Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.     

Establishment registration and listing for manufacturers of human cellular and tissue-based products--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to require manufacturers of certain human cellular and tissue-based products to register with the agency and list their products. In addition, the agency is proposing to amend the registration and listing regulations that currently apply to human cellular and tissue-based products regulated as drugs, devices, and/or biological products. This action is being taken to establish a unified registration and listing program for human cellular and tissue-based products.     

Aluminum in large and small volume parenterals used in total parenteral nutrition--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations to add certain labeling requirements concerning aluminum in large volume parenterals (LVP's) and small volume parenterals (SVP's) used in total parenteral nutrition (TPN). FDA is also proposing to specify an upper limit of aluminum permitted in LVP's and to require applicants to develop and to submit to FDA for approval validated assay methods for determining aluminum content in parenteral drug products. The agency is proposing these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially premature infants and patients with impaired kidney function.     

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring--FDA. Proposed rule

The Food and Drug Administration (FDA), in response to the requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA), is proposing to amend the drug and biologics regulations by adding provisions that would clarify the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases. The proposed regulations would describe certain types of indications for which FDA may approve diagnostic radiopharmaceuticals. The proposed rule also would include criteria that the agency would use to evaluate the safety and effectiveness of a diagnostic radiopharmaceutical under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act.     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The agency is taking this action to clarify the availability of review of scientific controversies by such advisory panels or committees. This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. If FDA receives any significant adverse comment, the direct final rule will be withdrawn, and the comments will be considered in the development of a final rule using usual notice and comment rulemaking based on this proposed rule.     

Quality mammography standards--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing mammography that published in a document entitled "Quality Mammography Standards." The purpose of these amendments is to eliminate a conflict between the mammography regulations, which must be followed by all facilities performing mammography, and FDA's Electronic Product Radiation Control (EPRC) performance standards, which establish radiation safety performance requirements for x-ray units, including mammographic systems.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); companion document to direct final rule. Food and Drug Administration, HHS. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action because the proposed changes are noncontroversial and FDA anticipates that it will receive no significant adverse comment.     

Medical devices; reports of corrections and removals; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing reports of corrections and removal of medical devices to eliminate the requirement for distributors to make such reports. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is issued under FDAMA and the act as amended.     

Investigational new drug applications; clinical holds; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing investigational new drug applications (IND's) for human drug and biological products. This proposed action would amend the IND clinical hold requirements to state that the agency will respond in writing to a sponsor's request that a clinical hold be removed from an investigation within 30-calendar days of the agency's receipt of the request and the sponsor's complete response to the issue(s) that led to the clinical hold. This proposed action is being taken in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. If FDA receives any significant adverse comment, the direct final rule will be withdrawn, and the comments will be considered in the development of a final rule using usual notice-and-comment rulemaking based on this proposed rule.     

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.     

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations to include a list of drug products that may not be used for pharmacy compounding pursuant to the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).     

Public Health Service--Health systems agency and state health planning and development agency reviews: certificate of need programs. Final regulation

These rules amend the Public Health Service regulations on health systems agency and State health planning and Development agency (State Agency) certificate of need reviews. These final regulations implement changes to Title XV of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub L. 96-79). Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth the minimum requirements for satisfactory certificate of need programs.     

Availability of information to the public--Department of Health and Human Services. Proposed rule

The Department of Health and Human Services is proposing to amend its regulations implementing the Freedom of Information Act (FOIA). This proposal would increase fees for FOIA searches and copying, to reflect increased costs to the Department. It also proposes guidelines for the waiver or reduction of fees.     

Miscellaneous amendments to the HHS procurement regulations--Department of Health and Human Services. Proposed rule

The Office of the Secretary, Department of Health and Human Services is proposing to amend its procurement regulations by revising and updating the general provisions for use in fixed price and cost-reimbursement type contracts (HHS-314, -315, -315A, and -316) and related miscellaneous amendments. The revisions will result in the consolidation of all additions, removals and revisions to the general provisions. The effect of the amendment will be the updating of the Department's general provisions.     

Revisions to the requirements applicable to blood, blood components, and source plasma. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment sufficient to terminate the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule. FDA is issuing this rule as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood, blood components, and Source Plasma.     

Federal performance standard for diagnostic x-ray systems and their major components--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The amendments revise the limits established for maximum patient entrance exposure rates for fluoroscopic x-ray systems during high-level control and other modes of operation. The revisions are being made due to concerns regarding excessively large radiation exposure rates on some fluoroscopic x-ray systems. In addition, an inadvertent error is being corrected to improve the accuracy of the regulations.     

New drugs for human use; clarification of requirements for patent holder notification--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations on notice of certification of invalidity or noninfringement of a patent to provide additional methods for new drug and abbreviated new drug applicants to provide notice to patent owners and new drug application (NDA) holders, without removing the existing means. These proposed amendments reflect current business practices and are intended to ensure that notice is provided to patent owners and NDA holders in a timely manner. FDA is also proposing to require certain applicants to submit to FDA a copy of the notice of certification.     

Electronic products; performance standard for diagnostic x-ray systems and their major components. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).     

Revisions to the general safety requirements for biological products; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by adding cellular therapy products to the list of products exempted from the general safety test (GST) and by adding an administrative procedure for obtaining exemptions from the GST requirements. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action because the GST may not be relevant or necessary for many types of biological products, including cellular therapy products, currently in various stages of development.