| Food and Drug Administration--Proposed Rule Stage
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 1113
| Over-the-Counter (OTC) Drug Review
| 0910-AA01 |
|
| 1114
| Hearing Aids; Professional and Patient Labeling; Conditions for Sale
(Reg Plan Seq. No. 28) | 0910-AA39 |
|
| 1115
| Investigational New Drugs: Export Requirements for Unapproved New Drug Products
| 0910-AA61 |
|
| 1116
| Adverse Drug Reaction Reporting and Recordkeeping Requirements for Marketed OTC Drugs
| 0910-AA86 |
|
| 1117
| Direct-to-Consumer Promotion Regulations
| 0910-AA90 |
|
| 1118
| Labeling for Human Prescription Drugs; Revised Format
(Reg Plan Seq. No. 29) | 0910-AA94 |
|
| 1119
| Suspected Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products
| 0910-AA97 |
|
| 1120
| Use of Ozone-Depleting Substances
| 0910-AA99 |
|
| 1121
| Radioactive Drugs for Basic Research
| 0910-AB00 |
|
| 1122
| Administrative Practices and Procedures; Advisory Opinions and Guidelines
| 0910-AB14 |
|
| 1123
| Registration of Foreign Establishments and Product Listing
| 0910-AB21 |
|
| 1124
| Blood Initiative
| 0910-AB26 |
|
| 1125
| Suitability Determination for Donors of Human Cellular and Tissue-Based Products
| 0910-AB27 |
|
| 1126
| Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products
| 0910-AB28 |
|
| 1127
| Antibiotic Drug Approval and Exclusivity
| 0910-AB33 |
|
| 1128
| Applications for FDA Approval to Market a New Drug, Complete Response Letter; Amendments to Unapproved Applications
| 0910-AB34 |
|
| 1129
| Expanded Access to Investigational Therapies
| 0910-AB37 |
|
| 1130
| Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs
| 0910-AB39 |
|
| 1131
| Electronic Submission of Adverse Drug Reaction Reports
| 0910-AB42 |
|
| 1132
| Distinguishing Marks for Drug Products Containing Insulin
| 0910-AB43 |
|
| 1133
| Pregnancy Labeling
| 0910-AB44 |
|
| 1134
| Supplemental Manufacturing Changes for New Animal Drugs
| 0910-AB49 |
|
| 1135
| Pharmacy and Physician Compounding of Drug Products
(Reg Plan Seq. No. 30) | 0910-AB58 |
|
| 1136
| Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness
| 0910-AB59 |
|
| 1137
| Discontinuation of a Life-Saving Product
| 0910-AB60 |
|
| 1138
| Pediatric Exclusivity
| 0910-AB62 |
|
| 1139
| Positron Emission Tomography Drugs; Current Good Manufacturing Practices
| 0910-AB63 |
|
| 1140
| Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims
| 0910-AB66 |
|
| 1141
| Designated Journals
| 0910-AB67 |
|
| 1142
| Presubmission Conferences
| 0910-AB68 |
|
| 1143
| Current Good Manufacturing Practice for Medicated Feeds
| 0910-AB70 |
|
| 1144
| Citizen Petitions; Actions That Can Be Requested by Petition; Summary Denial; and Referral for Other Administrative Action
| 0910-AB73 |
|
| 1145
| CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection
(Reg Plan Seq. No. 31) | 0910-AB76 |
|
| 1146
| Antibiotic Resistance Labeling
| 0910-AB78 |
|
| 1147
| Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use
| 0910-AB79 |
|
| 1148
| Repackaging Approval Requirements
| 0910-AB81 |
|
| 1149
| Stability Testing of Drugs
| 0910-AB82 |
|
| 1150
| Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports
| 0910-AB83 |
|
| 1151
| Amendment of Various Food Additive and Device Regulations to Reflect Current American Society for Testing and Materials Citations
| 0910-AB84 |
|
| 1152
| Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements
(Reg Plan Seq. No. 32) | 0910-AB88 |
|
| 1153
| Current Good Manufacturing for Blood and Blood Components; Blood Labeling Standards; Direct Final Rule
| 0910-AB89 |
|
| 1154
| Submission in Electronic Format of Certain Labeling Information
| 0910-AB91 |
|
| 1155
| Fees Relating to Drugs; Waiver and Reduction of Fees
| 0910-AB92 |
|
| 1156
| Skip Lot Testing
| 0910-AB93 |
|
| 1157
| Food Additives: Food Contact Substances Notification System
| 0910-AB94 |
References in boldface appear in the Regulatory Plan in Part II of this issue of the
| Food and Drug Administration--Final Rule Stage
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 1158
| New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
| 0910-AA02 |
|
| 1159
| Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and Clarifications
| 0910-AA08 |
|
| 1160
| Biological Product: Post-Marketing Surveillance Reports of Information Affecting Biological Product Safety and Quality
| 0910-AA12 |
|
| 1161
| Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices
(Reg Plan Seq. No. 33) | 0910-AA43 |
|
| 1162
| Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals
| 0910-AA45 |
|
| 1163
| Bioavailability and Bioequivalence Requirements
| 0910-AA51 |
|
| 1164
| Drugs Used for Treatment of Narcotic Addicts
| 0910-AA52 |
|
| 1165
| Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition
| 0910-AA74 |
|
| 1166
| New Drug Applications; Drug Master File
| 0910-AA78 |
|
| 1167
| Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening Illnesses
| 0910-AA84 |
|
| 1168
| Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation
| 0910-AA88 |
|
| 1169
| Informed Consent for Human Drugs and Biologics; Determination That Informed Consent Is Not Feasible
| 0910-AA89 |
|
| 1170
| Current Good Manufacturing Practice; Revision of Certain Labeling Controls
| 0910-AA98 |
|
| 1171
| Veterinary Feed Directives
| 0910-AB09 |
|
| 1172
| New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification
| 0910-AB12 |
|
| 1173
| Exports; Reporting and Recordkeeping Requirements
| 0910-AB16 |
|
| 1174
| Medicated Feed Mill Licenses
| 0910-AB18 |
|
| 1175
| Public Information; Communications With State and Foreign Government Officials
| 0910-AB22 |
|
| 1176
| 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 |
|
| 1177
| Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements
(Reg Plan Seq. No. 34) | 0910-AB30 |
|
| 1178
| Progestational Drug Products for Human Use; Requirements for Labeling Directed to the Patient
| 0910-AB45 |
|
| 1179
| Revisions to the General Safety Requirements for Biological Products; Direct Final Rule
| 0910-AB51 |
|
| 1180
| Bulk Drug Substances for Use in Pharmacy Compounding
| 0910-AB57 |
|
| 1181
| Manufacturing Changes for Drugs
| 0910-AB61 |
|
| 1182
| Classification of Sheep as a Minor Species for All Data Collection Purposes
| 0910-AB69 |
|
| 1183
| 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications
| 0910-AB80 |
|
| 1184
| Structure/Function
| 0910-AB97 |
References in boldface appear in the Regulatory Plan in Part II of this issue of the
| Health Care Financing Administration--Long-Term Actions
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 1268
| Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F)
| 0938-AB50 |
|
| 1269
| Changes to Peer Review Organization Regulations (HCFA-3135-F)
| 0938-AD38 |
|
| 1270
| Omnibus Nursing Home Reform Requirements (HCFA-3488-F)
| 0938-AD81 |
|
| 1271
| ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare Overpayment Liability (HCFA-1719-P)
| 0938-AD95 |
|
| 1272
| Protection of Income and Resources for Community Spouses of Institutionalized Individuals (HCFA-2023-P)
| 0938-AE12 |
|
| 1273
| Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F)
| 0938-AE39 |
|
| 1274
| Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028-F)
| 0938-AE72 |
|
| 1275
| Payment for Nursing and Allied Health Science Education (HCFA-1685-F)
| 0938-AE79 |
|
| 1276
| Coverage of Screening Pap Smears (HCFA-3705-F)
| 0938-AE98 |
|
| 1277
| Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC)
| 0938-AF02 |
|
| 1278
| Requirements for Certain Health Insuring Organizations and OBRA `90 Technical Amendments (HCFA-1018-F)
| 0938-AF15 |
|
| 1279
| Provider Reimbursement Determinations and Appeals (HCFA-1727-P)
| 0938-AF28 |
|
| 1280
| Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)
| 0938-AF32 |
|
| 1281
| Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC)
| 0938-AF42 |
|
| 1282
| Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)
| 0938-AF68 |
|
| 1283
| Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants, and Children Under Age 19 (HCFA-2052-F)
| 0938-AF69 |
|
| 1284
| Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)
| 0938-AF87 |
|
| 1285
| Revised Medicaid Management Information Systems (HCFA-2038-FN)
| 0938-AG10 |
|
| 1286
| Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P)
| 0938-AG31 |
|
| 1287
| Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth Scope of Work Contracts (HCFA-3207-N)
| 0938-AG32 |
|
| 1288
| Disclosure of Confidential PRO and ESRD Network Organization Information for Research Purposes (HCFA-3208-P)
| 0938-AG33 |
|
| 1289
| Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure Breathing Machine Therapy (HCFA-3781-FN)
| 0938-AG44 |
|
| 1290
| Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F)
| 0938-AG48 |
|
| 1291
| Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, Underpayments and Overpayments (HCFA-2215-P)
| 0938-AG59 |
|
| 1292
| Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With Tuberculosis (HCFA-2082-P)
| 0938-AG72 |
|
| 1293
| Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F)
| 0938-AG79 |
|
| 1294
| Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships--Expanded to Designated Health Services (HCFA-1809-F)
| 0938-AG80 |
|
| 1295
| Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)
| 0938-AG81 |
|
| 1296
| Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening of Applicants for Nursing Home Admission (HCFA-3815-P)
| 0938-AG84 |
|
| 1297
| CLIA Program: Categorization of Waived Tests (HCFA-2225-FC)
| 0938-AG99 |
|
| 1298
| Liability for Third Parties To Pay for Services (HCFA-2080-P)
| 0938-AH01 |
|
| 1299
| Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical Equipment (DME) and Home Health (HCFA-1834-P)
| 0938-AH16 |
|
| 1300
| State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P)
| 0938-AH24 |
|
| 1301
| Hospice Care--Conditions of Participation (HCFA-3844-P)
| 0938-AH27 |
|
| 1302
| CLIA Program; Cytology Proficiency Testing (HCFA-2233-N)
| 0938-AH35 |
|
| 1303
| Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-1843-P)
| 0938-AH37 |
|
| 1304
| Payment Amount if Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC)
| 0938-AH49 |
|
| 1305
| Limitations on Liability (HCFA-4859-FC)
| 0938-AH51 |
|
| 1306
| Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P)
| 0938-AH52 |
|
| 1307
| Revision to Accrual Basis of Accounting Policy (HCFA-1876-F)
| 0938-AH61 |
|
| 1308
| Medicaid; Estate Recoveries (HCFA-2083-P)
| 0938-AH63 |
|
| 1309
| Medicaid Hospice Care (HCFA-2016-P)
| 0938-AH65 |
|
| 1310
| Provider and Supplier Billing When Medicare Is Secondary Payor to Liability Insurance (HCFA-1848-P)
| 0938-AH66 |
|
| 1311
| Medicare Technical Conforming Amendments (HCFA-1858-FC)
| 0938-AH67 |
|
| 1312
| 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 |
|
| 1313
| Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)
| 0938-AH69 |
|
| 1314
| Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities Participating in an Experiment (HCFA-2236-GNC)
| 0938-AH72 |
|
| 1315
| 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 |
|
| 1316
| Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)
| 0938-AH83 |
|
| 1317
| Disclosure of Peer Review Organization Information in Response to Beneficiary Complaints (HCFA-3241-P)
| 0938-AH85 |
|
| 1318
| Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review Program (HCFA-2107-P)
| 0938-AH89 |
|
| 1319
| Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC)
| 0938-AH92 |
|
| 1320
| Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services (HCFA-2043-P)
| 0938-AH95 |
|
| 1321
| Revision to the Definition of an Unemployed Parent (HCFA-2106-FC)
| 0938-AH98 |
|
| 1322
| Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F)
| 0938-AI08 |
|
| 1323
| Medicare Program; Medicare Integrity Program (HCFA-7020-F)
| 0938-AI09 |
|
| 1324
| Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P)
| 0938-AI11 |
|
| 1325
| Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998 and Sustainable Growth Rate for Fiscal Year 1998 (HCFA-1893-FN)
| 0938-AI16 |
|
| 1326
| Medicaid: Medical Child Support (HCFA-2081-P)
| 0938-AI21 |
|
| 1327
| Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F)
| 0938-AI38 |
|
| 1328
| Medicare/Medicaid Program; User Fees for Information, Prodcuts, and Services (HCFA-6021-P)
| 0938-AI46 |
|
| 1329
| Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab. Agencies, Community Mental Health Centers, and Independent Diagnostic Testing Facilities (HCFA-6005-P)
| 0938-AI48 |
|
| 1330
| State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P)
| 0938-AI63 |
|
| 1331
| Recognition of the Community Health Accreditation Program, Inc. (CHAP) and Joint Commission for Accreditation of Healthcare Organizations (JCAHO) for Hospices (HCFA-2029-PN)
| 0938-AI69 |
|
| 1332
| Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC)
| 0938-AI73 |
|
| 1333
| Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P)
| 0938-AI74 |
|
| 1334
| Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan (HCFA-1777-P)
| 0938-AI75 |
|
| 1335
| Medicare Hospice Care (HCFA-1022-P)
| 0938-AI77 |
|
| 1336
| Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and Elimination of Reclassifications (HCFA-1883-P)
| 0938-AI80 |
|
| 1337
| Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-F)
| 0938-AI83 |
|
| 1338
| Medicare Program; Medicare Coverage of and Payment for Bone Mass Measurements (HCFA-3004-F)
| 0938-AI89 |
|
| 1339
| Health Insurance Reform Universal Health Care Identifier (HCFA-0048-NOI)
| 0938-AI91 |
|
| 1340
| Peer Review Organization Contracts: Solicitation of Statements of Interest From In-State Organizations (HCFA-3009-N)
| 0938-AI99 |
|
| 1341
| Replacement of Reasonable Charge Methodology by Fee Schedules (HCFA-1010-P)
| 0938-AJ00 |
|
| 1342
| External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-P)
| 0938-AJ06 |
|
| 1343
| HHS' Recognition of NAIC Model Standards for Regulation of Medigap Policy (HCFA-2025-N)
| 0938-AJ07 |
|
| 1344
| Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the Conditions of Participation for Home Health Agencies (HCFA-3006-IFC)
| 0938-AJ10 |
|
| 1345
| Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier Performance: Millennium Compliance (HCFA-4002-GNC)
| 0938-AJ15 |
|
| 1346
| Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-1910-P)
| 0938-AJ17 |
|
| 1347
| Hospital Conditions of Participation: Laboratory Services (HCFA-3 014-P)
| 0938-AJ29 |
|
| 1348
| Medicare Program; Procedures for Making Medical Services National Coverage Decisions (HCFA-3432-GN)
| 0938-AJ31 |
|
| 1349
| Medicare Program; Special Payment Limits for Certain Durable Medical Equipment and Prosthetic Devices (HCFA-1050-PN)
| 0938-AJ34 |
|
| 1350
| Medicare Hospice Care Amendments (HCFA-1022-P)
| 0938-AJ36 |
|
| 1351
| Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-FC)
| 0938-AJ39 |
|
| 1352
| Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2000 Rates (HCFA-1053-P) (Section 610 Review)
| 0938-AJ50 |
| Health Care Financing Administration--Completed Actions
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 1353
| Case Management (HCFA-2027-F)
| 0938-AF07 |
|
| 1354
| Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F)
| 0938-AH15 |
|
| 1355
| Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage Decisions--Second Quarter, 1998 (HCFA-9002-N)
| 0938-AI13 |
|
| 1356
| GME: Incentive Payments Under Plans for Voluntary Reduction in Number of Residents (HCFA-1001-F)
| 0938-AI27 |
|
| 1357
| Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities. (HCFA-1913-IFC)
| 0938-AI47 |
|
| 1358
| Medicare and Medicaid Programs; Quarterly Listing of Program Issuances -- First Quarter 1998 (HCFA-9879-N)
| 0938-AJ12 |
|
| 1359
| Medicare Program State Allotments for Payments of Medicare Part B Premium for Qualifying Individuals: Federal Fiscal Year for 1999 (HCFA-2032-N)
| 0938-AJ28 |
|
| 1360
| Medicaid Program; Civil Money Penalties for Nursing Homes (SNF/NF), Change in Notice Requirements, and Expansion of Discretionary Remedy (HCFA-2035-FC)
| 0938-AJ35 |
|
| 1361
| Medicare and Medicaid Programs; Quarterly Listing of Program Issuances -- Third Quarter, 1998 (HCFA-9000-N)
| 0938-AJ37 |
|
| 1362
| Recognition of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) for Hospices (HCFA-2039-FN)
| 0938-AJ41 |
|
| 1363
| Recognition of the Community Health Accreditation Program, Inc. (CHAP) for Hospices (HCFA-2029-FN)
| 0938-AJ42 |
|
| 1364
| Prospective Payment System and Consolidated Billing for Home Health Agencies (HCFA-1059-P)
| 0938-AJ51 |
|
| 1365
| Medicare and Medicaid Programs: Hospital Conditions of Participation; Patients' Rights (HCFA-3018-IFC)
| 0938-AJ56 |
|
| 1366
| Medicare Program: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities Update
| 0938-AJ58 |
|
| 1367
| Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2000 (HCFA-1065-P)
| 0938-AJ61 |
|
| 1368
| Medicaid Managed Care; Regulatory Program to Implement Certain Medicaid Provisions of the Balanced Budget Act of 1997
| 0938-AJ73 |