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Office of the Assistant Secretary for Planning and Evaluation |
Policy Information Center |
MISSION: To protect and promote public health through food, drug, medical device, and cosmetic regulation.
Evaluation Program
The Food and Drug Administrations FY 1998 Evaluation Program ultimately reflected some of the goals established and promulgated by the Department of Health and Human Services (HHS) for which FDA has responsibility. HHSs 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 FDAs dynamic environment. FDAs challenges, now and in the future, will rest on its ability to leverage it efforts in that environment, which grows increasingly complex and more institutionally networked. The Agency will strive to maintain the scientific knowledge base 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 PDUFA. The focus of these performance 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. For example, FDAMA has afforded FDA greater flexibility in the scope and amount of data collected and reported on medical devices than was possible under the previous mandate. The Agency has reevaluated the requirements already in place, 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 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 Leveraging, another element of FDA’s strategic framework, represents a significant shift in FDA’s direction for the twenty-first century as the Agency works to leverage a more technologically complex environment. One strategy involves 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 illustrated one of the initiatives in this area. Prior to the court decision that ended this program, FDA planned to reduce access to tobacco products by youths under 18 through new FDA requirements for retailers.
The article entitled, "Interferon beta-1b injection Site Reactions and Necroses," appearing in Multiple Sclerosis in May of 1998, explores the safety of Betaseron (interferon beta-1b). Beta interferon was first licensed for injection treatment of multiple sclerosis in 1993. It has generated the largest number of adverse event reports received by the Food and Drug Administration (FDA), with 8,300 reports received between 1995 and 1996. This represented the largest summary of adverse event data for a biological therapeutic product ever compiled at the agency. The findings in the report led to changes in product labeling, thereby reducing the risk of severe site reactions and necroses in multiple sclerosis patients.
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Gaines, Ann
301-827-3974
PIC ID: 7093
PERFORMER: Food and Drug Administration
Rockville MD
This analysis examines the potential benefits of new regulations the FDA is preparing to issue which would require pediatric studies of certain new and marketed drug and biological products. The regulations address two major problems associated with the lack of adequate information on the effects of drugs on pediatric patients: (1) frequent adverse drug reactions in children due to inadvertent drug overdoses or other drug administration problems that could be avoided with better information on appropriate pediatric use, and (2) frequent underuse of safe and effective drugs for children, due to the prescribing of an inadequate dosage or regimen, a less effective drug, or no drug at all, because of uncertainty over its effect on children or the lack of a pediatric formulation. By developing improved information on whether, and in what dosage, a drug is safe and effective for use in children, FDA believes that the regulation will result in fewer adverse drug reactions and fewer instances of less-than-optimal treatment of pediatric patients.
AGENCY SPONSOR: Office of Planning, Policy & Legislation
FEDERAL CONTACT: Braslow, Lawrence
301-827-5331
PIC ID: 7272
PERFORMER: Food and Drug Administration
Rockville MD
This report was prepared in response to Section 406(b) of the Food and Drug Modernization Act of 1997 (FDAMA) which stipulates that by July 1, 1999, FDA establish mechanisms for meeting review times for applications and submissions as specified in its enabling legislation. The report summarizes a listing of 110 mechanisms as of July 1, 1999 that were ascertained from FDA documents. These mechanisms were developed within the context of six strategic directions set forth in the FDA Plan for Statutory Compliance-November 1998, representing a combination of approaches that have reached a focal point as a result of FDAMA.
AGENCY SPONSOR: Office of Planning, Policy & Legislation
FEDERAL CONTACT: McEvoy, Kate
301-827-5251
PIC ID: 7273
PERFORMER: Office of Policy, Planning, and Legislation,
FDA
Rockville MD
Workload and accomplishments data for investigational new drug applications and new drug applications for fiscal year 1998 is compiled by the Office of New Drug Chemistry of the FDA's Office of Pharmaceutical Science on an annual basis and reported in this publication. Data include the number of submissions received, by type and quantity; trends in rate of original receipts; forecasts of workload for the next fiscal year with possible personnel requirements; adherence to schedules; and analysis of completed reviews.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Sherwood, Ted
301-827-5845
PIC ID: 7274
PERFORMER: Food and Drug Administration
Rockville, MD
The increasing popularity of dining out over the past two decades has raised the proportion of nutrients obtained from away- from-home food sources. Between 1977 and 1995, home foods significantly improved their nutritional quality, more so than away-from-home foods, which typically contained more of the nutrients overconsumed (fat and saturated fat) and less of the nutrients under-consumed (calcium, fiber, and iron) by Americans. Since the trend of eating out frequently is expected to continue, strategies to improve the American diet need to address consumers' food choices when eating out.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Guthrie, JoAnne
202-205-4179
PIC ID: 7294.2
PERFORMER: Food and Drug Administration
Rockville, MD
A survey conducted by the Center for Food Safety and Applied Nutrition in 1997 revealed that restaurant patrons did not want to be reminded about risks when ordering, found proposed menu labels repulsive, and said they already knew too much to get any benefit from them. To overcome such barriers to information dissemination and to develop a strategic approach to educating consumers about food safety, further research was conducted. This report presents a compendium of evaluations of recent food safety education programs, recent consumer surveys and qualitative consumer research related to food safety issues, epidemiological data on the magnitude and distribution of foodborne illness in the United States, and microbiological/risk assessment analyses of food consumption, handling, and preparation practices that increase or decrease the likelihood of foodborne illness. The report considers information obtained from meetings with experts identifying critical objectives, presents a comprehensive summary of the qualitative and quantitative research on food safety issues, identifies the information needs for developing a strategic approach to consumer education, and summarizes the results of focus groups conducted to meet those needs. Finally, the report encapsulates expert opinions on designing education programs and communication strategies to change food-handling behavior and presents proposals for developing a successful consumer food safety campaign.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Levy, Alan
202-205-9448
PIC ID: 7275
PERFORMER: Sutton Social Marketing
Washington, DC
This paper was prepared in order to assess people's awareness of specific food group recommendations of the Food Guide Pyramid between 1990-91 and 1994-95. Data included individuals who said they were using the main meal planners (from smapling procedure 1989-91) in their households. In 1994-95 the percentage of adults who believed they needed to consume a number of servings daily from each of the five major food groups corresponding to the Food Guide Pyramid varied considerably among food groups. For example, one half to about three-fifths of adults gave an answer that was within the correct range for the vegetable group, yet only 7 percent reported the correct recommendation for the bread, cereal, grains, and pasta group. The findings indicate, that for four of the five food groups, at least 50 percent of adults believe they should consume the number of servings recommended by the Food Guide Pyramid. Previous research indicated that knowledge of serving recommendations is associated with intakes of food groups that more closely match recommendations. Thus, increasing people's knowledge of food group serving recommendations is one strategy for improving diet quality.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Guthrie, JoAnne
202-205-4179
PIC ID: 7294.1
PERFORMER: Food and Drug Administration
Rockville, MD
This report describes the Food and Drug Administration's (FDA) development of information to include warning statements on packaged fruit and vegetable juice products that could contain life-threatening microorganisms. FDA contracted with Macro International to develop and test this information through the use of focus groups and qualitative research. The three focus groups consisted of three target populations: (1) parents of small children; (2) persons over the age of 60; and (3) members of the general public. The objective of the focus groups was to obtain consumer feedback on pasteurization effects and other treatment procedures on fruit and vegetable juices. The comments made by the three focus groups did not differ. Discussions included topics such as product and purchasing decisions, hazards awareness associated with unpasteurized juice, label information, and contents of brochure and warning labels.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Heaton, Alan
202-205-5394
PIC ID: 7081
PERFORMER: Macro International, Inc.
Calverton, MD
The Food and Drug Administration's (FDA), under contract with RTI, collected information, on the nature, size, and scope of the dietary supplement (DS) industry. The products that are the focus of this report are based on the definition of dietary supplements in the Dietary Supplement Health and Education Act of 1994 (DSHEA). They are: (1) vitamins; (2) minerals; (3) herbals and other botanicals; (4) amino acids; (5) dietary substances used to supplement the diet by increasing its total daily intake; and (6) concentrates, metabolites, constituents, extracts, and combinations of these ingredients. Nearly all of the information contained in this report was obtained from secondary data sources. In addition, RTI met with individuals to obtain further information on the industry. As new products are introduced, the range of DS products will continue to grow. Small manufacturers may be unable to serve the larger retailers that are increasingly selling DS products. Sales of these products by mass merchandisers such as Costco and Kmart are increasing and are expected to continue to grow. Consumers seeking consistent quality of products migrate toward particular brand names; the larger manufacturing firms are more likely to have the resources to maintain such quality, and the advertising budgets to establish brand name recognition. Due to rapid growth, the DS industry has attracted attention of Wall Street investors -- the influx of outside investment dollars will help continue the growth of this industry, both by adding new products and by serving additional markets.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Nardinelli, Clark
202-205-8702
PIC ID: 6865.1
PERFORMER: Research Triangle Park
Research Park, NC
Theory suggests that the decision to return to employment after childbirth and the decision to breast-feed may be jointly determined. Models of simultaneous equations were estimated for two different aspects of the relationship between maternal employment and breast feeding using 1993-1994 data from the U.S. Food and Drug Administration's Infant Feeding Practices Study. The researchers first explored the simultaneous duration of breast-feeding and work leave following childbirth. It was found that the duration of leave from work significantly affects the duration of breast-feeding, but the effect of breast-feeding on work leave is insignificant. The report estimate models of the daily hours of work and breast-feedings at infant ages 3 months and 6 months postpartum. At both times, the intensity of work effort significantly affects the intensity of breast- feeding, but the reverse is generally not found. Competition clearly exists between work and breast-feeding for many women in the sample.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Fein, Sara, Ph.D.
202-205-5349
PIC ID: 7294.4
PERFORMER: Food and Drug Administration
Rockville, MD
Health-related information provided by the news media is associated with increases in consumer awareness of diet -- disease relationships. This project focuses its awareness analysis on four diet - disease relationships: (1) cancer and fat; (2) heart disease and fat; (3) cancer and fiber; and (4) high blood pressure and sodium between 1984 and 1995 when timing and quantity of information varied across diet - diseases and information sources. This study shows that consumer awareness increased during times of increased news media activity, and decreased during increased time of advertising activity, possibly due to a low level of credence of producer - provided health information. No strong evidence was found to show either media or producer information decreased the difference in awareness between more and less educated individuals.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Levy, Alan
202-205-9448
PIC ID: 7238
PERFORMER: Food and Drug Administration
Rockville MD
This report provides the results of a study on the effects of health claims on consumer information search and processing behavior, and discusses the issues surrounding the regulation of health claims on food labels. Health claims on food labels are currently regulated under the 1990 Nutrition Labeling and Education Act (NLEA) with implementing rules that were issued in May 1994 by the U.S. Food and Drug Administration (FDA). The passage of NLEA was motivated in part by consumers and regulators who were concerned that unregulated health claims might be confusing and deceptive. It has been suggested that limiting the types and number of health claims may be costly; there has also been some evidence that consumers are capable of evaluating information from the Nutrition Facts panel, even when a contradictory health claim is on the front panel. This article introduces experimental data that suggests that the presence of health and nutrient-content claims on food packages will cause consumers to truncate their information search to the front panel of packages. The presence of a claim was associated with a more positive consumer summary judgment of products, and greater weight was given to the information mentioned in claims, than to information in the Nutritional Facts panel.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Levy, Alan
202-205-9448
PIC ID: 7237
PERFORMER: Food and Drug Administration
Rockville MD
This report looks at how much the typical American knows about nutrition, whether the average level of nutrition knowledge has increased, and what implications this has for changing eating habits. Using data from a variety of public and private sources (including the Food and Drug Administration's (FDA) Health and Diet Survey (HDS)), the U.S. Department of Agriculture's (USDA) Diet and Health Knowledge Survey (DHKS), the Food Marketing Institute's (FMI) Trends Survey, and the American Dietetic Association's (ADA) 1995 Nutrition Trends Survey, the level of nutrition knowledge among American consumers was examined. In general, to develop effective nutrition education and promotion messages, nutritionists need to consider what types of knowledge are most needed and how much knowledge average individuals can reasonably be expected to assimilate. An important step in promoting dietary change is to identify the nutrition-related knowledge and skills most needed by consumers and to develop simplifying tools such as the Food Guide Pyramid or the nutrition label to communicate them.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Levy, Alan
202-205-9448
PIC ID: 7294.3
PERFORMER: Food and Drug Administration
Rockville MD
This study was undertaken to evaluate trends in mammography quality before and after the implementation of the Mammography Quality Standards Act (MQSA) of 1992 and to compare technical data collected in the US with corresponding data obtained from the first survey of mammography facilities conducted in 1994-1995 in Canada. Data from MQSA inspections conducted in 1995-1997 were analyzed and compared with survey data on U.S. mammography facilities acquired before the MQSA. Technical indicators of mammography quality such as radiation dose, phantom image score, film processing, and darkroom fog were analyzed. The results indicate continuous improvement since 1985 in the US in areas such as phantom image scores, darkroom fog, and x-ray beam quality. The US mean glandular dose has increased to 1.6 mGy compared with the Canadian dose of 1.1 mGy. The mean total phantom image score with artifact subtraction was 11.1 in Canada in 1994-1995 and 11.8 in the US in 1997. The conclusions are that mammography quality is better today than it has been at any other time in the US and with the exception of radiation dose, Canadian technical measures of performance are comparable to measures before MQSA in the United States.
AGENCY SPONSOR: Office of Planning, Policy & Legislation
FEDERAL CONTACT: Tucker, Steve
301-827-5339
PIC ID: 6080.3
PERFORMER: Food and Drug Administration
Rockville MD
The Center for Devices and Radiological Health surveyed a random sample of 308 recipients of the Public Health Advisory on vacuum assisted delivery devices. 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. The survey was conducted during March, 1998, and has a sampling error of plus or minus 10 percentage points. Some highlights of the survey are as follows: ninety-nine percent of the respondents said the problem addressed in the advisory was clearly identified and easily understood. The respondents agreed that the actions for reducing risk in the Alert were clearly explained (86%), and that the Alert information was useful (81%) and timely (76%). Sixty-two percent would like to continue to receive future alerts, as they are currently sent, in printed form.
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Blanken, Gary
301-594-1284
PIC ID: 6733.1
PERFORMER: Food and Drug Administration
Rockville MD
This report outlines the first phase of the program to evaluate the feasibility and effectiveness of a new sentinel reporting system for documenting adverse events (those ending in serious injury or death) for medical devices in user facilities (See also PIC ID# 7108). It describes the schedule of events, the exploratory research performed before the study was launched, how the participating facilities were recruited and trained, the process of data collection, how the channels of communication were established among the participating facilities and the government and the results of qualitative and quantitative analyses. Such topics as overcoming reticence to participation and enhancing communication through use of newsletters and other devices are also discussed.
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Gardner, Susan
301-594-2812
PIC ID: 7108.1
PERFORMER: Food and Drug Administration
Rockville MD
This report details the results of the third audit of the Mammography Quality Standards Act (MQSA) Government Entity (GE) Declaration Program. The goal of the audit was to 1) notify facilities that they would be held accountable for their self- certification of fee exemption, and 2) to determine the rate of compliance with the program. Ninety out of 793 claiming GE status were randomly selected for review. A second sample of 51 facilities was reviewed out of 138 that had recently claimed fee exemption status while having paid a fee in the past. The 1993 GE audit yielded the same results as the 1997 GE audit-- a 97% compliance rate. Three of the facilities were not confirmed as government entities. The second sample yielded a 100% compliance rate. The appendices to the report contain the names of the facilities, numbers, and audit results. Recommendations for the GE Declaration Program include: 1) publish the results in "Mammography Matters" as in previous years; 2) calculate future audit samples from three groups: facilities claiming CDC funding; facilities claiming GE status, and facilities claiming GE status that previously paid. The sample would come from three groups rather than 2 groups, using the same statistical calculation to achieve a high confidence level.
AGENCY SPONSOR: Office of Planning, Policy & Legislation
FEDERAL CONTACT: Tucker, Steve
301-827-5339
PIC ID: 6080.2
PERFORMER: Food and Drug Administration
Rockville MD
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: Munson, Maryann
301-594-1284
PIC ID: 6732
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
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: Collins, Jerry
301-427-1065
PIC ID: 7103
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 10/1/2000
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: Hanig, Joe
301-594-5026
PIC ID: 7107
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
The objective of this project is to verify the suitability of New Drug Approval (NDA) and Abbreviated New Drug Applications (ANDA) analytical methods for drugs, antibiotics and hormones for quality control and regulatory purposes.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Hanig, Joe
301-594-5026
PIC ID: 7106
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
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 with the hope 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: Roberts, Rosemary, Ph.D.
301-827-2183
PIC ID: 6736
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 10/1/2000
The Food and Drug Administration (FDA) monitors food labels through the Food Label and Package Survey (FLAPS). FDA uses FLAPS as a tracking mechanism to keep abreast of the market response to regulations via changes in product package labels. The agency uses FLAPS data to support policy, regulatory, and food safety decisions, as well as economic impact assessments. For example, FDA has used FLAPS data to gain information on the prevalence of nutrition labeling on product packages; the extent of quantitative labeling of various nutrients, such as fatty acids; the extent of use of specific product ingredients (e.g., potassium bromate, monosodium glutamate, gelatin); the accuracy of product serving sizes; and the prevalence of various health claims on food products (e.g., the association between increased calcium and the reduced risk of osteoporosis.) In 1997, FDA conducted the eleventh FLAPS survey. The data reflect the status of processed, packaged food labels subsequent to the publication of regulations promulgated in response to the Nutrition Labeling and Education Act of 1990 (the NLEA). The current study focuses on nutrient content claims and health claims, as well as the percentage of packaged food products sold annually that bear quantitative nutrition labeling. Findings indicate that nutrition-labeled products accounted for an estimated 92% of the annual sales of processed, packaged foods. An additional 3% of the products sold were exempt from labeling. Nutrient content and health claims appeared on an estimated 39% and 4%, respectively, of the products sold.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Anderson, Ellen
202-205-5662
PIC ID: 5711.2
PERFORMER: A.C. Nielsen Company
Schaumburg IL
EXPECTED DATE OF COMPLETION: 9/30/2000
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 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, address the impact of changing food labels in order to provide information on trans-fatty acids. (See also 6865, 6865.1)
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Nardinelli, Clark
202-205-8702
PIC ID: 6865.2
PERFORMER: Research Triangle Park
Research Triangle Park, NC
EXPECTED DATE OF COMPLETION: 9/30/2000
On December 29, 1995, the FDA announced its plan to review its regulations pertaining to identity, quality and container fill 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. (See PIC ID 6865.1, 6865.2)
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Nardinelli, Clark
>202-205-8702
PIC ID: 6865
PERFORMER: Research Triangle Park
Research Triangle Park, NC
EXPECTED DATE OF COMPLETION: 9/30/2000
In November 1997, the OPA created the FOCUS team to reevaluate current procedures and recent streamlining efforts relating to the review process for food additive petitions for the approval of food contact substances. This group was also charged with the development of necessary procedures, plans, guidance, and regulations to implement the premarket notification process for food contact substances. Based on the work of this group, the OPA expects to announce revised guidance for premarket submissions for food contact substances in the first half of FY 1999. In addition, the OPA is currently developing the capability of incorporating Structure Activity Analysis (SAA) into the premarket review process for food contact substances and will continue training and process development in this area during FY 1999. Finally, during FY 1999, FOCUS will develop regulations required to implement the premarket notification process for food contact substances.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Rullis, Alan M.
202-418-3100
PIC ID: 7096
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
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: Benedict, Mary E
410-786-7724
PIC ID: 5711
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Levy, Alan
202-205-9448
PIC ID: 7294
PERFORMER: Food and Drug Administration
Rockville, MD
EXPECTED DATE OF COMPLETION: 9/30/2000
This project consists of a two-part survey of current hazard assessment quality control points (HACCP) 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: Nardinelli, Clark
202-205-8702
PIC ID: 6866
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 3/2/2001
The Food and Drug Modernization Act of 1997 (FDAMA) required FDA's Center for Radiological Health (CDRH) to change its user facility program from universal, mandated reporting of adverse events to a program of user reporting limited to certain facilities, constituting a representative profile. Although the 1992 amendments to the Safe Medical Device Act required reporting of all events causing serious injury or death due to medical devices, FDA did not have the resources or personnel to monitor the 40,000 to 50,000 user facilities involved. Thus, the FDAMA called for a solution to this problem by asking the FDA to establish a sentinel surveillance system by identifying a sample of facilities and a more proactive surveillance network among them. Congress also required the agency to submit a progress report by late 1999 on efforts towards implementing the new sentinel system. This project has been instrumental in assessing the feasibility and effectiveness of such a reporting program.
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Gardner, Susan
301-594-2812
PIC ID: 7108
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
The Nationwide Evaluation of X-Ray Trends (NEXT) is a collaborative program conducted jointly between the Food and Drug Administration (FDA) and State radiation control agencies. The study estimates the radiation dosage from diagnostic x- ray examinations, using data collected from previous NEXT surveys of 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: Suleiman, Orhan
301-594-3533
PIC ID: 4984
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
Recently passed laws have allowed food industries to label products containing added fiber with health claims. This proposed study will identify which type (and dietary level) of fiber would be of potential benefit for preventing or reducing breast cancer in women. The study will also provide FDA a scientific basis for making regulatory decisions concerning health-effect labels on fiber-rich products.
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Jackson, Carlton
870-543-7553
PIC ID: 7114
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
The objective of this study is to determine whether caloric consumption is a predictor of human health in general, or of certain specific health effects. The study will provide answers to questions concerning food intake and health, and in particular, issues addressing the correlations between caloric intake, weight, obesity and health risk.
AGENCY SPONSOR: National Center for Toxicological Research
FEDERAL CONTACT: Freni, Stan
870-543-7517
PIC ID: 7110
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
This study is part of a larger ongoing initiative to submit information to the Center electronically. CVM started receiving electronic submissions of Notices of Investigation Exemptions (NCIEs) during September 1997 on a pilot basis with a limited number of drug sponsors. Performance during the pilot period was evaluated and showed that processing time for electronic submissions was reduced to a third of that for comparable paper submissions before the pilot. As a result, in 1999 the Center released guidance allowing any registered sponsors to submit information in electronic format through e-mail. The advantages of this new system included: reduction in transmittal time from the sponsor to the Center, reduced processing time within the Center, reduced paper handling and storage requirements, increased customer satisfaction, and the ability of the Center to review, process, store and retrieve electronic records. The Center is preparing guidance documents to expand the scope of the electronic transmission process to include other reporting requirements. A report of this endeavor appears on FDA's home page under the electronic submissions section.
AGENCY SPONSOR: Center for Veterinary Medicine
FEDERAL CONTACT: Parbuoni, Elizabeth
301-827-7562
PIC ID: 7288
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000
The objective of this study was to review and evaluate current bioresearch monitoring (BIMO) functions and recommend changes, if appropriate, and determine the correlation between the Quality Assurance/Quality Control responsibilities of drug sponsors and the BIMO program. The report recommends actions to consider (such as timeliness of inspections) for improving the Center for Veterinary Medicine's (CVM's) existing BIMO program. With the possible exception of expanding the BIMO staff, the recommendations may be accomplished by using the Center's current resources. The report also presents a plan whereby the Office of Surveillance and Compliance and the Office of New Animal Drug Evaluation can make the BIMO program more efficient and relevant to the review process by providing as many tools as possible (especially to the reviewers) through center-wide access to BIMO information.
AGENCY SPONSOR: Center for Veterinary Medicine
FEDERAL CONTACT: Larkins, Marcia
301-827-0137
PIC ID: 7271
PERFORMER: Food and Drug Administration
Rockville MD
EXPECTED DATE OF COMPLETION: 9/30/2000