eDt 9AR9 23 p 1 98Jt190 O000Fm027Ft41 ft41 :SM\D4.0 adv42 Y:\SGML\ADV42.006 Sfmt4717 Fmt4717 Frm00257 PO00000 Jkt179005 12:32Apr21, 1998 VerDate 09-APR-98 federal register April 27,1998 Monday Semiannual RegulatoryAgenda Services Health andHuman Department of Part VIII 21931 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 ...... 0930-AA02
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Departmental ManagementÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
937 Implementation of the Equal Access to Justice Act in Agency Proceedings ...... 0990-AA02
Food and Drug AdministrationÐPrerule Stage
Regulation Sequence Title Identifier Number Number
938 Animal Drug Approvals for Minor Species and Minor Usage ...... 0910-AB07 939 Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements ...... 0910-AB30 940 Electronic Submission of Adverse Drug Reaction Reports ...... 0910-AB42 941 Supplemental Manufacturing Changes for New Animal Drugs ...... 0910-AB49
Food and Drug AdministrationÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
942 Over-the-Counter (OTC) Drug Review ...... 0910-AA01 943 Fees for Certification Services; Insulin and Color Additive Certification Programs ...... 0910-AA07 944 Review of Warnings, Use Instructions, and Precautionary Information Under Section 314 of the National Childhood Vaccine Injury Act of 1986 ...... 0910-AA14 945 Hearing Aids; Professional and Patient Labeling; Conditions for Sale ...... 0910-AA39 946 Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices ...... 0910-AA43 947 Bioavailability and Bioequivalence Requirements ...... 0910-AA51 948 Drugs Used for Treatment of Narcotic Addicts ...... 0910-AA52 949 Dietary Supplement Regulations in Response to DSHEA ...... 0910-AA59 950 Investigational New Drugs: Export Requirements for Unapproved New Drug Products ...... 0910-AA61 951 Adverse Drug Reaction Reporting, Recordkeeping, and Records Access Requirements for Marketed OTC Drugs .. 0910-AA86 952 Informed Consent for Human Drugs and Biologics; Determination That Informed Consent Is Not Feasible ...... 0910-AA89 953 Direct-to-Consumer Promotion Regulations ...... 0910-AA90 954 Labeling for Human Prescription Drugs; Revised Format ...... 0910-AA94 955 Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products ...... 0910-AA97 956 Chlorofluorocarbon Propellants in Self-Pressurized Containers; Determinations That Uses Are No Longer Essential 0910-AA99 957 Radioactive Drugs for Basic Research ...... 0910-AB00 958 Establishment Registration and Listing of Human Cellular and Tissue-Based Products ...... 0910-AB05 959 Veterinary Feed Directives: Distributor Notification ...... 0910-AB09 960 Use of Ozone-Depleting Substances in Aerosol Products or Other Pressurized Dispensers ...... 0910-AB10 961 Exports; Reporting and Recordkeeping Requirements ...... 0910-AB16 962 Requirements Pertaining to the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents; Use of Nontobacco Trade or Brand Names ...... 0910-AB17 963 Exemption From Preemption of State and Local Cigarette and Smokeless Tobacco Requirements; Applications for Exemption Submitted by Various State Governments; Group 1; Group 2 ...... 0910-AB19 964 Registration of Foreign Establishments and Product Listing ...... 0910-AB21 965 Public Information; Communications with State and Foreign Government Officials ...... 0910-AB22 966 Dissemination of Treatment Information on Unapproved Uses for Marketed Drugs and Devices ...... 0910-AB23 967 FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export ...... 0910-AB24 968 Blood Initiative ...... 0910-AB26 969 Suitability Determination for Donors of Human Cellular and Tissue-Based Products ...... 0910-AB27 970 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products ...... 0910-AB28 971 Biological Products Regulated Under Section 351 of the Public Health Services Act; Implementation of Biologics License; Elimination of Establishment License and Product License ...... 0910-AB29 972 Antibiotic Drug Approval and Exclusivity ...... 0910-AB33 973 Applications for FDA Approval to Market a New Drug or Antibiotic Drug; Complete Review Letter; Amendments to Unapproved Applications ...... 0910-AB34 974 Expanded Access to Investigational Therapies ...... 0910-AB37 975 Distinguishing Marks for Drug Products Containing Insulin ...... 0910-AB43
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00260 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.000 adv42 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda 21935
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Food and Drug AdministrationÐProposed Rule Stage (Continued)
Regulation Sequence Title Identifier Number Number
976 Progestational Drug Products for Human Use; Requirements for Labeling Directed to the Patient ...... 0910-AB45 977 Requirements for Liquid Medicated Feed and Free Choice Medicated Feed ...... 0910-AB50 978 Revisions to the General Safety Requirements for Biological Products; Direct Final Rule ...... 0910-AB51 979 Radiopharmaceuticals Used for In Vivo Diagnosis and Monitoring ...... 0910-AB52
Food and Drug AdministrationÐFinal Rule Stage
Regulation Sequence Title Identifier Number Number
980 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Res- toration Act (GADPTRA) ...... 0910-AA02 981 Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and Clarifications ...... 0910-AA08 982 Biological Products: Reporting of Errors and Accidents in Manufacturing ...... 0910-AA12 983 Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products ...... 0910-AA26 984 Prescription Drug Product Labeling; Medication Guide ...... 0910-AA37 985 Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals ...... 0910-AA45 986 Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant; Labeling Requirements; Warning Statement ...... 0910-AA74 987 New Drug Applications; Drug Master File ...... 0910-AA78 988 Over-the-Counter Human Drugs; Labeling Requirements ...... 0910-AA79 989 5nvestigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening Illnesses ...... 0910-AA84 990 Sterility Requirements for Inhalation Solution Products ...... 0910-AA88 991 Current Good Manufacturing Practice; Revision of Certain Labeling Controls ...... 0910-AA98 992 Definition of Substantial Evidence ...... 0910-AB08 993 Medicated Feed Mill Licenses ...... 0910-AB18 994 Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New Drugs and Biological Prod- ucts in Pediatric Patients ...... 0910-AB20 995 Revocation of Lather Brushes Regulation ...... 0910-AB25 996 Removal of Regulations Regarding Certification of Antibiotic Drugs ...... 0910-AB31 997 Revocation of Antibiotic Certification Requirements; Conforming Revisions to Regulations ...... 0910-AB32 998 Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin ...... 0910-AB38 999 Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs ...... 0910-AB39 1000 List of Drugs That Have Been Withdrawn or Removed from the Market for Reasons of Safety and Effectiveness ... 0910-AB40 1001 Streamlining Clinical Research ...... 0910-AB41 1002 Medical Devices; IDE Modifications ...... 0910-AB53 1003 Dispute Resolution ...... 0910-AB54
Food and Drug AdministrationÐLong-Term Actions
Regulation Sequence Title Identifier Number Number
1004 Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Require- ments, and Records and Reports ...... 0910-AA04 1005 Food Labeling Review ...... 0910-AA19 1006 Medical Foods ...... 0910-AA20 1007 Amalgam Ingredient Labeling ...... 0910-AA33 1008 Classification of Computer Software Programs That Are Medical Devices ...... 0910-AA41 1009 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution ...... 0910-AA49 1010 Reinventing FDA Food Regulations ...... 0910-AA58 1011 Reinvention of Administrative Procedures Regulations ...... 0910-AA69 1012 Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent Requirements ...... 0910-AA75 1013 Debarment Certification Regulations for Drug Applications ...... 0910-AA76 1014 Investigational New Drug Applications; Request for Information and Comments ...... 0910-AA83 1015 Investigational New Animal Drug Regulations ...... 0910-AB02 1016 New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification ...... 0910-AB12
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Food and Drug AdministrationÐLong-Term Actions (Continued)
Regulation Sequence Title Identifier Number Number
1017 Administrative Practices and Procedures; Advisory Opinions and Guidelines ...... 0910-AB14 1018 Pregnancy Labeling Revision ...... 0910-AB44
Food and Drug AdministrationÐCompleted Actions
Regulation Sequence Title Identifier Number Number
1019 Implementation of the Safe Medical Devices Act of 1990 ...... 0910-AA09 1020 Mammography Quality Standards Act of 1992 ...... 0910-AA24 1021 Financial Disclosure by Clinical Investigators ...... 0910-AA30 1022 Habit-Forming Drugs ...... 0910-AA50 1023 Revocation of Certain Regulations ...... 0910-AA54 1024 Investigational New Drug Applications; Clinical Holds ...... 0910-AA73 1025 Certification of Drugs Composed Wholly or Partly of Insulin ...... 0910-AA77 1026 Investigational New Drug Applications and New Drug Applications ...... 0910-AA82 1027 Postmarketing Periodic Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products ...... 0910-AA85 1028 New Drugs for Human Use; Clarification of Requirements for Application Supplements ...... 0910-AA87 1029 Definition of Adequate and Well-Controlled Studies ...... 0910-AB01 1030 FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export ...... 0910-AB06 1031 Clarification of the Scope of Treatment Uses With Investigational New Drugs That Can Be Authorized Under INDs and the Criteria for Charging for Investigational New Drugs Under INDs ...... 0910-AB11 1032 Prescription Drug Compounding ...... 0910-AB13 1033 Revocation of Regulation on Positron Emission Tomography Drug Products ...... 0910-AB46
Health Resources and Services AdministrationÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
1034 National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Cor- porate Shield ...... 0906-AA41 1035 National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Re- porting Adverse and Negative Actions ...... 0906-AA43 1036 Designation of Medically Underserved Populations and Health Professional Shortage Areas ...... 0906-AA44 1037 Health Care Fraud and Abuse Data Collection Program ...... 0906-AA46 1038 National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Providers: Clarifica- tion and Modernization of Regulatory Terms ...... 0906-AA48
Health Resources and Services AdministrationÐFinal Rule Stage
Regulation Sequence Title Identifier Number Number
1039 Organ Procurement and Transplantation Network Rules ...... 0906-AA32 1040 National Vaccine Injury Compensation Program: Effective Date Provisions of Coverage of Certain Vaccines to the Vaccine Injury Table ...... 0906-AA49
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Health Resources and Services AdministrationÐLong-Term Actions
Regulation Sequence Title Identifier Number Number
1041 Drug Pricing Program: Prime Vendor User Charge ...... 0906-AA45
Health Resources and Services AdministrationÐCompleted Actions
Regulation Sequence Title Identifier Number Number
1042 National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Charge for Self-Queries ...... 0906-AA42 1043 Grants for Residency Training and Advanced Education in the General Practice of Dentistry; Technical Amend- ments ...... 0906-AA47
Indian Health ServiceÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
1044 Acquisition Under the Buy Indian Act ...... 0917-AA00 1045 Indian Child Protection and Family Violence Prevention Act Minimum Standards of Character ...... 0917-AA02
National Institutes of HealthÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
1046 National Institutes of Health AIDS Research Loan Repayment Program ...... 0925-AA02 1047 Undergraduate Scholarship Program Regarding Professions Needed by the NIH ...... 0925-AA10 1048 Traineeships ...... 0925-AA11 1049 Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects in Research, and Pertaining to Human In Vitro Fertilization ...... 0925-AA14 1050 National Research Service Awards ...... 0925-AA16 1051 Removal of National Cancer Institute Clinical Cancer Education Program ...... 0925-AA17 1052 National Institutes of Health Loan Repayment Program for Research ...... 0925-AA18 1053 National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repay- ment Program ...... 0925-AA19 1054 Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects ...... 0925-AA20 1055 Federal Policy (Common Rule) for the Protection of Human Subjects ...... 0925-AA21
National Institutes of HealthÐFinal Rule Stage
Regulation Sequence Title Identifier Number Number
1056 National Institutes of Health Construction Grants ...... 0925-AA04 1057 National Institutes of Health Clinical Research Loan Repayment Program for Individuals From Disadvantaged Backgrounds ...... 0925-AA09 1058 Service Fellowship ...... 0925-AA22
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Office of Assistant Secretary for HealthÐLong-Term Actions
Regulation Sequence Title Identifier Number Number
1059 Standards of Compliance for Abortion-Related Services in Family Planning Service Projects ...... 0937-AA00
Public Health ServiceÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
1060 Public Health Service Standards for the Protection of Research Misconduct Whistleblowers ...... 0905-AE71
Health Care Financing AdministrationÐPrerule Stage
Regulation Sequence Title Identifier Number Number
1061 Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR) ...... 0938-AI72
Health Care Financing AdministrationÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
1062 ``Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare Overpayment Liability (HCFA-1719- P) ...... 0938-AD95 1063 Provider Reimbursement Determinations and Appeals (HCFA-1727-P) ...... 0938-AF28 1064 Revisions to Rules on Health Care Prepayment Plans (HCFA-1016-P) ...... 0938-AF97 1065 Conditions of Participation for Rural Health Clinics (HCFA-1764-P) ...... 0938-AG05 1066 Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P) ...... 0938-AG31 1067 Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, Underpayments and Overpayments (HCFA-2215-P) ...... 0938-AG59 1068 Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With Tuberculosis (HCFA-2082-P) .... 0938-AG72 1069 Physicians' Referrals to Health Care Entities With Which They Have Financial RelationshipsÐExpanded to Des- ignated Health Services (HCFA-1809-F) ...... 0938-AG80 1070 End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P) ...... 0938-AG82 1071 Liability for Third Parties To Pay for Care and Services (MB-080-P) ...... 0938-AH01 1072 Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical Equipment (DME) (BPD-834-P) ...... 0938-AH16 1073 Medicare Coverage of Organ Transplantation (HCFA-3835-PN) ...... 0938-AH17 1074 State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P) ...... 0938-AH24 1075 Hospice CareÐConditions of Participation (HCFA-3844-P) ...... 0938-AH27 1076 Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-1843-P) ...... 0938-AH37 1077 Payment Amount If Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC) ...... 0938-AH49 1078 Supplier Participation Agreements and Limits on Actual Charges of Nonparticipating Physicians (HCFA-1862-P) .... 0938-AH50 1079 Revision to Accrual Basis of Accounting Policy (HCFA-1876-P) ...... 0938-AH61 1080 Medicaid; Estate Recoveries (HCFA-2083-P) ...... 0938-AH63 1081 Provider and Supplier Billing When Medicare Is Secondary Payor to Liability Insurance (HCFA-1848-P) ...... 0938-AH66 1082 Medicare Technical Conforming Amendments (HCFA-1858-FC) ...... 0938-AH67 1083 Elimination of Certain Requirements for Peer Review Organizations in the Utilization and Quality Review Process and a Change in the Length of Peer Review Organization Contracts (HCFA-3235-FC) ...... 0938-AH68 1084 Determination of Substandard Care in SNFs and NFs (HCFA-2240-P) ...... 0938-AH69 1085 Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical Procedures for Ambulatory Surgical Centers Effective for Calendar Year 1998 (HCFA-1885-P) ...... 0938-AH81 1086 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P) ...... 0938-AH83 1087 Disclosure of Peer Review Organization Information in Response to Beneficiary Complaints (HCFA-3241-P) ...... 0938-AH85 1088 Medicare Program; Beneficiary Incentives Programs (HCFA-6144-P) ...... 0938-AH86 1089 National Standard for Identifiers of Health Plans (HCFA-4145-P) ...... 0938-AH87 1090 Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review Program (HCFA- 2107-P) ...... 0938-AH89
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Health Care Financing AdministrationÐProposed Rule Stage (Continued)
Regulation Sequence Title Identifier Number Number
1091 Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services (HCFA-2043-P) ...... 0938-AH95 1092 Medicare Coverage of Certified Nurse-Midwife Services (HCFA-1496-P) ...... 0938-AH96 1093 National Standard Health Care Provider Identifier (HCFA-0045-P) ...... 0938-AH99 1094 Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P) ...... 0938-AI11 1095 Newborns' and Mothers' Health Protection ...... 0938-AI13 1096 Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999 Rates (HCFA-1003-P) ...... 0938-AI22 1097 Children's Health Insurance: Program Implementations; State Plan Approval; State Payment; Coordination With State Medicaid Program (HCFA-2006-P) ...... 0938-AI28 1098 Standards for Electronic Transactions (HCFA-0149-P) ...... 0938-AI58 1099 National Standard Employer Identifier (HCFA-0047-P) ...... 0938-AI59
Health Care Financing AdministrationÐFinal Rule Stage
Regulation Sequence Title Identifier Number Number
1100 Deduction of Incurred Medical Expenses (Spenddown) (HCFA-2020-F) ...... 0938-AB07 1101 Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F) ...... 0938-AB50 1102 Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge Rights Notice, and Hos- pital Responsibility for Emergency Care (HCFA-1393-IFC) ...... 0938-AC58 1103 Medicare Secondary Payer for Disabled Individuals (HCFA-1482-F) ...... 0938-AD73 1104 Omnibus Nursing Home Reform Requirements (HCFA-3488-F) ...... 0938-AD81 1105 Coverage of Screening Pap Smears (BPD-705-F) ...... 0938-AE98 1106 Case Management (HCFA-2027-F) ...... 0938-AF07 1107 Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC) ...... 0938-AF42 1108 Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants, and Children Under Age 19 (HCFA-2052-F) ...... 0938-AF69 1109 Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and Competitive Medical Plans (HCFA-1015-F) ...... 0938-AF98 1110 Payment for Preadmission Services (HCFA-1731-F) ...... 0938-AG00 1111 Change in Provider Agreement Regulations Related to Federal Employee Health Benefits (HCFA-1748-F) ...... 0938-AG03 1112 Revised Medicaid Management Information Systems (MB-38-FN) ...... 0938-AG10 1113 Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia (Dry Mouth) (HCFA-3782- FN) ...... 0938-AG45 1114 Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F) ...... 0938-AG48 1115 Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F) ...... 0938-AG81 1116 CLIA Program: Categorization of Waived Tests (HCFA-2225-FC) ...... 0938-AG99 1117 Ambulance Services (HCFA-1813-F) ...... 0938-AH13 1118 Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F) ...... 0938-AH15 1119 CLIA Program: Cytology Proficiency Testing (HCFA-2233-N) ...... 0938-AH35 1120 Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-Based Group Health Plans (HCFA-2047-FC) ...... 0938-AH48 1121 Limitations on Liability (HCFA-4859-FC) ...... 0938-AH51 1122 Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC) ...... 0938-AH53 1123 Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998 Rates (HCFA-1878-F) ...... 0938-AH55 1124 Utilization Control and Discontinued Review Activities; Medicaid (MB-101-FC) ...... 0938-AH64 1125 Individual Market Health Ins. Reform Portability from Group to Indiv. Coverage; Federal Rules for Access in the Indiv. Market; State Alternative Mechanisms to Federal Rules (HCFA-2882-F) ...... 0938-AH75 1126 Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform (HCFA-2105-IFC) ...... 0938-AH76 1127 CLIA Program; Simplifying CLIA Regulations to Accreditation Exemption of Laboratories Under a State Licensure Program, and Proficiency Testing and Inspection (HCFA-2239-FC) ...... 0938-AH82 1128 Allocation of Enhanced Federal Matching Funds for Increased Administrative Costs (MB-103-N) ...... 0938-AH90 1129 Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC) ...... 0938-AH92 1130 Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal Fiscal Year 1998 (HCFA- 2110-N) ...... 0938-AH93 1131 Revision to the Definition of an Unemployed Parent (HCFA-2106-FC) ...... 0938-AH98 1132 Health Insurance Reform: Parity in the Application of Certain Limits to Mental Health Benefits (HCFA-2891-IFC) ... 0938-AI05
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Health Care Financing AdministrationÐFinal Rule Stage (Continued)
Regulation Sequence Title Identifier Number Number
1133 Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F) ...... 0938-AI08 1134 Part A Premium for 1998 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (HCFA-5056-N) ...... 0938-AI10 1135 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for 1998 (HCFA- 5057-N) ...... 0938-AI12 1136 Health Insurance Portability: Newborns' and Mothers' Health Protection (HCFA-2892-IFC) ...... 0938-AI17 1137 Medicare Program: Update of Ambulatory Surgical Center Payment Rates Effective for Services On or Before Oc- tober 1, 1997 (HCFA-1897-N) ...... 0938-AI18 1138 Medicaid Program: Charges for Vaccine Administration Under the Vaccines for Children (VCF) Program (HCFA- 2084-FNC) ...... 0938-AI20 1139 Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC) ...... 0938-AI25 1140 Medicare Program; Notice for the Solicitation for Proposals for a Demonstration Project for Congestive Heart Fail- ure Case Management HCFA-1104-N) ...... 0938-AI26 1141 GME: Incentive Payments under Plans for Voluntary Reduction in Number of Residents (HCFA-1001-IFC) ...... 0938-AI27 1142 Medicare + Choice Program; Regulatory Program to Implement Certain Medicare Provisions of the Balanced Budget Act of 1997 (OMC-030-IFC) ...... 0938-AI29 1143 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities. (HCFA- 1913-IFC) ...... 0938-AI47 1144 Resource Based Practice Expense Payments and Revisions to Payment Policies for CY 1999 (HCFA-1006-P) ...... 0938-AI52 1145 Medicare Program; Definition of Provider-Sponsored Organization and Related Requirements (HCFA-1027-IFC) ... 0938-AI60
Health Care Financing AdministrationÐLong-Term Actions
Regulation Sequence Title Identifier Number Number
1146 Criteria and Procedures for Developing Medical Services Coverage Policy (HCFA-3546-F) ...... 0938-AD07 1147 Medicare Coverage of Outpatient Occupational Therapy Services (HCFA-1425-P) ...... 0938-AD32 1148 Changes to Peer Review Organization Regulations (HCFA-3135-F) ...... 0938-AD38 1149 Protection of Income and Resources for Community Spouses of Institutionalized Individuals (HCFA-2023-P) ...... 0938-AE12 1150 Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F) ...... 0938-AE39 1151 Revisions to Regulations Implementing CLIA (HCFA-2226-F) ...... 0938-AE47 1152 Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F) ...... 0938-AE72 1153 Payment for Nursing and Allied Health Science Education (HCFA-1685-F) ...... 0938-AE79 1154 Medicare Coverage of, and Application of the Outpatient Mental Health Treatment Limitation to, Clinical Psycholo- gist and Clinical Social Worker Services (HCFA-3706-F) ...... 0938-AE99 1155 Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC) ...... 0938-AF02 1156 Requirements for Certain Health Insuring Organizations and OBRA'90 Technical Amendments (HCFA-1018-F) ..... 0938-AF15 1157 Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P) ...... 0938-AF32 1158 Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F) ...... 0938-AF68 1159 Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P) ...... 0938-AF87 1160 Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth Scope of Work Contracts (HCFA-3207-N) ...... 0938-AG32 1161 Disclosure of Confidential PRO and ESRD Network Organization Information for Research Purposes (HCFA-3208- P) ...... 0938-AG33 1162 Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure Breathing Machine Ther- apy (HCFA-3781-FN) ...... 0938-AG44 1163 Revision of Medicare Hospital Conditions of Participation (HCFA-3745-F) ...... 0938-AG79 1164 Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening of Applicants for Nursing Home Admission (BPD-815-P) ...... 0938-AG84 1165 Clinical Laboratory Improvement Amendment (CLIA) Fee Schedule Revision (HCFA-3219-GNC) ...... 0938-AG87 1166 Categorization and Certification Requirements for a New Subcategory of Moderate Complexity Testing (HCFA- 2222-F) ...... 0938-AG98 1167 Additional Supplier Standards (HCFA-1864-P) ...... 0938-AH19 1168 Criteria and Procedures for Extending Coverage to Certain Devices and Related Services (HCFA-3841-F) ...... 0938-AH21 1169 Delegation of Civil Money Penalties (HCFA-6135-FC) ...... 0938-AH22 1170 Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P) ...... 0938-AH52
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Health Care Financing AdministrationÐLong-Term Actions (Continued)
Regulation Sequence Title Identifier Number Number
1171 Conditions for Certification of Community Mental Health Centers and Coverage Requirements for Partial Hos- pitalization Services (HCFA-1871-P) ...... 0938-AH58 1172 Medicaid Hospice Care (HCFA-2016-P) ...... 0938-AH65 1173 Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities Participating in an Experiment (HCFA-2236-GNC) ...... 0938-AH72 1174 Provider and Supplier Enrollment and Re-enrollment Requirements (HCFA-1023-P) ...... 0938-AH73 1175 Medicare Program; Medicare Integrity Program (HCFA-7020-P) ...... 0938-AI09 1176 Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998 and Sustainable Growth Rate For Fiscal Year 1998 (HCFA-1893-FN) ...... 0938-AI16 1177 Medicaid: Medical Child Support (HCFA-2081-P) ...... 0938-AI21 1178 Collection of User Fees From Medicare+Choice Plans and Risk-Sharing Contractors (HCFA-1911-IFC) ...... 0938-AI35 1179 Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F) ...... 0938-AI38 1180 Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualified Individuals: Federal Fiscal Year 1998 (HCFA-2005-NC) ...... 0938-AI39 1181 Medicare Program: Payments for Teleconsultations in Rural Health Professional Shortage Areas (HCFA-1906-P) .. 0938-AI44 1182 Medicare Program: User Fees (HCFA-6021-P) ...... 0938-AI46 1183 Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab. Agencies, Community Mental Health Centers, and Independent Diagnostic Testing Facilities (HCFA-1026-P) ...... 0938-AI48 1184 Administrative Appeals Process for Suppliers Seeking To Enroll in Medicare Program (HCFA-1907-FC) ...... 0938-AI49 1185 Medicare Program; Prospective Payment System for Hospital Outpatient (HCFA-1005-P) ...... 0938-AI56 1186 Security and Electronic Signature Standards (HCFA-0049-P) ...... 0938-AI57 1187 Surety Bond for Suppliers of Medical Equipment (HCFA-2007-P) ...... 0938-AI63 1188 Child Health Insurance Allotments FY 1999 (HCFA-2014-N) ...... 0938-AI64 1189 State Children Health Plan Allotments and Payments to States (HCFA-2114-FC) ...... 0938-AI65 1190 DSH Payments - Institution for Mental Disease (HCFA-2007-P) ...... 0938-AI66 1191 Medicaid Program; Home and Community-Based Services (HCFA-2010-FC) ...... 0938-AI67 1192 Revisions to Payment Policies Under the Physician Fee Schedule and Other Part B Payment Policies for Calendar Year 1999 and the Rebasing of the Medicare Economic Index (HCFA-1006-P) ...... 0938-AI69 1193 Managed Care: Global Medicaid Managed Care Provisions in the Balanced Budget Act of 1997 (HCFA-2001-P) ... 0938-AI70 1194 New and Pending Demonstration Project Proposals Submitted Pursuant to Section 1115(a) of the Social Security Act July, August, September, October, and November 1997 ...... 0938-AI71 1195 Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC) ...... 0938-AI73 1196 Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P) ...... 0938-AI74 1197 Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan (HCFA-1777-P) ...... 0938-AI75 1198 Medicare Program; Advertising Costs (HCFA-1880-P) ...... 0938-AI76 1199 Medicare Hospice Care (HCFA-1022-P) ...... 0938-AI77 1200 State Allotments for Additional Federal Funding of Emergency Health Services Furnished to Undocumented Aliens: Federal Fiscal Years 1998 Through 2001 ...... 0938-AI78 1201 Medicaid Program; Extension of Waiver To Extend Medicaid Eligibility Timeframes (HCFA-2009-N) ...... 0938-AI79 1202 Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and Elimination of Reclassifications (HCFA-1883-P) ...... 0938-AI80 1203 Medicare and Medicaid Programs; Surety Bond and Capitalization Requirements for Home Health Agencies (HCFA-1038-NC) ...... 0938-AI82 1204 Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC) ...... 0938-AI83 1205 Schedule of Per-Beneficiary Limitations on Home Health Agency Costs for Cost Reporting Periods Begining On or After October 1, 1997 (HCFA-1905-FC) ...... 0938-AI84 1206 Expanded Coverage of Blood Glucose Monitors and Test Strips (HCFA-3003-IFC) ...... 0938-AI85 1207 Surety Bond Requirements for Home Health Agencies (HCFA-1152.1-F) ...... 0938-AI86 1208 Hospice Wage Index Notice (HCFA-1039-N) ...... 0938-AI87 1209 Medicare Program; Standardization of Medicare Coverage for Bone Mass Measurements (HCFA-3004-IFC) ...... 0938-AI89 1210 Recognition of the American Association for Accreditation of Ambulatory Surgery Facilities Inc., for Ambulatory Surgical Centers Program (HCFA-2008-PN) ...... 0938-AI90
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Health Care Financing AdministrationÐCompleted Actions
Regulation Sequence Title Identifier Number Number
1211 Effective Dates for Provider Agreements and Supplier Approvals (HCFA-3139-F) ...... 0938-AC88 1212 Prohibition on Unbundling of Hospital Outpatient Services (HCFA-1426-F) ...... 0938-AD33 1213 Resident Assessment in Long-Term Care Facilities (HCFA-2180-F) ...... 0938-AE61 1214 Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F) ...... 0938-AE63 1215 Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech Pathology, and Occupational Therapy (HCFA-1808-F) ...... 0938-AG70 1216 Home Health Agency Physician Certification Regulations (BPD-875-NC) ...... 0938-AH59 1217 Medicare Program; Establishment of an Expedited Review Process for Medicare Beneficiaries Enrolled in HMOs, CMPs, and HCPPs (HCFA-1025-FC) ...... 0938-AH62 1218 Use of the OASIS as Part of the Conditions of Participation for Home Health Agencies (HCFA-3238-F) ...... 0938-AH74 1219 Medicare Program; Revisions to Payment Policies and Adjustments to the Relative Value Units Under the Physi- cian Fee Schedule, Other Part B Payment Policies for Calendar YR 1998 (HCFA-1884-FC) ...... 0938-AH94 1220 Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medicare Insurance Premium Rate Be- ginning January 1, 1998 (OACT-055-N) ...... 0938-AI03 1221 Schedule of Limits on Home Health Agency Cost Per Visit for Cost Reporting Periods Beginning On or After Octo- ber 1, 1997 (BPD-904-FC) ...... 0938-AI24 1222 Surety Bond and Capitalization Requirements for Home Health Agencies (HCFA-1152-FC) ...... 0938-AI31 1223 Health Insurance Portability and Accountability Act (HIPPA) of 1996: Administrative Simplification ...... 0938-AI32 1224 Medicare Program: Delay in Implementing Adjustments to Practice Expense Relative Value Units Under the Physi- cian Fee Schedule For Calendar Year 1998 (HCFA-1901-NC) ...... 0938-AI33 1225 Medicare Program; Limit on the Valuation of Depreciable Asset Recognized as an Allowance for Depreciation and Interest on Capital Indebtedness After a Change of Ownership (HCFA-1004-FC) ...... 0938-AI34 1226 Application of Inherent Reasonableness to All Medicare Part B Services (Other than Physician Services) (HCFA- 1908-IFC) ...... 0938-AI37 1227 Medicare Program: Request for Public Comments on Implementation of the Medicare+Choice Program and Notice of Timeframes for Submission of Applications for Contracts (HCFA-1014-N) ...... 0938-AI45
Administration for Children and FamiliesÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
1228 Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan Reviews, MEPA Implementa- tion, and ASFA Implementation ...... 0970-AA97 1229 Construction of Head Start Facilities ...... 0970-AB54 1230 Methodology for Determining Child Poverty Rates ...... 0970-AB65 1231 Bonus to Reward High Performance States Under the Temporary Assistance for Needy Families Block Grant ...... 0970-AB66 1232 Child Support Enforcement for Indian Tribes ...... 0970-AB73 1233 Requirements for the Tribal Programs ...... 0970-AB78 1234 Refugee Resettlement Program: Responding to TANF Replacing AFDC ...... 0970-AB83 1235 Child Support Non-Performance Penalty ...... 0970-AB85 1236 Child Abuse and Neglect Prevention and Treatment ...... 0970-AB86 1237 Head Start Appeal Timelines ...... 0970-AB87 1238 Title IV-E Training ...... 0970-AB89 1239 Family Child Care Program Option for Head Start Programs ...... 0970-AB90 1240 Implementation of Adoption & Safe Families Act of Remaining Provisions of the 1997 and Other Title IV-B/IV-E Regulatory Amendments ...... 0970-AB94
Administration for Children and FamiliesÐFinal Rule Stage
Regulation Sequence Title Identifier Number Number
1241 Standards for Safe Transportation ...... 0970-AB24 1242 Standards for Purchase of Facilities ...... 0970-AB31 1243 Designation of Alternative Agency To Serve Indian Tribal Children ...... 0970-AB52 1244 Quarterly Wage and Unemployment Compensation Claims Reporting to the National Directory of New Hires ...... 0970-AB67
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) HHS
Administration for Children and FamiliesÐFinal Rule Stage (Continued)
Regulation Sequence Title Identifier Number Number
1245 State Law Concerning Paternity Establishment ...... 0970-AB69 1246 Automated Data Processing Requirements/State Case Registry ...... 0970-AB70 1247 Automated Data Processing Funding Limitation ...... 0970-AB71 1248 Grants to States for Access and Visitation Programs ...... 0970-AB72 1249 Child Care and Development Fund ...... 0970-AB74 1250 Temporary Assistance for Needy Families (TANF) ...... 0970-AB77 1251 Bonus to Reward Decrease in Illegitimacy ...... 0970-AB79 1252 Child Support Enforcement Program Omnibus Conforming Regulation ...... 0970-AB81 1253 Case Closure ...... 0970-AB82 1254 Data Collection and Elements for the Welfare to Work Program ...... 0970-AB92
Administration for Children and FamiliesÐCompleted Actions
Regulation Sequence Title Identifier Number Number
1255 Income Eligibility Criteria for Indian Tribes ...... 0970-AB53 1256 Income and Resource Disregards Related to Interests of Individual Indians in Trust or Restricted Lands ...... 0970-AB59 1257 State Case Registry and Expansion of the Federal Parent Locator Service (FPLS) ...... 0970-AB68 1258 Personal Responsibility and Work Opportunity Reconciliation Act of 1996 Conforming Regulation ...... 0970-AB84 1259 Title IV-B Planning Requirements for Tribes ...... 0970-AB88
Administration on AgingÐProposed Rule Stage
Regulation Sequence Title Identifier Number Number
1260 Grants for State and Community Programs on Aging, Intrastate Funding Formulas; Training, Research and Discre- tionary Programs; Vulnerable Elder Rights; and Grants to Indians & Native Hawaiians ...... 0985-AA00
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS) Proposed RuleHHS—OS Stage
921. ∑ REVISED OIG SANCTION resulting from the Balanced Budget Act Timetable: AUTHORITIES RESULTING FROM of 1997, Public Law 105-33. These Action Date FR Cite PUBLIC LAW 105-33 proposed revisions would protect and NPRM 06/00/98 Priority: Substantive, Nonsignificant strengthen Medicare and other Federal health care programs by increasing the NPRM Comment 08/00/98 Legal Authority: PL 105-33, sec 4301; OIG’s anti-fraud and abuse authorities Period End PL 105-33, sec 4303; PL 105-33, sec through new or revised exclusion and Small Entities Affected: None 4304; PL 105-33, sec 4331(c); PL 105- CMP provisions, including new CMPs Government Levels Affected: None 33, sec 4331(d) (1) against institutional health care Agency Contact: Joel Jay Schaer, CFR Citation: 42 CFR 1001; 42 CFR provider that employ, or enter into Regulations Officer, Department of 1002; 42 CFR 1003 contracts for medical services with, excluded individuals; (2) for failure to Health and Human Services, Office of Legal Deadline: None report information to the Healthcare the Secretary, 330 Independence Abstract: This proposed rule would Integrity and Protection Data Bank; and Avenue, OCIG, Washington, DC 20201 revise the OIG’s exclusion and civil (3) for health care providers who Phone: 202 619-0089 money penalty (CMP) authorities violate the anti-kickback statute. RIN: 0991–AA95
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS) Final RuleHHS—OS Stage
922. CLARIFICATION OF THE INITIAL 923. REPRODUCTION AND SALE OF Abstract: This final rule addresses OIG SAFE HARBOR PROVISIONS AND OFFICIAL FORMS AND revisions to the OIG’s sanction ESTABLISHMENT OF ADDITIONAL PUBLICATIONS authorities in conjunction with sections SAFE HARBOR PROVISIONS UNDER Priority: Info./Admin./Other 211, 212, and 213 resulting from the THE ANTI-KICKBACK STATUTE Health Insurance Portability and Legal Authority: PL 103-296, sec 312 Accountability Act of 1996, along with Priority: Other Significant (42 USC 1320b-10) other technical and conforming changes CFR Citation: 45 CFR 101 to the OIG exclusion authorities. The Reinventing Government: This revisions are specifically designed to rulemaking is part of the Reinventing Legal Deadline: None expand the protection of certain basic Government effort. It will revise text in Abstract: This interim final rule with fraud authorities and revise and the CFR to reduce burden or comment period will establish strengthen the current legal authorities duplication, or streamline procedures for implementation of pertaining to exclusions from Medicare requirements. section 312 of the Social Security and and other Federal health care Independence Act. That section amends Legal Authority: programs. PL 100-93, Sec 2; PL existing prohibitions against ‘‘misuse of 100-93, Sec 14 symbols, emblems, or names in Timetable: CFR Citation: 42 CFR 1001 reference to Social Security or Action Date FR Cite Medicare.’’ Section 312 newly prohibits NPRM 09/08/97 62 FR 47182 Legal Deadline: the ‘‘unauthorized reproduction, None NPRM Comment 11/07/97 reprinting, or distribution for fee’’ of a Abstract: This final rule serves both to Period End ‘‘form, application, or other publication Final Action 08/00/98 clarify various aspects of the original of the Social Security Administration safe harbor provisions and to add new or of the Department of Health and Small Entities Affected: None safe harbors as authorized under Human Services’’. It requires prior Government Levels Affected: None section 14 of PL 100-93. Specifically, authorization for any such activity in Agency Contact: this rule modifies the original set of accordance with the Secretary’s Joel Jay Schaer, final safe harbor provisions (56 FR regulations. The Department plans to Regulations Officer, Department of 35952, 7/29/91) to give greater clarity distinguish between forms and Health and Human Services, Office of to the rulemaking’s original intent. In publications that potentially involve the Secretary, Office of Inspector addition, this rule sets forth an misuse in contrast to benign or General, OCIG, 330 Independence expanded listing of safe harbor desirable reproductions and Avenue SW., Washington, DC 20201 provisions designed to protect distributions, and to provide pre- Phone: 202 619-0089 additional payment and business authorization for the latter. The rule RIN: 0991–AA87 practices from criminal prosecution and will be developed in consultation with civil sanctions under the anti-kickback the Social Security Administration. statute. 925. REVISED OIG CIVIL MONEY Timetable: PENALTIES RESULTING FROM Timetable: Action Date FR Cite PUBLIC LAW 104-191 Action Date FR Cite Interim Final Rule 06/00/98 Priority: Substantive, Nonsignificant NPRM 09/21/93 58 FR 49008 Small Entities Affected: None Legal Authority: PL 104-191, sec 231(a); PL 104-191, sec 231(b); PL 104- NPRM Comment 11/22/93 Government Levels Affected: None Period End 191, sec 231(c); PL 104-191, sec 231(d); Agency Contact: Suzanne Stoiber, Final Action 11/00/98 PL 104-191, sec 231(e); PL 104-191, sec Deputy Assistant Secretary for Planning 231(h); PL 104-191, sec 232 and Evaluation, Department of Health Small Entities Affected: None CFR Citation: 42 CFR 1003; 42 CFR and Human Services, Office of the 1005; 42 CFR 1006 Government Levels Affected: None Secretary, 200 Independence Avenue SW., Washington, DC 20201 Legal Deadline: None Additional Information: This final rule Phone: 202 690-8291 incorporates the safe harbor Abstract: This final rule will revise the clarification provisions previously RIN: 0991–AA83 OIG’s civil money penalty provisions in addressed in RIN 0991-AA74 and set conjunction with new and revised authorities set forth in the Health forth in proposed rulemaking 924. REVISED OIG EXCLUSION (59FR37202, July 21, 1994). Insurance Portability and AUTHORITIES RESULTING FROM Accountability Act of 1996. Among PUBLIC LAW 104-191 Agency Contact: Joel Jay Schaer, other provisions, this final rulemaking Regulations Officer, Office of Inspector Priority: Substantive, Nonsignificant would codify new civil money General, OCIG, Department of Health Legal Authority: PL 104-191, sec 211; penalties for (1) excluded individuals and Human Services, Office of the PL 104-191, sec 212; PL 104-191, sec retaining ownership or control interest Secretary, 330 Independence Avenue 213 in an entity; (2) upcoding and claims SW., Washington, DC 20201 for medically unnecessary services; (3) CFR Citation: 42 CFR 1000; 42 CFR Phone: 202 619-0089 offering inducements to beneficiaries; 1001; 42 CFR 1002; 42 CFR 1005 and (4) false certification of eligibility RIN: 0991–AA66 Legal Deadline: None for home health services.
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DEPARTMENT OF HEALTH AND OfficeHUMAN of theSERVICESFinal Secretary Rule (HHS) Stage(OS) HHSÐOS Final Rule Stage
Timetable: forth an exception from liability for Government effort. It will revise text in Action Date FR Cite remuneration between an eligible the CFR to reduce burden or organization under section 1876 of the duplication, or streamline NPRM 03/25/98 63 FR 14393 Social Security Act and an individual requirements. NPRM Comment 05/26/98 or entity providing items or services in Period End accordance with a written agreement Legal Authority: 42 USC 1320a-7d(b) Final Action 12/00/98 between these parties. The rule would CFR Citation: 42 CFR 1008 Small Entities Affected: None also allow remuneration between an organization and an individual or entity Government Levels Affected: None Legal Deadline: Final, Statutory, if a written agreement places the February 21, 1997. Agency Contact: Joel Jay Schaer, individual or entity at ‘‘substantial Regulations Officer, Department of financial risk’’ for the cost or utilization Abstract: This final rule sets forth the Health and Human Services, Office of of the items or services which the specific procedures by which the OIG, the Secretary, Office of the Inspector individual or entity is obligated to in consultation with the Department of General, OCIG, 330 Independence provide. Justice, will issue advisory opinions to Avenue SW., Washington, DC 20201 Timetable: outside parties regarding the Phone: 202 619-0089 Action Date FR Cite interpretation and applicability of RIN: 0991–AA90 certain statutes relating to the Medicare ANPRM 05/23/97 62 FR 28410 and State health care programs. ANPRM Comment 06/09/97 926. SHARED RISK EXCEPTION TO Period End Timetable: THE SAFE HARBOR PROVISIONS Interim Final Rule 10/00/98 Action Date FR Cite Priority: Substantive, Nonsignificant Small Entities Affected: None Interim Final Rule 02/19/97 62 FR 7350 Reinventing Government: This Government Levels Affected: None Final Action 07/00/98 rulemaking is part of the Reinventing Agency Contact: Joel Jay Schaer, Government effort. It will revise text in Regulations Officer, Department of Small Entities Affected: None the CFR to reduce burden or Health and Human Services, Office of duplication, or streamline the Secretary, Office of Inspector Government Levels Affected: None requirements. General, OCIG, 330 Independence Agency Contact: Joel Schaer, Legal Authority: 42 USC 1302 sec 216; Avenue SW., Washington, DC 20201 Phone: 202 619-0089 Regulations Officer, Department of 42 USC 1320a-7b; 42 USC 1395hh Health and Human Services, Office of RIN: 0991–AA91 CFR Citation: 41 CFR 1001 the Secretary, Office of Inspector Legal Deadline: Final, Statutory, General, 330 Independence Avenue January 1, 1997. 927. ISSUANCE OF ADVISORY SW., Washington, DC 20201 OPINIONS BY THE INSPECTOR Phone: 202 619-0089 Abstract: This interim final rule would GENERAL establish a new statutory exception for RIN: 0991–AA94 risk-sharing arrangements under the Priority: Substantive, Nonsignificant Federal health care programs anti- Reinventing Government: This kickback provisions. The rule would set rulemaking is part of the Reinventing
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Office of the Secretary (OS) Long-TermHHS—OS Actions
928. CIVIL MONEY PENALTIES (CMPS) services provided to Medicare or Agency Contact: Joel Jay Schaer, FOR CERTAIN HOSPITAL PHYSICIAN Medicaid beneficiaries who are under Regulations Officer, Department of INCENTIVE PLANS the direct care of that physician. The Health and Human Services, Office of rule would also set forth standards the Secretary, Office of Inspector Priority: Substantive, Nonsignificant governing the imposition of CMPs for General, OCIG, 330 Independence Legal Authority: PL 99-509, Sec each such individual for whom Avenue SW., Washington, DC 20201 9313(c); PL 101-239, Sec 6003(g)(3); PL payments are made. Phone: 202 619-0089 101-508, Sec 4204(a)(3); PL 101-508, RIN: 0991–AA45 Sec 4731(b)(1) Timetable: Action Date FR Cite CFR Citation: 42 CFR 1001; 42 CFR 929. CIVIL MONEY PENALTIES (CMPS) 1003 NPRM 12/01/94 59 FR 61571 FOR CERTAIN PRACTICES RELATING NPRM Comment 01/30/95 Legal Deadline: None TO MEDICARE SUPPLEMENTAL Period End POLICIES Abstract: This final rule will prohibit Final Action 00/00/00 a hospital from knowingly making Priority: Substantive, Nonsignificant Small Entities Affected: None incentive payments to a physician as Legal Authority: PL 100-360, Sec an inducement to reduce or limit Government Levels Affected: None 428(b); PL 101-508, Sec 4204(g)(1); PL
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DEPARTMENT OF HEALTH AND OfficeHUMAN of Long-TermtheSERVICES Secretary Actions(HHS) (OS) HHSÐOS Long-Term Actions
101-508, Sec 4351; PL 101-508, Sec individual or entity that notifies, or Agency Contact: Joel Jay Schaer, 4354(a)(1)(E); PL 101-508, Sec causes to notify, a home health agency, Regulations Officer, Department of 4354(a)(2); PL 101-508, Sec 4355(a); PL or a home or community-based health Health and Human Services, Office of 101-508, Sec 4357 care center or provider, of the time or the Secretary, Office of Inspector CFR Citation: 42 CFR 1003 date on which a standard survey is General, OCIG, 330 Independence scheduled to be conducted by a State Avenue SW., Washington, DC 20201 Legal Deadline: None or local agency. Phone: 202 619-0089 Abstract: This rule would authorize Timetable: CMPs against any individual or entity RIN: 0991–AA80 who knowingly and willfully uses Action Date FR Cite misleading or fraudulent practices in NPRM 00/00/00 932. SENIOR BIOMEDICAL the advertisement, solicitation, offering RESEARCH SERVICES for sale or delivery of Medicare Small Entities Affected: Undetermined supplemental health insurance Government Levels Affected: Priority: Info./Admin./Other (Medigap) policies. Penalties would Undetermined Legal Authority: 42 USC 228 also be established for failure to (1) Agency Contact: Joel Jay Schaer, meet Medigap policy loss-ratio Regulations Officer, Department of CFR Citation: 42 CFR 24 requirements, (2) comply with policy Health and Human Services, Office of simplification standards, or (3) obtain Legal Deadline: None the Secretary, Office of Inspector Secretarial certification of Medigap General, OCIG, 330 Independence Abstract: This regulation implements policies in States with non-approved Avenue SW., Washington, DC 20201 regulatory programs. In addition, this the Senior Biomedical Research Service Phone: 202 619-0089 rule would also set forth CMPs for the (SBRS), a personnel system established failure of sellers or issuers to solicit RIN: 0991–AA79 in the Public Health Service by section information, and to provide notice, 304 of Public Law 101-509. The SBRS about Medicaid status and eligibility will consist of 500 members appointed 931. CIVIL MONEY PENALTIES FOR by the Secretary without regard to the before selling or issuing Medigap FALSE INFORMATION ON DRUG policies. provisions of title 5, U.S. Code, MANUFACTURER PRICE SURVEYS regarding appointment, who are Timetable: AND REBATE AGREEMENTS outstanding in the field of biomedical Action Date FR Cite Priority: Substantive, Nonsignificant research or clinical research evaluation. NPRM 00/00/00 Appointments to the SBRS will be only Legal Authority: 42 USC 1302; 42 USC to individuals with doctoral-level Small Entities Affected: Undetermined 1396r-8 degrees in biomedicine or a related Government Levels Affected: CFR Citation: 42 CFR 1003 field. The regulation describes basic Undetermined Legal Deadline: None eligibility criteria, pay rates, performance appraisal system, optional Agency Contact: Joel Jay Schaer, Abstract: This proposed rule would set Regulations Officer, Department of retirement system, and procedure for forth civil money penalties against any removal from the SBRS. Health and Human Services, Office of manufacturer of covered outpatient the Secretary, Office of Inspector drugs thatfails to respond to a request Timetable: General, OCIG, 330 Independence for information about charges or prices, Action Date FR Cite Avenue SW., Washington, DC 20201 or knowingly provide false information, Phone: 202 619-0089 in a survey by the Secretary to verify Interim Final Rule 02/21/96 61 FR 6557 RIN: 0991–AA53 manufacturers’ reported prices under Interim Final Rule 03/31/96 Comment Period the Medicaid drug rebate program. In End 930. CIVIL MONEY PENALTIES FOR addition, this rule would set forth civil Final Action 00/00/00 NOTIFYING A HOME HEALTH money penalties against any drug AGENCY, OR A HOME OR manufacturer that, in accordance with Small Entities Affected: None section 1927(b)(3)(A) of the Social COMMUNITY-BASED HEALTH CARE Government Levels Affected: Federal CENTER OR PROVIDER, OF A Security Act, fails to provide rebate STANDARD SURVEY agreement price information on a Agency Contact: Rosemary Taylor, timely basis. Priority: Substantive, Nonsignificant Personnel Management Specialist, Timetable: Department of Health and Human Legal Authority: 42 USC 1395bbb; 42 Action Date FR Cite Services, Office of the Secretary, 200 USC 1396t Independence Avenue SW., Room CFR Citation: 42 CFR 1003 NPRM 00/00/00 522A, Washington, DC 20201 Legal Deadline: None Small Entities Affected: Undetermined Phone: 202 690-7358 Fax: 202 690-6758 Abstract: This proposed rule would set Government Levels Affected: forth civil money penalties against any Undetermined RIN: 0991–AA82
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS) CompletedHHS—OS Actions
933. CIVIL MONEY PENALTIES FOR Small Entities Affected: None CFR Citation: 45 CFR 74; 45 CFR 92; REFERRALS TO ENTITIES AND FOR 45 CFR 96 PROHIBITED ARRANGEMENTS AND Government Levels Affected: None Completed: SCHEMES Agency Contact: Joel Jay Schaer Priority: Substantive, Nonsignificant Phone: 202 619-0089 Reason Date FR Cite Reinventing Government: No Further Action 10/28/97 This RIN: 0991–AA65 rulemaking is part of the Reinventing Required Government effort. It will revise text in Small Entities Affected: None the CFR to reduce burden or 934. ADMINISTRATIVE duplication, or streamline REQUIREMENTS FOR GRANTEES TO Government Levels Affected: State, requirements. REFLECT SINGLE AUDIT ACT Local, Tribal CFR Citation: AMENDMENTS 42 CFR 1001; 42 CFR Agency Contact: Charles Gale 1003 Priority: Info./Admin./Other Phone: 202 690-6377 Completed: TDD: 202 690-6902 Unfunded Mandates: This action may Fax: 202 690-6415 Reason Date FR Cite affect State, local or tribal governments Final Action 10/20/93 58 FR 54096 and the private sector. RIN: 0991–AA92
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA) Long-TermHHS—SAMHSA Actions
935. BLOCK GRANTS FOR provisions would replace the existing Government Levels Affected: State, PREVENTION AND TREATMENT OF interim final rule published March 31, Tribal SUBSTANCE ABUSE 1993. Given the pending Additional Information: Previously Priority: Other Significant reauthorization of SAMHSA and the current Administration’s FY 1996 reported under RIN 0905-AD98. Legal Authority: 42 USC 300-x et seq, legislative proposal to turn the block as amended by PL 102-321 Alternate Contact: Jim Sayers, DSP, C grant into a ‘‘Performance Partnership,’’ SAT SAMHSA, 5515 Security Lane, CFR Citation: 45 CFR 96 publication of this regulation has been Suite 800, Rockville, MD 20852; 301- Legal Deadline: Final, Statutory, put on hold. 443-3820. August 25, 1992. Timetable: Awards to States after January 1, 1993 Agency Contact: Joseph D. Faha, cannot be made until implementing Action Date FR Cite Director, DLEA, SAMHSA, Department regulations are published. Interim Final Rule 03/31/93 58 FR 17062 of Health and Human Services, Interim Final Rule 06/01/93 Substance Abuse and Mental Health Abstract: Sets requirements for block Services Administration, 5600 Fishers grants for prevention and treatment of Comment Period End Lane, Room 12C-15, Rockville, MD substance abuse. The requirements Final Action 00/00/00 20857 include criteria for approval of State Phone: 301 443-4640 plans which must by statute be Small Entities Affected: Governmental prescribed in regulations. These Jurisdictions, Organizations RIN: 0930–AA01
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Substance Abuse and Mental Health Services Administration (SAMHSA) CompletedHHS—SAMHSA Actions
936. PROTECTION AND ADVOCACY Completed: Government Levels Affected: State, FOR INDIVIDUALS WITH MENTAL Reason Date FR Cite Local ILLNESS Final Action 10/15/97 62 FR 53548 Agency Contact: Joseph D. Faha Priority: Substantive, Nonsignificant Phone: 301 443-4640 Small Entities Affected: Governmental CFR Citation: 45 CFR 51 Jurisdictions, Organizations RIN: 0930–AA02
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Departmental Management (HHSDM) ProposedHHS—HHSDM Rule Stage
937. IMPLEMENTATION OF THE Contract with America Advancement Small Entities Affected: None EQUAL ACCESS TO JUSTICE ACT IN Act of 1996, which increased the AGENCY PROCEEDINGS amount of the hourly fees payable. The Government Levels Affected: None Priority: Substantive, Nonsignificant proposed rule revises 45 CFR Part 13 Agency Contact: Leslie L. Clune, (HHS’ regulation implementing the Associate General Counsel, Business Legal Authority: 5 USC 504(c)(1) Equal Access to Justice Act) to conform and Administrative Law Division, CFR Citation: 45 CFR 13 with statutory changes. Department of Health and Human Legal Deadline: None Timetable: Services, Room 5362, HHS Cohen Abstract: The Equal Access to Justice Building, 330 Independence Avenue Action Date FR Cite Act requires agencies to pay fees to SW., Washington, DC 20201 parties prevailing against the NPRM 06/19/87 52 FR 23311 Phone: 202 619-0150 government in certain administrative NPRM Comment 08/17/87 proceedings. The Act has been Period End RIN: 0990–AA02 amended several times since its 1980 Second NPRM 06/00/98 enactment, most recently by the Final Action 08/00/98
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Food and Drug Administration (FDA) PreruleHHS—FDA Stage
938. ANIMAL DRUG APPROVALS FOR Timetable: part, that FDA establish safe handling MINOR SPECIES AND MINOR USAGE Action Date FR Cite statements for shell eggs. FDA intends to propose to require safe handling Priority: Other Significant. Major status ANPRM 06/23/97 62 FR 33781 statements on labeling of shell eggs that under 5 USC 801 is undetermined. Notice of Availability 04/00/98 have not been treated to destroy Salmonella microorganisms that may be Legal Authority: PL 104-250 Small Entities Affected: Undetermined present. In accordance with Government Levels Affected: None CFR Citation: Not yet determined amendments to the Egg Products Additional Information: Request for Inspection Act, USDA proposed on Legal Deadline: Other, Statutory, April Comments 62 FR 33789, 6/23/97. October 27, 1992, to require that shell 9, 1998. Agency Contact: Linda Wilmot, eggs be stored at an ambient Animal Drug Availability Act of 1996. Veterinary Medical Officer, Department temperature of 7 degrees celcius (45 of Health and Human Services, Food degrees farenheit). USDA intends to Abstract: The Animal Drug Availability and Drug Administration, Center for finalize that requirement shortly. Act of 1996 (ADAA) requires FDA to Veterinary Medicine (HFV-112), 7500 However, the USDA rulemaking does consider legislative and regulatory Standish Place, Rockville, MD 20855 not include refrigeration at retail. As options for facilitating approval of new Phone: 301 594-0614 part of separate rulemaking, FDA animal drugs intended for use in minor intends to propose regulations, based species and for minor uses, and to RIN: 0910–AB07 on recommended provisions of the announce no later than April 9, 1998, Retail Food Code, to mandate that shell proposals for legislative or regulatory 939. ∑ SHELL EGGS: WARNING, eggs be stored for retail sale at 5 change to the approval process for such NOTICE AND SAFE HANDLING degrees celsius (41 degrees fahrenheit) drugs. Because the markets are small LABELING STATEMENTS AND or less. FDA is proposing this measure for approved new animal drugs REFRIGERATION REQUIREMENTS to ensure that shell eggs are handled intended for minor species or for minor in a manner to decrease the possible Priority: uses, there are often insufficient Other Significant. Major status growth of any SE that may be present economic incentives to motivate under 5 USC 801 is undetermined. in shell eggs. All of these actions are sponsors to develop the data necessary Legal Authority: 21 USC 321; 42 USC intended to reduce the occurrence of to support approvals. Manufacturers 264 illnesses and deaths associated with the have not, in many cases, been willing CFR Citation: 21 CFR 101.17(g); 21 consumption of improperly cooked to fund research to obtain these data, CFR 1240.63 shell eggs. so only small numbers of new animal Timetable: drugs intended for minor species or for Legal Deadline: None minor uses have been approved and are Abstract: There have been numerous Action Date FR Cite legally marketed. Facilitating approvals foodborne outbreaks of Salmonellosis, ANPRM 09/00/98 for minor uses and minor species will principally due to Salmonella Small Entities Affected: Undetermined bring about an increase in approvals of Enteritidis, that have been traced to the new animal drugs intended for these consumption of temperature abused Government Levels Affected: uses, which would be desirable to and/or undercooked shell eggs. The Undetermined address the scarcity of approved, Food and Drug Administration has Agency Contact: Geraldine A. June, legally marketed new animal drugs received petitions from Rose Acres Consumer Safety Officer, Department of intended for minor species or minor Farm, Inc., and the Center for Science Health and Human Services, Food and uses. in the Public Interest that request, in Drug Administration, Center for Food
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration SERVICESPrerule (HHS) (FDA)Stage HHSÐFDA Prerule Stage
Safety and Applied Nutrition, (HFS- Timetable: of 1997 added a new section to the 158), 200 C Street SW., Washington, DC Action Date FR Cite Federal Food, Drug, and Cosmetic Act 20204 that requires the agency to distinguish Phone: 202 205-5099 ANPRM 07/00/98 between moderate and minimal Fax: 202 205-4594 ANPRM Comment 10/00/98 manufacturing changes and to establish Email: [email protected] Period End systems for determining what Small Entities Affected: Undetermined information the agency would require RIN: 0910–AB30 Government Levels Affected: before drugs manufactured subject to Undetermined these changes may be distributed. The 940. ∑ ELECTRONIC SUBMISSION OF Center for Veterinary Medicine is Agency Contact: ADVERSE DRUG REACTION Thomas Kuchenberg, proposing to amend the regulations REPORTS Regulatory Counsel, Regulatory Policy regarding supplementary new animal Staff, Department of Health and Human drug regulations to incorporate the Priority: Other Significant. Major status Services, Food and Drug requirements of section 116. under 5 USC 801 is undetermined. Administration, Center for Drug Evaluation and Research (HFD-7), 1451 Unfunded Mandates: Undetermined Timetable: Rockville Pike, Suite 3047, Rockville, Action Date FR Cite Legal Authority: 21 USC 216; 21 USC MD 20852 262; 21 USC 263; 21 USC 263a; 21 USC Phone: 301 594-2041 ANPRM 05/00/98 264; 21 USC 300aa; 21 USC 321; 21 Fax: 301 827-5562 NPRM 12/00/98 USC 331; 21 USC 251 to 353; 21 USC RIN: 0910–AB42 Small Entities Affected: 355 to 357; 21 USC 371; 21 USC 374 Undetermined CFR Citation: 21 CFR 20; 21 CFR 310; Government Levels Affected: 941. ∑ SUPPLEMENTAL Undetermined 21 CFR 312; 21 CFR 314; 21 CFR 600 MANUFACTURING CHANGES FOR Legal Deadline: None NEW ANIMAL DRUGS Agency Contact: William Marnane, Priority: Substantive, Nonsignificant Department of Health and Human Abstract: This advance notice of Services, Food and Drug proposed rulemaking will discuss and Legal Authority: PL 105-115, sec 116 Administration, Center for Veterinary request comments on the electronic CFR Citation: 21 CFR 514.8 Medicine (HFV-200), 7500 Standish submission of adverse drug reaction Legal Deadline: None Place, Rockville, MD 20855 reports using international medical Phone: 301 594-0678 terminology, electronic data format, and Abstract: Section 116 of the Food and electronic transmission standards. Drug Administration Modernization Act RIN: 0910–AB49
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Food and Drug Administration (FDA) Proposed HHS—FDARule Stage
942. OVER-THE-COUNTER (OTC) drugs meeting the conditions of the Protectant Products.’’ NPRM for DRUG REVIEW monograph, or having an approved new ‘‘Mercurial (Topical) Products’’ was Priority: Routine and Frequent drug application, may be legally included in revised NPRM for marketed. NOTE: NPRM for ‘‘Antidotes, ‘‘Antimicrobial Products.’’ NPRM for Reinventing Government: This Toxic Ingestion Products’’ was ‘‘Alcohol (Topical) Products’’ was rulemaking is part of the Reinventing combined with NPRM for ‘‘Emetic included in revised NPRM for Government effort. It will eliminate Products’’ and reproposed as ‘‘Poison ‘‘Antimicrobial Products.’’ The NPRM existing text in the CFR. Treatment Products.’’ NPRM for for ‘‘Antimicrobial Products’’ was Legal Authority: 21 USC 321p; 21 USC ‘‘Astringent (Wet Dressings) Products’’ updated and split into two sections: 351; 21 USC 352; 21 USC 353; 21 USC was included in the NPRM for ‘‘Skin First Aid Products and Health Care 355; 21 USC 360a; 21 USC 371a Protectant Products.’’ NPRM for Antiseptic Products. CFR Citation: 21 CFR 310; 21 CFR 330; ‘‘Diaper Rash Products’’ was included in NPRMs for ‘‘Antifungal,’’ SMALL ENTITIES AFFECTED: The 21 CFR 333; 21 CFR 334; 21 CFR 335; effects, if any, vary depending on the 21 CFR 336; 21 CFR 337; 21 CFR 338; ‘‘Antimicrobial,’’ ‘‘External Analgesic’’ individual rulemaking. However, the 21 CFR 339; 21 CFR 340; 21 CFR 341; and ‘‘Skin Protectant Products.’’ NPRM Agency anticipates that the rules would 21 CFR 342; 21 CFR 343; 21 CFR 344; for ‘‘Fever Blister/Cold Sore Products not have a significant economic impact 21 CFR 345; ... (External)’’ was included in NPRMs for ‘‘External Analgesic’’ and ‘‘Skin on a substantial number of small Legal Deadline: None Protectant Products.’’ NPRM for ‘‘Insect entities as defined by the Regulatory Abstract: The OTC drug review Bites and Stings (Relief) Products’’ was Flexibility Act. establishes conditions under which included in NPRMs for ‘‘External OTC drugs are considered generally Analgesic’’ and ‘‘Skin Protectant recognized as safe and effective and not Products.’’ ‘‘Poison Ivy/Oak/Sumac misbranded. After a final monograph Prevention’’ was included in NPRMs (i.e., final rule) is issued, only OTC for ‘‘External Analgesic’’ and ‘‘Skin
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DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Timetable: Anticaries Products Benign Prostatic Hypertrophy Products ANPRM 03/28/80 (45 FR 20666) ANPRM 10/01/82 (47 FR 43566) Acne (Topical) Products NPRM 09/30/85 (50 FR 39854) NPRM 02/20/87 (52 FR 5406) ANPRM 03/23/82 (47 FR 12430) NPRM 06/15/88 (53 FR 22430) Final Action 02/27/90 (55 FR 6926) NPRM 01/15/85 (50 FR 2172) Final Action 10/06/95 (60 FR 52474) Boil Ointments NPRM (Amendment) 08/07/91 (56 FR Final Action (Technical Amendment) ANPRM 06/29/82 (47 FR 28306) 37622) 10/07/96 (61 FR 52285) NPRM 01/26/88 (53 FR 2198) Antidiarrheal Products Final Action 08/16/91 (56 FR 41008) Final Action 11/15/93 (58 FR 60332) ANPRM 03/21/75 (40 FR 12924) Alcohol (Oral) in OTC Drug Products Camphorated Oil Drug Products NPRM 04/30/86 (51 FR 16138) NPRM 10/21/93 (58 FR 54466) ANPRM 09/26/80 (45 FR 63869) Final Action 03/13/95 (60 FR 13590) NPRM (Amendment)(Trav. Diar.) 06/00/99 Final Action 06/00/99 Final Action 09/21/82 (47 FR 41716) NPRM (Amendment) 05/10/96 (61 FR Cholecystokinetic Products 21392) Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts) ANPRM 02/12/80 (45 FR 9286) Final Action (Amendment) 11/18/96 (61 ANPRM 01/05/82 (47 FR 444) NPRM 08/24/82 (47 FR 37068) FR 58629) Antiemetic Products Final Action 06/10/83 (48 FR 27004) Alcohol (Topical) Products (To be merged ANPRM 03/21/75 (40 FR 12934) NPRM (Amendment) 08/15/88 (53 FR w/other rulemkg) NPRM 07/13/79 (44 FR 41064) 30786) ANPRM 05/21/82 (47 FR 22324) Final Action 04/30/87 (52 FR 15886) Final Action (Amendment) 02/28/89 (54 Anorectal Products NPRM (Amendment) 08/26/93 (58 FR FR 8320) ANPRM 05/27/80 (45 FR 35576) 45216) Corn and Callus Remover Products NPRM 08/15/88 (53 FR 30756) Final Action 04/11/94 (59 FR 16981) ANPRM 01/05/82 (47 FR 522) Final Action 08/03/90 (55 FR 31776) NPRM (Amendment)(Warning) 08/29/97 NPRM 02/20/87 (52 FR 5412) Final Action (LYCD) 09/02/93 (58 FR (62 FR 45767) Final Action 08/14/90 (55 FR 33258) 46746) Antiflatulent Drug Products Cough/Cold (Anticholinergic) Products Final Action (Witch Hazel) 06/03/94 (59 FR NPRM 11/12/73 (38 FR 31260) ANPRM 09/09/76 (41 FR 38312) 28766) Final Action 06/04/74 (39 FR 19877) NPRM 07/09/82 (47 FR 30002) Antacid Drug Products NPRM (Amendment) 01/29/88 (53 FR Final Action 11/08/85 (50 FR 46582) ANPRM 04/05/73 (38 FR 8714) 2716) Cough/Cold (Antihistamine) Products NPRM 11/12/73 (38 FR 31260) Final Action (Amendment) 03/05/96 (61 ANPRM 09/09/76 (41 FR 38312) Final Action 06/04/74 (39 FR 9862) FR 8836) NPRM 01/15/85 (50 FR 2200) NPRM (Amendment) (Overindulgence) Antifungal (Topical) Products 12/24/91 (56 FR 66754) ANPRM 03/23/82 (47 FR 12480) NPRM (Amendment) 08/24/87 (52 FR NPRM 12/12/89 (54 FR 51136) Final Action (Amendment) (Warning) 31892) NPRM (Amendment) (Diaper Rash) 08/26/93 (58 FR 45204) Final Action 12/09/92 (57 FR 58356) 06/20/90 (55 FR 25240) NPRM (Amendment) (Testing) 09/23/93 Final Action (Amendment)(Warning) Final Action (Amdt.)(Diaper Rash) (58 FR 49826) 01/28/94 (59 FR 4216) 12/18/92 (57 FR 60430) NPRM (Amendment)(Warning) 08/29/97 NPRM (Amendment)(Sodium Bicarb.) Final Action (Partial) 09/02/93 (58 FR 02/02/94 (59 FR 5060) (62 FR 45767) 46744) Cough/Cold (Antitussive) Products Final Action (Technical Amendment) Final Action 09/23/93 (58 FR 49890) ANPRM 09/09/76 (41 FR 38312) 11/25/94 (59 FR 60555) Antimicrobial Products NPRM 10/19/83 (48 FR 48576) Final Action (Amendment) (Testing) ANPRM 09/13/74 (39 FR 33103) 02/08/96 (61 FR 4822) NPRM 01/06/78 (43 FR 1210) Final Action 08/12/87 (52 FR 30042) Final Action (Amendment)(Sodium B.) NPRM (Amendment) (Diaper Rash) NPRM (Amendment) 07/06/89 (54 FR 08/00/98 06/20/90 (55 FR 25246) 28442) Anthelmintic Products Antiperspirant Products NPRM (Amendment) 10/02/89 (54 FR ANPRM 09/09/80 (45 FR 59541) ANPRM 10/10/78 (43 FR 46694) 40412) NPRM 08/24/82 (47 FR 37062) NPRM 08/20/82 (47 FR 36492) Final Action (Amendment) 07/06/90 (55 Final Action 08/01/86 (51 FR 27756) Final Action 12/00/98 FR 27806) Antibiotic First Aid Products Antiseptic First Aid Final Action (Amendment) 10/03/90 (55 ANPRM 04/01/77 (42 FR 17642) ANPRM 09/13/74 (39 FR 33103) FR 40381) NPRM 07/09/82 (47 FR 29986) NPRM 01/06/78 (43 FR 1210) NPRM (Amendment)(Warning) 06/19/92 Final Action 12/11/87 (52 FR 47312) NPRM (Revised) 07/22/91 (56 FR 33644) (57 FR 27666) Final Action 00/00/00 NPRM (Amendment) 08/18/89 (54 FR NPRM (Amendment)(Ingredients) Antiseptic Products (Professional Use) 34188) 12/09/92 (57 FR 58378) ANPRM 09/13/74 (39 FR 33103) Final Action 03/15/90 (55 FR 9721) Final Action (Amendment)(Warning) NPRM 01/06/78 (43 FR 1210) 10/20/93 (58 FR 54232) NPRM (Amendment) 05/11/90 (55 FR NPRM (Revised) 06/17/94 (59 FR 31402) 19868) Final Action (Amdt.)(Ingredients) 06/03/94 Aphrodisiac Products (59 FR 29172) NPRM (Amendment) 06/08/90 (55 FR ANPRM 10/01/82 (47 FR 43572) 23450) NPRM (Amendment)(Warning) 08/29/97 NPRM 01/15/85 (50 FR 2168) (62 FR 45767) Final Action (Amendment) 10/03/90 (55 Final Action 07/07/89 (54 FR 28780) NPRM (Amendment)(Warning) 08/00/98 FR 40379) Aspirin (Heart Labeling) Final Action (Amendment) 12/05/90 (55 NPRM 10/20/93 (58 FR 54224) FR 50171) Aspirin (Reye Syndrome) NPRM (Amendment) (Warning) 02/14/96 NPRM 10/20/93 (58 FR 54228) (61 FR 5918) Astringent (Wet Dressings) Prdts (Merged Final Action (Amendment)(Warning) w/other rulemkg) 11/15/96 (61 FR 58471) ANPRM 09/07/82 (47 FR 39436)
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00276 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda 21951
DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Cough/Cold (Bronchodilator) Products Exocrine Pancreatic Insufficiency Products Internal Analgesic Products ANPRM 09/09/76 (41 FR 38312) ANPRM 12/21/79 (44 FR 75666) ANPRM 07/08/77 (42 FR 35346) NPRM 10/26/82 (47 FR 47520) NPRM 11/08/85 (50 FR 46594) NPRM 11/16/88 (53 FR 46204) Final Action 10/02/86 (51 FR 35326) NPRM (Reproposed) 07/15/91 (56 FR NPRM (Amendment) (Overindulgence) NPRM (Amendment)(Warning) 06/19/92 32282) 12/24/91 (56 FR 66762) (57 FR 27662) Final Action 04/24/95 (60 FR 20162) NPRM (Amdt.)(Sodium Bicarbonate) Final Action (Amendment)(Warning) External Analgesic Products 02/02/94 (59 FR 5068) 10/20/93 (58 FR 54238) ANPRM 12/04/79 (44 FR 69768) NPRM (Prof. Labeling)(Acute MI) 06/13/96 NPRM (Amendment)(MDI) 03/09/95 (60 NPRM 02/08/83 (48 FR 5852) (61 FR 30002) FR 13014) NPRM (Amendment) (Dandruff) 07/30/86 NPRM (Amendment)(Alcohol Warning) 11/14/97 (62 FR 61041) NPRM (Amendment)(Ephedrine) 07/27/95 (51 FR 27360) Final Action (ProfessionalLabeling) (60 FR 38643) NPRM (Amendment) (Anorectal) 08/25/88 06/00/98 Final Action (Amendment) (MDI) 05/20/96 (53 FR 32592) Final Action 06/00/98 (61 FR 25142) NPRM (Amendment) (Poison Ivy) 10/03/89 Cough/Cold (Combination) Products NPRM (Labeling-revised indications) (54 FR 40818) 10/00/99 ANPRM 09/09/76 (41 FR 38312) NPRM (Amendment) (Fvr Blister/Ext) Internal Deodorant Products NPRM 08/12/88 (53 FR 30522) 01/31/90 (55 FR 3370) ANPRM 01/05/82 (47 FR 512) NPRM (Amendment)(DPH Combinations) NPRM (Amendment) (1%Hydrocortisone) NPRM 06/17/85 (50 FR 25162) 02/23/95 (60 FR 10286) 02/27/90 (55 FR 6932) Final Action 05/11/90 (55 FR 19862) Final Action (Theophylline) 07/27/95 (60 NPRM (Amendment) (Diaper Rash) Labeling of Drug Products for OTC Human FR 38636) 06/20/90 (55 FR 25234) Use Final Action 03/00/99 Final Action (Diaper Rash) 12/18/92 (57 NPRM 04/05/93 (58 FR 17553) Cough/Cold (Diphenhydramine) Products FR 60426) Final Action 01/28/94 (59 FR 3998) Final Action/Enforcement Policy 04/09/96 NPRM (Amendment)(Warning) 08/29/97 NPRM (Do not mix drugs) 08/03/94 (59 FR (61 FR 15700) (62 FR 45767) 39499) Cough/Cold (Expectorant) Products Final Action 00/00/00 NPRM (Amendment) (Do not mix drugs) ANPRM 09/09/76 (41 FR 38312) Fever Blister Products (Internal) 10/04/95 (60 FR 52058) NPRM 07/09/82 (47 FR 30002) ANPRM 01/05/82 (47 FR 502) NPRM (Unless a doctor tells you) 03/04/96 Final Action 02/28/89 (54 FR 8494) NPRM 06/17/85 (50 FR 25156) (61 FR 8450) Final Action (Technical Changes) 06/30/92 Final Action 06/30/92 (57 FR 29166) NPRM (Calcium/Magnesium/Potassium) (57 FR 29176) Fvr Blister/Cold Sore Prdts (Ext.) (To be 04/22/96 (61 FR 17807) Cough/Cold (Expectorant/Ipecac) Products merged w/other rulemkg) NPRM (Unless a doc. tells you)(Wi.) Final Action 09/14/92 (57 FR 41857) ANPRM 09/07/82 (47 FR 39436) 02/27/97 (62 FR 9024) Cough/Cold (Nasal Decongestant) Products Hair Grower and Hair Loss Prevention Final Action (Format/Examples) 07/00/98 ANPRM 09/09/76 (41 FR 38312) Products Final Action (Ca/Mg/K) 12/00/98 Laxative Products NPRM 01/15/85 (50 FR 2220) ANPRM 11/07/80 (45 FR 73955) ANPRM 03/21/75 (40 FR 12902) NPRM (Amendment) 06/19/92 (57 FR NPRM 01/15/85 (50 FR 2190) 27658) NPRM 01/15/85 (50 FR 2124) Final Action 07/07/89 (54 FR 28772) Final Action 08/23/94 (59 FR 43386) NPRM (Amendment) (Directions/Bulk) Hormone (Topical) Products Final Action; Partial Stay 03/08/96 (61 FR 10/01/86 (51 FR 35136) ANPRM 01/05/82 (47 FR 430) 9570) NPRM (Amendment) (Docusate Salts) NPRM (Phenylpropanolamine) 00/00/00 NPRM 10/02/89 (54 FR 40618) 09/02/93 (58 FR 46589) Dandruff, Seborrheic Dermatitis and Final Action 09/09/93 (58 FR 57608) NPRM (Amendment)(Sodium Phosphates) Psoriasis Control Products Hypo/Hyperphosphatemia Products 03/31/94 (59 FR 15139) ANPRM 12/03/82 (47 FR 54646) ANPRM 12/09/80 (45 FR 81154) NPRM (Phenolphthalein) 09/02/97 (62 FR NPRM 07/30/86 (51 FR 27346) NPRM 01/15/85 (50 FR 2160) 46223) Final Action 12/04/91 (56 FR 63554) Final Action 05/11/90 (55 FR 19852) Final Action (Sodium Phosphates) NPRM (Amendment) 04/05/93 (58 FR Ingrown Toenail Relief Products 04/00/98 17554) ANPRM 10/17/80 (45 FR 69128) NPRM (Amendment)(Phosphates Label) 04/00/98 Final Action 01/28/94 (59 FR 4000) NPRM 09/03/82 (47 FR 39120) Final Action 09/00/98 Daytime Sedatives Final Action 09/09/93 (58 FR 47602) Leg Muscle Cramps (Nocturnal Relief) ANPRM 12/08/75 (40 FR 57292) Insect Bite & Sting (Relief) Prdts (Merged Products NPRM 06/13/78 (43 FR 25544) w/other rulemkg) ANPRM 09/07/82 (47 FR 39412) ANPRM 10/01/82 (47 FR 43562) Final Action 06/22/79 (44 FR 36378) NPRM 11/08/85 (50 FR 46588) Insect Repellent Drug Products (Internal) Diaper Rash Products (Merged w/other Final Action 08/22/94 (59 FR 43234) ANPRM 01/05/82 (47 FR 424) rulemkg) Male Genital Desensitizer Products NPRM 06/10/83 (48 FR 26986) ANPRM 09/07/82 (47 FR 39406) ANPRM 09/07/82 (47 FR 39412) Digestive Aid Products Final Action 06/17/85 (50 FR 25170) NPRM 10/02/85 (50 FR 40260) ANPRM 01/05/82 (47 FR 454) Final Action 06/19/92 (57 FR 27654) NPRM 01/29/88 (53 FR 2706) Menstrual Products Final Action 10/21/93 (58 FR 54450) ANPRM 12/07/82 (47 FR 55075) Eligibility Criteria for Additional Conditions NPRM 11/16/88 (53 FR 46194) ANPRM 10/03/96 (61 FR 51625) Mercurial (Active/Inactive) NPRM 10/00/98 NPRM 00/00/00 Emetic Products Mercurial (Topical) Products (To be merged ANPRM 03/21/75 (40 FR 12939) w/other rulemkg) NPRM 09/05/78 (43 FR 39544) ANPRM 01/05/82 (47 FR 436)
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00277 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21952 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Nailbiting/Thumbsucking Deterrent Poison Treatment Products Topical Drug Products Containing Benzoyl Products NPRM 01/15/85 (50 FR 2244) Peroxide (Labeling) ANPRM 10/17/80 (45 FR 69122) NPRM (Amendment) 12/00/98 NPRM 02/17/95 (60 FR 9554) NPRM 09/03/82 (47 FR 39096) Final Action 06/00/99 Vaginal Contraceptive Products Final Action 09/02/93 (58 FR 46749) Quinine for Malaria ANPRM 12/12/80 (45 FR 82014) Nighttime Sleep Aid Products NPRM 04/19/95 (60 FR 19650) NPRM 02/03/95 (60 FR 6892) ANPRM 12/08/75 (40 FR 57292) Final Action 07/00/98 Vaginal Drug Products NPRM 06/13/78 (43 FR 25544) Reporting of Adverse Reactions ANPRM 10/13/83 (48 FR 46694) Final Action 02/14/89 (54 FR 6814) NPRM 12/00/98 Withdrawal 02/03/95 (60 FR 5226) NPRM (Amendment) 08/26/93 (58 FR Skin Bleaching Products Vitamin/Mineral Products 45217) ANPRM 11/03/78 (43 FR 51546) ANPRM 03/16/79 (44 FR 16126) Final Action (Amendment) 04/11/94 (59 NPRM 09/03/82 (47 FR 39108) Withdrawal 11/27/81 (46 FR 57914) FR 16982) NPRM (Reproposed) 12/00/98 Wart Remover Products NPRM (Amendment) (Warning) 08/29/97 Skin Protectant Products ANPRM 10/03/80 (45 FR 65609) (62 FR 45767) NPRM 09/03/82 (47 FR 39102) NDA Labeling Exclusivity ANPRM 08/04/78 (43 FR 34628) NPRM 02/15/83 (48 FR 6820) NPRM (Amendment) 03/27/87 (52 FR NPRM 11/09/93 (58 FR 59622) 9992) Final Action 00/00/00 NPRM (Amendment) (Astringent) 04/03/89 (54 FR 13490) Final Action 08/14/90 (55 FR 33246) Ophthalmic Products NPRM (Amendment)(Directions) 01/28/94 ANPRM 05/06/80 (45 FR 30002) NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808) (59 FR 4015) NPRM 06/28/83 (48 FR 29788) Final Action (Amdt.)(Directions) 11/23/94 Final Action 03/04/88 (53 FR 7076) NPRM (Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362) (59 FR 60315) Final Action (Anti-infective) 12/18/92 (57 Water Soluble Gums FR 60416) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 25204) NPRM 10/30/90 (55 FR 45782) Oral Discomfort (Relief) Products Final Action 08/26/93 (58 FR 45194) ANPRM 05/25/82 (47 FR 22712) Final Action (Astringent) 10/21/93 (58 FR 54466) Weight Control Products NPRM 09/24/91 (56 FR 48302) ANPRM 02/26/82 (47 FR 8466) Final Action (Witch Hazel) 06/03/94 (59 FR Oral Health Care Products NPRM 10/30/90 (55 FR 45788) 28767) ANPRM 05/25/82 (47 FR 22760) Final Action 08/08/91 (56 FR 37792) Final Action (Poison Ivy) 06/00/98 NPRM 01/27/88 (53 FR 2436) NPRM (Amendment) 00/00/00 NPRM (Amendment) (Antimicrobials) Final Action 06/00/98 02/09/94 (59 FR 6084) Smoking Deterrent Products Small Entities Affected: None Final Action 00/00/00 ANPRM 01/05/82 (47 FR 490) Government Levels Affected: None Oral Mucosal Injury Products (Merged NPRM 07/03/85 (50 FR 27552) w/Oral Health Care) Final Action 06/01/93 (58 FR 31236) Additional Information: Previously ANPRM 11/02/79 (44 FR 63270) Sodium Labeling reported under RIN 0905-AA06. NPRM 07/26/83 (48 FR 33984) NPRM 04/25/91 (56 FR 19222) NOTE: Reinventing government applies Oral Wound Healing Products Final Action 04/22/96 (61 FR 17798) ANPRM 11/02/79 (44 FR 63270) Final Action (Technical Amendment) only to the Antacid Drug Products final NPRM 07/26/83 (48 FR 33984) 12/00/98 action. Final Action 07/18/86 (51 FR 26112) Status of Certain Category II and III Agency Contact: Rosemary Cook, Otic Products (Dry Water-Clogged Ears) Ingredients Supervisor, Project Management Staff, NPRM (Amendment) 12/00/98 NPRM 05/16/90 (55 FR 20434) Otic Products (Earwax) Office of Drug Evaluation V, Final Action 11/07/90 (55 FR 46914) Department of Health and Human NPRM 07/09/82 (47 FR 30012) NPRM 08/25/92 (57 FR 38568) Services, Food and Drug Final Action 08/08/86 (51 FR 28656) Final Action 05/10/93 (58 FR 27636) Otic Products (Swimmers Ear) NPRM 08/00/98 Administration, Center for Drug NPRM 07/30/86 (51 FR 27366) Stimulant (Overindulgence) Products Evaluation and Research (HFD-105), Final Action 02/15/95 (60 FR 8916) NPRM (Amendment) 12/24/91 (56 FR 5600 Fishers Lane, Rockville, MD Final Action Partial Stay 08/16/95 (60 FR 66758) 20857 42435) Stimulant Products Phone: 301 827-2222 Overindulgence Remedies ANPRM 12/08/75 (40 FR 57292) ANPRM 10/01/82 (47 FR 43540) RIN: 0910–AA01 NPRM 12/24/91 (56 FR 66742) NPRM 06/13/78 (43 FR 25544) NPRM (Amendment) (Warning) 05/05/93 Final Action 02/29/88 (53 FR 6100) (58 FR 26886) Stomach Acidifier Products 943. FEES FOR CERTIFICATION Final Action (Amendment) (Warning) ANPRM 10/19/79 (44 FR 60316) SERVICES; INSULIN AND COLOR 08/00/98 NPRM 01/15/85 (50 FR 2184) ADDITIVE CERTIFICATION Overindulgence Remedies/Prevention of Final Action 08/17/88 (53 FR 31270) PROGRAMS Inebriation Sunscreen Products ANPRM 10/01/82 (47 FR 43540) ANPRM 08/25/78 (43 FR 38206) Priority: Routine and Frequent Final Action 07/19/83 (48 FR 32872) NPRM 05/12/93 (58 FR 28194) Reinventing Government: This Pediculicide Products NPRM (Amendment) 06/08/94 (59 FR 29706) rulemaking is part of the Reinventing ANPRM 06/29/82 (47 FR 28312) Government effort. It will revise text in NPRM 04/03/89 (54 FR 13480) NPRM (Amendment)(Avobenzone) Final Action 12/14/93 (58 FR 65452) 09/16/96 (61 FR 48645) the CFR to reduce burden or Phenylpropanolamine Products (Labeling) Final Action (Avobenzone Enf. Pol.) duplication, or streamline NPRM 02/14/96 (61 FR 3912) 04/30/97 (62 FR 23350) requirements. Final Action 00/00/00 Final Action 03/00/99 Legal Authority: 21 USC 356; 21 USC Sweet Spirits of Nitre Poison Ivy/Oak/Sumac Prevention (Merged 371; 21 USC 379e(e) w/other rulemkg) ANPRM 02/22/80 (45 FR 11846) ANPRM 09/07/82 (47 FR 39412) Final Action 06/27/80 (45 FR 43400) CFR Citation: 21 CFR 80; 21 CFR 429
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00278 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda 21953
DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Legal Deadline: None 944. REVIEW OF WARNINGS, USE 945. HEARING AIDS; PROFESSIONAL INSTRUCTIONS, AND AND PATIENT LABELING; Abstract: Insulin Certification Program: PRECAUTIONARY INFORMATION CONDITIONS FOR SALE Section 506 of the Federal Food, Drug, UNDER SECTION 314 OF THE Priority: Other Significant. Major status and Cosmetic Act, which authorized NATIONAL CHILDHOOD VACCINE under 5 USC 801 is undetermined. the certification of drugs containing INJURY ACT OF 1986 Unfunded Mandates: This action may insulin, was repealed by section 125 of affect State, local or tribal governments the Food and Drug Administration Priority: Other Significant and the private sector. Modernization Act of 1997. The repeal Legal Authority: PL 99-660, sec 314 was effective on November 21, 1997. Reinventing Government: This CFR Citation: 21 CFR 601 rulemaking is part of the Reinventing Color Certification Program: Government effort. It will revise text in Legal Deadline: Final, Statutory, In the Federal Register of November 29, the CFR to reduce burden or 1994, FDA issued an interim rule February 1, 1991. duplication, or streamline requirements. effective December 29, 1994, which Abstract: Section 314 of the National amended the color additive regulations Childhood Vaccine Injury Act of 1986 Legal Authority: 21 USC 351; 21 USC by increasing the fees for certification mandated that the warnings, use 352; 21 USC 360d; 21 USC 371; 21 USC services. In the Federal Register of instructions, and precautionary 360j(e) February 1, 1996 (61 FR 3571), FDA information of specified childhood CFR Citation: 21 CFR 801.420; 21 CFR issued a final rule, effective March 4, vaccines be reviewed and that their 801.421 1996, which incorporated comments adequacy in warning health care FDA received from the International Legal Deadline: None professionals of the nature and extent Association of Color Manufacturers Abstract: FDA is considering revising of dangers posed by such vaccines be (IACM) on the interim rule. FDA its present regulation governing the determined. This precautionary received an objection from IACM to an labeling and conditions for sale of information is contained in the package annual escalator provision which hearing aids. The present rule requires would have allowed FDA to increase insert of each vaccine licensed by the an examination by a physician before the fees for color certification services agency. FDA held a public meeting to purchase of a hearing aid, but permits by a rate proportional with Federal receive public comment on the an informed adult to waive that salary increases. After considering the adequacy of these package inserts. requirement. There is some evidence objection, FDA decided not to Timetable: that this waiver provision is being implement this provision. The FDA’s misused. FDA is considering Office of Financial Management Action Date FR Cite eliminating the waiver provision and completed a fee study of the color instead requiring a medical evaluation certification program in May 1997 Notice of Public 07/31/92 57 FR 33915 Meeting; Public when certain previously undiagnosed which supports the maintenance of the Comment on medical conditions are found or when existing fee schedule. Package Inserts the prospective hearing aid user is Timetable: NPRM 09/00/98 under 18 years of age. In addition, FDA is considering restricting the dispensing Color Additives Small Entities Affected: None of a hearing aid to patients who have Interim Final Rule 11/29/94 (59 FR 60898) undergone a comprehensive hearing Final Action 02/01/96 (61 FR 3571) Government Levels Affected: State assessment within the past 12 months Insulin Interim Final Rule 10/04/91 (56 FR 50248) Additional Information: Previously and an evaluation to select and fit a Interim Final Rule 11/09/95 (60 FR 56515) reported under RIN 0905-AD72. hearing aid, both of which would be Removal of 21 CFR 429 04/00/98 required to be conducted by hearing A public meeting was held on 9/18/92 care professionals licensed by the Small Entities Affected: Undetermined on section 314 Labeling Review. States as competent to conduct such assessments and evaluations. FDA is Government Levels Affected: None Presentations were made by FDA, CDC, manufacturers, parents groups, and the also considering revisions to its Additional Information: Previously public on the adequacy of the current professional and patient labeling reported under RIN 0905-AD34 and labeling. requirements to require updated RIN 0910-AA27. information. Agency Contact: Dano B. Murphy, Statement of Need: FDA has become Agency Contact: David R. Petak, Regulatory Counsel, Department of Director, Division of Accounting, aware of changes in the nature of the Health and Human Services, Food and causes of hearing loss and the Department of Health and Human Drug Administration, Center for Services, Food and Drug technology of hearing aids that Biologics Evaluation and Research Administration, Office of Financial necessitate reconsideration of the (HFM-17), 1401 Rockville Pike, Suite Management (HFA-120), 5600 Fishers regulations governing the types of Lane, Rockville, MD 20857 200N, Rockville, MD 20852-1448 testing needed before a hearing aid Phone: 301 827-5004 Phone: 301 827-6210 purchase and the labeling for health Fax: 301 443-6242 professionals and patients. In the past, RIN: 0910–AA14 hearing loss often was caused by RIN: 0910–AA07 medically treatable conditions: because
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00279 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21954 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
of advances in health care, this is less Timetable: focus of its food safety assurance common. Therefore, there may be less Action Date FR Cite program away from periodic visual need for medical evaluation. On the inspection and end-product testing and other hand, advances in hearing aid ANPRM 11/10/93 58 FR 59695 toward prevention of food safety risks technology necessitate proper testing in ANPRM Comment 01/10/94 and problems, utilizing the state-of-the- order for a hearing aid to be effective. Period End art HACCP preventive approach. A first NPRM 06/00/98 Summary of the Legal Basis: Under step was taken when FDA published 21 USC 360j(e), FDA has the authority Small Entities Affected: Businesses a HACCP regulation for fish and fishery products on December 18, 1995. to restrict the sale, distribution, or use Government Levels Affected: State of a medical device, if FDA determines Consistent with FDA’s HACCP efforts, that, without such restrictions, there Additional Information: Previously USDA published a HACCP regulation cannot be reasonable assurance of its reported under RIN 0905-AE46. for meat and poultry on July 25, 1996. safety and effectiveness. Under 21 USC Agency Contact: Joseph M. Sheehan, As a next step in this food safety 352, FDA has the authority to require Chief, Regulations Staff, Department of program, FDA will propose a HACCP that the labeling of a medical device Health and Human Services, Food and regulation for the processing of juice. include adequate directions for use. Drug Administration, Center for As part of the development of this document, FDA is considering Alternatives: FDA considered applying Devices and Radiological Health (HFZ- information obtained during agency the rule only to first time purchasers 215), 1350 Piccard Drive, Rockville, MD HACCP pilot activities, and comments of hearing aids. FDA believes, however, 20850 and scientific and technological that this would not adequately protect Phone: 301 594-4765 information relating to fresh juices present users of inappropriate or RIN: 0910–AA39 provided during and after an agency unneeded hearing aids. FDA also public meeting on juice held on considered requiring additional tests, December 16 and 17, 1996. As a but has preliminarily determined to list 946. FRUIT AND VEGETABLE JUICES: separate rulemaking, the agency intends these tests as recommended only in DEVELOPMENT OF HACCP AND to propose to require warning order to provide additional flexibility. LABEL WARNING STATEMENTS FOR JUICES statements on the labels or in labeling Anticipated Costs and Benefits: FDA for juice products that have not been Priority: Economically Significant. has estimated the costs of the processed to reduce, control, or Major under 5 USC 801. mandatory testing required by the rule eliminate the presence of harmful would add an additional $24.8 million Legal Authority: 21 USC 321 et seq; bacteria. Such labeling will serve to to $51.7 million depending upon the 42 USC 264 reduce the risk of foodborne illness. assumptions concerning present CFR Citation: 21 CFR 120 practices. On the average, FDA Statement of Need: In this proposed estimates that this would add about $24 Legal Deadline: None rule, the Food and Drug Administration (FDA) is proposing to adopt regulations to the cost of a hearing aid. FDA Abstract: FDA announced in an that would establish requirements for expects that the benefits from the rule advance notice of proposed rulemaking would include: (1) Improving the a new comprehensive food safety of August 4, 1994, its plans to consider assurance program for both quality of life of hearing aid users; (2) the development of regulations avoiding the cost of inappropriate domestically produced and imported establishing requirements for a new fruit and vegetable juices that would hearing aid purchase; (3) reducing comprehensive food safety assurance doctor visits for hearing aid be based on the principles of Hazard program for both domestically Analysis Critical control Points evaluations; (4) lowering treatment produced and imported foods that costs due to early detection of serious (HACCP). FDA intends to propose a would be based on the principles of juice HACCP regulation because there conditions; and (5) encouraging the Hazard Analysis Critical Control Points dissemination of accurate information have been a number of outbreaks of (HACCP). The new food safety program illnesses associated with juice products, concerning the benefits and limitations would respond to new challenges, such of hearing aids. including some directly affecting as new food processing and packaging children, and because the agency Risks: If the hearing aid purchaser technologies, new food distribution and believes that a system of preventive inappropriately waives the medical consumption patterns, exposure to controls is the most effective and evaluation requirement under the industrial chemicals and chemical efficient way to ensure that these existing rule, treatable causes of hearing waste, the increasing importation of products will be safe. loss may go undetected. Many foods, new microbial pathogens, and purchasers who have not had proper resource constraints. Current Summary of the Legal Basis: Failure testing before a hearing aid purchase information shows that the most of a processor to have and implement will forego the use of a hearing aid serious of these challenges is presented a HACCP system will render the food because the one purchased does not by food-borne pathogens. The number products of that processor adulterated adequately improve their hearing of recognized food-borne pathogens has under section 402(a)(4) of the Federal ability. At this time, FDA believes that broadened considerably, as has the Food, Drug, and Cosmetic Act. Whether many hearing impaired people who awareness of long-term complications a processor’s actions are consistent may benefit from a hearing aid do not from certain food-borne illnesses--such with ensuring the safety of food will purchase one because they fear that as arthritis, heart disease, and kidney be determined through an evaluation of they will not benefit from one due to and neurological damage. To meet such the overall implementation of the firm’s inaccurate information. challenges, FDA intends to shift the HACCP system.
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DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Alternatives: The two principal made a decision to adopt a HACCP- Timetable: alternatives to HACCP are end-product based approach to regulation of Action Date FR Cite testing and comprehensive current good seafood, based on a considerable body manufacturing practices (CGMPs). FDA of literature and expertise in this area. NPRM 06/00/98 has concluded, based on information Likewise, FDA has reviewed current NPRM Comment 09/00/98 available at this time, that these information on hazards associated with Period End alternatives lack the distinct advantages unprocessed juice, and intends to Small Entities Affected: Undetermined of a HACCP-based approach. End- propose that processors use HACCP in Government Levels Affected: product testing does not address the the manufacture of certain juice Undetermined root causes of food safety problems, is products. Agency Contact: Christine Rogers, not preventive by design, and requires Timetable: that a large number of samples be Regulatory Counsel, Department of analyzed to ensure product integrity. Action Date FR Cite Health and Human Services, Food and CGMPs are not practical because they ANPRM 08/04/94 59 FR 39888 Drug Administration, Center for Drug are plant-wide operating procedures ANPRM Comment 12/02/94 Evaluation and Research (HFD-7), 1451 and do not concentrate on the Period End Rockville Pike, Suite 3047, Rockville, identification and prevention of food Economic Analysis for Juice HACCP and MD 20852 hazards. Labeling Phone: 301 594-2041 PRIA 04/00/98 Fax: 301 827-5562 Anticipated Costs and Benefits: In HACCP for Juice general terms, HACCP focuses on NPRM 04/00/98 RIN: 0910–AA51 prevention and is designed to prevent Label Warning Statements for Juice the occurrence of hazards affecting NPRM 04/00/98 948. DRUGS USED FOR TREATMENT food; HACCP permits more effective Small Entities Affected: Businesses OF NARCOTIC ADDICTS and efficient oversight by Federal, Government Levels Affected: State, and local governments; and Priority: Substantive, Nonsignificant. HACCP appropriately places primary Undetermined Major status under 5 USC 801 is responsibility for ensuring food safety Additional Information: Previously undetermined. on the food manufacturer/distributor to reported under RIN 0905-AE60. Unfunded Mandates: Undetermined analyze, in a rational, scientific Agency Contact: John E. Kvenberg, Reinventing Government: This manner, its production processes in Strategic Manager, Department of rulemaking is part of the Reinventing order to identify critical control points Health and Human Services, Food and Government effort. It will revise text in and establish critical limits and Drug Administration, Center for Food the CFR to reduce burden or monitoring procedures. FDA anticipates Safety and Applied Nutrition (HFS-10), duplication, or streamline that costs to industry generated by 200 C Street SW., Washington, DC requirements. implementation of HACCP would be 20204 Legal Authority: 21 USC 355; 21 USC offset in four ways: (1) by reducing the Phone: 202 205-4020 371; 21 USC 823; 42 USC 241; 42 USC amount of food-borne illnesses (for Fax: 202 205-4018 example, total illness reduction benefits Email: [email protected] 257; 42 USC 290; 42 USC 300 estimated to result from FDA’s HACCP- RIN: CFR Citation: 21 CFR 291 based requirements for seafood 0910–AA43 Legal Deadline: None regulation are between $15 and $75 million per year); (2) by increasing 947. BIOAVAILABILITY AND Abstract: The proposed rule will revise public confidence in the Nation’s food BIOEQUIVALENCE REQUIREMENTS the regulations under part 291 and title 42 to provide for the certification of supply; (3) by enabling U.S. food Priority: Substantive, Nonsignificant. companies to compete more effectively narcotic treatment programs as a basis Major status under 5 USC 801 is for fulfilling the Department’s in the world market (for example, undetermined. current recommendations of the Codex requirements of the Narcotic Addict Alimentarius Commission’s Committee Unfunded Mandates: Undetermined Treatment Act of 1974. Certification on Food Hygiene encourage the use of Reinventing Government: This will be based on accreditation by non- the HACCP system, and the European rulemaking is part of the Reinventing profit accrediting bodies. This new Community (EC) has begun to require Government effort. It will revise text in system will replace the current system that foods produced within the EC be the CFR to reduce burden or which relies solely on direct FDA processed under HACCP requirements); duplication, or streamline approval and inspection for and (4) by decreasing the number of requirements. determining whether narcotic treatment programs comply with Federal future product recalls. Legal Authority: 21 USC 321; 21 USC treatment standards. The proposed rule Risks: Any potential for contamination 351; 21 USC 352; 21 USC 355; 21 USC will provide for a transition period for of the food supply with industrial 357; 21 USC 371 programs operating under the existing chemicals or microbial pathogens must CFR Citation: 21 CFR 320 be considered a very serious risk regulatory system. because of the possibility that such Legal Deadline: None Timetable: contamination could be widespread, Abstract: The proposed rule would Action Date FR Cite affecting whole segments of the revise and clarify certain sections of population, causing some severe long- part 320 and eliminate duplication and NPRM 09/00/98 term effects and even loss of life. FDA inconsistencies. Small Entities Affected: Undetermined
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Government Levels Affected: (2) ‘‘Food Labeling; Requirements for Agency Contact: Elizabeth A. Yetley, Undetermined Nutrient Content Claims, Health Director, Office of Special Nutritionals, Agency Contact: Nicholas Reuter, Claims, and Statements of Nutritional Department of Health and Human Associate Director for International and Support for Dietary Supplements;’’ and Services, Food and Drug Domestic Drug Control, Department of (3) ‘‘Food Labeling; Nutrient Content Administration, Center for Food Safety Health and Human Services, Food and Claims: Definition for ‘‘High Potency’’ and Applied Nutrition (HFS-450), 200 Drug Administration, Office of Health and Definition for ‘‘Antioxident’’ for C Street SW. Washington, DC 20204 Affairs (HFY-20), 5600 Fishers Lane, Use in Nutrient Content Claims for Phone: 202 205-4168 Fax: 202 205-5295 Rockville, MD 20857 Dietary Supplements and Conventional Phone: 301 827-1696 Foods.’’ The agency received several RIN: 0910–AA59 Fax: 301 443-0232 petitions for reconsideration of aspects Email: [email protected] of the final rule on nutrition labeling and ingredient declaration for dietary 950. INVESTIGATIONAL NEW DRUGS: RIN: 0910–AA52 supplements. EXPORT REQUIREMENTS FOR UNAPPROVED NEW DRUG DHSEA also established an PRODUCTS 949. DIETARY SUPPLEMENT independent agency within the Priority: Routine and Frequent REGULATIONS IN RESPONSE TO Executive Branch known as the DSHEA Commission on Dietary Supplement Legal Authority: 21 USC 321; 21 USC Priority: Other Significant Labels. The Commission was charged 331; 21 USC 351; 21 USC 352; 21 USC with conducting a study on, and 353; 21 USC 355; 21 USC 356; 21 USC Legal Authority: 15 USC 1453; 15 USC 357; 21 USC 371; 21 USC 381; 21 USC 1454; 15 USC 1455; 21 USC 321; 21 providing recommendations for regulating label claims and statements 382; 21 USC 393; 42 USC 241; 42 USC USC 331; 21 USC 342; 21 USC 343; 243; 42 USC 262 21 USC 348; 21 USC 351; 21 USC 352; for dietary supplement, including using 21 USC 355; 21 USC 371 literature in connection with the sale CFR Citation: 21 CFR 312.110 of dietary supplements and procedures Legal Deadline: None CFR Citation: 21 CFR 101 for evaluating such claims. On Abstract: The proposed rule would Legal Deadline: None November 24, 1997, the Commission’s final report was released. FDA is amend the regulations on the Abstract: On January 4, 1994, FDA issuing a notice on its views on the exportation of unapproved new drug published final rules relative to Commission’s report and a proposed products, including biological products, nutrition labeling, nutrient content rule that responds to guidance in the for investigational use. The proposed claims and health claims for dietary report concerning statements about the rule would create four different routes supplements. The Dietary Supplement effect of dietary supplements on for exporting an unapproved new drug Health and Education Act (DSHEA) was structure or function of the body. product for investigational use. One enacted on October 25, 1994, modifying route would permit exportation if the the provisions for labeling of dietary Timetable: drug is the subject of an investigational supplements. FDA has initiated Comments on Report of the Commission on new drug application (IND). A second rulemaking to modify its regulations for Dietary Supp. Labels route would permit exportation, dietary supplements accordingly. One Notice 04/00/98 without prior Food and Drug proposal would modify the nutrition CGMPs in the Manufacturing, Packing, or Administration (FDA) approval and labeling and ingredient declaration Holding of Dietary Supps. without an IND, if the product is to requirements. A second proposal would ANPRM 02/06/97 (62 FR 5700) be exported for use in a clinical provide for the use of nutrient content Comment Period End 06/06/97 investigation and has received claims and health claims on dietary NPRM 00/00/00 marketing authorization in certain supplements and establish procedures High Potency and Antioxidant Terms; developed countries. The third route Dietary Supplements for the use of a disclaimer to NPRM 12/28/95 (60 FR 67184) would permit exportation, without accompany statements of nutritional Comment Period End 06/10/96 prior FDA approval and without an support. A third proposal would define Final Action 09/23/97 (62 FR 49808) IND, if the product is to be exported the terms ‘‘high potency’’ and Nutrient Content and Health Claims; Dietary for use in a clinical investigation in ‘‘antioxidant.’’ These three proposals Supplements certain developed countries specified in were published in the Federal Register NPRM 12/28/95 (60 FR 67176) the rule. The fourth route would permit on December 28, 1995. An ANPRM was Comment Period End 06/10/96 exportation only if FDA authorized published in February 1997 seeking Final Action 09/23/97 (62 FR 49859) shipment of the investigational drug; public comments on issues related to Nutrient Labeling and Ingredient Labeling; such authorization would be obtained Dietary Supplements the establishment of current good NPRM 12/28/95 (60 FR 67194) through submission of a written request manufacturing practices for dietary Comment Period End 06/10/96 to export the drug. Drugs exported supplements. FDA published three final Final Action 09/23/97 (62 FR 49826) under any of the first three routes rules on September 23, 1997, Regs on Statements Made for Diet. Supps would, however, be subject to certain responding to the proposals of re Effect of Product statutory requirements, such as not December 28, 1995, and entitled: (1) NPRM 04/00/98 conflicting with the foreign country’s ‘‘Food Labeling; Statement of Identity, Small Entities Affected: Businesses laws and not being sold or offered for Nutrition Labeling and Ingredient sale in the United States. Drugs Labeling of Dietary Supplements; Government Levels Affected: State, exported under either second or third Compliance Policy Guide, Revocation;’’ Federal routes would be subject to additional
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statutory requirements, such as being in Agency Contact: Audrey Thomas, Small Entities Affected: None substantial conformity with the current Consumer Safety Officer, Department of Government Levels Affected: None good manufacturing practices and Health and Human Services, Food and certain labeling requirements. These Drug Administration, Center for Drug Agency Contact: Bonnie M. Lee, provisions would implement recent Evaluation and Research (HFD-7), 1451 Senior Policy Analyst, Office of the changes in FDA’s export authority Rockville Pike, Suite 3047, Rockville, Executive Secretariat (HF-40), resulting from the FDA Export Reform MD 20852 Department of Health and Human and Enhancement Act of 1996. Phone: 301 594-2041 Services, Food and Drug Fax: 301 827-5562 Administration, Office of the Timetable: Commissioner, 5600 Fishers Lane, RIN: 0910–AA86 Action Date FR Cite Rockville, MD 20857 NPRM 05/00/98 Phone: 301 827-4433 952. INFORMED CONSENT FOR Fax: 301 443-1863 Small Entities Affected: None HUMAN DRUGS AND BIOLOGICS; RIN: 0910–AA89 Government Levels Affected: None DETERMINATION THAT INFORMED CONSENT IS NOT FEASIBLE Agency Contact: Philip L. Chao, Senior 953. DIRECT-TO-CONSUMER Priority: Other Significant Policy Analyst, Department of Health PROMOTION REGULATIONS and Human Services, Food and Drug Legal Authority: 21 USC 321; 21 USC Administration, Office of Policy (HF- 352; 21 USC 353; 21 USC 355; 21 USC Priority: Substantive, Nonsignificant. 23), 5600 Fishers Lane, Room 15-74, 357; 21 USC 360; 21 USC 371; 21 USC Major status under 5 USC 801 is Rockville, MD 20857 381; 42 USC 216; 42 USC 241; 42 USC undetermined. Phone: 301 827-3380 262 Unfunded Mandates: Undetermined Fax: 301 443-6906 CFR Citation: 21 CFR 50; 21 CFR 314; Legal Authority: 21 USC 321; 21 USC Email: [email protected] 21 CFR 601 331; 21 USC 334; 21 USC 351; 21 USC RIN: 0910–AA61 Legal Deadline: None 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 358; 21 USC Abstract: The Food and Drug 360e to 360i; 21 USC 360k; 21 USC 951. ADVERSE DRUG REACTION Administration is proposing to revoke 361; 21 USC 362; 21 USC 371; ... REPORTING, RECORDKEEPING, AND the interim final rule which permited RECORDS ACCESS REQUIREMENTS the Commissioner to determine, based CFR Citation: 21 CFR 200; 21 CFR 800 FOR MARKETED OTC DRUGS on a request by the Department of Legal Deadline: None Defense, that obtaining informed Priority: Other Significant. Major status Abstract: The Food and Drug under 5 USC 801 is undetermined. consent from military personnel for the use of investigational products is not Administration will issue proposed Unfunded Mandates: Undetermined feasible in certain military combat regulations for direct-to-consumer promotion of human and animal Legal Authority: 21 USC 321; 21 USC situations. The rule was used to permit prescription drugs, biologics, and 331; 21 USC 351; 21 USC 352; 21 USC a waiver from the informed consent restricted devices. The regulations will 353; 21 USC 355; 21 USC 356; 21 USC requirements for pyridostigmine set forth the requirements for what 357; 21 USC 358; 21 USC 360; 21 USC bromide and the botulinum toxoid information shall be contained in the 371; 21 USC 374; 21 USC 375; 21 USC vaccine during the Gulf War. The consumer directed advertisements for 379; 42 USC 216; ... agency is proposing this action after reviewing comments it received in these products and how the CFR Citation: 21 CFR 201; 21 CFR 211; response to a July 1997 Request for information shall be presented. 21 CFR 327; 21 CFR 330 Comment as to whether the agency Timetable: Legal Deadline: None should revise or revoke the rule. Action Date FR Cite Abstract: At the same time, it will propose to The proposed rule would NPRM 01/00/99 require manufacturers of marketed amend its new drug and biological product regulations to identify the kind NPRM Comment 03/00/99 nonprescription human drug products Period End to report to FDA information they of evidence needed to demonstrate the receive about adverse drug reactions, efficacy of drug and biological products Small Entities Affected: None maintain records of adverse drug used to treat or prevent the toxicity of Government Levels Affected: None reactions, and permit access by FDA to potentially devastating chemical or Agency Contact: adverse drug reaction records. biological substances when efficacy Nancy Ostrove, studies in humans ethically cannot be Division of Drug Marketing, Timetable: conducted because they would involve Advertising, and Communications, Action Date FR Cite administering a lethal or permanently Department of Health and Human Services, Food and Drug NPRM 10/00/98 disabling toxic substance to healthy human volunteers without a proven Administration, Center for Drug NPRM Comment 01/00/99 Evaluation and Research (HFD-40), Period End treatment. Room 17B-04, 5600 Fishers Lane, Small Entities Affected: Undetermined Timetable: Rockville, MD 20857 Government Levels Affected: Action Date FR Cite Phone: 301 827-2828 Undetermined NPRM 05/00/98 RIN: 0910–AA90
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954. LABELING FOR HUMAN 955. ADVERSE DRUG REACTION 335; 21 USC 342; 21 USC 346a; 21 USC PRESCRIPTION DRUGS; REVISED REPORTING REQUIREMENTS FOR 348; 21 USC 351; 21 USC 352; 21 USC FORMAT HUMAN DRUG AND BIOLOGICAL 355; 21 USC 357; 21 USC 360b; 21 USC PRODUCTS 361; 21 USC 371; ... Priority: Other Significant. Major status Priority: Other Significant. Major status CFR Citation: 21 CFR 2 under 5 USC 801 is undetermined. under 5 USC 801 is undetermined. Legal Deadline: None Unfunded Mandates: Undetermined Unfunded Mandates: Undetermined Abstract: The proposed rule presents Reinventing Government: This Legal Authority: 21 USC 216; 21 USC the policy FDA is proposing to adopt rulemaking is part of the Reinventing 262; 21 USC 263; 21 USC 263a; 21 USC on making and implementing determinations that uses of Government effort. It will revise text in 264; 21 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC chlorofluorocarbons (CFCs) currently the CFR to reduce burden or 355 to 357; 21 USC 371; 21 USC 374 designated essential will no longer be duplication, or streamline deemed essential under section 610 of requirements. CFR Citation: 21 CFR 20; 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 600 the Clean Air Act due to the Legal Authority: availability of safe and effective 21 USC 321; 21 USC Legal Deadline: None 331; 21 USC 351; 21 USC 352; 21 USC medical product technology that does 353; 21 USC 355; 21 USC 356; 21 USC Abstract: The proposed rule would not use CFCs. 357; 21 USC 358; 21 USC 360; 21 USC amend the expedited and periodic Timetable: safety reporting regulations for human 360b; 21 USC 360gg to 360ss; 21 USC Action Date FR Cite 371; 21 USC 374; 21 USC 379e drugs and biological products to revise certain definitions and reporting ANPRM 03/06/97 62 FR 10242 CFR Citation: 21 CFR 201 formats as recommended by the ANPRM Comment 05/05/97 International Conference on Period End Legal Deadline: None Harmonization and to define new NPRM 12/00/98 terms; to add to or revise current NPRM Comment 03/00/99 Abstract: The proposed rule would reporting requirements; to revise certain Period End revise existing regulations governing reporting time frames; and to make Small Entities Affected: Undetermined the format of prescription drug labeling other revisions to these regulations to Government Levels Affected: directed toward prescribers and other enhance the quality of adverse drug Undetermined health care professionals to increase the reaction reports received by FDA. usefulness of this labeling. The Agency Contact: Timetable: Leanne Cusumano, revisions to part 201.57 would reorder Regulatory Counsel, Regulatory Policy the content areas of the labeling; add Action Date FR Cite Staff, Department of Health and Human an introductory section of highlights NPRM 10/00/98 Services, Food and Drug and an index; and institute an NPRM Comment 01/00/99 Administration, Center for Drug identification system to enhance Period End Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, Rockville, accessibility to detailed information. Small Entities Affected: Undetermined MD 20852 Timetable: Government Levels Affected: Phone: 301 594-2041 Undetermined Action Date FR Cite Fax: 301 827-5562 Agency Contact: Audrey Thomas, RIN: 0910–AA99 NPRM 09/00/98 Consumer Safety Officer, Department of NPRM Comment 12/00/98 Health and Human Services, Food and Period End Drug Administration, Center for Drug 957. RADIOACTIVE DRUGS FOR BASIC RESEARCH Small Entities Affected: Undetermined Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, Rockville, Priority: Other Significant. Major status Government Levels Affected: MD 20852 under 5 USC 801 is undetermined. Undetermined Phone: 301 594-2041 Unfunded Mandates: Undetermined Fax: 301 827-5562 Agency Contact: Nancy Ostrove, Reinventing Government: This RIN: 0910–AA97 Division of Drug Marketing, Advertising rulemaking is part of the Reinventing and Communications, Department of Government effort. It will revise text in Health and Human Services, Food and 956. CHLOROFLUOROCARBON the CFR to reduce burden or Drug Administration, Center for Drug PROPELLANTS IN SELF- duplication, or streamline Evaluation and Research (HFD-40), PRESSURIZED CONTAINERS; requirements. 5600 Fishers Lane, Rockville, MD DETERMINATIONS THAT USES ARE Legal Authority: 21 USC 321; 21 USC 20857 NO LONGER ESSENTIAL 351; 21 USC 352; 21 USC 353; 21 USC Phone: 301 827-2828 Priority: Other Significant. Major status 355; 21 USC 371; 42 USC 262 Fax: 301 594-6759 under 5 USC 801 is undetermined. CFR Citation: 21 CFR 361 Unfunded Mandates: Legal Deadline: RIN: 0910–AA94 Undetermined None Legal Authority: 15 USC 402; 15 USC Abstract: The proposed rule would 409; 21 USC 321; 21 USC 331; 21 USC update FDA’s regulations on the use of
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radioactive drugs for basic research to sacrificing the protection of the public Anticipated Costs and Benefits: reflect technological changes in the health. Registration and listing will enable field of radiopharmaceuticals. The Statement of Need: Presently, FDA can FDA to characterize the industry proposed rule would also clarify and only approximate the numbers of without imposing any significant correct certain provisions. manufacturers involved in the procedural or monetary burdens. Timetable: production of human cellular and Registration and listing would provide tissue-based products. Recent effective means by which FDA can Action Date FR Cite innovations in the methods of monitor the production of human NPRM 10/00/98 manipulating human cells and tissues cellular and tissue-based products. The NPRM Comment 01/00/99 for therapeutic purposes has resulted in costs of registration and listing are Period End the rapid growth of the industry expected to be minimal because, as Small Entities Affected: Undetermined producing human cellular and tissue- stated above, the process would require based products. The growth has only the information necessary for FDA Government Levels Affected: occurred in industry segments that to identify the affected industry. Undetermined normally communicate with the agency Risks: FDA believes that the risks Agency Contact: Brian L. Pendleton, as well as in segments that have not posed by requiring registration and Regulatory Counsel, Regulatory Policy previously had any contact with FDA. listing of human cellular and tissue- Staff, Department of Health and Human In order to characterize the industry based products are minimal. In Services, Food and Drug and establish a basis for contrast, failure to identify Administration, Center for Drug communication with that industry, manufacturers involved in the Evaluation and Research (HFD-7), 1451 FDA is proposing that all production of human cellular and Rockville Pike, Suite 3047, Rockville, manufacturers of human cellular and tissue-based products would subject the MD 20852 tissue-based products register with FDA public to the great and avoidable risk Phone: 301 594-2041 and submit lists of all their products of contracting debilitating Fax: 301 827-5562 to the agency. communicable diseases. Without any RIN: 0910–AB00 Summary of the Legal Basis: The mechanism to target regulations Public Health Service Act (42 USC 216 intended to ensure the safety, purity et seq.) and the Federal Food, Drug, and potency of human cellular and 958. ESTABLISHMENT REGISTRATION and Cosmetic Act (21 USC 321 et seq.) tissue-based products, FDA’s oversight AND LISTING OF HUMAN CELLULAR authorize FDA to regulate biological of the industry would be severely AND TISSUE-BASED PRODUCTS products and to ensure that the hindered and the protection of the Priority: Other Significant products are safe, pure, potent, and public health jeopardized. Reinventing Government: This effective. The Public Health Service Act Timetable: also contains the authority under which rulemaking is part of the Reinventing Action Date FR Cite Government effort. It will revise text in FDA can promulgate regulations the CFR to reduce burden or designed to prevent the spread of NPRM 06/00/98 duplication, or streamline communicable diseases. In order to NPRM Comment 09/00/98 requirements. meet these objectives, FDA must be Period End able to identify those manufacturers Legal Authority: Small Entities Affected: Businesses 42 USC 264 participating in activities that may be CFR Citation: 21 CFR 1271 subject to regulation. FDA proposes the Government Levels Affected: None Legal Deadline: None registration and listing as a simple and Agency Contact: Dano B. Murphy, efficient means of acquiring the needed Regulatory Counsel, Regulations and Abstract: This action is a continuation information. Policy Staff, Department of Health and of FDA’s approach for the regulation Alternatives: FDA has considered two Human Services, Food and Drug of human tissues and is part of FDA’s Administration, Center for Biologics reinventing government initiative. The alternatives. The first alternative would be an information collection Evaluation and Research (HFM-17), proposed rule would require 1401 Rockville Pike, Suite 200N, manufacturers of human cellular and undertaken by the agency that would be entirely dependent on voluntary Rockville MD 20852 tissue-based products to register with Phone: 301 827-6210 the agency and submit a list of all such compliance. FDA considers this products produced. Future regulations alternative inefficient and lacking in RIN: 0910–AB05 would include the promulgation of any compliance inducements. good tissue practices (GTP) that will The second alternative is to compel the 959. VETERINARY FEED DIRECTIVES: provide good manufacturing standards registration of manufacturers and DISTRIBUTOR NOTIFICATION and regulations for donor screening and require registrants to list their products testing, promotion and labeling, and with the agency. Such a system has Priority: Other Significant compliance and procedural issues. The been proposed to industry and gained Legal Authority: PL 104-250 proposed approach would provide a general acceptance. Manufacturers CFR Citation: Not yet determined rational, comprehensive, and clear would simply fill out an electronically framework under which tissue available, registration and listing form Legal Deadline: None processors can develop and market and fax or mail the completed form to Abstract: The Animal Drug Availability their products without being subjected the agency with periodic updates. No Act (ADAA) amended the Federal to unnecessary regulation and without other paperwork should be required. Food, Drug, and Cosmetic Act (the act)
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to create a new section 504, Veterinary use of ozone-depleting substances for and Human Services, Food and Drug Feed Directive Drugs (VFD Drugs). VFD new uses of ozone-depleting Administration, Office of Policy (HF- drugs are animal drugs intended for use substances. FDA is also proposing to 23), 5600 Fishers Lane, Room 15-74, in or on animal feed which are limited amend the regulations to better conform Rockville, MD 20857 by an approved application filed to other statutes and regulations Phone: 301 827-3380 pursuant to section 512(b) of the act relating to ozone-depleting substances Fax: 301 443-6906 to use under the professional to eliminate potential confusion and Email: [email protected] supervision of a licensed veterinarian conflicts. FDA is also proposing to RIN: 0910–AB16 in the course of the veterinarian’s eliminate out-of-date transitional professional practice. This section provisions and make other requires, among other things, that the nonsubstantive housekeeping changes 962. REQUIREMENTS PERTAINING TO labeling, distribution and use of a VFD to its regulations on ozone-depleting THE SALE AND DISTRIBUTION OF drug be consistent with its approval; substances. CIGARETTES AND SMOKELESS that persons involved in the Timetable: TOBACCO TO PROTECT CHILDREN distribution and use of a VFD drug AND ADOLESCENTS; USE OF maintain copies of the VFD; and, that Action Date FR Cite NONTOBACCO TRADE OR BRAND persons distributing animal feed NPRM 07/00/98 NAMES provide a one time notice upon first NPRM Comment 10/00/98 Priority: Substantive, Nonsignificant engaging in the distribution of VFD Period End Legal Authority: 21 USC 352; 21 USC drugs. The proposed rule will provide Small Entities Affected: Undetermined guidance to the industry about how to 360; 21 USC 360(j); 21 USC 371; 21 comply with section 504 of the act and Government Levels Affected: USC 372 Undetermined will serve as a basis for enforcement CFR Citation: 21 CFR 897 action. Agency Contact: Leanne Cusumano, Legal Deadline: None Timetable: Regulatory Counsel, Regulatory Policy Staff, Department of Health and Human Abstract: The proposed rule would Action Date FR Cite Services, Food and Drug clarify the restrictions on the use of NPRM 12/00/98 Administration, Center for Drug nontobacco product names and other Small Entities Affected: Undetermined Evaluation and Research (HFD-7), 1451 identification on tobacco products and Rockville Pike, Suite 3047, Rockville, would modify the list of established Government Levels Affected: MD 20852 names for smokeless tobacco products. Undetermined Phone: 301 594-2041 Timetable: Agency Contact: George Graber, Fax: 301 827-5562 Action Date FR Cite Department of Health and Human RIN: 0910–AB10 Services, Food and Drug NPRM 06/00/98 Administration, Center for Veterinary Small Entities Affected: None Medicine (HFV-228), 7500 Standish 961. EXPORTS; REPORTING AND Place, Rockville, MD 20855 RECORDKEEPING REQUIREMENTS Government Levels Affected: None Phone: 301 594-1733 Priority: Routine and Frequent Agency Contact: Philip L. Chao, Senior Fax: 301 594-1512 Legal Authority: 15 USC 1453 to 1455; Policy Analyst, Department of Health RIN: 0910–AB09 21 USC 321; 21 USC 343; 21 USC 352; and Human Services, Food and Drug 21 USC 355; 21 USC 360b; 21 USC 362; Administration, Office of Policy (HF- 23), 5600 Fishers Lane, Room 15-74, 960. USE OF OZONE-DEPLETING 21 USC 371; 21 USC 381; 21 USC 382; Rockville, MD 20857 SUBSTANCES IN AEROSOL 21 USC 393; 42 USC 216; 42 USC 241; Phone: 301 827-3380 PRODUCTS OR OTHER 42 USC 243; 42 USC 262 Fax: 301 443-6906 PRESSURIZED DISPENSERS CFR Citation: 21 CFR 1 Email: [email protected] Priority: Other Significant. Major status Legal Deadline: None RIN: 0910–AB17 under 5 USC 801 is undetermined. Abstract: The proposed rule would Unfunded Mandates: Undetermined establish the recordkeeping and 963. EXEMPTION FROM PREEMPTION Legal Authority: 15 USC 402; 15 USC notification requirements for persons exporting human drugs, animal drugs, OF STATE AND LOCAL CIGARETTE 409; 21 USC 321; 21 USC 331; 21 USC AND SMOKELESS TOBACCO 335; 21 USC 342; 21 USC 346a; 21 USC biologics, and devices under the FDA Export Reform and Enhancement Act. REQUIREMENTS; APPLICATIONS FOR 348; 21 USC 351; 21 USC 352; 21 USC EXEMPTION SUBMITTED BY VARIOUS 355; 21 USC 357; 21 USC 360b; 21 USC Timetable: STATE GOVERNMENTS; GROUP 1; 361; 21 USC 371; ... Action Date FR Cite GROUP 2 CFR Citation: 21 CFR 2 NPRM 05/00/98 Priority: Substantive, Nonsignificant Legal Deadline: None Small Entities Affected: None Legal Authority: 21 USC 360k; 21 USC Abstract: FDA is proposing to amend 371 its essential-use regulations to provide Government Levels Affected: None CFR Citation: stricter scrutiny of proposed Agency Contact: Philip L. Chao, Senior 21 CFR 808 exemptions from the general ban on the Policy Analyst, Department of Health Legal Deadline: None
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DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Abstract: FDA published a notice of Legal Deadline: None predecisional documents (such as draft proposed rulemaking on November 7, Abstract: The proposal would amend rules and guidance documents) 1996, announcing that the agency the establishment registration and provided by FDA that do not include would be accepting applications for product listing regulations for human confidential commercial information. exemption from Federal preemption for drugs, biologics, animal drugs, and These changes are intended to facilitate State and local cigarette and smokeless devices to require foreign information exchanges with State and tobacco requirements. The notice manufacturers importing such products foreign governments. explained that FDA would consider the into the United States to register and Timetable: applications in two groups and set to list their products. deadlines for submitting applications. Action Date FR Cite Timetable: Group 1 applications, due December 9, NPRM 06/00/98 1996, pertain to State and local Action Date FR Cite Small Entities Affected: None requirements governing the sale and NPRM 10/00/98 distribution of cigarettes and smokeless Government Levels Affected: None tobacco that are different from, or in Small Entities Affected: None Additional Information: 5 USC 552 addition to, FDA requirements under Government Levels Affected: None Agency Contact: Philip L. Chao, Senior section 897.14(a) and section 897.14(b) Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of Health of the final tobacco rule (the age and Policy Analyst, Department of Health and Human Services, Food and Drug identification requirements). Group 2 and Human Services, Food and Drug Administration, Office of Policy (HF- applications, due May 6, 1997, pertain Administration, Office of Policy (HF- 23), 5600 Fishers Lane, Room 15-74, to State and local requirements 23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857 governing the sale and distribution of Rockville, MD 20857 Phone: 301 827-3380 cigarettes and smokeless tobacco that Phone: 301 827-3380 Fax: 301 443-6906 are different from, or in addition to, Fax: 301 443-6906 Email: [email protected] all other requirements under the final Email: [email protected] tobacco rule. RIN: 0910–AB22 RIN: Timetable: 0910–AB21 Group 1 966. ∑ DISSEMINATION OF NPRM 02/19/97 (62 FR 7390) 965. ∑ PUBLIC INFORMATION; TREATMENT INFORMATION ON NPRM Comment Period End 06/23/97 COMMUNICATIONS WITH STATE AND UNAPPROVED USES FOR MARKETED Final Action 11/28/97 (62 FR 63271) FOREIGN GOVERNMENT OFFICIALS DRUGS AND DEVICES Group 2 Priority: Other Significant NPRM 05/00/98 Priority: Info./Admin./Other Groups 1 and 2 Legal Authority: 18 USC 552; 18 USC Legal Authority: 21 USC 321; 21 USC Notice 11/07/96 (61 FR 57685) 1905; 19 USC 2531 to 2582; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC Small Entities Affected: None 321 to 393; 21 USC 1401 to 1403; 42 355; 21 USC 360b; 21 USC 360c; 21 USC 241; 42 USC 242; 42 USC 242a; USC 360e; 21 USC 371; 21 USC 374; Government Levels Affected: State, 42 USC 242e; 42 USC 242l; 42 USC PL 105-115 sec. 401 Local 242n; 42 USC 243; 42 USC 262; 42 USC CFR Citation: 21 CFR 99 Additional Information: Formerly listed 263; 42 USC 263b to 263n; ... under RIN 0910-AB03. Legal Deadline: None CFR Citation: 21 CFR 20.88; 21 CFR Abstract: Agency Contact: Anne M. Kirchner, 20.89 The proposal would establish Policy Analyst, Department of Health the procedures and requirements for Legal Deadline: None and Human Services, Food and Drug the dissemination of information on Administration, Office of Policy (HFD- Abstract: The proposed rule would unapproved new uses of marketed 11), 5600 Fishers Lane, Room 14-72, amend the regulations governing drugs, biologics, and devices. The Rockville, MD 20857 communications with State and foreign proposal would include requirements Phone: 301 827-5321 government officials. The proposed rule concerning submissions to the Food Fax: 301 443-5169 would permit the Food and Drug and Drug Administration, requests to Administration (FDA) to disclose extend the time period for completing RIN: 0910–AB19 confidential commercial information to studies needed to submit a international organizations having supplemental application for a new 964. ∑ REGISTRATION OF FOREIGN responsibility to facilitate global or use, applications for an exemption from ESTABLISHMENTS AND PRODUCT regional harmonization of standards the requirement to conduct studies, LISTING and requirements. These disclosures recordkeeping, and reporting. The proposal would also cover agency Priority: Routine and Frequent would, in almost all instances, occur only with the consent of the person actions on such submissions, requests, Legal Authority: 21 USC 321; 21 USC providing the confidential commercial and applications, as well as orders to 331; 21 USC 352; 21 USC 355; 21 USC information to FDA. The proposed rule cease or to terminate dissemination of 360; 21 USC 360b to 360c; 21 USC would also eliminate the need for a information. 360e; 21 USC 360i to 360j; 21 USC 371; written statement by a State or foreign Timetable: 21 USC 374; 42 USC 216; 42 USC 262 government official establishing that CFR Citation: 21 CFR 207; 21 CFR 607; government’s ability to protect from Action Date FR Cite 21 CFR 807 public disclosure nonpublic, NPRM 05/00/98
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00287 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21962 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Small Entities Affected: None complies with section 361 of the PHS requirements for donor suitability and Government Levels Affected: None Act. testing; viral inactivation; and Timetable: definitions for ‘‘analogous products.’’ Agency Contact: Peggy Dotzel, Senior These actions are intended to help Science Policy Advisor, Department of Action Date FR Cite ensure the continued safety of the Health and Human Services, Food and NPRM 05/00/98 nation’s blood supply. Drug Administration, Office of Policy (HF-13), 5600 Fishers Lane, Room 14- Small Entities Affected: None Timetable: 72, Rockville, MD 20857 Government Levels Affected: None CGMPs for Blood and Blood Components Phone: 301 827-5321 NPRM 10/00/98 Agency Contact: Philip L. Chao, Senior Fax: 301 443-5169 Definition for ``Analogous Products'' Policy Analyst, Department of Health RIN: NPRM 01/00/99 0910–AB23 and Human Services, Food and Drug Minor Changes to Reqs. for CGMP for Administration, Office of Policy (HF- Blood and Blood Components 967. ∑ FDA EXPORT REFORM AND 23), 5600 Fishers Lane, Room 15-74, Direct Final Rule 10/00/98 ENHANCEMENT ACT OF 1996; Rockville, MD 20857 Notification of End Users of Plasma Phone: 301 827-3380 Derivative Products REPORTING AND RECORDKEEPING NPRM 10/00/98 REQUIREMENTS FOR UNAPPROVED Fax: 301 443-6906 Email: [email protected] Notification of Permanently Deferred OR VIOLATIVE PRODUCTS IMPORTED Donors FOR FURTHER PROCESSING OR RIN: 0910–AB24 NPRM 01/00/99 INCORPORATION AND LATER Reqs. Applicable to Albumin (Human), EXPORT Plasma Protein Fraction 968. ∑ BLOOD INITIATIVE Direct Final Rule 10/00/98 Priority: Substantive, Nonsignificant Priority: Other Significant. Major status Requirements for Donor Testing Legal Authority: 15 USC 1453 to 1455; under 5 USC 801 is undetermined. NPRM 01/00/99 21 USC 321; 21 USC 343; 21 USC 352; Suitability Reqs. for Whole Blood and Unfunded Mandates: 21 USC 355; 21 USC 360b; 21 USC 362; Undetermined Source Plasma Donors 21 USC 371; 21 USC 374; 21 USC 381; Legal Authority: 21 USC 321; 21 USC NPRM 01/00/99 331; 21 USC 351; 21 USC 352; 21 USC Viral Inactivation 21 USC 382; 21 USC 393; 42 USC 216 NPRM 01/00/99 CFR Citation: 21 CFR 1.84 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC Small Entities Affected: Undetermined Legal Deadline: None 262; 42 USC 263; 42 USC 263a; 42 USC Government Levels Affected: None Abstract: The proposed rule would 264; 42 USC 300aa-25 Agency Contact: Steven F. Falter, establish reporting and recordkeeping CFR Citation: 21 CFR 600; 21 CFR 601; Director, Regulations and Policy Staff, requirements to implement sections 21 CFR 606; 21 CFR 607; 21 CFR 610; Department of Health and Human 801(d)(3) and 801 (d)(4) of the Federal 21 CFR 640; 21 CFR 660; 21 CFR 680 Food, Drug, and Cosmetic Act (the act) Services, Food and Drug as amended by the Food and Drug Legal Deadline: None Administration, Center for Biologics Administration (FDA) Export Reform Abstract: In multiple rulemakings, the Evaluation and Research (HFM-17), and Enhancement Act of 1996. Section Food and Drug Administration is 1401 Rockville Pike, Suite 200N, 801(d)(3) of the act provides that, under proposing to amend the biologics Rockville, MD 20852 prescribed conditions, drug and device regulations by removing, revising, or Phone: 301 827-6210 components, food and color additives, updating specific regulations applicable RIN: 0910–AB26 and dietary supplements may be to blood derivative products to be more imported if they are to be further consistent with current practices and to processed or incorporated into products remove unnecessary or outdated 969. ∑ SUITABILITY DETERMINATION that are to be exported from the United requirements. This action is based on FOR DONORS OF HUMAN CELLULAR States in accordance with sections a comprehensive review of the AND TISSUE-BASED PRODUCTS 801(e) or 802 of the act or section regulations that has been performed. It Priority: Other Significant 351(h) of the Public Health Service is also based on reports by the U.S. (PHS) Act. Section 801(d)(4) of the act House of Representatives Committee on Reinventing Government: This provides that blood, blood components, Government Reform and Oversight, rulemaking is part of the Reinventing source plasma, or source leukocytes, or Subcommittee on House Resources and Government effort. It will revise text in a component, accessory, or part thereof, Intergovernmental Relations; the the CFR to reduce burden or may not be imported under section General Accounting Office; the Institute duplication, or streamline 801(d)(3) of the act unless the of Medicine; as well as public requirements. importation complies with section comments received in response to the Legal Authority: 42 USC 216; 42 USC 351(a) of the PHS Act or FDA permits comprehensive review. Some of the 243; 42 USC 262; 42 USC 263a; 42 USC the importation under FDA-determined subjects to be addressed in the 264; 42 USC 271 appropriate circumstances and rulemakings include: ‘‘Lookback’’ CFR Citation: conditions. Additionally, section requirements for hepatitis C virus; 21 CFR 210.1(c); 21 CFR 801(d)(4) of the act prohibits the notification of consignees and end 210.2(a); 21 CFR 210.2(b); 21 CFR importation of tissue or a component users of product safety information for 311.1(b); 21 CFR 820.1(a)(1); 21 CFR or part of tissue under section 801(d)(3) plasma derivative products; notification 820.1(c); 21 CFR 1271 of the act unless the importation of permanently deferred donors; Legal Deadline: None
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DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Abstract: As part of implementing the handling, processing, and storage of Public Health Service Act. In lieu of proposed regulatory approach to human human cellular and tissue-based product licenses and establishment cellular and tissue-based products, the products, recordkeeping, and the licenses, FDA will require submission Food and Drug Administration is maintenance of a quality program. FDA and approval of a biologics license proposing to require manufacturers of is also proposing to amend the current application in order to market these human cellular and tissue-based good manufacturing practice biologic products in interstate products to screen and test the donors regulations that apply to human commerce. of cells and tissues used in those cellular and tissue-based products Timetable: products for evidence of or risk factors regulated as drugs, medical devices, for relevant communicable disease. As and/or biological products in order to Action Date FR Cite part of this action, the agency is incorporate the new GTP requirements NPRM 07/00/98 proposing to amend the current good into existing good manufacturing Small Entities Affected: None manufacturing practice regulations that practice regulations. apply to human cellular and tissue- Timetable: Government Levels Affected: None based products regulated as drugs, Agency Contact: Action Date FR Cite Timothy W. Beth, medical devices, and/or biological Consumer Safety Officer, Department of products in order to incorporate the NPRM 12/00/98 Health and Human Services, Food and new donor suitability requirements into Small Entities Affected: Businesses Drug Administration, Center for existing good manufacturing practice Biologics Evaluation and Research Government Levels Affected: None regulations. (HFM-17), 1401 Rockville Pike, Suite Timetable: Agency Contact: Paula S. McKeever, 200N, Rockville, MD 20852 Consumer Safety Officer, Department of Action Date FR Cite Phone: 301 827-6333 Health and Human Services, Food and Email: [email protected] NPRM 09/00/98 Drug Administration, Center for RIN: 0910–AB29 Small Entities Affected: Businesses Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite Government Levels Affected: None 200N, Rockville, MD 20852 972. ∑ ANTIBIOTIC DRUG APPROVAL Agency Contact: Paula S. McKeever, Phone: 301 827-6210 AND EXCLUSIVITY Consumer Safety Officer, Department of RIN: 0910–AB28 Priority: Other Significant. Major status Health and Human Services, Food and under 5 USC 801 is undetermined. Drug Administration, Center for Biologics Evaluation and Research 971. ∑ BIOLOGICAL PRODUCTS Unfunded Mandates: Undetermined (HFM-17), 1401 Rockville Pike, Suite REGULATED UNDER SECTION 351 OF Reinventing Government: This 200N, Rockville, MD 20852 THE PUBLIC HEALTH SERVICES ACT; rulemaking is part of the Reinventing Phone: 301 827-6210 IMPLEMENTATION OF BIOLOGICS Government effort. It will eliminate LICENSE; ELIMINATION OF RIN: 0910–AB27 existing text in the CFR. ESTABLISHMENT LICENSE AND PRODUCT LICENSE Legal Authority: PL 105-115, sec 125 970. ∑ CURRENT GOOD TISSUE Priority: Other Significant CFR Citation: Not yet determined PRACTICE FOR MANUFACTURERS Legal Deadline: None OF HUMAN CELLULAR AND TISSUE- Reinventing Government: This BASED PRODUCTS rulemaking is part of the Reinventing Abstract: This proposed rule will Government effort. It will revise text in implement the incorporation of Priority: Other Significant the CFR to reduce burden or antibiotics, which were formerly Reinventing Government: This duplication, or streamline regulated under authority of section rulemaking is part of the Reinventing requirements. 507 of the Federal Food, Drug, and Government effort. It will revise text in Legal Authority: 42 USC 262; PL 105- Cosmetic Act, into the new drug the CFR to reduce burden or 115 regulatory scheme under section 505 of duplication, or streamline the Act. The regulation will describe CFR Citation: 21 CFR 3; 21 CFR 5; 21 requirements. which antibiotics will be eligible for CFR 10; 21 CFR 20; 21 CFR 207; 21 exclusivity under sections 505(c)(3)(D) Legal Authority: 42 USC 216; 42 USC CFR 310; 21 CFR 312; 21 CFR 316; 21 and 505 (j)(4)(D) of the Act. 243; 42 USC 262; 42 USC 263a; 42 USC CFR 600; 21 CFR 601; 21 CFR 607; 21 264; 42 USC 271 CFR 610; 21 CFR 640; 21 CFR 660 Timetable: CFR Citation: 21 CFR 1271 Legal Deadline: None Action Date FR Cite Legal Deadline: None Abstract: As a ‘‘Reinventing NPRM 09/00/98 Abstract: As part of implementing the Government’’ initiative and to amend NPRM Comment 11/00/98 proposed regulatory approach to human regulations to implement section 123 of Period End cellular and tissue-based products, the the Food and Drug Administration Small Entities Affected: Undetermined Food and Drug Administration (FDA) Modernization Act of 1997; FDA is is proposing to require manufacturers proposing to eliminate the requirement Government Levels Affected: of human cellular and tissue-based and use of establishment licenses and Undetermined products to follow current good tissue product licenses for biological products Agency Contact: Wayne Mitchell, practice (GTP), which includes proper regulated under section 351 of the Regulatory Counsel, Department of
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00289 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21964 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Health and Human Services, Food and 974. ∑ EXPANDED ACCESS TO Abstract: This proposed rule will set Drug Administration, Center for Drug INVESTIGATIONAL THERAPIES forth a new system of distinctive colors Evaluation and Research (HFD-7), 1451 Priority: Other Significant. Major status and marks to identify different types Rockville Pike, Suite 3047, Rockville, under 5 USC 801 is undetermined. of insulin-containing drug products. MD 20852 Timetable: Phone: 301 594-2041 Unfunded Mandates: Undetermined Action Date FR Cite Fax: 301 827-5562 Legal Authority: PL 105-115, sec 402 NPRM 10/00/98 RIN: 0910–AB33 CFR Citation: Not yet determined NPRM Comment 01/00/99 Legal Deadline: None Period End 973. ∑ APPLICATIONS FOR FDA Abstract: This proposed rule will Small Entities Affected: Undetermined APPROVAL TO MARKET A NEW revise the investigational new drug DRUG OR ANTIBIOTIC DRUG; Government Levels Affected: regulations to clarify the conditions COMPLETE REVIEW LETTER; Undetermined under which individual patients may AMENDMENTS TO UNAPPROVED receive investigational drugs for Agency Contact: Wayne H. Mitchell, APPLICATIONS treatment use; to clarify the conditions Regulatory Counsel, Regulatory Policy Staff, Department of Health and Human Priority: Other Significant. Major status under which a small group of patients Services, Food and Drug under 5 USC 801 is undetermined. may receive investigational drugs for treatment use under an expanded Administration, Center for Drug Unfunded Mandates: Undetermined access protocol; and to clarify the Evaluation and Research (HFD-7), 1451 criteria under which sponsors can Rockville Pike, Suite 3047, Rockville, Reinventing Government: This MD 20852 rulemaking is part of the Reinventing recover costs for providing investigational drugs to patients for Phone: 301 594-2041 Government effort. It will eliminate Fax: 301 827-5562 existing text in the CFR. certain treatment uses. Timetable: RIN: 0910–AB43 Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC Action Date FR Cite 976. ∑ PROGESTATIONAL DRUG 353; 21 USC 355; 21 USC 356; 21 USC NPRM 08/00/98 357; 21 USC 371; 21 USC 374; 21 USC PRODUCTS FOR HUMAN USE; NPRM Comment 11/00/98 REQUIREMENTS FOR LABELING 379e Period End DIRECTED TO THE PATIENT Small Entities Affected: Undetermined CFR Citation: 21 CFR 312; 21 CFR 314 Priority: Other Significant. Major status Legal Deadline: None Government Levels Affected: under 5 USC 801 is undetermined. Undetermined Abstract: This proposed rule will Unfunded Mandates: Undetermined amend the regulations on marketing Agency Contact: Joseph Griffin, Legal Authority: 21 USC 321; 21 USC approval of new drugs to discontinue Regulatory Counsel, Regulatory Policy 331; 21 USC 351; 21 USC 352; 21 USC the use of approvable and not Staff, Department of Health and Human 353; 21 USC 355; 21 USC 356; 21 USC approvable letters when taking action Services, Food and Drug 357; 21 USC 360b to 360f; 21 USC 360j; on a marketing application and instead Administration, Center for Drug 21 USC 361(a); 21 USC 371; 21 USC use complete review letters. Evaluation and Research (HFD-7), 1451 374; 21 USC 375; 21 USC 379e; ... Rockville Pike, Suite 3047, Rockville, Timetable: MD 20852 CFR Citation: 21 CFR 310 Action Date FR Cite Phone: 301 594-2041 Legal Deadline: None Fax: 301 827-5562 NPRM 07/00/98 Abstract: This proposed rule will NPRM Comment 10/00/98 RIN: 0910–AB37 revoke 21 CFR 310.516 which requires Period End that progestational drug products be dispensed with a patient package insert Small Entities Affected: Undetermined 975. ∑ DISTINGUISHING MARKS FOR DRUG PRODUCTS CONTAINING containing a discussion of the risks of Government Levels Affected: INSULIN birth defects resulting from the use of Undetermined these drugs during the first four months Priority: Other Significant. Major status of pregnancy. The Food and Drug Agency Contact: Brian L. Pendleton, under 5 USC 801 is undetermined. Administration is proposing to revoke Regulatory Counsel, Regulatory Policy Unfunded Mandates: Undetermined this labeling requirement because of Staff, Department of Health and Human changes in the currently available Services, Food and Drug Legal Authority: 21 USC 321; 21 USC scientific information. Administration, Center for Drug 331; 21 USC 351; 21 USC 352; 21 USC Timetable: Evaluation and Research (HFD-7), 1451 353; 21 USC 355; 21 USC 357; 21 USC Rockville Pike, Suite 3047, Rockville, 358; 21 USC 360; 21 USC 360b; 21 USC Action Date FR Cite 360gg to 360ss; 21 USC 371; 21 USC MD 20852 NPRM 07/00/98 374; 21 USC 379e; 42 USC 216; ... Phone: 301 594-2041 NPRM Comment 10/00/98 Fax: 301 827-5562 CFR Citation: 21 CFR 201 Period End RIN: 0910–AB34 Legal Deadline: None Small Entities Affected: Undetermined
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DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Government Levels Affected: Phone: 301 594-1725 Agency Contact: Dano B. Murphy, Regulatory Counsel, Department of Undetermined RIN: 0910–AB50 Agency Contact: Christine Rogers, Health and Human Services, Food and Regulatory Counsel, Regulatory Policy Drug Administration, Center for Staff, Department of Health and Human 978. ∑ REVISIONS TO THE GENERAL Biologics Evaluation and Research Services, Food and Drug SAFETY REQUIREMENTS FOR (HFM-617), 1401 Rockville Pike, Suite Administration, Center for Drug BIOLOGICAL PRODUCTS; DIRECT 200N, Rockville, MD 20852-1448 Evaluation and Research (HFD-7), 1451 FINAL RULE Phone: 301 827-6210 Rockville Pike, Suite 3047, Rockville, Priority: Substantive, Nonsignificant RIN: 0910–AB51 MD 20852 Reinventing Government: This Phone: 301 594-2041 979. ∑ RADIOPHARMACEUTICALS Fax: 301 827-5562 rulemaking is part of the Reinventing Government effort. It will revise text in USED FOR IN VIVO DIAGNOSIS AND RIN: 0910–AB45 the CFR to reduce burden or MONITORING duplication, or streamline Priority: Substantive, Nonsignificant requirements. 977. ∑ REQUIREMENTS FOR LIQUID Unfunded Mandates: Undetermined MEDICATED FEED AND FREE CHOICE Legal Authority: 42 USC 351 Legal Authority: PL 105-115, sec 122 MEDICATED FEED CFR Citation: 21 CFR 610.11(g) CFR Citation: 21 CFR 315; 21 CFR 601 Priority: Substantive, Nonsignificant Legal Deadline: None Legal Deadline: NPRM, Statutory, May Legal Authority: PL 104-25; 21 USC 20, 1998. Final, Statutory, May 20, 360(b) Abstract: The Food and Drug Administration (FDA) is amending the 1999. CFR Citation: 21 CFR 558.5; 21 CFR biologics regulations by adding Abstract: Section 122 of FDAMA, 510.455 ‘‘cellular therapy products’’ to the list Requirements for Legal Deadline: None of products excepted from the general Radiopharmaceuticals, requires the Abstract: In response to a citizen safety test (GST), and by adding an Secretary, HHS, after consultation with petition filed by the American Feed administrative procedure for obtaining patient advisory groups, associations, Industry Association, the Food and exemptions from the GST requirements physicians licensed to use Drug Administration (FDA) is for other biological products. FDA is radiopharmaceuticals, and the regulated proposing to amend the requirements taking this action because the GST may industry, to issue proposed regulations for liquid medicated animal feed to not be relevant or necessary for all governing the approval of clarify what information and data are biological products, including cellular radiopharmaceuticals. The regulations required to demonstrate chemical and therapy products, currently in various shall provide that the determination of positional stability. The amended stages of development. This direct final safety and effectiveness of a regulations would also clarify the rule is part of FDA’s continuing effort radiopharmaceutical under section 505 provisions for the submission of such to achieve the objectives of the of the Federal Food, Drug, and data through a master file and the President’s ‘‘Reinventing Government’’ Cosmetic Act (21 U.S.C. 355) or section reference to master files by subsequent initiative, and is intended to reduce the 351 of the Public Health Service Act (42 U.S.C. 262) shall include applicants. Additionally, FDA is burden of unnecessary regulations on consideraton of the proposed use of the proposing to amend the regulations for biological products without radiopharmaceutical in the practice of free-choice medicated feed in order to diminishing the protection of the medicine, the pharmacological and ensure consistency with the public health. FDA is publishing a toxicological activity of the requirements for liquid medicated feed. companion proposed rule under FDA’s radiopharmaceutical (including any Finally, FDA is proposing to amend the usual procedures for notice and carrier or ligand component of the regulations for free choice medicated comment to provide a procedural radiopharmaceutical), and the feed and liquid medicated feed so that framework to finalize the rule in the estimated radiation dose of the these provisions comply with the terms event the agency receives any radiopharmaceutical. In addition, the of the Animal Drug Availability Act of significant adverse comment and indication for which a 1996. withdraws this direct final rule. radiopharmaceutical is approved for Timetable: Timetable: marketing may, in appropriate cases, Action Date FR Cite Action Date FR Cite refer to manifestations of disease (such as biochemical, physiological, NPRM 01/00/99 Direct Final Rule 04/00/98 Companion Document to Direct Final Rule anatomical, or pathological processes) Small Entities Affected: Undetermined Proposed Rule 04/00/98 common to, or present in, one or more Government Levels Affected: disease states. Small Entities Affected: None Undetermined Timetable: Government Levels Affected: None Agency Contact: William Price, Action Date FR Cite Department of Health and Human Procurement: This is a procurement- NPRM 05/00/98 Services, Food and Drug related action for which there is no Final Action 05/00/99 Administration, Center for Veterinary statutory requirement. There is a Medicine (HFV-200), 7500 Standish paperwork burden associated with this Small Entities Affected: Undetermined Place, Rockville, MD 20855 action. Government Levels Affected: None
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DEPARTMENT OF HEALTHFood AND and HUMANDrug AdministrationProposed SERVICES Rule (HHS) (FDA)Stage HHSÐFDA Proposed Rule Stage
Agency Contact: Dano B. Murphy, Biologics Evaluation and Research Phone: 301 827-6210 Regulatory Counsel, Department of (HFM-617), 1401 Rockville Pike, Suite Health and Human Services, Food and 200N, Rockville, MD 20852-1448 RIN: 0910–AB52 Drug Administration, Center for
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Food and Drug Administration (FDA) Final HHS—FDARule Stage
980. NEW ANIMAL DRUG APPROVAL ‘‘Reinventing the Regulation of Animal Administration, Center for Veterinary PROCESS; IMPLEMENTATION OF Drugs,’’ May 1996. In the reinventing Medicine (HFV-100), 7500 Standish TITLE I OF THE GENERIC ANIMAL regulations report, FDA proposed to Place, Rockville, MD 20855 DRUG AND PATENT TERM revise its regulations to reflect Phone: 301 594-1620 RESTORATION ACT (GADPTRA) numerous new process changes and RIN: 0910–AA02 Priority: Substantive, Nonsignificant. programs that will maintain safety and Major status under 5 USC 801 is effectiveness of new animal drugs and undetermined. enable a more streamlined animal drug 981. PRESCRIPTION DRUG application review and approval MARKETING ACT OF 1987; POLICY Reinventing Government: This process which will result in less INFORMATION, GUIDANCE, AND rulemaking is part of the Reinventing regulatory burden upon industry and CLARIFICATIONS Government effort. It will revise text in FDA. The Agency also proposes to the CFR to reduce burden or amend its regulations to implement Priority: Other Significant duplication, or streamline title I of the Generic Animal Drug and Legal Authority: PL 100-293 requirements. Patent Term Restoration Act, which Prescription Drug Marketing Act of Legal Authority: 21 USC 321; 21 USC established new standards for 1987 351; 21 USC 352; 21 USC 360b; 21 USC marketing approval of generic copies of 371; 21 USC 379e; 21 USC 381 animal drugs approved after 1962. CFR Citation: 21 CFR 203 CFR Citation: 21 CFR 514 Timetable: Legal Deadline: None Legal Deadline: Final, Statutory, Action Date FR Cite Abstract: The Prescription Drug November 16, 1989. ANPRM 11/21/96 61 FR 59209 Marketing Act of 1987 (PDMA) The deadline applies to the GADPTRA ANPRM Comment 01/21/97 amended the Federal Food, Drug, and sections. There is no deadline relating Period End Cosmetic Act to: (1) require State to the other sections. New Animal Drug Approval Process licensing of wholesale distributors of Abstract: On December 17, 1991, the NPRM 12/17/91 (56 FR 65544) prescription human drugs under Agency published a proposed revision NPRM 00/00/00 Federal guidelines including minimum of the existing regulations that is Reporting Requirements for Marketed standards for storage, handling, and Animal Drugs recordkeeping; (2) ban the consistent with the current procedural NPRM 12/17/91 (56 FR 65581) regulations for human drugs, where Final Action 12/00/98 reimportation of prescription human appropriate. The New Animal Drug drugs produced in the United States, Small Entities Affected: Application (NADA) revisions Businesses except when reimported by the articulate general requirements in Government Levels Affected: None manufacturer or for emergency use; (3) regulations containing performance Additional Information: Previously ban the sale, trade, or purchase of drug standards and would complement these reported under RIN 0905-AA96. samples; (4) ban trafficking in or regulations through detailed guidelines counterfeiting of drug coupons; (5) on, among other matters, appropriate For information concerning reporting mandate storage, handling, and ways of meeting requirements for requirements for marketed animal recordkeeping requirements for drug submission of chemistry, drugs, contact William C. Keller, samples; (6) require licensed pharmacology, and statistical data that Director, Division of Surveillance, practitioners to request drug samples in would better address the intricate Center for Veterinary Medicine, Food writing; (7) prohibit, with certain scientific issues involved. A separate and Drug Administration, 7500 exceptions, the resale of prescription proposed rule for reporting Standish Place, Rockville, MD 20855, human drugs purchased by hospitals or requirements for marketed animal drugs (301) 594-1722. For further information health care facilities; and (8) set forth also was published on that date. The concerning generic animal drugs, criminal and civil penalties for agency intends to repropose the NADA contact Lonnie W. Luther, Chief, violations of these provisions. In the proposed rule to incorporate some Generic Animal Drug and Quality Federal Register of September 14, 1990 recent changes in procedure. The Control Staff, Center for Veterinary (55 FR 38012), FDA issued a final rule NADA revisions are expected to Medicine, Food and Drug setting forth Federal guidelines for include regulations to implement the Administration, 7500 Standish Place, State licensing of wholesale drug provisions of the Animal Drug Rockville, MD 20855, (301) 594-1623. distributors. This final rule would Availability Act of 1996, specifically Agency Contact: Margaret Miller, provide information, guidance, and the definition of flexible labeling, and Deputy Director, Office of New Animal clarification of those sections of PDMA implement parts of the President’s Drug Evaluation, Department of Health that are not related to State licensing National Performance Report and Human Services, Food and Drug of wholesale distributors.
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Timetable: in the manufacture of blood and blood 1991. This action is in response to the Action Date FR Cite components; and facilitate a rapid 1991 tampering incidents and requires response where public health may be use of the term ‘‘tamper-evident’’ NPRM 03/14/94 59 FR 11842 at risk. The cost to licensed instead of ‘‘tamper-resistant’’, and that NPRM Comment 08/01/94 establishments would be minimal, all OTC human drug products marketed Period End since they already are required to in two-piece, hard gelatin capsules be Final Action 07/00/98 report. Unlicensed establishments sealed. Small Entities Affected: Businesses, would only have to make some changes Timetable: Organizations in standard operating procedures. Unlicensed establishments are already Action Date FR Cite Government Levels Affected: State, required to keep records and conduct Federal NPRM 01/18/94 59 FR 2542 investigations. Under the final rule they NPRM Comment 03/21/94 Additional Information: Previously would have to establish reporting Period End reported under RIN 0905-AD44. procedures and report to FDA. The Final Action 06/00/98 Agency Contact: Lee D. Korb, transfusion services would have to Final Action Effective 06/00/99 Regulatory Counsel, Regulatory Policy assure that their recordkeeping and Small Entities Affected: Businesses Staff, Department of Health and Human investigation procedures are sufficient, Government Levels Affected: Federal Services, Food and Drug and establish reporting procedures. Administration, Center for Drug Timetable: Additional Information: Previously Evaluation and Research (HFD-7), 1451 reported under RIN 0905-AE27. Action Date FR Cite Rockville Pike, Suite 3047, Rockville, Agency Contact: Thomas Kuchenberg, MD 20852 NPRM 09/23/97 62 FR 49642 Regulatory Counsel, Regulatory Policy Phone: 301 594-2041 NPRM Comment 12/22/97 Staff, Department of Health and Human Fax: 301 827-5562 Period End Services, Food and Drug Final Action 12/00/98 RIN: 0910–AA08 Administration, Center for Drug Small Entities Affected: Businesses, Evaluation and Research (HFD-7), 1451 Organizations Rockville Pike, Suite 3047, Rockville, 982. BIOLOGICAL PRODUCTS: Government Levels Affected: None MD 20852 REPORTING OF ERRORS AND Phone: 301 594-2041 ACCIDENTS IN MANUFACTURING Additional Information: Previously Fax: 301 827-5562 reported under RIN 0905-AD67. Priority: Substantive, Nonsignificant RIN: 0910–AA26 Agency Contact: Valerie A. Butler, Legal Authority: 21 USC 321; 21 USC Consumer Safety Officer, Department of 331; 21 USC 351 to 353; 21 USC 355; Health and Human Services, Food and 984. PRESCRIPTION DRUG PRODUCT 21 USC 360; 21 USC 360i; 21 USC 360j; Drug Administration, Center for LABELING; MEDICATION GUIDE 21 USC 371; 21 USC 374; 42 USC 216; Biologics Evaluation and Research 42 USC 262 to 264; 42 USC 300aa-25 Priority: Other Significant (HFM-17), 1401 Rockville Pike, Suite CFR Citation: 21 CFR 600; 21 CFR 606 200N, Rockville, MD 20852-1448 Legal Authority: 21 USC 321; 21 USC Phone: 301 827-6210 352; 21 USC 371; 21 USC 355; 42 USC Legal Deadline: None 262 RIN: 0910–AA12 Abstract: FDA is amending the CFR Citation: 21 CFR 201; 21 CFR 208; regulations that require licensed 21 CFR 314; 21 CFR 600 manufacturers of biological products to 983. TAMPER-EVIDENT PACKAGING Legal Deadline: None report errors and accidents in REQUIREMENTS FOR OVER-THE- manufacturing that may affect the COUNTER HUMAN DRUG PRODUCTS Abstract: In August, 1995 the Food and safety, purity, or potency of a product. Drug Administration (FDA) published a FDA defines terms used; establishes a Priority: Substantive, Nonsignificant proposed rule that specified standards reporting period for all licensed Legal Authority: 21 USC 321; 21 USC for the distribution and quality of biological products; and amends the 351; 21 USC 352; 21 USC 355; 21 USC useful prescription medication current good manufacturing practice 371 information, designed for patients, that (CGMP) regulations for blood and blood CFR Citation: 21 CFR 211 voluntary, private-sector efforts should components to require error and supply to patients receiving new accident reporting by unlicensed Legal Deadline: None prescriptions. On August 6, 1996, registered blood establishments and Abstract: FDA has required tamper- section 601 of the Agriculture Rural transfusion services currently reporting resistant packaging features for OTC Development, Food and Drug on a voluntary basis. The reporting drug products since 1982. The tamper- Administration, and Related Agencies requirements will expedite reporting of resistant packaging regulations were Appropriations Act, 1997 was enacted errors and accidents in manufacturing revised in 1989 in response to which places the proposed rule as it of biological products; provides FDA continuing tampering incidents. Despite relates to a voluntary program in with a more accurate surveillance of the regulatory protection provided by abeyance. The legislation did not the Nation’s blood supply, enabling the regulations, two-piece, hard gelatin address the provisions that would have FDA to monitor actions taken in capsules remain vulnerable to required mandatory Medication Guides response to the errors and accidents malicious tampering and were in relatively rare instances detected for all establishments involved implicated in tampering incidents in (approximately 5 products annually)
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where a product poses a serious and regulations in response to technological Timetable: significant public health concern changes and the agency’s experience Action Date FR Cite requiring immediate distribution of with the regulations. NPRM 01/05/98 63 FR 176 FDA-approved patient information. Timetable: FDA is in the process of finalizing the NPRM Comment 04/06/98 requirement for mandatory Medication Action Date FR Cite Period End Final Action 11/00/98 Guides for these rare products. NPRM 05/03/96 61 FR 20104 Timetable: NPRM Comment 09/30/96 Small Entities Affected: Undetermined Period End Action Date FR Cite Government Levels Affected: Final Action 12/00/98 Undetermined NPRM 08/24/95 60 FR 44182 Final Action Effective 03/00/99 Agency Contact: Leanne Cusumano, Final Action 07/00/98 Small Entities Affected: Businesses Regulatory Counsel, Regulatory Policy Small Entities Affected: Businesses Government Levels Affected: Federal Staff, Department of Health and Human Government Levels Affected: State, Additional Information: Previously Services, Food and Drug Federal reported under RIN 0905-AE63. Administration, Center for Drug Evaluation and Research (HFD-7), 1451 Additional Information: Previously Agency Contact: Thomas Kuchenberg, Rockville Pike, Suite 3047, Rockville, reported under RIN 0905-AE43. Regulatory Counsel, Regulatory Policy MD 20852 Staff, Department of Health and Human Agency Contact: Nancy M. Ostrove, Phone: 301 594-2041 Services, Food and Drug Division of Drug Marketing, Fax: 301 827-5562 Advertising, and Communications, Administration, Center for Drug Department of Health and Human Evaluation and Research (HFD-7), 1451 RIN: 0910–AA74 Services, Food and Drug Rockville Pike, Suite 3047, Rockville, Administration, Center for Drug MD 20852 987. NEW DRUG APPLICATIONS; Evaluation and Research (HFD-240), Phone: 301 594-2041 DRUG MASTER FILE 5600 Fishers Lane, Rockville, MD Fax: 301 827-5562 Priority: Substantive, Nonsignificant 20857 RIN: 0910–AA45 Phone: 301 594-6828 Reinventing Government: This RIN: 0910–AA37 rulemaking is part of the Reinventing 986. PARENTERAL DRUG PRODUCTS Government effort. It will revise text in CONTAINING ALUMINUM AS AN the CFR to reduce burden or 985. CURRENT GOOD INGREDIENT OR CONTAMINANT; duplication, or streamline MANUFACTURING PRACTICE; LABELING REQUIREMENTS; requirements. AMENDMENT OF CERTAIN WARNING STATEMENT Legal Authority: 21 USC 321; 21 USC REQUIREMENTS FOR FINISHED Priority: Other Significant. Major status 331; 21 USC 351 to 353; 21 USC 355 PHARMACEUTICALS under 5 USC 801 is undetermined. to 357; 21 USC 371; 21 USC 374; 21 Priority: Other Significant Unfunded Mandates: Undetermined USC 379 Legal Authority: 21 USC 321; 21 USC Legal Authority: 21 USC 321; 21 USC CFR Citation: 21 CFR 314 351 to 352; 21 USC 355 to 357; 21 USC 331; 21 USC 351 to 353; 21 USC 355 Legal Deadline: None 360b; 21 USC 371; 21 USC 374 to 358; 21 USC 360; 21 USC 371; 21 Abstract: The final rule eliminates CFR Citation: 21 CFR 210.3; 21 CFR USC 374; 21 USC 379; 42 USC 216; Type I Drug Master Files, which 211.22; 21 CFR 211.68; 21 CFR 211.82; 42 USC 241; 42 USC 262; 21 USC 264 contain information about 21 CFR 211.84; 21 CFR 211.101; 21 CFR Citation: 21 CFR 201 manufacturing sites, facilities, operating CFR 211.103; 21 CFR 211.110; 21 CFR Legal Deadline: None procedures, and personnel, because 211.111; 21 CFR 211.113; 21 CFR these files contain outdated 211.115; 21 CFR 211.160; 21 CFR Abstract: The rule will establish a information, duplicate information 211.166; 21 CFR 211.192; 21 CFR maximum level of aluminum permitted contained in marketing applications, 211.220; ... in large volume parenterals used in total parenteral nutrition therapy; and are not used by application review Legal Deadline: None require that the maximum aluminum divisions or field inspectors. Abstract: FDA is finalizing revisions to content present at the time of release Timetable: the current good manufacturing be stated on the immediate container practice (CGMP) regulations at 21 CFR label of certain small volume Action Date FR Cite parts 210 and 211 regarding finished parenterals and pharmacy bulk NPRM 07/03/95 60 FR 34486 pharmaceuticals. The new regulations packages; require that the package NPRM Comment 10/02/95 codify current agency policies or insert of all parenterals include a Period End current industry practices. Among other warning statement on the effects of Final Action 06/00/98 things, the rule will create or clarify aluminum toxicity in patients with Final Action Effective 12/00/98 requirements for process and methods impaired kidneys receiving total Small Entities Affected: None validation, appropriate laboratory parenteral nutrition therapy; and testing procedures, and protection require manufacturers to develop Government Levels Affected: None against contamination. The rule is validated assay methods for Agency Contact: Thomas Kuchenburg, designed to update the CGMP determining the aluminum content. Regulatory Counsel, Department of
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Health and Human Services, Food and authority to ensure that drug labeling Action Date FR Cite Drug Administration, Center for Drug convey all material information to the NPRM Comment 10/06/97 62 FR 33379 Evaluation and Research, (HFD-7), 1451 consumer (21 USC 321(n) and 352(a)), Period End Rockville Pike, Suite 3047, Rockville, and that the labeling communicates this Final Action 08/00/98 MD 20852 information in a manner that is ‘‘likely Phone: 301 594-2041 to be read and understood by the Small Entities Affected: Businesses Fax: 301 827-5562 ordinary individual under customary Government Levels Affected: None conditions of purchase and use.’’ (21 RIN: 0910–AA78 USC 352(c)). Regulating the content of Agency Contact: Cazemiro Martin, OTC drug product labeling is consistent Division of OTC Drug Evaluation, 988. OVER-THE-COUNTER HUMAN with FDA’s authority to ensure that the Department of Health and Human DRUGS; LABELING REQUIREMENTS products are safe and effective for use Services, Food and Drug (sections 201(n) and (p), 502, and 505 Administration, Center for Drug Priority: Other Significant. Major status of the act). Evaluation and Research (HFD-560), under 5 USC 801 is undetermined. 9201 Corporate Blvd., Rockville, MD Alternatives: FDA considered several Unfunded Mandates: Undetermined 20850 alternatives. First, the agency Phone: 301 827-2222 Legal Authority: 21 USC 321; 21 USC considered but rejected a voluntary 351; 21 USC 352; 21 USC 353; 21 USC labeling scheme, as previous industry RIN: 0910–AA79 355; 21 USC 360; 21 USC 371 efforts have been unsuccessful in CFR Citation: 21 CFR 201; 21 CFR 330 achieving both a uniform format and 989. 5NVESTIGATIONAL NEW DRUG an acceptable minimum print size for APPLICATIONS; CLINICAL HOLDS Legal Deadline: None a majority of the products on the FOR DRUGS FOR LIFE-THREATENING market. Second, the agency considered Abstract: The final rule will provide ILLNESSES standardized format and content but rejected revising all OTC requirements for OTC drug product monographs on an individual basis Priority: Other Significant. Major status labeling, including legibility and design because this approach would not under 5 USC 801 is undetermined. features of such information as the uses achieve a standardized labeling format Legal Authority: 21 USC 321; 21 USC for the drug, directions for use, for a majority of the marketed products 331; 21 USC 351; 21 USC 352; 21 USC warnings, drug interactions, in a timely manner. Third, the agency 353; 21 USC 355; 21 USC 356; 21 USC precautions, active ingredients, and considered alternative implementation 357; 21 USC 371; 42 USC 262 other information that the consumer periods but chose the option proposed CFR Citation: would need to know to use the product because it believed that the chosen 21 CFR 312 safely and effectively. approach provides significant reduction Legal Deadline: None in cost while meeting the agency Statement of Need: Currently, the objective of achieving a standardized Abstract: The final rule amends the design, format, and placement of labeling format for a majority of the provisions governing investigational required labeling information varies products in a timely manner. new drug applications to permit FDA considerably among OTC products. As to place a clinical hold on one or more a result, consumers often have Anticipated Costs and Benefits: The studies under an IND involving a drug difficulty finding, reading, and final rule is expected to cost a total that is intended to treat a life- understanding this labeling of $14 million when implemented. This threatening disease affecting both information. Modifying and simplifying cost includes a 1-year extension for genders if men or women with the manner in which the information implementation time of individual OTC reproductive potential who have the is presented can improve the legibility drug products having sales of less than disease are excluded from eligibility in and understandability of OTC drug $25,000 per year. any phase of the investigation because product labeling. Therefore, this final In general, the rule will benefit of a risk or potential risk of rule will establish a standardized consumers by allowing them to make reproductive or developmental toxicity format for the labeling of all marketed more appropriate choices for self- from use of the investigational drug. OTC drug products. This action is treatment, and to reduce trial and error Timetable: intended to enable consumers to better approaches to self-medication. read and understand OTC drug product Consequently, this could lead to Action Date FR Cite labeling and to apply this information decreased overall health care costs NPRM 09/24/97 62 FR 49946 to the safe and effective use of OTC resulting from reduced visits to the NPRM Comment 12/23/97 drug products. doctor or hospital for treatment. Period End Summary of the Legal Basis: FDA’s Additionally, the easy to read, Final Action 10/00/98 standardized format will directly legal authority to modify and simplify Small Entities Affected: Undetermined the manner in which certain benefit consumers by helping ensure Government Levels Affected: information is presented in OTC drug the safe and effective use of the product labeling derives from sections product. Undetermined 201, 502, 505, and 701 of the Federal Risks: None. Agency Contact: Andrea Masciale, Food, Drug, and Cosmetic Act (the act). Timetable: Regulatory Counsel, Department of Regulating the order, appearance, and Health and Human Services, Food and format of OTC drug product labeling Action Date FR Cite Drug Administration, Center for Drug is consistent with the agency’s NPRM 02/27/97 62 FR 9024 Evaluation and Research (HFD-5), 1451
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Rockville Pike, Suite 6027, Rockville, CFR Citation: 21 CFR 210; 21 CFR 211 Small Entities Affected: None MD 20852 Legal Deadline: None Government Levels Affected: None Phone: 301 594-2041 Fax: 301 827-5562 Abstract: The final rule amends the Agency Contact: Gail Schmerfeld, labeling control provisions in the Special Assistant, Department of Health RIN: 0910–AA84 current good manufacturing practice and Human Services, Food and Drug regulations to make the provisions less Administration, Center for Veterinary 990. STERILITY REQUIREMENTS FOR burdensome while still reducing the Medicine (HFV-100), 7500 Standish INHALATION SOLUTION PRODUCTS frequency of drug product mislabeling Place, Rockville, MD 20855 Priority: Other Significant. Major status and associated drug product recalls Phone: 301 827-0205 under 5 USC 801 is undetermined. associated with cut labeling. Fax: 301 594-2297 Unfunded Mandates: Undetermined Timetable: RIN: 0910–AB08 Legal Authority: 21 USC 321; 21 USC Action Date FR Cite 331; 21 USC 351 to 353; 21 USC 355 NPRM 07/29/97 62 FR 40489 993. MEDICATED FEED MILL to 358; 21 USC 360; 21 USC 371; 21 NPRM Comment 10/27/97 LICENSES USC 374 to 375 Period End Priority: Substantive, Nonsignificant CFR Citation: 21 CFR 200 Final Action 11/00/98 Legal Authority: PL 104-250 Legal Deadline: None Small Entities Affected: Undetermined CFR Citation: 21 CFR 5; 21 CFR 207; Abstract: The final rule requires that Government Levels Affected: 21 CFR 225; 21 CFR 510; 21 CFR 514; all inhalation solution products be Undetermined 21 CFR 515; 21 CFR 558 manufactured to be sterile. Based on Agency Contact: Thomas Kuchenberg, Legal Deadline: None reports of adverse drug experiences Regulatory Counsel, Regulatory Policy from contaminated nonsterile Staff, Department of Health and Human Abstract: The Animal Drug Availability inhalation solution products and recalls Services, Food and Drug Act of 1996 (ADAA) amends sections of these products, FDA is taking this Administration, Center for Drug 512(a) and 512(m) of the Federal Food, action to prevent future additional Evaluation and Research (HFD-7), 1451 Drug, and Cosmetic Act (the act) to adverse health consequences. Rockville Pike, Suite 3047, Rockville, require a single facility license for the Timetable: MD 20852 manufacture of feeds containing approved new animal drugs, rather Action Date FR Cite Phone: 301 594-2041 Fax: 301 827-5562 than multiple medicated feed NPRM 09/23/97 62 FR 49638 applications (MFAs) for each feed mill, NPRM Comment 12/22/97 RIN: 0910–AA98 as previously required by the act. Prior Period End to the passage of the ADAA, an Final Action 09/00/98 992. DEFINITION OF SUBSTANTIAL approved medicated feed application Small Entities Affected: Undetermined EVIDENCE was required by the act for the manufacture of medicated feed. The Government Levels Affected: Priority: Other Significant Undetermined ADAA eliminates the requirement that Legal Authority: 21 USC 360(b); PL a feed mill submit a separate medicated Agency Contact: Carol Drew, 104-250 feed application for the manufacture of Regulatory Counsel, Regulatory Policy CFR Citation: 21 CFR 514.4 each type of medicated feed and Staff, Department of Health and Human instead provides for feed mills to be Services, Food and Drug Legal Deadline: NPRM, Statutory, licensed and allows a licensed facility Administration, Center for Drug October 9, 1997. Final, Statutory, to manufacture any feed containing an Evaluation and Research (HFD-7), 1451 October 9, 1998. approved new animal drug. Rockville Pike, Suite 3047, Rockville, Abstract: Additionally, the act, as amended by MD 20852 The ADAA requires FDA to issue within 24 months after the date the ADAA, provides the agency with Phone: 301 594-2041 the authority to exempt facilities that Fax: 301 827-5562 of its enactment final proposed regulations to encourage dose range manufacture certain types of medicated RIN: 0910–AA88 labeling and to further define the term feed from the requirement of a ‘‘substantial evidence,’’ as the term is medicated feed mill license. 991. CURRENT GOOD defined in section 512(d)(3) of the The Food and Drug Administration MANUFACTURING PRACTICE; Federal Food, Drug, and Cosmetic Act, published on July 30, 1997, a proposed REVISION OF CERTAIN LABELING as amended by the ADAA, in a manner rule to amend the animal drug CONTROLS that encourages the submission of regulations and add a new part (21 CFR applications and supplemental Priority: 515) to provide for feed mill licensing Other Significant. Major status applications. under 5 USC 801 is undetermined. in accordance with the ADAA. The Timetable: proposed regulation implements the Unfunded Mandates: Undetermined requirements for feed mill licensing set Legal Authority: 21 USC 321; 21 USC Action Date FR Cite forth in the ADAA. Under this 351; 21 USC 352; 21 USC 355; 21 USC ANPRM 11/21/96 61 FR 59209 proposal, those medicated feeds 356; 21 USC 357; 21 USC 360b; 21 USC NPRM 11/05/97 62 FR 59830 exempted from the MFA requirement 371; 21 USC 374 Final Action 10/00/98 under 21 CFR 558.4 will also be
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exempt from the requirement of a Despite previous efforts to increase the potentially safe and effective drug medicated feed mill license. amount of pediatric use information in products because the physician either Timetable: drug labeling, the majority of new prescribed an inadequate dosage drugs and biological products are still regimen, prescribed a less effective Action Date FR Cite insufficiently tested in the pediatric drug, or did not prescribe a drug, due NPRM 07/30/97 62 FR 40765 population and their labeling carries to the physician’s uncertainty about NPRM Comment 10/28/97 little or no information on pediatric whether the drug or the dose was safe Period End safety and effectiveness. The final rule and effective in children. Approved Final Action 12/00/98 would help address this lack of pediatric indications should therefore pediatric information. increase sales of affected products to Small Entities Affected: None Summary of the Legal Basis: Under pediatric patients. Government Levels Affected: None 502(a), 502(f), 505(d)(7), and 201(n) of Risks: None. Agency Contact: William D. Price, the Federal Food, Drug, and Cosmetic Timetable: Special Assistant, Department of Health Act (the act), FDA may require a and Human Services, Food and Drug product to carry labeling that provides Action Date FR Cite Administration, Center for Veterinary safety and effectiveness information on NPRM 08/15/97 62 FR 43899 Medicine (HFV-200), 7500 Standish use in subpopulations in which the NPRM Comment 11/13/97 Place, Rockville, MD 20855 product is customarily or commonly Period End Phone: 301 594-1724 used. Section 505(i) of the act Final Action 10/00/98 authorizes the issuance of regulations RIN: Small Entities Affected: Businesses 0910–AB18 governing the use of investigational drugs, and provision 505(k) of the act, Government Levels Affected: None 994. REGULATIONS REQUIRING which requires regulations issued Agency Contact: Paula Botstein, MANUFACTURERS TO ASSESS THE under 505(i) to have ‘‘due regard * * Director, Office of Drug Evaluation III, SAFETY AND EFFECTIVENESS OF * for the interests of patients,’’ together Department of Health and Human NEW DRUGS AND BIOLOGICAL authorize FDA to impose conditions on Services, Food and Drug PRODUCTS IN PEDIATRIC PATIENTS the investigation of new drugs, Administration, Center for Drug including conditions related to the Priority: Other Significant Evaluation and Research (HFD-103), interests of patients. Section 351 of the 5600 Fishers Lane, Room 13B-45, Legal Authority: 21 USC 321; 21 USC Public Health Service Act (42 USC 262) Rockville, MD 20857 331; 21 USC 352; 21 USC 355; 21 USC provides authority to regulate the Phone: 301 827-3144 371; 21 USC 502; 42 USC 262 labeling and shipment of biological Fax: 301 480-3761 CFR Citation: 21 CFR 200; 21 CFR 312; products. Email: botstein@[email protected] 21 CFR 314; 21 CFR 601 Alternatives: With OMB’s concurrence RIN: 0910–AB20 FDA previously published proposed Legal Deadline: None and final rules in an attempt to Abstract: The final rule, if encourage manufacturers to include 995. ∑ REVOCATION OF LATHER promulgated, would require pediatric pediatric labeling on drug products for BRUSHES REGULATION studies of a limited class of new drug which there was existing safety and Priority: Info./Admin./Other and biological products so that the effectiveness data on pediatric patients. Legal Authority: 42 USC 216; 42 USC products will have sufficient data and These previous attempts, which 243; 42 USC 264; 42 USC 271 information to support directions for included a NPRM published on October pediatric use for the claimed 16, 1992 (57 FR 47423), and a final CFR Citation: 21 CFR 1240.70 indications. rule published on December 13, 1994 Legal Deadline: None (59 FR 64240), stopped short of Statement of Need: Many new drugs Abstract: The final rule would revoke and biological products represent requiring studies and have not produced a significant increase in the regulation pertaining to the treatments that are, at least at times, treatment, sterilization, handling, the best available treatment for pediatric labeling. This final rule will be a step towards addressing the storage, marking, and inspection of children, but most of them have not lather brushes. The Food and Drug been adequately tested in the pediatric current absence of adequate pediatric labeling. Administration is revoking this population. As a result, product regulation because the regulation is no labeling frequently fails to provide Anticipated Costs and Benefits: longer necessary to protect the public directions for safe and effective use in Estimated costs will range from $13.5 health. pediatric patients. The absence of million to $20.9 million when Timetable: pediatric labeling information poses a implemented. The rule will result in number of disadvantages to pediatric fewer adverse reactions in children Action Date FR Cite patients, including the potential for (i.e., drug reactions that occur because NPRM 10/20/97 62 FR 54398 under- or over-dosing leading to of the use of inadvertent drug NPRM Comment 01/05/98 ineffective treatment or excessive or overdoses or other drug administration Period End unanticipated side effects. It may also problems that can be avoided with Final Action 06/00/98 result in the failure to provide optimal better information on appropriate treatment to children because of the pediatric use); and will help prevent Small Entities Affected: None lack of appropriate scientific data. the under treatment of children with Government Levels Affected: None
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration SERVICESFinal Rule (HHS) (FDA)Stage HHSÐFDA Final Rule Stage
Agency Contact: Philip L. Chao, Senior CFR Citation: Not yet determined Agency Contact: Wayne H. Mitchell, Policy Analyst, Department of Health Legal Deadline: None Regulatory Counsel, Regulatory Policy and Human Services, Food and Drug Staff, Department of Health and Human Administration, Office of Policy (HF- Abstract: This direct final rule will Services, Food and Drug 23), 5600 Fishers Lane, Room 15-74, make conforming changes to 21 CFR to Administration, Center for Drug remove references to section 507 of the Rockville, MD 20857 Evaluation and Research (HFD-7), 1451 Federal Food, Drug, and Cosmetic Act, Phone: 301 827-3380 Rockville Pike, Suite 3047, Rockville, and references to deleted monograph Fax: 301 443-6906 MD 20852 sections. Email: [email protected] Phone: 301 594-2041 RIN: 0910–AB25 Timetable: Fax: 301 827-5562 Action Date FR Cite RIN: 0910–AB38 996. ∑ REMOVAL OF REGULATIONS Direct Final Rule 06/00/98 REGARDING CERTIFICATION OF Small Entities Affected: None ANTIBIOTIC DRUGS 999. ∑ AMENDMENT OF Government Levels Affected: None Priority: Other Significant REGULATIONS REGARDING CERTAIN Agency Contact: Christine Rogers, LABEL STATEMENTS ON Reinventing Government: This Regulatory Counsel, Department of PRESCRIPTION DRUGS rulemaking is part of the Reinventing Health and Human Services, Food and Government effort. It will eliminate Drug Administration, Center for Drug Priority: Other Significant existing text in the CFR. Evaluation and Research (HFD-7), 1451 Legal Authority: PL 105-115, sec 126 Legal Authority: PL 105-115, sec 125 Rockville Pike, Suite 3047, Rockville, CFR Citation: 21 CFR 430; 21 CFR 431; MD 20852 CFR Citation: 21 CFR 201; 21 CFR 250; 21 CFR 432; 21 CFR 433; 21 CFR 436; Phone: 301 594-2041 21 CFR 310; 21 CFR 329; 21 CFR 361; 21 CFR 440; 21 CFR 441; 21 CFR 442; Fax: 301 827-5562 21 CFR 369 21 CFR 443; 21 CFR 444; 21 CFR 446; RIN: 0910–AB32 21 CFR 448; 21 CFR 450; 21 CFR 452; Legal Deadline: None 21 CFR 453; ... 998. ∑ REMOVAL OF REGULATIONS Abstract: This direct final rule will Legal Deadline: None REGARDING CERTIFICATION OF revise 21 CFR parts 201, 250, 310, and Abstract: This direct final rule will DRUGS COMPOSED WHOLLY OR 361 by removing the requirement that remove 21 CFR parts 430 through 460 PARTLY OF INSULIN prescription drugs be labeled ‘‘Caution: Federal law prohibits the dispensing (antibiotic monographs and antibiotic Priority: Other Significant certification program regulations). without prescription’’ and substituting Reinventing Government: This Timetable: a requirement that prescription drugs rulemaking is part of the Reinventing be labeled ‘‘Rx only’’. The rule will also Action Date FR Cite Government effort. It will eliminate revise parts 201, 329, and 369 by Direct Final Rule 04/00/98 existing text in the CFR. removing the requirement that certain Small Entities Affected: None Legal Authority: PL 105-115, sec 125 habit-forming narcotics or hypnotics bear the statement ‘‘Warning--May be Government Levels Affected: None CFR Citation: 21 CFR 3; 21 CFR 5; 21 CFR 10; 21 CFR 16; 21 CFR 25; 21 CFR habit forming.’’ Agency Contact: Christine Rogers, 50; 21 CFR 56; 21 CFR 58; 21 CFR 71; Timetable: Regulatory Counsel, Department of 21 CFR 200; 21 CFR 201; 21 CFR 210; Health and Human Services, Food and 21 CFR 211; 21 CFR 310 Action Date FR Cite Drug Administration, Center for Drug Evaluation and Research (HFD-7), 1451 Legal Deadline: None Direct Final Rule 07/00/98 Rockville Pike, Suite 3047, Rockville, Abstract: This direct final rule will Small Entities Affected: None MD 20852 remove all regulations dealing with the Phone: 301 594-2041 certification of insulin, remove citations Government Levels Affected: None Fax: 301 827-5562 to section 506 in various authority Agency Contact: RIN: 0910–AB31 sections in title 21 of the Code of Christine Rogers, Federal Regulations, eliminate citations Regulatory Counsel, Regulatory Policy to section 506 in regulations that do Staff, Department of Health and Human 997. ∑ REVOCATION OF ANTIBIOTIC not deal primarily with the certification Services, Food and Drug CERTIFICATION REQUIREMENTS; of insulin, and eliminate out-of-date Administration, Center for Drug CONFORMING REVISIONS TO provisions dealing with labeling and Evaluation and Research (HFD-7), 1451 REGULATIONS testing of insulin. Rockville Pike, Suite 3047, Rockville, Priority: Other Significant Timetable: MD 20852 Phone: 301 594-2041 Reinventing Government: This Action Date FR Cite rulemaking is part of the Reinventing Fax: 301 827-5562 Government effort. It will eliminate Direct Final Rule 04/00/98 RIN: 0910–AB39 existing text in the CFR. Small Entities Affected: None Legal Authority: PL 105-115, sec 125 Government Levels Affected: None
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration SERVICESFinal Rule (HHS) (FDA)Stage HHSÐFDA Final Rule Stage
1000. ∑ LIST OF DRUGS THAT HAVE require the Food and Drug Government Levels Affected: BEEN WITHDRAWN OR REMOVED Administration (FDA), in situations in Undetermined FROM THE MARKET FOR REASONS which FDA has placed a clinical OF SAFETY AND EFFECTIVENESS investigation on clinical hold, to Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Priority: Other Significant. Major status respond in writing to a sponsor’s under 5 USC 801 is undetermined. written request to lift the clinical hold Health and Human Services, Food and within 30 days of receipt of the request. Drug Administration, Center for Unfunded Mandates: Undetermined Timetable: Devices and Radiological Health (HFZ- Legal Authority: PL 105-115 215), 1350 Piccard Drive, Rockville, MD Action Date FR Cite CFR Citation: Not yet determined 20850 Direct Final Rule 06/00/98 Phone: 301 827-2974 Legal Deadline: None Abstract: Section 127 of the Food and Small Entities Affected: None RIN: 0910–AB53 Drug Administration Modernization Act Government Levels Affected: None of 1997 (Pub. L. 105-115) added section Agency Contact: Andrea Masciale, 1003. ∑ DISPUTE RESOLUTION 503A to the Food, Drug and Cosmetic Regulatory Counsel, Regulatory Policy Act (21 U.S.C 353a). Section 503A Staff, Department of Health and Human Priority: Substantive, Nonsignificant governs the application of Federal law Services, Food and Drug to the practice of pharmacy Administration, Center for Drug Unfunded Mandates: Undetermined compounding. Section 503A(b)(1)(C) Evaluation and Research (HFD-7), 1451 Legal Authority: PL 105-115, sec 404 directs FDA to publish a list of drug Rockville Pike, Suite 3047, Rockville, products that have been withdrawn or MD 20852 CFR Citation: 21 CFR 10 removed from the market for reasons Phone: 301 594-2041 of safety or effectiveness. Section Fax: 301 827-5562 Legal Deadline: Final, Statutory, 503A(d)(1) directs that the list be November 21, 1998. issued as a regulation. Drugs on the list RIN: 0910–AB41 may not be compounded by Abstract: The Food and Drug pharmacists or licensed practioners. 1002. ∑ MEDICAL DEVICES; IDE Administration (FDA) is amending its Timetable: MODIFICATIONS regulations governing the review of agency decisions by inserting a Action Date FR Cite Priority: Substantive, Nonsignificant statement that a sponsor, applicant, or Final Action 06/00/98 Legal Authority: 21 USC 360j(g) manufacturer of a drug or device may Small Entities Affected: Undetermined CFR Citation: 21 CFR 812 request the review of a scientific Government Levels Affected: Legal Deadline: Final, Statutory, controversy by an FDA advisory panel Undetermined November 21, 1998. or committee. This action is being taken to clarify that review of scientific Agency Contact: Abstract: Under the Food and Drug Wayne H. Mitchell, disputes by outside experts and Regulatory Counsel, Regulatory Policy Administration Modernization Act of advisory committees is available. Staff, Department of Health and Human 1997 (Pub. L. 105-15). FDA must Services, Food and Drug publish a regulation under which the Timetable: Administration, Center for Drug sponsor of a device with an Evaluation and Research (HFD-7), 1451 investigational device exemption that is Action Date FR Cite Rockville Pike, Suite 3047, Rockville, in effect may make developmental Direct Final Rule 11/00/98 MD 20852 changes to the device that do not Phone: 301 594-2041 constitute a significant change in Small Entities Affected: Undetermined Fax: 301 827-5562 design or basic principles of operation Government Levels Affected: RIN: 0910–AB40 and that are made in response to information gathered during the course Undetermined of the investigation, and changes that Agency Contact: Suzanne O’Shea, 1001. ∑ STREAMLINING CLINICAL do not affect the validity of the data, Regulatory Counsel, Department of RESEARCH the scientific soundness of the Health and Human Services, Food and Priority: Other Significant investigational plan or the rights, safety or welfare of the human subjects. Drug Administration, Office of the Legal Authority: PL 105-115, sec 117 Commissioner (HF-7), 5600 Fishers Timetable: CFR Citation: 21 CFR 312 Lane, Suite 13C-26, Rockville, MD 20857 Legal Deadline: None Action Date FR Cite Phone: 301 827-3390 Abstract: This direct final rule will Direct Final Rule 11/00/98 amend the clinical hold regulations to Small Entities Affected: Undetermined RIN: 0910–AB54
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Food and Drug Administration (FDA) Long-TermHHS—FDA Actions
1004. INFANT FORMULA: GOOD agency has identified additional areas Misleading Containers; Nonfunctional Slack MANUFACTURING PRACTICE, that should be the subject of Fill QUALITY CONTROL PROCEDURES, rulemaking. FDA issued a proposal on NPRM 01/06/93 (58 FR 2957) QUALITY FACTORS, NOTIFICATION Final Action 12/06/93 (58 FR 64123) January 6, 1993, to establish Nutrient Content Claims and Health Claims; REQUIREMENTS, AND RECORDS AND requirements for the identification of Restaurant Foods REPORTS certain ingredients on food labels. FDA NPRM 06/15/93 (58 FR 33055) Priority: Other Significant proposed on June 15, 1993, to amend Final Action 08/02/96 (61 FR 40320) its January 6, 1993, final rules on Nutrient Content, Definition of the Term, Legal Authority: 21 USC 350a nutrient content and health claims to Healthy CFR Citation: 21 CFR 107; 21 CFR 106 remove the provisions that exempted NPRM 01/06/93 (58 FR 2944) restaurant menus from the requirements Final Action 05/10/94 (59 FR 24232) Legal Deadline: None Placement of Nutrition Facts Panel for how nutrient content claims and NPRM 08/18/93 (58 FR 44091) Abstract: The agency published a health claims are to be made. The proposed rule on July 9, 1996, that will Final Action 04/05/95 (60 FR 17202) agency proposed January 4, 1994, to Final Action Effective 05/05/95 establish current good manufacturing establish reference daily intakes based Final Action Correction 06/12/95 (60 FR practice regulations, quality control on the 9th and 10th editions of the 30788) procedures, quality factors, notification National Research Council’s Protein Hydrolysates; Broth in Tuna; and/or requirements, and reports for the Recommended Dietary Allowances. On Labeling production of infant formulas. This March 14, 1994, FDA published a NPRM (Declaration of Ingredients) proposal was issued in response to the proposal describing the provisions for 01/06/93 (58 FR 2950) Infant Formula Act of 1986. Final Action (Dec. of Ingredients) 00/00/00 exemptions for low-volume food Reference Daily Intakes Timetable: products of small businesses that were NPRM 01/04/94 (59 FR 427) Current Good Mfg. Practices; Qual Control established by the Nutrition Labeling Final Action 12/28/95 (60 FR 67164) Proc and Education Act Amendments of Small Business Exemption, Nutrition NPRM 07/09/96 (61 FR 36154) 1993. On August 18, 1993, FDA Labeling NPRM Comment Period End 12/06/96 published a proposal concerning the NPRM 03/14/94 (59 FR 11872) Final Rule 00/00/00 placement of the nutrition facts panel Final Action 08/07/96 (61 FR 40963) Infant Form Cons Comp, Micro Test & Recd Voluntary Guidelines for Nutrition Labeling Retention Req on food labels. Finally, on July 18, 1994, FDA published proposed revised Produce NPRM 01/26/89 (54 FR 3783) NPRM 07/18/94 (59 FR 36379) NPRM Comment Period End 03/27/89 guidelines for the voluntary declaration Final Action 08/16/96 (61 FR 42742) Final Rule 12/24/91 (56 FR 66566) of nutrition labeling for raw produce Small Entities Affected: Businesses Small Entities Affected: None and fish. A final rule concerning the placement of the nutrition facts panel Government Levels Affected: State, Government Levels Affected: None was published on April 5, 1995. A final Federal Additional Information: Previously rule establishing reference daily intakes Additional Information: Previously reported under RIN 0905-AC46. based on the 9th and 10th editions of reported under RIN 0905-AD89. Agency Contact: Carolyn W. Miles, Recommended Dietary Allowances was published on December 28, 1995. Agency Contact: Elizabeth J. Campbell, Nutritionist, Department of Health and Director, Office of Food Labeling, Human Services, Food and Drug FDA published a final rule on August Department of Health and Human Administration, Center for Food Safety 2, 1996, on nutrient content claims and Services, Food and Drug and Applied Nutrition (HFS-456), 200 health claims to remove the provisions Administration, Center for Food Safety C Street SW., Washington, DC 20204 that exempted restaurant menus from and Applied Nutrition (HFS-150), 200 Phone: 202 401-9858 the requirements for how nutrient C Street SW., Washington, DC 20204 RIN: 0910–AA04 content claims and health claims are Phone: 202 205-4561 to be made. FDA published a final rule Fax: 202 205-4594 on August 7, 1996, describing RIN: 0910–AA19 1005. FOOD LABELING REVIEW provisions for an exemption for small Priority: Routine and Frequent businesses from the requirements for 1006. MEDICAL FOODS Legal Authority: 15 USC 1453; 15 USC nutrition labeling and providing 1454; 15 USC 1455; 21 USC 321; 21 instructions on how to file a notice Priority: Other Significant USC 331; 21 USC 342; 21 USC 343; claiming the exemption. FDA published Legal Authority: 21 USC 321; 21 USC 21 USC 348; 21 USC 371 on August 16, 1996, final guidelines in 341; 21 USC 342; 21 USC 343; 21 USC the voluntary declaration of nutrition 348; 21 USC 350; 21 USC 351; 21 USC CFR Citation: 21 CFR 100; 21 CFR 101; labeling for raw produce and fish. 21 CFR 102; 21 CFR 161 352; 21 USC 355; 21 USC 360ee; 21 USC 371 Legal Deadline: None Timetable: Amend Standard of Identity for Grain CFR Citation: Not yet determined Abstract: The Nutrition Labeling and Products (Folic Acid) Legal Deadline: None Education Act of 1990 (NLEA) requires NPRM 10/14/93 (58 FR 53305) that most foods bear nutrition labeling. Final Action 03/05/96 (61 FR 8781) Abstract: The Food and Drug The agency issued final rules Health Claims and Label Statements Administration is considering implementing most of the provisions NPRM Folic Acid and Neural Tube Def development of regulations for medical contained in the NLEA on January 6, 10/14/93 (58 FR 53254) foods, as defined by the Orphan Drug 1993. Subsequently, however, the Final Action 03/05/96 (61 FR 8752) Act Amendments of 1988 (21 USC
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration Long-TermSERVICES Actions(HHS) (FDA) HHSÐFDA Long-Term Actions
360ee(b)(3)) to assure, among other 215), 1350 Piccard Drive, Rockville, MD Radiological Health (HFZ-84), 2098 things, the safety and effectiveness of 20850 Gaither Road, Rockville, MD 20850 these products, proper labeling of the Phone: 301 594-4765 Phone: 301 594-4765 nutrient content and purported uses, RIN: 0910–AA33 RIN: 0910–AA41 including adequate and appropriate directions for use, and quality control and good manufacturing practices. 1008. CLASSIFICATION OF 1009. REGISTRATION OF PRODUCERS OF DRUGS AND Timetable: COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL DEVICES LISTING OF DRUGS IN COMMERCIAL Action Date FR Cite DISTRIBUTION Priority: Other Significant. Major status ANPRM 11/29/96 61 FR 60661 under 5 USC 801 is undetermined. Priority: Other Significant. Major status ANPRM Comment 04/28/97 under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Period End Unfunded Mandates: Undetermined NPRM 00/00/00 Legal Authority: 21 USC 321(h); 21 Reinventing Government: This Small Entities Affected: Businesses USC 351; 21 USC 352; 21 USC 360; 21 USC 360c to 360l; 21 USC 371 to rulemaking is part of the Reinventing Government Levels Affected: State, 374 Government effort. It will revise text in Federal the CFR to reduce burden or CFR Citation: Not yet determined duplication, or streamline Additional Information: Previously requirements. reported under RIN 0905-AD91. Legal Deadline: None Legal Authority: 21 USC 331; 21 USC Agency Contact: Abstract: FDA is considering whether Robert Moore, Senior 351; 21 USC 352; 21 USC 355; 21 USC Regulatory Scientist, Department of to classify stand-alone computer software products that fit the definition 356; 21 USC 357; 21 USC 360; 21 USC Health and Human Services, Food and 371 Drug Administration, Center for Food of a medical device under the Federal Safety and Applied Nutrition (HFS- Food, Drug, and Cosmetic Act. CFR Citation: 21 CFR 207 456), 200 C Street SW., Washington, DC Although the Secretary has not made Legal Deadline: None 20204 a final decision to initiate such a program, the Agency is considering Abstract: The proposed rule would Phone: 202 205-4605 revise the regulations under part 207 Fax: 202 260-8957 classifying these devices by using a risk-based approach as required under to clarify the burden on manufacturers RIN: 0910–AA20 the Medical Device Amendments to the packers, and distributors, and to act. In addition, the agency would use consolidate, reorganize, and streamline the requirements. 1007. AMALGAM INGREDIENT existing exemptions from regulation LABELING where appropriate. Under this Timetable: approach, low risk medical software Priority: Action Date FR Cite Substantive, Nonsignificant devices would be subject only to the Legal Authority: 21 USC 352 adulteration and misbranding NPRM 00/00/00 provisions of the act. Moderate risk NPRM Comment 00/00/00 CFR Citation: 21 CFR 801 Period End devices would additionally be subject Legal Deadline: None to the registration, listing, good Small Entities Affected: Undetermined Abstract: Certain dental amalgams may manufacturing practice requirements, Government Levels Affected: contain ingredients which may cause and reporting and recordkeeping Undetermined requirements. High risk devices would some persons severe adverse reactions. Agency Contact: Lee D. Korb, be the only products to require Therefore, FDA would propose that Regulatory Counsel, Department of labeling for dental amalgams must premarket submissions. FDA is also Health and Human Services, Food and include the ingredients so that health seeking comment on potential criteria Drug Administration, Center for Drug professionals may choose the related to the intended uses of medical Evaluation and Research (HFD-7), 1451 appropriate dental material for the software devices that might be used in Rockville Pike, Suite 3047, Rockville, patient. determining the level of risk. MD 20852 Timetable: Timetable: Phone: 301 594-2041 Fax: 301 827-5562 Action Date FR Cite Action Date FR Cite RIN: 0910–AA49 NPRM 00/00/00 NPRM 00/00/00 Small Entities Affected: Undetermined Small Entities Affected: Undetermined 1010. REINVENTING FDA FOOD Government Levels Affected: None Government Levels Affected: None REGULATIONS Additional Information: Previously Additional Information: Previously Priority: Substantive, Nonsignificant reported under RIN 0905-AE39. reported under RIN 0905-AE58. Reinventing Government: This Agency Contact: Joseph M. Sheehan, Agency Contact: Chuck Furfine, rulemaking is part of the Reinventing Chief, Regulations Staff, Department of Regulatory Review Scientist/Software Government effort. It will revise text in Health and Human Services, Food and Expert, Department of Health and the CFR to reduce burden or Drug Administration, Center for Human Services, Food and Drug duplication, or streamline Devices and Radiological Health (HFZ- Administration, Center for Devices and requirements.
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration Long-TermSERVICES Actions(HHS) (FDA) HHSÐFDA Long-Term Actions
Legal Authority: 15 USC 1453; 15 USC were obsolete or no longer necessary company’s determination that use of a 1454; 15 USC 1455; 21 USC 321 et seq to achieve public health goals. The substance in food is generally CFR Citation: 21 CFR 101; 21 CFR 102; final rule (pertaining to food recognized as safe (GRAS). regulations only) published on June 3, 21 CFR 103; 21 CFR 131; 21 CFR 133; Agency Contact: L. Robert Lake, 1996. A confirmation of effective date 21 CFR 135; 21 CFR 136; 21 CFR 137; Director, Office of Policy Planning and (CED) on those regulations promulgated 21 CFR 139; 21 CFR 145; 21 CFR 146; Strategic Initiatives, Department of under the formal rulemaking 21 CFR 150; 21 CFR 152; 21 CFR 155; Health and Human Services, Food and procedures of section 701(e) of the 21 CFR 156; ... Drug Administration, Center for Food Federal Food, Drug, and Cosmetic Act Legal Deadline: Safety and Applied Nutrition (HFS- None (21 USC 371(e)) pertaining to diabetic 150), 200 C Street SW., Washington, DC Abstract: In response to President labeling (21 CFR 105.67) and sodium 20204 Clinton’s memorandum to heads of intake (cont) departments and agencies entitled Phone: 202 205-4561 Timetable: Fax: 202 401-7739 ‘‘Regulatory Reinvention Initiative,’’ Exempt Infant Formula; Plan for Revisions FDA has initiated rulemaking to retain, ANPRM 06/12/96 (61 FR 29701) RIN: 0910–AA58 revise, or revoke certain of its Comment Period End 10/10/96 regulations for food. FDA published an NPRM 00/00/00 advance notice of proposed rulemaking Food Standards of Identity, Quality, and Fill 1011. REINVENTION OF (ANPR) on December 29, 1995, of Container ADMINISTRATIVE PROCEDURES requesting information on the need to ANPRM 12/29/95 (60 FR 67492) REGULATIONS Comment Period Ends 06/28/96 retain, revise, or revoke its food Priority: Other Significant standards of identity regulations and its NPRM 00/00/00 Food, Color Additive, GRAS Regulations Reinventing Government: This common or usual name regulations. In ANPRM 06/12/96 (61 FR 29701) the same issue of the Federal Register Comment Period Ends 09/10/96 rulemaking is part of the Reinventing FDA proposed to improve the NPRM 00/00/00 Government effort. It will revise text in coordination of the food additive, Food, Color, and GRAS; Simult. Pet. Rev. by the CFR to reduce burden or GRAS, and color additive approval USDA (Meat/Poultry) duplication, or streamline process with USDA for substances used NPRM 12/29/95 (60 FR 67490) requirements. in meat and poultry products. FDA Comment Period End 03/14/96 Extension of Comment Period 06/03/96 Legal Authority: 5 USC 504; 5 USC 551 proposed to revoke several lower fat to 558; 5 USC 701 to 721; 7 USC 138; milk standards on November 9, 1995. Final Action 00/00/00 Notification Procedures for Independent 7 USC 2271; 15 USC 638; 15 USC 1261 On June 12, 1996, FDA published an GRAS Determinations to 1282; 15 USC 1451 to 1461; 15 USC ANPR announcing its intention to NPRM 04/17/97 (62 FR 18938) 3701 to 3711; 21 USC 41 to 50; 21 USC review (1) its human food labeling NPRM Comment Period End 07/16/97 61 to 63; 21 USC 141 to 149; 21 USC regulations pertaining to the exemption Final Action 00/00/00 321 to 394 for soft drinks from requirements for Revocation of Certain Food Labeling and the type size and placement of certain Cosmetic Regulations CFR Citation: 21 CFR 1 to 3; 21 CFR information on the information panel, NPRM 06/12/96 (61 FR 29708) 5; 21 CFR 10; 21 CFR 12; 21 CFR 19 requirements for listing ‘‘statements of Comment Period Ends 08/26/96 to 20; 21 CFR 56; 21 CFR 58 identity,’’ and requirements for flavor Final Action 08/12/97 (62 FR 43071) Revocation of Lower Fat Milk Standards Legal Deadline: None labeling; (2) its infant formula NPRM 11/09/95 (60 FR 56541) regulations to ensure that they fully Comment Period Ends 01/23/96 Abstract: FDA is considering ways to reflect the Federal Food, Drug, and Partial Final 11/20/96 (61 FR 58991) further streamline its administrative Cosmetic Act; (3) its regulations Confirmation of Effective Date 02/24/97 procedure regulations that are outdated pertaining to the discharge of waste (62 FR 8163) or otherwise in need of reform. The aboard casino ships, passenger ships, Revocation of Lower Fat Yogurt Standards agency is taking this action in response and ferries; and (4) its food additive NPRM 11/09/95 (60 FR 56541) to President Clinton’s March 4, 1995 regulations to consolidate certain Confirmation of Effective Date 00/00/00 directive to all Federal agencies to existing regulations. In the same June Final Action (Yogurt) 00/00/00 conduct a page-by-page review of their Revocation of Obsolete Regulations 12 issue of the Federal Register, FDA NPRM 10/13/95 (60 FR 53480) regulations as part of the ‘‘Reinventing published a second ANPR seeking Comment Period Ends 01/11/96 Government’’ initiative. FDA plans to public comment on possible ways to Final Action 06/03/96 (61 FR 27771) reinvent approximately 45 percent of streamline various food additive Confirmation of Eff. Date 08/27/96 (61 FR its regulations to ease the burden on regulations. FDA also proposed on June 43963) regulated industry and consumers 12, 1996, to revoke certain food Small Entities Affected: Businesses without sacrificing public health labeling regulations pertaining to protection. For those regulations labeling of food with number of Government Levels Affected: State requiring Congressional permission to servings and labeling Kosher and Additional Information: ABSTRACT reinvent, the Administration will seek Kosher-style foods and to revoke the CONT: labeling (21 CFR 105.69) was legislative changes. agency’s voluntary filing of cosmetic published on August 27, 1996. Timetable: product experiences. The latter was In the Federal Register of April 17, published August 12, 1997. 1997 (62 FR 18938), FDA proposed to Action Date FR Cite On October 13, 1995, FDA proposed to establish a notification procedure for ANPRM 06/04/96 61 FR 28116 revoke certain agency regulations that companies to use inform FDA of a NPRM 00/00/00
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration Long-TermSERVICES Actions(HHS) (FDA) HHSÐFDA Long-Term Actions
Small Entities Affected: Businesses, 1013. DEBARMENT CERTIFICATION Abstract: This rulemaking would Governmental Jurisdictions, REGULATIONS FOR DRUG permit certain uses of investigational Organizations APPLICATIONS new drugs by individual investigators who are not included in a commercial Government Levels Affected: State, Priority: Other Significant. Major status sponsor’s application provided that, Local, Tribal, Federal under 5 USC 801 is undetermined. among other things, the drugs are in Agency Contact: Lisa M. Helmanis, Unfunded Mandates: Undetermined Phase 2 of commercial development. Office of Policy (HF-26), Department of Legal Authority: 15 USC 1451 to 1461; Timetable: Health and Human Services, Food and 21 USC 321; 21 USC 331; 21 USC 335; Drug Administration, 5600 Fishers 21 USC 351 to 353; 21 USC 355 to Action Date FR Cite Lane, Rockville, MD 20857 357; 21 USC 360; 21 USC 371; 21 USC ANPRM 00/00/00 Phone: 301 443-3480 374; 21 USC 379; 21 USC 381 to 382; Small Entities Affected: Undetermined Fax: 301 443-2946 42 USC 216; 42 USC 241; 42 USC 262 to 263 Government Levels Affected: RIN: 0910–AA69 Undetermined CFR Citation: 21 CFR 314; 21 CFR 514; 21 CFR 601 Agency Contact: Joseph Griffin, 1012. LONG-TERM CONTRACEPTIVE Regulatory Counsel, Regulatory Policy Legal Deadline: DRUG PRODUCTS AND MEDICAL None Staff, Department of Health and Human DEVICES; INFORMED CONSENT Abstract: The proposed rule would Services, Food and Drug REQUIREMENTS amend the regulations to require Administration, Center for Drug Priority: Substantive, Nonsignificant. applicants to submit a debarment Evaluation and Research (HFD-7), 1451 Major status under 5 USC 801 is certification statement in accordance Rockville Pike, Suite 3047, Rockville, undetermined. with 21 U.S.C. 335a(k). MD 20852 Timetable: Phone: 301 594-2041 Unfunded Mandates: Undetermined Fax: 301 594-5562 Action Date FR Cite Legal Authority: 21 USC 321; 21 USC RIN: 0910–AA83 331; 21 USC 351; 21 USC 352; 21 USC NPRM 00/00/00 353; 21 USC 355; 21 USC 356; 21 USC Small Entities Affected: Undetermined 1015. INVESTIGATIONAL NEW 357; 21 USC 358; 21 USC 360; 21 USC Government Levels Affected: ANIMAL DRUG REGULATIONS 371; 21 USC 374; 21 USC 379; 42 USC 216; 42 USC 241; ... Undetermined Priority: Substantive, Nonsignificant. Agency Contact: Leanne Cusumano, Major status under 5 USC 801 is CFR Citation: 21 CFR 201; 21 CFR 801 Regulatory Counsel, Regulatory Policy undetermined. Legal Deadline: None Staff, Department of Health and Human Unfunded Mandates: Undetermined Services, Food and Drug Abstract: The proposed rule would Administration, Center for Drug Reinventing Government: This require that patient labeling for long- Evaluation and Research (HFD-7), 1451 rulemaking is part of the Reinventing acting contraceptive drugs and medical Rockville Pike, Suite 3047, Rockville, Government effort. It will revise text in devices include an informed consent MD 20852 the CFR to reduce burden or form that must be signed by the patient Phone: 301 594-2041 duplication, or streamline before any long-acting contraceptive is Fax: 301 827-5562 requirements. administered. The proposed rule is Legal Authority: 21 USC 321; 21 USC intended to help ensure that patients RIN: 0910–AA76 351; 21 USC 353; 21 USC 360b; 21 USC receive adequate information to enable 371; 21 USC 381 them to make an informed decision 1014. INVESTIGATIONAL NEW DRUG about whether or not to use a long- APPLICATIONS; REQUEST FOR CFR Citation: 21 CFR 511; 21 CFR 512 acting contraceptive. INFORMATION AND COMMENTS Legal Deadline: None Timetable: Next Action Undetermined Priority: Other Significant. Major status Abstract: FDA is proposing to revise Small Entities Affected: Undetermined under 5 USC 801 is undetermined. its regulations governing investigational Unfunded Mandates: Undetermined use of new animal drugs by proposing Government Levels Affected: to delete 21 CFR 511 and establish in Undetermined Reinventing Government: This 21 CFR part 512 revised investigational rulemaking is part of the Reinventing use new animal drug regulations. The Agency Contact: Carol Drew, Government effort. It will revise text in investigational use new animal drug Regulatory Counsel, Department of the CFR to reduce burden or regulations are expected to include Health and Human Services, Food and duplication, or streamline regulations to implement provisions of Drug Administration, Center for Drug requirements. the Animal Drug Availability Act of Evaluation and Research (HFD-7), 1451 1996, specifically presubmission Rockville Pike, Suite 3047, Rockville, Legal Authority: 21 USC 321; 21 USC conferences, and implement parts of MD 20852 331; 21 USC 351 to 353; 21 USC 355 the President’s National Performance Phone: 301 594-2041 to 357; 21 USC 371; 42 USC 262 Report ‘‘Reinventing the Regulation of Fax: 301 827-5562 CFR Citation: 21 CFR 56; 21 CFR 312 Animal Drugs,’’ May 1996. In the RIN: 0910–AA75 Legal Deadline: None reinventing regulations report, FDA
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00303 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21978 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration Long-TermSERVICES Actions(HHS) (FDA) HHSÐFDA Long-Term Actions
proposed to revise its regulations to Small Entities Affected: Undetermined Phone: 301 594-2041 reflect numerous new process changes Government Levels Affected: Fax: 301 827-5562 and programs that will enable a more Undetermined streamlined animal drug application RIN: 0910–AB14 review and approval process, and Agency Contact: Leanne Cusumano, which would result in less regulatory Regulatory Counsel, Regulatory Policy 1018. ∑ PREGNANCY LABELING burden upon industry and FDA while Staff, Department of Health and Human REVISION maintaining safety and effectiveness of Services, Food and Drug new animal drugs. Administration, Center for Drug Priority: Other Significant. Major status Timetable: Evaluation and Research (HFD-7), 1451 under 5 USC 801 is undetermined. Rockville Pike, Suite 3047, Rockville, Action Date FR Cite MD 20852 Unfunded Mandates: Undetermined Phone: 301 594-2041 ANPRM 11/21/96 61 FR 59209 Legal Authority: 21 USC 321; 21 USC Fax: 301 827-5562 ANPRM Comment 01/21/97 331; 21 USC 351; 21 USC 352; 21 USC Period End RIN: 0910–AB12 353; 21 USC 355; 21 USC 357; 21 USC NPRM 12/00/99 358; 21 USC 360; 21 USC 360b; 21 USC Small Entities Affected: Undetermined 1017. ADMINISTRATIVE PRACTICES 360gg to 360ss; 21 USC 371; 21 USC Government Levels Affected: AND PROCEDURES; ADVISORY 374; 21 USC 379e; 42 USC 216; ... Undetermined OPINIONS AND GUIDELINES CFR Citation: 21 CFR 201 Agency Contact: Marty Schoenemann, Priority: Other Significant. Major status Legal Deadline: None Department of Health and Human under 5 USC 801 is undetermined. Services, Food and Drug Abstract: This advance notice of Administration, Center for Veterinary Unfunded Mandates: Undetermined proposed rulemaking will announce Medicine (HFV-120), 7500 Standish Legal Authority: 15 USC 1451 to 1461; that the Food and Drug Administration Place, Rockville, MD 20855 21 USC 41 to 50; 21 USC 141 to 149; is considering ways to revise the Phone: 301 827-0220 21 USC 321 to 394; 21 USC 467f; 21 regulatory requirements for the RIN: 0910–AB02 USC 679; 21 USC 821; 21 USC 1034; pregnancy labeling subsection of the 42 USC 201; 42 USC 262; 42 USC 263b; labeling requirements for human drugs 42 USC 264 1016. NEW DRUGS FOR HUMAN USE; and biologics. The notice will make CLARIFICATION OF REQUIREMENTS CFR Citation: 21 CFR 10; 21 CFR 808 available preliminary proposals for FOR PATENT HOLDER NOTIFICATION Legal Deadline: None changing the current requirements and will invite comments on all aspects of Priority: Substantive, Nonsignificant. Abstract: This proposed rule would the notice. Major status under 5 USC 801 is amend FDA regulations in 21 CFR part undetermined. 10 concerning advisory opinions and Timetable: Unfunded Mandates: Undetermined guidelines to provide consistency with Action Date FR Cite the agency’s Good Guidance Practices Legal Authority: 21 USC 321; 21 USC and applicable case law. ANPRM 00/00/00 331; 21 USC 351 to 353; 21 USC 355 to 357; 21 USC 371; 21 USC 374; 21 Timetable: Small Entities Affected: Undetermined USC 379e Action Date FR Cite Government Levels Affected: CFR Citation: 21 CFR 314 NPRM 00/00/00 Undetermined Legal Deadline: None Small Entities Affected: Undetermined Agency Contact: Joseph Griffin, Abstract: This proposed rule would Government Levels Affected: Regulatory Counsel, Regulatory Policy clarify the methods by which Undetermined Staff, Department of Health and Human application holders may provide notice Services, Food and Drug to patent holders. Agency Contact: Andrea Masciale, Administration, Center for Drug Timetable: Regulatory Counsel, Regulatory Policy Evaluation and Research (HFD-7), 1451 Staff, Department of Health and Human Action Date FR Cite Rockville Pike, Suite 3047, Rockville, Services, Food and Drug MD 20852 NPRM 03/06/98 63 FR 11174 Administration, Center for Drug Phone: 301 594-2041 NPRM Comment 06/04/98 Evaluation and Research (HFD-7), 1451 Fax: 301 827-5562 Period End Rockville Pike, Suite 3047, Rockville, Final Action 00/00/00 MD 20852 RIN: 0910–AB44
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Food and Drug Administration (FDA) CompletedHHS—FDA Actions
1019. IMPLEMENTATION OF THE Completed: Phone: 301 443-3480 SAFE MEDICAL DEVICES ACT OF Reason Date FR Cite Fax: 301 443-2946 1990 Final Action 02/02/98 63 FR 5233 RIN: 0910–AA54 Priority: Other Significant. Major status under 5 USC 801 is undetermined. Small Entities Affected: None 1024. INVESTIGATIONAL NEW DRUG Government Levels Affected: CFR Citation: 21 CFR 860; 21 CFR 820; None APPLICATIONS; CLINICAL HOLDS 21 CFR 807; 21 CFR 803; 21 CFR 17; Agency Contact: Mary Gross Priority: Substantive, Nonsignificant. 21 CFR 812; 21 CFR 7; 21 CFR 814; Phone: 301 827-3440 Major status under 5 USC 801 is 21 CFR 821; 21 CFR 861; 21 CFR 895 Fax: 301 594-0113 undetermined. Completed: RIN: 0910–AA30 Unfunded Mandates: Undetermined Reason Date FR Cite Reinventing Government: This 1022. HABIT-FORMING DRUGS Withdrawn - Replaced 01/28/98 rulemaking is part of the Reinventing by Food and Drug Priority: Substantive, Nonsignificant. Government effort. It will revise text in Administration Major status under 5 USC 801 is the CFR to reduce burden or Modernization Act undetermined. duplication, or streamline Small Entities Affected: Businesses, Unfunded Mandates: Undetermined requirements. Governmental Jurisdictions, Reinventing Government: This CFR Citation: 21 CFR 312 Organizations rulemaking is part of the Reinventing Completed: Government Levels Affected: State, Government effort. It will revise text in Local, Federal the CFR to reduce burden or Reason Date FR Cite duplication, or streamline Withdrawn - Replaced 01/30/98 Agency Contact: Joseph M. Sheehan requirements. by FDAMA sec 117 Phone: 301 594-4765 Regulations CFR Citation: 21 CFR 329 RIN: 0910–AA09 Completed: Small Entities Affected: Undetermined Reason Date FR Cite Government Levels Affected: 1020. MAMMOGRAPHY QUALITY Undetermined STANDARDS ACT OF 1992 Withdrawn - Replaced 01/30/98 by FDAMA Agency Contact: Joseph Griffin Priority: Other Significant. Major under Phone: 301 594-2041 5 USC 801. Small Entities Affected: Undetermined Fax: 301 827-5562 Government Levels Affected: Unfunded Mandates: This action may RIN: 0910–AA73 affect State, local or tribal governments Undetermined and the private sector. Agency Contact: Wayne H. Mitchell Phone: 301 594-2041 1025. CERTIFICATION OF DRUGS CFR Citation: 21 CFR 900 Fax: 301 827-5562 COMPOSED WHOLLY OR PARTLY OF INSULIN Completed: RIN: 0910–AA50 Reason Date FR Cite Priority: Other Significant. Major status under 5 USC 801 is undetermined. Final Action 10/28/97 62 FR 55852 1023. REVOCATION OF CERTAIN Final Action Effective 04/28/99 REGULATIONS Unfunded Mandates: Undetermined Small Entities Affected: Businesses, Priority: Other Significant Reinventing Government: This Governmental Jurisdictions rulemaking is part of the Reinventing Reinventing Government: This Government effort. It will revise text in Government Levels Affected: State, rulemaking is part of the Reinventing the CFR to reduce burden or Local, Federal Government effort. It will eliminate duplication, or streamline existing text in the CFR. Agency Contact: Ruth Fischer requirements. CFR Citation: Phone: 301 594-3311 21 CFR 100 to 101; 21 CFR Citation: 21 CFR 200; 21 CFR 429 CFR 103 to 105; 21 CFR 109; 21 CFR RIN: 0910–AA24 137; 21 CFR 161; 21 CFR 163; 21 CFR Completed: 182; 21 CFR 186; 21 CFR 197; 21 CFR Reason Date FR Cite 1021. FINANCIAL DISCLOSURE BY 505; 21 CFR 507 to 508; 21 CFR 601; 21 CFR 620; 21 CFR 630; 21 CFR 640 Withdrawn - Replaced 01/30/98 CLINICAL INVESTIGATORS by FDAMA sec 125. to 660; ... Priority: Other Significant Completed: Small Entities Affected: Undetermined CFR Citation: 21 CFR 54; 21 CFR Reason Date FR Cite Government Levels Affected: 312.53; 21 CFR 312.57; 21 CFR 312.64; Undetermined 21 CFR 314.50; 21 CFR 314.60; 21 CFR Final Action 07/23/97 62 FR 39439 Agency Contact: Wayne Mitchell 314.94; 21 CFR 314.200; 21 CFR Small Entities Affected: Businesses 314.300; 21 CFR 320.36; 21 CFR 330.10; Phone: 301 594-2041 21 CFR 601.2; 21 CFR 807.31; 21 CFR Government Levels Affected: Federal Fax: 301 827-5562 807.87; 21 CFR 807.100; ... Agency Contact: Lisa M. Helmanis RIN: 0910–AA77
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration CompletedSERVICES Actions(HHS) (FDA) HHSÐFDA Completed Actions
1026. INVESTIGATIONAL NEW DRUG 1029. DEFINITION OF ADEQUATE AND 1032. PRESCRIPTION DRUG APPLICATIONS AND NEW DRUG WELL-CONTROLLED STUDIES COMPOUNDING APPLICATIONS Priority: Substantive, Nonsignificant Priority: Other Significant. Major status Priority: Other Significant under 5 USC 801 is undetermined. CFR Citation: 21 CFR 514.117 CFR Citation: 21 CFR 312; 21 CFR 314 Unfunded Mandates: Undetermined Completed: Completed: CFR Citation: 21 CFR 201; 21 CFR 207; Reason Date FR Cite 21 CFR 211; 21 CFR 310; 21 CFR 314 Reason Date FR Cite Final Action 03/05/98 63 FR 10765 Completed: Final Action 02/11/98 63 FR 6854 Reason Date FR Cite Small Entities Affected: Businesses, Small Entities Affected: None Organizations Withdrawn - Replaced 01/30/98 Government Levels Affected: by FDAMA sec 127 Undetermined Government Levels Affected: Federal Small Entities Affected: Undetermined Agency Contact: Nancy E. Derr Agency Contact: Marty Schoenemann Government Levels Affected: Phone: 301 594-5408 Phone: 301 827-0220 Undetermined Fax: 301 594-6197 RIN: 0910–AB01 Agency Contact: Richard Schwartzbard RIN: 0910–AA82 Phone: 301 594-2041 Fax: 301 827-5562 1030. FDA EXPORT REFORM AND 1027. POSTMARKETING PERIODIC ENHANCEMENT ACT OF 1996; RIN: 0910–AB13 ADVERSE EXPERIENCE REPORTING REPORTING AND RECORDKEEPING REQUIREMENTS FOR HUMAN DRUG REQUIREMENTS FOR UNAPPROVED 1033. ∑ REVOCATION OF AND LICENSED BIOLOGICAL OR VIOLATIVE PRODUCTS IMPORTED PRODUCTS REGULATION ON POSITRON FOR FURTHER PROCESSING OR EMISSION TOMOGRAPHY DRUG Priority: Other Significant INCORPORATION AND LATER PRODUCTS EXPORT CFR Citation: 21 CFR 314; 21 CFR 600 Priority: Other Significant Completed: Completed: Legal Authority: PL 105-115, sec 121 Reason Date FR Cite Reason Date FR Cite CFR Citation: 21 CFR 211 Withdrawn - Duplicate 02/26/98 Legal Deadline: Final, Statutory, Merged With RIN 01/30/98 of 0910-AB24 0910-AA97 December 21, 1997. RIN: Small Entities Affected: Businesses, 0910–AB06 Abstract: This final rule revokes a Organizations regulation on positron emission tomography (PET) radiopharmaceutical Government Levels Affected: None 1031. CLARIFICATION OF THE SCOPE OF TREATMENT USES WITH drug products. The regulation Agency Contact: Audrey Thomas INVESTIGATIONAL NEW DRUGS permitted the Food and Drug Phone: 301 594-2041 THAT CAN BE AUTHORIZED UNDER Administration to approve requests Fax: 301 827-5562 INDS AND THE CRITERIA FOR from manufacturers of PET drugs for exceptions or alternatives to provisions RIN: 0910–AA85 CHARGING FOR INVESTIGATIONAL NEW DRUGS UNDER INDS of the current good manufacturing practice regulations. Priority: 1028. NEW DRUGS FOR HUMAN USE; Other Significant. Major status Timetable: CLARIFICATION OF REQUIREMENTS under 5 USC 801 is undetermined. FOR APPLICATION SUPPLEMENTS Action Date FR Cite Unfunded Mandates: Undetermined Priority: Substantive, Nonsignificant Final Action Mandated 12/19/97 62 FR 66522 CFR Citation: 21 CFR 312 by the Food and CFR Citation: 21 CFR 314 Drug Modernization Completed: Act. Completed: Reason Date FR Cite Final Action Effective 12/21/97 Reason Date FR Cite Withdrawn - Replaced 01/30/98 Small Entities Affected: None Withdrawn - Replaced 01/30/98 by FDAMA sec 402 Government Levels Affected: None by FDAMA sec 116 Small Entities Affected: Undetermined Agency Contact: Brian L. Pendleton, Small Entities Affected: Businesses, Regulatory Counsel, Regulatory Policy Organizations Government Levels Affected: Staff, Department of Health and Human Government Levels Affected: None Undetermined Services, Food and Drug Administration, Center for Drug Agency Contact: Thomas Kuchenberg Agency Contact: Joseph Griffin Evaluation and Research (HFD-7), 1451 Phone: 301 594-2041 Phone: 301 594-2041 Rockville Pike, Suite 3047, Rockville, Fax: 301 827-5562 Fax: 301 827-5562 MD 20852 RIN: 0910–AA87 RIN: 0910–AB11 Phone: 301 594-2041
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DEPARTMENT OF HEALTHFood AND and HUMANDrug Administration CompletedSERVICES Actions(HHS) (FDA) HHSÐFDA Completed Actions
Fax: 301 827-5562 RIN: 0910–AB46
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Resources and Services Administration (HRSA) ProposedHHS—HRSA Rule Stage
1034. NATIONAL PRACTITIONER Bureau of Health Professions, HRSA, Phone: 301 443-2300 DATA BANK FOR ADVERSE Department of Health and Human RIN: 0906–AA43 INFORMATION ON PHYSICIANS AND Services, Health Resources and Services OTHER HEALTH CARE Administration, Parklawn Building, PRACTITIONERS: CORPORATE Room 8A-55, 5600 Fishers Lane, 1036. DESIGNATION OF MEDICALLY SHIELD Rockville, MD 20857 UNDERSERVED POPULATIONS AND HEALTH PROFESSIONAL SHORTAGE Priority: Substantive, Nonsignificant Phone: 301 443-2300 AREAS Legal Authority: 42 USC 11131 RIN: 0906–AA41 Priority: Substantive, Nonsignificant CFR Citation: 45 CFR 60 Reinventing Government: This Legal Deadline: None 1035. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE rulemaking is part of the Reinventing Abstract: This NPRM proposes to INFORMATION ON PHYSICIANS AND Government effort. It will revise text in require that in addition to reporting the OTHER HEALTH CARE the CFR to reduce burden or National Practitioner Data Bank PRACTITIONERS: REPORTING duplication, or streamline medical malpractice payments made ADVERSE AND NEGATIVE ACTIONS requirements. where physicians or other health care Legal Authority: 42 USC 254b; 42 USC Priority: Substantive, Nonsignificant practitioners are named in judgments 254e or settlements, payments be reported Legal Authority: 42 USC 1396r-2, note where they are made for the benefit of CFR Citation: 42 CFR 5; 42 CFR 51c physicians or other health care CFR Citation: 45 CFR 60 Legal Deadline: None practitioners not named in the Legal Deadline: None Abstract: This rule would consolidate judgements or settlements but who the process for designating areas of furnished or failed to furnish the health Abstract: Public Law 100-93 amended health professional shortage and care services upon which the actions section 1921 of the Social Security Act medical underservice that apply in or claims were based. The purpose of to require that each State have in effect several department programs, and this NPRM is to prevent the evasion a system of reporting disciplinary would improve the criteria for of the medical malpractice payment licensure actions taken against all designating medically underserved reporting requirement of the Data Bank licensed health care practitioners and populations (MUPs) and Primary Care through the agreement of the parties to entities. It also requires States to report Health Professional Shortage Areas a lawsuit to use the ‘‘corporate shield’’ any negative action or finding which (HPSAs). to prevent the health care practitioner a peer review organization, private from being reported. accreditation entity or a State has Timetable: concluded against a health care Action Date FR Cite It would also allow, in very limited practitioner or entity. Section 1921 circumstances when it is impossible to directs the Secretary to provide for NPRM 05/00/98 identify the practitioner who furnished maximum appropriate coordination in NPRM Comment 07/00/98 or failed to furnish the health care the implementation of these reporting Period End services upon which the actions or requirements with those of the Health Small Entities Affected: None claims were based, to report why the Care Quality Improvement Act of 1986 practitioner could not be identified, the (title IV of Public Law 99-660). Government Levels Affected: None name of the hospital or health care Agency Contact: Timetable: Richard Lee, Public organization for whose benefit the Health Analyst, Bureau of Primary payment was made, the amount of Action Date FR Cite Health Care, Department of Health and payment, and the name (if known) of NPRM 06/00/98 Human Services, Health Resources and any hospital or health care organization Services Administration, 4350 East- with which the practitioner is affiliated Small Entities Affected: None West Highway, Bethesda, MD 20814 or associated. Government Levels Affected: None Phone: 301 594-4280 Timetable: Agency Contact: Thomas C. Croft, RIN: 0906–AA44 Action Date FR Cite Director, Division of Quality Assurance, NPRM 05/00/98 Bureau of Health Professions, 1037. HEALTH CARE FRAUD AND Small Entities Affected: None Department of Health and Human ABUSE DATA COLLECTION Services, Health Resources and Services PROGRAM Government Levels Affected: None Administration, Parklawn Building, Agency Contact: Thomas C. Croft, Room 8A-55, 5600 Fishers Lane, Priority: Substantive, Nonsignificant Director, Division of Quality Assurance, Rockville, MD 20857 Legal Authority: 42 USC 1320a-7e
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DEPARTMENTHealth ResourcesOF HEALTH and AND Services HUMAN AdministrationProposed SERVICES Rule (HRSA)(HHS) Stage HHSÐHRSA Proposed Rule Stage
CFR Citation: 42 CFR 61 (New) Government Levels Affected: feedback, the Department reviewed the Undetermined Health Care Quality Improvement Act Legal Deadline: Final, Statutory, Agency Contact: of 1986 and its regulations. Through January 1, 1997. Joel Jay Schaer, Regulations Officer, Department of this review, the Department recognizes Abstract: This proposed rule would Health and Human Services, Health the need to clarify and/or broaden implement the requirements of section Resources and Services Administration, certain definitions due to the rapid 1128E of the Social Security Act, as Office of the Secretary, Office of evolution of the health care system in added by section 221(a) of the Health Inspector General, 330 Independence order to fully implement Congressional Insurance Portability and Avenue SW., Washington, DC 20201 intent, which was to give access to Data Accountability Act of 1996. Section Phone: 202 619-0089 Bank information to those health care organizations reviewing the quality of 1128E of the Act directs the RIN: 0906–AA46 Department to establish a national physician care in order to protect health care fraud and abuse data patients from incompetent practitioners collection program for the reporting 1038. NATIONAL PRACTITIONER with previous damaging or incompetent and disclosure of certain final adverse DATA BANK FOR ADVERSE performance. INFORMATION ON PHYSICIANS AND actions taken against health care Timetable: OTHER HEALTH CARE PROVIDERS: providers, suppliers and practitioners. CLARIFICATION AND Action Date FR Cite The statute also requires the MODERNIZATION OF REGULATORY Department to implement the national NPRM 08/00/98 TERMS health care fraud and abuse data Small Entities Affected: None collection program in such a manner Priority: Substantive, Nonsignificant as to avoid with reporting requirements Legal Authority: 45 USC 11101 to Government Levels Affected: None established for the National Practitioner 11152 Data Bank under the Health Care Agency Contact: Thomas C. Croft, CFR Citation: 45 CFR 60 Quality Improvement Act of 1986. Director, Division of Quality Assurance, Legal Deadline: None Bureau of Health Professions, Department of Health and Human Timetable: Abstract: Since the opening of the Data Services, Health Resources and Services Action Date FR Cite Bank, the Department has received Administration, Parklawn Building, NPRM 08/00/98 feedback that several terms defined in Room 8-A55, 5600 Fishers Lane, NPRM Comment 10/00/98 the regulations have caused confusion. Rockville, MD 20857 Period End These items include ‘‘health care Phone: 301 443-2300 entity’’, ‘‘formal peer review process’’, Small Entities Affected: None and ‘‘clinical privileges’’. Based on this RIN: 0906–AA48
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Health Resources and Services Administration (HRSA) FinalHHS—HRSA Rule Stage
1039. ORGAN PROCUREMENT AND also requires that for organ the OPTN and for participation in the TRANSPLANTATION NETWORK procurement costs attributable to OPTN by transplant hospitals and RULES payments to an Organ Procurement OPOs. Priority: Other Significant. Major under Organization (OPO) to be paid by Summary of the Legal Basis: Section 5 USC 801. Medicare or Medicaid, the OPO must 215 of the Public Health Service Act, be a member of and abide by the rules along with the provision of sections Legal Authority: 42 USC 1320b-8 sec and requirements of the OPTN. No 372 and 374 of the Act (42 USC 216, 1138 of the Social Security Act; 42 USC other entity (for example, a 274 and 274, respectively) provide 274 sec 372 of the Public Health histocompatibility laboratory) is authority to issue OPTN regulations. In Service Act; 42 USC 274b sec 374 of required to be a member of or abide addition section 1138 of the Social the Public Health Service Act; 42 USC by the rules of the OPTN under the Security Act (42 USC 1320b-8) requires 216 sec 215 of the Public Health provisions of the statute. It is the Medicare and Medicaid participating Service Act Department’s position that no rule, hospitals that perform organ transplants CFR Citation: 42 CFR 121 requirement, policy, or other issuance to be members of and abide by the Legal Deadline: None of the OPTN will be considered to be rules and requirements of the Organ a ‘‘rule or requirement’’ of the Network Procurement and Transplantation Abstract: Section 1138 of the Social within the meaning of section 1138 Network (OPTN) as established by Security Act requires Medicare and unless the Secretary has formally section 372 of the Public Health Service Medicaid participating hospitals that approved that rule. The OPTN is Act (42 USC 274). perform organ transplants to be currently in operation and these rules Alternatives: The alternative was to members of and abide by the rules and will impose no further cost. requirements of the Organ Procurement continue without codifying existing and Transplantation Network (OPTN) Statement of Need: These regulations policies. as established by section 372 of the are needed to establish a legally Anticipated Costs and Benefits: There Public Health Service Act. Section 1138 binding framework for the operation of are no anticipated costs beyond the cost
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DEPARTMENTHealth ResourcesOF HEALTH and AND Services HUMAN Administration SERVICESFinal Rule (HRSA)(HHS) Stage HHSÐHRSA Final Rule Stage
of preparing the regulations Agency Contact: Jon Nelson, Acting or deaths related to hepatitis B, Hib, (approximately $100,000.00). The Director, Division of Transplantation, and varicella vaccines may now be anticipated benefit is that the Office of Special Programs, Department filed under the VICP. This technical regulations will make mandatory of Health and Human Services, Health amendment (final rule) will amend the adherence to the policies set forth in Resources and Services Administration, CFR to include a date certain (August the regulations. Room 7-29 Parklawn Bldg., 5600 6, 1997) in section 100.3(c), so that Risks: None known. Fishers Lane, Rockville, MD 20857 there will be no uncertainty as to the Phone: 301 443-7577 Timetable: coverage of these three vaccines. RIN: 0906–AA32 Action Date FR Cite Timetable: NPRM 09/08/94 59 FR 46482 1040. ∑ NATIONAL VACCINE INJURY Action Date FR Cite NPRM Comment 12/07/94 COMPENSATION PROGRAM: Period End Final Action 08/00/98 EFFECTIVE DATE PROVISIONS OF Final with Comment 04/02/98 63 FR 16296 Period COVERAGE OF CERTAIN VACCINES Small Entities Affected: Undetermined TO THE VACCINE INJURY TABLE Comment Period End 06/01/98 Government Levels Affected: None Small Entities Affected: None Priority: Info./Admin./Other Agency Contact: Thomas E. Balbier, Government Levels Affected: None Legal Authority: 42 USC 300aa.15(a)(3)(B) Jr., Director, Division of Vaccine Injury Additional Information: Previously CFR Citation: 42 CFR 100 Compen., Department of Health and reported under RIN 0905-AD26. Human Services, Health Resources and Sections 215, 372, and 374 of the PHS Legal Deadline: None Services Administration, Room 8A-35, Act provide general authority to Abstract: Section 904(b) of the Parklawn Building, 5600 Fishers Lane, regulate the activities of the Organ Taxpayer Relief Act of 1997 provides Rockville, MD 20857 Procurement and Transplantation for an excise tax for three new Phone: 301 443-6593 Network (OPTN) established under vaccines, effective August 6, 1997, and section 372. petitions for compensation for injuries RIN: 0906–AA49
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Health Resources and Services Administration (HRSA) Long-TermHHS—HRSA Actions
1041. DRUG PRICING PROGRAM: Legal Deadline: None Government Levels Affected: None PRIME VENDOR USER CHARGE Abstract: This rule proposes to include Agency Contact: Jimmy Mitchell, Priority: Routine and Frequent a user charge (not over 1/2 of 1% of Acting Director, Office of Drug Pricing, Reinventing Government: This total drug sale revenue) to be paid by Department of Health and Human rulemaking is part of the Reinventing the prime vendor to HRSA. It is Services, Health Resources and Services intended to cover costs that HRSA Government effort. It will revise text in Administration, 4350 East/West incurs in providing information and the CFR to reduce burden or Highway, Bethesda, MD 20814 services essential to prime vendor duplication, or streamline Phone: 301 594-4353 requirements. operations. Fax: 301 594-4992 Legal Authority: PL 102-585 Timetable: Next Action Undetermined RIN: 0906–AA45 CFR Citation: 45 CFR 8 Small Entities Affected: None
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Health Resources and Services Administration (HRSA) CompletedHHS—HRSA Actions
1042. NATIONAL PRACTITIONER Small Entities Affected: None 1043. GRANTS FOR RESIDENCY DATA BANK FOR ADVERSE TRAINING AND ADVANCED INFORMATION ON PHYSICIANS AND Government Levels Affected: None EDUCATION IN THE GENERAL OTHER HEALTH CARE PRACTICE OF DENTISTRY; Agency Contact: Thomas C. Croft PRACTITIONERS: CHARGE FOR TECHNICAL AMENDMENTS Phone: 301 443-2300 SELF-QUERIES Priority: Substantive, Nonsignificant RIN: 0906–AA42 Priority: Info./Admin./Other CFR Citation: 42 CFR 57 subpart L CFR Citation: 45 CFR 60 Completed: Completed: Reason Date FR Cite Reason Date FR Cite Final Action 10/01/97 62 FR 51373 Final Action 03/24/98 63 FR 14059 Small Entities Affected: None
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DEPARTMENTHealth ResourcesOF HEALTH and AND Services HUMAN Administration CompletedSERVICES Actions(HRSA)(HHS) HHSÐHRSA Completed Actions
Government Levels Affected: None Phone: 301 443-6853 Fax: 301 443-1164 Agency Contact: Bernice Parlak RIN: 0906–AA47
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Indian Health Service (IHS) Proposed RuleHHS—IHS Stage
1044. ACQUISITION UNDER THE BUY Procurement: This is a procurement- Abstract: The Indian Health Service INDIAN ACT related action for which there is a (IHS) is proposing to establish statutory requirement. There is a regulations as mandated by the Indian Priority: Substantive, Nonsignificant paperwork burden associated with this Child Protection and Family Violence Legal Authority: 25 USC 47 action. Protection Act, P.L. 101-630, 25 U.S.C. 3201-3211, that prescribe minimum CFR Citation: 48 CFR ch 3, app A Additional Information: Previously standards of character for individuals reported under RIN 0905-AE09. Legal Deadline: None whose duties and responsibilities Agency Contact: Myrna Mooney, Small involve regular contact with, or control Abstract: This regulation will update and Disadvantaged Business Utilization over, Indian children. and standardize existing regulations for Specialist, Department of Health and Timetable: the Buy Indian Act to coincide with Human Services, Indian Health Service, the Department of Interior regulations 12300 Twinbrook Parkway, Suite 450, Action Date FR Cite at 48 CFR chapter 14. There are no Rockville, MD 20852 NPRM 06/00/98 costs associated with these revised Phone: 301 443-1480 regulations. These revisions will NPRM Comment 09/00/98 increase competition among Indian RIN: 0917–AA00 Period End economic enterprises and facilitate Small Entities Affected: None economic development of Indian 1045. INDIAN CHILD PROTECTION Government Levels Affected: Tribal reservations by increasing opportunities AND FAMILY VIOLENCE PREVENTION for Indian businesses. Agency Contact: Ramona D. Williams, ACT MINIMUM STANDARDS OF Child Protection Coordinator, Timetable: CHARACTER Department of Health and Human Action Date FR Cite Priority: Info./Admin./Other Services, Indian Health Service, 5300 Homestead Road NE., Albuquerque, NPRM 05/00/98 Legal Authority: 25 USC 3201 et seq NM 87110 Small Entities Affected: None CFR Citation: 42 CFR 36 Phone: 505 837-4245 Government Levels Affected: Tribal Legal Deadline: None RIN: 0917–AA02
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
National Institutes of Health (NIH) Proposed RuleHHS—NIH Stage
1046. NATIONAL INSTITUTES OF Small Entities Affected: Undetermined 1047. UNDERGRADUATE HEALTH AIDS RESEARCH LOAN SCHOLARSHIP PROGRAM REPAYMENT PROGRAM Government Levels Affected: REGARDING PROFESSIONS NEEDED Undetermined BY THE NIH Priority: Substantive, Nonsignificant Additional Information: Previously Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC reported under RIN 0905-AD18. Legal Authority: 42 USC 216; 42 USC 288-1 288-4 CFR Citation: 42 CFR 68 Agency Contact: Jerry Moore, NIH CFR Citation: 42 CFR 68b Regulations Officer, Department of Legal Deadline: None Legal Deadline: None Health and Human Services, National Abstract: Section 487D of the Public Abstract: Section 487A of the Public Institutes of Health, 6011 Executive Health Service Act, as added by the Health Service Act creates a program Blvd., Room 601, MSC 7669, Rockville, National Institutes of Health through which appropriately qualified MD 20852 Revitalization Act of 1993, creates a health professionals may obtain Phone: 301 496-4606 program offering scholarships, in an federally funded repayment of Fax: 301 402-0169 amount not to exceed $20,000 per year educational loans by conducting AIDS Email: [email protected] of academic study, to individuals from research as NIH employees. disadvantaged backgrounds who are RIN: 0925–AA02 Timetable: enrolled as full-time students at accredited institutions pursuing Action Date FR Cite academic programs appropriate for NPRM 09/00/98 careers in professions needed by the
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DEPARTMENT OF HEALTHNational AND HUMAN InstitutesProposed SERVICES of Health Rule (HHS) (NIH)Stage HHSÐNIH Proposed Rule Stage
NIH. For each year of scholarship 1049. ADDITIONAL DHHS support, by engaging in a second year support, the recipient agrees to service PROTECTIONS FOR PREGNANT of NRSA supported research training. (employment) after graduation, at the WOMEN AND HUMAN FETUSES Timetable: NIH, for one year. Additionally, the INVOLVED AS SUBJECTS IN individual agrees to at least ten RESEARCH, AND PERTAINING TO Action Date FR Cite consecutive weeks of service HUMAN IN VITRO FERTILIZATION NPRM 04/00/98 (employment) a the NIH during which Priority: Other Significant Small Entities Affected: the individual is attending the None institution and receiving the NIH Legal Authority: 5 USC 301; 42 USC Government Levels Affected: None 289 scholarship. The proposed new Agency Contact: Jerry Moore, NIH regulations will cover this program. CFR Citation: 45 CFR 46, subpart B Regulations Officer, Department of Timetable: Legal Deadline: None Health and Human Services, National Institutes of Health, 6100 Executive Action Date FR Cite Abstract: Current regulations which Blvd., Room 601, MSC 7669, Rockville, have been in effect for two decades will NPRM 09/00/98 MD 20852 be revised to reflect provisions of Phone: 301 496-4606 Small Entities Affected: None Public Law 103-43 and recent changes Fax: 301 402-0169 Government Levels Affected: None in NIH and FDA policies on the Email: [email protected] Additional Information: Previously involvement of women and human RIN: 0925–AA16 reported under RIN 0905-AE57. fetuses in research. Agency Contact: Jerry Moore, NIH Timetable: Regulations Officer Department of Action Date FR Cite 1051. REMOVAL OF NATIONAL Health and Human Services, National CANCER INSTITUTE CLINICAL NPRM 04/00/98 Institutes of Health, 6011 Executive CANCER EDUCATION PROGRAM Blvd., Room 601, MSC 7669, Rockville, Small Entities Affected: Undetermined Priority: Info./Admin./Other MD 20852 Government Levels Affected: Reinventing Government: This Phone: 301 496-4606 Undetermined Fax: 301 402-0169 rulemaking is part of the Reinventing Agency Contact: Michele Russell- Government effort. It will eliminate RIN: 0925–AA10 Einhorn, J.P., Director of Regulatory existing text in the CFR. Affairs, Department of Health and Legal Authority: 42 USC 216 1048. TRAINEESHIPS Human Services, National Institutes of Health, Office for Protection from CFR Citation: 42 CFR 52d Priority: Info./Admin./Other Research Risks, 6100 Executive Blvd., Legal Deadline: None Legal Authority: 42 USC 216; 42 USC Ste. 3B01, MSC 7507, Rockville, MD Abstract: Current regulations relating 283g(d)(2); 42 USC 284(b)(1)(C); 42 USC 20892-7507 to the National Cancer Institute Clinical 286b-3 Phone: 301 435-5649 Cancer Education Program will be Fax: 301 402-2071 CFR Citation: 42 CFR 63 rescinded because the regulations are Legal Deadline: None RIN: 0925–AA14 obsolete. Current guidelines communicated by NCI with respect to Abstract: Regulations governing NIH the care of cancer patients no longer traineeships will be amended to set 1050. NATIONAL RESEARCH SERVICE reflect the type of program described forth additional conditions under AWARDS in the current regulations. This action which awards may be terminated. Priority: Info./Admin./Other will not affect the authority of the Timetable: Legal Authority: 42 USC 216; 42 USC Director, NCI, to support appropriate Action Date FR Cite 288 programs of education and training, including clinical research training set NPRM 06/00/98 CFR Citation: 42 CFR 66 forth in section 414 of the Public Small Entities Affected: None Legal Deadline: None Health Service Act. Government Levels Affected: None Abstract: Current HHS regulations will Timetable: Additional Information: Previously be amended to reflect provisions of the Action Date FR Cite reported under RIN 0905-AE62. ADAMHA Reorganization Act and the andthe National Institutes of Health NPRM 08/00/98 Agency Contact: Jerry Moore, NIH Revitalization Act of 1993. New Small Entities Affected: None Regulations Officer, Department of language concerning the service Health and Human Services, National payback obligation will set forth that Government Levels Affected: None Institutes of Health, 6011 Executive a service payback obligation is incurred Agency Contact: Jerry Moore, NIH Blvd., Room 601, MSC 7669, Rockville, only during the first tweleve months Regulations Officer, Department of MD 20852 of postdoctoral support and individuals Health and Human Services, National Phone: 301 496-4606 may pay back this service obligation by Institutes of Health, 6011 Executive Fax: 301 402-0169 engaging in equal period of health- Blvd., Room 601, MSC 7669, Rockville, Email: [email protected] realted teaching or if the individual MD 20852 RIN: 0925–AA11 finished the first twelve months of Phone: 301 496-4606
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DEPARTMENT OF HEALTHNational AND HUMAN InstitutesProposed SERVICES of Health Rule (HHS) (NIH)Stage HHSÐNIH Proposed Rule Stage
Fax: 301 402-0169 two NICHD Infertility Research Centers Fax: 301 402-0169 Email: [email protected] due to limited availability of funds. Email: [email protected] RIN: 0925–AA17 Timetable: RIN: 0925–AA20 Action Date FR Cite 1052. NATIONAL INSTITUTES OF NPRM 09/00/98 1055. ∑ FEDERAL POLICY (COMMON HEALTH LOAN REPAYMENT RULE) FOR THE PROTECTION OF PROGRAM FOR RESEARCH Small Entities Affected: None HUMAN SUBJECTS Priority: Substantive, Nonsignificant Government Levels Affected: None Priority: Other Significant Legal Authority: 42 USC 216; 42 USC Agency Contact: Jerry Moore, NIH Legal Authority: 5 USC 301; 42 USC 288-3 Regulations Officer, Department of 289; 42 USC 300v-1(b) Health and Human Services, National CFR Citation: 42 CFR 68d Institutes of Health, 6011 Executive CFR Citation: 45 CFR 46 Legal Deadline: None Blvd., Room 601, MSC 7669, Rockville, Legal Deadline: None MD 20852 Abstract: Regulations will be issued to The President’s Memorandum prohibits Phone: 301 496-4607 govern the awarding of educational agencies fromconducting or supporting Fax: 301 402-0169 loan repayments for research classified human subject research Email: [email protected] authorized under section 487C of the without having proposed and Public Health Service Act, as added by RIN: 0925–AA19 promulaged the Common Rule and the provisions of the National Institutes of changes. Abstract: In compliance with the Health Revitalization Act of 1993. 1054. SCIENTIFIC PEER REVIEW OF President’s Memorandum of March 27, Timetable: RESEARCH GRANT APPLICATIONS 1997, this proposed rule would amend AND RESEARCH AND DEVELOPMENT Action Date FR Cite the Federal Policy (Common Rule) for CONTRACT PROJECTS NPRM 09/00/98 the Protection of Human Subjects to Priority: Substantive, Nonsignificant add a new section that applies only to Small Entities Affected: None Reinventing Government: This classified research involving human Government Levels Affected: None rulemaking is part of the Reinventing subjects. The new section would Agency Contact: Jerry Moore, NIH Government effort. It will revise text in modify the Federal Policy by (1) Regulations Officer, Department of the CFR to reduce burden or prohibiting any executive branch Health and Human Services, National duplication, or streamline agency from engaging in classified Institutes of Health, 6011 Executive requirements. research involving human subjects unless the agency has adopted the Blvd., Room 601, MSC 7669, Rockville, Legal Authority: 42 USC 216; 42 USC MD 20852 Federal Policy and the proposed rule; 282(b)(6); 42 USC 284(c)(3); 42 USC (2) eliminating the availability of Phone: 301 496-4606 289a; 42 USC 290aa-3 Fax: 301 496-0125 waiver of informed consent and Email: [email protected] CFR Citation: 42 CFR 52h expedited review for classified research involving human subjects; (3) Legal Deadline: None RIN: 0925–AA18 enhancing the informed consent Abstract: NIH staff have been requirements and allowing for 1053. NATIONAL INSTITUTE OF CHILD reexamining the peer review process as disclosure of classified information if HEALTH AND HUMAN DEVELOPMENT part of its reinvention initiatives and necessary; and (4) changing the CONTRACEPTION AND INFERTILITY have found ambiguities, misstatements, composition of the institutional review RESEARCH LOAN REPAYMENT and voids in the existing regulations board (IRB) and establishing a process PROGRAM governing peer review in NIH, for individual IRM members to appeal SAMHSA, and HRSA. These from any IRB approvals of classified Priority: Substantive, Nonsignificant regulations, which govern the first level research. Legal Authority: 42 USC 216; 42 USC of review, would be amended to reflect Timetable: 288-2 current policies and procedures. Action Date FR Cite CFR Citation: 42 CFR 68c Timetable: NPRM 04/00/98 Legal Deadline: None Action Date FR Cite Small Entities Affected: None Abstract: Section 487B of the Public NPRM 09/00/98 Government Levels Affected: None Health Service Act creates a program Small Entities Affected: None through which appropriately qualified Agency Contact: Michele Russell- health professionals may obtain Government Levels Affected: None Einhorn, J.D., Director of Regulatory federally funded repayment of Agency Contact: Jerry Moore, NIH Affairs, Department of Health and education loans by conducting research Regulations Officer, Department of Human Services, National Institutes of with respect to contraception and/or Health and Human Services, National Health, Office for Protection from infertility. The initial implementation Institutes of Health, 6011 Executive Research Risks, 6100 Executive Blvd., of the program will be limited to Blvd., Room 601, MSC 7669, Rockville, Room 3B01, MSC 7505, Rockville, MD employees of the three NICHD MD 20852 29852 Contraception Research Centers and Phone: 301 496-4606 Phone: 301 496-7005
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DEPARTMENT OF HEALTHNational AND HUMAN InstitutesProposed SERVICES of Health Rule (HHS) (NIH)Stage HHSÐNIH Proposed Rule Stage
Fax: 301 402-2071 RIN: 0925–AA21
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
National Institutes of Health (NIH) Final RuleHHS—NIH Stage
1056. NATIONAL INSTITUTES OF Blvd., Room 601, MSC 7669, Rockville, 1058. ∑ SERVICE FELLOWSHIP HEALTH CONSTRUCTION GRANTS MD 20852 Phone: 301 496-4606 Priority: Other Significant Priority: Other Significant Fax: 301 402-0169 Reinventing Government: This Reinventing Government: This Email: [email protected] rulemaking is part of the Reinventing rulemaking is part of the Reinventing RIN: 0925–AA04 Government effort. It will revise text in Government effort. It will revise text in the CFR to reduce burden or the CFR to reduce burden or duplication, or streamline 1057. NATIONAL INSTITUTES OF duplication, or streamline requirements. requirements. HEALTH CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR Legal Authority: 42 USC 209; 42 USC Legal Authority: 42 USC 216; 42 USC INDIVIDUALS FROM 210; 42 USC 216 285a-2; 42 USC 285a-3; 42 USC 285b- DISADVANTAGED BACKGROUNDS 3; 42 USC 285b-4; 42 USC 285d-6; 42 CFR Citation: 42 CFR 61, subpart B USC 285i; 42 USC 285m-3; 42 USC Priority: Substantive, Nonsignificant 285o-4; 42 USC 287a-2; 42 USC 287a- Legal Authority: 42 USC 216; 42 USC Legal Deadline: None 3; 42 USC 300cc-41 288-5 Abstract: This interim final rule CFR Citation: 42 CFR 52b CFR Citation: 42 CFR 68a amends the regulations governing service fellowships by revising the Legal Deadline: None Legal Deadline: None current authority citation, extending the Abstract: Regulations will be issued to Abstract: Regulations concerning NCI time limitation on initial appointments govern the awarding of educational construction grants will be amended to from 2 to 5 years, permitting extensions loan repayments under the NIH Clinical make them generally applicable to all of appointments for up to 5 years rather Research Loan Repayment Program for NIH extramural programs with than year-to-year, and removing Individuals From Disadvantaged construction grant authority. obsolete references to the Surgeon Backgrounds authorized by section Additionally, the regulations will be General and obsolete requirements 487E of the Public Health Service Act, amended to show new administrative regarding the qualifications of as added by provisions of the National and technical requirements, add new applicants. These changes are being Institutes of Health Revitalization Act procedures for the recovery of grant of 1993. made to provide HHS health agencies funds for facilities no longer used for with greater flexibility to recruit and biomedical research, show new Public Timetable: retain their talented scientists and to Health Service Act section numbers, Action Date FR Cite update obsolete references. and update the listing of other HHS NPRM 02/10/97 62 FR 5953 regulations relevant to contruction Timetable: NPRM Comment 04/11/97 grants. Period End Action Date FR Cite Timetable: Final Action 09/00/98 Interim Final Rule 04/00/98 Action Date FR Cite Small Entities Affected: None Final Action 06/00/98 NPRM 07/06/95 60 FR 35266 Government Levels Affected: None Small Entities Affected: None NPRM Comment 09/05/95 Additional Information: Previously Government Levels Affected: None Period End reported under RIN 0905-AE56. Final Action 09/00/98 Agency Contact: Jerry Moore, NIH Agency Contact: Jerry Moore, NIH Small Entities Affected: None Regulations Officer, Department of Regulations Officer, Department of Health and Human Services, National Government Levels Affected: None Health and Human Services, National Institutes of Health, 6011 Executive Institutes of Health, 6011 Executive Additional Information: Previously Blvd., Room 601, MSC 7669, Rockville, Blvd., Room 601, MSC 7669, Rockville, reported under RIN 0905-AD49. MD 20852 MD 20852 Phone: 301 496-4606 Agency Contact: Jerry Moore, NIH Phone: 301 496-4606 Fax: 301 402-0169 Fax: 301 402-0169 Regulations Officer, Department of Email: [email protected] Health and Human Services, National Email: [email protected] Institutes of Health, 6011 Executive RIN: 0925–AA09 RIN: 0925–AA22
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Office of Assistant Secretary for Health (OASH) Long-TermHHS—OASH Actions
1059. STANDARDS OF COMPLIANCE standard operative prior to February 2, Government Levels Affected: State FOR ABORTION-RELATED SERVICES 1988, with regard to the statutory Additional Information: Previously IN FAMILY PLANNING SERVICE provision prohibiting abortion as a reported under RIN 0905-AE03. PROJECTS method of family planning in projects funded under that title. Agency Contact: Thomas C. Kring, Priority: Substantive, Nonsignificant Acting Deputy Assistant Secretary for Legal Authority: 42 USC 300a-4 Timetable: Population Affairs, Department of Health and Human Services, Office of CFR Citation: 42 CFR 59 Action Date FR Cite Assistant Secretary for Health, East- Legal Deadline: None NPRM 02/05/93 58 FR 7464 West Towers, Suite 200, West Bldg., NPRM Comment 08/09/93 58 FR 34024 Abstract: This rule would return the 4350 East-West Highway, Bethesda, MD Period End 20814 Family Planning Service Program, Final Action 00/00/00 funded under title X of the Public Phone: 301 594-4000 Health Service Act, to the regulatory Small Entities Affected: None RIN: 0937–AA00
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS) Proposed HHS—PHSRule Stage
1060. PUBLIC HEALTH SERVICE Under this proposed regulation, Small Entities Affected: Businesses, STANDARDS FOR THE PROTECTION covered institutions must follow certain Governmental Jurisdictions, OF RESEARCH MISCONDUCT requirements for preventing and Organizations WHISTLEBLOWERS responding to occurrences of retaliation Government Levels Affected: State Priority: Substantive, Nonsignificant against whistleblowers. The purpose of this part is to protect: (1) persons who Agency Contact: Barbara Bullman, Legal Authority: 42 USC 216; 42 USC make a good faith allegation that a 241; 42 USC 289b covered institution or member thereof Policy Analyst, OPHS, Office of CFR Citation: 42 CFR 94 engaged in, or failed to (2) persons who Research Integrity, Department of Health and Human Services, Public Legal Deadline: None cooperate in good faith with an investigation of research misconduct. Health Service, 5515 Security Lane, Abstract: To implement section 493(e) Suite 700, Rockville, MD 20852 of the Public Health Service Act (added Timetable: Phone: 301 443-5300 by section 163 of the National Institutes Fax: 301 443-5351 of Health Revitalization Act of 1993, Action Date FR Cite Public Law 103-43), the Department is NPRM 06/00/98 RIN: 0905–AE71 proposing to add new part 94 to title NPRM Comment 09/00/98 42 of the Code of Federal Regulations. Period End
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Health Care Financing Administration (HCFA) PreruleHHS—HCFA Stage
1061. ∑ PROSPECTIVE FEE setting the payment rates, the Secretary Timetable: SCHEDULE FOR AMBULANCE is to ensure that the aggregate amount Action Date FR Cite SERVICES (HCFA-1002-NR) of payment made for ambulance services in 2000 may not exceed the Notice of Intent to 04/00/98 Priority: Other Significant Negotiate amount of payment that would have Unfunded Mandates: Undetermined been made absent the fee schedule. Small Entities Affected: Undetermined Legal Authority: PL 105-33, sec 4531(b) This is a cap on payment, not a budget Government Levels Affected: CFR Citation: 42 CFR 410 neutrality adjustment. The Secretary is Undetermined to consult with national organizations Legal Deadline: Agency Contact: Final, Statutory, representing individuals and entities Nancy Edwards, January 1, 2020. Center for Medicaid and State that furnish and regulate ambulance Operations, Department of Health and Abstract: The Balanced Budget Act of services and share relevant data with Human Services, Health Care Financing 1997 requires that the Secretary these organizations. This provision will establish a fee schedule for ambulance Administration, 7500 Security Blvd, be met through the negotiated Baltimore, MD 21244 services through negotiated rulemaking. rulemaking process. The fee schedule is to be effective Phone: 410 786-4531 beginning with services furnished on or Email: [email protected] after January 1, 2000. In addition to RIN: 0938–AI72
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA) ProposedHHS—HCFA Rule Stage
1062. ``WITHOUT FAULT'' AND 1063. PROVIDER REIMBURSEMENT 417.820; 42 CFR 417.822; 42 CFR BENEFICIARY WAIVER OF DETERMINATIONS AND APPEALS 417.824 RECOVERY AS IT APPLIES TO (HCFA-1727-P) Legal Deadline: None MEDICARE OVERPAYMENT LIABILITY Priority: Substantive, Nonsignificant Abstract: (HCFA-1719-P) This regulation would Legal Authority: 42 USC 1302; 42 USC impose a range of requirements on Priority: Substantive, Nonsignificant 1395f(b); 42 USC 1395g(A); 42 USC health care prepayment plans (HCPP) 1395l; 42 USC 1395x(v); 42 USC corresponding to certain provisions for Reinventing Government: This 1395x(v)(1)(a); 42 USC 1395hh; 42 USC prepaid health plans under section rulemaking is part of the Reinventing 1395ii; 42 USC 1395oo; 42 USC 1876 of the Social Security Act. The Government effort. It will revise text in 1395ww; 42 USC 405; 42 USC 300e; expanded regulatory requirements the CFR to reduce burden or 42 USC 300e-5; 42 USC 300e-9; 31 USC would increase beneficiary protections duplication, or streamline 9701 and strengthen Federal oversight of the HCPP program. We will also address requirements. CFR Citation: 42 CFR 405.1801 to related requirements of the Balanced Legal Authority: 42 USC 1395gg 405.1889; 42 CFR 413.30 to 413.64; 42 Budget Act of 1997. CFR 417.576; 42 CFR 417.810 CFR Citation: Timetable: 42 CFR 401; 42 CFR Legal Deadline: None 403.310; 42 CFR 405; 42 CFR 410.1; Action Date FR Cite 42 CFR 411.23; 42 CFR 411.28; 42 CFR Abstract: Section 1878 of the Social NPRM 10/00/98 413.20; 42 CFR 413.153; 42 CFR 447.31; Security Act and 42 CFR part 405, 42 CFR 466.86; 42 CFR 466.94; 42 CFR subpart R provide for administrative Small Entities Affected: None 473.14; 42 CFR 493.1834 and judicial review in accordance with Government Levels Affected: None prescribed requirements, of certain Legal Deadline: None disputes regarding Medicare Additional Information: OMC-016 reimbursement for participating Agency Contact: Tracy Jensen, Center Abstract: This rule would amend the providers of services. This proposed for Health Plans and Providers, Medicare regulations to clarify our rule would revise, update, and clarify Department of Health and Human interpretation of ‘‘without fault’’ as it various provisions of the regulations Services, Health Care Financing applies to physician, provider, supplier pertaining to provider appeals and Administration, S3-23-25, 7500 and beneficiary liability for make conforming changes to other Security Boulevard, Baltimore, MD overpayments. This definition would regulations 21244 result in greater uniformity of Timetable: Phone: 410 786-1033 determinations by carriers and RIN: 0938–AF97 intermediaries. Additionally, this rule Action Date FR Cite would amend the Medicare regulations NPRM 04/00/98 governing liability for overpayments to 1065. CONDITIONS OF Small Entities Affected: None eliminate application of certain PARTICIPATION FOR RURAL HEALTH regulations of the Social Security Government Levels Affected: None CLINICS (HCFA-1764-P) Administration and to replace them Additional Information: BPD-727 Priority: Other Significant with HCFA regulations more specific to Agency Contact: Morty Marcus, Center Reinventing Government: This circumstances involving Medicare for Health Plans and Providers, rulemaking is part of the Reinventing overpayments. Department of Health and Human Government effort. It will revise text in Timetable: Services, Health Care Financing the CFR to reduce burden or Administration, C4-07-07, 7500 duplication, or streamline Action Date FR Cite Security Boulevard, Baltimore, MD requirements. NPRM 04/00/98 21244 Legal Authority: 42 USC 1395l(a); 42 Phone: 410 786-4477 USC 1395x(aa); 42 USC 1395y(a)(14); Small Entities Affected: None RIN: 0938–AF28 42 USC 1396a(a)(13)(E); 42 USC 263a; 42 USC 1302; 42 USC 1395hh Government Levels Affected: None CFR Citation: 1064. REVISIONS TO RULES ON 42 CFR 405; 42 CFR 410; Additional Information: BPD-719 HEALTH CARE PREPAYMENT PLANS 42 CFR 491 Agency Contact: David Walczak, (HCFA-1016-P) Legal Deadline: None Center for Health Plans and Providers, Priority: Other Significant Abstract: This rule would update our Plan & Provider Purchasing Policy regulations to incorporate several Legal Authority: 42 USC 1302; 42 USC Group, Department of Health and health care coverage and payment 1395hh; 42 USC 13951; 42 USC 300e; Human Services, Health Care Financing provisions contained in OBRAs ’86, ’87, 42 USC 300e-5; 42 USC 300e-9; 31 USC ’89, and ’90 and would propose Administration, C4-07-07, 7500 9701 Security Blvd., Baltimore, MD 21244 administrative changes that clarify Phone: 410 786-4475 CFR Citation: 42 CFR 471.800; 42 CFR policy related to sharing space between 417.801; 42 CFR 417.806; 42 CFR rural health clinics and other entities, RIN: 0938–AD95 417.812; 42 CFR 417.814; 42 CFR such as physician offices, the 417.816; 42 CFR 417.818; 42 CFR replacement of the provider-based cost
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00315 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21990 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
basis system with the all-inclusive rate Government Levels Affected: 1068. MEDICAID: OPTIONAL payment system, and the allowance of Undetermined COVERAGE OF TB-RELATED separate payment under part B for more SERVICES FOR INDIVIDUALS Additional Information: complex laboratory services. Some HSQ-204 INFECTED WITH TUBERCULOSIS changes pertain to federally qualified Agency Contact: Judith Kari, Center for (HCFA-2082-P) health centers as well as rural health Medicaid and State Operations, Priority: Other Significant clinics. Division of Outcomes and Legal Authority: 42 USC Timetable: Improvements, Department of Health and Human Services, Health Care 1396a(a)(10)(A)(ii); PL 103-66, Sec Action Date FR Cite Financing Administration, S2-19-26, 13603; 42 USC 1396a(z) NPRM 05/00/98 7500 Security Boulevard, Baltimore, CFR Citation: 42 CFR 435.219; 42 CFR 435.201; 42 CFR 440.250; 42 CFR Small Entities Affected: Businesses, MD 21244 436.201; 42 CFR 436.219; 42 CFR Organizations Phone: 410 786-6829 440.164 Government Levels Affected: None RIN: 0938–AG31 Legal Deadline: None Additional Information: BPD-764 1067. EFFECT OF CHANGE OF Abstract: This rule would provide for Agency Contact: Helen Klein, Center OWNERSHIP ON PROVIDER AND optional Medicaid coverage of low- for Health Plans and Providers, SUPPLIER PENALTIES, SANCTIONS, income individuals infected with Division of Integrated Services, UNDERPAYMENTS AND tuberculosis (TB). These individuals Department of Health and Human OVERPAYMENTS (HCFA-2215-P) would be eligible only for specified Services, Health Care Financing tuberculosis related services. The rule Administration, C4-06-07, 7500 Priority: Substantive, Nonsignificant would incorporate and interpret Security Boulevard, Baltimore, MD provisions of section 13603 of OBRA Legal Authority: 21244 42 USC 1302; 42 USC ’93. Phone: 410 786-4641 1395f(b); 42 USC 1395g(a); 42 USC 1395hh; 42 USC 1395ii; 42 USC Timetable: RIN: 0938–AG05 1395oo; 42 USC 1395xx; 42 USC Action Date FR Cite 1395x(v); 42 USC 13951; 42 USC 405; NPRM 04/00/98 1066. ALTERNATIVE SANCTIONS FOR 42 USC 1395ww Small Entities Affected: None RENAL DIALYSIS FACILITIES (HCFA- CFR Citation: 42 CFR 405.1803; 42 CFR 3204-P) 405.1811; 42 CFR 405.1835; 42 CFR Government Levels Affected: State, Priority: Substantive, Nonsignificant 405.1843; 42 CFR 405.1805; 42 CFR Local 489.2; 42 CFR 489.18 Legal Authority: 42 USC 1395rr(c); 42 Additional Information: HCFA-2082-P USC 1395rr(g) Legal Deadline: None Agency Contact: Ingrid Osborne, Center for Medicaid and State CFR Citation: 42 CFR 405; 42 CFR 488; Abstract: This rule would amend the 42 CFR 498 Operations, Department of Health and regulations on provider and certain Human Services, Health Care Financing Legal Deadline: None supplier agreements by clarifying the Administration, C4-19-24, 7500 effect a change of ownership has on Abstract: This proposed rule would set Security Boulevard, Baltimore, MD penalties and sanctions incurred by the forth circumstances under which HCFA 21244 former provider or supplier. It also could impose denial of payment as an Phone: 410 786-4461 would clarify our policy on changes alternative sanction instead of involving leased departments. RIN: 0938–AG72 terminating coverage when an ESRD facility is not in substantial compliance Timetable: 1069. PHYSICIANS' REFERRALS TO with the conditions for coverage, but Action Date FR Cite its deficiencies do not pose immediate HEALTH CARE ENTITIES WITH WHICH jeopardy to patient health or safety. NPRM 04/00/98 THEY HAVE FINANCIAL RELATIONSHIPSÐEXPANDED TO Before section 1881 of the Social Small Entities Affected: None Security Act was amended by section DESIGNATED HEALTH SERVICES 12 of the Medicare and Medicaid Government Levels Affected: (HCFA-1809-F) Patient and Program Protection Act of Undetermined Priority: Other Significant 1987 (Public Law 100-93), HCFA was Additional Information: HSQ-215 Legal Authority: 42 USC 1302; 42 USC authorized to impose alternative 1395hh; 42 USC 1395nn; 42 USC 1396b sanctions only when an ESRD facility Agency Contact: Mike Goldman, failed to cooperate in the goals and Division of Integrated Health Systems, CFR Citation: 42 CFR 411.350 to activities of the ESRD network for the Department of Health and Human 411.361; 42 CFR 424.22; 42 CFR area in which the facility is located. Services, Health Care Financing 435.1012; 42 CFR 455.108; 42 CFR 455.109 Timetable: Administration, S2-14-27, 7500 Security Boulevard, Baltimore, MD Legal Deadline: None Action Date FR Cite 21244 Abstract: This rule provides that a Phone: 410 786-6813 NPRM 06/00/98 physician who has (or whose Small Entities Affected: Undetermined RIN: 0938–AG59 immediate family member has) a
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
financial relationship with a health care in quality, comprehensive care for the for Medicare reimbursement. In entity may not make referrals to that dialysis patient. addition, section 1881(c) of the Act entity for certain services (designated Statement of Need: Section 1881(b)(1) establishes ESRD network areas and health services) under the Medicare of the Social Security Act stipulates network organizations to assure that program except under specified that payment is made to individuals, dialysis patients are provided circumstances. In the Medicaid context, providers of services, and renal dialysis appropriate care. The requirements this rule would deny payment to a facilities that meet the requirements for from section 1881(b) and (c) are State for expenditures for designated institutional dialysis services and implemented in regulations at 42 CFR health services furnished on the basis supplies that are determined by the part 405, subpart U, Conditions for of a physician referral that, all things Secretary. These requirements are the Coverage for ESRD Facilities. being equal, would result in denial of end-stage renal disease (ESRD) Section 1138(b)(1)(D) of the Act payment under Medicare. The conditions for coverage. requires hospitals to be members and provisions of the rule are based on Our decision to propose major changes abide by the rules and requirements of sections 13562 and 13624 of OBRA ’93 to the existing conditions is based on the Organ Procurement and Transplant and section 152 of SSAA ’94. several considerations. Revising the Network. Section 1861(s)(2)(F) of the Timetable: ESRD requirements is part of HCFA’s Act describes ‘‘medical and other health services’’ covered under Action Date FR Cite effort to move toward a patient outcome-based system that focuses on Medicare to include home dialysis NPRM 01/09/98 63 FR 1659 quality assessment and performance supplies and equipment, self-care home NPRM Comment 05/11/98 improvement. We believe that revising dialysis support services, and Period End the conditions will encourage improved institutional dialysis services and Final Action 00/00/00 outcomes of care for beneficiaries. The supplies, and section 1862(a) of the Act Small Entities Affected: Businesses ESRD conditions for coverage have not specifies the exclusions from coverage. Government Levels Affected: State been comprehensively revised since Section 1869(e)(9) of the Act requires their inception in 1976. The existing hospitals to meet such other Additional Information: BPD-809 requirements emphasize the policies requirements as the Secretary finds Agency Contact: Joanne Sinsheimer, and procedures that must be in place necessary in the interest of health and Center for Health Plans and Providers, to support good patient care, and they safety of individuals who are furnished Department of Health and Human focus on a facility’s capacity to furnish services in the institution. Services, Health Care Financing care rather than on the actual provision Alternatives: In the past, HCFA has Administration, C4-11-23, 7500 of quality care to patients and the revised sections of the ESRD Security Blvd., Baltimore, MD 21244 outcomes of that care. regulations. However, we have Phone: 410 786-4620 During the 1980’s and early 1990’s determined that a complete and RIN: 0938–AG80 major changes took place in the thorough revision would be a more delivery of services to dialysis patients, effective mechanism for developing a and these advances are not reflected in 1070. END STAGE RENAL DISEASE comprehensive approach to quality care the existing requirements. Thus we (ESRD) CONDITIONS FOR COVERAGE for the dialysis patient. In addition, this have concluded that significant (HCFA-3818-P) approach provides greater potential for revisions to the conditions for coverage successful implementation. Another Priority: Other Significant for ESRD facilities are essential. The option is to update the current Reinventing Government: This regulation would have an emphasis on regulations and maintain the process- rulemaking is part of the Reinventing the patient’s total experience with oriented standards without focusing on Government effort. It will revise text in dialysis. The proposed changes, which patient outcome. However, for the the CFR to reduce burden or were undertaken in a collaborative reasons discussed, we believe it is duplication, or streamline effort with the renal community, reflect important to move forward with a requirements. improvements in standard care proposed regulation that is patient- practices, the use of more advanced Legal Authority: 42 USC 1395rr centered and intended to stimulate technology and equipment, and, most improvements in processes and CFR Citation: 42 CFR 400; 42 CFR 405; notably, the adoption of quantifiable outcomes of care. 42 CFR 406; 42 CFR 409; 42 CFR 410; performance measures that are viewed 42 CFR 412; 42 CFR 413; 42 CFR 414; in the renal community to be related, Anticipated Costs and Benefits: The 42 CFR 489; 42 CFR 492 at least in part, to the quality of care purpose of this proposed rule is to provided to dialysis patients. ensure that ESRD beneficiaries are Legal Deadline: None receiving quality care dialysis and Abstract: This proposed rule would Following publication of the proposed transplantation. We believe that revised revise the current conditions for rule, we will consult further with the regulations are necessary to ensure that coverage for end stage renal disease industry. all facilities are using the most effective (ESRD) facilities approved to provide Summary of the Legal Basis: Section technology and equipment. The ESRD service under Medicare. It would 1881(b)(1) of the Act authorizes the primary benefit of updating the update the conditions to reflect Secretary to prescribe health and safety conditions for coverage is the developments in technology and requirements (known as conditions for development of performance equipment, emphasize the total patient coverage) that a facility providing expectations for the facility that would experience and develop performance dialysis and transplantation services to result in the comprehensive, integrated expectations for the facility that result dialysis patients must meet to qualify care and outcomes the patient needs
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00317 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21992 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
and wants. As a result, the beneficiaries receiving Medicaid. It would also Agency Contact: Thomas Hoyer, would receive an improved quality of require States to enact a law under Center for Health Plans and Providers, care. The revised regulations would which the State is deemed to have Department of Health and Human also address the issue of adequacy of acquired a recipient’s right to payment Services, Health Care Financing dialysis, which would have a by a third party. Administration, C4-02-16, 7500 significant impact on ensuring that Timetable: Security Blvd., Baltimore, MD 21244 patients are not being under-dialysised. Phone: 410 786-4605 Action Date FR Cite Items that have the potential to affect RIN: 0938–AH16 the cost of the ESRD program include NPRM 04/00/98 data gathering, infection control, and Small Entities Affected: Businesses 1073. MEDICARE COVERAGE OF achieving the specified outcome ORGAN TRANSPLANTATION (HCFA- measure. However, at this time the cost Government Levels Affected: State, 3835-PN) or savings to the Medicare program Federal have not yet been established, but costs Additional Information: MB-080 Priority: Other Significant should not be significant. Agency Contact: Robert Nakielny, Legal Authority: 42 USC 1395y(a)(1)(A) Risks: If the ESRD conditions are not Center for Medicaid and State CFR Citation: None updated, our regulations will not reflect Operations, Department of Health and new developments in the industry, Human Services, Health Care Financing Legal Deadline: None thereby denying the improved Administration, C4-21-01, 7500 Abstract: This proposed notice would protections to patients’ health care that Security Blvd., Baltimore, MD 21244 announce changes in Medicare’s would result from this proposed rule. Phone: 410 786-4466 national coverage policy for organ Timetable: RIN: 0938–AH01 transplantations. Action Date FR Cite Timetable: NPRM 04/00/98 1072. DEFINITION OF SKILLED Action Date FR Cite NURSING FACILITY (SNF) FOR Small Entities Affected: Proposed Notice 04/00/98 Businesses, COVERAGE OF DURABLE MEDICAL Organizations EQUIPMENT (DME) (BPD-834-P) Small Entities Affected: Businesses Government Levels Affected: None Priority: Substantive, Nonsignificant Government Levels Affected: None Additional Information: HCFA-3818-P Legal Authority: 42 USC 1395x(n); 42 Additional Information: HCFA-3835-PN Agency Contact: Lynn Merritt-Nixon, USC 1395i-3(a)(1); 42 USC 1396r(a)(1) Agency Contact: Jacqueline Sheridan, Office of Clinical Standards and CFR Citation: 42 CFR 409; 42 CFR 410 Office of Clinical Standards and Quality, Department of Health and Quality, Department of Health and Legal Deadline: Human Services, Health Care Financing None Human Services, Health Care Financing Administration, C5-05-15, 7500 Abstract: This proposed rule would Administration, C5-05-27, 7500 Security Boulevard, Baltimore, MD define skilled nursing facilities (SNFs) Security Boulevard, Baltimore, MD 21244 under section 1819(A)(1) of the Social 21244 Phone: 410 786-4652 Security Act for purposes of Medicare Phone: 410 786-4653 RIN: 0938–AG82 coverage of durable medical equipment RIN: 0938–AH17 (DME) and home health services. A Medicare SNF (as defined under 1071. LIABILITY FOR THIRD PARTIES section 1819 of the Social Security Act) 1074. STATE PLAN AMENDMENT TO PAY FOR CARE AND SERVICES cannot be considered a home under (SPA) RECONSIDERATION PROCESS (MB-080-P) Medicare part B for DME and home (HCFA-2096-P) Priority: Other Significant health coverage. This proposed rule Priority: Substantive, Nonsignificant Legal Authority: 42 USC would presume that all Medicare Reinventing Government: This 1396a(a)(25)(A); 42 USC 1396b(o) nursing facilities are section 1819(A)(1) facilities and thus would not be rulemaking is part of the Reinventing CFR Citation: 42 CFR 433.135 to considered a Home for DME. This Government effort. It will revise text in 433.152 would define non-Medicare nursing the CFR to reduce burden or Legal Deadline: None homes as skilled facilities based upon duplication, or streamline requirements. Abstract: This rule would incorporate the receipt of skilled care by at least provisions of OBRA ’93 by amending once a week by a proportion of its Legal Authority: 42 USC 1316; 42 USC the regulations governing third party residents population. 1396a(a) liability. It would add ERISA plans, Timetable: CFR Citation: 42 CFR 430.18; 42 CFR service benefit plans, and health Action Date FR Cite 430.60 maintenance organizations to the definition of liable third parties. It NPRM 04/00/98 Legal Deadline: None would require States to prohibit any Small Entities Affected: Businesses Abstract: This proposed rule would health insurer from taking into account, revise and streamline the State Plan when enrolling or making payments, Government Levels Affected: None Amendment (SPA) reconsideration that an individual is eligible for or Additional Information: BPD-834 process. Currently, when a State
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
requests reconsideration of a denied Small Entities Affected: Businesses, Legal Deadline: None SPA, a hearing is held in all cases, even Organizations Abstract: A provider whose charges are when the only dispute is over the Government Levels Affected: None lower than its reasonable costs for those interpretation of the statute. Under the Additional Information: HCFA-3844 services in any cost reporting period proposed regulation, the State and beginning January 1, 1974, but before HCFA could avoid the cost and delay Agency Contact: Lynn Merritt-Nixon, April 28, 1988, may carry forward costs of the hearing process when the only Office of Standard & Quality, that are unreimbursed for two issue is interpretation of the statute by Department of Health and Human succeeding cost reporting periods. permitting the State expedited judicial Services, Health Care Financing Sufficient time has passed since the review, without a full administrative Administration, C5-05-15, 7500 publication of this provision to warrant hearing, after HCFA has a brief Security Blvd., Baltimore, MD 21244 the deletion from the regulation text of opportunity to reconsider its decision. Phone: 410 786-4652 any reference to the carryover Timetable: RIN: 0938–AH27 provision. Since payment for durable Action Date FR Cite medical equipment (DME) provided by home health agencies (HHAs) is no NPRM 04/00/98 1076. MEDICARE COVERAGE OF longer based on the lesser of the Small Entities Affected: Undetermined SERVICES OF SPEECH-LANGUAGE reasonable cost or reasonable charge PATHOLOGISTS AND AUDIOLOGISTS but rather on 80% of the lesser of the Government Levels Affected: (HCFA-1843-P) Undetermined actual charge for the item or the Priority: Substantive, Nonsignificant payment amount recognized under the Additional Information: HCFA-2096-P DME fee schedule and, for nominal Legal Authority: 42 USC 1302; 42 USC Agency Contact: Robert Tomlinson, charge HHAs, on 80% of the DME fee 1395x; 42 USC 1395x(cc)(1); 42 USC Center for Medicaid and State schedule amount, the lesser of costs or 1395x(ll) Operations, Department of Health and charges provision no longer applies and Human Services, Health Care Financing CFR Citation: 42 CFR 484; 42 CFR 485 should be deleted from the CFR. Administration, C4-20-21, 7500 Legal Deadline: None Timetable: Security Boulevard, Baltimore, MD 21244 Abstract: This proposed rule would Action Date FR Cite Phone: 410 786-4463 implement SSA ’94 provisions to NPRM 04/00/98 provide coverage for speech-language RIN: 0938–AH24 pathology services furnished by a Small Entities Affected: Undetermined qualified pathologist. Government Levels Affected: 1075. HOSPICE CAREÐCONDITIONS Timetable: Undetermined OF PARTICIPATION (HCFA-3844-P) Action Date FR Cite Additional Information: BPD-860 Priority: Other Significant Agency Contact: Ward Pleines, NPRM 06/00/98 Reinventing Government: This Chronic Care Purchasing Policy Group, rulemaking is part of the Reinventing Small Entities Affected: None Division of Cost Reporting, Department Government effort. It will revise text in Government Levels Affected: None of Health and Human Services, Health the CFR to reduce burden or Care Financing Administration, C5-02- Additional Information: BPD-843 duplication, or streamline 23, 7500 Security Boulevard, Baltimore, requirements. Agency Contact: Jackie Gordon, MD 21244 Legal Authority: 42 USC 1302; 42 USC Division of Cost Reporting, Department Phone: 410 786-4528 1395x(dd); 42 USC 1395hh of Health and Human Services, Health RIN: 0938–AH49 Care Financing Administration, C4-07- CFR Citation: 42 CFR 418 14, 7500 Security Boulevard, Baltimore, Legal Deadline: None MD 21244 1078. SUPPLIER PARTICIPATION AGREEMENTS AND LIMITS ON Abstract: Phone: 410 786-4517 This proposed rule would ACTUAL CHARGES OF RIN: revise the Medicare conditions of 0938–AH37 NONPARTICIPATING PHYSICIANS participation for hospices to help (HCFA-1862-P) ensure the provision of quality care 1077. PAYMENT AMOUNT IF through an emphasis on patient- Priority: Other Significant CUSTOMARY CHARGES ARE LESS centered outcomes. Areas of change THAN REASONABLE COSTS (HCFA- Reinventing Government: This would include, among others, 1860-FC) rulemaking is part of the Reinventing assessment of patient needs, Government effort. It will revise text in clarification of physician roles, Priority: Other Significant the CFR to reduce burden or coordination of care for hospice Reinventing Government: This duplication, or streamline patients residing in nursing homes, rulemaking is part of the Reinventing requirements. clarification of nursing roles, patient Government effort. It will eliminate Legal Authority: 42 USC 1302; 42 USC rights, and provision of services. existing text in the CFR. 1395u(h); 42 USC 1395hh; 42 USC Timetable: Legal Authority: 42 USC 1395f(b); 42 1395rr(b)(1) Action Date FR Cite USC 1395l(a); 42 USC 1395m(a) CFR Citation: 42 CFR 400; 42 CFR 414 NPRM 04/00/98 CFR Citation: 42 CFR 413.13 Legal Deadline: None
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00319 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21994 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
Abstract: The Deficit Reduction Act of FICA or other taxes that have accrued Phone: 410 786-4461 1984 established a voluntary up to the end of the reporting period RIN: 0938–AH63 participation program for physicians will be treated as allowable costs in the and suppliers under which physicians current reporting period. and suppliers enter into an agreement Timetable: 1081. PROVIDER AND SUPPLIER with Medicare that binds them to BILLING WHEN MEDICARE IS accept payment on an assignment- Action Date FR Cite SECONDARY PAYOR TO LIABILITY related basis for all services they NPRM 04/00/98 INSURANCE (HCFA-1848-P) furnish to Medicare beneficiaries. This Small Entities Affected: Businesses Priority: Other Significant proposed rule would set forth the terms and conditions of the participation Government Levels Affected: None Reinventing Government: This rulemaking is part of the Reinventing agreements. This proposed rule would Additional Information: HCFA-1876-P reflect provisions of OBRA ’93 as to Government effort. It will revise text in the suppliers subject to the charge Agency Contact: John Eppinger, Center the CFR to reduce burden or limits, and provisions of SSA ’94 as for Health Plans and Providers, duplication, or streamline to administrative procedures for Department of Health and Human requirements. Services, Health Care Financing enforcing the charge limits. This Legal Authority: Administration, C5-03-18, 7500 42 USC 1302; 42 USC rulemaking will revise text in the CFR 1395cc; 42 USC 1395dd; 42 USC to reduce burden or duplication, or Security Boulevard, Baltimore, MD 21244 1395hh; 42 USC 1395ww; 42 USC streamline requirements. It will give 1395x; 42 USC 1395aa beneficiaries the opportunity to make Phone: 410 786-4518 informed consumer decisions regarding RIN: 0938–AH61 CFR Citation: 42 CFR part 411; 42 CFR the choice of Medicare Part B services. part 489 Legal Deadline: None Timetable: 1080. MEDICAID; ESTATE Action Date FR Cite RECOVERIES (HCFA-2083-P) Abstract: This proposed rule would revise current regulations to require Priority: Substantive, Nonsignificant NPRM 08/00/98 that providers and suppliers attempt to Small Entities Affected: Businesses Legal Authority: 42 USC 1396a; 42 collect payment from the proceeds of USC 1396p Government Levels Affected: None liability insurance during the CFR Citation: 42 CFR 433.36 ‘‘promptly period.’’ This rule would Additional Information: BPD-862 also permit providers and suppliers to Legal Deadline: None Agency Contact: Anita Heygster, choose either to pursue collection of Center for Health Plans & Providers, Abstract: This proposed rule is being payment from the proceeds of liability Department of Health and Human developed as a result of the OBRA 1993 insurance after the ‘‘promptly period’’ Services, Health Care Financing provisions that mandated States to seek has ended or to bill Medicare. Administration, C4-04-27, 7500 adjustment or recovery from the estates Timetable: Security Boulevard, Baltimore, MD of Medicaid beneficiaries for amounts 21244 correctly spent by Medicaid on Action Date FR Cite Phone: 410 786-4486 permanently institutionalized NPRM 09/00/98 RIN: 0938–AH50 individuals (any age) and individuals age 55 or older for certain services. The Small Entities Affected: Businesses OBRA 1993 provision also defines Government Levels Affected: None 1079. REVISION TO ACCRUAL BASIS ‘‘estate,’’ and further requires States to Additional Information: BPD-848 OF ACCOUNTING POLICY (HCFA- establish hardship procedures, in 1876-P) accordance with standards specified by Agency Contact: Anita Heygster, Priority: Substantive, Nonsignificant the Secretary for waiver of recovery in Center for Health Plans and Providers, cases where undue hardship would Department of Health and Human Legal Authority: 42 USC 1395x(v); 42 result. Services, Health Care Financing USC 1302; 42 USC 1395hh Timetable: Administration, C4-08-25, 7500 CFR Citation: 42 CFR 413.100 Security Boulevard, Baltimore, MD Action Date FR Cite Legal Deadline: None 21244 NPRM 04/00/98 Phone: 410 786-4486 Abstract: The proposed rule would specify the providers’ share of the costs Small Entities Affected: Undetermined RIN: 0938–AH66 of FICA and other employee payroll Government Levels Affected: State taxes that will be allowable under 1082. MEDICARE TECHNICAL Additional Information: HCFA-2083-P Medicare when the payroll period ends CONFORMING AMENDMENTS (HCFA- subsequent to the end of the reporting Agency Contact: Ingrid Osborne, 1858-FC) period. The proposed rule would Center for Medicaid and State Priority: provide that if payment would be made Operations, Department of Health and Substantive, Nonsignificant to an employee during a lost reporting Human Services, Health Care Financing Reinventing Government: This period but for the fact that the regularly Administration, C4-22-06, 7500 rulemaking is part of the Reinventing scheduled payment date is after the end Security Boulevard, Baltimore, MD Government effort. It will revise text in of the period, that portion of employees 21244 the CFR to reduce burden or
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
duplication, or streamline Timetable: Administration, S2-19-14, 7500 requirements. Action Date FR Cite Security Boulevard, Baltimore, MD 21244 Legal Authority: 42 USC 1302; 42 USC NPRM 09/00/98 1395k Phone: 410 786-6780 Small Entities Affected: Businesses RIN: 0938–AH69 CFR Citation: 42 CFR 409.50; 42 CFR 409.61; 42 CFR 410.152 Government Levels Affected: None Legal Deadline: None Additional Information: HSQ-235-FC 1085. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES Agency Contact: Bill Roskey, Office of Abstract: This final rule with comment AND THE LIST OF COVERED Clinical Standards and Quality, period will update our regulations to SURGICAL PROCEDURES FOR Department of Health and Human reflect that payment for durable AMBULATORY SURGICAL CENTERS Services, Health Care Financing medical equipment is on the basis of EFFECTIVE FOR CALENDAR YEAR Administration, S1-09-18, 7500 a fee schedule. 1998 (HCFA-1885-P) Security Boulevard, Baltimore, MD Timetable: 21244 Priority: Economically Significant. Action Date FR Cite Phone: 410 786-0433 Major under 5 USC 801. NPRM 10/00/98 RIN: 0938–AH68 Legal Authority: 42 USC 13951(i)(2)(A) Small Entities Affected: None CFR Citation: 42 CFR 416.61(b); 42 1084. DETERMINATION OF CFR 416.65(a)(4); 42 CFR 416.65(c); 42 Government Levels Affected: None SUBSTANDARD CARE IN SNFS AND CFR 416.120(c)(1); 42 CFR 416.125; 42 Additional Information: BPD-858 NFS (HCFA-2240-P) CFR 416.130; 42 CFR 416.140(a); 42 CFR 416.140(b) Agency Contact: Martha Kuespert, Priority: Substantive, Nonsignificant Center for Health Plans and Providers, Legal Deadline: None Legal Authority: 42 USC 1395i-3; 42 Department of Health and Human USC 1396r Abstract: This proposed rule discusses Services, Health Care Financing several policy changes affecting Administration, C4-02-16, 7500 CFR Citation: 42 CFR 488.301 coverage of and payment for Security Boulevard, Baltimore, MD Legal Deadline: None Ambulatory Surgical Center (ASC) 21244 facility services as provided under Abstract: This proposed rule would Phone: 410 786-4605 sections 1833(i)(1A) and (2A) of the revise the definition of ‘‘substandard Social Security Act. It would include RIN: 0938–AH67 quality of care’’ as it applies to skilled the criteria for identifying procedures nursing facilities, in the Medicare that are appropriate and safely program, and nursing facilities, in the 1083. ELIMINATION OF CERTAIN performed in an ASC; the method used Medicaid program. ‘‘Substandard REQUIREMENTS FOR PEER REVIEW to set ASC payment rates; and the quality of care’’ is one type of ORGANIZATIONS IN THE UTILIZATION schedule for publishing and noncompliance with Federal AND QUALITY REVIEW PROCESS implementing payment and coverage participation requirements that carries AND A CHANGE IN THE LENGTH OF updates. PEER REVIEW ORGANIZATION with it statutory consequences to CONTRACTS (HCFA-3235-FC) facilities providing such care. The Timetable: purpose of this proposed revision is to Action Date FR Cite Priority: Substantive, Nonsignificant improve the definition of substandard NPRM 04/00/98 Reinventing Government: This quality of care so that the process can rulemaking is part of the Reinventing make a more meaningful distinction Small Entities Affected: Businesses Government effort. It will revise text in between facility noncompliance that Government Levels Affected: None the CFR to reduce burden or warrants the consequences mandated duplication, or streamline by the statute for a finding of Additional Information: BPD-885-P requirements. substandard quality of care and Agency Contact: Joan Sanow, Center noncompliance that does not. Legal Authority: 42 USC 1302; 42 USC for Health Plans and Providers, 1395hh Timetable: Department of Health and Human Services, Health Care Financing CFR Citation: 42 CFR 462.107; 42 CFR Action Date FR Cite Administration, 7500 Security Blvd., 466.71; 42 CFR 466.73 NPRM 04/00/98 Baltimore, MD 21244 Phone: 410 786-5723 Legal Deadline: None Small Entities Affected: Businesses, Abstract: This proposed rule would Organizations RIN: 0938–AH81 eliminate the requirement that Peer Government Levels Affected: State, Review Organizations (PROs) conduct Local, Federal 1086. REVISIONS TO CONDITIONS quarterly random sample reviews of Additional Information: HSQ-240 FOR COVERAGE FOR AMBULATORY hospital discharges. It would also SURGICAL CENTERS (HCFA-3887-P) change the period for PRO contracts Agency Contact: Pat Miller, Center for from 2 years to 3 years and would Medicaid and State Operations, Priority: Other Significant eliminate certain notification Department of Health and Human Legal Authority: 42 USC 1302; 42 USC requirements regarding contract awards. Services, Health Care Financing 1395hh
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00321 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 21996 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
CFR Citation: 42 CFR 416 that do not meet professionally 1089. NATIONAL STANDARD FOR Legal Deadline: None recognized standards of health care and IDENTIFIERS OF HEALTH PLANS inform each beneficiary of the final (HCFA-4145-P) Abstract: This proposed rule would disposition of his or her complaint. revise the ambulatory surgical center Priority: Other Significant. Major under conditions for coverage to reflect Timetable: 5 USC 801. current innovations in healthcare Action Date FR Cite Legal Authority: 42 USC 1320d-2 delivery, quality assessment, and NPRM 04/00/98 CFR Citation: 45 CFR 142 performance improvement. The focus would be to improve outcomes of Small Entities Affected: Businesses Legal Deadline: Final, Statutory, health care and satisfaction for Government Levels Affected: None February 21, 1998. Medicare beneficiaries, while Agency Contact: William Roskey, Abstract: This rule would implement streamlining structural and procedural a standard identifier to identify health requirements where possible. Center for Medicaid and State Operations, Department of Health and plans that process and pay certain Timetable: Human Services, Health Care Financing electronic health care transactions. It would implement one of the Action Date FR Cite Administration, 7500 Security Blvd, S1- 09-07, Baltimore, MD 21244 requirements for administrative NPRM 04/00/98 Phone: 410 786-0433 simplification in section 262 of the Small Entities Affected: Businesses Health Insurance Portability and RIN: 0938–AH85 Accountability Act of 1996. Government Levels Affected: None Timetable: Additional Information: BPD-887 1088. MEDICARE PROGRAM; Action Date FR Cite Agency Contact: Judy Goldfarb, Office BENEFICIARY INCENTIVES of Clinical Standards & Quality, PROGRAMS (HCFA-6144-P) NPRM 05/00/98 Department of Health and Human Priority: Other Significant Small Entities Affected: Undetermined Services, Health Care Financing Administration, 7500 Security Blvd, S2- Legal Authority: PL 104-191, sec 203 Government Levels Affected: 199.06, Baltiore, MD 21244 CFR Citation: 42 CFR 420.400; 42 CFR Undetermined Phone: 410 786-6747 420.405; 42 CFR 420.410 Additional Information: BPO-145 RIN: 0938–AH83 Legal Deadline: Final, Statutory, Agency Contact: Faye Broseker, Center October 21, 1996. for Beneficiary Services, Department of Health and Human Services, Health 1087. DISCLOSURE OF PEER REVIEW Abstract: This proposed rule would Care Financing Administration, S3-04- ORGANIZATION INFORMATION IN establish a program for payment to 05, 7500 Security Blvd., Baltimore, MD RESPONSE TO BENEFICIARY individuals who provide information 21244 COMPLAINTS (HCFA-3241-P) on Medicare fraud and abuse. It would also establish a program to collect Phone: 410 786-3342 Priority: Other Significant suggestions to improve Medicare RIN: 0938–AH87 Legal Authority: 42 USC 1302; 42 USC program efficiency and allow for 1395hh payment to the individuals who 1090. MEDICAID PROGRAM; CFR Citation: 42 CFR 466.70(a); 42 provide the suggestions. Overall, it would implement sections 203(b) and AMENDMENT TO THE PREADMISSION CFR 476.101; 42 CFR 476.107; 42 CFR SCREENING AND ANNUAL RESIDENT 476.132; 42 CFR 476.133(b)(4) 203(c) of the Health Insurance Portability and Accountability Act of REVIEW PROGRAM (HCFA-2107-P) Legal Deadline: None 1996. Priority: Substantive, Nonsignificant Abstract: This proposed rule would Timetable: Reinventing Government: This change our policy regarding the Action Date FR Cite rulemaking is part of the Reinventing disclosure of peer review organization Government effort. It will revise text in (PRO) information in responding to NPRM 06/00/98 the CFR to reduce burden or beneficiary complaints about Small Entities Affected: Undetermined duplication, or streamline physicians, other practitioners, and requirements. other institutional and non-institutional Government Levels Affected: providers of health care, including Undetermined Legal Authority: 42 USC 1396r(e); 42 Health Maintenance Organizations and Additional Information: BPO-144-P USC 1396r(b) Competitive Medical Plans. Under the CFR Citation: Agency Contact: Delilah Schmitt, 42 CFR 405; 42 CFR 431; proposal, we would permit the 42 CFR 433; 42 CFR 441; 42 CFR 483 disclosure of PRO information about Program Integrity Group, Office of physicians and other individual Financial Management, Department of Legal Deadline: None practitioners without their permission Health and Human Services, Health Abstract: This proposed rule would to the extent necessary to comply with Care Financing Administration, 7500 make changes to the preadmission section 1154(a)(14) of the Social Security Blvd, S3-08-05, Baltimore, MD screening and annual resident review Security Act. This section requires 21244 program in accordance with the PROs to conduct reviews of beneficiary Phone: 410 786-4300 provisions of Public Law 104-315, complaints about the quality of services RIN: 0938–AH86 which were included in the
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
Reinventing Government effort. The Additional Information: MB-43 standardized provider identifier. It rule would repeal the Medicaid Agency Contact: David Worgo, Center would implement one of the program requirement for an annual for Medicaid and State Operations, requirements for administrative review of nursing facility (NF) residents Department of Health and Human simplification in section 262 of the with mental illness or mental Services, Health Care Financing Health Insurance Portability and retardation. This proposed rule also Administration, 7500 Security Blvd, Accountability Act of 1996. A standard would add the requirement for NFs to C4-15-18, Baltimore, MD 21244 provider identifier would save the notify the State when there is a Phone: 410 786-5919 health insurance industry significant significant change in the physical or costs incurred in maintaining multiple mental condition of a resident and add RIN: 0938–AH95 identifier systems. a statutory requirement that the State Timetable: conduct a review promptly after 1092. MEDICARE COVERAGE OF notification of the resident’s change in CERTIFIED NURSE-MIDWIFE Action Date FR Cite condition. SERVICES (HCFA-1496-P) NPRM 04/00/98 Timetable: Priority: Substantive, Nonsignificant Small Entities Affected: Undetermined Action Date FR Cite Legal Authority: 42 USC 1395x(s); 42 Government Levels Affected: NPRM 10/00/98 USC 1395x(gg) Undetermined Small Entities Affected: Businesses, CFR Citation: 42 CFR 405.2411; 42 CFR Additional Information: HCFA-0045-P Governmental Jurisdictions 405.2414; 42 CFR 405.2415; 42 CFR 410.10; 42 CFR 410.77 Agency Contact: Karen Trudel, Office Government Levels Affected: State of Information Services, Department of Additional Information: HCFA-2107-P Legal Deadline: None Health and Human Services, Health Agency Contact: Jan Earle, Center for Abstract: This proposed rule would Care Financing Administration, 7500 Medicaid and State Operations, implement section 4073 of OBRA 1987 Security Blvd., N3-06-13, Baltimore, Department of Health and Human by amending Medicare regulations to MD 212244 Services, Health Care Financing reflect part B coverage of the services Phone: 410 786-9937 Administration, 7500 Security Blvd, of certified nurse-midwives furnished RIN: 0938–AH99 C4-12-23, Baltimore, MD 21244 without the supervision of a physician. Phone: 410 786-3326 It would define ‘‘certified nurse- Fax: 410 786-3262 midwife’’ and ‘‘certified nurse-midwife 1094. MEDICARE PROGRAM; services.’’ IMPROVEMENTS TO THE APPEALS RIN: 0938–AH89 Timetable: PROCESS FOR MEDICARE BENEFICIARIES ENROLLED IN HMOS, 1091. MEDICAID PROGRAM; Action Date FR Cite CMPS, AND HCPPS (HCFA-4024-P) COVERAGE AND PAYMENT FOR NPRM 04/00/98 Priority: Other Significant FEDERALLY QUALIFIED HEALTH Small Entities Affected: CENTER SERVICES (HCFA-2043-P) None Legal Authority: 42 USC 1395mm(c)(5) Government Levels Affected: None Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 417 Additional Information: BPD-496-P Legal Authority: 42 USC 1396a(a)(13); Legal Deadline: None 42 USC 1396d(a) Agency Contact: Roberta Epps, Center Abstract: This proposed rule would for Health Plans and Providers, CFR Citation: 42 CFR 431; 42 CFR 440; establish new administrative review Division of Practitioner & Ambulatory 42 CFR 441; 42 CFR 447 requirements for Medicare beneficiaries Care, Department of Health and Human enrolled in health maintenance Legal Deadline: None Services, Health Care Financing organizations (HMOs), competitive Abstract: This proposed rule would Administration, 7500 Security Blvd, medical plans (CMPs), and health care incorporate and interpret in regulations C4-0516, Baltimore, MD 21244 prepayment plans. This rule would coverage and payment requirements for Phone: 410 786-4475 implement section 1876(c)(5) of the services furnished by a federally RIN: 0938–AH96 Social Security Act, which specifies the qualified health center (FQHC) under appeal and grievance rights of Medicare the Medicaid program. This rule will include changes in the payment 1093. NATIONAL STANDARD HEALTH enrollees in HMOs and CMPs. This rule provisions to FQHCS made by section CARE PROVIDER IDENTIFIER (HCFA- would reduce time lines for nonurgent 4712 of the Balanced Budget Act of 0045-P) denials of care and make other 1997 PL-105-33. improvements. We will also address Priority: Other Significant. Major under related requirements of the Balanced Timetable: 5 USC 801. Budget Act of 1997. Action Date FR Cite Legal Authority: 42 USC 1320d-2 Timetable: NPRM 04/00/98 CFR Citation: 45 CFR 142 Action Date FR Cite Small Entities Affected: Businesses, Legal Deadline: Final, Statutory, NPRM 04/00/98 Governmental Jurisdictions February 21, 1998. Small Entities Affected: Government Levels Affected: State, Abstract: This rule would address the None Tribal health care industry’s need for a Government Levels Affected: None
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
Agency Contact: Cheryl Slay, Director, necessary changes arising from our 1097. CHILDREN'S HEALTH Division of Beneficiary Protections, continuing experience with the INSURANCE: PROGRAM Department of Health and Human systems. IMPLEMENTATIONS; STATE PLAN Services, Health Care Financing APPROVAL; STATE PAYMENT; Administration, 7500 Security Blvd., Statement of Need: Section 1886(e)(5) COORDINATION WITH STATE Baltimore, MD 21244 of the Social Security Act, as amended MEDICAID PROGRAM (HCFA-2006-P) by section 4644(a)(1) and (b)(1) of the Phone: 410 786-6478 Priority: Economically Significant Balanced Budget Act of 1997, requires RIN: 0938–AI11 the Secretary to publish a proposed Legal Authority: PL 105-33, sec 4901 rule on prospective payment system to 4913 1095. NEWBORNS' AND MOTHERS' policies and payment rates in the CFR Citation: 42 CFR ch IV HEALTH PROTECTION Federal Register by April 1 and a final Legal Deadline: None Priority: rule by August 1. Substantive, Nonsignificant Abstract: Several proposed rules will Legal Authority: 42 USC 100 Summary of the Legal Basis: As noted include regulations for States on the CFR Citation: 45 CFR 300 above, publication of proposed and implementation of the new State final rules concerning hospital Children’s Health Insurance Program Legal Deadline: None prospective payment system policies (CHIP) under title XXI of the Social Abstract: This needs information. and payment rates is required by law. Security Act and corresponding Timetable: The statute sets forth several specific changes to title XIX (Medicaid). The requirements concerning what must be CHIP program was established to Action Date FR Cite included in the prospective payment provide Federal funding to help States NPRM 04/00/98 system proposed and final rules. (See to initiate and expand child health assistance to uninsured, low-income sections 1886(b)(3)(B), 1886(d)(1)(A), Small Entities Affected: None children. The regulations will address 1886(d)(2)(H), 1886(d)(3)(A), Government Levels Affected: None a variety of aspects of CHIP, including 1886(d)(3)(E), 1886(d)(4)(C), 1886(e)(5), but not limited to the procedure for Agency Contact: Ann White, and 1886(G)(1)(A).) approving state child health plans, Regulations Coordinator, Department of policies on the issuance of grants and Health and Human Services, Health Alternatives: Publication of these rules the distribution of payments to States Care Financing Administration, 200 is not discretionary. Thus, no with approved plans and the Indepedendence Avenue, Washington, alternatives exits. coordination of a State’s approved child DC 20201 health plan with its Medicaid program. Phone: 202 690-6824 Anticipated Costs and Benefits: Estimates of the economic impact that The following changes related to title RIN: 0938–AI13 will stem from these rules have not yet XIX will be included among the been completed. regulations: (1) the Medicaid option for 1096. CHANGES TO THE HOSPITAL targeted low-income children; (2) Risks: INPATIENT PROSPECTIVE PAYMENT Not applicable. Medicaid optional presumptive eligibility for children; and (3) the SYSTEMS AND FISCAL YEAR 1999 Timetable: RATES (HCFA-1003-P) Medicaid option to accelerate phase in Action Date FR Cite of poverty level group for children up Priority: Other Significant. Major under to 19. The regulations will also 5 USC 801. NPRM 04/00/98 establish financial rules that would Legal Authority: 42 USC 1395ww Final Action 08/00/98 apply to the treatment of various program expenditures. CFR Citation: 42 CFR 412; 42 CFR 413 Small Entities Affected: Businesses, Organizations Statement of Need: The new title XXI Legal Deadline: NPRM, Statutory, April statutory authority implement and 1, 1998. Final, Statutory, August 1, Government Levels Affected: Federal interpret necessitates the promulgation 1998. of regulations to complement the Abstract: Medicare pays for hospital Additional Information: HCFA-1003 statute. Title XXI allows for States to inpatient services under a prospective Agency Contact: Tzvi Hefter, Director, submit state plans and, if approved, payment system (PPS) in which Division of Acute Care, Center for receive Federal matching funds each payment is made at a predetermined Health Plans and Providers, Department year up to the specified allotments for specific rate for the operating and use by the States in the provision of of Health and Human Services, Health capital-related costs associated with insurance coverage and other child Care Financing Administration, 7500 each discharge. These rules would health assistance for targeted low- Security Boulevard, C5-08-27, announce the prospective payment income children for periods beginning rates for operating and capital-related Baltimore, MD 21244 October 1, 1997. The Department of costs for FY 1999 that reflect changes Phone: 410 786-4487 Health and Human Services must issue made by the Balanced Budget Act of RIN: 0938–AI22 regulations on a timely basis in order 1997. We would also revise the for States to carry out the provisions Medicare hospital inpatient prospective of the statute to comply with plan payment systems for operating and approval requirements, requirements capital-related costs to implement for State payment and requirements for
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN AdministrationProposed SERVICES Rule (HCFA)(HHS) Stage HHSÐHCFA Proposed Rule Stage
coordination of the child health plan Agency Contact: Rick Fenton, Center Phone: 410 786-6165 with the State’s Medicaid program. for Medical and State Operations, Email: [email protected] Absent such regulatory guidance, there Department of Health and Human is the potential that the intent of the Services, Health Care Financing RIN: 0938–AI58 legislation to provide health coverage Administration, 7500 Security for low-income, uninsured children Boulevard, Baltimore, MD 21244 1099. ∑ NATIONAL STANDARD will not be realized. Phone: 410 786-5920 EMPLOYER IDENTIFIER (HCFA-0047- Summary of the Legal Basis: Title XXI RIN: 0938–AI28 P) of the Social Security Act constitutes budget authority in advance of Priority: Other Significant. Major under appropriations (section 2101(c)) and 1098. ∑ STANDARDS FOR 5 USC 801. ELECTRONIC TRANSACTIONS (HCFA- represents the obligation of the Federal Legal Authority: 42 USC 1320d-2 Government to provide for the payment 0149-P) to States of amounts provided under Priority: Other Significant. Major under CFR Citation: 45 CFR 142 subpart A; section 2104 of the Act. 5 USC 801. 45 CFR 142 subpart F Alternatives: This is a new program for Legal Authority: 42 USC 1320d Legal Deadline: Final, Statutory, Federal oversight and is optional for CFR Citation: 45 CFR 142 subpart A; February 21, 1998. States. Once States elect the option to 45 CFR 142 subparts J-R establish a CHIP program under title Abstract: This rule proposes the XXI, there are no alternatives to Legal Deadline: Final, Statutory, April employer identification number as the providing Federal funding under 1998. standard for identifying employers for approved State child health plans for Abstract: The rule proposes code set purposes of administrative approved program expenditures. standards and standards for 8 electronic simplification, as required by the Anticipated Costs and Benefits: transactions to be used by health plans, Health Insurance Portability and Section 2104 of the Social Security Act certain health care providers, and Accountability Act of 1996. Use of one specifies the following Federal funding health care clearing houses. It would standard in the health care industry allotment amounts that are to be implement requirements for would reduce the cost of identifying provided to States and Territories: administrative simplification in section employers in electronic health care $4.275 billion each for FY 1998, FY 262 of the Health Insurance Portability transactions. 1999, FY 2000, and FY 2001; $3.150 and Accountability Act of 1996. The billion for FY 2002, FY 2003, and FY standards would significantly reduce Timetable: 2004; $4.050 billion for FY 2005 and costs for processing health care Action Date FR Cite transactions. FY 2006; and $5 billion for FY 2007. NPRM 06/00/98 Benefits: More low-income children Timetable: will receive needed health coverage. Small Entities Affected: Undetermined Action Date FR Cite Risks: Unknown at this time. NPRM 04/00/98 Government Levels Affected: Timetable: Undetermined Small Entities Affected: Allotments and State Payment Policies Undetermined NPRM 04/00/98 Government Levels Affected: Agency Contact: Mary Emerson, Office Other CHIP Activities Undetermined of Information Services, Department of NPRM 04/00/98 Health and Human Services, Health Agency Contact: Barbara Redding, Small Entities Affected: Businesses, Care Financing Administration, 7500 Office of Information Services, Security Blvd, Baltimore, MD 21228 Governmental Jurisdictions, Department of Health and Human Organizations Phone: 410 786-7065 Services, Health Care Financing Email: [email protected] Government Levels Affected: State, Administration, S1-03-27, 7500 Local, Federal Security Blvd, Baltimore, MD 21228 RIN: 0938–AI59
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Health Care Financing Administration (HCFA) FinalHHS—HCFA Rule Stage
1100. DEDUCTION OF INCURRED Legal Deadline: None family to become Medicaid eligible. MEDICAL EXPENSES (SPENDDOWN) The revisions permit States greater (HCFA-2020-F) Abstract: This final rule amends and flexibility by offering options that will responds to comments on a final rule Priority: Substantive, Nonsignificant allow them to simplify the with comment period published in the administration of their Medicaid Unfunded Mandates: This action may Federal Register on January 12, 1994. programs. affect State, local or tribal governments. That rule permits States flexibility to revise the process by which incurred Timetable: Legal Authority: 42 USC 1302 medical expenses are considered to Action Date FR Cite CFR Citation: 42 CFR 435.831; 42 CFR reduce an individual’s or a family’s 436.831 income in order for the individual or NPRM 09/02/83 48 FR 39959
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Action Date FR Cite Additional Information: BPD-309 Action Date FR Cite NPRM Comment 11/16/83 Agency Contact: Charles Spalding, Comment Period End 08/22/94 Period End Center for Medicaid and State Final Action 04/00/98 Final Rule With 01/12/94 59 FR 1659 Operations, Department of Health and Small Entities Affected: Businesses Comment Period Human Services, Health Care Financing Interim Final Rule 03/04/94 59 FR 1659 Administration, 7500 Security Blvd., Government Levels Affected: None Comment Period End 03/14/94 Baltimore, MD 21244 Additional Information: BPD-393 Effective Date 03/14/94 Phone: 410 786-4496 Final Action 04/00/98 Agency Contact: Tzvi Hefter, Center RIN: 0938–AB50 for Health Plans and providers, Small Entities Affected: None Department of Health and Human Government Levels Affected: None 1102. PARTICIPATION IN CHAMPUS Services, Health Care Financing Additional Information: HCFA-2020 AND CHAMPVA, HOSPITAL Administration, C5-08-27, 7500 ADMISSIONS FOR VETERANS, Security Blvd., Baltimore, MD 21244 Agency Contact: Jackie Wilder, Center Phone: 410 786-1304 for Medicaid and State Operations, DISCHARGE RIGHTS NOTICE, AND Department of Health and Human HOSPITAL RESPONSIBILITY FOR RIN: 0938–AC58 Services, Health Care Financing EMERGENCY CARE (HCFA-1393-IFC) Administration, C4-23-07, 7500 Priority: Other Significant 1103. MEDICARE SECONDARY PAYER Security Boulevard, Baltimore, MD Legal Authority: 42 USC 1395x; 42 FOR DISABLED INDIVIDUALS (HCFA- 21244 USC 1395cc; 42 USC 1395dd 1482-F) Phone: 410 786-4579 CFR Citation: 42 CFR 488.18; 42 CFR Priority: Substantive, Nonsignificant RIN: 0938–AB07 489.20; 42 CFR 489.24; 42 CFR 489.25; Reinventing Government: This 42 CFR 489.26; 42 CFR 489.27; 42 CFR rulemaking is part of the Reinventing 1101. PAYMENT FOR CLINICAL 489.53; 42 CFR 1003 Government effort. It will revise text in DIAGNOSTIC LABORATORY TESTS Legal Deadline: None the CFR to reduce burden or (HCFA-1309-F) duplication, or streamline Abstract: This final rule will require requirements. Priority: Substantive, Nonsignificant Medicare participating hospitals with Legal Authority: 42 USC 1302; 42 USC emergency departments to provide Legal Authority: 42 USC 1395y(b); 44 1395f(b); 42 USC 1395g; 42 USC 1395k; upon request medical examinations and USC 3501 to 3511 42 USC 1395l; 42 USC 1395x; 42 USC treatments for individuals with CFR Citation: 42 CFR 400; 42 CFR 411 1395hh; 42 USC 1395rr; 42 USC 1395tt; emergency medical conditions and Legal Deadline: None 42 USC 1395ww; 42 USC 1396b women in labor. A participating Abstract: This rule will codify in the CFR Citation: 42 CFR 405; 42 CFR 413; hospital that has specialized capabilities or facilities (such as burn, CFR the Medicare secondary payer 42 CFR 414; 42 CFR 424; 42 CFR 431; (MSP) provision, under the Social 42 CFR 447 shock trauma, or neonatal intensive care units) must accept an appropriate Security Act, for disabled individuals Legal Deadline: None transfer if they have the capacity to who are covered under large group Abstract: This rule will incorporate treat the individual. Hospitals failing to health plans (LGHPs). Under this provisions of the Deficit Reduction Act meet those requirements may have their provision LGHPs may not take into of 1984, COBRA ’85, OBRA ’86, OBRA Medicare provider agreements account that such individuals are ’87, TMRA ’88, OBRA ’89, and OBRA terminated, and hospitals and entitled to Medicare. The rule contains ’90 regarding payment and responsible physicians may be subject procedures under which a plan can ‘‘assignment’’ for diagnostic clinical to civil money penalties. Under section appeal a determination of laboratory tests establishing in 9122 of COBRA ’85, Medicare nonconformance which could lead to regulations the methods for participating hospitals are required to an excise tax. It reflects statutory implementing fee schedules. This rule accept CHAMPUS and CHAMPVA revisions mandated by OBRA ’86, will set forth the methods by which payment as payment in full for services OBRA ’89, and OBRA ’93, some of the fee schedules will be updated and provided to CHAMPUS and CHAMPVA which also affect the MSP provisions will allow certain adjustments for beneficiaries. These regulations also for persons who are entitled on the exceptions to the fee schedule. It will implement section 9305(b) of OBRA basis of age or end-stage renal disease. also reflect a statutory revision ’86, which requires Medicare hospitals Timetable: mandated by OBRA ’93. to give patients a notice of their Action Date FR Cite Timetable: discharge rights. Timetable: NPRM 03/08/90 55 FR 8491 Action Date FR Cite Comment Period End 10/30/92 NPRM 08/18/93 58 FR 43156 Action Date FR Cite Final Rule 08/31/95 60 FR 45344 NPRM Comment 10/18/93 NPRM 06/16/88 53 FR 22513 Effective Date 10/02/95 Period End NPRM Comment 08/15/88 Final Action 10/00/98 Final Action 09/00/98 Period End Small Entities Affected: None Small Entities Affected: None Final Rule With 06/22/94 59 FR 32086 Comment Period Government Levels Affected: None Government Levels Affected: None Effective Date 07/22/94 Additional Information: BPD-482
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Agency Contact: Herbert Pollock, 1105. COVERAGE OF SCREENING Action Date FR Cite Center for Health Plans and Providers, PAP SMEARS (BPD-705-F) NPRM Comment 12/14/93 Division of Integrated Services, Priority: Other Significant Period End Department of Health and Human Final Action 04/00/98 Services, Health Care Financing Legal Authority: 42 USC 1302; 42 USC Administration, C4-08-14, 7500 1395hh Small Entities Affected: None Security Blvd., Baltimore, MD 21244 CFR Citation: 42 CFR 410.10; 42 CFR Government Levels Affected: State, Phone: 410 786-4474 410.32; 42 CFR 410.56; 42 CFR 411.15 Local RIN: 0938–AD73 Legal Deadline: None Additional Information: HCFA-2027-F Abstract: This rule establishes Agency Contact: Pat Helphenstine, 1104. OMNIBUS NURSING HOME regulations under section 6115 of Disabled & Elderly Health Program REFORM REQUIREMENTS (HCFA- OBRA ’89 to govern Medicare part B Group, Center for Medicaid and State 3488-F) coverage of screening pap smears Operations, Department of Health and (including a physician’s interpretation Priority: Other Significant. Major under Human Services, Health Care Financing of the test results) provided to a woman 5 USC 801. Administration, C4-13-13, 7500 for the early detection of cervical Security Blvd., Baltimore, MD 21244 Reinventing Government: This cancer. Phone: 410 786-5900 rulemaking is part of the Reinventing Timetable: Government effort. It will revise text in RIN: 0938–AF07 the CFR to reduce burden or Action Date FR Cite duplication, or streamline NPRM 11/26/93 58 FR 62312 1107. MEDICAID PAYMENT FOR requirements. NPRM Comment 01/24/94 COVERED OUTPATIENT DRUGS Legal Authority: 42 USC 1395i-3; 42 Period End UNDER REBATE AGREEMENTS USC 1395x; 42 USC 1396r; 42 USC Final Action 04/00/98 (HCFA-2046-FC) 1302 Small Entities Affected: None Priority: Other Significant CFR Citation: 42 CFR 431; 42 CFR 482; Government Levels Affected: None Reinventing Government: This 42 CFR 483; 42 CFR 488 Additional Information: BPD-705 rulemaking is part of the Reinventing Legal Deadline: None Agency Contact: Joyce Eng, Office of Government effort. It will revise text in Abstract: This final rule will Clinical Standards and Quality, the CFR to reduce burden or implement several provisions of OBRA Department of Health and Human duplication, or streamline ’87 that concern services to residents Services, Health Care Financing requirements. of nursing homes. This rule will Administration, C4-02-26, 7500 Legal Authority: 42 USC 1396a(a); 42 implement provisions that include Security Blvd., Baltimore, MD 21244 USC 1396r-8; 42 USC 1396b(a); 42 USC Federal standards for evaluating State Phone: 410 786-4619 1302 waivers of nursing facility nurse RIN: 0938–AE98 CFR Citation: staffing requirements, use of physical 42 CFR 447; 42 CFR 441 and chemical restraints in nursing Legal Deadline: None 1106. CASE MANAGEMENT (HCFA- facilities, qualifications of facility Abstract: This final rule with comment 2027-F) administrators, notice of Medicaid period will incorporate section 4401 of rights to be given to persons admitted Priority: Other Significant OBRA ’90 to add specific requirements to nursing facilities, and other technical Legal Authority: 42 USC 1396d; 42 for Medicaid payment for covered changes. USC 1396n outpatient drugs. The requirements Timetable: concern: denial of Federal financial CFR Citation: 42 CFR 431.51(c); 42 participation unless rebate agreements Action Date FR Cite CFR 431.54; 42 CFR 440.169; 42 CFR and drug use review are in effect; 440.250; 42 CFR 441.10; 42 CFR 441.18; NPRM 02/05/92 57 FR 4516 prohibiting some State plan drug access 42 CFR 447.327 NPRM Comment 04/06/92 limitations for drugs covered under a Period End Legal Deadline: None rebate agreement; and the content of Final Action 06/00/98 Abstract: This rule will incorporate the rebate agreements. (The drug rebate Small Entities Affected: Businesses provisions of COBRA ’85, OBRA ’86, agreement was previously published in Government Levels Affected: None TEFRA ’86, OBRA ’87 and TMRA ’88 the Federal Register on February 21, 1991 (56 FR 7049)). This rule will Additional Information: BPD-488 dealing with case management services. It will provide for optimal Medicaid reflect statutory revisions mandated by Agency Contact: Bill Ullman, Office of coverage of case management services the Veteran’s Health Care Act of 1992 Clinical Standards and Quality, furnished to specific groups in specific and OBRA ’93. Revision of the drug Department of Health and Human geographic areas or political rebate dispute resolution process is part Services, Health Care Financing subdivisions within a State. areas or of the Department’s regulatory Administration, C4-11-06, 7500 political subdivisions within a State. reinvention initiative. Security Boulevard, Baltimore, MD Timetable: Timetable: 21244 Phone: 410 786-5667 Action Date FR Cite Action Date FR Cite RIN: 0938–AD81 NPRM 10/15/93 58 FR 53481 NPRM 09/19/95 60 FR 48442
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Action Date FR Cite Operations, Department of Health and CFR Citation: 42 CFR 412.2(c); 42 CFR Human Services, Health Care Financing 413.40 NPRM Comment 11/20/95 Period End Administration, C4-20-21, 7500 Legal Deadline: None Final Action 08/00/98 Security Boulevard, Baltimore, MD 21244 Abstract: This rule finalizes provisions Small Entities Affected: Businesses Phone: 410 786-4463 published in an interim final rule with comment period on January 12, 1994, Government Levels Affected: State RIN: 0938–AF69 and responds to comments received on Additional Information: HCFA-2046-FC that rule. The interim final rule Agency Contact: Sue Williams, Center 1109. RETROACTIVE ENROLLMENT implemented section 4003 of OBRA for Medicaid and State Operations, AND DISENROLLMENT IN RISK ’90, entitled ‘‘Expansion of DRG Department of Health and Human HEALTH MAINTENANCE Payment Window,’’ which amended the Services, Health Care Financing ORGANIZATIONS AND COMPETITIVE statutory definition of ‘‘operating costs Administration, C4-15-26, 7500 MEDICAL PLANS (HCFA-1015-F) of inpatient hospital services’’ to Security Blvd., Baltimore, MD 21244 Priority: Other Significant include certain preadmission services. Phone: 410 786-3334 Legal Authority: 42 USC 1395mm; 43 Timetable: RIN: 0938–AF42 USC 1302; 42 USC 1395hh Action Date FR Cite CFR Citation: 42 CFR 417.448; 42 CFR Interim Final Rule 01/12/94 59 FR 1654 1108. MEDICAID: OUTSTATIONED 417.450; 42 CFR 417.456; 42 CFR Interim Final Rule 01/12/94 INTAKE LOCATIONS FOR CERTAIN 417.460; 42 CFR 417.461; 42 CFR Effective Date LOW-INCOME PREGNANT WOMEN, 417.462; 42 CFR 417.464; 42 CFR Interim Final Rule 03/14/94 INFANTS, AND CHILDREN UNDER 417.584; 42 CFR 417.436 Comment Period End AGE 19 (HCFA-2052-F) Legal Deadline: None Final Rule 02/11/98 63 FR 6864 Priority: Substantive, Nonsignificant Abstract: This rule implements section Final Action 04/00/98 Legal Authority: 42 USC 1396a(a)(55) 4204(e) of OBRA ’90. It permits HCFA Small Entities Affected: Businesses CFR Citation: 42 CFR 435.901; 42 CFR to make retroactive payments for up to Government Levels Affected: None 435.902; 42 CFR 435.903; 42 CFR 90 days when there is a delay in 435.904; 42 CFR 435.907; 42 CFR 436.2; notifying HCFA that a beneficiary has Additional Information: HCFA-1731-F 42 CFR 436.3; 42 CFR 435.3 enrolled under a section 1876 (of the Social Security Act) risk contract Agency Contact: Nancy Edwards, Legal Deadline: None through an employer health plan. In Center for Health Plans and Providers, Department of Health and Human Abstract: This rule will finalize the addition, the rule will permit the Services, Health Care Financing interim final rule that requires State Secretary to authorize retroactive Administration, C5-06-27, 7500 Medicaid agencies to provide for disenrollment in specific cases. We will Security Blvd., Baltimore, MD 21244 receipt and initial processing of also address related requirements of the Phone: 410 786-4531 Medicaid applications filed by certain Balanced Budget Act of 1997. low-income pregnant women, infants, Timetable: RIN: 0938–AG00 and children under age 19, at locations Action Date FR Cite which are other than those used for 1111. CHANGE IN PROVIDER receipt and processing of applications NPRM 12/27/93 58 FR 68366 AGREEMENT REGULATIONS for cash assistance under title IV-A of NPRM Comment 02/25/94 Period End RELATED TO FEDERAL EMPLOYEE the Social Security Act. The rule is HEALTH BENEFITS (HCFA-1748-F) based on section 1902(a)(55) of the Final Action 06/00/98 Social Security Act, as added by Small Entities Affected: None Priority: Substantive, Nonsignificant section 4602 of OBRA ’90, PL 101-508. Government Levels Affected: None Reinventing Government: This Timetable: rulemaking is part of the Reinventing Additional Information: OMC-015 Government effort. It will revise text in Action Date FR Cite Agency Contact: Anne Manley, Center the CFR to reduce burden or Interim Final Rule With 09/23/94 59 FR 48805 for Health Plans and Providers, duplication, or streamline Comment Period Department of Health and Human requirements. Interim Final Rule 10/24/94 Services, Health Care Financing Legal Authority: 5 USC 8904(b) Effective Date Administration, S3-02-01, 7500 Interim Final Rule 11/22/94 Security Boulevard, Baltimore, MD CFR Citation: 42 CFR 489 Comment Period 21244 Legal Deadline: None End Phone: 410 786-1096 Final Action 04/00/98 Abstract: This final rule will amend RIN: 0938–AF98 current Medicare regulations to require Small Entities Affected: None that payment limitations apply to Government Levels Affected: State 1110. PAYMENT FOR PREADMISSION hospitals that furnish inpatient hospital Additional Information: HCFA-2052-F SERVICES (HCFA-1731-F) services to retired Federal workers, aged 65 or older, who are enrolled in Agency Contact: Robert Tomlinson, Priority: Substantive, Nonsignificant a Federal Employee Health Benefits Center for Medicaid and State Legal Authority: 42 USC 1395ww(a)(4) (FEHB) plan but not covered under
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Medicare part A (Hospital Insurance). Federal Government for administrative Quality Coverage and Analysis Group, The payment amount will approximate or audit purposes. The revised Department of Health and Human the Medicare diagnosis-related group requirements allow States more Services, Health Care Financing payment rates established under the flexibility to exercise variations in the Administration, C4-04-05, 7500 inpatient hospital Medicare prospective implementation. Security Boulevard, Baltimore, MD payment rate. This rule will also amend Timetable: 21244 current Medicare regulations to Phone: 410 786-4614 Action Date FR Cite authorize HCFA to consider terminating RIN: 0938–AG45 or nonrenewing a hospital’s Medicare Proposed Notice 11/22/93 58 FR 61692 provider agreement if the hospital Comment Period End 01/21/94 repeatedly fails to accept the Medicare Final Action 04/00/98 1114. TELEPHONE REQUESTS FOR REVIEW OF PART B INITIAL CLAIM rate as payment in full for inpatient Small Entities Affected: None hospital services provided to retired DETERMINATIONS (HCFA-4121-F) Government Levels Affected: State Federal workers enrolled in a fee-for- Priority: Substantive, Nonsignificant service from a FEHB plan who do not Additional Information: MB-038 Reinventing Government: This have Medicare part A coverage. This Agency Contact: Richard Friedman, rulemaking is part of the Reinventing rule will implement section 7002(f) of Center for Medicaid and State Government effort. It will revise text in OBRA ’90, enacted November 5, 1990. Operations, Department of Health and the CFR to reduce burden or It will clarify that an institutional Human Services, Health Care Financing duplication, or streamline provider may not discriminate against Administration, C4-22-27, 7500 requirements. Medicare patients in providing services Security Boulevard, Baltimore, MD Legal Authority: 42 USC 1302; 42 USC because it is dissatisfied with the level 21244 1395ff(b); 42 USC 1395hh; 42 USC of Medicare payment. Phone: 410 786-4451 1395ii; 42 USC 1395u(b)(3)(C) Timetable: RIN: 0938–AG10 CFR Citation: 42 CFR 405.802; 42 CFR Action Date FR Cite 405.807 NPRM 02/10/94 59 FR 6228 1113. NONCOVERAGE OF Legal Deadline: None NPRM Comment 04/11/94 ELECTROSTIMULATION OF Period End SALIVARY GLANDS FOR THE Abstract: This rule will make it easier Final Action 04/00/98 TREATMENT OF XEROSTOMIA (DRY for beneficiaries, providers, suppliers, MOUTH) (HCFA-3782-FN) physicians, and other practitioners who Small Entities Affected: Businesses, are entitled to appeal Medicare part B Organizations Priority: Substantive, Nonsignificant initial claim determinations to request Government Levels Affected: None Legal Authority: 42 USC 1395y(a)(1)(A) a review of the carrier’s initial Additional Information: BPD-748 CFR Citation: 45 CFR 300 determination. Currently, these initial claim requests must be in writing. This Agency Contact: Bernadette Legal Deadline: None final rule will allow those requests to Schumaker, Center for Health Plans and Abstract: This notice announces the be made by telephone, which will Providers, Department of Health and Medicare program’s intent to exclude expedite the appeals process, and save Human Services, Health Care Financing from coverage electrostimulation of the time and costs for all parties. Allowing Administration, C4-02-26, 7500 salivary glands in the treatment of the use of telephone requests will Security Boulevard, Baltimore, MD xerostomia secondary to Sjogren’s supplement, not replace, the current 21244 Syndrome. Public Health Service (PHS) procedures for initiating appeals. By Phone: 410 786-4568 studies show that there is insufficient providing quick and easy access to the RIN: 0938–AG03 data to establish the clinical utility of appeals process, this rule will also electrostimulation to evaluate its long- improve carrier relationships with the term effectiveness, or to identify those beneficiary, physician and other 1112. REVISED MEDICAID xerostomia patients who would benefit suppliers. MANAGEMENT INFORMATION from this procedure. Also, PHS reports Timetable: SYSTEMS (MB-38-FN) that electrostimulation is not widely Priority: Substantive, Nonsignificant accepted as a treatment for xerostomia Action Date FR Cite Legal Authority: 42 USC 1396b(r) secondary to Sjogren’s Syndrome. NPRM 07/10/95 60 FR 35544 Timetable: NPRM Comment 09/08/95 CFR Citation: None Period End Legal Deadline: None Action Date FR Cite Final Action 04/00/98 Abstract: This notice sets forth revised Proposed Notice 05/23/94 59 FR 26653 Small Entities Affected: None Comment Period End 07/22/94 general functional requirements for the Government Levels Affected: None Medicaid Management Information Final Action 06/00/98 System (MMIS). The MMIS consists of Small Entities Affected: None Additional Information: BPO-121 software and hardware used to process Government Levels Affected: None Agency Contact: Rosalind Little, Medicaid claims and to retrieve and Center for Beneficiary Services, produce utilization and management Additional Information: BPD-782 Department of Health and Human information about services that are Agency Contact: Francine Spencer, Services, Health Care Financing required by the Medicaid agency or Office of Clinical Standards and Administration, S1-05-18, 7500
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Security Boulevard, Baltimore, MD Action Date FR Cite and to waive otherwise applicable 21244 quality standards for these procedures. NPRM Comment 06/09/97 Phone: 410 786-6972 Period End Additionally, the Clinical Laboratory Improvement Advisory Committee RIN: Final Action 06/00/98 0938–AG48 (CLIAC) was established to advise and Small Entities Affected: Businesses, make recommendations on technical 1115. HOME HEALTH AGENCY (HHA) Organizations and scientific aspects of the regulations. CONDITIONS OF PARTICIPATION Government Levels Affected: None The CLIAC recommended that the (HCFA-3819-F) criteria for categorizing tests as waived Additional Information: HCFA-3819-F be better defined. As a result of the Priority: Other Significant Agency Contact: Mary Vienna, Office comments concerning waived tests and Reinventing Government: This of Clinical Standards and Quality, the CLIAC recommendations, the rulemaking is part of the Reinventing Department of Health and Human Centers for Disease Control and Government effort. It will revise text in Services, Health Care Financing Prevention developed criteria for the CFR to reduce burden or Administration, C4-05-27, 7500 placing tests in the waived category as duplication, or streamline Security Boulevard, Baltimore, MD outlined in this proposal. requirements. 21244 Alternatives: Performance standards Phone: 410 786-6940 Legal Authority: 42 USC 1302; 42 USC based on current analysis of specific 1395x; 42 USC 1395cc(a); 42 USC RIN: 0938–AG81 criteria would continue to limit 1395hh; 42 USC 1395bb technology and inhibit expansion of waived tests. CFR Citation: 42 CFR 484 1116. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS Anticipated Costs and Benefits: This Legal Deadline: None (HCFA-2225-FC) regulation decreases burden, especially for physician office laboratories Abstract: This final rule will revise Priority: Other Significant. Major under performing waived tests due to home health agency conditions of 5 USC 801. virtually no regulatory oversight. It participation to center on the patient, Reinventing Government: This increases access to a greater variety of using outcome-oriented measures. Most rulemaking is part of the Reinventing waived tests. Physician office of the current HHA conditions of Government effort. It will revise text in laboratories may expand the range of participation have remained unchanged the CFR to reduce burden or tests they perform without an increase since home health services became a duplication, or streamline in costs/burden. The regulation creates Medicare benefit in 1966. Some limited requirements. incentives for manufacturers to develop modifications have been made over the more test systems that meet the Legal Authority: 42 USC 263a years to comply with legislative clarified waiver criteria and criteria for changes. As a result, most of the CFR Citation: 42 CFR 493.2; 42 CFR approval for home use. It eliminates conditions of participation continue to 493.7; 42 CFR 493.8; 42 CFR 493.9; 42 inspection fees for many of the 60,000 be structure and process oriented. In CFR 493.15; 42 CFR 493.20; 42 CFR physician offices and other small addition, this final rule will require 493.25; 42 CFR 493.35; 42 CFR 493.37; laboratories performing tests that will that HHAs use a standard core 42 CFR 493.39; 42 CFR 493.45; 42 CFR fall into the waived category as a result assessment data set the ‘‘Outcome and 493.47; 42 CFR 493.49; 42 CFR 493.53; of the clarifications to the waived Assessment Information Set’’ (OASIS) 42 CFR 493.1775 criteria. when evaluating adult, nonmaternity patients receiving home health care. Legal Deadline: None Risks: The clarification of the waived Abstract: As part of the CLIA program criteria and development of a process Alternatives: We considered an (see RIN: 0938-AE47), this rule will protocol will provide for consistent alternative to requiring use of the revise our current process of evaluating application of detailed standards in OASIS. Specifically, rather than tests against generic criteria. A waiver order to ensure that tests categorized requiring HHAs to incorporate the will be granted to any test that meets as waived preclude any reasonable risk OASIS items into their own assessment the statutory criteria, provided that of harm to a patient as a result of a systems, we considered permitting scientifically valid data are submitted testing error. HHAs to choose, with our approval. verifying that the criteria were met. Timetable: Among sets of measures including those they devise themselves. We Statement of Need: This final rule will Action Date FR Cite rejected this option because the OASIS clarify the waiver criteria and NPRM 09/13/95 60 FR 47534 is the only rigorously validated and streamline the waiver process so that NPRM Comment 11/13/95 reliable core assessment data set more tests may be categorized as Period End available today in home care. In time waived; that is, exempt from CLIA Final Action 04/00/98 we will entertain the possibility of performance and personnel Small Entities Affected: Businesses other standard data sets if they meet requirements. Government Levels Affected: None our needs. Summary of the Legal Basis: The Additional Information: HSQ-225 Timetable: CLIA statute specifically authorizes the Secretary to determine which simple Agency Contact: Judy Yost, Division of Action Date FR Cite laboratory procedures have an Outcomes and Improvements, NPRM 03/10/97 62 FR 11005 insignificant risk of an erroneous result, Department of Health and Human
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Services, Health Care Financing 1118. ADJUSTMENT IN PAYMENT announces a supplement to the Administration, S2-09-28, 7500 AMOUNTS FOR NEW TECHNOLOGY rulemaking record of a final rule Security Blvd., Baltimore, MD 21244 INTRAOCULAR LENSES (HCFA-3831- published February 28, 1992. In Phone: 410 786-3531 F) publishing the proposed rule, HHS complied with a Federal court order RIN: 0938–AG99 Priority: Substantive, Nonsignificant requiring publication of a proposal that Reinventing Government: This would require that cytology proficiency 1117. AMBULANCE SERVICES (HCFA- rulemaking is part of the Reinventing testing be conducted to the extent 1813-F) Government effort. It will revise text in practicable, under normal working the CFR to reduce burden or conditions. As required, we proposed Priority: Other Significant duplication, or streamline to revise regulations to require that Legal Authority: 42 USC 1302; 42 USC requirements. proficiency testing be conducted at a 1395hh Legal Authority: 42 USC 1395k(a)(2); pace corresponding to the maximum workload rate for individuals CFR Citation: 42 CFR 410.40; 42 CFR 42 USC 1395l examining slides. We also solicited 410.41; 42 CFR 424.124 CFR Citation: 42 CFR 416 comments on the use of computer Legal Deadline: None Legal Deadline: NPRM, Statutory, facsimile representations of cytology October 31, 1995. specimens, as an alternative to glass- Abstract: This rule updates and revises slide proficiency testing. After the policy on coverage of ambulance Abstract: This rule establishes a proposed rule was published, the services. It bases coverage and payment process under which interested parties appeals court revised the lower court’s for ambulance services on the medical could request, with respect to a class order, allowing us to withdraw the services needed to treat the of new technology intraocular lenses proposed rule and supplement the beneficiary’s condition. It also clarifies (IOLs), a review of the appropriateness record to the final rule. Medicare policy on coverage of non- of the current payment amount for IOLs emergency ambulance services for furnished by Medicare-participating Timetable: Medicare beneficiaries. It defines an ambulatory surgical centers. This rule Action Date FR Cite ambulance by describing the is part of HCFA’s regulatory reform requirements for furnishing both basic initiative. NPRM 11/30/95 60 FR 61509 NPRM Comment 01/29/96 and advanced life support levels of Timetable: ambulance services. The rule would Period End require use of additional HCFA Action Date FR Cite Final Action 04/00/98 common procedure coding systems NPRM 09/04/97 62 FR 46698 Small Entities Affected: Businesses (HCPCS) codes to show the origin and Final Action 04/00/98 Government Levels Affected: None destination of the ambulance Small Entities Affected: None transportation on the billing form. It Additional Information: HSQ-233-N. requires use of international Government Levels Affected: None We are publishing a notice to advise the public that no final rule is classification of diseases, 9th revision, Additional Information: HCFA-3831-F clinical modification (ICD-9-CM) codes necessary because the court decided the to bill the Medicare program for basic Agency Contact: Claude Mone, Office case in our favor. and advanced levels of ambulance of Clinical Standards and Quality, Agency Contact: Rhonda Whalen, services. Department of Health and Human Senior Health Scientist, Department of Services, Health Care Financing Timetable: Health and Human Services, Centers for Administration, C5-04-24, 7500 Disease Control and Prevention, 4770 Action Date FR Cite Security Boulevard, Baltimore, MD Buford Highway, NE., MS F 11, 21244 Atlanta, GA 30341-3724 NPRM 06/17/97 62 FR 32715 Phone: 410 786-5666 NPRM Comment 08/17/97 Phone: 770 488-7670 RIN: Period End 0938–AH15 RIN: 0938–AH35 Final Action 04/00/98
Small Entities Affected: Businesses, 1119. CLIA PROGRAM: CYTOLOGY 1120. REQUIREMENTS FOR Governmental Jurisdictions, PROFICIENCY TESTING (HCFA-2233- ENROLLMENT OF MEDICAID Organizations N) RECIPIENTS UNDER COST Government Levels Affected: None Priority: Other Significant EFFECTIVE EMPLOYER-BASED GROUP HEALTH PLANS (HCFA-2047- Additional Information: HCFA-1813-F Legal Authority: 42 USC 263a(f)(4)(B)(iv) FC) Agency Contact: Margot Blige, Center Priority: Substantive, Nonsignificant for Health Plans and Providers, CFR Citation: 42 CFR 493.855 Department of Health and Human Legal Deadline: None Legal Authority: 42 USC 1396a(a)(10); Services, Health Care Financing 42 USC 1396a(u)(1); 42 USC 1396d(a); Abstract: This notice announces the Administration, C4-02-26, 7500 42 USC 1396a(a)(25); 42 USC 1396a(e); withdrawal of a proposed rule on Security Blvd., Baltimore, MD 21244 42 USC 1396e cytology proficiency testing that was Phone: 410 786-4642 published in the Federal Register CFR Citation: 42 CFR 435; 42 CFR 436 RIN: 0938–AH13 November 30, 1995, and instead, Legal Deadline: None
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Abstract: This rule will provide for beneficiary liability for certain medical Government Levels Affected: None continuation of payment of health equipment and supplies. This Additional Information: BPD-877 insurance premiums for individuals rulemaking is part of the Reinventing who are entitled to elect COBRA Government effort. We are working Agency Contact: Luisa Iglesias, continuation coverage under a group with industry representatives to Division of Regulation and Issuances, health plan provided by an employer develop guidelines that will streamline Department of Health and Human with 75 or more employees. Medicaid requirements, reduce burden and Services, Health Care Financing recipients may be required to apply for duplication, and give beneficiaries the Administration, Room 409-B Humphry enrollment in employer-based cost opportunity to make informed Bldg, 200 Independence Ave SW., eligibility; require State agencies to pay consumer decisions regarding certain Washington, DC for premiums, eligibility. This rule also medical equipment and supplies. Phone: 202 690-6383 RIN: requires State agencies to pay for Timetable: 0938–AH53 premiums, deductibles, coinsurances Action Date FR Cite and other cost sharing obligations 1123. CHANGES TO THE HOSPITAL under employer-based cost effective Final Action 04/00/98 INPATIENT PROSPECTIVE PAYMENT group health plans, and define Small Entities Affected: None SYSTEM AND FISCAL YEAR 1998 ‘‘COBRA continuation coverage’’ and RATES (HCFA-1878-F) ‘‘COBRA beneficiaries.’’ In addition, Government Levels Affected: None Priority: Other Significant. Major under this rule incorporates the changes of Additional Information: BPD-859 section 1906 due to the Balanced 5 USC 801. Budget Act of 1997. Agency Contact: Denis Garrison, Legal Authority: 42 USC 1395ww Division of Beneficiary Protections, Timetable: Department of Health and Human CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 489 Action Date FR Cite Services, Health Care Financing Administration, C4-06-21, 7500 Legal Deadline: NPRM, Statutory, May NPRM 06/20/94 59 FR 31569 Security Boulevard, Baltimore, MD 1, 1997. Final, Statutory, September 1, NPRM Comment 08/19/94 21244 1997. Period End Phone: 410 786-5643 Final Action 10/00/98 Abstract: This final rule responds to RIN: 0938–AH51 public comments received on those Small Entities Affected: None portions of a final rule with comment Government Levels Affected: None period published in the Federal 1122. TERMS, DEFINITIONS, AND Additional Information: MB-047 Register on August 29, 1997, that ADDRESSES: TECHNICAL revised the Medicare hospital inpatient Previously published under RIN 0938- AMENDMENTS (HCFA-9877-FC) prospective payment systems for AF64. Priority: Substantive, Nonsignificant operating costs and capital-related costs Agency Contact: Gwendolyn Talvert, Reinventing Government: This to implement necessary changes Center for Medicaid and State rulemaking is part of the Reinventing resulting from the Balanced Budget Act Operations, Department of Health and Government effort. It will eliminate (BBA) of 1997, Public Law 105-33. This Human Services, Health Care Financing existing text in the CFR. rule also addresses public comments on Administration, C4-20-20, 7500 other BBA changes relating to cost Security Boulevard, Baltimore, MD Legal Authority: 42 USC 1302; 42 USC limits for hospitals and hospital unites 21244 1395x(v)(1)(A); 42 USC 1395hh excluded from the prospective payment Phone: 410 786-5928 CFR Citation: 42 CFR 400 to 420; 42 systems, as well as direct graduate medical education payments, that were RIN: 0938–AH48 CFR 421 to 430; 42 CFR 431 to 440; 42 CFR 442 to 447; 42 CFR 455 to 456; included in the August 29, 1997 42 CFR 462 to 466; 42 CFR 473 to 476; document. Generally, these BBA 1121. LIMITATIONS ON LIABILITY 42 CFR 482 to 489; 42 CFR 491 to 498 changes were applicable to hospital (HCFA-4859-FC) discharges occurring on or after October Legal Deadline: None Priority: Substantive, Nonsignificant 1, 1997. Abstract: This is a technical final rule Timetable: Reinventing Government: This with comment period that will initiate rulemaking is part of the Reinventing the rationalization of our system of Action Date FR Cite Government effort. It will revise text in definitions, correct outdated addresses NPRM 06/02/97 62 FR 29902 the CFR to reduce burden or and formulas, clarify which steps of the NPRM Comment 08/01/97 duplication, or streamline appeals process are binding and which Period End requirements. are final, remove content that is Final Rule With 08/29/97 62 FR 45966 Legal Authority: 42 USC 1302; 42 USC duplicative or unnecessary, and make Comment Period 1395hh; 42 USC 1395pp other clarifying editorial changes. Final Rule Comment 10/28/97 Period End Timetable: CFR Citation: 42 CFR 411.404 Final Action 04/00/98 Legal Deadline: None Action Date FR Cite Small Entities Affected: Businesses, Abstract: This final rule with comment Final Rule With 08/00/98 Organizations period will implement section 1879 (h) Comment Period Government Levels Affected: State, of the Social Security Act, which limits Small Entities Affected: None Federal
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Additional Information: HCFA-1878-F Security Boulevard, Baltimore, MD CFR Citation: 42 CFR 435.1003; 42 CFR HCFA published a final rule with 21244 457 comment period on 8/29/97. HCFA is Phone: 410 786-2638 Legal Deadline: None RIN: 0938–AH64 responding to the comments in a final Abstract: The Personal Responsibility rule under development. and Work Opportunity Reconciliation Agency Contact: Tzvi Hefter, Center 1125. INDIVIDUAL MARKET HEALTH Act of 1996 and the Contract With for Health Plans and Providers, INS. REFORM PORTABILITY FROM America Advancement Act of 1996 Department of Health and Human GROUP TO INDIV. COVERAGE; made statutory changes affecting the Services, Health Care Financing FEDERAL RULES FOR ACCESS IN eligibility of large numbers of Medicaid Administration, C5-08-27, 7500 THE INDIV. MARKET; STATE recipients. Changes were made to the Security Boulevard, Baltimore, MD ALTERNATIVE MECHANISMS TO definition of disability for children and 21244 FEDERAL RULES (HCFA-2882-F) eligibility requirements of non-U.S. Phone: 410 786-4487 Priority: Other Significant. Major under citizens and individuals receiving RIN: 0938–AH55 5 USC 801. disability cash assistance based on a finding of alcoholism and drug Unfunded Mandates: This action may addiction. In order to protect Federal 1124. UTILIZATION CONTROL AND affect the private sector under financial participation in State DISCONTINUED REVIEW ACTIVITIES; PL 104-4. Medicaid expenditures for States with MEDICAID (MB-101-FC) Legal Authority: 42 USC 300gg-41, et unusual volumes of eligibility Priority: Substantive, Nonsignificant seq redeterminations caused by these statutory changes, we published a final CFR Citation: 45 CFR 148 Reinventing Government: This rule with comment period on January rulemaking is part of the Reinventing Legal Deadline: None 13, 1997. That rule changed our Government effort. It will revise text in Abstract: This final rule will address regulations to provide additional time the CFR to reduce burden or comments received on the interim final for States to process redeterminations duplication, or streamline rule published on April 8, 1997 and and provide services pending the requirements. further clarifies the Departmental redeterminations. We are analyzing the Legal Authority: 42 USC 1302; 42 USC position on HIPAA requirements in the public comments to the January 13 rule 1396a(a)(26); 42 USC 1396a(a)(30); 42 individual market. in preparation of a final rule. USC 1396a(a)(31); 42 USC 1396a(a)(44); Timetable: Timetable: 42 USC 1396b(g) Action Date FR Cite Action Date FR Cite CFR Citation: 42 CFR 400; 42 CFR 431; 42 CFR 456 Interim Final Rule 04/08/97 62 FR 16985 Final Rule Effective 01/13/97 Interim Final Rule 04/08/97 Final Rule With 01/13/97 62 FR 1682 Legal Deadline: None Effective Date Comment Period Abstract: This proposed rule would Interim Final Rule 07/07/97 Final Action 06/00/98 codify in regulations the statutory Comment Period Small Entities Affected: None requirements that make physician End certification and development of plan Final Action 04/00/98 Government Levels Affected: State of care and utilization review State Small Entities Affected: Businesses, Agency Contact: Bob Tomlinson, plan requirements under the Medicaid Governmental Jurisdictions, Center for Medicaid and State program. States would no longer be Organizations Operations, Department of Health and required to make quarterly showings Government Levels Affected: State, Human Services, Health Care Financing that they have complied with those Local, Federal Administration, Medicaid Bureau, C4- requirements and other provisions 20-21, 7500 Security Blvd., Baltimore, would be removed. Regulatory Additional Information: BPD-882-F MD 21244 provisions on regional staff Agency Contact: Gertrude Saunders, Phone: 410 786-4463 subsampling of State Medicaid quality Center for Medicaid and State RIN: 0938–AH76 control. Operations, Department of Health and Timetable: Human Services, Health Care Financing Administration, 7500 Security Blvd., 1127. CLIA PROGRAM; SIMPLIFYING Action Date FR Cite Baltimore, MD 21244 CLIA REGULATIONS TO Final Action 04/00/98 Phone: 410 786-5888 ACCREDITATION EXEMPTION OF LABORATORIES UNDER A STATE RIN: Small Entities Affected: Businesses 0938–AH75 LICENSURE PROGRAM, AND Government Levels Affected: State PROFICIENCY TESTING AND INSPECTION (HCFA-2239-FC) Additional Information: MB-101 1126. MEDICAID PROGRAM; REDETERMINATIONS OF MEDICAID Priority: Substantive, Nonsignificant Agency Contact: Wanda White, Office ELIGIBILITY DUE TO WELFARE of Medicaid and State Operations, REFORM (HCFA-2105-IFC) Reinventing Government: This Department of Health and Human rulemaking is part of the Reinventing Services, Health Care Financing Priority: Substantive, Nonsignificant Government effort. It will revise text in Administration, C4-25-02, 7500 Legal Authority: 42 USC 1302 the CFR to reduce burden or
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
duplication, or streamline Medicaid eligibility determinations as a some individuals who would otherwise requirements. result of the provisions of 1931 of the lose their Medicaid benefits to retain Legal Authority: 42 USC 263a; 42 USC Social Security Act as amended by the their eligibility. Personal Responsibility and Work 1302; 42 USC 1395x(e); 42 USC Timetable: 1395x(s)(11) to 1395x(s)(16) Opportunity Reconciliation Act of 1996. Action Date FR Cite CFR Citation: 42 CFR 493 Timetable: Interim Final Rule 04/00/98 Legal Deadline: None Action Date FR Cite Small Entities Affected: None Abstract: This final rule with comment period will respond to various Notice 05/14/97 62 FR 26545 Government Levels Affected: State comments received on an earlier final Notice Comment 07/13/97 Period End Additional Information: MB-109 rule with a comment period Final Action 04/00/98 implementing the Clinical Laboratory Agency Contact: Jackie Wilder, Center Improvement Amendments of 1988, Small Entities Affected: None for Medicaid and State Operations, which was published in the Federal Government Levels Affected: State Department of Health and Human Register on February 28, 1992, in the Services, Health Care Financing Additional Information: MB-103 areas of proficiency testing and Administration, 7500 Security Blvd, inspections for clinical laboratories. Agency Contact: Richard Strauss, C4-20-06, Baltimore, MD 21244 This rule will follow the Center for Medicaid and State Phone: 410 786-4579 Administration’s regulatory reform Operations, Department of Health and RIN: 0938–AH92 initiative by reducing duplicative Human Services, Health Care Financing material, emphasizing outcome-oriented Administration, 7500 Security Blvd, results, and simplifying regulations. We C4-18-26, Baltimore, MD 21244 1130. FINAL LIMITATIONS ON also are streamlining our regulation in Phone: 410 786-2019 AGGREGATE PAYMENTS TO the areas of State exemption, and RIN: 0938–AH90 DISPROPORTIONATE SHARE granting deemed status to laboratories HOSPITALS: FEDERAL FISCAL YEAR accredited by an approved accreditation 1998 (HCFA-2110-N) organization. 1129. MEDICALLY NEEDY DETERMINATIONS UNDER WELFARE Priority: Substantive, Nonsignificant Timetable: REFORM (HCFA-2109-IFC) Legal Authority: 42 USC 1396(a)(13); Action Date FR Cite Priority: Substantive, Nonsignificant 42 USC 1396r-4(f) Final Action 06/00/98 Reinventing Government: This CFR Citation: 42 CFR 447.297; 42 CFR Small Entities Affected: None rulemaking is part of the Reinventing 447.298; 42 CFR 447.299 Government effort. It will revise text in Government Levels Affected: None the CFR to reduce burden or Legal Deadline: Other, Statutory, April Additional Information: HSQ-239 duplication, or streamline 1998. Regulatory Deadline Agency Contact: Judy Yost, Center for requirements. Medicaid and State Operations, Legal Authority: 42 USC 1302; 42 USC Abstract: This notice announces the Division of Outcomes and 1396a(a)(10)(C) final Federal fiscal year 1998 national Improvement, Department of Health CFR Citation: 42 CFR 435; 42 CFR 436 target and individual State allotments and Human Services, Health Care for Medicaid payment adjustments Legal Deadline: Financing Administration, 7500 None made to hospitals that serve a Security Blvd., Baltimore, MD 21244 Abstract: This interim final rule with disproportionate number of Medicaid Phone: 410 786-3531 comment period will revise our rules recipients and low-income patients to allow States to include individuals RIN: 0938–AH82 with special needs. who are described as categorically needy to be covered as medically Timetable: 1128. ALLOCATION OF ENHANCED needy. The State must specify the Action Date FR Cite FEDERAL MATCHING FUNDS FOR income and resources criteria for the Notice 11/00/98 INCREASED ADMINISTRATIVE COSTS medically needy group in the State (MB-103-N) plan. If an individual is also described Small Entities Affected: None Priority: Substantive, Nonsignificant as categorically needy, the individual Government Levels Affected: State would receive Medicaid as categorically Legal Authority: 42 USC 1396a(a) needy if the State elected to cover the Additional Information: MB-110 categorically needy group into which CFR Citation: None Agency Contact: Richard Strauss, the individual fits. If the State has not Center for Medicaid and State Legal Deadline: None elected to cover that group, the Operations, Department of Health and Abstract: This notice will provide a individual would be medically needy. Human Services, Health Care Financing formula for the allocation of a special This change will allow more Administration, 7500 Security Blvd., $500 million fund for enhanced Federal individuals to become eligible for C4-17-27, Baltimore, MD 21244 matching for State Agency’s Medicaid as medically needy and Phone: 410 786-2019 expenditures attributable to additional eliminate an inequity in current Medicaid administrative costs of regulations. This revision also allows RIN: 0938–AH93
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
1131. REVISION TO THE DEFINITION limits. It will implement sections 702 Timetable: OF AN UNEMPLOYED PARENT and 703 of the Mental Health Parity Action Date FR Cite (HCFA-2106-FC) Act of 1996. Interim Final Rule 04/08/97 62 FR 16894 Priority: Substantive, Nonsignificant Timetable: Interim Final Rule 06/07/97 Legal Authority: 42 USC 607; 42 USC Action Date FR Cite Effective 1396u-1 Interim Final Rule 07/07/97 Interim Final Rule 12/22/97 62 FR 66932 CFR Citation: Comment Period 45 CFR 233 Final Action 04/00/98 End Legal Deadline: None Small Entities Affected: Businesses, Final Rule 04/00/98 Abstract: This final rule with comment Governmental Jurisdictions, Small Entities Affected: Businesses period will make a change necessary Organizations Government Levels Affected: Federal for a State to further facilitate Government Levels Affected: State, coordination of its Medicaid and foster Additional Information: BPD-890-IFC Local, Federal care program in cases where coverage Agency Contact: Dave Holstein, has been expanded under its Agency Contact: Marc Thomas, Center Insurance Standards Team, Department Temporary Assistance for Needy for Medicaid & State Operations, of Health and Human Services, Health Families beyond the definition of Department of Health and Human Care Financing Administration, 7500 unemployed parent contained in Services, Health Care Financing Security Blvd., Baltimore, MD 21244 existing Aid to Families with Administration, 7500 Security Blvd., Phone: 410 786-1564 Dependent Children regulations. This Baltimore, MD 21244 RIN: 0938–AI08 rule revises the definition of Phone: 410 786-7154 unemployment of a principal wage RIN: 0938–AI05 earner for purposes of coverage of 1134. PART A PREMIUM FOR 1998 dependent children of unemployed FOR THE UNINSURED AGED AND parents. It will also allow States to 1133. PORTABILITY AND FOR CERTAIN DISABLED eliminate inequitable policies that are NONDISCRIMINATION IN THE GROUP INDIVIDUALS WHO HAVE a disincentive to family unity. HEALTH INSURANCE MARKET EXHAUSTED OTHER ENTITLEMENT Timetable: (HCFA-2890-F) (HCFA-5056-N) Action Date FR Cite Priority: Other Significant. Major under Priority: Other Significant. Major under 5 USC 801. 5 USC 801. Interim Final Rule 04/00/98 Legal Authority: 42 USC 201 Legal Authority: 42 USC 1395i-2; 42 Small Entities Affected: None USC 1395i-20 CFR Citation: 45 CFR 146 Government Levels Affected: State CFR Citation: 45 CFR 300 Legal Deadline: None Additional Information: HCFA-2106-FC Legal Deadline: Other, Statutory, Agency Contact: Judith Rhoades, Abstract: This final rule will address September 30, 1998. Center for Medicaid and State comments received on the interim final Notice publication rule published April 8, 1997. It will Operations, Department of Health and Abstract: This notice announces the also further clarify the Department’s Human Services, Health Care Financing hospital insurance premium for position on the minimum requirements Administration, 7500 Security Blvd., calendar year 1998 under Medicare’s applicable with respect to group health CA-20-05, Baltimore, MD 21244 hospital insurance program (part A) for plans and health insurance issuers Phone: 410 786-4462 the uninsured aged and for certain offering group health insurance Fax: 410 786-3252 disabled individuals who have coverage. A group health plan or health exhausted other entitlement. The RIN: 0938–AH98 insurance issuer offering group health uninsured aged are those individuals coverage may provide greater rights to who are not insured under the Social participants and beneficiaries than 1132. HEALTH INSURANCE REFORM: Security or Railroad Retirement Acts those currently provided. This rule will PARITY IN THE APPLICATION OF and do not otherwise meet the include the following: (1) limitations on CERTAIN LIMITS TO MENTAL HEALTH requirements for entitlement to preexisting condition exclusion BENEFITS (HCFA-2891-IFC) Medicare part A. The disabled periods; (2) certification and disclosure Priority: beneficiaries are those who lose Other Significant of previous coverage; (3) special monthly Social Security cash payments Legal Authority: 42 USC 300gg-5 enrollment periods for individuals (and because they returned to work even dependents) losing other coverage; (4) CFR Citation: 45 CFR 146 though their disability continues. use of affiliation period by HMOs as Section 1818(d) of the Social Security Legal Deadline: None alternative to preexisting condition Act specifies the method to be used to Abstract: This interim final rule will exclusion; (5) prohibited discrimination determine this amount. impose requirements on the large group against individual participants and health plan market. It will require beneficiaries based on health status; (6) Timetable: parity of mental health benefits with guaranteed availability in the small Action Date FR Cite medical and surgical benefits under a group market; and (7) guaranteed group health plan in the application of renewability in the large and small Notice 04/00/98 aggregate lifetime limits and annual group markets. Small Entities Affected: None
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
Government Levels Affected: None Mothers’ Health Protection Act of 1996. Phone: 410 786-5763 It provides that a health insurance Agency Contact: John Wandishin, RIN: 0938–AI18 Office of Strategic Planning, issuer that covers hospital length of Department of Health and Human stay in connection with childbirth may Services, Health Care Financing not restrict the stay for the mother or 1138. MEDICAID PROGRAM: Administration, N3-26-00, 7500 newborn to less than 48 hours CHARGES FOR VACCINE Security Blvd., Baltimore, MD 21244 following a normal vaginal delivery or ADMINISTRATION UNDER THE Phone: 410 786-6389 96 hours following a cesarean section. VACCINES FOR CHILDREN (VCF) However, discharge may occur earlier PROGRAM (HCFA-2084-FNC) RIN: 0938–AI10 if the attending provider in Priority: consultation with the mother decides Substantive, Nonsignificant 1135. INPATIENT HOSPITAL to discharge earlier. Unfunded Mandates: This action may DEDUCTIBLE AND HOSPITAL AND Timetable: affect State, local or tribal governments and the private sector. EXTENDED CARE SERVICES Action Date FR Cite COINSURANCE AMOUNTS FOR 1998 Legal Authority: 42 USC 1302; 42 USC (HCFA-5057-N) Interim Final Rule 04/00/98 1396(a)(62) Small Entities Affected: Undetermined Priority: Substantive, Nonsignificant CFR Citation: None Government Levels Affected: None Legal Authority: 42 USC 1395e Legal Deadline: None Agency Contact: CFR Citation: None Marc Thomas, Health Insurance Standards Team, Department Abstract: This notice lists, by State, the Legal Deadline: None of Health and Human Services, Health finalized regional maximum charges Abstract: This notice announces the Care Financing Administration, 7500 that providers may impose for the inpatient hospital deductible and the Security Blvd, C4-02-16, Baltimore, MD administration of pediatric vaccines to hospital and extended care services 21244 federally vaccine-eligible children coinsurance amounts for services Phone: 410 786-7154 under the Vaccines for Children (VFC) program. This notice also specifies the furnished in calendar year 1998 under RIN: 0938–AI17 Medicare’s hospital insurance program methodology that HCFA used to (Medicare part A). The Medicare statute establish the revised maximum charges. specifies the formula to be used to 1137. MEDICARE PROGRAM: UPDATE In addition, this notice provides States OF AMBULATORY SURGICAL determine these amounts. that purchase vaccines for all children CENTER PAYMENT RATES the option to use these regional Timetable: EFFECTIVE FOR SERVICES ON OR maximum charges or devise their own Action Date FR Cite BEFORE OCTOBER 1, 1997 (HCFA- administration fees, and clarifies that 1897-N) State Medicaid agencies may establish Notice 10/00/98 Priority: Other Significant lower fees than these maximum charges Small Entities Affected: None if the agencies assure access to Legal Authority: 42 USC 1395l(a)(4); 42 Government Levels Affected: None immunizations for Medicaid-eligible USC 1395l(i)(l)(a); 42 USC 1833(i)(2)(c) children to the same extent as the Agency Contact: John Wandishin, CFR Citation: 42 CFR 416.25 general population. This notice also Deputy Director, Division of Medicare Legal Deadline: None responds to comments on the October and Medicaid Cost Estimates, 3, 1994 notice with comment period. Department of Health and Human Abstract: This notice implements Services, Health Care Financing section 1833(i)(2)(c) of the Social Timetable: Administration, N3-36-24, 7500 Security Act, which mandates an Action Date FR Cite Security Blvd., Baltimore, MD 21244 inflation adjustment to Medicare Phone: 410 786-6389 payment amounts for ambulatory Notice With Comment 10/03/94 59 FR 50235 surgical center (ASC) facility services Period RIN: 0938–AI12 during the years when the payment Notice 04/10/95 60 FR 18136 amounts are not updated based on a Final Notice 04/00/98 1136. HEALTH INSURANCE survey of the actual audited costs Small Entities Affected: None PORTABILITY: NEWBORNS' AND incurred by ASCs. Government Levels Affected: None MOTHERS' HEALTH PROTECTION Timetable: (HCFA-2892-IFC) Additional Information: HCFA-2084- Action Date FR Cite Priority: Other Significant. Major status FNC Final Action 04/00/98 under 5 USC 801 is undetermined. Agency Contact: Marge Sciulli, Center Small Entities Affected: Businesses Legal Authority: 42 USC 300gg-4; 42 for Medicaid and State Operations, USC 300gg-51 Government Levels Affected: None Department of Health and Human Services, Health Care Financing Agency Contact: Joan Sanow, Center CFR Citation: 45 CFR 146.136; 45 CFR Administration, C4-22-06, 7500 for Health Plans and Providers, 148.151 Security Boulevard, Baltimore, MD Department of Health and Human 21244 Legal Deadline: None Services, Health Care Financing Phone: 410 786-0691 Abstract: This interim final rule Administration, 7500 Security Blvd., implements the Newborns’ and C4-11-16, Baltimore, MD 21244 RIN: 0938–AI20
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
1139. SOLVENCY STANDARDS FOR Timetable: Department of Health and Human PROVIDER-SPONSORED Action Date FR Cite Services, Health Care Financing ORGANIZATIONS (HCFA-1011-IFC) Administration, C5-08-16, 7500 Notice 04/00/98 Security Blvd, Baltimore, MD 21244- Priority: Other Significant. Major status 1850 under 5 USC 801 is undetermined. Small Entities Affected: None Phone: 410 786-4539 Government Levels Affected: None Unfunded Mandates: Undetermined RIN: 0938–AI27 Agency Contact: Catherine Jansto, Legal Authority: 42 USC 1395w-26(a) Social Science Research Analyst, CFR Citation: 42 CFR part 422 Department of Health and Human 1142. MEDICARE + CHOICE Services, Health Care Financing PROGRAM; REGULATORY PROGRAM Legal Deadline: None Administration, 7500 Security TO IMPLEMENT CERTAIN MEDICARE Abstract: This rule sets forth the Boulevard, C3-15-06, Baltimore, MD PROVISIONS OF THE BALANCED solvency standards for provider 21244 BUDGET ACT OF 1997 (OMC-030-IFC) sponsored organizations under Phone: 410 786-7762 Priority: Economically Significant. Medicare part C Email: [email protected] Major under 5 USC 801. Timetable: RIN: 0938–AI26 Legal Authority: 42 USC 1302; 42 USC Action Date FR Cite 1395w 21 to 27; 42 USC 1395hh 1141. GME: INCENTIVE PAYMENTS CFR Citation: Interim Final Rule 04/00/98 42 CFR 400; 42 CFR 403; UNDER PLANS FOR VOLUNTARY 42 CFR 471; 42 CFR 422; 42 CFR 489; Small Entities Affected: Undetermined REDUCTION IN NUMBER OF 42 CFR 498 RESIDENTS (HCFA-1001-IFC) Government Levels Affected: Legal Deadline: Other, Statutory, June Undetermined Priority: Other Significant. Major status 1, 1998. under 5 USC 801 is undetermined. Interim Final Rule. Agency Contact: Maureen Miller, Department of Health and Human Legal Authority: 42 USC 1395ww(h); Abstract: This interim final rule Services, Health Care Financing PL 105-33, Sec 4626 implements the new Medicare+Choice Administration, 7500 Security Blvd, CFR Citation: 42 CFR 413 program established by the Balanced Baltimore, MD 21244 Budget Act (BBA) of 1997. Under the Legal Deadline: Other, Statutory, Phone: 410 786-1097 Medicare+Choice program (part C of February 5, 1998. title XVIII of the Social Security Act) RIN: 0938–AI25 Interim final regulations with comment eligible individuals may choose to period must be published within 6 receive their Medicare benefits under months of the date of enactment of the 1140. MEDICARE PROGRAM; NOTICE any of several types of health care Balanced Budget Act 1997 (August 5, FOR THE SOLICITATION FOR plans: coordinated care plans; medical 1997). PROPOSALS FOR A savings account plans; fee-for service DEMONSTRATION PROJECT FOR Abstract: Under current law and plans. CONGESTIVE HEART FAILURE CASE regulations, hospitals are paid for direct Statement of Need: The Balanced MANAGEMENT HCFA-1104-N) medical education based on the number Budget Act of 1997, (Pub. L. 105-33) of residents participating in accredited Priority: Info./Admin./Other significantly expanded the types of graduated medical education programs. organizations that may be eligible for Legal Authority: 42 USC 1395 (b)(1) This interim final rule would contracts with us to provide all implement section 4626 of the CFR Citation: Not yet determined Medicare part A and Medicare part B Balanced Budget Act of 1997 which items and services directly to Legal Deadline: None allows hospitals to apply to received beneficiaries on a prospective incentive payments for reducing the Abstract: This notice announces reimbursement basis. In addition, the number of residents in training. The current Medicare requirements for HCFA’s solicitation for proposals for a hospital must submit a plan to the demonstration project to test the managed care organizations, with Secretary outlining how they will make respect to reimbursement, beneficiary applicability of cost-effective, existing voluntary residency reductions. clinical case management delivery participation, beneficiary and program models for beneficiaries with Timetable: protections, organizational requirements, marketing activities, and congestive heart failure in the Medicare Action Date FR Cite fee-for-service program. Section 402(a) provider participation, have been Interim Final Rule 06/00/98 of the Social Security Amendments of significantly revised by the Congress. Final Action 08/00/98 1967 (P.L. 90-248) authorizes projects The Act requires that the Secretary for one of eleven specified purposes. Small Entities Affected: Businesses promulgate implementing regulations, HCFA solicits proposals for which may be through an interim final Government Levels Affected: State, rule, by June 1, 1998. demonstrations that will use innovative Local, Federal case management interventions to Summary of the Legal Basis: Section improve clinical outcomes and quality Additional Information: HCFA-1003- 1876 of the Social Security Act (42 of life for Medicare beneficiaries with IFC U.S.C. 1935mm) established the congestive heart failure while saving Agency Contact: Marc Hartstein, authority for Medicare reimbursement Medicare funds. Center for Health Plans and Providers, of managed care organizations that
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
meet specific requirements. Regulations Agency Contact: Anthony Hausner, Legal Deadline: NPRM, Statutory, May implementing the statutory Department of Health and Human 1, 1998. requirements are found at 42 CFR Services, Health Care Financing 417.400 et. seq. The Balanced Budget Administration, 7500 Security Abstract: This proposed rule would Act (BBA) establishes a new part C Boulevard, Room S3-23-24, Baltimore, make several policy changes affecting statutory authority under title XVIII of MD 21244 Medicare part B payment. The changes the Social Security Act. Provisions in Phone: 410 786-1093 relate to physician services, including the new part C establish the conditions RIN: 0938–AI29 resource-based practice expense relative under which entities may qualify to value units, medical direction and contract directly with HCFA as medical supervision rules for ‘‘Medicare + Choice’’ plans to provide 1143. ∑ MEDICARE PROGRAM; anesthesiologists, payment for Pap all Medicare part A and part B services PROSPECTIVE PAYMENT SYSTEM smears and for outpatient rehabilitation to beneficiaries. Part C also establishes AND CONSOLIDATED BILLING FOR services, and payment based on actual SKILLED NURSING FACILITIES. significant new program requirements charges. Under the law, we are required (HCFA-1913-IFC) in the following areas: contractor to develop a resource-based system for reimbursement, beneficiary eligibility Priority: Other Significant determining practice expense relative and enrollment, information Legal Authority: PL 105-33, sec 4432(a) value units. The Balance Budged Act dissemination, solvency standards, CFR Citation: 42 CFR 409; 42 CFR 410; of 1997 (BBA 1997) delayed, for 1 year, marketing, quality of care, data implementation of the resource-based reporting, access and coverage. 42 CFR 411; 42 CFR 413; 42 CFR 483; 42 CFR 489 practice expense relative value units Alternatives: The Balanced Budget Act until January 1, 1999. Under BBA 1997, Legal Deadline: None of 1997 requires that the provisions in we are required to revise our payment part C be implemented through Abstract: This interim final rule policy for nonphysician practitioners regulations. implements provisions in section 4432 for drugs and biologicals not paid on Anticipated Costs and Benefits: These of the Balanced Budget Act of 1997 a cost or prospective payment basis. In rules will accomplish the objectives of related to Medicare payment for skilled addition, BBA 1997 permits certain increasing availability of services and nursing facility services. These include physicians and practitioners to opt out access for beneficiaries that reside in the implementation of a Medicare of Medicare and furnish covered prospective payment system for skilled rural and underserved urban areas of serviced to medicare beneficiaries nursing facilities, consolidated billing, the country. The implementation of through private contracts. Also, we and a number of related changes. The statutory provisions at part C will also would rebase the Medicare Economic result in significant Medicare program prospective payment system described in this rule replaces the retrospective Index from a 1989 base year to a 1996 cost savings, by expanding the types of base year. entities that can elect to receive reasonable cost based system currently payment on a capita basis, and by utilized by Medicare for payment of Timetable: skilled nursing facility services under revising the reimbursement Action Date FR Cite methodology for such payments. part A of the program. Risks: Regulated industries and Timetable: Final Action 05/00/98 providers have a significant stake in the Action Date FR Cite Final Action Effective 01/00/99 provisions of the final rules and we Interim Final Rule 04/00/98 Small Entities Affected: Businesses anticipate significant volume and Small Entities Affected: Governmental complexity of comments once the rules Government Levels Affected: None are published. Publication will Jurisdictions demonstrate the Administration’s Government Levels Affected: Federal Additional Information: Legal position on various sensitive and Agency Contact: Laurence Wilson, Authority: PL-105-33, sec 4505 PL-105- political issues related to the legislative Center for Health Plans and Providers, 33, sec 4505 PL-105-33, sec 4507 PL- provisions. Department of Health and Human 105-33, sec 4511 PL-105-33, sec 4512 One possible risk is that beneficiaries Services, Health Care Financing PL-105-33, sec 4541 PL-105-33, sec will be confused by the wide array of Administration, 7500 Security Blvd, 4556 choices and make selections that are C4-7-04, Baltimore, MD 21244 Agency Contact: Stanley Weintraub, not in their best interest. The Phone: 410 786-4603 Center for Health Plans and Providers, comparative information provided by RIN: 0938–AI47 HCFA will facilitate plan selection. Department of Health and Human Services, Health Care Financing Timetable: 1144. ∑ RESOURCE BASED PRACTICE Administration, 7500 Security Blvd, Action Date FR Cite EXPENSE PAYMENTS AND Baltimore, MD 21244 Interim Final Rule With 06/00/98 REVISIONS TO PAYMENT POLICIES Phone: 410 786-4498 Comment Period FOR CY 1999 (HCFA-1006-P) RIN: 0938–AI52 Small Entities Affected: Governmental Priority: Other Significant Jurisdictions, Organizations Legal Authority: 42 USC 1395-W-4 Government Levels Affected: State, CFR Citation: 42 CFR 405; 42 CFR 410; Local, Federal 42 CFR 414 to 415
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration SERVICESFinal Rule (HCFA)(HHS) Stage HHSÐHCFA Final Rule Stage
1145. ∑ MEDICARE PROGRAM; significantly expands the health care Small Entities Affected: Businesses, DEFINITION OF PROVIDER- options available to Medicare Organizations SPONSORED ORGANIZATION AND beneficiaries. Under this program, RELATED REQUIREMENTS (HCFA- eligible individuals may elect to receive Government Levels Affected: None 1027-IFC) Medicare benefits through enrollment Agency Contact: Maureen Miller, in a provider-sponsored organization. Priority: Other Significant Center for Health Plans and Providers, This interim final rule with comment Legal Authority: Social Security Act period defines the term ‘‘provider- Department of Health and Human Amendment, sec 1851 and 1855 sponsored organization’’ for purposes of Services, Health Care Financing CFR Citation: 42 CFR 422.350; 42 CFR the Medicare program and establishes Administration, S3-23-07, 7500 422.352; 42 CFR 422.354; 42 CFR requirements related to meeting this Security Blvd., Baltimore, MD 21244 422.356 definition. Phone: 410 786-1097 Legal Deadline: Email: [email protected] None Timetable: Abstract: The Balanced Budget Act of RIN: 0938–AI60 1997 establishes a new Action Date FR Cite Medicare+Choice program that Interim Final Rule 04/00/98
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Health Care Financing Administration (HCFA) Long-TermHHS—HCFA Actions
1146. CRITERIA AND PROCEDURES 1147. MEDICARE COVERAGE OF Administration, C4-03-18, 7500 FOR DEVELOPING MEDICAL OUTPATIENT OCCUPATIONAL Security Blvd., Baltimore, MD 21244 SERVICES COVERAGE POLICY THERAPY SERVICES (HCFA-1425-P) Phone: 410 786-1782 (HCFA-3546-F) Priority: Substantive, Nonsignificant RIN: 0938–AD32 Priority: Other Significant Legal Authority: 2 USC 1302; 42 USC Legal Authority: 42 USC 1395y 1395hh; 42 USC 1395k; 42 USC 13951; 1148. CHANGES TO PEER REVIEW CFR Citation: 42 CFR 400.404; 42 CFR 42 USC 1395w-4; 42 USC 1395x(s); 42 ORGANIZATION REGULATIONS 405.201; 42 CFR 405.203; 42 CFR USC 1395x(p); 42 USC 1395cc(e); 44 (HCFA-3135-F) 405.205; 42 CFR 405.207; 42 CFR USC 3501 to 3511 Priority: 405.211 CFR Citation: 42 CFR 400; 42 CFR 410; Substantive, Nonsignificant Legal Deadline: None 42 CFR 424; 42 CFR 484; 42 CFR 485; Reinventing Government: This 42 CFR 486; 42 CFR 488; 42 CFR 489; rulemaking is part of the Reinventing Abstract: This rule will announce 42 CFR 498 Government effort. It will revise text in generally applicable criteria and the CFR to reduce burden or procedures for determining whether a Legal Deadline: None duplication, or streamline service is ‘‘reasonable and necessary’’ Abstract: This rule would implement requirements. under the Medicare program. It will section 9337 of OBRA ’86 which also announce generally applicable provides Medicare coverage for Legal Authority: 42 USC 1320c; 42 criteria and procedures for determining outpatient occupational therapy USC 1396a(a)(30); 42 USC 1395cc(a) whether a service is ‘‘reasonable and services furnished by providers and CFR Citation: 42 CFR 400.200; 42 CFR necessary’’ under the Medicare independent practitioners, identical to 411.15; 42 CFR 431.630; 42 CFR 433.15; program. the coverage for outpatient physical 42 CFR 462.1; 42 CFR 462.101; 42 CFR Timetable: therapy. It also would implement 462.102; 42 CFR 462.106; 42 CFR section 6133(a) of OBRA ’89 which Action Date FR Cite 462.107; 42 CFR 466.1; 42 CFR 466.71; increased the payment limit for 42 CFR 466.76; 42 CFR 466.78; 42 CFR NPRM 01/30/89 54 FR 4302 outpatient occupational therapy 466.83 NPRM Comment 03/31/89 services provided by independent Period End practitioners. Legal Deadline: None Final Action 00/00/00 Timetable: Abstract: This rule will set forth Small Entities Affected: None Action Date FR Cite several changes to regulations that Government Levels Affected: None govern Peer Review Organizations NPRM 00/00/00 Additional Information: BPD-432 (PROs) and is based on statutory Small Entities Affected: None changes contained in COBRA ’85 and Agency Contact: Ron Milhorn, Office Government Levels Affected: None OBRA ’86. In addition, several of Clinical Standards and Quality, technical changes will be included as Department of Health and Human Additional Information: BPD-425 a result of experience gained with the Services, Health Care Financing Agency Contact: Sheridan Gladhill, PRO program by HCFA. This rule also Administration, C4-10-07, 7500 Center for Health Plans and Providers, implements the new quality review Security Blvd., Baltimore, MD 21244 Division of Chronic Care Management, requirements for certain Medicaid Phone: 410 786-5663 Department of Health and Human health maintenance organization RIN: 0938–AD07 Services, Health Care Financing contracts.
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Timetable: 1150. SURVEY REQUIREMENTS AND rule with comment period published on Action Date FR Cite ALTERNATIVE SANCTIONS FOR February 28, 1992. The rule revised HOME HEALTH AGENCIES (HCFA- regulations applicable to laboratories NPRM 03/16/88 53 FR 8654 2169-F) and implemented provisions of the NPRM Comment 05/16/88 Priority: Other Significant Clinical Laboratory Improvement Period End Amendments of 1988 (CLIA). The Final Action 00/00/00 Legal Authority: 42 USC 1395bbb; 42 regulations apply to laboratories that USC 1395hh; 42 USC 1302 Small Entities Affected: None examine human specimens for the CFR Citation: 42 CFR 488; 42 CFR 489; diagnosis, prevention, or treatment of Government Levels Affected: None 42 CFR 498 any disease or impairment of, or the Additional Information: HSQ-135 Legal Deadline: None assessment of the health of, human beings. They specify the performance Agency Contact: Bill Roskey, Office of Abstract: These rules will establish requirements, based on test complexity Clinical Standards and Quality, Health periodic, unannounced surveys of and risk factors related to erroneous Standards and Quality Bureau, home health agencies (HHAs) and other test results as required by CLIA. They Department of Health and Human survey requirements and also will also list requirements that permit Services, Health Care Financing specify sanctions that could be used waiver of the certification and Administration, S1-09-18, 7500 when an HHA is out of compliance inspection requirements for laboratories Security Blvd., Baltimore, MD 21244 with Federal requirements (as an performing only limited testing. Phone: 410 786-0433 alternative or in addition to terminating Statement of Need: On October 31, RIN: 0938–AD38 an HHA’s participation in the Medicare program). 1988, the Congress enacted comprehensive changes to existing Timetable: 1149. PROTECTION OF INCOME AND laboratory regulations in CLIA. This RESOURCES FOR COMMUNITY Action Date FR Cite statute requires the regulation of any SPOUSES OF INSTITUTIONALIZED NPRM 08/02/91 56 FR 37054 facility (including physician offices) INDIVIDUALS (HCFA-2023-P) NPRM Comment 10/01/91 that performs tests on human beings for the purpose of providing information Priority: Other Significant Period End Final Action 00/00/00 for the diagnosis, prevention, or Legal Authority: 42 USC 1396r-5; 42 treatment of any disease or impairment Small Entities Affected: USC 1302 Businesses, of, or the assessment of the health of, Governmental Jurisdictions CFR Citation: 42 CFR 435.650 to 674; human beings. CLIA requires that the Government Levels Affected: State, 42 CFR 435.750 to 754 Department regulate by test, using what Local, Federal is commonly referred to as the Legal Deadline: None Additional Information: HSQ-169 ‘‘complexity model’’ to categorize individual laboratory tests based on the Abstract: This rule would interpret TIMETABLE CONT: Pending statutory changes made in 1988, 1989, experience, skills, and judgement completion of RIN 0938-AG81 (HCFA- required to perform each test 1990 and 1993 that allocate income and 3819-P) resources between an institutionalized accurately. Requirements vary as a Agency Contact: spouse and the spouse remaining in the Wayne Smith, Ph.D., function of the complexity of the tests community. It would also provide Director, Division of Integrated Health the laboratory conducts. Systems, Department of Health and special post-eligibility rules for The law requires the Secretary to Human Services, Health Care Financing institutionalized individuals who have implement the numerous provisions Administration, S2-11-07, 7500 spouses in the community to retain through regulation to ensure the quality Security Blvd., Baltimore, MD 21244 more income to meet living expenses. of laboratory testing, regardless of Phone: 410 786-6762 Timetable: where it is provided or who is RIN: 0938–AE39 providing the testing. The law also Action Date FR Cite requires that the CLIA program be NPRM 00/00/00 1151. REVISIONS TO REGULATIONS operated through the assessment of user IMPLEMENTING CLIA (HCFA-2226-F) fees paid by entities subject to these Small Entities Affected: Undetermined requirements. Priority: Other Significant Government Levels Affected: State, On May 21, 1990, the Department Local Reinventing Government: This published proposed rules to implement Additional Information: HCFA-2023 rulemaking is part of the Reinventing CLIA and received public comments Government effort. It will revise text in from over 60,000 commenters. Based on Agency Contact: Roy Trudel, Center the CFR to reduce burden or analysis of these comments, the Centers for Medicaid & State Operations, duplication, or streamline for Disease Control and Prevention Department of Health and Human requirements. together with Health Care Financing Services, Health Care Financing Legal Authority: 42 USC 263a Administration developed a final rule Administration, C4-20-15, 7500 CFR Citation: 42 CFR 493 with comment period that set forth Security Boulevard, Baltimore, MD standards for all entities performing 21244 Legal Deadline: None laboratory testing based on test Phone: 410 786-3417 Abstract: This rule will respond to complexity. This rule was published on RIN: 0938–AE12 public comments received on a final February 28, 1992, and was effective
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
September 1, 1992. This regulation was early detection of health problems. The Timetable: revised by regulations with comment Department does not at this time have Action Date FR Cite periods published on January 19, 1993, an estimate of the magnitude and December 6, 1994, April 24, 1995, and severity of these types of risks, but NPRM 10/01/93 58 FR 51288 May 12, 1997. believes that both the original NPRM Comment 11/30/93 regulations and the revisions will, on Period End Issues addressed in this rule include Final Action 00/00/00 quality control; quality assurance; balance, contribute to better diagnosis. personnel standards; cytology Timetable: Small Entities Affected: Undetermined requirements; proficiency testing (PT) Action Date FR Cite Government Levels Affected: State, requirements; employee workplace drug Local testing; and other issues raised by NPRM 05/21/90 55 FR 20896 commenters based on experience with Comment Period End 09/21/90 Additional Information: MB-028 CLIA implementation. Final Rule With 02/28/92 57 FR 7002 Comment Period Agency Contact: Cindy Ruff, Center for The Clinical Laboratory Improvement Next Action Undetermined Medicaid and State Operations, Advisory Committee (CLIAC), which is Department of Health and Human Small Entities Affected: Businesses composed of members of professional Services, Health Care Financing organizations and private citizens, is Government Levels Affected: None Administration, C4-16-08, 7500 actively involved in making Additional Information: HSQ-226 Security Boulevard, Baltimore, MD recommendations regarding technical 21244 and scientific aspects of the regulations. Agency Contact: David Cade, Family Phone: 410 786-5916 In addition, we actively solicit & Children’s Health Programs Group, comments from outside organizations Center for Medicaid and State RIN: 0938–AE72 such as the American Medical Operations, Department of Health and Association, the Association of State Human Services, Health Care Financing 1153. PAYMENT FOR NURSING AND and Territorial Public Health Administration, 7500 Security Blvd., ALLIED HEALTH SCIENCE Laboratory Directors, and other Baltimore, MD 21244 EDUCATION (HCFA-1685-F) professional and medical organizations Phone: 410 786-3870 regarding the interpretive guidelines for Priority: Other Significant surveyors. RIN: 0938–AE47 Legal Authority: PL 101-239, Sec 6205; Summary of the Legal Basis: This rule PL 101-508, Sec 4004; PL 101-508, Sec 1152. EARLY AND PERIODIC summarizes and responds to CLIA 4159; 42 USC 1395x recommendations and public comments SCREENING, DIAGNOSTIC, AND to several previously published CLIA TREATMENT (EPSDT) SERVICES (MB- CFR Citation: 42 CFR 413 regulations. 28-F) Legal Deadline: Final, Statutory, June Alternatives: We continually assess Priority: Substantive, Nonsignificant 30, 1990. ongoing program experience and input Legal Authority: 42 USC 1396a(a)(43); Abstract: This rule will set forth our from laboratories and our partners in 42 USC 1396d(r) carrying out CLIA-related activities. policy for the payment of the costs of Issues not requiring regulation changes CFR Citation: 42 CFR 441.50; 42 CFR approved nursing and allied health are addressed using administrative 440.40 science programs, as directed by section 6205(b)(2) of OBRA ’89. For the mechanisms. Legal Deadline: None most part, the provisions set forth in Anticipated Costs and Benefits: It is Abstract: Section 1905(r) of the Social this rule restate or clarify our current not possible to project costs and Security Act, added by section 6403 of policies governing these costs, which benefits of the rule at this time. These OBRA ’89 defines the following EPSDT were previously set forth in the regulations serve to ensure consistent, services: screening services, vision provider reimbursement manual and reliable laboratory testing that is an services, dental services and hearing other documents, but have never been integral part of ensuring that services. EPSDT services also are included in the regulations. In addition, individuals receive appropriate defined to include such other necessary we are amending the list of approved treatment. health care, diagnostic services, programs and clarifying payment rules Risks: Inferior and inappropriate treatment, and other measures for certified registered nurse anesthetist laboratory testing can result in described in section 1905(a) of the Act programs. This rule will also address misdiagnosis causing patient harm. to correct or ameliorate defects, section 4004 of OBRA ’90 which CLIA reduces the potential for illnesses and conditions discovered by provides that, effective with cost inaccurate diagnosis resulting from the screening services whether or not reporting periods beginning on or after poorly performed laboratory testing the services are covered under the State October 1, 1990, under certain since entities must meet requirements plan. Section 1902(a)(43) of the Act conditions, costs incurred by a hospital (e.g., quality assurance, proficiency requires States to report to the or educational institution related to the testing, quality control, personnel Secretary certain information about hospital for clinical training are treated requirements) that have a direct impact EPSDT services provided under the as pass-through costs and paid on the on laboratory testing results. Overly plan during each fiscal year. This rule basis of reasonable cost even though stringent standards could, however, would set forth requirements to the hospital does not operate the discourage needed testing and reduce implement these statutory provisions. education programs.
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Timetable: Action Date FR Cite Small Entities Affected: None Action Date FR Cite NPRM Comment 02/28/94 Government Levels Affected: None Period End NPRM 09/22/92 57 FR 43659 Additional Information: HSQ-175 Final Action 00/00/00 NPRM Comment 11/23/92 TIMETABLE: This regulation may be Period End Small Entities Affected: None published only with the concurrence of Final Action 00/00/00 Government Levels Affected: None the U.S. District Court in Smith v. Small Entities Affected: None Additional Information: HCFA-3706-F Shalala. Government Levels Affected: None Agency Contact: Regina Walker-Wren, Agency Contact: Helene Fredeking, Additional Information: HCFA-1685 Center for Health Plans and Providers, Director, Division of Outcomes and Division of Practitioner & Ambulatory Improvements, Department of Health Agency Contact: Marc Hartstein, Care, Department of Health and Human and Human Services, Health Care Center for Health Plans & Providers, Services, Health Care Financing Financing Administration, S2-21-27, Department of Health and Human Administration, C4-08-16, 7500 7500 Security Boulevard, Baltimore, Services, Health Care Financing Security Blvd., Baltimore, MD 21244 MD 21244 Administration, C5-08-27, 7500 Phone: 410 786-6735 Phone: 410 786-7304 Security Blvd., Baltimore, MD 21244 Phone: 410 786-4539 RIN: 0938–AE99 RIN: 0938–AF02 RIN: 0938–AE79 1155. CHANGES TO THE LONG-TERM 1156. REQUIREMENTS FOR CERTAIN CARE FACILITY SURVEY PROCESS HEALTH INSURING ORGANIZATIONS 1154. MEDICARE COVERAGE OF, (HCFA-3175-FC) AND OBRA'90 TECHNICAL AND APPLICATION OF THE AMENDMENTS (HCFA-1018-F) OUTPATIENT MENTAL HEALTH Priority: Substantive, Nonsignificant TREATMENT LIMITATION TO, Reinventing Government: This Priority: Substantive, Nonsignificant CLINICAL PSYCHOLOGIST AND rulemaking is part of the Reinventing Legal Authority: 42 USC 1396b(m); 42 CLINICAL SOCIAL WORKER Government effort. It will eliminate USC 1396a(e)(2)(A) SERVICES (HCFA-3706-F) existing text in the CFR. CFR Citation: 42 CFR 434.20 to 72; 42 Priority: Substantive, Nonsignificant Legal Authority: PL 101-239, Sec CFR 435.212; 42 CFR 435.326 6901(a); 42 USC 1395i-3; 42 USC Legal Authority: 42 USC 1395l(c); 42 1395aa(d); 42 USC 1396r Legal Deadline: None USC 1395x(hh)(2); 42 USC 1395x(ii) CFR Citation: 42 CFR 442; 42 CFR 488 Abstract: This final rule amends the CFR Citation: 42 CFR 410; 42 CFR 417; Medicaid regulations to apply Medicaid Legal Deadline: None 42 CFR 424 regulations governing prepaid health Legal Deadline: None Abstract: This final rule with comment plans to those health insuring period will amend the Medicare and organizations that provide or arrange Abstract: This rule will address Medicaid regulations by removing for health care services to Medicaid provisions of OBRA ’89 and OBRA ’90. obsolete long-term care survey forms, recipients but are not subject to the OBRA ’89 provides the services of guidelines, and procedures used by requirements for health maintenance clinical psychologists (CPs) and clinical State agencies when they evaluate a organizations (HMOs) set forth in social workers. It requires CPs to agree Medicare skilled nursing facility or a section 1903(m)(2)(A) of the Social to consult with the patient’s primary Medicaid nursing facility for Security Act. It also incorporates care or attending physician. (Also, it compliance with Federal certification technical amendments relating to HMO will eliminate the dollar limitation that requirements. Effective October 1, 1990, and/or competitive medical plan previously applied to mental health the application of new Federal enrollment, disenrollments, guaranteed services, although the 62.5 percent participation requirements for these eligibility, and provisional status limitation still applies). OBRA ’89 also facilities with an increased focus on included in OBRA ’90 and the provides coverage for clinical social actual or potential resident outcomes Balanced Budget Act of 1997. worker services, but places two has made the survey forms and process limitations on separate payment, which in existing regulations outdated. Timetable: apply to services provided to inpatients Retention of the outdated items can Action Date FR Cite of hospitals and skilled nursing cause confusion in connection with facilities that are Medicare directions State survey agencies must NPRM 05/09/94 59 FR 23820 participating. OBRA ’90 unbundled CP follow in determining facility NPRM Comment 07/08/94 Period End services from the definition of compliance. This rule is part of the Final Action 00/00/00 ‘‘inpatient hospital services.’’ It also Administration’s reinventing implements two sections (psychology government and regulatory reform Small Entities Affected: Organizations services in hospitals and consultation initiatives. Publication of this Government Levels Affected: None by social workers) of the Social regulation is dependent upon court Security Act Amendments of 1994. approval which has been sought. Additional Information: OMC-018 Timetable: Timetable: Agency Contact: Jane McClard, Center for Medicaid and State Operations, Action Date FR Cite Action Date FR Cite Department of Health and Human NPRM 12/29/93 58 FR 68829 Final Action 00/00/00 Services, Health Care Financing
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Administration, S3-02-14, 7500 1158. REFERRAL TO CHILD SUPPORT primary payer, rather than as the Security Blvd., Baltimore, MD 21244 ENFORCEMENT AGENCIES OF secondary payer. We also propose to Phone: 410 786-4460 MEDICAID FAMILIES (HCFA-2051-F) clarify the date of determination that Priority: Substantive, Nonsignificant an overpayment has occurred so that RIN: 0938–AF15 all parties would have a clear Legal Authority: 42 USC 1396k; 42 understanding of the period subject to USC 1302 payment of interest charges. 1157. ALTERNATIVE SANCTIONS FOR CFR Citation: 42 CFR 433.135; 42 CFR PSYCHIATRIC HOSPITALS (HCFA- Timetable: 433.137; 42 CFR 433.151; 42 CFR 2191-P) 433.160 Action Date FR Cite Priority: Substantive, Nonsignificant Legal Deadline: None NPRM 00/00/00 Small Entities Affected: None Legal Authority: 42 USC 1395cc; 42 Abstract: This rule will require State USC 1396a Medicaid agencies to refer Medicaid Government Levels Affected: None families with an absent parent to child Additional Information: BP0-108 CFR Citation: 42 CFR 488 support enforcement (CSE) agencies. Section 9142 of OBRA ’87 required CSE Agency Contact: John Albert, Office of Legal Deadline: None agencies to provide all CSE services to Financial Management, Department of such Medicaid families who have Health and Human Services, Health Abstract: This proposed rule would assigned to the State their rights to Care Financing Administration, S3-02- provide an alternative to terminating a medical support. The purpose of these 26, 7500 Security Boulevard, Baltimore, psychiatric hospital’s participation in rules is to require States to make this MD 21244 the Medicare and Medicaid programs referral to State CSE agencies to ensure Phone: 410 786-7457 for facilities found to be out of that those recipients requiring CSE RIN: 0938–AF87 compliance with participation services receive them. requirements. Alternative sanctions could be imposed instead of, or in Timetable: 1160. DESCRIPTION OF HCFA'S addition to, terminating a psychiatric Action Date FR Cite EVALUATION METHODOLOGY FOR hospital’s participation in the Medicare NPRM 09/22/93 58 FR 49272 THE PEER REVIEW ORGANIZATIONS and Medicaid programs when NPRM Comment 11/22/93 FIFTH SCOPE OF WORK CONTRACTS deficiencies do not pose immediate Period End (HCFA-3207-N) jeopardy to the health and safety of Final Action 00/00/00 Priority: Substantive, Nonsignificant psychiatric hospital patients. These amendments are necessary to conform Small Entities Affected: None Legal Authority: 42 USC 1302; 42 USC HCFA regulations to changes made by Government Levels Affected: State 1320c; 42 USC 1320c-2(h)(z) OBRA ’89 and OBRA ’90. The statutory Additional Information: HCFA-2051-F CFR Citation: 42 CFR part 462 and regulatory revisions are intended Legal Deadline: to encourage correction of deficiencies Agency Contact: Robert Nakielny, None that do not jeopardize patient health Center for Medicaid and State Abstract: This notice with comment and safety before termination of a Operations, Department of Health and period will provide general criteria and facility becomes necessary. Human Services, Health Care Financing standards that will be used to evaluate Administration, C4-21-01, 7500 the effective and efficient performance Timetable: Security Boulevard, Baltimore, MD of Utilization and Quality Control Peer Action Date FR Cite 21244 Review Organizations (known as PROs) Phone: 410 786-4466 for contracts entered into on or after NPRM 00/00/00 RIN: 0938–AF68 April 1, 1996. Small Entities Affected: Businesses, Timetable: Organizations 1159. ASSESSING INTEREST Action Date FR Cite AGAINST MEDICARE SECONDARY Government Levels Affected: NPRM 07/02/97 62 FR 35824 State, PAYER (MSP) DEBTS (HCFA-6108-P) Federal NPRM Comment 09/02/97 Priority: Substantive, Nonsignificant Period End Additional Information: HSQ-191 Legal Authority: 31 USC 3711; 42 USC Next Action Undetermined Agency Contact: Robert Streimer, 1395y(b)(2)(B) Small Entities Affected: None Center for Medicaid and State CFR Citation: 42 CFR 405.378; 42 CFR Government Levels Affected: None Operations, Disabled and Elderly 411.24(m); 42 CFR 411.39 Additional Information: HSQ-207 Health Program Group, Department of Legal Deadline: None Health and Human Services, Health Agency Contact: Heidi Gelzer, Office Care Financing Administration, S2-14- Abstract: This proposed rule would of Clinical Standards and Quality, 27, 7500 Security Boulevard, Baltimore, amend the regulations concerning Department of Health and Human MD 21244 interest charges on amounts owed to Services, Health Care Financing Phone: 410 786-6810 the Federal government when an Administration, S1-08-24, 7500 overpayment occurs because Medicare Security Boulevard, Baltimore, MD RIN: 0938–AF32 was billed and made payment as the 21244
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Phone: 410 786-9352 1162. MEDICARE PROGRAM: to participate in the Medicare and LIMITATIONS ON MEDICARE Medicaid programs. The revised RIN: 0938–AG32 COVERAGE OF INTERMITTENT requirements focus on patient care and POSITIVE PRESSURE BREATHING the outcomes of that care, reflect a 1161. DISCLOSURE OF MACHINE THERAPY (HCFA-3781-FN) cross-functional view of patient CONFIDENTIAL PRO AND ESRD Priority: Substantive, Nonsignificant treatment, encourage flexibility in NETWORK ORGANIZATION meeting quality standards, and Legal Authority: 42 USC 1395x(n); 42 INFORMATION FOR RESEARCH eliminate unnecessary procedural USC 1395y(a)(1)(A) PURPOSES (HCFA-3208-P) requirements. These changes are CFR Citation: 45 CFR 500 necessary to reflect advances in health Priority: Substantive, Nonsignificant Legal Deadline: None care practices since the requirements were last revised in 1986. Legal Authority: 42 USC 1320c-9; 42 Abstract: Intermittent positive pressure USC 1302 breathing (IPPB) machine therapy is Statement of Need: The purpose of the currently covered under Medicare as hospital conditions of participation is CFR Citation: 42 CFR 405.2115; 42 CFR to protect patient health and safety and 476.144 durable medical equipment for patients whose ability to breathe is severely help assure that quality care is Legal Deadline: None impaired. Based on an Office of Health furnished to all hospital patients. Technology Assessment Hospitals must meet the conditions of Abstract: This rule would allow Peer recommendation, we will place participation in order to participate in Review Organizations (PROs) to limitations on Medicare coverage of Medicare or Medicaid. Revised disclose confidential information to IPPB machine therapy. conditions are necessary to ensure that researchers without the consent of the our regulations focus primarily on the individuals who would be identified. Timetable: actual quality of care furnished to The research must be directly related Action Date FR Cite patients, and the outcomes of that care, to the purposes of the PRO or ESRD Proposed Notice 06/29/94 59 FR 33520 rather than on procedural compliance. program. Currently, PROs can only Comment Period End 08/29/94 These changes are intended to give disclose to the public nonconfidential Next Action Undetermined hospitals the flexibility needed to aggregate data where no one is achieve high-quality outcomes in the specifically identified. The statute, Small Entities Affected: None most cost-effective manner. however, provides for limited Government Levels Affected: None In addition, the regulations are disclosure and allows the Secretary to Additional Information: BPD-781 intended to promote a cross-functional, provide for disclosure in the interdisciplinary approach to hospital regulations while assuring adequate Agency Contact: Francine Spencer, Office of Clinical Standards and performance, instead of an approach protection of the rights and interests of geared towards evaluating each patients, health care practitioners, and Quality Coverage and Analysis Group, Department of Health and Human department of a hospital as a stand- providers. HCFA is now emphasizing alone entity. This approach is in line the sharing of PRO data for educational Services, Health Care Financing Administration, C4-04-05, 7500 with current best practices in hospitals, and research purposes as evidenced by in which patients routinely encounter the implementation of the Uniform Security Boulevard, Baltimore, MD 21244 many care-givers and services that often Clinical Data Set and the Health Care cut across department lines. Quality Improvement Initiative. This Phone: 410 786-4614 Summary of the Legal Basis: regulatory revision would make RIN: 0938–AG44 Section confidential PRO information accessible 1861(e) of the Social Security Act (the to researchers while still protecting the Act) provides that a hospital identities of beneficiaries and 1163. REVISION OF MEDICARE participating in the Medicare program practitioners from unwarranted HOSPITAL CONDITIONS OF must meet certain specified disclosure. PARTICIPATION (HCFA-3745-F) requirements. In addition, section Priority: Other Significant 1861(e)(9) of the Act specifies that a Timetable: Next Action Undetermined hospital also must meet such Reinventing Government: This requirements that the Secretary finds Small Entities Affected: None rulemaking is part of the Reinventing are necessary in the interest of the Government effort. It will revise text in Government Levels Affected: None health and safety of the hospital’s the CFR to reduce burden or patients. Under this authority, the Additional Information: HSQ-208 duplication, or streamline Secretary has established in regulations requirements. Agency Contact: Bill Roskey, Office of the requirements that a hospital must Clinical Standards and Quality, Legal Authority: 42 USC 1395x; 42 meet to participate in Medicare. These Department of Health and Human USC 1302; 42 USC 1395(cc); 42 USC requirements are set forth in regulations Services, Health Care Financing 1395(hh); 42 USC 1320(b)(8) at 42 CFR part 482, Conditions of Administration, S1-09-26, 7500 CFR Citation: 42 CFR 416; 42 CFR 482; Participation for Hospitals. Section Security Boulevard, Baltimore, MD 42 CFR 485; 42 CFR 489 1905(a) of the Act provides that Medicaid payments may be applied to 21244 Legal Deadline: None Phone: 410 786-0433 hospital services. Under regulations at Abstract: This final rule will revise the 42 CFR 440.10(a)(3)(iii), hospitals RIN: 0938–AG33 requirements that hospitals must meet generally are required to meet the
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Medicare conditions of participation in 1164. DISTINCT PART updated certificate fees that laboratories order to participate in Medicaid. REQUIREMENTS FOR NURSING must pay as required by CLIA ’88. Fee HOMES AND PROHIBITION OF increases are necessary to meet the Alternatives: HCFA considered the FINANCIAL SCREENING OF costs of program administration, which possibility of revising individual APPLICANTS FOR NURSING HOME are to be borne by the laboratories. sections of the current hospital ADMISSION (BPD-815-P) Timetable: regulations. However, we determined Priority: Other Significant that the best means of achieving the Action Date FR Cite systematic changes needed in the Legal Authority: 42 USC 1395i-3; 42 General Notice With 08/29/97 62 FR 45815 regulations was to revise the hospital USC 1396r(a); 42 USC 1302; 42 USC Comment Period conditions in their entirety. The 1395hh Comment Period End 10/28/97 specific areas that are likely to form CFR Citation: 42 CFR 409; 42 CFR 483 Next Action Undetermined the core of the revised requirements Legal Deadline: None Small Entities Affected: Businesses, include patient rights, patient Organizations Abstract: This proposed rule would assessment, patient care, quality define ‘‘distinct part’’ by specifying that Government Levels Affected: None assessment and improvement, and a distinct part is a physically Additional Information: HSQ-219 information management. identifiable unit of an institution (that Agency Contact: Judy Yost, Division of is, an entire ward, wing, floor, or Anticipated Costs and Benefits: There Outcomes and Improvements, building) including all beds in the unit. would not be significant costs Department of Health and Human This proposed rule would also prohibit associated with this final rule. The Services, Health Care Financing nursing homes from financially benefits that would be derived from the Administration, S2-09-28, 7500 screening private pay applicants for rule are discussed in the Need section, Security Blvd, Baltimore, MD 21244 admission. Instead, nursing homes above. Phone: 410 786-3531 would be permitted to charge private Risks: By revising these regulations to pay applicants up to a 2-month deposit RIN: 0938–AG87 focus on the quality of the actual care before admission to ensure that given to an individual and the sufficient funds are available to pay for 1166. CATEGORIZATION AND effectiveness of that care for the care which the individual may receive CERTIFICATION REQUIREMENTS FOR individual patient, we hope to reduce before discharge. A NEW SUBCATEGORY OF risks to beneficiaries’ health and safety. Timetable: MODERATE COMPLEXITY TESTING Revised procedures can better focus on Action Date FR Cite (HCFA-2222-F) ensuring that the care being given to Priority: Other Significant a patient is the care that is actually NPRM 00/00/00 Reinventing Government: This Small Entities Affected: Businesses necessary and effective for that patient. rulemaking is part of the Reinventing No quantitative estimates of risk Government Levels Affected: None Government effort. It will revise text in reductions are available yet. Additional Information: BPD-815 the CFR to reduce burden or duplication, or streamline Timetable: Agency Contact: Deborah Schoeneman, requirements. Action Date FR Cite Office of Clinical Standards & Quality, Department of Health and Human Legal Authority: 42 USC 263a NPRM 12/19/97 62 FR 66726 Services, Health Care Financing CFR Citation: 42 CFR 493.2; 42 CFR NPRM Comment 03/20/98 Administration, S2-19-04, 7500 493.3; 42 CFR 493.5; 42 CFR 493.18; Period End Security Blvd., Baltimore, MD 21244 42 CFR 493.20; 42 CFR 493.21; 42 CFR Final Action 00/00/00 Phone: 401 786-6771 493.25; 42 CFR 493.43; 42 CFR 493.45; 42 CFR 493.48; 42 CFR 493.49; 42 CFR Small Entities Affected: Businesses, RIN: 0938–AG84 493.51; 42 CFR 493.53; 42 CFR 493.638 Organizations Legal Deadline: None 1165. CLINICAL LABORATORY Government Levels Affected: None IMPROVEMENT AMENDMENT (CLIA) Abstract: As part of the CLIA program Additional Information: HCFA-3745-F FEE SCHEDULE REVISION (HCFA- (see RIN 0938-AE47), this rule will 3219-GNC) develop criteria for simple and easy- Agency Contact: Frank Emerson, to-use test systems that have Priority: Other Significant Office of Clinical Standards and demonstrated accuracy and precision Quality, Department of Health and Legal Authority: 42 USC 1302; 42 USC through scientific studies. We have Human Services, Health Care Financing 1395x(e); 42 USC 1395x(s)(11); 42 USC proposed to waive the routine 2-year Administration, C7-08-24, 7500 1395x(s)(12); 42 USC 1395x(s)(13); 42 survey of users of accurate and precise Security Boulevard, Baltimore, MD USC 1395x(s)(14); 42 USC 1395x(s)(15) technology (APT) tests, conducting 21244 CFR Citation: 42 CFR 493.638; 42 CFR surveys only if there are indications of Phone: 410 786-4656 493.639 problems or complaints. We also proposed that a small number of Legal Deadline: None RIN: 0938–AG79 surveys be conducted to validate the Abstract: This general notice with criteria for determining APT and to comment period will announce assure quality.
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Timetable: interest. Three of the standards in the past. It should be noted that Action Date FR Cite spontaneously required by section HCFA also is energetically pursuing 1834(j)(i)(B) were addressed in a final other opportunities to find and stop NPRM 09/15/95 60 FR 47982 rule with comment period published in abusive practices of all those who NPRM Comment 11/14/95 the Federal Register on December 11, furnish services to our beneficiaries. Period End 1995, (60 FR 3440). At the same time Therefore, the savings specifically Final Action 00/00/00 we incorporated the statutorily required associated with this rule are Small Entities Affected: None standards items in regulations, we indeterminable at this time. Government Levels Affected: None intensified our oversight of fraudulent Risks: Durable Medical Equipment and abusive supplier practices and Additional Information: HSQ-222 associations and leaders of the industry identified a number of additional join us in a quest to strengthen supplier Agency Contact: Judy Yost, Center for requirements that, if implemented, standards in order to keep out Medicaid and State Operations, would provide additional safeguards. fraudulent suppliers. As noted, many Division of Outcomes and Failure to comply with any one of the of the proposed requirements are good Improvement, Department of Health standards may result in revocation of business practices currently being met and Human Services, Health Care the supplier billing number. voluntarily. The supplies that Medicare Financing Administration, S2-09-28, Summary of the Legal Basis: Section patients need are abundantly available 7500 Security Blvd., Baltimore, MD 131 of the Social Security Act in all sections of the country, so that 21244 Amendments of 1994 (Public Law 103- no scarcity will result. Rather we Phone: 410 786-3531 432, enacted on October 31, 1994) believe that what these standards RIN: 0938–AG98 added a new subsection (j) to section would do in terms of protecting the 1834 of the Act dealing with supplier health and safety of beneficiaries and standards and required the Secretary to preserving the Medicare Trust Fund far 1167. ADDITIONAL SUPPLIER promulgate regulations setting forth outweighs any slight cutback in the STANDARDS (HCFA-1864-P) additional standards after consulting overall number of suppliers. Priority: Other Significant with representatives of suppliers, Timetable: carriers and consumers. Section 4312 Legal Authority: 42 USC 1302; 42 USC Action Date FR Cite 1395hh of the Balanced Budget Act of 1997 (Pub. L. 105-33) requires Durable NPRM 01/20/98 63 FR 2926 CFR Citation: 42 CFR 424.57 Medical Equipment suppliers to NPRM Comment 03/23/98 Legal Deadline: None provide the Secretary with a surety Period End Abstract: This rule would establish bond in an amount that is not less than Next Action Undetermined additional standards for entities seeking $50,000. The Secretary also issues Small Entities Affected: Businesses regulations under the general authority to qualify as Medicare suppliers for Government Levels Affected: None purposes of submitting claims for of section 1102 of the Social Security Additional Information: durable medical equipment and Act. HCFA-1864-P supplies. This rule is part of HCFA’s Alternatives: We believe it was the Agency Contact: Larry Bonander, regulatory reform initiative and Congress’ intent to strengthen DMEPOS Center for Health Plans and Providers, includes changes related to surety supplier standards to protect Department of Health and Human bonds as required by the Balanced beneficiaries and the Medicare program Services, Health Care Financing Budget Act of 1997. from potential fraud and abuse in Administration, C4-11-24, 7500 Security Boulevard, Baltimore, MD Statement of Need: Section 131 of The billing practices. The statutorily listed 21214 Social Security Act Amendments of supplier standards are minimal Phone: 410 786-4479 1994, established additional safeguards and we attempted to balance requirements that a supplier of durable any additional requirements against RIN: 0938–AH19 medical equipment, prosthetics, possible barriers to competition and orthotics, and supplies (DMEPOS) must adding burdens on the many small businesses involved in this area of 1168. CRITERIA AND PROCEDURES meet, effective January 1, 1996, in order FOR EXTENDING COVERAGE TO to obtain a number to bill the Medicare activity. For example, imposing requirements with respect to liability CERTAIN DEVICES AND RELATED program. In addition, the Amendments SERVICES (HCFA-3841-F) gave the Secretary of HHS insurance but not proposing a specified responsibility to develop other supplier minimum amount. Similarly, we are Priority: Other Significant standards. The requirements are proposing a requirement that suppliers Legal Authority: 42 USC 1395y(a)(1)(A) designed to protect beneficiaries from obtain a surety bond but suggest use of a sliding scale so that the final bond CFR Citation: 42 CFR 405.201 TO 215; abusive practices by suppliers. These 42 CFR 411.15; 42 CFR 411.406 legislative changes indicate that the amount will not discourage new Congress has serious concerns about participants to the Medicare program. Legal Deadline: None the business practices employed by Anticipated Costs and Benefits: In that Abstract: We published a final rule certain suppliers, and that beneficiaries the regulation will diminish the with comment period. It provided that require additional protection from these possibility of abusive suppliers getting certain medical devices with an practices. We believe it is the Congress’ or retaining a Medicare billing number, investigational device exemption intent to strengthen existing supplier the Trust Funds will not suffer from approved by the FDA may be covered standards in order to protect the public fraudulent and abusive practices found under Medicare. It set forth the process
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by which the FDA is to assist HCFA 1170. MEDICARE SECONDARY PAYER changes would provide oversight for in identifying nonexperimental CLARIFICATIONS AND AMENDMENTS CMHCs, help curtail inappropriate investigational devices that may be (HCFA-1865-P) utilization of partial hospitalization potentially covered under Medicare. Priority: Substantive, Nonsignificant services, and ensure Medicare payment This final rule responds to comments of reasonable and necessary services to on that rule and restates the policy after Legal Authority: 42 USC 1302; 42 USC eligible individuals. 1395hh considering the comments. Timetable: CFR Citation: 42 CFR part 411 Timetable: Action Date FR Cite Legal Deadline: None Action Date FR Cite NPRM 00/00/00 Abstract: This proposed rule would Final Rule 09/19/95 60 FR 48417 codify in regulations policies regarding Small Entities Affected: Undetermined Comment Period End 10/20/95 liability insurance, such as structured Effective Date 11/01/95 Government Levels Affected: liability settlements, future medical Next Action Undetermined Undetermined expenses, provider malpractice, Additional Information: BPD-871 Small Entities Affected: None wrongful death, and Federal Tort Agency Contact: Janet Samen, Center Government Levels Affected: None Claims Act policy. It would also clarify the rules dealing with group health for Health Plans and Policy, Additional Information: BPD-841 plan bankruptcies, religious orders, and Department of Health and Human Services, Health Care Financing Agency Contact: Sharon Hippler, foreign group health plans, and make Administration, C4-08-15, 7500 Office of Clinical Standards & Quality, numerous other changes. Security Boulevard, Baltimore, MD Department of Health and Human Timetable: 21244 Services, Health Care Financing Action Date FR Cite Phone: 410 786-9161 Administration, C4-11-04, 7500 Security Boulevard, Baltimore, MD NPRM 00/00/00 RIN: 0938–AH58 21244 Small Entities Affected: None Phone: 410 786-4633 Government Levels Affected: None 1172. MEDICAID HOSPICE CARE RIN: (HCFA-2016-P) 0938–AH21 Additional Information: BPD-865 Priority: Agency Contact: Herb Pollock, Center Substantive, Nonsignificant 1169. DELEGATION OF CIVIL MONEY for Health Plans & Providers, Division Legal Authority: 42 USC 1395hh; 42 PENALTIES (HCFA-6135-FC) of Integrated Services, Department of USC 1302 Priority: Substantive, Nonsignificant Health and Human Services, Health CFR Citation: 42 CFR 418.24; 42 CFR Care Financing Administration, C4-08- 418.28; 42 CFR 418.98; 42 CFR 440.167; Legal Authority: 42 USC 405(a); 42 27, 7500 Security Boulevard, Baltimore, USC 1302; 42 USC 1320a to 7a; 42 USC 42 CFR 440.250(q); 42 CFR 441; 42 CFR MD 21244 447 1395cc; 42 USC 1395u(j)(2); 42 USC Phone: 410 786-4474 1395hh; 42 USC 1395ii Legal Deadline: None RIN: 0938–AH52 CFR Citation: 42 CFR 402 Abstract: This proposed rule would provide for optional Medicaid coverage Legal Deadline: None 1171. CONDITIONS FOR of hospice care for terminally ill Abstract: This final rule with comment CERTIFICATION OF COMMUNITY recipients who elect to receive care period will contain the processes and MENTAL HEALTH CENTERS AND from a participating hospice, establish procedures to be undertaken in the COVERAGE REQUIREMENTS FOR eligibility requirements, covered imposition of civil money penalties and PARTIAL HOSPITALIZATION services, reimbursement procedures, assessments and in the appeals process. SERVICES (HCFA-1871-P) and conditions that a hospice must meet to provide services to Medicaid Timetable: Priority: Other Significant recipients. It would make conforming Action Date FR Cite Legal Authority: 42 USC 1395k; 42 technical revisions to the Medicare USC 1395x; 42 USC 1395cc Final Action 00/00/00 regulations governing hospice care. CFR Citation: 42 CFR 410.43; 42 CFR Timetable: Small Entities Affected: None 410.110; 42 CFR 410.150; 42 CFR Action Date FR Cite Government Levels Affected: None 410.172 Legal Deadline: NPRM 00/00/00 Additional Information: HCFA-6135-FC None Abstract: This proposed rule would Small Entities Affected: Governmental Agency Contact: Joel Cohen, Office of establish health and safety standards Jurisdictions, Organizations Financial Management, Department of that Community Mental Health Centers Health and Human Services, Health Government Levels Affected: State, (CMHCs) must meet to participate in Care Financing Administration, S3-11- Local the Medicare program. It would also 26, 7500 Security Boulevard, Baltimore, establish requirements for coverage of Additional Information: HCFA-2016-P MD 21244 partial hospitalization services Agency Contact: Tom Shenk, Center Phone: 410 786-3349 furnished by CMHCs or furnished in for Medicaid and State Operations, RIN: 0938–AH22 hospital outpatient settings. These Medicaid Bureau, Department of Health
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
and Human Services, Health Care 1174. PROVIDER AND SUPPLIER Portability and Accountability Act of Financing Administration, C4-13-01, ENROLLMENT AND RE-ENROLLMENT 1996) by establishing the Medicare 7500 Security Boulevard, Baltimore, REQUIREMENTS (HCFA-1023-P) Integrity Program to carry out Medicare MD 21244 Priority: Other Significant payment integrity activities. Under this Phone: 410 786-3295 program HCFA may enter into new Legal Authority: 42 USC 1302; 42 USC contracts with entities to perform these RIN: 0938–AH65 1395hh activities. This proposed rule would CFR Citation: 42 CFR 489 identify the services to be procured, set 1173. WAIVER OF STAFFING Legal Deadline: None forth competitive requirements, REQUIREMENTS FOR END STAGE establish procedures for identification, RENAL DISEASE (ESRD) FACILITIES Abstract: This proposed rule would evaluation, and resolution of conflicts PARTICIPATING IN AN EXPERIMENT establish conditions for enrolling of interest, and rules regarding (HCFA-2236-GNC) providers and suppliers that furnish contractor liability. In addition, this items or services to Medicare proposed rule would revise the list of Priority: Other Significant beneficiaries. These conditions would intermediary and carrier functions set Reinventing Government: This improve current enrollment procedures forth in existing regulations to make rulemaking is part of the Reinventing so as to more accurately identify such them consistent with sections 1816, Government effort. It will revise text in providers and suppliers and to secure 1842, and 1893 of the Social Security the CFR to reduce burden or information and documentation Act. duplication, or streamline necessary to the effective and efficient Statement of Need: The Health requirements. administration of the Medicare Insurance Portability and program. The more accurate Legal Authority: 42 USC 1302; 42 USC Accountability Act of 1996 (HIPAA), identification of providers and Public Law 104-191 creates the 1320; 42 USC 1395x; 42 USC 1395y; suppliers, coupled with the collection 42 USC 1395hh; 42 USC 1395rr Medicare Integrity Program (MIP). of certain information, will facilitate Among other things, it requires the CFR Citation: 42 CFR 405.2136; 42 CFR the administration of many aspects of Department to set forth procedures for 405.2161; 42 CFR 405.2162; 42 CFR the Medicare program including, but entering into contracts for the 405.2163 not necessarily limited to, monitoring performance of specific Medicare for compliance with program rules and Legal Deadline: None program integrity activities. combating fraud and abuse. Abstract: This general notice with Improvements in enrolling providers The MIP will help us shift emphasis comment period announces our and suppliers will afford both the from post-payment recoveries on intention to conduct a demonstration Medicare trust funds and program fraudulent claims to prepayment that would grant selected ESRD beneficiaries with greater protection. strategies to ensure claims are paid correctly the first time. It will allow facilities a 2-year waiver of staffing Timetable: Next Action Undetermined requirements. The ESRD staffing us to broaden our use of contractors requirements pertain to: the governing Small Entities Affected: Businesses to include a variety of contractors with body and management, director of a Government Levels Affected: None new and different skill sets, bringing innovation into the fraud and abuse facility, on-duty licensed health care Additional Information: HCFA-1023-P professionals, and providing adequate prevention arena. Through conflict of laboratory, social, and dietetic services. Agency Contact: Ralph Goldberg, interest provisions, it will permit us to Facilities would be given flexibility to Center for Health Plans and Providers, deal with the current phenomenon of deviate from specified regulation Provider Purchasing and diversification of ownership requirements, provided assurances are Administration Group, Department of arrangements, especially where in place ensuring that quality of care Health and Human Services, Health Medicare intermediaries and carriers standards are not being compromised. Care Financing Administration, S3-16- become closely allied with managed 07, 7500 Security Boulevard, Baltimore, care and other providers and suppliers. Timetable: MD 21244 Summary of the Legal Basis: Sections Action Date FR Cite Phone: 410 786-4870 1816(a) and 1842(a), (b) and (f) of the Final Action 00/00/00 RIN: 0938–AH73 Social Security Act, which pertain to contracting with intermediaries and Small Entities Affected: Businesses carriers remain in effect. HIPPA added 1175. MEDICARE PROGRAM; Government Levels Affected: None a new section 1893 to the Act, under MEDICARE INTEGRITY PROGRAM which HCFA is required to establish by Additional Information: HSQ-236 (HCFA-7020-P) regulation, procedures for awarding Agency Contact: William Roskey, Priority: Other Significant. Major under MIP contracts. Center for Medicaid and State 5 USC 801. Alternatives: We considered identifying Operations, Department of Health and Legal Authority: PL 104-191 specific situations in which we would Human Services, Health Care Financing CFR Citation: 42 CFR 400; 42 CFR 421 never award a contract because Administration, S1-09-07, 7500 potential conflicts of interest existed. Security Boulevard, Baltimore, MD Legal Deadline: None We favor an approach that permits an 21244 Abstract: This rule implements section offeror to mitigate conflicts, thereby Phone: 410 786-0433 1893 of the Social Security Act (added opening competition to both current RIN: 0938–AH72 by section 202 of the Health Insurance Medicare contractors and other entities.
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
We also considered whether the 1176. MEDICARE PROGRAM; insurers, employers, and State regulation should specify all the PHYSICIAN FEE SCHEDULE Medicaid agencies. information that would be needed in CONVERSION FACTOR FOR Timetable: all situations to determine whether a CALENDAR YEAR 1998 AND Action Date FR Cite conflict of interest exists. We decided SUSTAINABLE GROWTH RATE FOR on an approach that gives us flexibility FISCAL YEAR 1998 (HCFA-1893-FN) NPRM 00/00/00 to tailor our requirements for Priority: Other Significant. Major under Small Entities Affected: Businesses, information to the specific 5 USC 801. Governmental Jurisdictions procurement. Legal Authority: 42 USC 1395w-4 Government Levels Affected: State Anticipated Costs and Benefits: The Legal Deadline: None Additional Information: HCFA-2081-P Congress provided a direct Abstract: This notice announces the Agency Contact: Sue Knefley, Center appropriation from the Health calendar year 1998 Medicare physician for Medicaid and State Operations, Insurance Trust Funds for carrying out fee schedule conversion factor and the Department of Health and Human the Medicare Integrity Program. We fiscal year 1998 sustainable growth rate Services, Health Care Financing expect that, on average, every dollar for expenditures for physicians’ Administration, 7500 Security expended in fiscal year 1998 to perform services under the Medicare Boulevard, Baltimore, MD 21244 integrity functions will save $12 in Supplementary Medical Insurance (part Phone: 410 786-0488 Medicare program costs. B) program as required by sections 1848(d) and (f) of the Social Security RIN: 0938–AI21 Risks: The statute provides that we Act. may enter into MIP contracts without Timetable: 1178. ∑ COLLECTION OF USER FEES final rules having been published. Action Date FR Cite FROM MEDICARE+CHOICE PLANS However, the statute requires that we AND RISK-SHARING CONTRACTORS establish, by regulation, competitive ANPRM 10/31/97 62 FR 59261 (HCFA-1911-IFC) procedures to be used in awarding Next Action Undetermined Priority: Other Significant those contracts, as well as procedures Small Entities Affected: None for identifying, evaluating, and Legal Authority: 42 USC 1302; 42 USC resolving conflicts of interest, and Government Levels Affected: None 1395hh; 42 USC 1395mm(k)(4)(d) procedures under which a contract may Agency Contact: Terrence Kay, Center CFR Citation: 42 CFR 417.470; 42 CFR be renewed noncompetitively. It also for Health Plans and Providers, 417.472 requires that we provide, in regulations, Division of Practitioner and for limitation of a contractor’s liability Ambulatory Care, Department of Health Legal Deadline: None under the contract. We believe that this and Human Services, Health Care Abstract: This interim final rule with proposed rule should be published as Financing Administration, 7500 a request for comments establishes the soon as possible so that the procedures Security Blvd., C4-10-26, Baltimore, methodology that will be employed to related to conflicts of interest can be MD 21244 assess fees applicable to Medicare risk- established in regulations. Phone: 410 786-4497 sharing contractors for fiscal year (FY) RIN: 0938–AI16 1998. Under section 4002 of the Timetable: Balanced Budget Act of 1997, these Action Date FR Cite contractors must contribute their pro 1177. MEDICAID: MEDICAL CHILD rata share of costs relating to NPRM 03/20/98 63 FR 13590 SUPPORT (HCFA-2081-P) beneficiary enrollment, dissemination Final Action 00/00/00 Priority: Substantive, Nonsignificant of information, and certain counseling and assistance programs. The Small Entities Affected: None Legal Authority: 42 USC 1302; 42 USC 1396a(a)(60) Medicare+Choice regulation to be Government Levels Affected: None published in June of 1998 will CFR Citation: 42 CFR 433 implement this requirement for Additional Information: OFH-020-P, PL Legal Deadline: None Medicare+Choice plans. 104-191, sec. 202 Abstract: This proposed rule would Timetable: require States to provide assurances Agency Contact: Rodney Benson, Action Date FR Cite satisfactory to the Secretary that the Office of Internal Customer Support, State has in effect laws relating to Interim Final Rule 12/02/97 62 FR 63669 Department of Health and Human medical child support. This Effective Date 01/01/98 Services, Health Care Financing requirement would implement section Comment Period End 02/02/98 Administration, C2-02-17, 7500 13623 of the Omnibus Budget Next Action Undetermined Security Blvd., Baltimore, MD 21244 Reconciliation Act of 1993 (Public Law Small Entities Affected: None Phone: 410 786-9280 103-66), commonly cited as OBRA 1993. The medical child support laws Government Levels Affected: None RIN: 0938–AI09 that the States must have in effect are Agency Contact: Marty Abeln, Center set forth in section 1908 of the Social for Health Plans and Providers, Security Act (the Act). These laws Department of Health and Human would impose requirements on Services, Health Care Financing
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Administration, 7500 Security Blvd, S3- 1902(a)(10)(E)(iv)(I) and (II) of the Act. 1182. ∑ MEDICARE PROGRAM: USER 21-17, Baltimore, MD 21244-1850 In this notice, we are not applying FEES (HCFA-6021-P) Phone: 410 786-1032 precisely the statutory formula to Priority: Substantive, Nonsignificant RIN: 0938–AI35 determine the individual State allotments. A precise application of the Legal Authority: 31 USC 9701 allocation formula in the statue would CFR Citation: 42 CFR 401 1179. ∑ MEDICARE PROGRAM: require us to determine State-specific Legal Deadline: None PHYSICIANS' REFERRALS; ISSUANCE estimates of the number of individuals Abstract: OF ADVISORY OPINIONS (HCFA-1902- who are entitled to Medicare part A; This proposed rule would F) have incomes in the poverty level establish regulations relating to user fees for services HCFA provides that Priority: Substantive, Nonsignificant ranges specified; have assets not exceeding twice the amount allowed confer benefits on specific individuals Legal Authority: 42 USC 1395nn(g)(6) under the SSI program; and would not that are over and above those benefits received by the general public. CFR Citation: 42 CFR 411.370 to be eligible for Medicaid but for the 411.389 provisions of section 1902(a)(19)(E) of Timetable: Next Action Undetermined Legal Deadline: None the Act regarding QI’s. Small Entities Affected: None Abstract: This final rule will set forth Timetable: Next Action Undetermined Government Levels Affected: None the procedures HCFA will use to issue Small Entities Affected: None Agency Contact: David Escobedo, written advisory opinions to outside Government Levels Affected: State, Office of Financial Management, parties concerning whether a Federal Department of Health and Human physician’s referral of a Medicare Services, Health Care Financing beneficiary for certain designated Agency Contact: Miles McDermott, Administration, 7500 Security Blvd, health services is prohibited under Center for Medicaid and State Baltimore, MD section 1877 of the Social Security Act. Operations, Department of Health and Phone: 410 786-5401 Human Services, Health Care Financing Timetable: RIN: Administration, 7500 Security Blvd, 0938–AI46 Action Date FR Cite Baltimore, MD 21244 Interim Final Rule 01/09/98 63 FR 1646 Phone: 410 786-3722 1183. ∑ SURETY BOND Next Action Undetermined Email: mmcdermott REQUIREMENTS FOR RIN: 0938–AI39 COMPREHENSIVE OUTPATIENT Small Entities Affected: None REHAB. FACILITIES, REHAB. Government Levels Affected: None AGENCIES, COMMUNITY MENTAL 1181. ∑ MEDICARE PROGRAM: HEALTH CENTERS, AND Agency Contact: Joanne Sinsheimer, PAYMENTS FOR INDEPENDENT DIAGNOSTIC TESTING Technical Assistant, CHPPS, TELECONSULTATIONS IN RURAL FACILITIES (HCFA-1026-P) Department of Health and Human HEALTH PROFESSIONAL SHORTAGE Priority: Other Significant Services, Health Care Financing AREAS (HCFA-1906-P) Administration, 7500 Security Blvd, Legal Authority: 42 USC 1302; 42 USC Baltimore, MD 21244 Priority: Substantive, Nonsignificant 1395x(v); 42 USC 1395hh Phone: 410 786-4620 Legal Authority: 42 USC 105-33 CFR Citation: 42 CFR 413; 42 CFR 489 RIN: 0938–AI38 CFR Citation: 42 CFR 410.75; 42 CFR Legal Deadline: None 414.1; 42 CFR 414.62 Abstract: The Balanced Budget Act of 1180. ∑ MEDICAID PROGRAM; STATE Legal Deadline: None 1997 (BBA 1997) requires suppliers of ALLOTMENTS FOR PAYMENT OF Abstract: This proposed rule would durable medical equipment, home MEDICARE PART B PREMIUMS FOR provide for payment for health agencies, comprehensive QUALIFIED INDIVIDUALS: FEDERAL teleconsultation with regard to a outpatient rehabilitation facilities, and FISCAL YEAR 1998 (HCFA-2005-NC) Medicare beneficiary who resides in a rehabilitation agencies to furnish us Priority: Economically Significant. rural health professional shortage area. with a surety bond in order to Major under 5 USC 801. This proposed rule would also establish participate in the Medicare Program. The BBA 1997 also affords us the Unfunded Mandates: This action may a methodology for determining the discretion to require other health care affect State, local or tribal governments. amount of payment. providers (other than physicians or Timetable: Next Action Undetermined Legal Authority: 42 USC other practitioners) to furnish us with 1396a(a)(10)(E)(iv); 42 USC 1396u-3 Small Entities Affected: Businesses a surety bond to participate in the CFR Citation: Not yet determined Government Levels Affected: None Medicare program. This proposed rule discusses the implementation of these Legal Deadline: None Agency Contact: Craig Dobyski, provisions to require comprehensive Abstract: This notice announces the Program Analyst, CHPPS, Department outpatient rehabilitation facilities, availability of individual State of Health and Human Services, Health rehabilitation agencies, and certain allotments for Federal fiscal year 1998 Care Financing Administration, 7500 other providers and suppliers we have for the Medicaid payment of Medicare Security Blvd., Baltimore, MD selected to furnish us with a surety part B premiums for qualifying Phone: 410 786-4584 bond on a continuing basis in order to individuals identified under section RIN: 0938–AI44 participate in the Medicare program.
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Timetable: Next Action Undetermined CFR Citation: 42 CFR 409.10; 42 CFR Phone: 410 786-4510 Small Entities Affected: Businesses 410.2; 42 CFR 410.27; 42 CFR 410.28; RIN: 0938–AI56 42 CFR 410.30; 42 CFR 411.15; 42 CFR Government Levels Affected: None 412.50; 42 CFR 413.118; 42 CFR Agency Contact: Ralph Goldberg, 413.122; 42 CFR 413.124; 42 CFR 1186. ∑ SECURITY AND ELECTRONIC Center for Health Plans and Providers, 413.130; 42 CFR 413-New subpart L; SIGNATURE STANDARDS (HCFA- Department of Health and Human 42 CFR 489.20; 42 CFR 1003.101 to 0049-P) Services, Health Care Financing 102; 42 CFR 1003.105 Priority: Other Significant. Major under Administration, 7500 Security Blvd, Legal Deadline: Final, Statutory, 5 USC 801. Baltimore, MD 21244 November 1, 1998. Phone: 410 786-4870 Legal Authority: 42 USC 1320d Email: [email protected] Abstract: As required by sections 4521, CFR Citation: 45 CFR 142 subpart C RIN: 0938–AI48 4522, and 4523 of the Balanced Budget Act of 1997, this proposed rule would Legal Deadline: Final, Statutory, eliminate formula driven overpayment February 21, 1998. 1184. ∑ ADMINISTRATIVE APPEALS for certain outpatient hospital services Abstract: This rule would implement PROCESS FOR SUPPLIERS SEEKING extend reductions in payment for costs some of the requirements of the TO ENROLL IN MEDICARE PROGRAM of hospital outpatient services, and administrative simplification subtitle of (HCFA-1907-FC) establish in regulations a prospective the Health Insurance Portability and Priority: Substantive, Nonsignificant payment system for hospital outpatient Accountability Act of 1996. It proposes services (and for Medicare part B standards for the security of individual Legal Authority: 42 USC 1302; 42 USC services furnished to inpatients who health information and electronic 1395u(b)(3)(C); 42 USC 1395ff(b) have no part A coverage), effective signature use by health plans, health CFR Citation: 42 CFR 405.874 January 1, 1999. The prospective care clearing houses, and health care Legal Deadline: None payment system would simplify our providers. current payment system and apply to Abstract: This rule would establish an Timetable: Next Action Undetermined all hospitals, including those that are administrative appeal process whereby exempt from the inpatient prospective Small Entities Affected: Undetermined suppliers can request an appeal for a payment system. However, the determination that affects their Government Levels Affected: Medicare part B billing numbers. The Balanced Budget Act delays application Undetermined of the system to cancer hospitals until purpose of this rule is to update and Agency Contact: John Parmigiani, January 1, 2000. clarify our policy and the Office of Internal Customer Support, administrative appeal rights for current This proposed rule would also Department of Health and Human and prospective providers and implement section 9343(c) of the Services, Health Care Financing suppliers who are denied enrollment in Omnibus Budget Reconciliation Act of Administration, N3-14-14, 7500 the Medicare program or whose 1986, which prohibits Medicare Security Blvd., Baltimore, MD Medicare billing privileges are revoked. payment for nonphysician services Phone: 410 786-2976 Timetable: Next Action Undetermined furnished to a hospital outpatient by RIN: 0938–AI57 a provider or supplier other than a Small Entities Affected: None hospital unless the services are Government Levels Affected: None furnished under an arrangement with 1187. ∑ SURETY BOND FOR Agency Contact: Charles Waldhauser, the hospital. This section also SUPPLIERS OF MEDICAL EQUIPMENT Division of Provider/Supplier authorizes the Department of Health (HCFA-2007-P) Enrollment, Department of Health and and Human Services’ Office of Priority: Other Significant Human Services, Health Care Financing Inspector General to impose a civil Unfunded Mandates: This action may Administration, S1-03-07, 75 Security monetary penalty, not to exceed $2,000 affect State, local or tribal governments. Blvd., Baltimore, MD 21207-0476 against any individual who knowingly Phone: 410 786-6140 and willfully presents a bill in violation Legal Authority: 42 USC 1396(a)a of an arrangement. RIN: 0938–AI49 CFR Citation: 42 CFR 441 This proposed rule would also establish Legal Deadline: None in regulations the requirements for 1185. ∑ MEDICARE PROGRAM; designating certain entities as provider- Abstract: This proposed rule would PROSPECTIVE PAYMENT SYSTEM based or as a department of a hospital. establish in regulations a requirement FOR HOSPITAL OUTPATIENT (HCFA- that durable medical equipment Timetable: 1005-P) Next Action Undetermined suppliers be required to furnish Priority: Economically Significant. Small Entities Affected: Businesses Medicaid State agencies with a surety Major under 5 USC 801. Government Levels Affected: None bond in order to participate in the Medicaid program. This proposed rule Unfunded Mandates: This action may Agency Contact: Janet Wellham, affect the private sector under would implement section 4724(g) of the Center for Health Plans and Providers, Balanced Budget Act of 1997. PL 104-4. Department of Health and Human Legal Authority: PL 105-33, Sec 4521; Services, Health Care Financing Timetable: Next Action Undetermined PL 105-33, Sec 4522; PL 105-33, Sec Administration, 7500 Security Blvd, Small Entities Affected: Governmental 4523; PL 99-509, Sec 9343(c) Baltimore, MD 21244 Jurisdictions
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Government Levels Affected: State 1189. ∑ STATE CHILDREN HEALTH 1396r-4(f); 42 USC 1396r-4(h); 42 USC PLAN ALLOTMENTS AND PAYMENTS 1396r-4(i) Agency Contact: Mary Linda Morgan, TO STATES (HCFA-2114-FC) CFR Citation: Center for Medicaid and State Not yet determined Priority: Economically Significant. Operations, Department of Health and Legal Deadline: None Major status under 5 USC 801 is Human Services, Health Care Financing undetermined. Abstract: This notice announces the Administration, 7500 Security Blvd, Federal share disproportionate share C4-20-07, Baltimore, MD 21244 Unfunded Mandates: This action may hospital (DSH) allotments for Federal Phone: 410 786-2011 affect State, local or tribal governments. fiscal year (FFYs) 1998 through 2002. Email: [email protected] Legal Authority: 42 USC 1302 This notice also describes the methodology for calculating the Federal RIN: 0938–AI63 CFR Citation: 45 CFR 92.4; 45 CFR 95.1; 45 CFR 95.13; 45 CFR 95.503; 45 share DSH allotments for FFYs 2003 CFR 95.601; 45 CFR 95.611; 45 CFR and thereafter as well as announces the 1188. ∑ CHILD HEALTH INSURANCE 95.703; 42 CFR 459 FFY 1998 and FFY 1999 limitations on ALLOTMENTS FY 1999 (HCFA-2014-N) aggregate DSH payments States may Legal Deadline: None make to institutions for mental disease Priority: Other Significant. Major status Abstract: This interim final rule with (IMD) and other mental health under 5 USC 801 is undetermined. comment period will establish in facilities. It also provides clarification regulations the methodology and of the new requirement for direct DSH Unfunded Mandates: This action may procedures that HCFA will use to payment by the State on behalf of affect State, local or tribal governments. determine the fiscal year State managed care enrollees and the DSH allotments available to provide Federal reporting requirements required by Legal Authority: 42 USC 1302, PL 105- funding to individual States, section 4721(b) of the Balanced Budget 33, sec 4901 Commonwealths and Territories for Act of 1997. CFR Citation: Not yet determined expenditures for the new State Timetable: Next Action Undetermined Children’s Health Insurance Program Legal Deadline: None (CHIP) established under title XXI of Small Entities Affected: Undetermined the Social Security Act. Government Levels Affected: State Abstract: This notice provides advance notification of the reserved fiscal year This rule also establishes in regulations Agency Contact: Christine Hinds, (FY) 1999 State allotments available to the payment and grant award process Center for Medicaid and State provide Federal funding to individual that will be used for the States, the Operations, Department of Health and States, Commonwealths, and Territories Commonwealths and Territories to Human Services, Health Care Financing for expenditures in the new State claim and receive Federal financial Administration, 7500 Security Blvd, Children’s Health Insurance Program payment (FFP) for expenditures under Baltimore, MD 21244 established under title XXI of the Social the State Children’s Health Insurance Phone: 410 786-4578 Security Act. The reserved allotments Program and related Medicaid RIN: 0938–AI66 is determined in accordance with expansions. Timetable: Next Action Undetermined section 2104 of the Act. These reserved 1191. ∑ MEDICAID PROGRAM; HOME State allotments are estimates of States Small Entities Affected: Governmental AND COMMUNITY-BASED SERVICES FY 1999 title XXI allotments, assuming Jurisdictions (HCFA-2010-FC) that each State were to submit, and Government Levels Affected: receive approval for, a State child State, Priority: Substantive, Nonsignificant Federal health plan. Under title XXI the amount Unfunded Mandates: This action may of a State’s allotment for a fiscal year Agency Contact: Richard Strauss, affect State, local or tribal governments. Center for Medicaid and State is available for 3 years for States with Legal Authority: 42 USC 1302; PL 105- Operations, Department of Health and approved child health plans. 33, sec 4743 Human Services, Health Care Financing Timetable: Next Action Undetermined Administration, C4-18-26, 7500 CFR Citation: 42 CFR 440; 42 CFR 441 Security Boulevard, Baltimore, MD Small Entities Affected: Legal Deadline: None Governmental 21244 Abstract: This final rule with comment Jurisdictions Phone: 410 786-2019 period expands State flexibility in Email: [email protected] Government Levels Affected: State providing prevocational, educational RIN: 0938–AI65 and supported employment services Agency Contact: Richard Strauss, under the Medicaid home and Center for Medicaid and State community-based services waiver Operations, Department of Health and 1190. ∑ DSH PAYMENTS - provisions of section 1915(c) of the Human Services, Health Care Financing INSTITUTION FOR MENTAL DISEASE Social Security Act. Administration, C4-18-26, 7500 (HCFA-2007-P) Security Boulevard, Baltimore, MD Priority: Other Significant Timetable: Next Action Undetermined 21244 Unfunded Mandates: This action may Small Entities Affected: Undetermined Phone: 410 786-2014 affect State, local or tribal governments. Government Levels Affected: State Email: [email protected] Legal Authority: PL 105-33, sec Agency Contact: Bill Coons, Center for RIN: 0938–AI64 4721(b); 42 USC 1396r-4(a); 42 USC Medicaid and State Operations,
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Department of Health and Human October 1, 1997, including the use of 1195. ∑ ELIMINATION OF Services, Health Care Financing Mandatory Managed Care under a State APPLICATION OF FEDERAL Administration, 7500 Security Blvd, plan, requirements for beneficiary FINANCIAL PARTICIPATION LIMITS Baltimore, MD 21244 Choice, enrollment and termination (HCFA-2111-IFC) Phone: 410 786-5921 provisions, and primary care Priority: Substantive, Nonsignificant RIN: 0938–AI67 management services. It will also delete current regulations no longer required Legal Authority: 42 USC 1302 as a result of the BBA. Until this CFR Citation: 42 CFR 435 1192. ∑ REVISIONS TO PAYMENT regulation is published, States will be Legal Deadline: None POLICIES UNDER THE PHYSICIAN unable to use the BBA exception from FEE SCHEDULE AND OTHER PART B Choice requirements for rural areas and Abstract: This interim final rule with PAYMENT POLICIES FOR CALENDAR provisions of current regulations will comment period eliminates the YEAR 1999 AND THE REBASING OF remain in effect. requirement that Federal financial THE MEDICARE ECONOMIC INDEX participation income limits be applied (HCFA-1006-P) Timetable: Next Action Undetermined when States use less restrictive income and resource methodologies to Priority: Other Significant. Major under Small Entities Affected: Undetermined determine eligibility for aged, blind and 5 USC 801. Government Levels Affected: State, disabled individuals, as well as for the Unfunded Mandates: This action may Federal optional categorically needy and the affect the private sector under medically needy. This rule conforms PL 104-4. Agency Contact: Bruce Johnson, Center the application of the FFP limits to the Legal Authority: 42 USC 1395w-4; 42 for Medicaid and State Operations, policy that the use of less restrictive USC 1385x Department of Health and Human income methodologies are not subject Services, Health Care Financing to FFP limits. This change will give CFR Citation: 42 CFR 405; 42 CFR 414 Administration, 7500 Security Blvd, States additional flexibility in setting Legal Deadline: None Baltimore, MD 21244 Medicaid eligibility requirements. Abstract: This rule proposes updates to Phone: 410 786-6015 Timetable: Next Action Undetermined physician payments by Medicare as RIN: 0938–AI70 Small Entities Affected: None required by sections 1848 and 1861 of the Social Security Act. In this proposal Government Levels Affected: State we set forth policy involving resource- 1194. ∑ NEW AND PENDING Agency Contact: Jackie Wilder, Center based practice expense relative value DEMONSTRATION PROJECT for Medicaid and State Operations, units, payment for drugs, the use of PROPOSALS SUBMITTED PURSUANT Department of Health and Human private contracts by Medicare TO SECTION 1115(A) OF THE SOCIAL Services, Health Care Financing beneficiaries and rebasing the Medicare SECURITY ACT JULY, AUGUST, Administration, 7500 Security Blvd, Economic Index. SEPTEMBER, OCTOBER, AND C4-22-06, Baltimore, MD 21244 Timetable: Next Action Undetermined NOVEMBER 1997 Phone: 410 786-4579 Email: jwilder@hcfa. Small Entities Affected: Businesses Priority: Substantive, Nonsignificant RIN: 0938–AI73 Government Levels Affected: None Legal Authority: 42 USC 1315 Agency Contact: Stanley Weintraub, Center for Health Plans and Providers, CFR Citation: Not yet determined 1196. ∑ MEDICAID PROGRAM; Department of Health and Human CHANGES TO ELIGIBILITY OF NON- Legal Deadline: None Services, Health Care Financing U.S. CITIZENS (HCFA-2108-P) Administration, C4-10-26, 7500 Abstract: This notice lists any new, Priority: Substantive, Nonsignificant. Security Blvd, Baltimore, MD 21244- pending, approved, disapproved, and Major status under 5 USC 801 is 1850 withdrawn proposals for the undetermined. Phone: 410 786-4498 demonstration projects. Unfunded Mandates: Undetermined RIN: 0938–AI69 Timetable: Next Action Undetermined Legal Authority: 42 USC 1302; PL 104- 193, sec 401 to 403 1193. ∑ MANAGED CARE: GLOBAL Small Entities Affected: None CFR Citation: 42 CFR 435; 42 CFR 436; MEDICAID MANAGED CARE Government Levels Affected: 42 CFR 440 PROVISIONS IN THE BALANCED Undetermined Legal Deadline: None BUDGET ACT OF 1997 (HCFA-2001-P) Abstract: The Personal Responsibility Priority: Other Significant Agency Contact: Gloria Smiddy, Center for Medicaid and State and Work Opportunity Reconciliation Legal Authority: PL 105-33, sec 4701(a) Operations, Department of Health and Act of 1996 created changes in Federal CFR Citation: 42 CFR 430; 42 CFR 434; Human Services, Health Care Financing law making most non-U.S. citizens 42 CFR 435; 42 CFR 440 Administration, 7500 Security Blvd, ineligible for Supplemental Security Income (SSI). In most States, receipt of Legal Deadline: None C3-18-26, Baltimore, MD 21244 Phone: 410 786-7723 SSI confers automatic Medicaid Abstract: This regulation will include eligibility. Although many States have new BBA provisions that were effective RIN: 0938–AI71 elected optional eligibility, groups that
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
provide a basis for covering persons Government Levels Affected: None Abstract: This proposed rule would who do not receive SSI, some States Agency Contact: Ann Pash, Center for implement section 4441(a), 4442-4446, have not done so. In these States, these Health Plans and Providers, Department and 4448 of the Balanced Budget Act individuals would be left without of Health and Human Services, Health of 1997. Specific changes include: access to Medicaid (including Care Financing Administration, 7500 updating hospice payment rates, emergency services). To conform with Security Blvd, Baltimore, MD 21244 specifying payment according to the the new law, we are proposing Phone: 410 786-4516 site of service, modifying the hospice regulations that would result in the loss Email: [email protected] benefit periods, clarifying the services of Medicaid for qualified aliens in covered under the benefit, allowing those States that cover only SSI RIN: 0938–AI75 hospices to contract for physician recipients. We are also seeking services, allowing waivers of certain comments on whether there remains 1198. ∑ MEDICARE PROGRAM; staffing requirements for hospice care any statutory basis to continue ADVERTISING COSTS (HCFA-1880-P) programs in non-urbanized areas, and Medicaid coverage for these extending the period for physician Priority: Substantive, Nonsignificant. individuals. certification of an individual’s terminal Major status under 5 USC 801 is illness. Additionally, the proposed rule Timetable: Next Action Undetermined undetermined. would also clarify other current Small Entities Affected: None Unfunded Mandates: Undetermined policies. Government Levels Affected: Legal Authority: 42 USC 1302; 42 USC Timetable: Next Action Undetermined Undetermined 1395 x(v); 42 USC 1395 hh Small Entities Affected: None Agency Contact: Bob Tomlinson, CFR Citation: Not yet determined Government Levels Affected: Center for Medicaid and State Legal Deadline: None Operations, Department of Health and Undetermined Human Services, Health Care Financing Abstract: This proposed rule would Procurement: This is a procurement- Administration, 7500 Security Blvd, clarify our long-standing policy on related action for which there is a Baltimore, MD 21244 advertising costs that is found in statutory requirement. There is no Phone: 410 786-4463 section 2136 of the Medicare Provider paperwork burden associated with this Reimbursement Manual. Our policy is action. RIN: 0938–AI74 that advertising to solicit new patients Agency Contact: Carol Blackford, is an unallowable cost under Medicare. Center for Health Plans and Providers, 1197. ∑ MEDICARE PROGRAM; We would add a new section that Department of Health and Human ADVANCE REFUNDING OF DEBT AND addresses issues including, but not Services, Health Care Financing METHODOLOGY FOR REPAYMENT limited to, advertising for outreach Administration, 7500 Security Blvd, OF LOAN (HCFA-1777-P) programs and recruitment of new Baltimore, MD 21244 employees, and yellow pages Priority: Substantive, Nonsignificant. Phone: 410 786-5909 advertising. Major status under 5 USC 801 is Email: [email protected] undetermined. Timetable: Next Action Undetermined RIN: 0938–AI77 Unfunded Mandates: Undetermined Small Entities Affected: Businesses Legal Authority: 42 USC 1302; 42 USC Government Levels Affected: None 1200. ∑ STATE ALLOTMENTS FOR 1395hh; 42 USC 1395x(v) Agency Contact: William Gill, Center ADDITIONAL FEDERAL FUNDING OF CFR Citation: 42 CFR 413 for Health Plans and Providers, EMERGENCY HEALTH SERVICES Department of Health and Human FURNISHED TO UNDOCUMENTED Legal Deadline: None Services, Health Care Financing ALIENS: FEDERAL FISCAL YEARS Abstract: This proposed rule would Administration, 7500 Security Blvd, 1998 THROUGH 2001 amend current regulations to clarify our Baltimore, MD 21244 Priority: Other Significant. Major status policies regarding the treatment of Phone: 410 786-7156 under 5 USC 801 is undetermined. interest expense. The rule would Fax: 410 786-0594 require that, when only part of the Legal Authority: PL 105-33, sec 4723 RIN: 0938–AI76 interest on a loan is allowable, CFR Citation: Not yet determined repayment would be made first to that Legal Deadline: None portion of the loan on which expense 1199. ∑ MEDICARE HOSPICE CARE notice is allowable. This rule also would (HCFA-1022-P) Abstract: This notice announces the clarify how this policy is to be applied Priority: Substantive, Nonsignificant. in situations in which there are Federal fiscal year allotments that are Major status under 5 USC 801 is available to certain States to furnish multiple loans and one or more of the undetermined. loans are not related to patient care. emergency health services to In addition, we would define the Unfunded Mandates: Undetermined undocumented aliens. The 12 States allowable costs associated with advance Legal Authority: PL 105-33, sec having the highest number of refunding of debt, and clarify the 4441(a); PL 105-33, sec 4442 to 4446; undocumented aliens residing in the treatment of revenue and expenses. PL 105-33, sec 4448 State will receive limited Federal funds for fiscal years 1998 through 2001 as Timetable: Next Action Undetermined CFR Citation: 42 CFR 418 additional compensation for providing Small Entities Affected: Undetermined Legal Deadline: None emergency health services to the
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
undocumented alien population. This Department of Health and Human 1203. ∑ MEDICARE AND MEDICAID notice also describes the methodology Services, Health Care Financing PROGRAMS; SURETY BOND AND used to determine each State’s Administration, 7500 Security Blvd, CAPITALIZATION REQUIREMENTS allotment. Baltimore, MD 21244 FOR HOME HEALTH AGENCIES This notice implements section 4723 of Phone: 410 786-5855 (HCFA-1038-NC) the Balanced Budget Act of 1997, Email: [email protected] Priority: Routine and Frequent Public Law 105-33. RIN: 0938–AI79 Unfunded Mandates: This action may Timetable: Next Action Undetermined affect State, local or tribal governments Small Entities Affected: None and the private sector. 1202. ∑ REVISION OF PROCEDURES Government Levels Affected: State, Major: Undetermined FOR REQUESTING EXCEPTIONS TO Federal COST LIMITS FOR SNFS AND Legal Authority: 42 USC 1302; 42 USC Additional Information: HCFA-2000-N ELIMINATION OF 1395hh Agency Contact: Miles McDermott, RECLASSIFICATIONS (HCFA-1883-P) CFR Citation: Not yet determined Center for Medicaid and State Legal Deadline: None Operations, Department of Health and Priority: Other Significant. Major status Human Services, Health Care Financing under 5 USC 801 is undetermined. Abstract: The Balanced Budget Act of Administration, 7500 Security Blvd, 1997 requires each home health agency Unfunded Mandates: Baltimore, MD 21244 Undetermined to secure a surety bond in order to Phone: 410 786-3722 Reinventing Government: This participate in the medicare and medicaid programs. Our January 5, Email: [email protected] rulemaking is part of the Reinventing 1998 publication in the Federal Register RIN: 0938–AI78 Government effort. It will revise text in required each home health agency to the CFR to reduce burden or secure a bond that is the greater of 1201. ∑ MEDICAID PROGRAM; duplication, or streamline $50,000 or 15 percent of the annual EXTENSION OF WAIVER TO EXTEND requirements. amount paid to the home health agency MEDICAID ELIGIBILITY TIMEFRAMES Legal Authority: 42 USC 1302; 42 USC and submit the bond to HCFA or the (HCFA-2009-N) 1395hh states medicaid agency, or both, by Priority: Substantive, Nonsignificant February 27, 1998. This notice CFR Citation: 42 CFR 413.30 announces our intent to make technical Legal Authority: 42 USC 1302 changes to the January 5, 1998 CFR Citation: Not yet determined Legal Deadline: None document to help home health agencies secure surety bonds. These changes Legal Deadline: None Abstract: This proposed rule would were brought to our attention after the Abstract: Included in the passage of revise the procedures for granting publication of our January 5, 1998 final the Balanced Budget Act of 1997 Public exceptions to the cost limits for skilled rule. Law 105-33 are the development of the nursing facilities and retain the current Child Health Insurance Program, the procedures for exceptions to the cost Timetable: Next Action Undetermined extension of the Supplemental Security limits for home health agencies. It Small Entities Affected: None Income Insurance (SSI) cut off date for would remove the provision allowing Government Levels Affected: State, aliens, and the continuance of reclassification for all providers. Medicaid eligibility for children who Tribal lose SSI. These are changes in Federal Timetable: Next Action Undetermined Agency Contact: Ralph Goldberg, law that affect a large number of Center for Health Plans and Providers, individuals while placing a significant Small Entities Affected: Undetermined Department of Health and Human additional workload on States. Government Levels Affected: Services, Health Care Financing This notice protects Federal financial Undetermined Administration, 7500 Security Blvd, participation (FFP) State Medicaid Baltimore, MD 21244 expenditures for States with unusual Procurement: This is a procurement- Phone: 410 786-4870 volumes of eligibility redeterminations related action for which there is a RIN: 0938–AI82 caused by these recent changes in the statutory requirement. The agency has law. Under this provision, the usual not yet determined whether there is a FFP timeframe requirements are paperwork burden associated with this 1204. ∑ SOLVENCY STANDARDS FOR waived, and States are allowed up to action. PROVIDER-SPONSORED 120 days to process the unusual ORGANIZATIONS (HCFA-1011-IFC) volume of redeterminations. Agency Contact: Steve Raitzyk, Center Priority: Other Significant. Major status for Health Plans and Providers, under 5 USC 801 is undetermined. Timetable: Next Action Undetermined Department of Health and Human Small Entities Affected: None Services, Health Care Financing Unfunded Mandates: Undetermined Government Levels Affected: State Administration, 7500 Security Blvd, Legal Authority: 42 USC 1302; 42 USC Baltimore, MD 21244 1395w-21 to 1395w-27; 42 USC 1395hh Additional Information: HCFA-2009-N Phone: 410 786-4599 Agency Contact: Mark Ross, Center for CFR Citation: 42 CFR 422 Medicaid and State Operations, RIN: 0938–AI80 Legal Deadline: None
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
Abstract: This interim final rule with 1206. ∑ EXPANDED COVERAGE OF comments we received in response to a request for comments establishes BLOOD GLUCOSE MONITORS AND the January 5, 1998 final rule that solvency standards for provider- TEST STRIPS (HCFA-3003-IFC) pertains to the issues discussed in the sponsored organizations (PSO’s) under Priority: Other Significant March 4, 1998 notice, (HCFA-1038-N). the new Medicare+Choice Program. The Balanced Budget Act of 1997 requires Legal Authority: PL 105-33, Balanced Timetable: Next Action Undetermined Budget Act of 1997 the Secretary to establish these Small Entities Affected: None standards by April 1, 1998. CFR Citation: 42 CFR 410.38 Government Levels Affected: State, Legal Deadline: Timetable: Next Action Undetermined None Tribal Small Entities Affected: Undetermined Abstract: This interim final rule with comment period expands Medicare Agency Contact: Ralph Goldberg, Government Levels Affected: coverage for blood glucose monitors Center for Health Plans and Providers, Undetermined and test strips, under certain Department of Health and Human Services, Health Care Financing Agency Contact: Maureen Miller, conditions, to a diabetic beneficiary Administration, 7500 Security Blvd, Center for Health Plans and Providers, without regard to the beneficiary use Baltimore, MD 21244 Department of Health and Human of insulin. It implements part of section Phone: 410 786-4870 Services, Health Care Financing 4105 of the BBA ’97. Administration, 7500 Security Blvd., Timetable: Next Action Undetermined RIN: 0938–AI86 Baltimore, MD 21244 Small Entities Affected: None Phone: 410 786-1097 Government Levels Affected: None 1208. ∑ HOSPICE WAGE INDEX RIN: 0938–AI83 NOTICE (HCFA-1039-N) Agency Contact: Betty S. Burrier, Department of Health and Human Priority: Other Significant. Major status 1205. ∑ SCHEDULE OF PER- Services, Health Care Financing under 5 USC 801 is undetermined. BENEFICIARY LIMITATIONS ON HOME Administration, 7500 Security Blvd, HEALTH AGENCY COSTS FOR COST Baltimore, MD 21244-1850 Unfunded Mandates: Undetermined REPORTING PERIODS BEGINING ON Phone: 410 786-4649 Legal Authority: 42 USC 1395F(i) OR AFTER OCTOBER 1, 1997 (HCFA- RIN: 0938–AI85 1905-FC) CFR Citation: 42 CFR 418.306(c) Priority: Other Significant. Major status Legal Deadline: None under 5 USC 801 is undetermined. 1207. ∑ SURETY BOND REQUIREMENTS FOR HOME HEALTH Abstract: A revised Hospice Wage Unfunded Mandates: Undetermined AGENCIES (HCFA-1152.1-F) Index was published in the Federal Legal Authority: 42 USC 1395x; PL Priority: Substantive, Nonsignificant Register on August 8, 1997. This wage index was applicable for services 105-33, Balanced Budget Act of 1997 Unfunded Mandates: This action may provided beginning on October 1, 1997 affect State, local or tribal governments CFR Citation: 42 CFR 413.30 through September 1998. The revised and the private sector. Legal Deadline: Final, Statutory, April hospic wage index will be phased in 1998. Legal Authority: 42 USC 1302; 42 USC under a three year transition period. 1395hh The second transition year is scheduled Abstract: This final rule with comment CFR Citation: 42 CFR 441.16; 42 CFR to begin October 1, 1998. Annual period sets forth, in accordance with updates are required to begin with the section 4602 of the Balanced Budget 489.60 to 489.62; 42 CFR 489.65 to 489.67; 42 CFR 489.71; 42 CFR 489.73 start of the second transition year Act of 1997, a new schedule of (October 1, 1998). This note will limitations on home health agency Legal Deadline: None provide the wage index values for the costs that may be paid under the Abstract: This final rule revises several second transition year as required. medicare program for cost reporting provisions of the final rule with periods beginning on or after October comment period published in the Timetable: Next Action Undetermined 1, 1997. Federal Register on January 5, 1998 and Small Entities Affected: Undetermined Timetable: Next Action Undetermined establishes the surety bond compliance date, as described in a notice and final Government Levels Affected: Small Entities Affected: Undetermined rule published in the Federal Register Undetermined Government Levels Affected: on March 4, 1998. The March 4, 1998 Agency Contact: Carol Blackford, Undetermined documents advised the public that we Center for Health Plans and Providers, intended to make technical revisions to Agency Contact: Mike Bussacca, Department of Health and Human the January 5, 1998 final rule and Center for Health Plans and Providers, Services, Health Care Financing extend the February 27, 1998 Department of Health and Human Administration, 7500 Security Blvd, compliance date for all home health Services, Health Care Financing Baltimore, MD 21244 agencies to furnish a surety bond to Administration, 7500 Security Blvd., Phone: 410 786-5909 HCFA and/or state medicaid agency, or Baltimore, MD 21244-1850 Fax: 410 786-0169 both, until 60 days after the date of Phone: 410 786-4602 Email: [email protected] publication of this final rule. In this RIN: 0938–AI84 rule we are also responding to RIN: 0938–AI87
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration Long-TermSERVICES Actions(HCFA)(HHS) HHSÐHCFA Long-Term Actions
1209. ∑ MEDICARE PROGRAM; Small Entities Affected: Undetermined CFR Citation: Not yet determined STANDARDIZATION OF MEDICARE Government Levels Affected: Legal Deadline: None COVERAGE FOR BONE MASS Undetermined MEASUREMENTS (HCFA-3004-IFC) Agency Contact: Bill Larson, Office of Abstract: This notice announces the Priority: Other Significant. Major status Communications & Operations Support, receipt of an application from the under 5 USC 801 is undetermined. Department of Health and Human American Association of Ambulatory Unfunded Mandates: Undetermined Services, Health Care Financing Surgery Facilities, Inc. for recognition Administration, 7500 Security Blvd, as a national accreditation program for Legal Authority: 42 USC 1302; 42 USC ambulatory surgical centers that wish 1395hh; 42 USC 1395rr(b)(1); 42 USC Baltimore, MD 21244 Phone: 410 786-4639 to participate in the Medicare and BBA 4106 Medicaid programs. RIN: CFR Citation: 42 CFR 410; 42 CFR 414 0938–AI89 Timetable: Next Action Undetermined Legal Deadline: Other, Statutory, July 1, 1998. 1210. ∑ RECOGNITION OF THE Small Entities Affected: Organizations BBA Section 4106 AMERICAN ASSOCIATION FOR ACCREDITATION OF AMBULATORY Government Levels Affected: None Abstract: This interim final rule with SURGERY FACILITIES INC., FOR comment period provides for the Agency Contact: Joan C. Berry, Center AMBULATORY SURGICAL CENTERS for Medicaid and State Operations, standardization of coverage of bone PROGRAM (HCFA-2008-PN) mass measurements for qualified Department of Health and Human Medicare beneficiaries for services Priority: Info./Admin./Other Services, Health Care Financing furnished on or after July 1, 1998. It Unfunded Mandates: This action may Administration, 7500 Security Blvd, implements provisions in section 4106 affect the private sector under Baltimore, MD 21244 of the Balanced Budget Act of 1997. PL 104-4. Phone: 410 786-7233 Timetable: Next Action Undetermined Legal Authority: 42 USC 1395bb RIN: 0938–AI90
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Health Care Financing Administration (HCFA) CompletedHHS—HCFA Actions
1211. EFFECTIVE DATES FOR Completed: 1214. POST-CONTRACT BENEFICIARY PROVIDER AGREEMENTS AND Reason Date FR Cite PROTECTIONS AND OTHER SUPPLIER APPROVALS (HCFA-3139- PROVISIONS (OMC-003-F) F) Incorporated into RIN 02/16/98 0938-AI56 Priority: Substantive, Nonsignificant Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 417 Small Entities Affected: Businesses Completed: CFR Citation: 42 CFR 431; 42 CFR 442; Government Levels Affected: None 42 CFR 488; 42 CFR 489; 42 CFR 498 Reason Date FR Cite Agency Contact: Janet Wellham Completed: Withdrawn due to the 12/29/97 Phone: 410 786-4510 BBA of 1997 Reason Date FR Cite RIN: 0938–AD33 Small Entities Affected: Businesses Final Action 08/18/97 62 FR 43931 Government Levels Affected: None Final Action Effective 08/18/97 1213. RESIDENT ASSESSMENT IN Agency Contact: Tracy Jensen Small Entities Affected: Businesses LONG-TERM CARE FACILITIES Phone: 410 786-1033 (HCFA-2180-F) RIN: 0938–AE63 Government Levels Affected: State, Priority: Other Significant Federal CFR Citation: 42 CFR 483 1215. SALARY EQUIVALENCY Agency Contact: Diane Bavaria GUIDELINES FOR PHYSICAL Phone: 410 786-6773 Completed: THERAPY, RESPIRATORY THERAPY, Reason Date FR Cite SPEECH PATHOLOGY, AND RIN: 0938–AC88 OCCUPATIONAL THERAPY (HCFA- Final Action 12/23/97 62 FR 67174 1808-F) Final Action Effective 12/23/97 1212. PROHIBITION ON UNBUNDLING Priority: Other Significant. Major under OF HOSPITAL OUTPATIENT Small Entities Affected: Businesses, 5 USC 801. Organizations SERVICES (HCFA-1426-F) CFR Citation: 42 CFR 413.106 Priority: Other Significant Government Levels Affected: None Completed: Agency Contact: Cindy Hake CFR Citation: Reason Date FR Cite 42 CFR 409; 42 CFR 410; Phone: 410 786-3404 42 CFR 411; 42 CFR 412; 42 CFR 489; Final Action 01/31/98 42 CFR 1003 RIN: 0938–AE61 Final Action Effective 01/31/98
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DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration CompletedSERVICES Actions(HCFA)(HHS) HHSÐHCFA Completed Actions
Small Entities Affected: Businesses, CFR Citation: 42 CFR 484 1221. SCHEDULE OF LIMITS ON Organizations HOME HEALTH AGENCY COST PER Completed: Government Levels Affected: None VISIT FOR COST REPORTING Reason Date FR Cite PERIODS BEGINNING ON OR AFTER Agency Contact: Jacqueline Gordon OCTOBER 1, 1997 (BPD-904-FC) Phone: 410 786-4517 Final Action 03/10/97 62 FR 11035 Priority: Other Significant. Major under RIN: Final Action Effective 04/01/98 0938–AG70 5 USC 801. Small Entities Affected: Businesses CFR Citation: 42 CFR 50 1216. HOME HEALTH AGENCY PHYSICIAN CERTIFICATION Government Levels Affected: Local Completed: REGULATIONS (BPD-875-NC) Agency Contact: Mary Vienna Reason Date FR Cite Priority: Substantive, Nonsignificant Phone: 410 786-6940 Final Action 01/02/98 63 FR 89 CFR Citation: 42 CFR 424.22 Final Action Effective 01/01/98 RIN: 0938–AH74 Completed: Small Entities Affected: Businesses Reason Date FR Cite Government Levels Affected: None 1219. MEDICARE PROGRAM; Final Action 01/05/98 62 FR 59818 REVISIONS TO PAYMENT POLICIES Agency Contact: Michael Bussacca Small Entities Affected: Businesses, AND ADJUSTMENTS TO THE Phone: 410 786-4602 Organizations RELATIVE VALUE UNITS UNDER THE RIN: 0938–AI24 PHYSICIAN FEE SCHEDULE, OTHER Government Levels Affected: None PART B PAYMENT POLICIES FOR Agency Contact: Jennifer Carter CALENDAR YR 1998 (HCFA-1884-FC) 1222. SURETY BOND AND Phone: 410 786-4615 CAPITALIZATION REQUIREMENTS FOR HOME HEALTH AGENCIES RIN: 0938–AH59 Priority: Other Significant (HCFA-1152-FC) CFR Citation: 42 CFR 410; 42 CFR 414 Priority: Substantive, Nonsignificant 1217. MEDICARE PROGRAM; Completed: ESTABLISHMENT OF AN EXPEDITED Unfunded Mandates: This action may REVIEW PROCESS FOR MEDICARE Reason Date FR Cite affect State, local or tribal governments BENEFICIARIES ENROLLED IN HMOS, and the private sector. Final Action 10/31/97 62 FR 59048 CMPS, AND HCPPS (HCFA-1025-FC) CFR Citation: 42 CFR 441.16; 42 CFR Priority: Other Significant Small Entities Affected: Businesses 489.67 Completed: CFR Citation: 42 CFR 417.600; 42 CFR Government Levels Affected: None 417.604; 42 CFR 417.606; 42 CFR Reason Date FR Cite 417.608; 42 CFR 417.609; 42 CFR Agency Contact: Stanley Weintraub 417.614; 42 CFR 417.616; 42 CFR Phone: 410 786-4498 Final Action 01/05/98 63 FR 292 417.617; 42 CFR 417.618; 42 CFR Small Entities Affected: None RIN: 0938–AH94 417.620 Government Levels Affected: State, Completed: Tribal Reason Date FR Cite 1220. MEDICARE PROGRAM: Agency Contact: Ralph Goldberg MONTHLY ACTUARIAL RATES AND Phone: 410 786-4870 Final Action 04/30/97 62 FR 23368 MONTHLY SUPPLEMENTARY Final Action Effective 06/30/97 MEDICARE INSURANCE PREMIUM RIN: 0938–AI31 Small Entities Affected: None RATE BEGINNING JANUARY 1, 1998 Government Levels Affected: Federal (OACT-055-N) 1223. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY Agency Contact: Maureen Miller Priority: Substantive, Nonsignificant Phone: 410 786-1097 ACT (HIPPA) OF 1996: CFR Citation: 45 CFR 900 ADMINISTRATIVE SIMPLIFICATION RIN: 0938–AH62 Priority: Completed: Other Significant CFR Citation: 45 CFR 142 1218. USE OF THE OASIS AS PART Reason Date FR Cite OF THE CONDITIONS OF Completed: Final Action 11/04/97 62 FR 59715 PARTICIPATION FOR HOME HEALTH Reason Date FR Cite AGENCIES (HCFA-3238-F) Final Action Effective 11/01/97 Withdrawn - 02/12/98 Priority: Other Significant Small Entities Affected: None Superseded by Reinventing Government: This Individual Government Levels Affected: None rulemaking is part of the Reinventing Regulations Government effort. It will revise text in Agency Contact: Carter Warfield Small Entities Affected: None the CFR to reduce burden or Phone: 410 786-6396 duplication, or streamline Government Levels Affected: None requirements. RIN: 0938–AI03 Agency Contact: Karen Trudel
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00358 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda 22033
DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration CompletedSERVICES Actions(HCFA)(HHS) HHSÐHCFA Completed Actions
Phone: 410 786-9937 Legal Deadline: None carrier) will consider and the RIN: 0938–AI32 Abstract: This final rule with comment procedures it will follow in establishing period revises the Medicare provider realistic and equitable payment reimbursement regulations relative to amounts. 1224. ∑ MEDICARE PROGRAM: DELAY allowable costs and sets a limit on the Timetable: IN IMPLEMENTING ADJUSTMENTS TO valuation of a depreciable asset that PRACTICE EXPENSE RELATIVE Action Date FR Cite may be recognized in establishing an VALUE UNITS UNDER THE appropriate allowance for depreciation Interim Final Rule 01/07/98 63 FR 687 PHYSICIAN FEE SCHEDULE FOR and for interest on capital indebtedness Final Action 01/07/98 63 FR 687 CALENDAR YEAR 1998 (HCFA-1901- after a change of ownership that occurs Final Action Effective 03/09/98 NC) on or after December 1, 1997. These Small Entities Affected: None Priority: Info./Admin./Other provisions apply to providers that are Government Levels Affected: reimbursed on the basis of reasonable State, Legal Authority: 42 USC 1302; 42 USC Federal 1395w-4; 42 USC 1395hh costs. This change implements the mandate in section 4404 of the Agency Contact: William J. Long, Legal Deadline: None Balanced Budget Act of 1997 (Pub. L. Center for Health Plans and Providers, Abstract: This notice identifies 105-33). Department of Health and Human provisions in the Medicare Physician Timetable: Services, Health Care Financing Fee Schedule regulations that are Administration, C4-12-18, 7500 affected by the enactment of the Action Date FR Cite Security Blvd207, Baltimore, MD 21228 Balanced Budget Act of 1997 (BBA Final Action 01/09/98 63 FR 1379 Phone: 410 786-5655 1997). Section 4505 of the BBA 1997 Final Action Effective 01/09/98 Email: [email protected] postponed implementation of a Small Entities Affected: Businesses RIN: 0938–AI37 resource-based practice expense relative value unit system until January 1, 1999 Government Levels Affected: None 1227. ∑ MEDICARE PROGRAM: and provides for a 4-year transition. In Procurement: This is a procurement- REQUEST FOR PUBLIC COMMENTS addition, it provides for new practice related action for which there is a ON IMPLEMENTATION OF THE expense relative value units by May 1, statutory requirement. There is no MEDICARE+CHOICE PROGRAM AND 1998, thus requiring significant revision paperwork burden associated with this NOTICE OF TIMEFRAMES FOR of our proposal contained in the action. proposed rule published June 18, 1997 SUBMISSION OF APPLICATIONS FOR (62 FR 33158). Agency Contact: Ann Pash, Health CONTRACTS (HCFA-1014-N) Insurance Specialist, Department of Priority: Timetable: Health and Human Services, Health Info./Admin./Other Action Date FR Cite Care Financing Administration, 7500 Legal Authority: PL 105-33, sec 4001 Security Boulevard C5-03-03, CFR Citation: Not yet determined Final Action 10/31/97 62 FR 59267 Baltimore, MD 21207 Small Entities Affected: None Phone: 410 786-4516 Legal Deadline: None Government Levels Affected: None RIN: 0938–AI34 Abstract: This notice solicits public comments on issues related to Agency Contact: Stan Weinstraub, implementation of the Center for Health Plans and Providers, 1226. ∑ APPLICATION OF INHERENT Medicare+Choice Program. It also Department of Health and Human REASONABLENESS TO ALL includes preliminary information Services, Health Care Financing MEDICARE PART B SERVICES regarding applications procedures for Administration, 7500 Security Blvd, (OTHER THAN PHYSICIAN SERVICES) organizations that intend to contract C4-05-23, Baltimore, MD 21244 (HCFA-1908-IFC) with us to participate in the Phone: 410 786-4498 Priority: Other Significant Medicare+Choice Program. RIN: 0938–AI33 Legal Authority: 42 USC 1302; 42 USC Timetable: 1395hh Action Date FR Cite 1225. ∑ MEDICARE PROGRAM; LIMIT CFR Citation: 42 CFR 405 ON THE VALUATION OF Final Action 01/20/98 DEPRECIABLE ASSET RECOGNIZED Legal Deadline: None Final Action Effective 01/20/98 AS AN ALLOWANCE FOR Abstract: This interim final rule Small Entities Affected: None DEPRECIATION AND INTEREST ON implements section 4316 of the Government Levels Affected: None CAPITAL INDEBTEDNESS AFTER A Balanced Budget Act of 1997. It revises CHANGE OF OWNERSHIP (HCFA- the process for establishing a realistic Additional Information: Legal authority 1004-FC) and equitable payment amount for all sections 4001 of Public Law 105-33 Priority: Economically Significant. Medicare part B services (except Agency Contact: Tony Hausner, Center Major under 5 USC 801. physician services) when the existing for Health Plans and Providers, payment amounts are inherently Department of Health and Human Legal Authority: PL 105-33, sec 4404 unreasonable because they are grossly Services, Health Care Financing CFR Citation: 42 CFR 413.134(b); 42 excessive or deficient. This rule Administration, 7500 Security Blvd., CFR 413.134(f); 42 CFR 413.134(g) describes the factors HCFA (or its Baltimore, MD 21244
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00359 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 22034 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENT OFHealth HEALTH Care FinancingAND HUMAN Administration CompletedSERVICES Actions(HCFA)(HHS) HHSÐHCFA Completed Actions
Phone: 410 786-1093 RIN: 0938–AI45
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Administration for Children and Families (ACF) Proposed HHS—ACFRule Stage
1228. TITLE IV-E FOSTER CARE 1229. CONSTRUCTION OF HEAD Agency Contact: Howard Rolston, ELIGIBILITY REVIEWS AND CHILD START FACILITIES Director, Office of Planning, Research, AND FAMILY SERVICES STATE PLAN Priority: Other Significant and Evaluation, Department of Health REVIEWS, MEPA IMPLEMENTATION, and Human Services, Administration AND ASFA IMPLEMENTATION Legal Authority: 42 USC 9801 et seq for Children and Families, 7th Floor, CFR Citation: 45 CFR 1309 370 L’Enfant Promenade SW., Priority: Other Significant Legal Deadline: None Washington, DC 20447 Legal Authority: 42 USC 627; 42 USC Phone: 202 401-9220 671; 42 USC 1302; 42 USC 1320a-1a Abstract: This NPRM will establish Fax: 202 205-3598 procedures to be used by Head Start CFR Citation: 45 CFR 1355; 45 CFR agencies in requesting to use Head Start RIN: 0970–AB65 1356 grant funds to construct or renovate a Legal Deadline: Final, Statutory, July Head Start facility. 1231. BONUS TO REWARD HIGH 1, 1995. Timetable: PERFORMANCE STATES UNDER THE TEMPORARY ASSISTANCE FOR Abstract: This NPRM will propose Action Date FR Cite NEEDY FAMILIES BLOCK GRANT requirements that implement the NPRM 08/00/98 statutory provisions of the Social Priority: Other Significant Small Entities Affected: Governmental Security Act Amendments of 1994 on Legal Authority: 42 USC 603 (a)(4) review of State programs under parts Jurisdictions, Organizations B and E of the Social Security Act for Government Levels Affected: Local, CFR Citation: Not yet determined conformity with State Plan Tribal Legal Deadline: None requirements including the Adoption Agency Contact: Douglas Klafehn, Abstract: The Administration for and Safe Families Act requirements Deputy Associate Commissioner, Head Children and Families in consultation related to State plan issue. It will Start Bureau, Department of Health and with the National Governors’ propose requirements that govern on- Human Services, Administration for Association and the American Public site eligibility reviews that the Children and Families, P.O. Box 1182, Welfare Association, will propose a Administration for Children and Washington, DC 20013 formula for measuring State Families conducts to assure State Phone: 202 205-8569 performance under the Temporary agencies’ compliance with the statutory Assistance for Needy Families Block requirements under title IV-E of the RIN: 0970–AB54 Grant as the basis for payment of a Social Security Act for the eligibility bonus to high performing States. of foster care providers and the 1230. METHODOLOGY FOR eligibility of children in foster care. The DETERMINING CHILD POVERTY Timetable: NPRM will provide for enforcement of RATES Action Date FR Cite the prohibition on race-based Priority: discrimination in the foster care and Other Significant NPRM 06/00/98 adoptive placements. Legal Authority: 42 USC 613(i)(5) Small Entities Affected: None Timetable: CFR Citation: 45 CFR CFR 284(new) Government Levels Affected: State Action Date FR Cite Legal Deadline: None Agency Contact: Howard Rolston, NPRM 07/00/98 Abstract: This NPRM will propose a Director, Office of Planning, Research methodology to be used by States to and Evaluation, Department of Health Small Entities Affected: None determine their child poverty rates: and Human Services, Administration Government Levels Affected: State section 413(i) of the Social Security for Children and Families, 370 L’Enfant Act, as amended, requires that the Promenade SW., 7th Floor West, Additional Information: This action Secretary establish this methodology by Washington, DC 20447 was previously reported under RIN regulation and mentions three specific Phone: 202 401-9220 0970-AB60. factors which shall be included in the Fax: 202 205-3598 methodology. Agency Contact: Kathleen McHugh, RIN: 0970–AB66 CB/ACYF, Department of Health and Timetable: Human Services, Administration for Action Date FR Cite Children and Families, Washington, DC 1232. CHILD SUPPORT 20013 NPRM 06/00/98 ENFORCEMENT FOR INDIAN TRIBES Phone: 202 401-5789 Small Entities Affected: None Priority: Other Significant RIN: 0970–AA97 Government Levels Affected: State Legal Authority: 42 USC 655(f)
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DEPARTMENTAdministration OF HEALTH ANDfor Children HUMAN Proposedand SERVICES Families Rule (HHS) (ACF)Stage HHSÐACF Proposed Rule Stage
CFR Citation: Not yet determined This Tribal work activities program is Abstract: This regulation will Legal Deadline: None called the Native Employment Works implement the requirements in 42 USC (NEW) Program. 609(a)(8) which provides for a penalty Abstract: This NPRM will specify how Timetable: of 1 percent to 5 percent of a State’s tribes can obtain direct payments from Temporary Assistance for Needy the Department of Health and Human Action Date FR Cite Families (TANF) funds if the Secretary Services for provision of child support NPRM 07/00/98 of HHS determines that the State failed enforcement services if they submit a to meet the paternity establishment Small Entities Affected: None plan meeting the objectives of title IV- percentages or other performance D, including establishment of paternity Government Levels Affected: State, measures established by the Secretary. establishment, modification and Tribal, Federal enforcement of support orders, and Timetable: Agency Contact: John Bushman, location of absent parents. Director, Division of Tribal Services, Action Date FR Cite Timetable: Department of Health and Human NPRM 03/00/99 Action Date FR Cite Services, Administration for Children and Families, Office of Community Small Entities Affected: None NPRM 03/00/99 Services, 370 L’Enfant Promenade SW., Government Levels Affected: State Small Entities Affected: None Washington, DC 20447 Government Levels Affected: State, Phone: 202 401-2418 Agency Contact: Elizabeth C. Tribal Fax: 202 205-5887 Matheson, Director, Division of Policy Email: [email protected] and Planning, Department of Health Agency Contact: Elizabeth C. RIN: 0970–AB78 and Human Services, Administration Matheson, Director, Division of Policy for Children and Families, 370 L’Enfant and Planning, Department of Health Promenade SW., Mail Stop OCSE/DPP, and Human Services, Administration 1234. REFUGEE RESETTLEMENT Washington, DC 20447 for Children and Families, OCSE, 370 PROGRAM: RESPONDING TO TANF Phone: 202 401-9385 L’Enfant Promenade SW., Mail Stop: REPLACING AFDC Fax: 202 401-5559 OCSE/DPP, Washington, DC 20447 Priority: Other Significant Email: [email protected] Phone: 202 401-9386 Fax: 202 401-5559 Legal Authority: 8 USC 1522(a)(9) RIN: 0970–AB85 Email: [email protected] CFR Citation: 45 CFR 400 RIN: 0970–AB73 Legal Deadline: None 1236. CHILD ABUSE AND NEGLECT Abstract: This regulation will revise PREVENTION AND TREATMENT 1233. REQUIREMENTS FOR THE refugee resettlement program Priority: Substantive, Nonsignificant TRIBAL PROGRAMS regulations to respond to the Legal Authority: 42 USC 5101 et seq Priority: Other Significant Temporary Assistance for Needy Families (TANF) program replacing the CFR Citation: 45 CFR 1340 Legal Authority: 42 USC 612 Aid to Families with Dependent CFR Citation: 45 CFR 286(New); 45 Children (AFDC) program. Legal Deadline: None CFR 287(New) Timetable: Abstract: These proposed rules would Legal Deadline: None Action Date FR Cite amend current regulations to reflect statutory changes made by the CAPTA Abstract: NPRM 12/00/98 Amendments of 1996. This NPRM proposes a process for: the Small Entities Affected: None completion and submission of Tribal Timetable: TANF plans; the determination of Government Levels Affected: State Action Date FR Cite funding levels for Tribal Tanf grants; Agency Contact: Toyo Biddle, Director, establishing criteria to determine Division of Refugee Self-Sufficiency, NPRM 11/00/98 minimum work participation Department of Health and Human Small Entities Affected: Governmental requirements and time limits for Tribal Services, Administration for Children Jurisdictions TANF programs; and the review and and Families, 370 L’Enfant Promenade approval of Tribal TANF plans. This SW., Washington, DC 20447 Government Levels Affected: State NPRM proposes program requirements Phone: 202 401-9250 Agency Contact: Emily Cooke, for the application of penalties and for RIN: 0970–AB83 data collection and reporting. Department of Health and Human Services, Administration for Children The NPRM proposes procedures for and Families, CB/OCAN, 330 C Street planning and operating a program to 1235. CHILD SUPPORT NON- PERFORMANCE PENALTY SW., Room 2106, Switzer Building, make work activities available to Tribal Washington, DC 20201 Priority: members. Funds for this program are Substantive, Nonsignificant Phone: 202 205-8709 available to Indian tribes and Alaska Legal Authority: 42 USC 609(a)(8) Fax: 202 260-9351 Native organizations that operated a Job Email: [email protected] Opportunities and Basic Skills Training CFR Citation: 45 CFR 305 (JOBS) program in fiscal year 1995. Legal Deadline: None RIN: 0970–AB86
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DEPARTMENTAdministration OF HEALTH ANDfor Children HUMAN Proposedand SERVICES Families Rule (HHS) (ACF)Stage HHSÐACF Proposed Rule Stage
1237. HEAD START APPEAL removal and work for reunification or 1240. ∑ IMPLEMENTATION OF TIMELINES other permanent placements for ADOPTION & SAFE FAMILIES ACT OF Priority: Substantive, Nonsignificant children in foster care. In addition, REMAINING PROVISIONS OF THE there are areas of ambiguity in the 1997 AND OTHER TITLE IV-B/IV-E Legal Authority: 42 USC 9801 et seq current rule which need clarification to REGULATORY AMENDMENTS CFR Citation: 45 CFR 1303 assure consistent application of policy. Priority: Other Significant Legal Deadline: None Timetable: Abstract: This proposed amendment to Action Date FR Cite Legal Authority: 42 USC 620 to 628; 42 USC 629 to 629(c); 42 USC 670 to part 1303 will provide timelines and NPRM 09/00/98 selected procedural changes for 679 Small Entities Affected: None conducting administrative hearings on CFR Citation: 45 CFR 1355; 45 CFR Government Levels Affected: adverse actions taken against Head State 1356; 45 CFR 1357 Start agencies. Agency Contact: Judith Reich, Training Timetable: Specialist, Children’s Bureau, Legal Deadline: None Department of Health and Human Action Date FR Cite Abstract: This NPRM implements the Services, Administration for Children changes in titles IV-B and IV-E of the NPRM 06/00/98 and Families, DHHS/ACYF/ACF, Social Security Act as mandated by the Washington, DC 20013 Small Entities Affected: Governmental Adoption & Safe Families Act of 1997, Phone: 202 205-8713 Jurisdictions, Organizations Public Law 105-89. These changes Government Levels Affected: State, RIN: 0970–AB89 include: reasonable efforts, Local, Tribal dispositional (permanency) hearings, background checks, termination of Agency Contact: Douglas Klafehn, 1239. FAMILY CHILD CARE PROGRAM parental rights and procedures for Deputy Commissioner, Head Start OPTION FOR HEAD START expediting a fostercare child’s Bureau, Department of Health and PROGRAMS permanent placement and to assure the Human Services, Administration for Priority: Substantive, Nonsignificant child’s safety in all aspects. In addition, Children and Families, ACYF, P.O. Box Legal Authority: 42 USC 9801 et seq the NPRM will revise the title IV-B, 1182, Washington, DC 20013 subpart 1 planning requirements to Phone: 202 205-8569 CFR Citation: 45 CFR 1306 make the plans more accurately reflect RIN: 0970–AB87 Legal Deadline: None the amount of funding available to Abstract: This rule would allow Head Indian Tribes/Tribal Organizations Start programs to choose Family Child 1238. TITLE IV-E TRAINING through the program. Care as Head Start program option. Timetable: Priority: Substantive, Nonsignificant Timetable: Legal Authority: Action Date FR Cite 42 USC 672; 42 USC Action Date FR Cite 673 NPRM 02/00/99 NPRM 09/00/98 CFR Citation: 45 CFR 1356.60; 45 CFR 235.63 to 235.66(a) Small Entities Affected: Governmental Small Entities Affected: None Jurisdictions, Organizations Legal Deadline: None Government Levels Affected: State Government Levels Affected: State, Abstract: This NPRM will revise the Local, Tribal Agency Contact: Kathleen McHugh, title IV-E training regulations. The Director, Policy Division, Department of current title IV-E training regulations Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head Health and Human Services, are a carryover from the old title IV- Administration for Children and A regulations. They have never been Start, Bureau, Department of Health and Human Services, Administration Families, 330 C St. SW., Wasington, DC revised to reflect the different 20201 requirements and emphases that Public for Children and Families, ACYF, PO Box 1182, Washington, DC 20013 Phone: 202 401-5789 Law 96-272 placed on states regarding Email: [email protected] the removal of children from their Phone: 202 205-8569 homes, the efforts required to prevent RIN: 0970–AB90 RIN: 0970–AB94
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Administration for Children and Families (ACF) Final HHS—ACFRule Stage
1241. STANDARDS FOR SAFE Legal Deadline: None training and safety rules for children TRANSPORTATION and staff while en route and loading Abstract: This rule establishes Head and unloading of vehicles. Priority: Other Significant Start Performance Standards for the Legal Authority: 42 USC 9801 et seq safe transportation of Head Start children, including vehicle CFR Citation: 45 CFR 1310 requirements, driver qualifications and
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DEPARTMENTAdministration OF HEALTH ANDfor Children HUMAN and SERVICESFinal Families Rule (HHS) (ACF)Stage HHSÐACF Final Rule Stage
Timetable: identify and establish an alternative 1245. STATE LAW CONCERNING Action Date FR Cite agency to provide Head Start Services PATERNITY ESTABLISHMENT if the agency previously serving the Priority: Substantive, Nonsignificant NPRM 06/15/95 60 FR 31612 tribe is terminated. NPRM Comment 08/14/95 Legal Authority: 42 USC 666(a)(5) Period End Timetable: CFR Citation: 45 CFR 302.70; 45 CFR Final Action 02/00/99 Action Date FR Cite 303.5; 45 CFR 304.20 Small Entities Affected: Organizations NPRM 12/16/97 62 FR 65778 Legal Deadline: None Government Levels Affected: Local, Final Action 08/00/98 Abstract: Tribal This regulation covers Small Entities Affected: Organizations voluntary paternity establishment Agency Contact: Douglas Klafehn, Government Levels Affected: Tribal services offered by hospitals and birth Deputy Associate Commissioner, Head record agencies and specifies the types Start Bureau, Department of Health and Agency Contact: Douglas Klafehn, of other entities that may offer Human Services, Administration for Deputy Associate Commissioner, Head voluntary paternity establishment Children and Families, P.O. Box 1182, Start Bureau, Department of Health and services. The provision of such services Washington, DC 20013 Human Services, Administration for must include a requirement that such Phone: 202 205-8569 Children and Families, P.O. Box 1182, an entity use the same notice provision, RIN: 0970–AB24 Washington, DC 20013 materials, training, and evaluation as Phone: 202 205-8569 the ones used by the voluntary RIN: 0970–AB52 paternity establishment programs of 1242. STANDARDS FOR PURCHASE hospitals and birth record agencies. OF FACILITIES Timetable: Priority: Other Significant 1244. QUARTERLY WAGE AND UNEMPLOYMENT COMPENSATION Action Date FR Cite Legal Authority: 42 USC 9801 et seq CLAIMS REPORTING TO THE NPRM 01/05/98 63 FR 187 CFR Citation: 45 CFR 1309 NATIONAL DIRECTORY OF NEW NPRM Comment 03/06/98 Legal Deadline: None HIRES Period End Abstract: This regulation establishes Priority: Substantive, Nonsignificant Final Action 01/00/99 standards for the purchase of facilities Legal Authority: 42 USC 653A(g)(2)(B) Small Entities Affected: None as required by the Head Start Government Levels Affected: State, Improvement Act of 1992. CFR Citation: 45 CFR 303.108 (new) Local Timetable: Legal Deadline: None Agency Contact: Jan Rothstein, Action Date FR Cite Abstract: This regulation specifies the Program Specialist, Division of Policy NPRM 12/01/94 59 FR 61575 information on wages and and Planning, Department of Health NPRM Comment 01/30/95 unemployment compensation paid to and Human Services, Administration Period End individuals that certain State entities for Children and Families, OCSE, Final Action 08/00/98 will be required to provide to the DHHS, 370 L’Enfant Promenade SW., National Directory of New Hires on a Mail Stop: OCSE/DPP, Washington, DC Small Entities Affected: Organizations quarterly basis. 20447 Government Levels Affected: Local, Timetable: Phone: 202 401-5073 Tribal Fax: 202 401-5559 Action Date FR Cite Agency Contact: Douglas Klafehn, Email: [email protected] Deputy Associate Commissioner, Head NPRM 10/07/97 62 FR 52306 RIN: 0970–AB69 Start Bureau, Department of Health and NPRM Comment 12/08/97 Human Services, Administration for Period End Children and Families, P.O. Box 1182, Final Action 07/00/98 1246. AUTOMATED DATA PROCESSING REQUIREMENTS/STATE Washington, DC 20013 Small Entities Affected: None Phone: 202 205-8569 CASE REGISTRY Government Levels Affected: State, Priority: Other Significant RIN: 0970–AB31 Federal Legal Authority: 42 USC 654(24); 42 Agency Contact: Anne M. Benson, USC 654A(e) and 654A(f) 1243. DESIGNATION OF Program Specialist, Department of ALTERNATIVE AGENCY TO SERVE Health and Human Services, CFR Citation: 45 CFR 302.85; 45 CFR INDIAN TRIBAL CHILDREN Administration for Children and 304.20; 45 CFR 307 Priority: Substantive, Nonsignificant Families, OCSE, 370 L’Enfant Legal Deadline: Final, Statutory, Legal Authority: 42 USC 9801 et seq Promenade SW., Mail Stop: OCSE/DPP, August 22, 1998. Washington, DC 20447 Abstract: This regulation implements CFR Citation: 45 CFR 1302 Phone: 202 401-1467 statutory provisions in the Personal Fax: 202 401-5559 Legal Deadline: None Responsibility and Work Opportunity Email: [email protected] Abstract: This NPRM will specify a Reconciliation Act of 1996 related to process by which an Indian tribe may RIN: 0970–AB67 child support automation. It sets a
VerDate 09-APR-98 12:32 Apr 21, 1998 Jkt 179005 PO 00000 Frm 00363 Fmt 1254 Sfmt 1254 Y:\SGML\ADV42.006 adv42 22038 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Unified Agenda
DEPARTMENTAdministration OF HEALTH ANDfor Children HUMAN and SERVICESFinal Families Rule (HHS) (ACF)Stage HHSÐACF Final Rule Stage
deadline of October 1, 2000, for Department of Health and Human Timetable: implementation of new Automated Data Services, Administration for Children Action Date FR Cite Processing requirements for the Child and Families, OPS/OSS/OD, Room Support Enforcement Program. The rule 326F, 200 Independence Avenue SW., NPRM 07/23/97 62 FR 39610 also sets the framework to support Washington, DC 20201 Final Action 07/00/98 ACF’s standards for certifying Phone: 202 690-6639 Small Entities Affected: None computerized child support Fax: 202 401-6400 Government Levels Affected: State, enforcement systems and addresses RIN: 0970–AB71 Tribal security and confidentiality safeguards. The regulation also specifies what Agency Contact: Carmen Nazario, constitutes the minimum amount of 1248. GRANTS TO STATES FOR Associate Commissioner, Child Care information on child support cases ACCESS AND VISITATION Bureau, Department of Health and recorded in the State Case Registry that PROGRAMS Human Services, Administration for Children and Families, P.O. Box 1182, is necessary to operate the Federal Case Priority: Substantive, Nonsignificant Registry. Washington, DC 20013 Legal Authority: 42 USC 669B Phone: 202 690-6782 Timetable: CFR Citation: 45 CFR 303.109(New) RIN: 0970–AB74 Action Date FR Cite Legal Deadline: None NPRM 03/25/98 63 FR 14402 1250. TEMPORARY ASSISTANCE FOR Abstract: This regulation specifies the NPRM Comment 05/11/98 NEEDY FAMILIES (TANF) Period End monitoring, evaluating, and reporting of Final Action 08/00/98 State grants designed to support and Priority: Other Significant facilitate absent parents’ access to and Small Entities Affected: None Legal Authority: 42 USC 601; 42 USC visitation of their children. 601 note; 42 USC 603 to 604; 42 USC Government Levels Affected: State Timetable: 606 to 611; 42 USC 613; 42 USC 617; Agency Contact: Michael P. Fitzgerald, 42 USC 619; 42 USC 862a; 42 USC Action Date FR Cite Senior Computer Specialist, 1302; 42 USC 1308 Department of Health and Human NPRM 03/31/98 63 FR 15351 CFR Citation: 45 CFR 270 to 275(new) Services, Administration for Children Final Action 12/00/98 Legal Deadline: None and Families, DHHS Room 326F, 200 Small Entities Affected: None Independence Avenue SW., Abstract: This regulation governs key Washington, DC 20201 Government Levels Affected: State provisions of the new welfare block Phone: 202 401-6403 Agency Contact: David Arnaudo, grant program enacted in August 1996 as part of the Personal Responsibility RIN: 0970–AB70 Technical Advisor, Department of Health and Human Services, and Work Opportunity Reconciliation Administration for Children and Act of 1996 (PRWORA). This new 1247. AUTOMATED DATA Families, OCSE, 370 L’Enfant program, called the Temporary PROCESSING FUNDING LIMITATION Promenade SW., Mail Stop: OCSE/DPP, Assistance for Needy Families -- or TANF -- program, replaced the national Priority: Other Significant Washington, DC 20447 Phone: 202 401-5364 welfare program known as Aid to Legal Authority: PL 104-193, sec 344 Fax: 202 401-5559 Families with Dependent Children CFR Citation: 45 CFR 307.30 Email: [email protected] (AFDC) and the related programs known as the Job Opportunities and Legal Deadline: None RIN: 0970–AB72 Basic Skills Training Program (JOBS) Abstract: This regulation will set the and the Emergency Assistance (EA) allocation formula for the total amount 1249. CHILD CARE AND program. The regulation addresses the payable to a State for fiscal years 1996 DEVELOPMENT FUND five-year time limit, work, through 2001 based on the $400 million accountability, and data collection and in federal funds for automated child Priority: Other Significant reporting provisions of the new TANF support enforcement systems Legal Authority: 42 USC 618; 42 USC program. enhancements under the Personal 9858 Statement of Need: This regulation is Responsibility and Work Opportunity CFR Citation: 45 CFR 98; 45 CFR 99 necessary to provide States with a basic Reconciliation Act of 1996 (P.L. 104- set of rules which will assist them in 193). Legal Deadline: None implementing the TANF program. Timetable: Abstract: The Administration for Alternatives: There are no viable Children and Families will amend Action Date FR Cite alternatives. existing regulations which govern the NPRM 03/02/98 63 FR 10173 administration of the Child Care and Anticipated Costs and Benefits: No Final Action 08/00/98 Development Block Grant program. The additional costs to the public. Small Entities Affected: None purpose of this regulatory package will Risks: None. be to implement the legislative changes Timetable: Government Levels Affected: State contained in the Personal Agency Contact: Helen Morgan Smith, Responsibility and Work Opportunity Action Date FR Cite Electronic Benefits Transfer Specialist, Reconciliation Act of 1996. NPRM 11/20/97 62 FR 62124
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DEPARTMENTAdministration OF HEALTH ANDfor Children HUMAN and SERVICESFinal Families Rule (HHS) (ACF)Stage HHSÐACF Final Rule Stage
Action Date FR Cite Email: [email protected] Legal Deadline: None NPRM Comment 02/18/98 RIN: 0970–AB79 Abstract: This rule amends regulations Period End governing the case closure process in Final Action 08/00/98 1252. CHILD SUPPORT the child support enforcement program. Small Entities Affected: None ENFORCEMENT PROGRAM OMNIBUS Timetable: CONFORMING REGULATION Government Levels Affected: State, Action Date FR Cite Tribal, Federal Priority: Substantive, Nonsignificant NPRM 02/24/98 63 FR 9172 Additional Information: This action Reinventing Government: This NPRM Comment 04/27/98 includes information previously rulemaking is part of the Reinventing Period End reported under RIN 0970-AB64 and RIN Government effort. It will revise text in Final Action 11/00/98 0970-AB76. the CFR to reduce burden or duplication, or streamline Small Entities Affected: None Agency Contact: Mack Storrs, Director, requirements. Government Levels Affected: Division of Self-Sufficiency Programs, State, Department of Health and Human Legal Authority: 42 USC 1302 Local, Tribal Services, Administration for Children CFR Citation: 45 CFR 304; 45 CFR 305 Agency Contact: Elizabeth C. and Families, Office of Family Legal Deadline: None Matheson, Director, Division of Policy Assistance, 370 L’Enfant Promenade and Planning, Department of Health Abstract: SW., Washington, DC 20447 This rule eliminates child and Human Services, Administration Phone: 202 401-9289 support enforcement program for Children and Families, 370 L’Enfant Fax: 202 205-5887 regulations rendered obsolete or Promenade SW., Mail Stop: OCSE/DPP, Email: [email protected] inconsistent with the Personal Washington, DC 20447 Responsibility and Work Opportunity RIN: 0970–AB77 Phone: 202 401-9385 Reconciliation Act of 1996. Fax: 202 401-5559 Timetable: Email: [email protected] 1251. BONUS TO REWARD Action Date FR Cite DECREASE IN ILLEGITIMACY RIN: 0970–AB82 Interim Final Rule 06/00/98 Priority: Other Significant Small Entities Affected: None 1254. DATA COLLECTION AND Legal Authority: 42 USC 603 Government Levels Affected: State ELEMENTS FOR THE WELFARE TO CFR Citation: WORK PROGRAM 45 CFR 283(new) Agency Contact: Marilyn R. Cohen, Legal Deadline: None Program Specialist, Department of Priority: Other Significant Abstract: This regulation describes Health and Human Services, Legal Authority: 42 USC 611 how bonuses will be awarded to those Administration for Children and CFR Citation: 45 CFR 276(new) States that experience the largest Families, 370 L’Enfant Promenade SW., decreases in out-of-wedlock Mail Stop: OCSE/DPP, Washington, DC Legal Deadline: None childbearing and also reduce their 20447 Abstract: This interim final rule will abortion rates. The total amount of the Phone: 202 401-5366 Fax: 202 401-5559 specify the data elements that will have bonus will be $100 million in each of Email: [email protected] to be reported for the Welfare-to-Work fiscal years 1999 through 2002. RIN: 0970–AB81 program. Timetable: Timetable: Action Date FR Cite 1253. CASE CLOSURE Action Date FR Cite NPRM 03/02/98 63 FR 10264 Priority: Substantive, Nonsignificant Interim Final Rule 08/00/98 NPRM Comment 05/01/98 Period End Reinventing Government: This Small Entities Affected: None Final Action 10/00/98 rulemaking is part of the Reinventing Government effort. It will revise text in Government Levels Affected: State Small Entities Affected: None the CFR to reduce burden or Agency Contact: Howard Rolston, Government Levels Affected: State duplication, or streamline Director, Office of Planning, Research Agency Contact: Kelleen Kaye, Office requirements. and Evaluation, Department of Health of the Assistant Secretary for Planning Legal Authority: 42 USC 651 to 658; and Human Services, Administration and Evaluation, Department of Health 42 USC 660; 42 USC 663; 42 USC 664; for Children and Families, 370 L’Enfant and Human Services, Administration 42 USC 666; 42 USC 667; 42 USC 1302; Promenade SW., 7th Floor West, for Children and Families, 200 42 USC 1396a(a)(25); 42 USC Washington, DC 20447 Independence Avenue SW., 1396(d)(2); 42 USC 1396b(o); 42 USC Phone: 202 401-9220 Washington, DC 20201 1396b(p); 42 USC 1396(k) Fax: 202 205-3598 Phone: 202 401-6634 CFR Citation: 45 CFR 303.11 RIN: 0970–AB92
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Administration for Children and Families (ACF) CompletedHHS—ACF Actions
1255. INCOME ELIGIBILITY CRITERIA 1257. STATE CASE REGISTRY AND Completed: FOR INDIAN TRIBES EXPANSION OF THE FEDERAL Reason Date FR Cite Priority: PARENT LOCATOR SERVICE (FPLS) Substantive, Nonsignificant Final Action 12/05/97 62 FR 64301 CFR Citation: 45 CFR 1305 Priority: Substantive, Nonsignificant Small Entities Affected: None Completed: CFR Citation: 45 CFR 307 Government Levels Affected: State, Reason Date FR Cite Completed: Tribal, Federal Final Action 03/16/98 63 FR 12652 Reason Date FR Cite Agency Contact: Ann Burek Final Action Effective 04/15/98 Withdrawn - 03/02/98 Phone: 202 401-9223 Small Entities Affected: Organizations Incorporated Into RIN: 0970–AB84 RIN 0970-AB70 Government Levels Affected: Tribal Small Entities Affected: None Agency Contact: Douglas Klafehn 1259. TITLE IV-B PLANNING Phone: 202 205-8569 Government Levels Affected: State, REQUIREMENTS FOR TRIBES RIN: 0970–AB53 Federal Priority: Substantive, Nonsignificant Agency Contact: Anne M. Benson Reinventing Government: This 1256. INCOME AND RESOURCE Phone: 202 401-1467 rulemaking is part of the Reinventing DISREGARDS RELATED TO Fax: 202 401-5559 Government effort. It will revise text in INTERESTS OF INDIVIDUAL INDIANS Email: [email protected] the CFR to reduce burden or IN TRUST OR RESTRICTED LANDS RIN: 0970–AB68 duplication, or streamline requirements. Priority: Substantive, Nonsignificant CFR Citation: 45 CFR 1356; 45 CFR CFR Citation: 45 CFR 233 1258. PERSONAL RESPONSIBILITY AND WORK OPPORTUNITY 1357 Completed: RECONCILIATION ACT OF 1996 Completed: Reason Date FR Cite CONFORMING REGULATION Reason Date FR Cite Withdrawn - 03/02/98 Priority: Substantive, Nonsignificant Regulation no Merged With RIN 03/25/98 longer necessary Reinventing Government: This 0970-AB94 due to PRWORA of rulemaking is part of the Reinventing Small Entities Affected: Governmental 1996. Government effort. It will revise text in Jurisdictions Small Entities Affected: None the CFR to reduce burden or duplication, or streamline Government Levels Affected: State, Government Levels Affected: State requirements. Tribal Agency Contact: Mack A. Storrs CFR Citation: 45 CFR 205; 45 CFR 232; Agency Contact: Angelina, Palmiero Phone: 202 401-9289 45 CFR 233; 45 CFR 250; 45 CFR 255; Phone: 202 205-8666 RIN: 0970–AB59 45 CFR 256; 45 CFR 257 RIN: 0970–AB88
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Administration on Aging (AOA) Proposed HHS—AOARule Stage
1260. GRANTS FOR STATE AND CFR Citation: 45 CFR 1321; 45 CFR Timetable: COMMUNITY PROGRAMS ON AGING, 1324; 45 CFR 1326; 45 CFR 1327; 45 Action Date FR Cite INTRASTATE FUNDING FORMULAS; CFR 1328 TRAINING, RESEARCH AND NPRM - OAA 11/00/98 DISCRETIONARY PROGRAMS; Legal Deadline: None Amendments in FY '98 VULNERABLE ELDER RIGHTS; AND Unknown until law is reauthorized. GRANTS TO INDIANS & NATIVE Small Entities Affected: Businesses, Abstract: The Administration on Aging Governmental Jurisdictions HAWAIIANS (AoA) anticipates revising current rules Government Levels Affected: State, Priority: Substantive, Nonsignificant to reflect the changes resulting from the pending reauthorization of the Older Tribal Reinventing Government: This Americans Act which incorporates Additional Information: The rulemaking is part of the Reinventing greater flexibility for the States. Administration on Aging, in Government effort. It will revise text in PURPOSE: The purpose of these consultation with the Office of the CFR to reduce burden or revisions will be to implement new Management and Budget, has duplication, or streamline legislation on the development and determined that it is no longer requirements. provision of community-based services. necessary to pursue final action on rules earlier proposed to implement the Legal Authority: 42 USC 3001 et seq 1992 amendments to the Older Americans Act. The provisions of the
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DEPARTMENT OF HEALTH ANDAdministration HUMANProposed SERVICES on Aging Rule (HHS) (AOA)Stage HHSÐAOA Proposed Rule Stage
Act remain in force and need no further Agency Contact: Edwin Walker, 4733, Cohen Bldg., Washington, DC regulations to implement them. AoA Director, Office of Program Operations 20201 anticipates promulgating rules in the and Development, Department of Phone: 202 619-0011 latter part of 1998 to implement the Health and Human Services, RIN: provisions to the next reauthorization Administration on Aging, 330 0985–AA00 of the Older Americans Act, if Independence Avenue SW., Room [FR Doc. 98-8612 Filed 04-24-98; 8:45 am] necessary. BILLING CODE 4150-04-F]
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