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Significant Items in Appropriations Committee Reports

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Food and Drug Administration
Significant Items

 

House Report 109-102 - AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION,
AND RELATED AGENCIES APPROPRIATIONS BILL, 2006 -- Significant Items

 

Item

Generic Drugs - The base funding includes not less than $56,228,000 in funding for the Generic Drugs Program. This is a vital program and the Committee is concerned that its potential as part of the solution to high quality and affordable health care is not realized. (Page 80)

Action Taken or To Be Taken

The Committee provided base funding includes not less than $56,228,000 in funding for the Generic Drugs Program. FDA has made significant progress in recent years in expediting the review of generic drug applications and will strive to maintain that progress.  FDA will include base funding includes not less than $55,666,000 in funding for the Generic Drugs Program. The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $56,228,000 specified in the Congressional report.

Item

Bovine Spongiform Encephalophathy (BSE)- The Committee provides the total amount requested, $29,566,000 for BSE prevention activities, primarily to continue enforcement of the 1997 feed ban. (Page 80)

Action Taken or to be Taken

The Committee provides the total amount requested, $29,566,000 for BSE prevention activities, primarily to continue enforcement of the 1997 feed ban.  In FY 2006, FDA will devote no less than $29,260,000 BSE prevention activities, primarily to continue enforcement of the 1997 feed ban.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $29,566,000 specified in the Congressional report.

Item

Women's health- The Committee recommendation includes not less than $4,000,000 for the Office of Women's Health. The Committee continues to be committed to this function, and in particular activities related to cardiovascular disease in women and the hormone therapy education program.  (Page 81)

Action Taken or to be Taken

The Committee recommendation includes not less than $4,000,000 for the Office of Women's Health. The Committee continues to be committed to this function, and in particular activities related to cardiovascular disease in women and the hormone therapy education program.  The Office of Women's Health has identified heart disease in women as a high priority.  FDA will monitor the progress and review the results of the research projects funded in prior fiscal years and generate consumer friendly information for women on hormone therapy.  FDA will spend $3,960,000 for the Office of Women's Health.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $4,000,000 specified in the Congressional report.

Item

Orphan products - The Committee directs that no less than $15,000,000 be available for grants and contracts awarded under section 5 of the Orphan Drug Act, the same amount as fiscal year 2005.  (Page 81)

Action Taken or to be Taken

The Committee directs that no less than $15,000,000 be available for grants and contracts awarded under section 5 of the Orphan Drug Act, the same amount as fiscal year 2005.  FDA will spend $14,549,000 for Orphan Product Grants.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $14,696,000 specified in the Conference Language.

Item

Financial management - In the fiscal year 2005 appropriations Act, Congress directed that the funding level for the Unified Financial Management System (UFMS) was at the same level as in fiscal year 2004. In response to the Questions for Record submitted to the Committee in April 2005, FDA reports that spending for the UFMS was $9,389,000 in fiscal year 2004 and is expected to be $13,582,000 in fiscal year 2005, a 45 percent increase. The Committee has not received the required notification of this increase. For fiscal year 2006, the Committee directs that no more than $9,389,000 is available for UFMS, and requires a quarterly report on the expenditures. The Committee reiterates that any additional costs for this purpose, either direct or by transfer, are subject to approval by the Committee. (Page 81)

Action Taken or to be Taken

The Committee directs that no more than $9,389,000 is available for UFMS, and requires a quarterly report on the expenditures. FDA is aware of the Congressional concern to stay within the appropriated limits for the Unified Financial Management System (UFMS).   As provided in the conference agreement, FDA will not spend more than $12,896,094 for UFMS in FY 2006.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $13,026,357 specified in the FY2006 Congressional report.  Quarterly spending reports will be prepared and submitted one month after the end of each quarter

Item

Consolidation - The Committee directs DHHS to include all future consolidations that impact FDA in the President's budget request submitted to Congress.

Action Taken or To Be Taken

The Committee directs DHHS to include all future consolidations that impact FDA in the President's budget request submitted to Congress.  FDA will submit all planned consolidations that impact the President's budget request to the Committee.

Item

Fees -The Committee directs that none of the funds made available to FDA in this bill be for any assessments, fees, or charges by DHHS or any other Department or Office unless such assessments, fees, or charges are identified in the FDA budget justification and expressly provided by Congress, or approved by Congress in the official reprogramming process as required in the General Provisions of this bill.

Action Taken or to be Taken

The Committee directs that none of the funds made available to FDA in this bill be for any assessments, fees, or charges by DHHS or any other Department or Office unless such assessments, fees, or charges are identified in the FDA budget justification and expressly provided by Congress, or approved by Congress in the official reprogramming process as required in the General Provisions of this bill.  FDA has included a table and exhibit in this document, the Congressional Justification, entitled "DHHS Charges and Assessments."  This table and exhibit list the actual and estimated fees or charges from DHHS.  We have also included an exhibit on "Funding from Outside Sources."  Any significant changes to these estimates will be handled through an official reprogramming.

Item

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 that work. The Committee expects the FDA to require all states to work cooperatively in conformity with the National Shellfish Sanitation Program implemented by the ISSC. (Page 82)

Action Taken or To Be Taken

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 that work. FDA continues to work with the Interstate Shellfish Sanitation Conference (ISSC) to address Vibrio vulnificus and work cooperatively with all relevant states in conformity with the ISSC's National Shellfish Sanitation Program at a level of $198,000.00.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $200,000 specified in the Congressional report.  These joint efforts include actions to encourage the use of post-harvest treatment by the shellfish industry (e.g., improvements in validation of treatment methods, marketability studies), education of at-risk consumers on the risks posed by the organism, and monitoring of the frequency of occurrence of V. vulnificus illnesses. 

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. FDA will provide $248,000 to ISSC for education and outreach programs on V. vulnificus. The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $250,000 specified in the Congressional report.  Since the initiation of the ISSC V. vulnificus illness reduction goal, the Gulf oyster industry has made great strides in the post-harvest treatment of oysters, with the capacity to treat in excess of 25 percent of the Gulf production.  The impact of Hurricanes Katrina and Rita remain unclear.

Item

Food safety - The Committee recognizes the contributions which the National Center for Food Safety and Technology (NCFST) is making toward ensuring the security of the nation's food supply. The Committee directs that FDA continue to provide $3,000,000 to NCFST through the cooperative agreement. The $3,000,000 in funding shall be exclusive of any additional initiative funds that FDA may award to NCFST. (Page 82)

Action Taken to be Taken

The Committee directs that FDA continue to provide $3,000,000 to NCFST through the cooperative agreement.  The National Center for Food Safety and Technology (NCFST) continues to make contributions toward ensuring the security of the nation's food supply. A five year renewal of the cooperative agreement with NCFST was completed in FY 2004. FDA will continue to provide funding of $2,970,000 to NCFST.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $3,000,000 specified in the Congressional report.

Item

Test method evaluation - The Committee directs that the agency continue its contract to conduct method evaluation of rapid test methods of fresh fruits and vegetables for microbiological pathogens with New Mexico State University's Physical Science Laboratory at the fiscal year 2005 level. (Page 82)

Action Taken or To Be Taken

The Committee directs that the agency continue its contract to conduct method evaluation of rapid test methods of fresh fruits and vegetables for microbiological pathogens with New Mexico State University's Physical Science Laboratory at the fiscal year 2005 level.  FDA will spend $2,358,972 in a contract for New Mexico State University's Physical Sciences Laboratory to operate the Food Technology Evaluation Laboratory.  Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $2,382,800 specified in the Congressional report. Under contract to FDA, New Mexico State University (NMSU) Physical Science Laboratory has provided method assessment, development and validation data for targeted commodities identified as high profile/high risk for implementation into national food safety and food defense programs.

NMSU is evaluating rapid test methods for microbiological analyses in food samples under the Rapid Commercial Test Kit Evaluation Program.  NMSU's evaluation includes the assessment of rapid test methods for a particular analyte(s) or food commodity to be measured against the FDA Bacteriological Analytical Manual.   This comparison is necessary prior to the Agency adopting a rapid test method for use for Food Safety.

Additionally, NMSU is also being utilized to examine the use of these rapid test methods in the arena of Food Defense.  Interim counter terrorism methods have been developed for the rapid identification of agents of bioterrorism, but require further evaluation against food matrices of interest. NMSU serves to provide the validation of these counterterrorism methods.  FDA's contract with NMSU enhances and complements the Agency's ability to be responsive in our food defense responsibilities and activities, especially those that involve field food import examinations and the associated testing of those commodities in the Field and/or at the border.

Item

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 the fiscal year 2005 level.  (Page 82)

Action Taken or To Be Taken

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 the fiscal year 2005 level. In FY 2006, FDA will fund $98,200 to a grant awarded in 1995 to continue support for WERC and its work in food safety technology verification and education.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $99,200 specified in the Congressional report.

Item

Hearing on budget request -The Committee has taken the step of withholding five percent of the funds provided to the central offices at FDA until there is a public hearing with the head of the agency on the fiscal year 2006 budget request. The Committee appreciates the willingness of the agency's head to present the budget request in March 2005, and regrets that the administration insisted on postponing his scheduled appearance. The Committee wants to make it clear to the administration that it will insist on a hearing with the agency's head before providing it the funds requested in the budget.  (Page 83)

Action Taken or To Be Taken

The Committee wants to make it clear to the administration that it will insist on a hearing with the agency's head before providing it the funds requested in the budget.  FDA plans to have the Acting Commissioner present the budget request to the House Appropriations Subcommittee at the hearing scheduled for February 16, 2006. 

Item

Direct to consumer advertising - The Committee provides an increase of $884,000 for the review of direct-to-consumer drug ads. Because staff levels for these activities, under the Division of Drug Marketing, Advertising and Communication in the Center for Drug Evaluation and Research in FDA, have remained flat for some time, despite the growth of direct to consumer ads, the Committee believes this increase is needed.  (Page 83)

Action Taken or To Be Taken

The Committee provides an increase of $884,000 for the review of direct-to-consumer drug ads.  In FY 2006, FDA will spend an additional $875,160 for the review of direct-to-consumer drug ads.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $884,000 specified in the Congressional report.

FDA's goal is to promote and protect the health of Americans by ensuring that drug advertisements and the promotional materials are truthful and balanced.  We operate a comprehensive program of education, surveillance and enforcement about drug advertising and promotion.  FDA appreciates the Committee's recognition of the need for additional resources to regulate direct-to-consumer advertising.  These additional resources will bolster our existing review staff in the Division of Drug Marketing, Advertising, and Communication (DDMAC) who are responsible for monitoring and evaluating promotional materials. 

 

 

Senate Report 109-092 - AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION,
AND RELATED AGENCIES APPROPRIATIONS BILL, 2006 - Significant Items

 

Item

Budget Structure - The Committee does not approve the proposed restructuring of FDA's budget for the field activities, rent activities, and other activities accounts. The Committee directs the Agency to submit the fiscal year 2007 budget request in a format that follows the same account structure as the fiscal year 2005 budget request unless otherwise approved by the Committee.  (Page 148)

Action Taken or To Be Taken

The Committee does not approve the proposed restructuring of FDA's budget for the field activities, rent activities, and other activities accounts. The Committee directs the Agency to submit the fiscal year 2007 budget request in a format that follows the same account structure as the fiscal year 2005 budget request unless otherwise approved by the Committee.  FDA has presented the FY 2007 President's Budget in a format that follows the same account structure as the FY 2005 budget.

Item

Codex Alimentarius - Within the total funding available, at least $2,500,000 is for FDA activities in support of Codex Alimentarius. (Page 148)

Action Taken or To Be Taken

The Committee directs $2,500,000 is for FDA activities in support of Codex Alimentarius. In FY 2006, FDA will devote $2,475,000 in resources in order to continue its leadership role to provide scientifically sound international public health standards.  Congressional directive in Public Law 109-148 applied a 1 percent rescission to the 2,500,000 specified in the Congressional report.  This will be accomplished by heading US delegations, continuing interactions with other key government leads, strategic meetings with regional groups of countries, public outreach meetings in the US, coordination with US codex office and Rome secretariats, and assuring adequate FDA participation in Codex committee and commission sessions.  In FY 2006, FDA will provide U.S. delegate to one Codex Commissioner Session, six cross-cutting general subject committee, and two commodity committee meetings.

Item

Bovine Spongiform Encephalopathy- The Committee provides $29,556,000 for Bovine Spongiform Encephalopathy [BSE]. The Committee understands that this funding will be used to conduct yearly inspections of all renderers and feed mills processing products containing prohibited materials; extend BSE inspections into targeted segments of industries subject to the BSE Feed regulation but previously minimally inspected; validate test methods for the detection of bovine-derived proteins in animal feed; and continue to conduct research on Transmissible Spongiform Encephalopathies in FDA's product centers. (Page 148)

Action Taken or To Be Taken

The Committee provides $29,556,000 for Bovine Spongiform Encephalopathy (BSE).  In FY 2006, FDA will devote no less than $29,260,000 BSE prevention activities, primarily to continue enforcement of the 1997 feed ban.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $29,566,000 specified in the Congressional report.

Item

Agricultural Products Food Safety Laboratory - The Committee provides an increase of $250,000 above the fiscal year 2005 funding level for the FDA to expand 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, including advanced risk-based systems for screening and inspection, to facilitate FDA's regulations and responsibilities in food safety, product safety, homeland security, bioterrorism, and other initiatives. (Page 148)

Action Taken or To Be Taken

The Committee provides an increase of $250,000 above the fiscal year 2005 funding level for the FDA to expand its contract with New Mexico State University's Physical Sciences Laboratory to operate the Food Technology Evaluation Laboratory.  FDA will spend $2,358,972 in a contract for New Mexico State University's Physical Sciences Laboratory to operate the Food Technology Evaluation Laboratory.  Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $2,382,800 specified in the Congressional report. Under contract to FDA, New Mexico State University (NMSU) Physical Science Laboratory has provided method assessment, development and validation data for targeted commodities identified as high profile/high risk for implementation into national food safety and food defense programs.

Item

Waste Management Education and Research Consortium - 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 fiscal year 2005 level. (Page 148)

Action Taken or To Be Taken

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 the fiscal year 2005 level.    In FY 2006, FDA will award a $98,200 grant to the Waste Management Educational Research Consortium to continue its support for the Waste Management Education and Research Consortium (WERC) and its work in food safety technology verification and education.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $99,200 specified in the Congressional report.

Item

National Center for Food Safety and Technology - 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 includes $3,000,000 for the National Center to continue the important work done there. (Page 148)

Action Taken or To Be Taken

The Committee includes $3,000,000 for the National Center to continue the important work done at the National Center for Food Safety and Technology (NCFST).  NCFST continues to make contributions toward ensuring the security of the nation's food supply. A five year renewal of the cooperative agreement with NCFST was completed in FY 2004. FDA will continue to provide funding of $2,970,000 to NCFST.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $3,000,000 specified in the Congressional report.

Item

Seafood Safety- 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. (Page 149)

Action Taken or To Be Taken

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.  Food Safety is one of the Agencies top priorities and FDA will continue promote the development of new food safety technologies that can cost-effectively reduce the incidence of pathogens.  

Item

Vibrio Vulnificus - The Committee supports the ongoing work of the Interstate Shellfish Sanitation Conference and its joint efforts with the FDA and the shellfish industry to formulate shellfish safety regulations through the National Shellfish Sanitation Program. The Committee recommends no less than $200,000 be directed through the Office of Seafood Inspection to continue these activities, and directs that $250,000 be directed to the Interstate Shellfish Sanitation Conference for the Vibrio Vulnificus Education Program. 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 Conference'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. (Page 149)

Action Taken or To Be Taken

The Committee recommends no less than $200,000 be directed through the Office of Seafood Inspection to continue these activities, and directs that $250,000 be directed to the Interstate Shellfish Sanitation Conference for the Vibrio Vulnificus Education Program. FDA continues to work with the Interstate Shellfish Sanitation Conference (ISSC) to address Vibrio vulnificus and work cooperatively with all relevant states in conformity with the ISSC's National Shellfish Sanitation Program at a level of $198,000.00.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $200,000 specified in the Congressional report.  These joint efforts include actions to encourage the use of post-harvest treatment by the shellfish industry (e.g., improvements in validation of treatment methods, marketability studies), education of at-risk consumers on the risks posed by the organism, and monitoring of the frequency of occurrence of V. vulnificus illnesses.  FDA will provide $247,500 to ISSC for education and outreach programs on V. vulnificus. The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $250,000 specified in the Congressional report.  Since the initiation of the ISSC V. vulnificus illness reduction goal, the Gulf oyster industry has made great strides in the post-harvest treatment of oysters, with the capacity to treat in excess of 25 percent of the Gulf production.  The impact of Hurricanes Katrina and Rita remain unclear.

Item

Hazard Analysis Critical Control Point  - The Committee also continues its concern with the agency's failure to bring FDA-regulated seafood into compliance with Hazard Analysis Critical Control Point [HACCP] standards. 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. (Page 149)

Action Taken to be Taken

The Committee 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.   FDA's seafood HACCP program is designed to allow processors to design preventive controls that best accommodate their own circumstances so long as they provide an appropriate assurance of product safety.  Of course, the level of safety assurance cannot be compromised based on cultural or traditional processing practices at the point of origin. 

The special or unique circumstances involve 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 with proper care of the catch.  Once a tuna dies, it can begin to decompose and form scombrotoxin if not properly chilled. 

FDA's Office of Seafood has engaged in a continuing dialog with the auction house in Hawaii on how it can most effectively and practically ensure the control of scombrotoxin as a result of the death of tuna and other species while still on the line.  During 2005, the Hawaiian seafood industry, NMFS and FDA collaborated in an important study on the conditions under which large, longline-caught tuna will form histamine.  At present, the samples collected during this study are being analyzed and FDA anticipates using this data to refine its recommendations to the Hawaiian industry and other scombroid fishing industries on appropriate controls for this hazard. 

Item

Imported Farmed 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 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. (Page 149)

Action Taken to be Taken

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.  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 safety of the use of such additives in seafood.  

Item

Alaska -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. A new contract became effective on July 1, 2005. It funds at least 292 inspections, approximately 272 seafood/HACCP inspections and 20 other food inspections. The establishments to be inspected will be mutually agreed upon by FDA and the State of Alaska. (Page 149)

Action Taken to be Taken

He Committee directs the funding provided for food safety will ensure the continuation of food contract inspections in the State of Alaska. 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. A new contract will be negotiated in July 2006. Its goal will be to fund at least 292 inspections, approximately 272 seafood/HACCP inspections and 20 other food inspections. The establishments to be inspected will be mutually agreed upon by FDA and the State of Alaska.   

Item

Chloramphenicol.-The Committee continues to have serious concerns regarding seafood safety issues posed by banned antibiotic contamination in farm-raised shrimp imports. In addition, the Committee is concerned that the FDA inspects less than 2 percent of shrimp being imported into the United States. Therefore, the Committee provides an increase of $500,000 for the FDA to develop, in cooperation with State testing programs, a program for increasing the inspection of imported shrimp, possibly including coldstorage inventories, for banned antibiotics, including chloramphenicol. (Page 150)

Item

National Antimicrobial Resistance Monitoring System- The Committee supports the work of the National Antimicrobial Resistance Monitoring System [NARMS] and its collaborative relationship between FDA, USDA, and the Centers for Disease Control. 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, and encourages FDA to equally divide research funding among the three branches of the program. The Committee directs FDA to provide a detailed financial report as well as an executive summary of 2004 NARMS data and a preliminary report on 2005 data to the Committee by March 1, 2006 in a format that is accessible to users of the data. Further, the Committee directs FDA to perform a review of all components of the NARMS program to ensure that the program remains scientifically sound and relevant to public health. (Page 150)

Action Taken or To Be Taken

FDA strongly supports NARMS and all its components. FDA believes that all three arms are integral to the success of the NARMS program and are necessary to achieve the benefits envisioned at its inception and agreed upon by all three agencies.  FDA has funded NARMS since it was conceived in 1996 and is committed to the continued funding of this program to the extent possible without compromising other core programs.

FDA met with a panel of outside experts for an external review of all three arms of the NARMS program in order to review key elements and establish future directions.  FDA has begun implementing several of these recommendations.  A FDA Science Board Peer Review is currently appraising the NARMS program. 

FDA will continue efforts to maximize cooperation and communication between FDA, USDA, and CDC and strengthen data reporting to increase efficient use of resources.  FDA is in the process of preparing a report on the NARMS program requested by Congress in the conference committee report.

Item

Dietary Supplements- The Committee includes total funding of approximately $5,560,000 for the CFSAN Adverse Events Reporting System [CAERS], of which approximately $1,700,000 is for dietary supplements. This is $1,060,000 more than the amount in the budget request. The Committee is aware that efforts are underway to authorize a mandatory adverse event reporting system for dietary supplements. The Committee requests, within 90 days of the enactment of this Act, a report on the cost of such a system. (Page 150)

Action Taken or To Be Taken

The Committee includes total funding of approximately $5,560,000 for the CFSAN Adverse Events Reporting System [CAERS], of which approximately $1,700,000 is for dietary supplements. This is $1,060,000 more than the amount in the budget request. The conference agreement includes total funding of $5,360,000 for the CFSAN Adverse Events Reporting System.  FDA will include base funding includes not less than $5,306,400 in funding for the CFSAN Adverse Events Reporting System. The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $5,360,000 specified in the Congressional report.

Item

Orphan Products Grants - Included in the Center for Drug Evaluation and Research is $14,392,000 for the Orphan Products Grants Program. (Page 150)

Action Taken or To Be Taken

The Committee includes in the Center for Drug Evaluation and Research is $14,392,000 for the Orphan Products Grants Program. FDA will spend $14,549,000 for Orphan Product Grants.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $14,696,000 specified in the Conference Language.

Item

Dietary Supplement Health and Education Act of 1994 - The Committee is encouraged by the FDA's recent activities to enforce provisions contained within the Dietary Supplement Health and Education Act of 1994 [DSHEA] (Public Law 103-417). The Committee has included funding to continue enforcement of the provisions contained in DSHEA. It is the Committee's intent that these funds be prioritized by the agency to step up activities against products that are clearly in violation of DSHEA. In addition, the Committee is concerned that Current Good Manufacturing Practice [CGMP] regulations, which have been under development for some time, have not been issued. Accordingly, the Committee requests that FDA issue the dietary supplement CGMP regulations. (Page 150)

Action Taken or To Be Taken

The Committee has included funding to continue enforcement of the provisions contained in DSHEA.  FDA will work to ensure dietary supplements are not in violation of DSHEA and take action on violators. Public comments have been reviewed and a draft of the Current Good Manufacturing Practice regulations are in the final stages of clearance. 

Item

National Center for Natural Products Research - 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 provides an increase of $500,000 for review of botanicals in dietary supplements. This work is being carried out by FDA in collaboration with the National Center for Natural Products Research, Oxford, MS. (Page 150)

Action Taken to be Taken

The Committee provides an increase of $500,000 for review of botanicals in dietary supplements. This work is being carried out by FDA in collaboration with the National Center for Natural Products Research, Oxford, MS.  As directed in the conference report FDA will spend $3,243,240 for research at the National Center for Natural Products Research in Oxford, MS, which is an increase of $300,000 over the FY 2005 level of $2,976,000.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $3,276,000 specified in the Conference Language.  In FY 2005 FDA will continue to identify and obtain botanical dietary ingredients of concern to FDA from a safety perspective, and determine research needs to support comprehensive safety evaluations.  FDA will continue to acquire and characterize authenticated botanical materials, including raw plant materials, processed plant materials, and purified natural products. FDA scientists will continue to exchange technical and scientific information, methods, and botanical materials with NCNPR scientists and continue to build international network of botanical experts to meet needs for sourcing and identification. 

Item

Standards of Identity- 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 FDA's current lack of enforcement of standards of identity as it relates to the potential illegal use of milk protein concentrate in standardized cheese. (Page 150)

Action Taken to be Taken

The Committee remains concerned with FDA's current lack of enforcement of standards of identity as it relates to the potential illegal use of milk protein concentrate in standardized cheese.  In response to complaints, FDA 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 cheese products.  As a result of these inspections, FDA sent warning letters to two cheese manufacturers, Kraft Foods North America, Inc. and Lactoprot USA, advising them that standardized cheeses and cheese products containing MPCs are in violation of the misbranding provisions of the FD&C Act.

Both firms responded to the warning letters outlining the actions they were taking. Kraft Foods indicated that it would no longer label products containing MPC as a standardized cheese.  Lactoprot USA announced that it would remove MPC as an ingredient in its standardized cheese products. FDA will continue to monitor to ensure that MPCs are not being used in standardized cheeses and cheese products.

Item

Office of Women's Health- The Committee believes that it is imperative for FDA to pay sufficient attention to gender-based research, ensuring that products approved by the FDA are safe and effective for women as well as men. The Committee notes that in the budget request, the Office of Women's Health at FDA is funded at not less than $4,000,000 for program operation and oversight. The Committee encourages FDA to ensure that the Office of Women's Health is sufficiently funded to carry out its activities, and to enhance its funding if necessary. (Page 150)

Action Taken or To Be Taken

The Committee encourages FDA to ensure that the Office of Women's Health is sufficiently funded to carry out its activities, and to enhance its funding if necessary.  The Office of Women's Health is committed to conducting gender-based research, ensuring that products approved by the FDA are safe for women as well as men.  FDA will spend at least $3,960,000 for the Office of Women's Health.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $4,000,000 specified in the Congressional report.

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Rare Diseases Clinical Trials and Drug Evaluation - The Committee supports rapid access to therapeutics for children and adults with rare diseases. It is the view of the Committee that improvements can be made with respect to clinical trial design and FDA Advisory Committees. The Committee encourages the FDA to make the best possible use of FDA's Advisory Committee members in FDA's considerations of clinical trial design and allow the same panel to participate in final review meetings, when feasible. The Committee supports utilization of qualified independent consultants as reflected in the draft guidance document `Independent Consultants for Biotechnology Clinical Protocols' issued by CBER/CDER on May 12, 2003. The Committee encourages enhanced exploration of potential surrogate endpoints and use of FDAMA's fast-track provision, where appropriate, to make drugs available as early as possible for serious and life-threatening orphan diseases that have no treatment. The Committee believes these policy enhancements will lead to more efficient and timely evaluation of rare disease therapeutics and further stimulate private sector investment in rare disease research. (Page 151)

Action Taken or To Be Taken

The Committee encourages the FDA to make the best possible use of FDA's Advisory Committee members in FDA's considerations of clinical trial design and allow the same panel to participate in final review meetings, when feasible.  FDA supports development of drugs to treat rare diseases and we have a very good track record for prompt assessment of such drugs.  Regarding the issue of clinical trial design, FDA has an ongoing program for orphan product protocol and product development assistance that has helped many sponsors develop appropriate clinical trials.  The FDA also welcomes pre-IND, end of phase 2 and pre-NDA meetings.  It should be noted that sponsors usually consult with recognized experts in the orphan disease and bring them to meetings with FDA.  Indeed, such experts usually conduct the studies.

In addition, FDA supports the use of advisory committees to provide advice on approaches to clinical trial design and analysis for orphan and rare diseases, particularly where there is uncertainty over the appropriate course of action and/or likely disagreement between company and FDA.

We will continue to work with sponsors and outside experts to ensure that development programs for rare diseases are based on sound science and focus on increasing the availability of treatment options to patients while also ensuring that patients are not put at unnecessary risk of harm.  To that end, we support the use of surrogate markers provided that they have biological and medical plausibility.  Reliance on a surrogate endpoint must be determined case by case.  Under our accelerated approval rule and FDAMA, for serious diseases with no good treatment, FDA can rely on surrogate endpoints that have been validated with definitive clinical data to be obtained after the drug is marketed.

Item

Perchlorate - The Committee directs the FDA to continue conducting perchlorate surveys of food and bottled water and to report back to Congress the findings of these surveys. The surveys should include a variety of produce and fluid milk samples and should identify level of contamination in order to determine the need for risk management strategies. The Committee believes it is important to assess produce, milk, and bottled water produced in areas with known perchlorate contamination, with naturally occurring perchlorate, or grown near sites where perchlorate was or is used.  (Page 153)

Action Taken or To Be Taken

The Committee directs the FDA to continue conducting perchlorate surveys of food and bottled water and to report back to Congress the findings of these surveys.  In February 2005, FDA issued an expanded survey assignment to determine perchlorate levels in 450 samples of various domestic and imported foods.  The first phase of the assignment called for collection and analysis of 240 food samples that include fresh fruits and vegetables, fruit juices, and grain products.  The second phase of the assignment called for collection and analysis of additional samples of fresh fruits and vegetables, fruit juices, and grain products and seafood. 

FDA also expanded application of methods for perchlorate analysis to additional high priority foods (e.g., grain products, fruit juices, fish fillets) requested for collection in the FDA 2005 perchlorate field assignments.

In FY2006, the agency is planning to analyze relevant foods collected for 4 market baskets of FDA's Total Diet Study.  In addition, FDA will perform exposure assessments on the data from its analyses.

Item

Glucose Monitoring- The Committee encourages the FDA to support a workshop to provide a forum for the developers of continuous glucose monitoring technologies to discuss ways in which promising continuous glucose monitoring technologies can be expeditiously reviewed. (Page 153)

Action Taken or To Be Taken

The Committee encourages the FDA to support a workshop to provide a forum for the developers of continuous glucose monitoring technologies to discuss ways in which promising continuous glucose monitoring technologies can be expeditiously reviewed. FDA, in conjunction with NIH and the Juvenile Diabetes Research Foundation held an open public workshop entitled "Obstacles and Opportunities on the Road to an Artificial Pancreas:  Closing the Loop" on December 19, 2005.  This program was attended by more then 100 participants from government, industry, academia and the consumer community.  Obstacles to development of new technologies for diabetes monitoring were discussed and suggestions made for how to deal with them. 

FDA has offered to review research proposals from JDRF to assist them in launching and managing a new research initiative in the area of non-invasive glucose testing.  In addition to this activity, FDA continues to work directly with medical device manufacturers to encourage development and help expedite new technologies to the marketplace. 

Item

Diabetes Product Characteristics - The Committee urges FDA to develop guidance, initiate collaborations, and promote consensus development activities to evaluate the utility and need for additional biomarkers and surrogate endpoints that will assist manufacturers' efforts to demonstrate efficacy of diabetes product characteristics with clinical outcomes, and where need exists, to aid in their development and validation. Where there is a demonstrated need, the Committee urges FDA to work with diabetes stakeholders to refine therapeutic endpoints.  (Page 153)

Action Taken or To Be Taken

The Committee urges FDA to work with diabetes stakeholders to refine therapeutic endpoints the agency is currently developing guidance for industry on demonstrating efficacy of diabetes products.  In addition to input from within the agency, we have received input from external special interest groups, including NIH and the Juvenile Diabetes Research Foundation International.  The document will be published for comment once it has completed the clearance process.  We are planning to publish the draft document sometime this year.

Item

HIV/AIDS Vaccines - The Committee recognizes the importance of ensuring that promising HIV/AIDS vaccines are tested in infants and youth as early as is medically and ethically appropriate. The Committee requests that the Commissioner of the Food and Drug Administration, in consultation with appropriate public and private entities, consider the logistical, regulatory, medical and ethical issues presented by pediatric testing of these vaccines so that children can share in the benefit of any advances in vaccine research. The Committee urges FDA to issue guidance not later than 6 months after the enactment of this Act on the minimum requirements for obtaining FDA approval to test an HIV vaccine in pediatric populations and the minimum requirements for obtaining FDA approval of a pediatric indication of an HIV vaccine.  (Page 153)

Action Taken or To Be Taken

The Committee urges FDA to issue guidance not later than 6 months after the enactment of this Act on the minimum requirements for obtaining FDA approval to test an HIV vaccine in pediatric populations and the minimum requirements for obtaining FDA approval of a pediatric indication of an HIV vaccine.  Vaccine development in the U.S. occurs in a stepwise fashion, starting with clinical studies in adults and then proceeding to children, as appropriate.  This development pathway has led to the licensure of numerous pediatric vaccines over the past decade, including new vaccines against whooping cough, chickenpox, hepatitis A, pneumococcus, influenza, and meningococcus.  The same development pathway applies to HIV vaccines.  The regulatory issues that relate to pediatric drug and biological product development are well outlined in the Pediatric Research Equity Act of 2003 (PREA).  PREA requires that the application for any new product must include an assessment of safety and effectiveness in pediatric patients except in a limited number of defined situations.  A draft FDA guidance document on the implementation of PREA was issued in September 2005.  This guidance document applies to both drugs and biologics (including vaccines).  Also, FDA has guidance on the Clinical Investigation of Medicinal Products in the Pediatric Population (ICH E11), which is intended to facilitate timely pediatric product development.

FDA is currently working to meet the timeline in the legislation to provide guidance for the development of pediatric HIV vaccines.  While the Agency recognizes the importance of developing HIV vaccines, the absence of an HIV-specific guidance document is not preventing clinical development of HIV vaccines for pediatric populations in the U.S.  Rather, the HIV virus has presented significant scientific challenges to vaccine development.  We are not aware of even preliminary evidence of efficacy for any preventive HIV vaccine in adults from any trial, in the U.S. or elsewhere.  Identifying promising HIV vaccine candidates (for any population) has been difficult, due to profound scientific impediments (lack of understanding of what aspect of the immune system will confer protection, etc.).

Item

Foodborne Illness - The Committee is pleased that the FDA, USDA, and CDC recently reported declines in foodborne infections due to common bacterial pathogens, including E. coli 0157, campylobacter, and salmonella infections. The Committee is aware of the effective work of the Partnership for Food Safety Education, in collaboration with these agencies, to provide information to the general public about simple, commonsense suggestions regarding safe food preparation and handling. Currently, the Partnership for Food Safety Education is working to develop a public education campaign aimed at populations vulnerable to listeria, including pregnant women and adults with weakened immune systems. The Committee believes this is a worthwhile effort, and encourages FDA to continue working with the Partnership for Food Safety Education in executing this education campaign. In addition, the Committee encourages the FDA to provide funding, as appropriate, to support this collaborative effort.  (Page 154)

Action Taken or To Be Taken

He Committee encourages FDA to continue working with the Partnership for Food Safety Education in executing this education campaign. As specified by the Memorandum of Understanding (MOU) between FDA and the Partnership for Food Safety Education (the Partnership), FDA continues to fulfill its coordination and programmatic participation and supply in-kind services and materials to promote food safety measures.  The Partnership has established three work groups to carry out its initiatives.  They are: public relations and web activities; program evaluation; and outreach.  

In FY 2006 FDA played an active role in the update of the Fight BAC!® Brochure which now includes more food safety information about FDA-regulated foods and participates in developing E-cards to its BAC Fighters list serve, a database of state, local and Federal health educators, food industry staff, teachers and consumer activists.  All 19 of the education projects conducted by FDA Public Affairs Specialists around the country emphasize the Partnership's four basic food safety messages and utilize Fight BAC!® materials extensively.  FDA's Reduce the Risk of Foodborne Listeria campaign and Food Safety for Moms-To-Be campaign strongly support the Partnership's Listeria prevention initiative. 

The Partnership has begun a review and renovation of its web site and FDA is playing an active role in this project which will be completed in 2006.  With FDA's participation the USDA's Food Safety and Inspection Service (FSIS) and the Partnership issued a statement on consumption of poultry & poultry products, addressing consumers' questions about whether there could be a danger of getting "bird flu" through consumption of poultry or eggs.

Item

Global Evaluation Scale - The Committee notes that there has been public criticism about the Global Evaluation Scale used in studies submitted to FDA to determine efficacy of acne products. The Committee has been assured that, to date, FDA has not adopted this scale, the matter has been presented to the Advisory Committee, and will be addressed in guidance developed with the benefit of public comment. The Committee urges FDA to complete this guidance development process prior to adopting this scale as a preferred method of evaluating acne products.  (Page 154)

Action Taken or To Be Taken

The Committee urges FDA to complete this guidance development process prior to adopting this scale as a preferred method of evaluating acne products.  On September 19, 2005, CDER published Draft Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment.  This guidance can be accessed at http://www.fda.gov/cder/guidance/6499dft.htm to facilitate additional public input before any final guidance document is issued. 

A number of comments on the draft guidance were submitted to the public docket.  We are in the process of reviewing these comments and modifying the Draft Guidance for Industry, including re-evaluating the assessment scales for acne.  The Agency will fully consider all comments received on the draft guidance before developing and publishing a final guidance.

Item

Collaborative Drug Safety Research - The Committee commends FDA for its work in developing the Critical Path Initiative to foster collaboration with outside researchers and develop new tools to both promote drug safety and accelerate the development of innovative new therapies. The Committee further commends the C-Path Institute, founded by the University of Arizona, for its innovative research efforts to develop more efficient tools for medical product development and drug safety. For this important effort, the Committee provides $750,000, to support collaborative research with the C-Path Institute and the University of Utah on cardiovascular biomarkers predictive of safety and clinical outcomes. This research would help address the critical public health threat of heart failure which affects over 5 million Americans, with over 250,000 dying annually from this condition. The Committee understands the research would involve identifying candidate genes and proteins in University of Utah databases, designing and conducting genomic and proteomic biomarker validation experiments by the C-Path Institute, the University of Utah, FDA and manufacturers, determining which biomarkers identify heart failure patients who are most likely to respond favorably to drug therapy and those at highest risk of adverse events. The Committee expects that this research will enhance patient safety, reduce the number of patients necessary for clinical testing, and enable manufacturers to accelerate drug development and bring safer, innovative life-saving drugs to market more quickly.  (Page 154)

Action Taken or To Be Taken

The Committee provides $750,000, to support collaborative research with the C-Path Institute and the University of Utah on cardiovascular biomarkers predictive of safety and clinical outcomes.  In FY 2006, FDA will spend an $742,500 to support collaborative research with the C-Path Institute and the University of Utah on cardiovascular biomarkers predictive of safety and clinical outcomes.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $750,000 specified in the Congressional report.  The FDA has initiated discussions with the C-Path Institute and the University of Utah to clarify the terms of this collaborative research (e.g., defining the roles and responsibilities of each participant), including use of the University of Utah databases to identify candidate cardiovascular safety biomarkers, collaborative design of validation research, and conduct of that research.  FDA is also in the process of identifying the appropriate contracting vehicle or vehicles for execution of the collaboration.

Item

Ocular Health - The Committee has included a general provision to promote the ocular health of contact lens wearers by barring the use of funds to facilitate a practice 32 State Attorneys General alleged to be illegal and detrimental to patient health.

The FDA has recognized the importance of timely replacement of contact lenses, advising consumers to comply with the wearing schedules established by their eye care providers. Federal and State regulators have reported that as contact lenses become less expensive and more convenient to replace, consumers will replace them more frequently, leading to increased patient safety, including decreases in eye infections and inflammation.  In the 1990s, 32 State Attorneys General, citing these health benefits, sued to stop major contact lens manufacturers from engaging in the practice of limiting distribution of their lenses to eye care providers. Since contact lens prescriptions are branded, with no substitutions allowed, this practice was designed to increase prices and limit consumers' options for obtaining replacement lenses. A consent decree was reached between the parties involved.   The provision effectively codifies the consent decrees reached with the Attorneys General.  (Page 155)

Action Taken or To Be Taken

The Committee has included a general provision to promote the ocular health of contact lens wearers by barring the use of funds to facilitate a practice 32 State Attorneys General alleged to be illegal and detrimental to patient health.  It is within FDA's mission to assure that medical devices, including contact lenses, meet the statutory requirements for safety and effectiveness.  It is not within FDA's mission to prevent medical device manufacturers from engaging in anticompetitive practices that have no relation to health or safety.  Reining in anticompetitive practices is ordinarily the responsibility of the FTC and the Department of Justice.  FDA believes it is not in the best interest of public health and safety to divert it from its mission.

FDA does not believe that it has the expertise or the resources to determine whether contact lens manufacturers are marketing their lenses in a "non-discriminatory" manner.  If a manufacturer were to sign a statement certifying that it makes its lenses available in a "non-discriminatory" manner, FDA could not confirm the truth of such a statement without diverting its limited enforcement resources to examining contact lens sales practices.  FDA's enforcement professionals are not trained for, and FDA believes they should not be required to investigate anti-competitive marketing.

Item

Authorized Generics - The Committee is aware that amendments to the Hatch-Waxman Act (Public Law 98-417) provided 180 day marketing exclusivity to a generic drug that successfully challenges the patent of a name brand pharmaceutical company, and that the purpose of this exclusivity was to provide incentives to bring lower cost generic drugs to the market as quickly as possible. Recently, the Committee has been informed that `authorized' generics are entering the market at the same time as generic drugs, and is concerned that this practice may have the ultimate effect of decreasing the number of generic drugs that enter the market, keeping prices ultimately higher for the consumer. Therefore, the Committee strongly encourages FDA to work to ensure that incentives for generic drugs, which are currently written into law, are protected, and that consumers continue to have access to safe, effective generic drugs at the earliest possible time.  (Page 155)

Action Taken or To Be Taken

The Committee strongly encourages FDA to work to ensure that incentives for generic drugs, which are currently written into law, are protected, and that consumers continue to have access to safe, effective generic drugs at the earliest possible time.  Please be assured that FDA continues to work to ensure that incentives for generic drugs, which are currently written into law, are protected, and that consumers continue to have access to safe, effective generic drugs at the earliest possible time.

FDA stated in a July 2, 2004 response to two citizen petitions submitted by Teva Pharmaceuticals (the world's largest generic drug manufacturer) and Mylan Pharmaceuticals (another of the largest generics), that the Agency does not have the legal authority to prohibit or delay the marketing of authorized generics during the 180-day exclusivity period.  In June 2005 in a suit brought by Teva, the DC Circuit confirmed FDA's reading of the statute.  Teva Pharmaceutical Industries Ltd. v. Crawford, 410 F.3d 51 (D.C. Cir. 2005).  A federal district court for West Virginia has also confirmed FDA's reading.  Mylan Pharms. Inc. v. FDA, No.  1:04cv00242-IMK, 2005 WL 2411674, (N.D. W.Va. Sept. 29, 2005).  That decision is currently on appeal to the Fourth Circuit. 

Discussion of authorized generics has focused on the competitive effects of their being marketed during the 180-day exclusivity period.  This exclusivity period can be awarded to the first applicants seeking approval under an abbreviated new drug application, ANDA, that challenge (as invalid or not infringed by their products) a patent claiming the approved drug they wish to copy.  ANDA applicants that challenge a patent can sometimes obtain approval to market their products before the patent expires, and if those applicants are also eligible for 180-day exclusivity, they can sometimes market their products for six months before other ANDA applicants can have their applications approved.

The prospect of 180-day exclusivity provides an extra incentive (in addition to that of possibly being able to enter the market before a patent expires) for generic drug manufacturers to challenge patents.  Marketing of authorized generics during a 180-day exclusivity period could increase competition, reducing the value of this incentive.  FDA recognizes that there is concern that potentially reducing the value of 180-day exclusivity might have a "chilling" effect on generics challenging drug patents (and thereby exposing themselves to patent infringement litigation risk).  FDA further recognizes that there is concern that authorized generics might slow the rate at which generic versions of drugs come to market. 

Item

Influenza - Most experts estimate that there will be a lag time of 6 to 9 months before a vaccine can be produced in sufficient quantities to protect individuals against a pandemic strain of influenza to which most people will have no natural immunity. While issues around vaccine manufacturing, distribution, safety and access are complex; the United States and other nations are putting protocols in place now with respect to creating a rapid-response approval process for a pandemic flu vaccine. The Committee understands that FDA's Center for Biologics Evaluation and Research is engaging potential manufacturers of influenza vaccines and that FDA is writing a guidance document for the clinical development of new influenza vaccines, including pandemic influenza vaccines. The Committee encourages the Food and Drug Administration's Center for Biologics Evaluation and Research to continue its efforts in working with potential influenza vaccine manufacturers to facilitate the development of influenza vaccines for a pandemic. (Page 156)

Action Taken or to be Taken

The Committee encourages the Food and Drug Administration's Center for Biologics Evaluation and Research to continue its efforts in working with potential influenza vaccine manufacturers to facilitate the development of influenza vaccines for a pandemic. The FDA are actively engaged with sponsors and manufacturers interested in developing new technologies for influenza vaccine manufacture, including antigen sparing vaccines using both alum and novel adjuvants (a nonspecific simulator of immune response), as well as cell-culture based and recombinant (combining DNA from two or more sources) vaccines. The Agency has extensive experience in overseeing the development and licensure of cell-culture based and recombinant vaccines including those for prevention of other infectious diseases, such as chicken pox, polio, rubella, and hepatitis A and B.  In November 2005, FDA convened the Vaccines and Related Biological Products Advisory Committee to discuss the use of Madin Darby Canine Kidney cell cultures, including those that are highly tumorigenic, in the manufacture of inactivated influenza vaccines.

FDA scientists work with manufacturers throughout the year to collect information on the capability of new influenza viruses to be used for large-scale production of influenza virus vaccines.  FDA has initiated annual inspections of licensed influenza manufacturers, which may eliminate the need for additional inspections in an emergent circumstance.  FDA is working with NIAID and manufacturers to determine what additional studies are needed pertaining to influenza virus subtypes with pandemic potential. 

CONFERENCE REPORT (House Report 109-255) - MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT,
FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES PROGRAMS FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2006, AND FOR OTHER PURPOSES -Significant Items

Item

Direct-To-Consumer Advertising -  The conference agreement provides $884,000 for activities related to direct-to-consumer advertising.

Action Taken or To Be Taken

The conference agreement provides $884,000 for activities related to direct-to-consumer advertising.  In FY 2006, FDA will spend an additional $875,160 for the review of direct-to-consumer drug ads.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $884,000 specified in the Congressional report.  We promote and protect the health of Americans by influencing drug companies directly and indirectly so that they ensure their drug advertisements and other promotional materials are truthful and balanced. We operate a comprehensive program of education, surveillance and enforcement about drug advertising and promotion.  FDA appreciates the Committee's recognition of the need for additional resources to regulate direct-to-consumer advertising.  These additional resources will bolster our existing review staff in the Division of Drug Marketing, Advertising, and Communication (DDMAC) who are responsible for monitoring and evaluating promotional materials. (Page 100)

Item

New Mexico State University - The Conference Agreement provides an increase of $200,000 for agricultural product testing at the Physical Science Laboratory at New Mexico State University. (Page 100)

Action Taken or To Be Taken

The Conference Agreement provides an increase of $200,000 for agricultural product testing at the Physical Science Laboratory at New Mexico State University.  FDA will spend $2,358,972 in a contract for New Mexico State University's Physical Sciences Laboratory to operate the Food Technology Evaluation Laboratory.  Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $2,332,800 specified in the Congressional report.  Under contract to FDA, New Mexico State University (NMSU) Physical Science Laboratory has provided method assessment, development and validation data for targeted commodities identified as high profile/high risk for implementation into national food safety and food defense programs.

Item

Orphan Product grants - The conference agreement provides $14,696,000 for Orphan Product grants. (Page 100)

Action Taken or To Be Taken

The conference agreement provides $14,696,000 for Orphan Product grants.

FDA will spend $14,549,000 for Orphan Product Grants.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $14,696,000 specified in the Conference Language.

Item

Office of Women's Health - The conference agreement provides not less than $4,000,000 for the Office of Women's Health. (Page 100)

Action Taken or To Be Taken

The conference agreement provides not less than $4,000,000 for the Office of Women's Health. FDA will spend $3,960,000 for the Office of Women's Health.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $4,000,000 specified in the Congressional report.

Item

Generic Drugs -The conference agreement provides not less than $56,228,000 for the generic drug program.  (Page 100)

Action Taken or To Be Taken

Generic Drugs -The conference agreement provides not less than $56,228,000 for the generic drug program. FDA has made significant progress in recent years in expediting the review of generic drug applications and will strive to maintain that progress.  FDA will include base funding includes not less than $55,666,000 in funding for the Generic Drugs Program. The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $56,228,000 specified in the Congressional report.

Item

Bovine Spongiform Encephalopathy - The conference agreement provides no less than $29,556,000 for Bovine Spongiform Encephalopathy (BSE), as requested. The conferees understand that this funding will support agency-wide BSE activities including conducting yearly inspections of all renderers and feed mills processing products containing prohibited materials, extending BSE inspections into targeted segments of industries subject to the BSE Feed regulation, validating test methods for the detection of bovine-derived proteins in animal feed, and continuing to conduct research on Transmissible Spongiform Encephalopathies in FDA's product centers.  (Page 100)

Action Taken or To Be Taken

The conference agreement provides no less than $29,556,000 for Bovine Spongiform Encephalopathy (BSE), as requested. In FY 2006, FDA will devote no less than $29,260,000 BSE prevention activities, primarily to continue enforcement of the 1997 feed ban.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $29,566,000 specified in the Congressional report.  This funding will support agency-wide BSE activities including conducting inspections of renderers and feed mills processing products containing prohibited materials, extending BSE inspections into targeted segments of industries subject to the BSE Feed regulation, validating test methods for the detection of bovine-derived proteins in animal feed, and continuing to conduct research on Transmissible Spongiform Encephalopathies in FDA's product centers.  

Item

Chloramphenicol - The conferees have serious concerns regarding seafood safety issues posed by banned antibiotic contamination in farm-raised shrimp imports. In addition, the conferees are concerned that the FDA inspects less than 2 percent of shrimp being imported into the United States. The conferees recommend that the FDA, in cooperation with any state testing programs, continue testing of farm-raised shrimp imports for chloramphenicol and other related harmful antibiotics.  (Page 101)

Action Taken or To Be Taken

The conferees recommend that the FDA, in cooperation with any state testing programs, continue testing of farm-raised shrimp imports for chloramphenicol and other related harmful antibiotics.  FDA will continue to work in cooperation with the states in evaluating farm-raised shrimp imports for chloramphenicol and other related harmful antibiotics.

Item

CFSAN Adverse Events Reporting System - The conference agreement includes total funding of $5,360,000 for the CFSAN Adverse Events Reporting System, of which approximately $1,500,000 is for dietary supplements. This is $860,000 more than the amount in the budget request.

Action Taken or To Be Taken

The conference agreement includes total funding of $5,360,000 for the CFSAN Adverse Events Reporting System.  FDA will include base funding includes not less than $5,306,400 in funding for the CFSAN Adverse Events Reporting System. The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $5,360,000 specified in the Congressional report.

Item

NARMS - The conferees support the work of the National Antimicrobial Resistance Monitoring System (NARMS) and its collaborative relationship between FDA, USDA, and the Centers for Disease Control. The conferees expect 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, and encourage FDA to equally divide research funding among the three branches of the program. Further, the conferees direct that FDA perform a review of all components of the NARMS program to analyze the program's scientific soundness and relevance to public health, the criteria utilized to evaluate the program, the transparency of the program, opportunities for public input, and report the result to the Committees.  (Page 101)

Action Taken or To Be Taken

The conferees expect 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, and encourage FDA to equally divide research funding among the three branches of the program. Further, the conferees direct that FDA perform a review of all components of the NARMS program to analyze the program's scientific soundness and relevance to public health, the criteria utilized to evaluate the program, the transparency of the program, opportunities for public input, and report the result to the Committees.  FDA strongly supports NARMS and all its components. FDA believes that all three arms are integral to the success of the NARMS program and to achieve the benefits envisioned at its inception and agreed upon by all three agencies.  FDA has funded NARMS since it was conceived in 1996 and is committed to the continued funding of this program to the extent possible without compromising other core programs.

FDA met with a panel of outside experts for an external review of all three arms of the NARMS program in order to review key elements and establish future directions.  FDA has begun implementation of several of these recommendations.  The NARMS program is also being currently appraised by the FDA Science Board Peer Review. 

FDA will continue efforts to maximize cooperation and communication between FDA, USDA, and CDC and strengthen data reporting to increase efficient use of resources.  FDA is in the process of preparing a conference report to Congress on the NARMS program.

Item

National Center for Natural Products Research - The conference agreement provides an increase of $300,000 to enhance the collaboration between FDA and the National Center for Natural Products Research and allow increased participation by FDA staff in the research on botanicals and dietary supplements being conducted at the National Center for Natural Products Research in Oxford, MS. (Page 101)

Action Taken or To Be Taken

The conference agreement provides an increase of $300,000 to enhance the collaboration between FDA and the National Center for Natural Products Research and allow increased participation by FDA staff in the research on botanicals and dietary supplements being conducted at the National Center for Natural Products Research in Oxford, MS.  FDA will spend $3,243,240 for research at the National Center for Natural Products Research in Oxford, MS, which is an increase of $300,000 over the FY 2005 level of $2,976,000.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $3,276,000 specified in the Conference Language.

Item

Imports of Ethnic Foods -The conferees are aware of concerns about the regulation of imports of ethnic foods in the Los Angeles district. Concerns include the issues of communication to importers about shipments being held by FDA, the amount of time that shipments are held, and proper declaration of products. The conferees understand that in 2004 FDA's Los Angeles District implemented new operating procedures and held a public meeting on these issues. Since two years have elapsed, the conferees suggest that FDA now review the performance of the program and solicit input from the import community.  (Page 102)

Action Taken or To Be Taken

The conferees suggest that FDA now review the performance of the program and solicit input from the import community.  In 2004 FDA's Los Angeles District implemented new operating procedures and held a public meeting on shipments being held by FDA, the amount of time that shipments are held, and proper declaration of products. FDA will review the performance of the program and solicit further input from the import community on how imported food is handled by FDA.

Item

Abuse-Resistant Drugs - The conferees note that FDA may use available funds to support review and action on new drug applications and supplements seeking approval for replacement or alternative abuse-resistant formulations of currently-available drug products that include an active ingredient that is a listed chemical under the Controlled Substances Act. Further, it is the understanding of the conferees that these applications may be considered under the expedited, priority review process at FDA. (Page 102)

Action Taken or To Be Taken

The conferees note that FDA may use available funds to support review and action on new drug applications and supplements seeking approval for replacement or alternative abuse-resistant formulations of currently-available drug products that include an active ingredient that is a listed chemical under the Controlled Substances Act.  Drugs that are less prone to abuse would not generally meet the criteria for an expedited, priority review.  Products regulated by CDER are eligible for priority review if they provide a significant improvement compared to marketed products in the treatment, diagnosis, or prevention of a disease.   Products that are modified or reformulated to be "abuse-resistant" are considered, by regulations, to be the same active pharmaceutical ingredients as the original approved products, and therefore do not meet the criteria for expedited review, because for the intended population, they do not offer a significant improvement compared to the originally marketed product. 

However, if CDER received a new drug application for a product for which there is reasonable evidence or scientific basis to conclude it would be safer and have a lower abuse potential in people other than the intended population, compared to an already marketed product, we would work with the company to achieve an expedited action.

Item

Sunscreen Monographs- The conferees are aware that the FDA issued a monograph for sunscreen products in 2002, and the monograph was stayed shortly thereafter so that FDA could address the issue of measuring protection against UVA rays, which cause skin cancer. Since that time, no further official action has been taken by the FDA, although skin cancer rates continue to rise, especially among young persons and women. The conferees believe that a comprehensive monograph would be useful to consumers. Therefore, the conferees direct FDA to issue a comprehensive final monograph for over-the-counter sunscreen products, including UVA and UVB labeling requirements, within six months of enactment of this Act.  (Page 102)

Action Taken or To Be Taken

The conferees direct FDA to issue a comprehensive final monograph for over-the-counter sunscreen products, including UVA and UVB labeling requirements.   FDA concurs with the conferees that a comprehensive monograph will be very useful to consumers.  We are in the process of developing a comprehensive monograph for over-the-counter sunscreen products, including UVA and UVB labeling requirements, and expect to have the proposed rule for a monograph published soon.  FDA will then address comments we receive on the proposed rule in an effort to publish the final rule.

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Commissioner's Testimony - The conferees do not include language in the House bill that withheld five percent of the funds provided to FDA's central offices pending a public hearing with the agency head on the fiscal year 2006 budget, because this requirement was satisfied by former Commissioner Crawford's testimony before the House subcommittee in July. However, the conferees expect the head of the agency to testify before the House and Senate subcommittees on the fiscal year 2007 budget during the regular course of budget hearings.  (Page 102)

Action Taken or To Be Taken

The conferees expect the head of the agency to testify before the House and Senate subcommittees on the fiscal year 2007 budget during the regular course of budget hearings. FDA plans to have the Acting Commissioner present the budget request to the House Appropriations Subcommittee at the hearing scheduled for February 16, 2006. 

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Budget Structure - The conferees appreciate the detailed information provided in the budget justification prepared by the Food and Drug Administration and rely heavily on this information when considering budget proposals. These materials have traditionally been prepared for the sole use of the Committees on Appropriations in a format consistent with the structure of the Appropriations Act. The account organization in the fiscal year 2006 budget request does not present information in a format that is useful to the Committees. Therefore, the conferees do not approve the proposed restructuring of FDA's budget for the field activities, rent activities, and other activities accounts. The conferees direct the Agency to submit the fiscal year 2007 budget request in a format that follows the same account structure as the fiscal year 2005 budget request unless otherwise approved by the Committees.  (Page 102)

Action Taken or To Be Taken

The conferees do not approve the proposed restructuring of FDA's budget for the field activities, rent activities, and other activities accounts. The conferees direct the Agency to submit the fiscal year 2007 budget request in a format that follows the same account structure as the fiscal year 2005 budget.   FDA has presented the FY 2007 President's Budget in a format that follows the same account structure as the FY 2005 budget.

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Consolidations -- The conferees direct the Department of Health and Human Services (HHS) to include all anticipated consolidations that impact FDA in the FDA budget request submitted to Congress. Further, the conferees direct that none of the funds made available to FDA in this Act be used for any assessments, fee, or charges by HHS unless such assessments, fees, or charges are identified in the FDA budget justification and expressly provided by Congress, or approved by Congress in the official reprogramming process as required in the General Provisions of this Act. The conferees further direct HHS to include in the fiscal year 2007 budget submission all sources of funding projected to be received by FDA from all other federal agencies in fiscal years 2006 and 2007, by agency, with a brief description of the reason for which the funds are to be provided to FDA.  (Page 103)

Action Taken or To Be Taken

The conferees direct the Department of Health and Human Services (HHS) to include all anticipated consolidations that impact FDA in the FDA budget request submitted to Congress. FDA has included a table and exhibit in this document, the Congressional Justification, entitled "DHHS Charges and Assessments."  This table and exhibit list the actual and estimated fees or charges from DHHS.  We have also included an exhibit on "Funding from Outside Sources."

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Research, Development and Evaluation -  In its fiscal year 2006 budget, FDA requested $146,213,000 for `research, development and evaluation' (RD&E) activities. This amounts to about 10 percent of the agency's discretionary request. FDA provided only general descriptions of its planned RD&E activities within the context of its strategic plan, without specifying the dollars requested, and provided only total proposed expenditures for each `research theme.' The conferees direct FDA to provide the same level of budget justification for its research activities in the fiscal year 2007 budget as it does other activities, including a justification of both base spending and any proposed increases by activity within center or office.  (Page 103)

Action Taken or To Be Taken

The conferees direct FDA to provide the same level of budget justification for its research activities in the fiscal year 2007 budget as it does other activities, including a justification of both base spending and any proposed increases by activity within center or office.  FDA has included information on research and development in our program resource change, justification of base and accomplishment sections of the program narratives. 

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The conference agreement provides $750,000 to support collaborative research with the C-Path Institute and the University of Utah on cardiovascular biomarkers predictive of safety and clinical outcomes. The conferees understand the research would involve identifying candidate genes and proteins in University of Utah databases, designing and conducting genomic and proteomic biomarker validation experiments by the C-Path Institute, the University of Utah, FDA and manufacturers, determining which biomarkers identify heart failure patients who are most likely to respond favorably to drug therapy and those at highest risk of adverse events.

Action Taken or To Be Taken

The conference agreement provides $750,000 to support collaborative research with the C-Path Institute and the University of Utah on cardiovascular biomarkers predictive of safety and clinical outcomes.  In FY 2006, FDA will spend an $742,500 to support collaborative research with the C-Path Institute and the University of Utah on cardiovascular biomarkers predictive of safety and clinical outcomes.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $750,000 specified in the Congressional report.  The FDA has initiated discussions with the C-Path Institute and the University of Utah to clarify the terms of this collaborative research (e.g., defining the roles and responsibilities of each participant), including use of the University of Utah databases to identify candidate cardiovascular safety biomarkers, collaborative design of validation research, and conduct of that research.  FDA is also in the process of identifying the appropriate contracting vehicle or vehicles for execution of the collaboration.

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The conferees remain concerned about the legal and regulatory issues relating to approval of drugs as both prescription and over the counter products, and urge FDA to expedite rulemaking on this topic.

Action Taken or To Be Taken

The conferees have expressed concern about legal and regulatory issues relating to the approval of drugs as prescription and over the counter products.  FDA is evaluating these issues and the need for rulemaking, where necessary.

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St. Louis - SEC. 730. 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.

Action Taken or To Be Taken

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.

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SEC. 795. (a) Subject to subsection (b), none of the funds made available in this Act may be used to-- (1) grant a waiver of a financial conflict of interest requirement pursuant to Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)(4)) for any voting member of an advisory committee or panel of the Food and Drug Administration; or (2) make a certification under section 208(b)(3) of title 18, United States Code, for any such voting member.

(b) Subsection (a) shall not apply to a waiver or certification if-- (1) not later than 15 days prior to a meeting of an advisory committee or panel to which such waiver or certification applies, the Secretary of Health and Human Services discloses on the Internet website of the Food and Drug Administration-- (A) the nature of the conflict of interest at issue; and (B) the nature and basis of such waiver or certification (other than information exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act)); or (2) in the case of a conflict of interest that becomes known to the Secretary less than 15 days prior to a meeting to which such waiver or certification applies, the Secretary shall make such public disclosure as soon as possible thereafter, but in no event later than the date of such meeting.

(c) None of the funds made available in this Act may be used to make a new appointment to an advisory committee or panel of the Food and Drug Administration unless the Commissioner of Food and Drugs submits a quarterly report to the Inspector General of the Department of Health and Human Services and the Committees on Appropriations of the House and Senate on the efforts made to identify qualified persons for such appointment with minimal or no potential conflicts of interest.

Action Taken or To Be Taken

The Committee directs that not later than 15 days prior to a meeting of an advisory committee or panel to which such waiver or certification applies, the Secretary of Health and Human Services discloses on the Internet website of the Food and Drug Administration.  This information can be found at the following FDA website.  http://www.fda.gov/ohrms/dockets/ac/06acdocs.htm  The total number of waivers posted from November to December 31, 2005 is 32.  

The Committee directs that none of the funds made available in this Act may be used to make a new appointment to an advisory committee or panel of the Food and Drug Administration unless the Commissioner of Food and Drugs submits a quarterly report to the Inspector General of the Department of Health and Human Services and the Committees on Appropriations of the House and Senate on the efforts made to identify qualified persons for such appointment with minimal or no potential conflicts of interest.

FDA will submit the required quarterly reports to the Inspector General of the Department of Health and Human Services and the Committees on Appropriations of the House and Senate on the efforts made to identify qualified persons for such appointment with minimal or no potential conflicts of interest.

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Buildings and Facilities - The conference agreement provides $8,000,000 for the Food and Drug Administration Buildings and Facilities instead of $5,000,000 as proposed by the House and $7,000,000 as proposed by the Senate. Of the total, $4,000,000 is for the repair and improvement of existing buildings and facilities, and $4,000,000 is to complete the final phase of the Arkansas Regional Laboratory.

Action taken or to be taken

The conference agreement provides $8,000,000 for the Food and Drug Administration Buildings and Facilities.   FDA will spend $3,960,000 for repair and improvement of existing buildings and facilities nation-wide.  The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $4,000,000 specified in the Congressional report.  FDA will spend $3,960,000 for the final phase of Building 50 of the Arkansas

Regional Laboratory.  Funds will be utilized to develop the program, design and complete the fit-out of the remaining floors.  This will complete the Arkansas Regional Laboratory Facility project. The Congressional directive in Public Law 109-148 applied a 1 percent rescission to the $4,000,000 specified in the Congressional report.

 

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