Omnibus Conference Report 105-825
Item
"The conference agreement includes an increase of $2,500,000 for the Office of Cosmetics and Colors. . ."
Action to be taken
FDA is the focal point for cosmetic safety in the U.S. FDA will allocate the additional $2,500,000 to the Cosmetics Program to fund activities to ensure that cosmetics are safe and properly labeled. These activities include: public health/safety issues, policy development, consumer and industry assistance, research, compliance/regulatory activities, and international harmonization.
Item
"The conference agreement includes an increase of. . .$500,000 to begin development of a new approval process for food packaging materials. . ."
Action to be taken
FDA will use the $500,000 to begin development of the Premarket Notification Program (PMN) for Food Contact Substances. The PMN program established under the Food and Drug Administration Modernization Act of 1997 (FDAMA) requires FDA to object to a notification within 120 days or the food contact substance may be legally marketed. To effectively implemented the program, the Agency plans to:
Item
"The conference agreement includes an increase of. . .$250,000 for the Office of Seafood Inspection. Within the amount for the Office of Seafood Inspection $200,000 is for a grant to the Interstate Shellfish Sanitation Commission."
Action to be taken
FDA will use the $250,000 for to establish equivalency agreements in the area of imported seafood. The Agency has so far received requests from thirty foreign countries to determine whether their food safety systems for seafood match or exceed U.S. standards. Such evaluations require laborious reviews of key components of their systems, such as laboratory reviews and comparisons of food additives in seafood. Funds will be devoted towards hiring three full-time equivalents and expenses related to foreign site visits. FDA's involvement in seafood equivalency agreements is yet another example of the Agency's determination to ensure the American public of safer imported foods.
FDA will also provide $200,000 to continue funding a high priority cooperative program with the Interstate Shellfish Sanitation Conference (ISSC). One important aspect of that cooperative program will be to conduct an economic assessment of post-harvest treatment of shellfish aimed at reducing the risk of illness associated with naturally occurring bacteria, such as Vibrio vulnificus, to consumers with pre-existing medical conditions such as liver disease. The ISSC also matches funds or offers grants to states, universities, or industry involved in programs to improve the safety of molluscan shellfish for human consumption. These activities will enhance the efforts of FDA to ensure the safety of molluscan shellfish moving in interstate commerce. The $200,000 may also fund other important cooperative efforts relating to health hazards and other problems associated with shellfish, as well as effective program management. These activities are done in conjunction with the National Food Safety Initiative.
Item
"The conference agreement includes an increase of $25,000,000 for the Food Safety Initiative. The FDA should use $24,500,000 for increased food inspection and $500,000 for research at NCTR."
Action to be taken
This funding will continue progress made under the Food Safety Initiative. The $24,500,000 will be used for high-priority inspection activities, such as border surveillance, overseas evaluations of foreign food processing systems, and Hazard Analysis Critical Control Point (HACCP). The $500,000 will be used for the research that is critical to help target inspection resources to the most needed areas.
Item
"The conferees note that the Food and Drug Administration will soon consider a citizen petition requesting approval of disjunctive labeling for surimi. The conferees strongly urge the agency to act in an expeditious manner to propose a rule in response to the petition, but in no case shall the FDA propose such a rule later than six months after the receipt of the citizen petition, nor shall the agency finalize such a rule later than twelve months after the receipt of the citizen petition."
Action to be taken
FDA will seek to issue a proposed rule within the prescribed time frames in response to the manufacturer's petition received in October 1998 for the disjunctive labeling of surimi.
Item
"The conference agreement includes language proposed by the Senate (Section 755) that amends the Agricultural Marketing Act of 1976 regarding shipment of shell eggs and mandates a report on egg safety and repackaging." [SEC. 755. (a) Section 203(h) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1622(h)) is amended by adding at the end the following: "Shell eggs packed under the voluntary grading program of the Department of Agriculture shall not have been shipped for sale previous to being packed under the program, as determined under a regulation promulgated by the Secretary.". (b) Not later than 90 days after the date of enactment of this Act, the Secretary of Agriculture, and the Secretary of Health and Human Services, shall submit a joint status report to the Committees on Appropriations of the House of Representatives and the Senate that describes actions taken by the Secretary of Agriculture and the Secretary of Health and Human Services-- (1) to enhance the safety of shell eggs and egg products; (2) to prohibit the grading, under the voluntary grading program of the Department of Agriculture, of shell eggs previously shipped for sale; and (3) to assess the feasibility and desirability of applying to all shell eggs the prohibition on repackaging to enhance food safety, consumer information, and consumer awareness.]
Action to be taken
FDA and the Department of Health and Human Services (DHHS) is working with USDA in producing a report on egg safety and packaging. The report outlines the particular responsibilities of each Department and those interagency responsibilities that manifest a national policy for the safety of eggs and egg products. This report highlights past, future, and planned developments within the key components of a coordinated policy for egg safety: regulatory/enforcement; guidance; research; educational activities; and public meetings.
Item
"The conferees direct the General Accounting Office (GAO) to conduct a comprehensive study on the potential effects of mandatory country of origin labeling of fresh produce. This report should assess the impact of such mandatory labeling requirements on importers, producers, consumers, and retailers, including a cost/benefit analysis. The report should identify U.S. trading-partner countries which currently have country of origin practices in place, the nature and scope of such practices, and a record of U.S. challenges to those requirements. The GAO report should also address the ability of the Federal government and the public to respond to warnings about the outbreak of food-borne illness arising from imported produce. The final report should be submitted to the Congress no later than six months after the enactment of this Act."
Action to be taken
FDA is assisting the General Accounting Office (GAO) in providing them information on foodborne illness related to imported produce. GAO held an Entrance Conference with FDA on December 11, 1998 and the two agencies determined what support FDA would provide to GAO in producing the report.
Item
"The conferees direct the USDA to consult with the Food and Drug Administration regarding food safety research objectives of that agency and recommend that $5,000,000 of the funds provided for the food safety component of the National Research Initiative be used to meet those needs.
Action to be taken
FDA has provided USDA with the most important research needs, specifically those efforts to develop and implement scientifically sound food safety policies for the foods under FDA's jurisdiction. FDA also highlighted corresponding research areas where USDA is currently active and identified areas where USDA could incorporate FDA-related activities into their plans such as those related to pre-harvest research. This coordination is part of a three-year research plan developed by both FDA and USDA in FY 1998 that concentrates on the highest priorities within food safety research and on eliminating duplicative efforts.
Item
"CENTERS FOR DISEASE CONTROL AND PREVENTION...Disease Control, Research, and Training...Between 1985 and 1991, 82 percent of Salmonella outbreaks were traced to contaminated shell eggs. It is understood that a new pasteurization technology has been developed employing heat and water which achieves the established FDA standards for the destruction of all strains of Salmonella commonly found in shell eggs. The technology preserves egg quality during extended refrigerated storage without materially changing either the aesthetics or the physical characteristics from those of a fresh raw egg. CDC is urged to work with other Federal agencies to assess various methods to improve egg safety."
Action to be taken
FDA and CDC maintain a constant dialogue with regard to foodborne disease, especially when illnesses are related to Salmonella outbreaks. Some of FDA's core functions assist CDC in assessing the methods to improving egg safety. One such means is through FDA's development of egg risk assessments to understand the scientific interaction between pathogens and eggs, and susceptibility to such hazards by certain populations. Another form of assistance to CDC is through the development of policies, procedures, and/or regulations related to the production of eggs. Lastly, the Agency provides CDC with feedback on egg safety methods by way of inspections for tracebacks. These combined efforts assist CDC in assessing the strengths and weaknesses in the current methods used to produce safer eggs.
Item
"The conference agreement includes an increase of. . .$1,000,000 for the Office of Generic Drugs. . ."
Action to be taken
The Office of Generic Drugs will use the $1,000,000 appropriated in 1999 to fund FTE and Information Technology (IT) infrastructure.
Item
"The conferees expect the FDA to publish a proposed rule concerning the use of foreign marketing data in the review of new sunscreen active ingredients in the sunscreen over-the-counter drug monograph. The conferees expect the proposed rule will be published not later than June 1, 1999."
Action to be taken
The proposed over the counter (OTC) sunscreen monograph and proposed rule for use of foreign marketing data for OTC monographs are being handled as separate rulemakings. The proposed rule for use of foreign marketing data will cover all OTC drugs. The OTC Sunscreen Final Monograph does not incorporate ingredients which were marketed only in foreign countries. FDA expects to publish the Sunscreen Final Rule by May 21, 1999 as mandated by FDAMA.
The proposed rule on the use of foreign marketing data would permit additional conditions to be considered under the OTC drug review (i.e., monographs). FDA plans to publish this proposed rule by June 1, 1999.
Item
"Included within the amount appropriated is $700,000 for the Clinical Pharmacology program. The conferees expect these funds to be used for competitive grants."
Action to be taken
Among the four previously-competed grantees in this program (University of Illinois at Peoria, Meharry Medical College, State University of New York at Binghamton, and the Mayo Clinic), the FDA will make available $500,000 to continue the operation of these programs throughout Fiscal Year 1999.
Item
"The conferees note that recent court decisions (Mova Pharmaceutical Corp. v. Shalala, 104 F.3d 1061 (D.C. Cir. 1998); Granutec, Inc. v. Shalala, No. 97-1873 and No. 97-1874, 1998 U.S. App. LEXIS 6685 (4th Cir. Apr 3, 1998)) have invalidated an element of the Food and Drug Administration's regulations regarding the 180-day exclusivity period for first applicants under section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act. The conferees strongly urge the FDA to use the funds provided to issue new regulations and guidance for industry to fulfill the intent of the Generic Drug Act (Waxman/Hatch) for the broadest possible availability of generic drugs to consumers consistent with the Act."
Action to be taken
FDA is changing the regulation to make it consistent with the court decisions.
Item
"The conference agreement includes language (Section 746) as proposed by the Senate that prohibits the Food and Drug Administration from closing or relocating the Division of Drug Analysis in St. Louis, MO." [SEC. 746. 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 Drug Analysis in St. Louis, Missouri.]
Action 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 Drug Analysis in St. Louis, Missouri.
Item
"The conferees note the Senate's interest in a transition from the use of chlorofluorocarbons (CFCs) in metered-dose inhalers (MDIs) to less environmentally damaging substances, as required by international treaty. The use of CFCs has been shown to be harmful to the atmospheric ozone layer, which protects humans from skin cancer, although the magnitude of the environmental impact of the amount of CFCs used in MDIs is unclear. Metered-dose inhalers, which contain CFCs as propellants, are used primarily for the treatment of asthma and other chronic pulmonary disorders. Asthma and pulmonary patients and physicians rightfully believe that the Food and Drug Administration (FDA) must consider their concerns, as well as the need to have a range of suitable substitutes in place before the current products are withdrawn from the market, as the agency moves forward with a proposal to manage the transition from CFC to non-CFC products. At the time, clear and timely guidance about a transition process is needed by both patients and care givers. Therefore, the conferees direct FDA to devote the resources necessary to ensure that a proposed rule is issued no later than September 1, 1999."
Action to be taken
FDA plans to publish a proposed rule on CFCs by September 1, l999.
Item
"NATIONAL INSTITUTES OF HEALTH...The Office of Rare Diseases (ORD) is to be commended for its leadership in the development and implementation of databases to match patients with ongoing or planned clinical research projects and in the convening of scientific workshops and symposia to identify and stimulate research on rare diseases. ORD is encouraged to expand initiatives to equip the NIH to respond to inquiries of patients, care givers, research investigators, and health care providers about genetic and rare disorders and to stimulate rare disorders research. ORD is also encouraged, with the assistance of the research Institutes and centers of NIH, to review the existing infrastructure of biological samples, human cell, and tissue banks supported by the NIH and develop an information program to publicize the availability of these resources and the methods to contribute or gain access to these samples for research purposes. The conference agreement notes the fact that the Report from the Special Emphasis Panel on Coordination of Research on Rare Diseases is near completion and endorses the collaboration with the Food and Drug Administration to provide support for toxicity studies for gene vectors for rare disorders."
Action to be taken
FDA will continue to collaborate with the NIH, as part of the Agency's FDAMA commitment to reach out to other agencies, to provide support for toxicity studies for gene vectors for rare disorders.
Item
"The conference agreement includes language (Section 737) as proposed by the House that amends the technical definition of the word "antibacterial" in the Federal Food, Drug, and Cosmetic Act." [SEC. 737. Section 512(d)(4)(D)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)(4)(D)(iii)) is amended by inserting before the semicolon the following: ", except that for purposes of this clause, antibacterial ingredient or animal drug does not include the ionophore or arsenical classes of animal drugs."]
Action to be taken
Congress amended Section 512(d)(4)(D)(iii) of the Federal Food, Drug, and Cosmetic Act by inserting before the semicolon the following: ", except that for purposes of this clause, antibacterial ingredient or animal drug does not include the ionophore or arsenical classes of animal drugs." Section 514(d)(4) provides a modified approval process for combination new animal drugs that contain active ingredients or animal drugs that have previously been separately approved for the particular uses and conditions of use for which they are intended for use in the combination. Section 512(d)(4)(D) describes the evidence needed to demonstrate the effectiveness of such a combination new animal drug intended for use in animal feed or drinking water. This statutory change is being implemented and FDA will include the revised definition of antibacterial in its final rule further defining substantial evidence that is required under the Animal Drug Availability Act of 1996, to be published.
Item
"The conference agreement provides $3,000,000 for construction of Phase III at the National Center for Toxicological Research...The conferees expect these funds, in addition to any Phase II remaining balances, to be sufficient to initiate Phase III construction."
Action to be taken
FDA is using the $3,000,000 to initiate construction of Phase III of the Arkansas Regional Laboratory. This enables the agency to retain the current contractor and continue on the original completion schedule.
Item
"The conference agreement includes language (Section 754) proposed by the Senate that prohibits funds from being used to prepare a budget submission to Congress that assumes reductions from the previous year's budget due to user fee proposals unless the submission also identifies spending reductions which should occur if the user fees are not enacted." [SEC. 754. None of the funds appropriated by this Act or any other Act shall be used to pay the salaries and expenses of personnel who prepare or submit appropriations language as part of the President's Budget submission to the Congress of the United States for programs under the jurisdiction of the Appropriations Subcommittees on Agriculture, Rural Development, and Related Agencies that assumes revenues or reflects a reduction from the previous year due to user fees proposals that have not been enacted into law prior to the submission of the Budget unless such Budget submission identifies which additional spending reductions should occur in the event the users fees proposals are not enacted prior to the date of the convening of a committee of conference for the fiscal year 2000 appropriations Act.
Action to be taken
FDA has not proposed reductions from the FY 1999 budget due to unauthorized user fee proposals in the FY 2000 budget request. The user fee proposals noted in this justification are for funds that would be in addition to FDA's current resources.
Item
"The conferees agree to a new provision that provides that for fiscal year 1999 and each fiscal year thereafter, each executive agency of the Federal government shall make available at a minimum $50,000 of expenses necessary to carry out a flexiplace work telecommuting program."
Action to be taken
FDA will dedicate the expenses necessary to carry out a flexiplace telecommuting program.
Item
"YEAR 2000 CONVERSION OF FEDERAL INFORMATION TECHNOLOGY SYSTEMS Funds Appropriated to the President The conferees have provided $2,250,000,000 for emergency expenses related to Year 2000 conversion of Federal information technology systems for all federal Departments and agencies. . ."
Action to be taken
FDA plans to make the facilities that it owns or manages Y2K compliant in FY 1999 and continue the development of detailed contingency plans for mission critical systems and processes. FDA received $11.1 million of these funds in FY 1999 for its Y2K work.
Item
"The conferees agree to continue a provision which prohibits the use of appropriated funds in this or any other Act to acquire information technology which does not comply with part 39.106 (Year 2000 compliance of the Federal acquisition regulations." [SEC. 622. None of the funds appropriated in this or any other Act shall be used to acquire information technologies which do not comply with part 39.106 (Year 2000 compliance) of the Federal Acquisition Regulation, unless an agency's Chief Information Officer determines that noncompliance with part 39.106 is necessary...Any waiver granted shall be reported to the Office of Management and Budget, and copies shall be provided to Congress.]
Action to be Taken
FDA will support and comply with this provision.
Item
"The conference agreement includes Title XVII, the Government Paperwork Elimination Act, which requires the development of procedures for the use and acceptance of electronic signatures by Executive agencies of the U.S. Government."
Action to be Taken
FDA is pursuing the development of procedures for use and acceptance of electronic signatures.
Item
"BILATERAL ECONOMIC ASSISTANCE Agency for International Development Child Survival and Disease Programs Funds. . .The total available to combat infectious diseases should be $215,000,000 in fiscal year 1999. In implementing programs, projects, and activities to combat infectious diseases, the conferees support AID's new strategy to address the global threat of infectious diseases, which focuses on activities to improve surveillance and response, and to combat anti-microbial resistance. . .They expect AID to continue to consult closely with Appropriations Committees, the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), and other relevant agencies involved in international health issues."
Action to be Taken
FDA will work cooperatively with AID and other relevant agencies, as needed, to support AID's new strategy to address the global threat of infectious diseases, which focuses on activities to improve surveillance and response, and to combat anti-microbial resistance.
Senate Report 105-212
Item
"The Committee has included in its recommendation $82,866,000 for FDA rental payments to the General Services Administration [GSA], the same level as proposed in the budget. The Committee has become concerned that FDA's rent payments are in arrearage and that past administration budgets have failed to request amounts sufficient to fully compensate GSA for space and services received by the agency. The amount provided in this bill will begin to correct the rent payment deficiency and the Committee directs FDA to examine its space utilization requirements to contain these costs."
Action to be Taken
The Agency will examine its space utilization requirements to contain costs of compensation to GSA for space and services received.
Item
"Of the funds available for food safety, FDA's Office of Seafood is to continue to research and develop methods to identify a reference dose and detect the different strains within the various vibrio pathogens, as well as continue research efforts to determine whether there are any risks associated with consumption of shellfish and other seafood and illnesses from algae blooms, pfiesteria piccida, and other related toxins."
Action to be taken
FDA will use $250,000 for to establish equivalency agreements in the area of imported seafood. The Agency has so far received requests from thirty foreign countries to determine whether their food safety systems for seafood match or exceed U.S. standards. Such evaluations require laborious reviews of key components of their systems, such as laboratory reviews and comparisons of food additives in seafood. Funds will be devoted towards hiring three full-time equivalents and expenses related to foreign site visits. FDA's involvement in seafood equivalency agreements is yet another example of the Agency's determination to ensure the American public of safer imported foods.
FDA will also provide $200,000 to continue funding a high priority cooperative program with the Interstate Shellfish Sanitation Conference (ISSC). One important aspect of that cooperative program will be to conduct an economic assessment of post-harvest treatment of shellfish aimed at reducing the risk of illness associated with naturally occurring bacteria, such as Vibrio vulnificus, to consumers with pre-existing medical conditions such as liver disease. The ISSC also matches funds or offers grants to states, universities, or industry involved in programs to improve the safety of molluscan shellfish for human consumption. These activities will enhance the efforts of FDA to ensure the safety of molluscan shellfish moving in interstate commerce. The $200,000 may also fund other important cooperative efforts relating to health hazards and other problems associated with shellfish, as well as effective program management. These activities are done in conjunction with the National Food Safety Initiative.
Item
"In light of the fact that generic drugs provide important cost benefits to consumers and the Federal Government, the Committee also encourages the FDA to devote additional resources to generic drug reviews in order to address the backlog of applications and provide reviews within the 6-month period required by statute."
Action to be Taken
FDA will use an additional $1,000,000 in FY 1999 to fund FTE in the Office of Generic Drugs and Information Technology Technology infrastructure.
Item
"FDA's core mission. -- The Committee believes that FDA's first priority must be to ensure timely performance of its core mission. The Federal Food, Drug, and Cosmetic Act requires FDA to conduct various premarket approvals of foods, drugs, and medical devices within prescribed review periods, and to address ancillary matters related to those products. As it has expressed in the past, the Committee is concerned that FDA is not performing its core mission to review applications and petitions within the prescribed statutory review period. FDA delays have significant implications for public health. Each FDA delay extends the time it takes for consumers to benefit from new products that provide significant therapeutic benefits. The Committee believes that FDA's statutory obligations to perform its core regulatory activities must remain the agency's top priority.
"Food safety and food regulatory activities -- As part of FDA's core mission to protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled, the Committee notes with approval that the Secretary has directed that food safety be given first priority among food regulatory activities of FDA. Continued FDA efforts to enhance food safety are an important part of keeping America's food supply the world's safest. FDA also has extensive food regulatory responsibility regarding activities that are not central to assuring food safety. As long as FDA has a statutory obligation to exercise regulatory control regarding these other important food matters, the Committee expects FDA to fulfill those duties in a timely and appropriate manner. If FDA deems the exercise of any of its regulatory responsibilities as unwarranted, FDA should promptly act to repeal those duties through rulemaking or the proposal of legislation.
"The Committee directs FDA to submit by February 1, 1999, a fiscal year 1998 food regulatory report regarding: petitions for rulemaking; applications for certificate of free sale; applications for temporary marketing permits; generally recognized as safe [GRAS] notifications; referrals from industry self-policing organizations; health claim notification submissions; nutrient content claim notification submissions; requests for advisory opinions; requests for alternative compliance procedures for nutrition labeling; requests for FDA approval of nutrition labeling data bases; and petitions for changes in standard of identity. The report should include the number pending, the number of days pending final action, the number approved and disapproved, the average time for filing until final agency action, and other reasonable measures of agency performance."
Action to be taken
FDA has completed the report which is now under review within the Agency. We plan to forward the report shortly.
Item
"The National Center for Food Safety and Technology -- The National Center has established a strong public-private partnership among the FDA, universities, and the food industry over the past 10 years to assist in providing safe technologies in processing and packaging the Nation's food supply. The Committee expects the FDA to at least maintain the Center's funding at the fiscal year 1998 level."
Action to be taken
FDA will maintain at least the same funding level in FY 1999 for the National Center for Food Safety and Technology as in fiscal year 1998.
Item
"Over-the-counter sunscreen monograph -- The Committee is concerned with FDA's lack of progress in implementing a final rule for over-the-counter [OTC] sunscreen drug products. The Committee understands that the final rule is currently being drafted and is scheduled to be published no later than May 21, 1999, the date set by the FDAMA. The Committee expects FDA to meet this deadline."
Action to be taken
FDA expects to publish the Sunscreen Final Rule by May 21, 1999 as mandated by FDAMA.
Item
"Blood and blood product safety -- The Committee is encouraged by the steps taken by the FDA in working with the National Hemophilia Foundation to improve the safety of blood and blood products. Of particular importance are the FDA's efforts to enhance inspections of blood products manufacturing facilities and enforcement of good manufacturing practices. The Committee, however, remains concerned about our Nation's ability to respond rapidly and effectively to cases of viral or pathogenic contamination of blood products and, therefore, expects the FDA to work closely with the Centers for Disease Control and Prevention and the Foundation in establishing an ongoing system for timely investigation of and response to incidents of possible transmission of infectious disease. In addition, the Committee directs the FDA to ensure full implementation and oversight of a voluntary patient notification system and expects a progress report on its efforts no later than December 31, 1998."
Action to be taken
FDA has submitted a report addressing these issues under separate cover.
Senate Report 105-300
Item
"The Committee is aware of the high number of accidental needle-stick injuries that occur primarily to health care workers. These injuries are major risk factors for the transmission of HIV, hepatitis B, and hepatitis C. The Committee urges the Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health, the Food and Drug Administration, and the Occupational Safety and Health Administration of the Department of Labor to make reduction of accidental needle sticks a priority by increasing cooperation among these agencies and taking all necessary actions to address this serious public health problem."
Action to be taken
The involved Agencies are taking measures to reduce the incidence of accidental needle stick injuries in the health community. The Agencies are presently developing a notice to the healthcare community on capillary tubes that are used primarily to capture blood samples from infants. The notice will recommend means to avert needle stick-related injuries. In addition, FDA is responding to OSHA's call for comments on the revision of the bloodborne pathogens rule. For example, FDA has commented on the safe design aspects for medical devices as a means to enhance worker safety. These aspects may be incorporated into OSHA's regulation on engineering controls. FDA is meeting frequently with OSHA to discuss means to foster worker safety. Further, FDA is actively working with the World Health Organization and CDC on new technologies (e.g., new types of jet injectors) for drug and biologics delivery that do not have the potential for sharps injuries.
House Report 105-588
Item
"The Committee has provided an additional $250,000 for a total of $450,000 for the Office of Seafood Inspection for seafood safety and equivalency agreements for imported seafood. The amount includes $200,000, the same as fiscal year 1998, for a grant to the Interstate Shellfish Sanitation Commission."
Action to be taken
FDA will use the $250,000 for to establish equivalency agreements in the area of imported seafood. The Agency has so far received requests from thirty foreign countries to determine whether their food safety systems for seafood match or exceed U.S. standards. Such evaluations require laborious reviews of key components of their systems, such as laboratory reviews and comparisons of food additives in seafood. Funds will be devoted towards hiring three full-time equivalents and expenses related to foreign site visits. FDA's involvement in seafood equivalency agreements is yet another example of the Agency's determination to ensure the American public of safer imported foods.
Item
"The Committee expects the Food and Drug Administration to report to Congress by April 1, 1999, on implementation of the Animal Drug Availability Act of 1996 (Pub. L. No. 104-250). The report should address, among other matters, submission numbers, approval numbers, and review times for various types of animal drug applications, making a distinction between food and non-food producing animals. The report also should address the types and numbers of studies, including field investigations, utilized in the approval of animal drug applications."
Action to be taken
FDA has assigned a work group responsible for the development of the report on the Implementation of ADAA. FDA will describe and quantify, with the information available to us and to the extent discernible, the effects of the ADAA on FDA's processing and approval of new animal drug applications. A report will be submitted to Congress by April 1, 1999.
Public Law 105-277
Item
"The conferees agree to a new provision directing agencies to assess the impact of Federal regulations and policies on families." [SEC. 654. (a) PURPOSES.- The purposes of this section are to- (1) require agencies to assess the impact of proposed agency actions on family well-being; and (2) improve the management of executive branch agencies.
(b) DEFINITIONS.-In this section- (1) the term "agency" has the meaning given the term "Executive agency" by section 105 if title 5. . .(2) the term "family" means- (A) a group of individuals related by blood marriage, adoption, or other legal custody who live together as a single household; and (B) any individual who is not a member of such group, but who is related by blood, marriage, or adoption to a member of such group, and over half of whose support in a calendar year is received from such group.
(c) FAMILY POLICYMAKING ASSESSMENT.-Before implementing policies and regulations that may affect family well-being, each agency shall assess such actions with respect to whether--(1) the action strengthens or erodes the stability or safety of the family and, particularly the marital commitment; (2) the action strengthens or erodes the authority and rights of parents in the education, nurture, and supervision of their children; (3) the action helps the family perform its functions, or substitutes governmental activity for the function; (4) the action increases or decreases disposable income or poverty of families and children; (5) the proposed benefits of the action justify the financial impact on the family; (6) the action may be carried out by State or local government or by the family; and (7) the action establishes an implicit or explicit policy concerning the relationship between the behavior and personal responsibility of youth, and the norms of society.
(d) GOVERNMENT FAMILY POLICY COORDINATION AND REVIEW- (1) CERTIFICATION AND RATIONALE.-With respect to each proposed policy or regulation that may affect family well-being, the head of each agency shall-(A) submit a written certification to the Director of the Office of Management and Budget and to Congress that such policy or regulation has been assessed in accordance with this section; and (B) provide an adequate rationale for implementation of each policy or regulation that may negatively affect family well-being. (2) OFFICE OF MANAGEMENT AND BUDGET.-The Director of the Office of Management and Budget shall-(A) ensure that policies and regulations proposed by agencies are implemented consistent with this section; and (B) compile, index, and submit annually to the Congress the written certifications received pursuant to paragraph (1)(A). (3) OFFICE OF POLICY DEVELOPMENT.-The Office of Policy development shall- (A) assess proposed policies and regulations in accordance with this section; (B) provide evaluations of policies and regulations that may affect family well-being to the Director of the Office of Management and Budget; and (c) advise the President on policy and regulatory actions that may be taken to strengthen the institutions of marriage and family in the United States.
(e) ASSESSMENTS UPON REQUEST BY MEMBERS OF CONGRESS.-Upon request by a Member of Congress relating to a proposed policy or regulations, an agency shall conduct an assessment in accordance with subsection (c), and shall provide a certification and rationale in accordance with subsection (d).
(f) JUDICIAL REVIEW.-This section is not intended to create any right of benefit, substantive or procedural, enforceable at law by a party against the United States,. . .]
Action to be Taken
FDA actively supports the conferees provision to assess the impact of Federal regulations an policies on families.