Delegations of authority and organization; Ryan White Comprehensive AIDS Resources Emergency Act of 1990--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority by adding a new authority delegated by the Assistant Secretary for Health to the Commissioner of Food and Drugs. The authority being added is under title XXVI of the Public Health Service Act, section 2672, Provisions Relating to Blood Banks, as amended.     

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

The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.     

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 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.     

World Trade Center Health Program; addition of certain types of cancer to the list of WTC-related health conditions. Final rule

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with WTC Health Program regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds to the List of WTC-Related Health Conditions the types of cancer proposed for inclusion by the notice of proposed rulemaking.     

World Trade Center Health Program requirements for the addition of new WTC-related health conditions. Final rule

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. This final rule establishes the processes by which the WTC Program Administrator may add a new condition to the list of WTC-related health conditions through rulemaking, including a process for considering petitions by interested parties to add a new condition.     

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.     

Food and Drug Administration Modernization Act of 1997; list of documents issued by the Food and Drug Administration that apply to medical devices regulated by the Center for Biologics Evaluation and Research. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is publishing a list of documents issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA), and clarifying their applicability to medical devices regulated by the Center for Biologics Evaluation and Research (CBER). This notice is intended to inform the public of the availability of these documents, clarify their scope of applicability, and to provide instructions on ways to access them.     

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.     

Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.     

Maternal and child assistance programs; model application form--HHS, Department of Agriculture. Notice

This notice publishes a model application form that States have the option of using in full, in part, with modification or not at all. It would be used by pregnant women or by children under 6 years of age to apply for benefits simultaneously under several congressionally specified "maternal and child assistance programs": (1) The Medicaid program under title XIX of the Social Security Act; (2) the Health Care for the Homeless grant program under section 340 of the Public Health Service Act; (3) the Maternal and Child Health (MCH) Services block grand program under title V of the Social Security Act; (4) the Migrant and Community Health Centers programs under sections 329 and 330 of the Public Health Service Act; (5) the Head Start program under the Head Start Act; and (6) the Special Supplemental Food Program for Women, Infants and Children (WIC) under section 17 of the Child Nutrition Act of 1966. This notice is published in accordance with section 6506(a) of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239), which requires the Secretary of Health and Human Services, in consultation with the Secretary of Agriculture, to develop a model application form for the specified maternal and child assistance programs for publication in the Federal Register. This model application form represents a first effort to develop a joint model application form covering the programs mandated by Congress. If modifications are necessary due to changes in program requirements, or States or other user experience, they will be pursued.     

Establishment and maintenance of records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and is necessary to help address credible threats of serious adverse health consequences or death to humans or animals. The requirement to establish and maintain records is one of several tools that will help improve FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food. In the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the information will improve FDA's ability to quickly notify the consumers and/or facilities that might be affected by the outbreak.     

Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the best interests of the individual recipients.     

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.     

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).     

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.     

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

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 31, 1998 (63 FR 40858). The document proposed to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Services Act. The document published with an incorrect address. This document corrects that error.     

Fees for certifying insulin drugs--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing interim regulations to revise the fee schedule for insulin certification services. Under the revision, FDA will charge a fixed fee for each master lot or batch submitted for certification. The changes in fee schedule reflect a change in agency testing policy for certification and release of batches of insulin. The changes in fees will allow FDA to continue to maintain an adequate insulin certification program as required by the Federal Food, Drug, and Cosmetic Act (the act). The fees are intended to recover the full costs of operation of FDA's insulin certification program, including the unfunded liability of the Civil Service Retirement Fund and appropriate overhead costs of the Public Health Service and Department of Health and Human Services.     

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.