Delegations of authority to the Commissioner of Food and Drugs--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to redelegate the authority of the Assistant Director for Health to make determinations to close advisory committee meetings to the public to the Commissioner of Food and Drugs (the Commissioner) and other agency heads. FDA is further redelegating this authority from the Commissioner to the Deputy Commissioner for Operations.     

Food and Drug Administration--Delegations of authority and organization, health information and health promotion programs. Final rule

This document amends the regulations for delegations of authority to the Commissioner of Food and Drugs and the redelegation of authority to agency officials. This action is taken because of a new delegation of authority under Title XVII of the Public Health Service Act.     

Delegations of authority and organization; National Childhood Vaccine Injury Act of 1986--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority by adding new authorities delegated by the Assistant Secretary for Health to the Commissioner of Food and Drugs (the Commissioner). The new authorities are under certain provisions of the Public Health Service Act (the PHS Act) and of the National Childhood Vaccine Injury Act of 1986. The authorities added are being further redelegated, from the Commissioner to the Director, Center for Biologics Evaluation and Research (CBER), and the Associate Director for Policy Coordination and Public Affairs, CBER.     

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.     

Control of communicable diseases; apprehension and detention of persons with specific diseases; transfer of regulations. Food and Drug Administration and Centers for Disease Control and Prevention, HHS. Final rule

The Secretary of Health and Human Service (the Secretary) is transferring a portion of the Food and Drug Administration (FDA) "Control of Communicable Diseases" regulations to the Centers for Disease Control and Prevention (CDC). In general, these regulations provide the Secretary with the authority to apprehend, detain, or conditionally release individuals to prevent the spread of specified communicable diseases. The regulations implement the provisions of the Public Health Service Act (PHS Act) to prevent the introduction, transmission, or spread of communicable diseases from one State or possession into any other State or possession. CDC will have authority for interstate quarantine over persons, while FDA will retain regulatory authority over animals and other products that may transmit or spread communicable diseases. The Secretary is taking this action to consolidate regulations designed to control the spread of communicable diseases, thereby increasing the agencies' efficiency and effectiveness.     

Delegations of authority and organization; Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to premarket approval of products that are or contain a biologic, a device, or a drug. The amendment grants directors, deputy directors, and certain other supervisory personnel in the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) reciprocal premarket approval authority to approve such products.     

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.     

Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect redelegations to other officials within the Center for Devices and Radiological Health (CDRH) pertaining to: Certifying true copies and using the Department seal, disclosing official records, issuing reports of minor violations, and medical device reporting procedures. This amendment is intended to reflect those redelegations.     

Establishment, maintenance, and availability of records: amendment to record availability requirements. Interim final rule; request for comments

The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals.     

Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order

The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.     

Medical device recall authority--FDA. Final rule

The Food and Drug Administration (FDA) is establishing procedures for implementing the medical device recall authority provided in the Safe Medical Devices Act of 1990 (the SMDA). This statutory authority protects the public health by permitting FDA to remove dangerous devices from the market promptly. This authority complements other provisions of the device law, including tracking and notification.     

Delegations of authority and organization; Office of the Commissioner--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to redelegate the Commissioner's authority to designate primary jurisdiction over the premarket review and regulation of combination products under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)(1)) a provision of the Safe Medical Devices Act of 1990 to the ombudsman as the product jurisdiction officer, Office of the Commissioner. Under a regulation published elsewhere in this issue of the Federal Register, the FDA ombudsman is the designated product jurisdiction officer.     

Delegations of authority and organization; new drug applications--Food and Drug Administration. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority regarding approval of new drug applications (NDA's) by redelegating to the Directors of Divisions conducting new drug evaluations authority to approve an additional class of NDA's to expedite the approval process. Published elsewhere in this issue of the Federal Register is a notice reorganizing the Bureau of Drugs and Bureau of Biologics into the National Center for Drugs and Biologics. This document also updates organizational references in accordance with the reorganization.     

Delegations of authority and organization; Center for Drug Evaluation and Research--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to the approval of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and their supplements to add the Deputy Director (Medical and Scientific Affairs), Center for Drug Evaluation and Research (CDER), to the list of officials authorized to approve certain NDA's, ANDA's, and their supplements for drugs for human use. In addition, FDA is adding authority to approve applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (505(b)(2) applications) to these officials. These authorities were given to FDA under section 505 of the act.     

Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.     

Delegations of authority and organization; issuance of written notices--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to the issuance of written notices concerning failure to file patent information and to comply with requirements pertaining to current good manufacturing practices and labeling for new drugs, new animal drugs, and feeds bearing or containing new animal drugs from the Commissioner of Food and Drugs to certain FDA officials. This action is being taken to make the process of issuing written notices more efficient.     

Disqualification of a clinical investigator--FDA. Final rule

The Food and Drug Administration (FDA) is amending the investigational new drug regulation that provides for disqualification of clinical investigators who submit false information. The revision is intended to clarify the agency's authority to reach sponsor-investigators under the regulation.     

Delegations of authority and organization--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority and organization to set forth the current organizational structure of the agency as well as the current addresses for headquarters and field offices. This action is necessary to ensure the continued accuracy of the regulations.     

State certification of mammography facilities. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments implement the "States as Certifiers" (SAC) provisions of the Mammography Quality Standards Act of 1992 (MQSA). These amendments permit FDA to authorize individual States to certify mammography facilities, conduct facility inspections, enforce the MQSA quality standards, and administer other related functions. The amendments establish the standards to be met by States receiving this authority. They also establish procedures for application, approval, evaluation, and withdrawal of approval of States as certification agencies. FDA retains oversight responsibility for the activities of the States to which this authority is given. Mammography facilities certified by those States must continue to meet the quality standards established by FDA for mammography facilities nationwide.     

Mutual recognition of pharmaceutical good manufacturing practice inspection reports, medical device quality system audit reports, and certain medical device product evaluation reports between the United States and the European Community--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations pursuant to an international agreement between the United States and the European Community (EC). The agreement is entitled "Agreement on Mutual Recognition Between the United States and the European Community (MRA). Under the terms of the agreement, the importing country authority may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by the exporting authority determined by the importing authority to have an equivalent regulatory system. Likewise, the importing country authority may normally endorse medical device quality system evaluation reports and certain medical device product evaluation reports by conformity assessment bodies (CAB's) determined by the importing country authority to have equivalent assessment procedures. FDA is taking this action to enhance its ability to ensure the safety and effectiveness of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The proposed rule which published in the Federal Register on April 10, 1998 (63 FR 17744), carried an incorrect docket number in its heading. This final rule carries the correct docket number.