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Office of the Assistant Secretary |
Policy Information Center |
FOOD AND DRUG ADMINISTRATION
MISSION: To protect and promote public health through food, drug, medical device, and cosmetic regulation.
Evaluation Program
The Food and Drug Administration's FY 1998 Evaluation
Program ultimately reflects the four broad goals established and promulgated by
the Department of Health and Human Services (HHS) for which FDA has
responsibility. HHS's goals are products of its strategic performance planning
process, and FDA uses its own strategic framework to accomplish these goals.
This process also satisfies the implementation requirements of the Government
Performance and Results Act (GPRA) and the Food and Drug Administration
Modernization Act of 1997 (FDAMA). The strategic and performance process is an
evolving set of program directions for FDA as changes occur in FDA's dynamic
environment. FDA's challenges, now and in the future, will rest on its ability
to leverage that environment, which will grow increasingly complex and become
more institutionally networked. The Agency will strive to develop and maintain
the scientific integrity necessary to achieve greater effectiveness in assuring
the quality and availability of the products it regulates.
One goal area within FDA's strategic framework is Pre-Market Review, where the objective is to make timely and cost-effective pre-market review decisions, while assuring product safety and efficacy. The results achieved and reported in the Prescription Drug User Fee Act (PDUFA) FY 1998 Performance Report, are one indication of how well FDA is meeting its goal of making timely pre-market review decisions. FDA exceeded all of the performance goals specified under the Prescription Drug User Fee Act. FDAMA continues the progression toward quicker review times initiated under the Prescription Drug User Fee Act of 1992, extending into the investigative phase of drug development with a series of new goals that will take effect in FY 1999. The objective of the FDAMA goals is to expedite the entire drug development and review process, from research to approval, without compromising the safety or the quality expected from the Agency's application review process.
Another goal area within FDA's strategic framework is Internal Capacity, which focuses onFDA's ability to make effective pre- and post-market regulatory decisions. One strategy for accomplishing this goal is through the implementation of decision-supportive information systems where reporting burdens are being reduced for the regulated industry. FDAMA is affording FDA greater flexibility in the scope and amount of data collected and reported on medical devices than was possible under the previous mandate. It has removed the mandatory requirements for post-market surveillance and tracking, thereby enabling the Agency to redirect resources to more significant health concerns. The Agency has reevaluated those requirements already in place, while removing those that no longer made sense from a public health perspective. As a result, hundreds of device tracking and post-market surveillance orders were rescinded for more than a dozen product types. FDAMA has also enabled FDA to modify its user-facility reporting program for medical devices from a mandated universe of facilities to a representative sample of facilities.
External Leverage, another element of FDA's strategic framework, reflects the ability of external stakeholders to manage FDA-regulated risk. This goal represents a significant shift in FDA's direction for the twenty-first century, as the Agency will attempt to leverage a more technologically complex environment. One strategy used to accomplish this goal is fostering industry quality assurance programs, thereby capitalizing on the quality and safety control capabilities already resident in the regulated industry. HACCP (Hazard Analysis Critical Control Point) programs and the implementation of the Mammography Quality Standards Act (MQSA) are two examples of this approach that are underway.
The fourth and final goal area within FDA's
strategic framework is Post-Market Assurance, a goal that strives to strengthen
the assurance that products on the market, or about to enter the market, are
safe. One strategy of accomplishing this goal is by targeting high-risk
products. The Tobacco Program illustrates one of the initiatives in this area.
FDA plans to reduce access to tobacco products by youths under 18 through new
FDA requirements for retailers.
Summary of Fiscal Year 1998 Evaluations
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TITLE: Assessment of Nutrient Requirements for Infant Formulas
ABSTRACT: This report on infant formulas was prepared by the American Society of Nutrition Sciences under contract with the Food and Drug Administration (FDA). It contains the results of a literature review to identify information pertaining to the questions raised by the FDA regarding nutrient specifications for infant formulas. It also contains specific recommendations by an expert panel of scientists with expertise in infant nutrition. The FDA needs this information in order to assure the safety and nutritional quality of infant formulas as mandated by the Infant Formula Act of 1980 (IFA). Regulations for infant formulas include specifications for minimum levels of 29 nutrients and maximum levels of nine nutrients. These nutrient specifications were last revised in 1985. Because additional research has provided information on the nutritional needs of infants not available at that time, the FDA needed to review nutrient requirements of infants as a prerequisite to consideration of revision of nutrient specifications for infant formulas.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: James Tanner
PHONE NUMBER: 202-205-4525
PIC ID: 7078
PERFORMER ORGANIZATION: American Society of Nutrition Sciences,
Bethesda, MD
TITLE: Consumer Responses to Warning Labels on Menus
ABSTRACT: The U.S. Food and Drug Administration conducted two series of focus groups exploring the proposed use of consumer advisories in restaurants to alert consumers to the potential risks of foodborne illnesses. The first series of focus groups was conducted in 1996 and the second in 1998. The focus groups concentrated on persons with compromised immune systems, parents of young children, people over age 60, and the general population. The research indicates that the biggest defect in the consumer advisory statement is that it allows multiple interpretations that may lead to inconsistent behavioral responses. Consumers recognized that risk information can have multiple purposes that are not equally appropriate in a restaurant context. Depending on the purpose, consumers may question both the utility and the appropriateness of the information. Respondents reported getting most of their information about food safety from television, which was their preferred method of receiving food safety information.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Alan Heaton
PHONE NUMBER: 202-205-5394
PIC ID: 7080
PERFORMER ORGANIZATION: Macro International, Inc. Calverton, MD
TITLE: FY 1998 PDUFA Performance Report
ABSTRACT: In FY 1998, the Food and Drug Administration exceeded all performance goals specified under the Prescription Drug User Fee Act of 1992 (PDUFA). The Agency made its review decisions for drug and biological product submissions on time in almost every case, reviewing 100 percent of the new product applications and 99 percent of the supplements within target review times. By historic standards, approval rates remain high and review times and total approval times remain short. The Food and Drug Administration Modernization Act of 1997 (FDAMA) continues the progression toward quicker reviews begun under PDUFA, and extends into the investigative phase of drug development with a series of new goals that take effect in FY 99. The objective of the FDAMA goals is to speed up the entire drug development process, from research to approval, without compromising safety or sacrificing quality of the application review process.
AGENCY SPONSOR: Office of Planning and Evaluation
FEDERAL CONTACT: Hill, Dennis
PHONE NUMBER: 301-827-5255
PIC ID: 6079.3
PERFORMER ORGANIZATION: Office of Planning and Evaluation, FDA
Rockville MD 20857
TITLE: Pharmaceutical Industry Cost Savings Through Use of the Scale-up and Post-Approval Change Guidance for Immediate Release Solid Oral Dosage Forms (SUPAC-IR)
ABSTRACT: The purpose of this study was to determine the impact on, and cost savings to, industry resulting from the Immediate Release Solid Oral Dosage Forms (SUPAC-IR) guidance. Representatives of six pharmaceutical firms were interviewed to ascertain their experiences with the SUPAC-IR program. The survey showed that positive results were achieved because the Food and Drug Administration (FDA) had established a uniform policy for post-approval chemistry and manufacturing and control changes that brought clarity to the regulatory requirements. All of those interviewed thought that the greatest impact of the SUPAC-IR program was the enhancement of industry's ability to plan, implement change, and manage its resources efficiently.
AGENCY SPONSOR: Office of Planning and Evaluation
FEDERAL CONTACT: Nancy Gieser
PHONE NUMBER: 301-827-5335
PIC ID: 7059
PERFORMER ORGANIZATION: Eastern Research Group, Inc. Chantilly, VA
TITLE: Readership Survey Analysis for the FDA Public Health Advisory: Interference Between Digital TV Transmitters and Medical Telemetry Systems
ABSTRACT: The Food and Drug Administration (FDA) Center for Devices and Radiological Health uses Safety and Public Health Advisories to transmit information pertaining to radiological health risks of medical devices to health care practitioners. A randomly selected sample of 308 recipients of the Public Health Advisory entitled, "Interference Between TV Transmissions and Medical Telemetry Systems" were surveyed. The purpose of the survey was to help the Center evaluate the format and content of the advisory, as well as its effectiveness as a means of communication. Most respondents felt that the problem addressed in the advisory was clearly identified, easily understood, timely, useful, and that actions for reducing risks were clearly enumerated. Approximately 37 percent of the sample group reported that they had taken actions to eliminate or reduce risk as a result of the advisory. The most commonly reported reason for not taking action was that the subject matter of the advisory was not applicable. An annual survey will continue to be conducted in order to determine the impact of safety alerts and public health advisories on the behavior and knowledge of the recipients. The collection and reporting of these data are important steps in determining how well the Food and Drug Administration (FDA) is communicating risk.
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Gary Blanken
PHONE NUMBER: 301-594-1284
PIC ID: 6733
PERFORMER ORGANIZATION: Center for Devices and Radiological Health, FDA Rockville MD
TITLE: Tobacco Retailer Study
ABSTRACT: The Food and Drug Administration (FDA) conducted an advertising campaign aimed at raising tobacco retailers' awareness of the new FDA tobacco regulations and motivating retailers to comply. The campaign ran in ten states to study levels of awareness of, and reported compliance with, both the regulations before and after the advertising campaign.
AGENCY SPONSOR: Office of Planning and Evaluation
FEDERAL CONTACT: Sharon Natanblut
PHONE NUMBER: 301-827-3442
PIC ID: 7079.1
PERFORMER ORGANIZATION: Market Facts, Inc., McLean VA
TITLE: Tobacco Retailer Study: Arkansas Pilot Methods Report
ABSTRACT: The Tobacco Program is part of the Food and Drug Administration (FDA) Post-Market Assurance strategic goal. This goal assures that products on the market, or about to enter the market, are safe. With an estimated 420,000 annual deaths from tobacco use, the FDA plans to reduce access to tobacco products by youth under age 18 through new FDA requirements for retailers. The FDA is developing a national campaign targeting these retailers with the goal of increasing awareness of the new requirements and encouraging compliance. A pilot media campaign was launched during 1998 in two Arkansas markets and a questionnaire was used to assess the campaign's effectiveness. While the Tobacco Retailer Study Arkansas Pilot Methods Report did not attempt to analyze the study findings, the pilot test indicated that the questionnaire was acceptable, and that the media campaign would have the intended impact.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Alan Heaton
PHONE NUMBER: 202-205-5394
PIC ID: 7079
PERFORMER ORGANIZATION: Market Facts, Inc., McLean VA
TITLE: FDA Activities in Support of Small Business
ABSTRACT: Under the Small Business Regulatory Enforcement Fairness Act, the Food and Drug Administration (FDA) must establish a program to respond to inquiries and to assist and advise small businesses and other small entities to apply FDA rules. Currently, FDA provides assistance and advice to small businesses in a number of ways. This project assessed the level of success achieved in coordinating multiple sources of advice and the usefulness and appropriateness of the assistance. Elements evaluated included the frequency, subjects, sources, and recipients of inquiries and the type and timeliness of the response. Summaries of activities conducted by FDA offices in support of small business during the last five quarters were completed. FDA's Small Business Guide as well as a comprehensive list of agency guidance, rules, and regulations are available on the FDA's homepage on the Internet at www.fda.gov.
AGENCY SPONSOR: Office of Planning and Evaluation
FEDERAL CONTACT: John Friel
PHONE NUMBER: 301-827-3373
PIC ID: 6462
PERFORMER ORGANIZATION: Office of Planning and Evaluation, FDA, Rockville, MD
Evaluations in Progress
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TITLE: Economic Cost Benefit Studies: Analysis of Changing Food Labels to Include Information on Trans Fatty Acids
ABSTRACT: On February 14, 1994, the U.S. Food and Drug Administration (FDA) received a citizen petition from the Center for Science in the Public Interest (CSPI), requesting that the FDA amend the definition of saturated fatty acids to include trans fatty acids. The CSPI also requested that certain fat and cholesterol claims be based on the combined level of saturated and trans-fatty acids. The FDA is currently preparing to respond to this petition through rulemaking. When considering rulemaking, the FDA is required to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select the regulatory approach that maximizes net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity.) A rule is classified as significant if it meets any one of a number of specified conditions, including having an annual effect on the economy of at least $100 million, or adversely affecting in a material way a sector of the economy, competition or jobs, or if it raises novel legal or policy issues. In addition, the FDA is required by the Regulatory Flexibility Act to determine the impact of its rules on small entities. To fulfill its requirements, the FDA needs certain information. This study will analyze the impact of changing food labels in order to provide information on trans-fatty acids. (See also 6865, 6865.1)
AGENCY SPONSOR: Office of Management
FEDERAL CONTACT: Ed Arnold
PHONE NUMBER: 301-827-7161
PIC ID: 6865.2
PERFORMER ORGANIZATION: Research Triangle Institute, Research Triangle Park, NC
PROJECTED DATE OF COMPLETION: 11/2/98
TITLE: Harmonizing Nutritional Goals and Food Processing
ABSTRACT: This study will generate information that can be used to assess the costs and benefits of regulatory alternatives with respect to providing information on trans-fatty acids in food. The following will be available as a result of this initiative: (1) identification of products containing trans-fatty acids; (2) characterization of the firms that produce these products; (3) estimation of the industry response to the proposed regulatory changes; and (4) estimation of the consumer response to improved access to information on trans-fatty acids in food. A consumer study will also be conducted as part of this effort, to determine whether consumers would prefer particular elements of the standards to be retained, modified, or eliminated.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Clark Nardinelli
PHONE NUMBER: 202-205-8702
PIC ID: 6864
PERFORMER ORGANIZATION: Center for Food Safety and Applied Nutrition, FDA Washington, D.C.
PROJECTED DATE OF COMPLETION: 1/31/99
TITLE: Survey of Current Hazard Assessment Quality Control Points (HACCP) Practices of the Food Industry
ABSTRACT: This project consists of a two-part survey that will: (1) yield information for the purposes of estimating the HACCP-related practices of the food industry (except seafood, meat and poultry), and (2) estimate the marginal costs to firms for compliance with HACCP.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Clark Nardinelli
PHONE NUMBER: 202-205-8702
PIC ID: 6866
PERFORMER ORGANIZATION: Center for Food Safety and Applied Nutrition, FDA Washington, D.C.
PROJECTED DATE OF COMPLETION: 1/31/99
TITLE: Economic Cost Benefit Studies: Economic Characterization of the Dietary Supplement Industry
ABSTRACT: This study will provide information on the nature, size and scope of the dietary supplement industry, thereby enabling the Food and Drug Administration (FDA) to determine the effects of regulations issued under the authority established by the Dietary Supplement Health and Education Act of 1994 (DSHEA).
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Clark Nardinelli
PHONE NUMBER: 202-205-8702
PIC ID: 6865.1
PERFORMER ORGANIZATION: Center for Food Safety and Applied Nutrition, FDA, Washington, D.C.
PROJECTED DATE OF COMPLETION: 2/20/99
TITLE: Economic Cost Benefit Studies: Consumer Attitudes Toward Potential Changes in Food Standards of Identity
ABSTRACT: On December 29, 1995, the FDA announced its intention to review its regulations pertaining to identity, quality and fill of container for standardized foods, and its common or usual name regulations for non-standardized foods. The agency solicited comments from interested parties on whether these regulations should be retained, revised, or revoked. The FDA solicited comments on the benefits or lack of benefits of such regulations in facilitating domestic and international commerce. The FDA also asked for comments on the value of these regulations to consumers, and on alternative means of accomplishing the statutory objective of food standards. This was done in an effort to promote honesty and fairness in the interest of consumers. The FSIS published a similar announcement regarding its intent to consider whether to modify or eliminate specific Standards on Identity for meat and poultry products, or to modify its overall regulatory approach to standardized meat and poultry products. The FDA and the FSIS need information on how consumers would be affected by changes in Federal Standards of Identity for foods. Most importantly, the two agencies need information on whether consumers would prefer particular elements of Standards to be retained, modified, or eliminated for various types of food. The agencies are obtaining information on the consumer preferences. (See PIC ID 6865.1, 6865.2)
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Ed Puro
PHONE NUMBER: 202-205-4279
PIC ID: 6865
PERFORMER ORGANIZATION: Research Triangle Institute, Research Triangle Park, NC
PROJECTED DATE OF COMPLETION: 6/30/99
TITLE: Dietary Supplement Sales Information
ABSTRACT: The objective of this task order is to collect information on dietary supplement products sold in the United States. The type of information being collected includes: (1) product name, (2) manufacturer or distributor and address, (3) ingredients, and (4) claims currently being made (i.e., health or nutrient content claims and nutritional support statements). This information will provide the agency with the information necessary to perform its regulatory mission.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Laina Bush
PHONE NUMBER: 202-205-5271
PIC ID: 7082
PERFORMER ORGANIZATION: Research Triangle Institute, Research Triangle Park, NC
PROJECTED DATE OF COMPLETION: 9/30/99
TITLE: Fortification of Enriched Cereal-Grain Products in the U.S. with Folic Acid
ABSTRACT: This project will assess the level of folic acid in enriched cereal grain products. The Food and Drug Administration (FDA) regulations mandate the fortification with folic acid of a wide range of enriched cereal grain products. During FY 1998, the FDA developed a methodology for measuring folic acid in cereal grain products and conducted a study of more than 100 enriched cereal grain products from the marketplace. The results of the study will be published in FY 1999.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Gerad McCowin
PHONE NUMBER:
PIC ID: 7095
PERFORMER ORGANIZATION: Center for Food Safety and Applied Nutrition, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 9/30/99
TITLE: Food Labeling and Package Survey (FLAPS)
ABSTRACT: This survey was implemented by the Food and Drug Administration (FDA) in 1977 with the purpose of producing a database containing label and package information obtained from a sample of processed food products. Food Labeling and Packaging (FLAPS) data enable FDA personnel to keep abreast of market responses to food labeling rules via changes in package labels.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Beth Benedict
PHONE NUMBER: 410-786-7724
PIC ID: 5711
PERFORMER ORGANIZATION: Center for Food Safety and Applied Nutrition, FDA Washington, D.C. and A.C. Nielson Company Chicago IL
PROJECTED DATE OF COMPLETION: 12/31/99
TITLE: Develop and Validate Toxicology Predictive Modeling Systems
ABSTRACT: The reproductive toxicity predictive module is expected to assist review divisions in evaluating the potential reproductive risks to female subjects in association with early clinical trials of drugs that have not yet been tested for reproductive toxicity. Commercial distribution of the modules is expected to generate resources that can be used to support the maintenance, improvement and development of toxicology prediction software.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Ed Matthews
PHONE NUMBER: 301-827-5188
PIC ID: 7105
PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 6/20/99
TITLE: Methods Validation
ABSTRACT: This project seeks to verify the suitability of NDA and ANDA analytical methods for drugs, antibiotics and hormones for quality control and regulatory purposes.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Joe Hanig
PHONE NUMBER: 301-594-5026
PIC ID: 7106
PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 9/30/00
TITLE: Review of Therapeutic Agents as an Antimicrobial Adjunct in Treatment of Sepsis
ABSTRACT: Sepsis affects half a million people annually. Even though a large number of trials have been conducted, no therapeutic agent demonstrating clinical benefit or superiority to standard care has been identified. Designing clinical trials that have any probability of demonstrating efficacy is challenging, due to the heterogeneity of patient populations, poor understanding of the pathophysiology of acute sepsis, and lack of uniformly accepted standards of care in international trials. Intensive efforts have been undertaken by the Food and Drug Administration (FDA) to propose the optimal trial design and prospective analysis plans. Currently, an analysis of the failed sepsis trials is being initiated by the FDA in the hopes of better clinical trials for the evaluation of the adjunctive therapy of sepsis in the future.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Rosemary Roberts, Ph.D.
PHONE NUMBER: 301-827-2183
PIC ID: 6736
PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 10/1/00
TITLE: Drug Metabolism: Drug-Drug Interactions
ABSTRACT: Recent examples of studies that have provided information to specific review decisions include: (1) interactions and metabolism studies of anti-cancer drugs such as paclitaxel, (2) anti-abuse drugs such as LAAM, (3) anti-HIV drugs such as the protease inhibitors, (4) anti-epileptic drugs, (5) cardiovascular drugs, and (6) anti-malarial drugs. In addition to the general technical expertise brought to bear on these problems, results from the program have been incorporated into final product labeling for some drugs, including paclitaxel and saquinavir. Labeling changes for other drugs are under discussion. Also, cutting-edge issues regarding cases of intermediate potency for cytochrome P450 pathways are under investigation.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Jerry Collins
PHONE NUMBER: 301-427-1065
PIC ID: 7103
PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 10/1/00
TITLE: FDAMA Mandated User Facility Reporting Program
ABSTRACT: FDAMA mandated that CDRH change its current user facility reporting from a universal program to a sample of user facilities constituting a representative profile of facilities. On September 30, 1998, CDRH completed a year of data collection study designed to identify barriers to user reporting and to see whether or not the quality of the data would improve once the barriers were removed.
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Susan Gardner
PHONE NUMBER: 301-594-2812
PIC ID: 7108
PERFORMER ORGANIZATION: Center for Devices and Radiological Health, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 1/31/99
TITLE: Continuation of the Mammography Quality Standards Act of 1992
ABSTRACT: During FY 1998, the Food and Drug Administration (FDA) initiated new work requirements to accommodate additional regulations under FDA's GPRA-style program, the Mammography Quality Standards Act of 1992 (MQSA). These additional requirements consist of developing standards to authorize states as certifying bodies, thereby ensuring that mammography facilities comply with the final quality standards as implemented by the FDA. Analyses of the impacts of the enabling regulations will assist the agency in ensuring that proposed rules will minimize the impact on state regulatory bodies, while maintaining acceptable levels of facility quality. This work will include a methodology for estimating costs of regulations associated with authorizing states as certifying bodies. The following costs will be estimated: (1) inspecting facilities in certifying areas, (2) applying to become a certifying state, (3) the impact on national inspection fees after states acquire certification authority, and (4) rescinding authorization.
AGENCY SPONSOR: Office of Planning and Evaluation
FEDERAL CONTACT: Steve Tucker
PHONE NUMBER: 301-827-5339
PIC ID: 6080.2
PERFORMER ORGANIZATION: Office of Planning and Evaluation, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 9/30/99
TITLE: Nationwide Evaluation of X-Ray Trends (NEXT)
ABSTRACT: The Nationwide Evaluation of X-Ray Trends (NEXT) is a collaborative program conducted jointly between the FDA and state radiation control agencies. Data from this program are used to estimate the radiation dosage from diagnostic x-ray examinations associated with different types of x-ray examinations. The data are used by public health and professional organizations in setting policy.
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Orhan Suleiman
PHONE NUMBER: 301-594-3533
PIC ID: 4984
PERFORMER ORGANIZATION: Center for Devices and Radiological Health, FDA, Rockville, MD
PROJECTED DATE OF COMPLETION: 12/20/99
TITLE: Real-Time PMA Supplement Program Evaluation
ABSTRACT: The Office of Device Evaluation (ODE), Food and Drug Administration (FDA) is implementing the "Real-Time" program for pre-market application (PMA).
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Maryann Munson
PHONE NUMBER: 301-594-1284
PIC ID: 6732
PERFORMER ORGANIZATION: Office of Systems and Management, FDA, Rockville, MD
PROJECTED DATE OF COMPLETION: 9/30/00
TITLE: Laboratory Support Services for FDA Compliance and Surveillance
ABSTRACT: This initiative of the human drug program involves multiple evaluative aspects. Two examples are: (1) conducting the hormones surveillance program, and (2) developing analytical methods for drug fingerprinting in the assessment of drug quality. The anticipated outcome of this effort will support the Food and Drug Administration's (FDA's) regulatory actions by providing laboratory support for the agency's compliance and methods development functions. In addition, drug fingerprint profiles will provide forensic assessments of drug manufacturing origin in support of FDA investigational efforts in deterring drug counterfeiting.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Joe Hanig
PHONE NUMBER: 301-594-5026
PIC ID: 7107
PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD
PROJECTED DATE OF COMPLETION: 9/30/00
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