The following section represents FDA’s response to Congressional requirements or directives derived from House Report 108-193, Senate Report 108-107, and House Report 108-401.
Office of Women’s Health — The Committee recommendation includes an increase of $600,000 for the Office of Women’s Health (OWH), to make total funding for OWH not less than $3,675,000. Of this increase, not less than $500,000 should be dedicated to supporting and implementing important women’s health outreach activities, including the hormone replacement education initiative that was started in fiscal year 2003. It is critical that the Office of Women’s Health have the resources to partner with medical professional and women’s health groups, as well as other Federal agencies, to conduct a comprehensive public awareness outreach campaign about the appropriate use of hormone therapy, including the treatment of menopausal symptoms. [House Report 108-193, Page 85-86]
FDA’s Office of Women’s Health is spearheading an educational outreach effort, “Menopause and Hormones”, focused on providing clear, easy to understand information about the risks and benefits of hormone therapy for relief of menopausal symptoms.
All “Menopause and Hormones” materials that were developed in FY03 are currently undergoing both English and Spanish language focus group testing to ensure that the literature provides women with “need to know” information and serves as a valuable tool for making an informed decision about whether the use of menopausal hormone therapy is appropriate.
In FY2004, OWH and partner organizations will:
In addition to managing the “Menopause and Hormone” initiative in FY2004, the OWH will continue the “Take Time To Care…About Diabetes” campaign, the award winning program to increase women’s awareness of diabetes, reach those at risk, and encourage early diagnosis and proper treatment. A new launch of this campaign is scheduled for February 2004 in 10 cities around the nation.
WERC —The Committee expects the FDA to continue its support for the Waste Management Education and Research Consortium [WERC], and its work in food safety technology verification and education at no less than the FY 2003 level. [House Report 108-193, Page 86]
FDA awarded a five-year grant to the Waste Management Educational Research Consortium. Funding of the grant will continue at the same level for the duration of the grant period ending in FY 2005.
Shrimp/Chloramphenicol—The Committee has concerns regarding the adequacy of FDA efforts to address seafood safety issues, particularly chloramphenicol contamination in farm-raised shrimp imports. The Committee understands that FDA has increased its sampling rate of farm-raised shrimp imports fourfold, and encourages increased sampling over the current rate. The Committee also expects FDA to validate and employ the most current test methods for chloramphenicol, including development of testing capability for cold-storage inventories. The Committee directs the agency to report on its sampling frequency and violation rates for imported shrimp, and its efforts to ensure that any shrimp that test positive for chloramphenicol will not be subsequently consumed. [House Report 108-193, Page 87]
FDA continues to maintain the increased sampling rate for chloramphenicol in shrimp. The Agency has validated, and is employing, the most current test methods for chloramphenicol. As a result of this routine use of best available technology as it reaches maturity and is validated, the limit of detection for chloramphenicol was reduced from 5.0 ppb down to 1.0 ppb over a year ago and has recently been further reduced to 0.3 ppb. FDA has also validated a commercially available, rapid immunodiagnostic test kit.
Sampling is ongoing at the accelerated frequency of more than 50 samples of shrimp per month as part of an open-ended sampling program that is intended to be responsive to the chloramphenicol situation and is in addition to routine surveillance sampling. During the first year of increased sampling, from July 2002 to July 2003, over three hundred samples were taken. During the first six months of this time period, 10 positive samples were found. These shipments did not enter commerce and subsequent shipments from the source firms were detained without physical examination pending their analysis for chloramphenicol. During the subsequent six months of this time period, a similar number of samples were analyzed and none were found to be adulterated with chloramphenicol.
Samples are now being analyzed at the lower limit of detection of 0.3 ppb, with 80 shrimp samples collected and analyzed between 8/19/03 to 10/31/03. Six of these were found to be positive, with corresponding shipments refused entry, and subsequent shipments from these firms to be detained without physical examination.
Shellfish Safety— The Committee expects that FDA will continue its work with the Interstate Shellfish Sanitation Commission (ISSC) to promote educational and research activities related to shellfish safety in general, and Vibrio vulnificus in particular. The Committee directs the use of not less than $250,000 for this effort. In addition, the Committee expects that FDA will continue its work with ISSC through a memorandum of understanding, and that FDA will devote not less than $200,000 to this effort. [House Report 108-193, Page 87]
In FY 2003, FDA continued to work with the Interstate Shellfish Sanitation Conference (ISSC) to implement a control strategy for Vibrio vulnificus in raw oysters that was developed in July 2001. Accomplishments this year include: (1) a 28% reduction in V. vulnificus illnesses in the core reporting states was reported for 2002 compared to the baseline data. It is too early to assess whether this will continue as a trend in the future; (2) completion of research on the effectiveness of on-board or dockside refrigeration at reducing V. vulnificus levels in oysters, with a demonstration of positive effects on risk reduction; (3) continuation of research to study the effects of ultra high pressure processing on the reduction of V. vulnificus levels in oysters; (4) continuation of research on methodology for virulence determinacy factors useful in epidemiology and risk assessment (5) adoption of a final protocol for the validation of post-harvest treatment processes; (6) through a contractor, developed a media campaign to educate the Hispanic community on the risks of consuming raw oysters and implemented the campaign in Texas and Florida; and (7) through a contractor, conducted radio advertising and distributed print material through a major retail chain in areas of high Hispanic population throughout the country on the risks of consuming raw oysters.
In FY 2004, FDA’s CFSAN included in its FY 2004 workplan an “A-list” goal to continue to work with the ISSC to implement a control strategy for Vibrio vulnificus in raw oysters and a “B-list” goal to develop a final control strategy for Vibrio parahaemolyticus.
Color Certification Fees—The Committee understands that fees paid by the color certification industry have been used to pay rent on a much larger facility than is needed in FY 2003, due to logistics of using a temporary space, and that the same situation is expected in the budget year. The Committee is concerned that this temporary rent increase will be the basis for an increase in assessed fees for the industry. The Committee expects FDA to calculate fees based on reasonable expenses, excluding the anomaly of increased rent in the current and budget years. The Committee notes that augmentation of the FDA budget by the color certification fees is allowable only to offset reasonable expenses of running the color certification function, and that a separate accounting of the fees and expenses must be kept. [House Report 108-193, Page 87]
FDA has not increased the fees for the certification of colors since 1993. Consequently, FDA’s fee income for this function has been relatively constant. However, FDA’s costs tend to rise gradually over time as employees receive pay raises and as general inflation has an affect on other costs. In sum, in order to cover costs for maintaining the program, the Agency believes that an increase in fees is necessary at this time.
The Agency commented in August 2003 that the fees will need to be raised at some point during FY2004. The industry’s representative was informed of that likelihood. Importantly, although a fee raise is under consideration, the required formal process of comment rulemaking as announced in the Federal Register has not been initiated. This process would provide opportunity for all interested parties to raise any concerns.
FDA is committed to maintaining the program in the most efficient and cost-effective manner. The specific fee increases necessary to maintain the program have not been determined at present. The increase will be based on anticipated reasonable resource needs at the present time and anticipated future expenditures necessary to provide, maintain, and equip an adequate service for certification. At the time that the agency proposes a change in fees, our evaluation and conclusions for potential increases would be made available as part of the public docket.
FDA understands that fees collected and expenditures for certification must be separated from other agency accounts. In fact, Color Certification monies are maintained in an account separate from all appropriated FDA funds and have been since fees were first collected. The fund is under Inspector General annual audit to insure its integrity.
Detroit District Office — The Committee is pleased that FDA plans to relocate the Detroit District Office within the city center of Detroit, and that a long-term lease has been signed. The Committee supports the increase in personnel assigned to the Detroit District Office to meet needs in that area, and expects that the current level of 112 Full Time Equivalent employees will be maintained or exceeded in the budget year [FY2004]. [House Report 108-193, Page 88]
In December 2002, FDA relocated the Detroit District Office with the signing of a fifteen-year lease. The current staffing of Detroit District Office is 112 employees.
Standard of Identity for Yogurt—The Committee supports the agency’s plans to issue an Advanced Notice of Proposed Rulemaking (ANPR) in August 2003 to solicit comments on the petition regarding the standard of identity for yogurt. The Committee expects to receive notice when the ANPR is published, and to be briefed within 120 days of the close of the ANPR comment period on the comments received and on agency plans to issue a proposed rule on the yogurt standard of identity. [House Report 108-193, Page 88]
In FY 2003, FDA (1) published an ANPR to obtain public comment on the provisions proposed by the National Yogurt Association in a petition to amend the standard of identity for yogurt and cultured milk; and (2) re-opened the comment period to this ANPR in October 2003, in response to a request from NYA for additional time to comment. The current comment period ends January 27, 2004.
In FY 2004, FDA will review the comments received and report to Congress within 120 days of the close of the comment period of the ANPR on the comments received and the Agency’s plans to issue a proposed rule on the standard of identity for yogurt.
UFMS - The Committee recommendation includes a total of [$9,445,000] for the Unified Financial Management System. Any additional costs for this purpose either direct or by transfer, are subject to approval by the Committee. The Committee continues to request quarterly updates on the progress of the system, its ability to meet agency needs, and updated cost estimates for implementation. [House Report 108-193, Page 86]
DHHS/FDA will submit quarterly reports to the Appropriations Committees.
WERC - The Committee expects the FDA to continue its support for the Waste Management Education and Research Consortium [WERC] and its work in food safety technology verification and education at no less than the FY 2003 level. [Senate Report 108-107, Page 152]
FDA awarded a five-year grant to the Waste Management Educational Research Consortium. Funding of the grant will continue at the same level for the duration of the grant period ending in FY 2005.
NCSFT Collaboration - With the growing threat of foodborne illness to the public health, the Committee believes that collaborative research in food safety should continue among Government, academia, and private industry. The national model for that collaboration has been the National Center for Food Safety and Technology [NCFST] in Summit-Argo, Illinois. The Committee expects the FDA to maintain sufficient funding for the National Center to continue the important work done there. [Senate Report 108-107, Page 152]
The current five-year Cooperative agreement comes up for renewal in FY 2004. In FY2004 CFSAN has included in its FY 2004 work plan an A-level priority goal to continue the food processing and packaging research and outreach programs at the National Center for Food Safety and Technology (Moffett Center), with a focus on contemporary food safety and security issues. Among the new research ideas are studies on new processing technologies, new definitions for pasteurization, controlling food allergens, new methods of detecting package and seal integrity and mitigation strategies for select agents.
Alaska Food Inspection Contract - In addition, the funding provided for food safety will ensure the continuation of food contract inspections in the State of Alaska. Specifically, it will allow the FDA to renew its contract with the State of Alaska for inspections of food and seafood processors operating in Alaska. The current contract became effective on June 12, 2003. It will fund at least 292 inspections, approximately 272 seafood/HACCP inspections and 20 other food inspections, at a cost of approximately $269,000. The establishments to be inspected will be mutually agreed upon by FDA and the State of Alaska. [Senate Report 108-107, Page 153]
FDA continues its contract with the State of Alaska for inspections of food and seafood processors operating in Alaska. The current contract became effective on June 12, 2003. The contract equals approximately $269,000 to fund approximately 272 seafood/HACCP inspections and 20 other food inspections.
Seafood Safety—General Accounting Office [GAO] reports on the safety of seafood have documented the inadequacy of the FDA efforts to address foodborne hazards in seafood, including shellfish. GAO found FDA’s seafood inspection system provides consumers with inadequate protection for seafood-related foodborne illness.
The Committee urges FDA to promote the development of new food safety technologies such as irradiation, flash freezing, high-pressure processing, or others that can cost-effectively reduce the incidence of pathogens, and technologies that can ensure constant safe temperatures of seafood throughout the food chain. [Senate Report 108-107, Page 153]
FDA specifically encourages the use of technological improvements that increase effectiveness and assurances of safety in controlling human food safety hazards but does not promote any specific technology. For seafood, FDA is always interested in understanding new technologies and the extent to which they succeed in controlling human food safety hazards. FDA occasionally engages in research on the effectiveness of new technologies to control certain hazards. Where new technologies are known to work, FDA might make reference to them in hazards and controls guidelines that it develops for seafood processors. FDA takes new technologies into account in various other ways. For example, FDA recently worked with the Interstate Shellfish Sanitation Conference, a Federal/State/industry/academia consortium devoted to the safety of molluscan shellfish, to develop a national control plan for the pathogen Vibrio vulnificus. That plan relies substantially on the existence of emerging new post harvest treatment technologies to kill this organism.
Seafood safety - The Committee is concerned that FDA has not taken effective action to address foodborne illness risks from the consumption of raw shellfish. In particular, the Committee is concerned that Interstate Shellfish Sanitation Commission’s [ISSC] proposed steps to reduce the rates of death and illness due to consumption of Vibrio vulnificus-contaminated raw shellfish may not effectively address public health concerns. [Senate Report 108-107, Page 153]
In FY 2003, FDA’s CFSAN continued to work with the Interstate Shellfish Sanitation Conference (ISSC) to implement a control strategy for Vibrio vulnificus in raw oysters that was developed in July 2001. Accomplishments this year include: (1) a 28% reduction in V. vulnificus illnesses in the core reporting states was reported for 2002 compared to the baseline data. It is to early to assess whether this will continue as a trend in the future; (2) completion of research on the effectiveness of on-board or dockside refrigeration at reducing V. vulnificus levels in oysters, with a demonstration of positive effects on risk reduction; (3) continuation of research to study the effects of ultra high pressure processing on the reduction of V. vulnificus levels in oysters; (4) continuation of research on methodology for virulence determinance factors useful in epidemiology and risk assessment (5) adoption of a final protocol for the validation of post-harvest treatment processes; (6) through a contractor, developed a media campaign to educate the Hispanic community on the risks of consuming raw oysters and implemented the campaign in Texas and Florida; and (7) through a contractor, conducted radio advertising and distributed print material through a major retail chain in areas of high Hispanic population throughout the country on the risks of consuming raw oysters.
In FY 2004, FDA’s CFSAN has included in its FY 2004 workplan an “A-list” goal to continue to work with the ISSC to implement a control strategy for Vibrio vulnificus in raw oysters and a “B-list” goal to develop a final control strategy for Vibrio parahaemolyticus.
Hawaii HACCP Plan----The Committee also continues its concern with the agency’s failure to bring FDA-regulated seafood into compliance with HACCP. However, the Committee is aware that special or unique circumstances may exist for particular seafood processors. While ultimate HAACP compliance is not in question, the Committee is specifically aware of Hawaii’s lengthy and culturally important history of hook-and-line fisheries, auction markets, and the high consumption of raw tuna and other pelagic fish in Hawaii, and strongly encourages the Agency to take into account both the history and the industry’s practical experience in approving a plan that is consistent with healthy seafood products and national standards for seafood safety. [Senate Report 108-107, Page 153]
FDA's seafood HACCP program is designed to allow for unique processing situations. Processors may design one-of-a-kind HACCP systems to accommodate their own circumstances so long as they meet minimum national standards for safety. It is not practical, however, to expect or allow for gradations of safety in products sold for profit in interstate commerce based on culturally based processing practices at the point of origin.
The issue involves proper handling practices on board fishing vessels to insure that tuna do not form scombrotoxin as a result of time/temperature abuse. Scombrotoxin is one of the three most frequently reported illnesses from seafood in the United States and is completely avoidable. In this case, the issue involves what constitutes proper handling of fish that are allowed to die and remain in the water for some time before they are landed on the boat. Once a tuna dies, it can begin to decompose and form scombrotoxin if not properly chilled. FDA's Office of Seafood remains willing to review any research proposal developed by the auction house in Hawaii on the effect of death on the line. The Office of Seafood is also planning to conduct complimentary research in this area this year.
Uses of Additives in Seafood-Dye in Salmon - The Committee has been advised that farmed salmon imported from overseas is fed feed with chemical additives to change the color of its flesh or the flesh is artificially dyed. A lawsuit was recently filed against national grocery chains alleging they do not adequately label the fish which are dyed. The Committee directs the Food and Drug Administration to continue to monitor information concerning the safety of the use of such additives and dyes in seafood and to more aggressively enforce the clear and conspicuous disclosure of such additives and dyes to consumers on consumer packaging. [Senate Report 108-107, Page 153]
Under the Federal Food, Drug and Cosmetic Act, retailers are required to label salmon that has been colored by the use of astaxanthin or canthaxanthin to clearly denote that the food has had color added. The FDA will continue to monitor information concerning the use of such additives in seafood and encourage state enforcement authorities to ensure proper labeling.
FDA continues to maintain the increased sampling rate for chloramphenicol in shrimp. The Agency has validated, and is employing, the most current test methods for chloramphenicol. Because the Agency adopted the best available technology as it reached maturity and was validated, the limit of detection for chloramphenicol was reduced from 5.0 ppb down to 1.0 ppb over a year ago and has recently been further reduced to 0.3 ppb. FDA has also validated a commercially available, rapid immunodiagnostic test kit for sample screening.
Sampling levels have been accelerated significantly above the routine surveillance level. More than 50 samples of shrimp per month are collected as part of an open-ended sampling program that is intended to be responsive to the chloramphenicol situation. During the first year of increased sampling, from July 2002 to July 2003, over three hundred samples were taken. During the first six months of this time period, 10 positive samples were found. These shipments did not enter commerce and subsequent shipments from the source firms were detained without physical examination pending their analysis for chloramphenicol. During the subsequent six months of this time period, a similar number of samples were analyzed and none were found to be adulterated with chloramphenicol.
Samples are now being analyzed at the lower limit of detection of 0.3 ppb, with 80 shrimp samples collected and analyzed between August 19, and October 10, 2003. Six of these were found to be positive, with corresponding shipments refused entry, and subsequent shipments from these firms to be detained without physical examination.
Mercury - New reports highlight the need to increase Federal attention to mercury levels in seafood and improve Federal advisories on potential mercury exposure through fish consumption. The Committee strongly encourages FDA to restart its fish monitoring program to track levels of mercury in frequently consumed seafood or species with potentially high mercury levels, as well as revise its mercury advisory to be consistent with recommendations from the National Academy of Sciences and the FDA Food Advisory Committee. [Senate Report 108-107, Page 154]
In response to the senate report addressing mercury, FDA agrees that there is a need to revise the current advisory regarding methyl mercury in fish for the at-risk population (women who may become pregnant, women who are pregnant, nursing mothers and young children). FDA has been working closely with EPA to develop a revised joint advisory that will address both commercial and recreational fish and shellfish. FDA and EPA jointly hosted a series of stakeholder meetings in July 2003 to present their progress on developing a revised joint advisory. Following this meeting the advisory was further refined and then tested in focus groups in November 2003. The focus group testing led to further refinements of the advisory. The final draft advisory was then presented to the FDA Food Advisory Committee (FAC) in December 2003. The revised advisory is consistent with the recommendations from the National Academy of Sciences and the FDA Food Advisory Committee. Regarding the monitoring of fish and shellfish for mercury levels, during the last year FDA has undertaken a series of new monitoring studies for canned tuna and other fish. This involved testing 170 composites of canned albacore tuna and 119 composites of canned light tuna (each composite was composed of 12 cans). Other testing has involved 224 samples of a variety of fish for which there was a paucity of data. FDA proposes to continue such testing over the next twelve months in both tuna and other varieties of fish.
National Antimicrobial Resistance Monitoring System —The Committee supports the work of the National Antimicrobial Resistance Monitoring System [NARMS] and its collaborative relationship between FDA, the Department of Agriculture, and the Centers for Disease Control and Prevention. The Committee expects the coordination of activities among these three areas of Government to result in the most unbiased presentation of timely, accurate data in the best interest of public health. [Senate Report 108-107, Page 154]
FDA works in close collaboration with the Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA) on NARMS. Part of this collaboration includes interagency agreements with regard to collection and testing of isolates for antimicrobial resistance. A unique feature of NARMS is the tracking of susceptibility among isolates collected from humans, animals and retail meat. Through these partnerships, NARMS takes advantage of USDA’s and CDC's expertise and resources. It is vital that NARMS continues to be coordinated with FDA due to the Agency’s public health role in regulating the use of antimicrobials and other drugs in animals and humans. FDA uses NARMS to monitor the impact of drug use in food-producing animals on health and respond with appropriate action if human health is threatened.
Review of botanicals in dietary supplements - FDA has indicated that the ability to identify and analyze specific components in ingredients, including botanical ingredients, is an essential component of research and regulatory programs directed at ensuring the safety and effectiveness of dietary supplements. The Committee expects the same level of review of botanicals in dietary supplements to continue in fiscal year 2004. This work is being carried out by FDA in collaboration with the National Center for Natural Products Research, Oxford, MS. [Senate Report 108-107, Page 154-155]
The work performed by the National Center for Natural Products Research in Oxford, Mississippi to identify and analyze specific components in dietary supplement ingredients, including botanical ingredients, has become an essential component of FDA’s research and regulatory programs directed at ensuring the safety and effectiveness of dietary supplements. FDA will continue with the same level of review of botanicals in dietary supplements in fiscal year 2004.
Biotechnology - Allocate funds to Educate Regulators on the Evaluation of Biotechnology Safety — The Committee understands that the FDA frequently receives requests from foreign governments for FDA regulators to visit foreign countries to educate regulators on the evaluation of the safety of biotechnology. Providing information on the soundness of the U.S. regulatory process will promote the understanding of the benefits of biotechnology to human health and the environment and improve the climate for acceptance of U.S. agricultural products abroad. The Committee directs the FDA to allocate adequate funding so that agency representatives may perform this service. [Senate Report 108-107, Page 155]
Blood Safety - Standards for Source Plasma and Recovered Plasma Collection—The Committee is aware that multiple standards currently exist regarding the collection of recovered and source plasma from blood, and encourages FDA to work with all stakeholders to ensure the equivalence of these standards in safeguarding the Nation’s blood supply. [Senate Report 108-107, Page 155]
There are about 14 million units of Source Plasma collected every year that are used in the manufacture of a variety of plasma derivatives including Factor VIII used to treat clotting disorders, immune globulins used to treat immune deficiencies, and many other products. Standards for Source Plasma have a longstanding existence in FDA regulations (21 CFR 640). Recovered Plasma is collected as a by-product of Whole Blood collection (the plasma remaining after cellular components for transfusion are removed) or as a result of outdating of plasma collected for transfusion. Donors whose blood subsequently is used as recovered plasma must meet the same suitability requirements as those for donors of components for transfusion (21 CFR 640.3). Collections are tested by the same battery of tests required for blood and blood components used for transfusion (21 CFR 610.40). However, there are specific regulatory standards for Source Plasma including collections, labeling and storage. Standards for recovered plasma are primarily determined through short supply agreements (21 CFR 601.22) whereby the fractionators determine the acceptance criteria for recovered plasma as a raw material for further manufacturing. The FDA has brought the issue of standards for recovered plasma for discussion at the Blood Products Advisory Committee, most recently on June 20, 2003. The FDA intends to hold a workshop on developing standards for recovered plasma on February 26, 2004. After obtaining public input, it is our intention to develop comprehensive regulatory standards for recovered plasma.
FDA Reclassification of Medical Gloves—The Committee remains concerned about the prevalence of natural rubber latex allergy, particularly among heath care workers and patients, even though a small percentage of the general population is sensitive to latex protein. The Committee recognizes that proper glove choices are important, as health care workers and their patients will encounter risks of infection and/or disease if barrier protection against viral transmission is inadequate. The Committee understands that latex gloves are acknowledged for their barrier effectiveness. The Committee is also aware that as a result of technological advances in manufacturing; the residual protein in some latex gloves has been largely removed, reducing the potential for allergic sensitization. Recognizing the need for the public, and particularly health care workers, to be provided with the necessary information on proper glove choices, the Committee directs that FDA finalize the 1999 proposed regulation that would reclassify all surgeon’s and patient examination gloves as Class II Medical Devices. This would enable medical gloves that provide effective barrier protection with low or zero allergen risk to be better appreciated and identified. [Senate Report 108-107, Page 155]
Since the problem of latex allergy emerged, FDA’s Center for Devices and Radiological Health (CDRH) has undertaken numerous activities to understand and address this problem. These activities include: issuing an FDA medical alert; organizing conferences and workshops; providing information to consumers and health care professionals; developing an improved protein assay which was adopted as an American Society for Testing and Materials (ASTM) standard assay test; developing guidance for manufacturers for testing skin sensitization to chemicals in natural rubber products; compiling and posting on the Internet a comprehensive "Medical Glove Powder Report;" requiring in September 1998 specific content labeling statements on all medical devices and packaging containing natural rubber latex; and agreeing with OSHA that FDA will focus its regulatory efforts on aspects pertaining to the products themselves, while deferring workplace controls to OSHA. During the past year FDA, has worked with ASTM to develop a more sensitive immunologic test method for measuring antigenic protein and to establish recommended protein and powder limits for medical gloves.
FDA takes into consideration the intended uses of medical devices, voluntary consensus standard requirements, and the needs of the various user communities when clearing gloves for marketing in the U.S. The Agency has cleared for marketing a number of glove products to market that do not contain natural latex, and which provide appropriate barrier protection for natural latex-sensitive individuals. (Medical gloves currently are class I and are cleared for market via FDA's 510(k) process.)
In the Code of Federal Regulations under § 801.437, FDA requires “[u]ser labeling for devices that contain natural rubber”. As a part of this regulation it is specified that Natural Rubber Latex gloves are required to have a label stating, “CAUTION THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION”.
FDA is proposing to add new caution statements to the ones that are already currently required under § 801.437. FDA published a proposed regulation in July 30, 1999 to reclassify medical gloves from class I to class II, to limit maximum powder and protein levels of medical gloves, and to require new caution statements, including protein and powder labeling requirements. The comment period closed January 27, 2000. CDRH is currently reviewing the comments received regarding the proposed rule and drafting the final rule. FDA is currently working on the economic assessment associated with the regulation, and anticipates that the analysis will be completed in 2004.
Standards of Identity Milk Protein Concentrate (MPC)—The Committee is aware of the ongoing debate surrounding increased importation and use of milk protein concentrate. A General Accounting Office investigation highlighted a dramatic increase in milk protein concentrate imports. The Committee remains concerned with the Food and Drug Administration’s current lack of enforcement of standards of identity as it relates to the potential illegal use of milk protein concentrate in standardized cheese. [Senate Report 108-107, Page 156]
In FY 2002/2003, FDA (1) conducted inspections at specific cheese manufacturing sites to determine compliance with the cheese standards and to document the use of MPC in standardized cheeses and, as a result, issued warning letters to some cheese manufacturers using MPC in standardized cheese; (2) conducted a thorough review of the two petitions requesting the use of filtered milk in standardized cheeses and, subsequently, closed the petition submitted by the American Dairy Products Institute and converted it to a comment to the petition submitted by the National Cheese Institute; and (3) developed a proposed rule to provide for the use of fluid ultrafiltered milk in standardized cheeses.
In FY 2004, CFSAN/FDA intends to (1) publish a proposed rule to amend the definition of “milk” and “nonfat milk” in cheese standards to provide for the use of fluid ultrafiltered milk and (2) report to Congress, quarterly, on the status of petitions regarding the use of ultrafiltered milk, casein, or MPC in standardized dairy products.
Implanted Medical Devices—The Committee acknowledges current FDA regulations designed to improve post-market surveillance for medical devices, and strongly encourages FDA to devote the necessary resources to require registries and monitor well-designed long-term safety studies for implanted devices, including but not limited to jaw implants. As the aging U.S. population becomes more dependent on implanted devices, the Committee believes it is essential that the FDA allocate adequate resources to patient safety activities related to these devices, such as registries, post-market surveillance, and long-term phase IV trials. [Senate Report 108-107, Page 157]
As has been true in the past, FDA continues to monitor reports, through its nation-wide reporting system, of adverse events and product problems associated with medical devices, including implants. Of the approximately 120,000 device reports received during CY 2003, implants figured prominently and were noted among the top 10 in reports received (e.g., intraocular lenses and drug-eluting stents). Significant actions continue to be taken based on these reports. In CY 2002, for example, FDA, in collaboration with CDC, undertook a nation-wide epidemiologic investigation of the association of cochlear implants with meningitis, reports of which had been received earlier by the agency. The investigation resulted in a global product recall, changes to the national immunization policy regarding cochlear implant recipients, and national recommendations for mitigating meningitis risk. Based on continued reports of aneurysm rupture, FDA initiated a study of the mortality associated with endovascular stent-grafts used to treat abdominal aortic aneurysm. The study was completed in CY 2003 and resulted in a nation-wide public health notification to implanting surgeons informing them of the mortality risk versus standard open surgical repair.
FDA has been engaged in major efforts over the past two years to augment this reporting system. The Medical Product Surveillance Network (MedSuN) was established in response to the FDAMA 1997 Congressional mandate to establish a “sentinel surveillance network” among medical device user facilities. The intent of the network is to aid FDA in capturing significant device-related adverse events and product problems. It creates a partnership with the reporting hospitals so FDA may learn of problems with medical devices once they are in widespread clinical use and so FDA may use the reporting sites as a laboratory to answer questions about device use. Moving from its pilot phase to establishment and expansion, MedSuN has rapidly grown in the past two years from 25 hospitals to 200 currently, and is now recruiting facilities from the West coast resulting in representation from across the country. Major educational and training efforts have been underway to engage these facilities as full partners in assuring patient safety.
Other efforts to augment FDA’s device reporting system include two other initiatives. In CY 2003, FDA began working with the Consumer Products Safety Commission to utilize their nation-wide network of 100 emergency departments to obtain further information on, and national estimates of, device-related injury, including those related to implants.
FDA has also been working with the Centers for Medicare and Medicaid Services (CMS) the past two years to creatively use CMS’ substantial administrative databases to study device-related injuries. The recent focus has been on two implanted device types, i.e., central venous catheters and hip implants.
FDA is also very interested in registries as a postmarket tool to monitor device safety. For example, in anticipation of the rapid diffusion of a break-through technology, FDA worked with the sponsor in CY 2003 to establish a nation-wide, multi-center registry to capture detailed information on 2,000 consecutive patients receiving the first-of-a-kind drug-eluting coronary stent. Based on early reports of thrombosis and hypersensitivity with these implanted devices, FDA issued public health notifications to inform the clinical community of FDA’s ongoing assessment. The data from the registry, and other sources, will provide FDA with a more definitive assessment of any safety concern.
Lastly, FDA has contracted with the Institute of Medicine (IOM) for IOM to conduct a study of the adequacy of the postmarket surveillance of devices, particularly implants, used in the pediatric population. The study was called for under Section 212 of Medical Device User Fee and Modernization Act (MDUFMA). IOM is currently in the process of convening its expert panel.
As part of the conditions of approval for a premarket approval (PMA) application, FDA may impose a post approval study for continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use. FDA generally imposes a post-approval study requirement for new implants. One of the main purposes of the study is to gather long-term safety and effectiveness data for the device. These post-approval studies may strongly focus on the type of data to be collected for the long term collection of data on adverse events and device longevity, and may be collected for patients ranging from the original investigational study patient group to new patients treated after approval. FDA has imposed patient registries for some devices. In the case of temporomandibular joint (jaw) implants, FDA did impose a post-approval study requirement for these devices. Information gathered from post-approval studies is used to further refine the device labeling in terms of the target population, warnings, precautions, adverse events and device performance.
Tissue Safety (FINALIZE Rule by November 20, 2003)—Although FDA has placed proposed rules regarding donor suitability and good manufacturing practices related to tissue safety in the Unified Agenda as an ‘‘other significant’’ priority, the Committee remains concerned that these rules have not yet been finalized. In the fiscal year 2003 Senate report, printed in the January 15, 2003 Congressional Record, pages S356–S410, FDA was directed to finalize these rules ‘‘within 9 months of the enactment of this Act.’’ The fiscal year 2003 Omnibus Appropriations Act was signed into law on February 20, 2003. Therefore, the Committee expects FDA to finalize these proposed rules by November 20, 2003. [Senate Report 108-107, Page 157]
The Agency is fully committed to protecting public health by promoting the enhancement of the safety of tissues used in transplantation. The consistent regulation and enhanced assurance of safety in transplanted tissue will also be critical to public acceptance of this technology and its continuing development which offers so much promise to improve health and well being. FDA has advanced three risk based regulatory proposals. The first rule, proposed on May 14, 1998, was finalized on January 19, 2001, and requires registration and listing of tissue establishments. The second rule, proposed on Sept. 30, 1999, would establish suitability determinations for donors. The third rule, proposed on January 8, 2001, would require manufacturers to follow current good tissue practices. Since the time of the Committee's request, FDA has continued to place the highest priority on finalizing these rules and has made substantial and significant progress in completing the process. FDA is committed to effectively enhancing the safety of tissues, and we are continuing to move forward to accomplish that goal. We are optimistic that the rule making process can be concluded expeditiously.
Chlorofluorocarbon - The Committee is pleased that the FDA has published a rule articulating a transition strategy for removing chlorofluorocarbon [CFC] propelled medicines from the U.S. market. The Committee is aware that several well recognized patient and physician organizations which represent those who suffer from asthma and chronic obstructive pulmonary disease submitted a Citizen Petition to FDA requesting that it take measures to remove albuterol from the list of essential uses for CRCs. The Committee encourages the FDA to respond to the petition request in a timely manner and, if appropriate, expeditiously implement a transition strategy as alternative non-CFC products enter the U.S. market. [Senate Report 108-107, Page 157]
After evaluating the petition, comments submitted in response to the petition, and other information, FDA has tentatively determined that albuterol metered-dose inhalers (MDIs) meet the criteria in 21 CFR 2.125 for removal of an essential use. We are preparing a proposed rule to remove the essential use designation for albuterol MDIs, which is the agency action requested in the petition. Two albuterol MDIs that use a non-CFC propellant are currently being marketed and we have tentatively concluded that they are acceptable alternatives to albuterol MDIs containing CFCs. The proposed rule will ask for comments on medical, manufacturing, and economic issues involved in the phase-out of CFC albuterol MDIs. We anticipate publication of the proposed rule in March 2004, and publication of the final rule in March 2005.
Mercury – The conferees are concerned that different Federal agencies have published information on the level of methyl mercury exposure that is considered safe for humans, which may be confusing to consumers. The conferees understand that in the last nine months, FDA and the Environmental Protection Agency have been working together to develop a single joint advisory that will contain advice about all types of fish (commercial and locally caught). The conferees expect FDA to provide a copy of the resulting draft joint advisory to the Committees by January 2, 2004. [Conference Report 108-410, page 509]
On December 15th, 2003, FDA provided the House and Senate Agriculture et. al. Appropriations Subcommittees with a FDA/EPA joint advisory entitled, “Advice For Women Who Are Pregnant, Or Who Might Become Pregnant, and Nursing Mothers, About Avoiding Harm To Your Baby Or Young Child From Mercury in Fish and Shellfish.”
Tracking blood-derived products – The conferees request that FDA report to the Committees on its oversight plan regarding the adequacy of current systems for the tracking of blood-derived products and patient notification of adverse events. [Conference Report 108-410, Page 508]
Since the issuance of the advanced notice of proposed rule making (ANPRM), manufacturers have made considerable strides in improving patient notification. Voluntary programs supported by manufacturers are in place to notify product users when there is an issue related to the quality of the product. Specifically, the National Notification Center, www.notify1.com administers the Patient Notification System, www.patientnotificationsystem.org, and appears to be functioning well. Accordingly, the Agency currently lacks sufficient evidence on deficiencies of the voluntary notification system to justify the imposition of a regulation. Moreover, it is not clear that an FDA-sponsored notification system would work any better than a voluntary one. FDA has scant evidence that more individuals would sign up for an FDA-mandated system, or that more individuals would be notified by an FDA-imposed system.
FDA does not deny that there needs to be a system in place that goes down to the consumer (end-user) level to deal with the issues raised in 1996. Now that the voluntary system has been established, the Agency does not believe at this point, and based on the evidence available to it, that it needs to move ahead with a proposed rule.
Dietary Supplements & Ginseng - The conferees are aware that the Food and Drug Administration has issued a final rule regarding the labeling of dietary supplements containing ginseng (68 Federal Register 167, August 28, 2003) and has indicated that the industry must be in compliance with this labeling rule. The conferees encourage FDA to ensure that this final rule is being fully enforced. [Conference Report 108-410, Page 509]
FDA intends to take several actions to ensure industry compliance with the ginseng labeling requirement in 21 U.S.C. 343(u). We intend to put in place an import alert that would subject violative products to detention without physical examination if improperly labeled. We also intend to revise our current dietary supplement compliance program to include instructions to inspectors to examine labels during inspections of manufacturers and distributors for potential violations and to issue warning letters to firms with misbranded products. We also intend to issue an assignment to FDA’s field offices directing them to identify and initiate enforcement action against products that are labeled as containing ginseng but that are not eligible to use that identity labeling.
New Mexico State Lab - The conferees provide $1,900,000 for the Agricultural Products Food Safety Laboratory, an increase of $150,000 over the fiscal year 2003 level, for FDA to continue its contract with New Mexico State University's Physical Sciences Laboratory to operate the Food Technology Evaluation Laboratory, which conducts evaluation and development of rapid screening methodologies, technologies, and instrumentation; and to provide technology deployment modeling and data analysis for food safety and product safety in order to facilitate FDA's regulations and responsibilities in food safety, product safety, homeland security, bioterrorism, and other initiatives. [Conference Report 108-410, Page 508]
Through a Department of Defense contract, FDA continues to support New Mexico State University’s Physical Science Laboratory in evaluating rapid test kits for microbiological analyses. Physical Science Laboratory continues to assess potential rapid methods for particular analyte/food combinations which is essential before implementation in the regulatory arena.
Medical Gas CGMP guidance - The conferees are aware that on May 6, 2003, the FDA issued a draft guidance document on current good manufacturing practices for the medical gas industry, and that numerous comments were received on this draft prior to the deadline for public comments. The conferees expect the Agency to give consideration to each of these comments, and to respond to each comment accordingly. The conferees also encourage the FDA to undertake a risk-based and cost-benefit analysis before finalizing this document. [Conference Report 108-410, Page 509]
The Agency will use Good Guidance Practices (GGPs) to evaluate comments received and finalize the Medical Gas cGMP guidance. The phrase good guidance practices refers to the regulation published on September 19, 2000 (65 FR 56468) (codified at 21 CFR 10.115) that lays out the process and procedures for developing, issuing, and using Agency guidance documents. FDA will carefully review each comment received, including those that pertain to the costs, risks, and benefits associated with the draft guidance document.
Division of Pharmaceutical Analysis in St. Louis - SEC. 731. None of the funds made available to the Food and Drug Administration by this Act shall be used to close or relocate, or to plan to close or relocate the Food and Drug Administration Division of Pharmaceutical Analysis in St. Louis, Missouri, outside the city or county limits of St. Louis, Missouri.
FDA has no plans to close or relocate or to plan to close or relocate the FDA Division of Pharmaceutical Analysis in St. Louis, Missouri.
UFMS - The conference agreement recommendation includes a total of $9,445,000 for the Unified Financial Management System (UFMS), an increase of $1,145,000. The conferees direct that, from this total amount, no less than $4,503,000 is to be invested in improvements to FDA's legacy systems and is not to be used for UFMS contracts or global UFMS costs. [Conference Report 108-410, Page 508]
In FY04 FDA will work in concert with the Health and Human Service’s (HHS) Unified Financial Management System (UFMS) and its own efforts to conduct a series of Oracle Financial configuration sessions in a conference room pilot. A Conference Room Pilot is a prototyping technique used to help determine and validate that the design and configuration of UFMS meets the functional requirements of FDA. After the Conference Room Pilot is completed, FDA will begin developing the three interfaces and the necessary data conversion programs for UFMS. FDA will also begin preparing and conducting user acceptance testing in preparation for the implementation of the General Ledger module and the payroll interface starting October 1, 2004. Efforts will continue for developing a reporting system by validating the reports required for the implementation of Oracle Financials. FDA will also continue data cleanup, which is required for a successful data conversion. In addition, a Central Contractor Registration (CCR) system will be configured and developed as part of the procurement E-Gov initiative and be incorporated in the agency implementation of Prism, FDA's procurement and contracting system. FDA will also implement a HHS-348 (“Request for Approval to Accept Payment of Travel Expenses from a Non-federal Source”) sponsored-travel module to Travel Manager automating the approval and collection of fees for sponsored travel by outside organizations. Lastly, FDA will be gathering requirements from each of its centers for a cost management system that will be piloted in FY2005.
The UFMS project under the direction of the Department of Health and Human Services continues to meet all major milestones and operates within approved budgets. Project managers will continue to brief the Committee with quarterly status reports on the progress of the project. The following list summarizes the plans for this project in FY2004:
Mammography standards – The conferees concur with the requirement in the Senate bill for an Institute of Medicine (IOM) study on mammography standards. The conferees have provided $500,000 to carry out the IoM study as described in the Senate bill. The IOM study should include an evaluation of interpretive skills assessments as a possible tool to improve physician interpretation of mammograms (after consultation with those who have expertise in interactive skills assessments) and how the annual medical outcomes audit required under Mammography Quality Standards Act regulations could be used to improve mammography quality and interpretation. [Conference Report 108-410, Page 800 - Office of the Secretary, Department of Health & Human Services]
FDA agrees with the Committee that it is important to continue to improve the quality of mammography services provided to the American public. When the Institute of Medicine initiates their study of mammography standards, FDA will supply any data IOM requests from our Mammography Quality Standards Act data bases, respond to any requests IOM makes for current program information, as well as make determinations on how any new data collection or program ideas might be handled by the program; and advise IOM as to what new resources might be needed. FDA will also serve as a guide to point out other stakeholders who may have information relevant to the IOM study.