Advisory committee; Pediatric Advisory Committee; establishment. Final Rule

The Food and Drug Administration (FDA) is announcing the establishment of a Pediatric Advisory Committee in the Office of the Commissioner. Elsewhere in this issue of the Federal Register, FDA is publishing a document requesting nominations for the membership on this committee. This document adds the Pediatric Advisory Committee to the agency's list of standing advisory committees in 21 CFR 14.100.     

Advisory committees; OTC Drugs Advisory Committee; establishment--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the establishment by the Commissioner of Food and Drugs of the OTC Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. Elsewhere in this issue of the Federal Register, FDA is publishing a notice requesting nominations for membership on this committee. This document adds to the agency's list of standing advisory committees.     

Advisory committee; Medical Imaging Drugs Advisory Committee; re-establishment

The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.     

Advisory committees; establishment and termination--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the establishment by the Commissioner of Food and Drugs of the Medical Devices Advisory Committee and the termination of the existing devices panels. This document revises the agency's list of standing advisory committees to show these actions.     

Medicare program; interest calculation. Final Rule

This final rule changes the way we calculate interest on Medicare overpayments and underpayments to providers, suppliers, health maintenance organizations, competitive medical plans, and health care prepayment plans to be more reflective of current business practices. This change reduces the amount of interest assessed on overpayments and underpayments and simplifies the way the interest is calculated. This change in the way we calculate interest also applies to Medicare Secondary Payer debt.     

Medicare program; establishment of the Medicare Coverage Advisory Committee and request for nominations for members. Notice

This notice announces the establishment of the Medicare Coverage Advisory Committee that will advise the Secretary of Health and Human Services and the Administrator of the Health Care Financing Administration, as requested by the Secretary, whether medical items and services are reasonable and necessary under title XVIII of the Social Security Act. This notice requests nominations for members for the Committee. This notice also announces the signing by the Secretary on November 24, 1998 of the charter establishing the Committee. This charter ends at close of business on November 23, 2000 unless renewed by the Secretary.     

Medicaid program; eligibility and coverage requirements--HCFA. Final Rule

This final rule withdraws regulations setting forth a mandatory budgetary method for determining financial eligibility for individuals who are not receiving or deemed to be receiving Federal cash assistance but whose financial eligibility for Medicaid is being determined through the application of financial criteria of the Aid to Families with Dependent Children (AFDC) program. These regulations were previously issued as part of a final rule with comment period originally published on January 19, 1993, and were to be effective October 18, 1994. This final rule also makes conforming technical changes, as a result of this withdrawal, to the remainder of the January 19, 1993, final rule and reaffirms the August 18, 1994, effective date of this remaining part. These changes are being made as a result of consideration of public comments received.     

Medical Radiation Advisory Committee; request for nominations for membership--FDA. Notice

The Food and Drug Administration (FDA) is requesting nominations for membership on the Medical Radiation Advisory Committee. There is currently one vacancy on the committee and there will be three additional vacancies on June 30, 1985.     

Medicare program; establishment of the Medicare Advantage Program; interpretation. Final rule; interpretation

This final rule clarifies our interpretation of the meaning of "entity" in the final rule titled "Medicare Program; Establishment of the Medicare Advantage Program" published in the Federal Register on January 28, 2005 (70 FR 4588). Subsequent to the publication of the Medicare Advantage (MA) final rule on January 28, 2005, we have received inquiries from parties interested in offering an MA Regional Plan concerning whether they could jointly enter into a contract with us to offer a single MA Regional Plan in a multistate region. The participating health plans wish to contract with each other to create a single "joint enterprise." They have asked us whether such a joint enterprise could be considered an "entity" under sections 1859(a)(1)and 1855(a)(1) of the Social Security Act, for purposes of offering an MA Regional Plan. The MA final rule is scheduled to take effect on March 22, 2005. Our interpretation of the word "entity" that follows in the "Supplementary Information" section of this final rule is deemed to be included in that final rule.     

Medicare and Medicaid programs; civil money penalties for nursing homes. Final Rule

This final rule will revise and expand current Medicare and Medicaid regulations regarding the imposition and collection of civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements in accordance with section 6111 of the Affordable Care Act of 2010.     

Bioavailability and bioequivalence requirements: abbreviated applications. Final Rule

The Food and Drug Administration (FDA) is amending its regulations on bioavailability and bioequivalence and on the content and format of an abbreviated application to reflect current FDA policy and to correct certain typographical and inadvertent errors. This action is intended to improve the accuracy and clarity of the regulations.     

Grants for the establishment of Departments of Family Medicine--HRSA. Final rule

This final regulation amends the existing regulations governing the program for Grants for the Establishment of Departments of Family Medicine authorized by section 747(b) of the Public Health Service Act (the Act), to bring the regulations into conformity with technical amendments made by the Health Professions Extension Amendments of 1992 and to include other changes for consistency with current grant program policies.     

Work activity of persons working as members of advisory committees established under the Federal Advisory Committee Act (FACA). Final rule

We are revising our disability regulations under titles II and XVI of the Social Security Act to establish a new, special rule that affects individuals who are receiving payments or providing services as members or consultants of a committee, board, commission, council or similar group established under the Federal Advisory Committee Act (FACA). Under this special rule, we will not count any earnings an individual is receiving from serving as a member or consultant of a FACA advisory committee when we determine if the individual is engaging in substantial gainful activity under titles II and XVI of the Social Security Act (the Act). In addition, we will not evaluate any of the services the individual is providing as a member or consultant of the FACA advisory committee when determining if the individual has engaged in substantial gainful activity under titles II and XVI of the Act. Based on our experience with FACA advisory committees and the frequency and level of activity required by these committees, we believe that performance of activity on these committees does not demonstrate the ability to perform substantial gainful activity. We believe this to be consistent with Congress's view, as it has recognized in creating the Ticket to Work advisory committee, for example, that current disability beneficiaries should be considered for membership. This also will encourage individuals with disabilities to serve on FACA advisory committees, thereby providing the benefit of their unique perspective on policies and programs to the Federal Government.