials.  Economic incentives are granted post-approval to reward innovation in drug development.

 Computer Retrieval of Information on Scientific Projects

CRISP (Computer Retrieval of Information on Scientific Projects) is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions. The database, maintained by the Office of Extramural Research at the National Institutes of Health, includes projects funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Health Care Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH). Users, including the public, can use the CRISP interface to search for scientific concepts, emerging trends and techniques, or identify specific projects and/or investigators. You are able to access additional general information about the CRISP database, as well as obtain answers to questions frequently asked about CRISP. In addition, the CRISP home page serves as the gateway to interactive searching of Award Information. 

Economic Assistance, Pre-Approval

  • The Orphan Drug Program.  This program provides for research grants, tax credits for clinical research, and protocol assistance for the development of drugs for rare diseases and disorders.

  • Unsolicited Grant Applications.  Unsolicited grant applications are those not submitted in response to a published Request for Applications (RFA).  All unsolicited applications (except those that involve veterinary medicine) seeking FDA support should be submitted to the Center for Scientific Review (CSR) at the National Institutes of Health (NIH).  The CSR/NIH serves as the administrative coordinating center for unsolicited applications submitted to the FDA.  Applications involving veterinary medicine are submitted directly to the FDA because the NIH does not have the technical expertise to review these applications.  All unsolicited applications compete for available Agency funds.

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  • Small Business Innovative Research Program (SBIR).  The purpose of SBIR is to support small business research resulting in commercial products or services that will benefit the public.  SBIR grant awards are funded from a set-aside within the agency and not from the individual Centers.  All applications are received and reviewed by the National Institutes of Health.  The applications are then referred to FDA, the Division of Contracts and Procurement Management.  However, the Center plays an important role in the programmatic support of these projects.  When applications are received in the Division of Contracts and Procurement Management, they are forwarded to the Centers asking whether or not there is interest  within the Center for support of the grant project.   If the Center is interested in the grant application, a project officer is assigned from that Center.

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Economic Incentives Post-Approval 

  • The Orphan Drug Program.  This program provides for research grants, tax credits for clinical research, and protocol assistance for the development of drugs for rare diseases and disorders.  The program also provides marketing exclusivity for approved orphan drug products.

  • Frequently Asked Questions on the Patent Term Restoration Program (11/1/2000).  "Title II of the Drug Price Competition and Patent Term Restoration Act" established a program that extends patent life to compensate patent holders for marketing time lost while developing the product and awaiting government approval. Information on this program is contained in Frequently Asked Questions on the Patent Term Restoration.

  • Frequently Asked Questions About New Drug Product Exclusivity. (Posted 8/30/2001).  Title 1 of the "Drug Price Competition and Patent Term Restoration Act" established a system for rewarding research associated with significant innovation by providing for a delay in the submission or effective approval date of certain generic applications.   The preamble of Federal Register Notice of October 4, 1994, pp. 50336-50360 provides responses from the Agency to questions/comments from the external community. Please contact CDER's Drug Information Help Desk for a copy of the Notice.

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  • Pediatric Exclusivity.  The "Food and Drug Administration Modernization Act" of 1997 (the Modernization Act), created a requirement for FDA to develop, prioritize, and publish a list of approved drugs for which additional pediatric information may produce health benefits in the pediatric populations and update it annually.  As an incentive to industry to conduct studies requested by the Agency, section 505(A) of the Act  provides  for a 6-month period of marketing exclusivity.  The Guidance for Industry: Qualifying for Pediatric Exclusivity provides detailed information on how to qualify for exclusivity. For more information on Pediatric Exclusivity, please see CDER's Pediatric Drug Development website.

  • 180-Day Generic Drug Exclusivity.  The provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) which govern the generic drug approval process give 180 days of marketing exclusivity to certain generic drug applicants.  (Posted 9/13/2001)

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Economic Assistance, Pre-Approval and Post-Approval 

 Technology Transfer

  • The NIH Office of Technology Transfer (OTT) evaluates, protects, monitors, and manages the NIH invention portfolio to carry out the mandates of the Federal Technology Transfer Act of 1986. This is largely accomplished through overseeing patent prosecution, negotiating and monitoring licensing agreements, and providing oversight and central policy review of Cooperative Research and Development Agreements. OTT also manages the patent and licensing activities for the Food and Drug Administration (FDA). OTT is responsible for the central development and implementation of technology transfer policies for four research components of the PHS — the NIH, the FDA, and the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality.  

  • The Food and Drug Administration also has a website on technology transfer (FDA Technology Transfer). As the website states: "The purpose of technology transfer is to provide current policies and procedures to assist the FDA community and potential collaborators to develop and transfer federal technology to the commercial marketplace."