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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, this home page serves as the gateway to
interactive searching of Award Information.
http://crisp.cit.nih.gov/
Economic Assistance,
Pre-Approval
Prescription Drug User Fee Act
Waivers and Reductions for Small Business. Prescription Drug User Fee Act
(PDUFA) permits FDA to grant certain waivers and reductions from drug application fees
under limited circumstances. Guidance is provided for waivers of, and reductions in
these fees.
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 Medicine 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
Catalog
of Federal Domestic Assistance The Catalog provides access to a
database of all Federal programs, plus who to contact and how to apply.
Small Business Administration This website provides a wealth of information on establishing and financing small
businesses, including outreach programs for African Americans, Hispanic communities, and
women.
Presentation: Financial
Assistance and Incentives for Research and Development of New
Drug/Biologic Products, Ron Wilson Director of Small Business
Assistance, Center for Drug Development and Research, FDA, Society of
Clinical Research Associates, June 26,
2003.
(Posted 7/3/2003)
National Institute of Allergy and Infectious Diseases -
Biodefense Research
Federal Grants.gov
Technology Transfer
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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. http://ott.od.nih.gov/
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The Food and Drug Administration also has a website on
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."
http://www.fda.gov/oc/ofacs/partnership/techtran/overview.htm
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FDA/Center for Drug Evaluation and Research
Last Updated: April 19, 2006
Originator: OTCOM/DML
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