Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy.     

Health and Human Services policy for protection of human subjects research--HHS. Final rule

The Department of Health and Human Services (HHS) is amending its Human Subjects Protection regulations to rescind the provision requiring prior review and advice from an Ethical Advisory Board for research applications and proposals involving in vitro fertilization (IVF) of human ova as a prerequisite to funding by HHS and its components. The provision was nullified by the National Institutes of Health Revitalization Act of 1993. The regulations are being amended to reflect this statutory nullification. Institutional Review Board (IRB) review and approval of applications and proposals involving in vitro fertilization (IVF) of human ova continues to be required in accordance with other provisions of the Human Subjects Protection regulations. Furthermore, the Secretary may still exercise the option of seeking advice from an Ethical Advisory Board on ethical issues, including IVF, raised by research applications and proposals.     

Application, review, and reporting process for Waivers for State Innovation. Final rule

This final rule sets forth a procedural framework for submission and review of initial applications for a Waiver for State Innovation described in section 1332 of the Patient Protection and the Affordable Care Act including processes to ensure opportunities for public input in the development of such applications by States and in the Federal review of the applications.     

Revised federal allotments to states for social services expenditure pursuant to Title XX--Social Services Block Grant Act; promulgation for fiscal year 1985--HHS

The FY 1985 Federal allotments of $2.6 billion to States for social services under Section 2003 of the Social Security Act (Act) which were published in the Federal Register on October 27, 1983 (48 FR 49697) were based upon the authorization set forth in Section 2003 of the Act at the time they were prepared. Pub. L. 98-135, enacted October 24, 1983, amended Section 2003 of the Act by increasing the authorization to $2.7 billion for Fiscal Year 1984 and each succeeding fiscal year. Accordingly, the initial promulgation is rescinded and the promulgation as revised is set forth in the table below. These allotments are contingent upon Congressional appropriations actions for the year. If the Congress enacts, and the President approves, an amount different from the authorization, the allotments will be adjusted proportionately.     

Revised federal allotments to states for social services expenditures pursuant to the Title XX--Social Services Block Grant Act; promulgation for fiscal year 1983-HHS. Revised notification

Public Law 97-248, enacted September 3, 1982, among other things, amended Sec. 1101(a) of the Social Security Act, as amended, (Act) to define the term State when used in Title XX to no longer include American Samoa and the Trust Territory of the Pacific Islands. The Federal allotments to States for social services under Section 2003 of the Act which were promulgated in Vol. 46, No. 229 of the Federal Register page 58186 on November 30, 1981, included American Samoa and the Trust Territory of the Pacific Islands. Accordingly, the promulgation contained in such document is rescinded and the promulgation, as revised, is set forth in this issuance.     

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Clinical Laboratory Improvement Act Program fee collection--HCFA. Final rule with comment period

In the February 28, 1992, issue of the Federal Register (57 FR 7002), the Department of Health and Human Services established rules that set forth the test performance requirements for laboratories that are subject to the CLIA requirements. This rule corrects both typographical and technical errors made in that document as well as provides some additional clarification after a limited review of the comments we received after the publication of the rule.     

Medicare program; schedules of per-visit and per-beneficiary limitations on home health agency costs for cost reporting periods beginning on or after October 1, 1998; correction--HCFA. Correction of notice with comment period

In the August 11, 1998 issue of the Federal Register (63 FR 42912), we published a notice with comment period setting forth revised schedules of limitations on home health agency costs that may be paid under the Medicare program for cost reporting periods beginning on or after October 1, 1998. This document corrects technical and typographical errors made in that document.     

Health care programs; fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from Public Law 100-93-- Office of Inspector General, HHS. Final rule and clarification

This final rule clarifies the scope and purpose of the exclusion authority provisions originally set forth in final rulemaking published in the Federal Register on January 29, 1992 (57 FR 3298). That final rule implemented the OIG sanction and civil money penalty (CMP) provisions established through section 2 and other conforming amendments in the Medicare and Medicaid Patient and Program Protection Act of 1987, and other statutory authorities. This clarifying document modifies the final rule to give greater clarity to the original scope of the authorities contained in 42 CFR part 1001. In addition, this rule is providing further clarification to the discovery provision set forth in part 1005 of the regulations.     

International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3A(R) Impurities in New Drug Substances." The revised guidance, which updates a guidance on the same topic published in the Federal Register of January 4, 1996 (the 1996 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance clarifies the 1996 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a country, region, or member State.     

Additional protections for children involved as subjects in research--Department of Health and Human Services. Final rule

The Department of Health and Human Services (Department or HHS)( is prescribing additional requirements for protection of children involved as subjects in research. These regulations adopt, with some changes, the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) as were presented in the notice of proposed rulemaking (NPRM) 43 FR 31786 which preceded this final rule. Specifically, these regulations impose certain added responsibilities on Institutional Review Boards (IRBs) depending on the degree of risk involved in the research and the extent that the research is likely to be a benefit to the subject or relate to a subject's illness.     

Medicare program; update of the reasonable compensation equivalent limits for services furnished by physicians--HCFA. Notice

This notice sets forth updated payment limits on the amount of allowable compensation for services furnished by physicians to providers that are not covered by the prospective payment system or per resident payments for graduate medical education. These services are paid by Medicare on a reasonable cost basis. The revised reasonable compensation equivalent limits are based on updated economic index data and replace the limits that were published in the Federal Register on February 20, 1985 (50 FR 7123).     

Revised federal allotments to states for social services expenditures pursuant to Title XX--Social Services Block Grant Act; promulgation for fiscal year 1984--HHS. Notification

The Federal allotments of +2.5 billion to States for social services under Section 2003 of the Social Security Act (Act) which were published in the Federal Register November 26, 1982 (47 FR 53502) were based upon the authorization set forth in Section 2003 of the Act at that time and were contingent upon Congressional appropriations actions for the fiscal year. Public Law 98-135, enacted October 24, 1983, amended Section 2003 of the Act, by increasing the authorization to +2.7 billion for Fiscal Year 1984 and each succeeding fiscal year. The allocation of this authorized amount for Fiscal Year 1984 is shown in Column 1 of the table below, and it too is contingent upon Congressional appropriations actions. Public Law 98-139, enacted October 13, 1983 appropriates +2.675 billion for allocation to the States under Section 2003 of the Act for Fiscal Year 1984. The allocation of this appropriated amount is shown in Column 2 of the table below. Accordingly, the promulgation made in 47 FR 53502, November 26, 1982, is rescinded and the promulgation, as revised, is set forth in Column 2 of the table below.     

International Conference on Harmonisation; revised guidance on Q3B(R) Impurities in New Drug Products; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3B(R) Impurities in New Drug Products.' The revised guidance, which updates a guidance on the same topic published in the Federal Register of May 19, 1997 (the 1997 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug products produced by chemically synthesized new drug substances not previously registered in a country, region, or member State. The revised guidance clarifies the 1997 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance complements the ICH guidance entitled "Q3A(R) Impurities in New Drug Substances.'     

Medicare and state health care programs: fraud and abuse; safe harbors for protecting health plans--Office of Inspector General, HHS. Final rule

In accordance with section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, this final rule sets forth various standards and guidelines for safe harbor provisions designed to protect certain health care plans, such as health maintenance organizations and preferred provider organizations, under the Medicare and State health care programs' anti-kickback statute. These safe harbor provisions were originally published in the Federal Register on November 5, 1992 in interim final form. In response to the various public comments received, this final rule revises and clarifies various aspects of that earlier rulemaking.     

Federal financial participation in state assistance expenditures; federal matching shares for Aid to Families With Dependent Children, Medicaid, and aid to needy aged, blind, or disabled persons for October 1, 1994 through September 30, 1995--HHS. Notice

The Federal Percentages and Federal Medical Assistance Percentages for Fiscal Year 1995 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 1994 through September 30, 1995. This notice announces the calculated "Federal percentages" and "Federal medical assistance percentages" that we will use in determining the amount of Federal matching in State welfare and medical expenditures. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. Programs under title XIX of the Act exist in each jurisdiction; title IV-A programs in all jurisdictions except American Samoa and the Northern Mariana Islands; programs under titles I, X, and XIV operate only in Guam and the Virgin Islands; while a program under title XVI (AABD) operates only in Puerto Rico. The percentages in this notice apply to State expenditures for assistance payments and medical services (except family planning which is subject to a higher matching rate). The statute provides separately for Federal matching of administrative costs. Sections 1101(a)(8) and 1905(b) of the Act, as revised by section 9528 of Public Law 99-272, require the Secretary of Health and Human Services to publish these percentages each year. The Secretary is to figure the percentages, by formulas in sections 1101(a)(8) and 1905(b) of the Act, from the Department of Commerce's statistics of average income per person in each State and in the Nation as a whole.(ABSTRACT TRUNCATED AT 250 WORDS)     

Medicare program; schedule of limits on home health agency costs per visit for cost reporting periods beginning on or after July 1, 1992; correction--HCFA. Notice with comment period; correction

In the July 1, 1992 issue of the Federal Register (FR Doc. 92-15496) (57 FR 29410), we published a notice with comment period that set forth a revised schedule of limits on home health agency costs that may be paid under the Medicare program. The July 1, 1992 notice applies to cost reporting periods beginning on or after July 1, 1992. This notice corrects errors made in the July 1, 1992 document.     

Privacy Act; implementation. Office of Inspector General (OIG), HHS. Final rule

This final rule exempts the new system of records, the Healthcare Integrity and Protection Data Bank (HIPDB), from certain provisions of the Privacy Act (5 U.S.C. 552a). The establishment of the HIPDB is required by section 1128E of the Social Security Act (the Act), as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 1128E of the Act directed the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers or practitioners, and to maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners. Regulations implementing the new HIPDB were published in the Federal Register on October 26, 1999 (64 FR 57740). The exemption being set forth in this rule applies to investigative materials compiled for law enforcement purposes.     

Medicaid program; payment adjustment for provider-preventable conditions including health care-acquired conditions. Final rule

This final rule will implement section 2702 of the Patient Protection and Affordable Care Act which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulation. It will also authorize States to identify other provider-preventable conditions for which Medicaid payment will be prohibited.     

Area health education center programs--Public Health Service. Final regulations

These regulations set forth requirements for cooperative agreements entered into by the Secretary of Health and Human Services with schools of medicine or osteopathy for the planning, development, and operation of area health education center programs. The regulations conform provisions in 42 CFR Part 57, Subpart MM--Area Health Education Center Programs to Nurse Training Amendments of 1979 Pub. L. 96-76), the Federal Grant and Cooperative Agreement Act (Pub. L. 95-224), and the Omnibus Reconciliation Act of 1981 (Pub. L. 97-35). Also in response to public comments to the interim final regulations published in the Federal Register on November 27, 1978, clarification of several provisions were made to the final regulations.     

Federal financial participation in state assistance expenditures--HHS. Notice

The Federal Percentages and Federal Medical Assistance Percentages for Fiscal Year 1993 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 1992, through September 30, 1993. This notice announces the calculated "Federal percentages" and "Federal medical assistance percentages" that we will use in determining the amount of Federal matching in State welfare and medical expenditures for programs under titles I, IV-A, IV-E, IV-F, X, XIV, XVI (AABD) and XIX. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. The percentages in this notice apply to State expenditures for assistance payments and medical services (except family planning which is subject to a higher matching rate). The statute provides separately for Federal matching of administrative costs. Sections 1101(a)(8) and 1905(b) of the Act, as revised by section 9528 of Public Law 99-272, require the Secretary of Health and Human Services to publish these percentages each year. The Secretary is to figure the percentages, by formulas described in sections 1101(a)(8) and 1905(b) of the Act, using the Department of Commerce's statistics of average income per person in each State and in the Nation as a whole. The percentages are with upper and lower limits given in those two sections of the Act. The statute specifies the percentages to be applied to Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.(ABSTRACT TRUNCATED AT 250 WORDS)