Confidentiality of certain medical records--VA. Final rule

This document establishes Department of Veterans Affairs (VA) regulations to implement specific provisions of the Veterans Omnibus Health Care Act of 1976 and the Veterans' Benefits and Services Act of 1988 concerning the confidentiality of certain medical records. These regulations protect the confidentiality of VA records pertaining to drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus (HIV), and sickle cell anemia.     

Assistant Secretary of Defense for Health Affairs--DoD. Final rule

This document revises the responsibilities, functions, relationships, and authorities of the Assistant Secretary of Defense for Health Affairs ASD(HA). The principal revision, the assignment of the Health Affairs functions under the Under Secretary of Defense for Personnel and Readiness is consistent with Section 903 of the FY 1994 Defense Authorization Act.     

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--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.     

Occupational Safety and Health Administration--Access to employee exposure and medical records. Final rule

This final occupational safety and health standard, promulgated today as a revised 29 CFR 1910.20, provides for employee, designated representative, and OSHA access to employer-maintained exposure and medical records relevant to employees exposed to toxic substances and harmful physical agents. Access is also assured to employer analyses using exposure and medical records. The final standard requires long term preservation of these records, contains provisions concerning informing employees of their rights under the standard, and includes provisions protective of trade secret information.     

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 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.     

Medicare program; granting and withdrawal of deeming authority to national accreditation organizations--HCFA. Final rule

This rule implements section 1865(a) of the Social Security Act, as amended by sections 2345 and 2346 of the Deficit Reduction Act of 1984 and section 6019 of the Omnibus Budget Reconciliation Act of 1989. The amendments expand the types of providers and suppliers of services that we may consider to meet conditions of participation or certification, nursing home requirements, or conditions for coverage by virtue of their accreditation by a national accreditation program; these providers and suppliers are also subject to validation surveys. The rule also extends confidentiality to accreditation surveys, other than home health agency surveys, done by accreditation programs in addition to the Joint Commission on Accreditation of Healthcare Organizations, except that we may disclose survey and related information to the extent that such information relates to an enforcement action we take on the basis of accreditation survey findings. The rule also provides for: the release to, and use by, HCFA of all accreditation surveys and other relevant information even if a provider or supplier is not subject to a validation survey; the removing of deemed status of a facility based on a validation survey, an accreditation survey, or other information related to either; and appeal procedures for denied or withdrawn approval.     

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.     

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; 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 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 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.     

Medical devices; classification for medical washer and medical washer-disinfector. Final rule

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); revisions to the eligibility requirements. Department of Defense (DOD), Office of the Secretary of Defense. Final rule

This final rule revises the comprehensive CHAMPUS regulation pertaining to basic CHAMPUS benefits in accordance with several statutory changes. This final rule: sets forth the requirements for reinstatement of CHAMPUS eligibility for beneficiaries under age 65 who would otherwise have lost eligibility for CHAMPUS due to eligibility for Medicare as a result of disability or end-stage renal disease (ESRD); establishes new classes of CHAMPUS eligibles; establishes the Transitional Assistance Management Program which provides transitional health care for members (and their dependents) who served on active duty in support of a contingency operation and for members (and their dependents) who are involuntarily separated from active duty; allows former spouses who buy a conversion health policy to keep CHAMPUS eligibility for twenty-four (24) months for preexisting conditions that are not covered by the conversion policy; and makes minor technical revisions to the double coverage provisions. In order to expedite compliance with the statutory requirements, all of these provisions have been implemented under interim instructions. This final rule also adds a new category of eligible beneficiary under the Continued Health Care Benefit Program.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); medical documentation--Department of Defense. Final rule

This final rule amends DoD 6010.8-R (32 CFR part 199) which implements the Civilian Health and Medical Program of the Uniformed Services. The final rule clarifies and strengthens medical documentation requirements under the CHAMPUS. This will assist in the maintenance of an adequate level of quality care and help ensure that payment is made only for services rendered.     

Office of the Secretary; TRICARE; changes included in the National Defense Authorization Act for fiscal year 2005; TRICARE dental program. Final rule

The Department is publishing this final rule to implement sections 711 and 715 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA for FY05), Public Law 108-375. Specifically, that legislation makes young dependents of deceased Service members eligible for enrollment in the TRICARE Dental program when the child was not previously enrolled because of age, and authorizes post-graduate dental residents in a dental treatment facility of the uniformed services under a graduate dental education program accredited by the American Dental Association to provide dental treatment to dependents who are 12 years of age or younger and who are covered by a dental plan established under 10 U.S.C. 1076a. This adopts the interim rule published on September 21, 2005 (70 FR 55251).     

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.