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Monday April 27, 1998 Part VIII Department of Health and Human Services Semiannual Regulatory Agenda federal register 21931 VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00257 Fmt 4717 Sfmt 4717 Y:\SGML\ADV42.006 adv42 21932 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS DEPARTMENT OF HEALTH AND affect areas such as changes in Medicare 7500 Security Boulevard, C5-09-27, HUMAN SERVICES reimbursement rules for graduate Baltimore, Maryland 21244; phone 410- medical education; revisions to payment 786-4473. Office of the Secretary procedures for hospice and home health Food and Drug Administration: Ed services; and solvency standards for 21 CFR Ch. I Dutra, Director, Regulatory Policy and provider-sponsored organizations. Management Staff, 5600 Fishers Lane, 42 CFR Chs. I-V Also, the Health Insurance Portability Rockville, Maryland 20857; phone 301- and Accountability Act of 1996, along 443-3480. with its health insurance reforms, gives 45 CFR Subtitle A, Chs. II, III, and XIII Administration on Children and the Department major new Families: Madeline Mocko, Director, Unified Agenda of Federal Regulatory responsibilities concerning health data Division of Policy and Legislation, 7th and Deregulatory Actions standards and health record privacy. Floor, 370 L'Enfant Promenade SW., These provisions require the Secretary AGENCY: Office of the Secretary, HHS. Washington, DC 20447; phone 202-401- to adopt a series of data standards to 9223. ACTION: Semiannual regulatory agenda. support electronic data interchange for health insurance and related Administration on Aging: David SUMMARY: The President's Executive transactions, such as claims processing Bunoski, Executive Secretariat, Room Order 12866 and the Regulatory and enrollment. The standards will 4753 Wilbur H. Cohen Building, 330 Flexibility Act of 1980 require the apply to the entire health industry, not Independence Avenue SW., semiannual publication of an agenda just Federal programs. Washington, DC 20201; phone 202-260- 0669. which summarizes all current, And, the FDA Modernization Act put projected, and recently completed into law many of the initiatives Agency for Health Care Policy and rulemakings of the Department. The undertaken under the Vice President's Research: Peggy Washburn, 2101 East agenda enables the public to know Reinventing Government program. In Jefferson Street, Suite 603, Rockville, about and to participate in the addition, the Act requires, among many Maryland 20852; phone 301-594-1455. Department's regulations development other things, regulations to codify FDA's Centers for Disease Control: Dana work. The last such agenda was existing practices of increasing patient published on October 29, 1997. Weller, Policy Analyst, Office of access to experimental drugs and of Program and Planning and Evaluation, FOR FURTHER INFORMATION CONTACT: Ann accelerating review of important new Office of the Director, 1600 Clifton White, Department of Health and medications. The Act also requires Road, Building 16, Mail Stop D23, Human Services, Washington, DC regulations facilitating dissemination by Atlanta, Georgia 30333; phone 404-639- 20201, (202) 690-6824, or the contact manufacturers of peer-reviewed journal 7077. person for a specific component of the articles about unapproved uses of drugs Department as listed below. and medical devices, in exchange for Health Resource Services commitments by the manufacturers to Administration: Dolores R. Etherith, SUPPLEMENTARY INFORMATION: The submit research data to FDA regarding 5600 Fishers Lane, Room 14-A-08, agenda of regulatory actions set out safety and effectiveness of these Rockville, Maryland 20857; phone 301- below continues to reflect the products. 443-1786. Department's efforts to exemplify in its rulemaking the President's initiative to Underlying these initiatives, there Indian Health Service: Betty Penn, streamline the Federal regulatory system endures the focus and discipline which 12300 Twinbrook Parkway, Suite 450, so that it affords important benefits to the principles articulated in the Rockville, Maryland 20857; phone 301- the American people while creating President's Executive Order 12866 and 443-1116. fewer burdens. The agenda also reflects the many subsequent regulatory reform National Institutes of Health: Jerry emerging policy mandates for HHS, initiatives of the Administration have Moore, 6011 Executive Boulevard, stemming from several major new brought to the Department's regulatory Room 601, Mail Stop 7669, Rockville, pieces of legislation, broadly ranging program. Public comments are invited Maryland 20852; phone 301-496-4606. over child health; welfare reform; health to assist the Department in continuing insurance reform; food safety; improved to pursue the President's purposes. Substance Abuse and Mental Health regulation of drugs and medical Comments should be sent to the Services Administration: Joe Faha, 5600 products; the combating of waste, fraud, addresses listed below, depending on Fishers Lane, Room 12-A-17, Rockville, and abuse in the health care system; and the specific agenda entry that is of Maryland 20857; phone 301-443-4640. the restructuring of the Medicare and interest. Comments may be sent to the Office of the Secretary: Jacquelyn Y. Medicaid financing systems. Office of the Secretary if the responsible White, Deputy Executive Secretary to For example, the Balanced Budget Act component of the Department is not the Department, Office of the Executive of 1997 (BBA) includes numerous apparent or if a comment covers Secretariat, Room 603H, Hubert H. provisions requiring regulatory actions subjects crossing agency lines. Humphrey Building, 200 Independence substantially affecting the Health Care Financing Avenue SW., Washington, DC 20201. characteristics and administration of the Administration: Sue Brown, Director, LaVarne Burton, Medicare Program. These actions will Division of Regulations and Issuances, Executive Secretary to the Department. VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00258 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda 21933 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS Office of the SecretaryÐProposed Rule Stage Regulation Sequence Title Identifier Number Number 921 Revised OIG Sanction Authorities Resulting From Public Law 105-33 ........................................................................ 0991-AA95 Office of the SecretaryÐFinal Rule Stage Regulation Sequence Title Identifier Number Number 922 Clarification of the Initial OIG Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions Under the Anti-Kickback Statute .................................................................................................................................. 0991-AA66 923 Reproduction and Sale of Official Forms and Publications ........................................................................................... 0991-AA83 924 Revised OIG Exclusion Authorities Resulting From Public Law 104-191 ..................................................................... 0991-AA87 925 Revised OIG Civil Money Penalties Resulting From Public Law 104-191 .................................................................... 0991-AA90 926 Shared Risk Exception to the Safe Harbor Provisions .................................................................................................. 0991-AA91 927 Issuance of Advisory Opinions by the Inspector General ............................................................................................. 0991-AA94 Office of the SecretaryÐLong-Term Actions Regulation Sequence Title Identifier Number Number 928 Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans ............................................................ 0991-AA45 929 Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental Policies .............................. 0991-AA53 930 Civil Money Penalties for Notifying a Home Health Agency, or a Home or Community-Based Health Care Center or Provider, of a Standard Survey ............................................................................................................................... 0991-AA79 931 Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and Rebate Agreements ............. 0991-AA80 932 Senior Biomedical Research Services ........................................................................................................................... 0991-AA82 Office of the SecretaryÐCompleted Actions Regulation Sequence Title Identifier Number Number 933 Civil Money Penalties for Referrals to Entities and for Prohibited Arrangements and Schemes ................................. 0991-AA65 934 Administrative Requirements for Grantees To Reflect Single Audit Act Amendments ................................................. 0991-AA92 Substance Abuse and Mental Health Services AdministrationÐLong-Term Actions Regulation Sequence Title Identifier Number Number 935 Block Grants for Prevention and Treatment of Substance Abuse ................................................................................ 0930-AA01 Substance Abuse and Mental Health Services AdministrationÐCompleted Actions Regulation Sequence Title Identifier Number Number 936 Protection and Advocacy for Individuals With Mental Illness .......................................................................................