Delegations of authority and organization--FDA. Final rule

The Food and Drug Administration (FDA) is revising the regulations to set forth the current organizational structure of the agency as well as the current addresses for headquarters and field offices.     

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.     

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.     

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; 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.     

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.     

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.     

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--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.     

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; revised organization. Food and Drug Administration. Final rule

The Food and Drug Administration (FDA) is revising the regulation setting forth its organization structure. Several reorganizations have occurred since the structure was last issued. These revised regulations will present FDA's latest organization structure and give the latest addresses for the field organization.     

Enrollment--provision of hospital and outpatient care to veterans. Department of Veterans Affairs. Final rule

This document amends VA's medical regulations. The Veterans' Health Care Eligibility Reform Act of 1996 mandates that VA implement a national enrollment system to manage the delivery of healthcare services. Accordingly, the medical regulations are amended to establish provisions consistent with this mandate. Starting October 1, 1998, most veterans were required to be enrolled in the VA healthcare system as a condition of receiving VA hospital and outpatient care. Veterans will be allowed to apply to be enrolled at any time. They will be eligible to be enrolled based on funding availability and their priority status. In accordance with statutory provisions, the final rule also states that some categories of veterans are eligible for VA hospital and outpatient care even if not enrolled. This document further establishes a "medical benefits package" setting forth, with certain exceptions, the hospital and outpatient care that will be provided to enrolled veterans and certain other veterans. Moreover, this document announces that VA will enroll all 7 priority categories of veterans for the period October 1, 1999 through September 30, 2000, unless it is necessary to change this determination by a subsequent rulemaking document.     

Contract medical care; non-federal hospital payment rates--DVA and HHS. Final regulations

The Department of Health and Human Services (HHS) and the Department of Veterans Affairs (VA) have jointly amended VA's medical series of regulations to carry out provisions of Public Law 99-576, Veterans' Benefits Improvement and Health-Care Authorization Act of 1986. These regulations describe the payment methodology and amounts for non-Federal public and private hospital care provided at VA expense. Payment methodology and amounts will be determined by the Health Care Financing Administration (HCFA) PRICER.     

The Veterans Millennium Health Care and Benefits Act. Department of Veterans Affairs. Final rule

This document amends Department of Veterans Affairs (VA) adjudication regulations to reflect changes made by the Veterans Millennium Health Care and Benefits Act. These changes concern payment of dependency and indemnity compensation to the surviving spouses of certain former prisoners of war; the provision of health care, education and home loan benefits to surviving spouses upon termination of their remarriages; and the addition of bronchiolo-alveolar carcinoma to the list of diseases that VA presumes are the result of exposure to radiation during active military service.     

Per diem for nursing home care of veterans in State homes. Department of Veterans Affairs. Final rule

This document amends regulations regarding the payment of per diem to State homes that provide nursing home care to eligible veterans. The intended effect of the final rule is to ensure that veterans receive high quality care in State homes.     

Reasonable charges for medical care or services. Department of Veterans Affairs. Interim final rule

This document amends the Department of Veterans Affairs (VA) medical regulations concerning "reasonable charges" for medical care or services provided or furnished by VA to a veteran: (1) For a nonservice-connected disability for which the veteran is entitled to care (or the payment of expenses of care) under a health plan contract; (2) For a nonservice-connected disability incurred incident to the veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or (3) For a nonservice-connected disability incurred as a result of a motor vehicle accident in a State that requires automobile accident reparations insurance. This document amends the regulations to update databases and other provisions for the purpose of providing more precise charges.     

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.     

Veterans Administration--Medical benefits; readjustment counseling for Vietnam era veterans. Final regulations

The VA [Veterans Administration] has added regulations to comply with the Veterans Health Care Amendments of 1979. This law mandates that the VA provide readjustment counseling and related mental health services to Vietnam era veterans. The law allows for the providing for these services through contract sources. Contractors will be required to meet quality and effectiveness standards established by the Veterans Administration before they can be authorized to provide services.     

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.