Federal register
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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.
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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.
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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.
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This notice delays by 6 months the effective dates and compliance dates of the final rule with comment period on Medicaid Eligibility and Coverage Requirements published January 19, 1993 in the Federal Register (58 FR 4908).
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These regulations amend the requirements for coverage of certain groups of individuals under Medicaid and the requirements for determining Medicaid eligibility. The regulations relate to coverage of individuals in optional categorically needy groups; aged, blind and disabled individuals in States that use more restrictive requirements for Medicaid than those under the Supplemental Security Income (SSI) program; individuals receiving optional State supplementary payments; individuals under age 21 who are not receiving AFDC; individuals who are ineligible for cash assistance under the Social Security Act because of requirements that do not apply under Medicaid; and medically needy groups. ⋯ These regulations interpret provisions of the Tax Equity and Fiscal Responsibility Act of 1982, as amended by several acts, including, most recently, the Omnibus Budget Reconciliation Act of 1987, the Medicare Catastrophic Coverage Act of 1988, the Family Support Act of 1988, the Omnibus Budget Reconciliation Act of 1989, and the Omnibus Budget Reconciliation Act of 1990. We are also making some administrative changes to achieve more efficient operation of the Medicaid Program.