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.     

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; 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; 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; 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 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.     

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. 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.     

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; 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.     

Organization, functions, and authority delegations--FDA. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority and organization and formal evidentiary public hearing to reflect a change in the organizational structure and the name of one of its Divisions. FDA is also correcting a typographical error. This action is being taken to improve the accuracy and clarity of the regulations.     

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/claims for cost of medical care and services--Department of Veterans Affairs. Final regulations

The Department of Veterans Affairs (VA) has amended VA regulations to increase the settlement and waiver authority delegated to officials within the Office of the General Counsel and District Counsels. This change follows increased authority delegated by the Department of Justice to heads of departments and agencies of the United States.     

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; 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.     

Afterschool snacks in the Child and Adult Care Food Program. Final rule

This final rule incorporates into the Child and Adult Care Food Program (CACFP) regulations the provisions of the William F. Goodling Child Nutrition Reauthorization Act of 1998, which authorized afterschool care centers meeting certain criteria to be reimbursed for snacks served to at-risk children 18 years of age and younger. This rule establishes the eligibility of at-risk afterschool care centers to serve free snacks to children who participate in afterschool programs. The centers, which must be located in low-income areas, are reimbursed at the free rate for snacks. The intended effect of this rule is to support afterschool care programs through the provision of snacks that meet CACFP meal pattern requirements. The additional benefits provided by the 1998 reauthorization act and codified by this final rule were extended to institutions and children immediately after enactment. These changes were originally proposed by the Department in a rulemaking published on October 11, 2000.     

Further amendments to general regulations of the Food and Drug Administration to incorporate tobacco products. Final rule

The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products are subject to the same general requirements that apply to other FDA-regulated products.