[The Regulatory Plan and Unified Agenda of Federal Regulations]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]
_______________________________________________________________________
Part VIII
Department of Health and Human Services
_______________________________________________________________________
Semiannual Regulatory Agenda
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Ch. I
42 CFR Chs. I-V
45 CFR Subtitle A, Chs. II, III, and XIII
Unified Agenda of Regulations
AGENCY: Office of the Secretary, HHS.
ACTION: Publication of unified agenda of regulations.
_______________________________________________________________________
SUMMARY: The President's September 30, 1993, Executive order (12866)
and the Regulatory Flexibility Act of 1980 require the Department to
publish an agenda of significant regulations being developed and an
indication of those regulatory actions that are being analyzed for
their effect on small businesses. The Department published its last
agenda on May 8, 1995.
DATES: Data, information, and views due date: December 5, 1995, for
initial suggestions and any date thereafter for additional suggestions.
ADDRESSES: Addresses for submitting comments and information in
response to this document are listed at the end.
FOR FURTHER INFORMATION CONTACT: Ann White, Department of Health and
Human Services, Washington, DC 20201, (202) 690-6824, or the contact
person for a specific division or agency of the Department listed at
the end of this notice.
SUPPLEMENTARY INFORMATION:
Department of Health and Human Services' Regulatory Plan
For this edition of the Department's regulatory agenda, the
most important significant regulatory actions are included in The
Regulatory Plan, which appears in Part II of this issue of the
Federal Register. The Regulatory Plan entries are listed in the
Table of Contents below and are denoted by a bracketed bold
reference, which directs the reader to the appropriate Sequence
Number in Part II.
Background
On September 30, 1993, President Clinton issued Executive Order
12866 to make regulations less burdensome, more effective, and in
greater alignment with the Administration's priorities and
regulatory principles. As part of the Department of Health and
Human Services efforts to effectively implement the Executive
order, we published a notice in the Federal Register, January 20,
1994, providing a plan for periodic review of existing rules and
inviting public comments to assist in determining the best priority
for review.
The Executive order and the Administration's effort toward
implementation have proven successful by providing real progress in
reforming regulations. Building on those successes, in March of
1995, the President announced plans for more immediate,
comprehensive reform.
First, the President directed each agency to undertake an
exhaustive review of all regulations with an eye toward eliminating
or modifying those that are obsolete or which are otherwise in need
of reform. Second, the President directed each agency to change the
way performance is measured--focusing on results, not process.
Third, the President asked his senior executives to convene
meetings in order to establish grassroots partnerships which would
allow greater collaboration and participation in reinventing the
regulatory process. Finally, the President requested that we
further our efforts to negotiate more during the rulemaking
process.
As a result of the initiative discussed above, this semiannual
unified agenda reflects our efforts to reinvent rules identified as
needing reform. As we embark on this effort, we continue to invite
comments on our unified agenda entries and suggestions for
furthering the President's regulatory reinvention strategy.
Comments should be sent to the addresses listed below,
depending on the regulations addressed. Comments may be sent to the
Office of the Secretary when the responsible division is not known
or when the comment covers several regulatory areas crossing agency
lines.
Health Care Financing Administration: Mary Ann Troanovitch,
Executive for Regulations Management, Health Care Financing
Administration, Room 309G, Hubert H. Humphrey Building, Washington,
DC 20201; phone 202-690-7890.
Administration on Children and Families: Madeline Mocko,
Director, Division of Policy and Legislation, 7th Floor, 370
L'Enfant Promenade SW., Washington, DC 20447; phone 202-401-9223.
Administration on Aging: Jack McCarthy, Executive Secretariat,
Room 4753, Wilbur H. Cohen Building, 330 Independence Avenue SW.,
Washington, DC 20201; phone 202-619-0441.
Substance Abuse and Mental Health Services Administration: Joe
Faha, 5600 Fishers Lane, Room 12-A-17, Rockville, Maryland 20857;
phone 301-443-4640.
National Institutes of Health: Jerry Moore, 9000 Rockville
Pike, Building 31, Room 3B-11, Bethesda, Maryland 20205; phone 301-
496-4606.
Indian Health Services: Betty Penn, 5600 Fishers Lane,
Twinbrook Building, Suite 450, Rockville, Maryland 20857; phone
301-443-1116.
Health Resource Services Administration: Alice Wallis, 5600
Fishers Lane, Room 14-A-12, Rockville, Maryland 20857; phone 301-
443-1960.
Centers for Disease Control/Agency for Toxic Substances and
Disease Registry: Galen Morris, 1600 Clifton Road NE., Building 1,
Room 2050, Atlanta, Georgia 30333; phone 404-639-1548.
Agency for Health Care Policy and Research: Peggy Washburn,
6000 Executive Drive, Suite 603, Rockville, Maryland 20852; phone
301-594-1457.
Food and Drug Administration: Ed Dutra, Director, Regulatory
Policy and Management Staff, (HF26), 5600 Fishers Lane, Room 12-A-
17, Rockville, Maryland 20857; phone 301-443-3480.
Office of the Secretary: Jacquelyn Y. White, Deputy Executive
Secretary, Office of the Executive Secretariat, Room 603H, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
Claudia Cooley,
Executive Secretary to the Department.
Office of the Secretary--Proposed Rule Stage
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1192 Revisions to the Civil Money Penalty Provisions Relating to the Misuse of Certain
Symbols and Emblems................................................................... 0991-AA81
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Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1193 Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans........... 0991-AA45
1194 Uniform Administrative Requirements for Grants and Cooperative Agreements............. 0991-AA56
1195 Clarification of the Initial OIG Safe Harbor Provisions and Establishment of
Additional Safe Harbor Provisions Under the Anti-Kickback Statute..................... 0991-AA66
1196 Safe Harbors for Protecting Health Plans.............................................. 0991-AA69
1197 Revisions to the PRO Sanctions Process................................................ 0991-AA73
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Office of the Secretary--Long-Term Actions
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1198 Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental
Policies.............................................................................. 0991-AA53
1199 Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care
Entities.............................................................................. 0991-AA65
1200 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
1201 Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and
Rebate Agreements..................................................................... 0991-AA80
----------------------------------------------------------------------------------------------------------------
Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1202 Amendment to Grants Management Common Rule To Raise Threshold for Simplified Small
Purchases............................................................................. 0991-AA77
1203 Proposed Amendments to Nonprocurement Debarment and Suspension Common Rule To Achieve
Reciprocity With Procurement.......................................................... 0991-AA78
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Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1204 Protection and Advocacy for Individuals With Mental Illness........................... 0930-AA02
1205 Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions) (Reg
Plan Seq. No. 26)..................................................................... 0930-AA03
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1206 Block Grants for Prevention and Treatment of Substance Abuse.......................... 0930-AA01
----------------------------------------------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1207 Confidentiality of Substance Abuse Patient Records.................................... 0930-AA00
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1208 Respiratory Protective Devices........................................................ 0920-AA00
1209 National Center for Health Statistics, Special Statistical Services; Grants for Health
Education/Risk Reduction; Vaccines Information and Education--Repeal.................. 0920-AA01
----------------------------------------------------------------------------------------------------------------
Departmental Management--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1210 Implementation of the Equal Access to Justice Act in Agency Proceedings............... 0990-AA02
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1211 Reinventing FDA Food Regulations...................................................... 0910-AA58
1212 Food Standards of Identity, Quality, and Fill of Container; Common or Usual Name
Regulations: Request for Comments on Existing Regulations (Reg Plan Seq. No. 27)...... 0910-AA67
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1213 Over-the-Counter (OTC) Drug Review.................................................... 0910-AA01
1214 Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality
Factors, Notification Requirements, and Records and Reports........................... 0910-AA04
1215 Reporting of Errors and Accidents..................................................... 0910-AA12
1216 Mammography Quality Standards Act of 1992 (Reg Plan Seq. No. 28)...................... 0910-AA24
1217 Effective Date of Requirement for Submission of Premarket Approval Applications....... 0910-AA31
1218 Latex Condoms/Gloves: Expiration Date Labeling........................................ 0910-AA32
1219 Latex Warning......................................................................... 0910-AA34
1220 Premarket Approval of Medical Devices; Supplemental Applications...................... 0910-AA35
1221 Hearing Aids; Professional and Patient Labeling; Conditions for Sale.................. 0910-AA39
1222 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding
of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals..... 0910-AA45
1223 Animal Drug Amendments of 1994, Extra-Label Use; Implementation....................... 0910-AA47
1224 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
Products to Protect Children and Adolescents (Reg Plan Seq. No. 29)................... 0910-AA48
1225 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution.... 0910-AA49
1226 Habit Forming Drugs................................................................... 0910-AA50
1227 Bioavailability and Bioequivalence Requirements....................................... 0910-AA51
1228 Consolidation of Regulations.......................................................... 0910-AA53
1229 Revocation of Certain Regulations (Reg Plan Seq. No. 30).............................. 0910-AA54
1230 Name of Selling Agent or Distributor.................................................. 0910-AA56
1231 Streamlining Procedures for Changes in Production of Biologics (Reg Plan Seq. No. 31). 0910-AA57
1232 Dietary Supplement Regulations in Response to DSHEA................................... 0910-AA59
1233 Protection of Human Subjects; Informed Consent (Reg Plan Seq. No. 32)................. 0910-AA60
1234 OTC Drug Labeling Review.............................................................. 0910-AA63
1235 Medical Device Exemptions From Premarket Notification (Reg Plan Seq. No. 33).......... 0910-AA65
1236 Substances Approved for Use in the Preparation of Meat and Poultry Products........... 0910-AA66
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1237 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug
and Patent Term Restoration Act....................................................... 0910-AA02
1238 Current Good Manufacturing Practice for Blood and Blood Components; Notification of
Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV
Infection............................................................................. 0910-AA05
1239 Lead in Foods......................................................................... 0910-AA06
1240 Fees for Certification Services; Insulin and Color Additive Certification Programs.... 0910-AA07
1241 Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and
Clarifications........................................................................ 0910-AA08
1242 Implementation of the Safe Medical Devices Act of 1990................................ 0910-AA09
1243 Final Regulation to Establish Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products (Reg Plan Seq. No. 34)......................... 0910-AA10
1244 Bottled Water......................................................................... 0910-AA11
1245 Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket
Notification Procedures and Current Good Manufacturing Practices Regulations.......... 0910-AA17
1246 Food Labeling Review.................................................................. 0910-AA19
1247 Disqualification of Clinical Investigators............................................ 0910-AA21
1248 Investigational Device Exemption; Intraocular Lenses.................................. 0910-AA22
1249 Dietary Supplement Label Review....................................................... 0910-AA23
1250 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;
Addition of ``Geriatric Use'' Subsection in the Labeling.............................. 0910-AA25
1251 Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products........ 0910-AA26
1252 Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of
Drugs Composed Wholly or Partly of Insulin............................................ 0910-AA27
1253 Electronic Signatures; Electronic Records............................................. 0910-AA29
1254 Financial Disclosure by Clinical Investigators........................................ 0910-AA30
1255 Prescription Drug Product Labeling; Medication Guide (Reg Plan Seq. No. 35)........... 0910-AA37
1256 Human Tissue Intended for Transplantation: Proposed Rule.............................. 0910-AA40
1257 Iron Containing Drugs and Supplements................................................. 0910-AA42
1258 Public Information; Communications With State and Foreign Government Officials........ 0910-AA46
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1259 Policies Concerning Uses of Sulfiting Agents.......................................... 0910-AA03
1260 Review of Warnings, Use Instructions, and Precautionary Information Under Section 314
of the National Childhood Vaccine Injury Act of 1986.................................. 0910-AA14
1261 General Biological Product Standards; Alternative Procedures and Exceptions........... 0910-AA16
1262 Medical Foods......................................................................... 0910-AA20
1263 Adverse Experience Reporting Requirements for Human Drug and Licensed Biological
Products.............................................................................. 0910-AA28
1264 Amalgam Ingredient Labeling........................................................... 0910-AA33
1265 Classification of Computer Software Programs That Are Medical Devices................. 0910-AA41
1266 Development of Hazard Analysis Critical Control Points for the Food Industry; Request
for Comments.......................................................................... 0910-AA43
1267 Drugs Used for Treatment of Narcotic Addicts.......................................... 0910-AA52
1268 Export Requirements for Drugs for Investigational Use in Other Countries.............. 0910-AA61
1269 Export Requirements for Medical Devices............................................... 0910-AA62
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1270 Proposed Labeling for Drug Products Based on False or Fraudulent Data................. 0910-AA13
1271 Recordkeeping and Reporting: Electronic Products...................................... 0910-AA15
1272 Threshold of Regulation Policy for Components of Food Contact Articles................ 0910-AA18
1273 Medical Devices; Restricted Devices................................................... 0910-AA36
1274 Substances Prohibited for Use in Ruminant Feed........................................ 0910-AA38
1275 New Drug and Biological Product License Applications; Revisions to Existing
Regulations........................................................................... 0910-AA44
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1276 National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine
Injury Table - II..................................................................... 0906-AA36
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1277 Organ Procurement and Transplantation Network Rules (Reg Plan Seq. No. 36)............ 0906-AA32
1278 Technical Amendments to the Health Professions, Nursing, and Allied Health Training
Grant Programs Under 42 CFR Parts 57 and 58........................................... 0906-AA38
1279 Removal of Obsolete Regulations of the Title VII Grant for the Construction of
Teaching Facilities for Health Professions Personnel.................................. 0906-AA39
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1280 Health Education Assistance Loan (HEAL) Program: Lenders'/ Holders' Performance
Standards............................................................................. 0906-AA33
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1281 Grants for the Establishment of Departments of Family Medicine........................ 0906-AA34
1282 Federally Supported Health Centers Assistance Act of 1992............................. 0906-AA35
1283 National Practitioner Data Bank for Adverse Information on Physicians, Dentists, and
Other Health Care Practitioners: Payment of Fees...................................... 0906-AA37
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1284 National Institutes of Health AIDS Research Loan Repayment Program.................... 0925-AA02
1285 National Institutes of Health Clinical Research Loan Repayment Program for Individuals
From Disadvantaged Backgrounds........................................................ 0925-AA09
1286 Undergraduate Scholarship Program Regarding Professions Needed by the NIH............. 0925-AA10
1287 Traineeships (Termination Policies)................................................... 0925-AA11
1288 Additional DHHS Protection for Pregnant Women and Human Fetuses Involved as Subjects
for Research, and Pertaining to Human In Vitro Fertilization.......................... 0925-AA14
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1289 Grants for Research Projects.......................................................... 0925-AA01
1290 Hazardous Substances Basic Research and Training Grants............................... 0925-AA03
1291 National Institutes of Health Construction Grants..................................... 0925-AA04
1292 Training Grants....................................................................... 0925-AA05
1293 National Institutes of Health Center Grants........................................... 0925-AA06
1294 Grants for National Alcohol Research Centers.......................................... 0925-AA08
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1295 Responsibilities of Public Health Service-Funded Institutions for Promoting
Objectivity in Research............................................................... 0925-AA07
----------------------------------------------------------------------------------------------------------------
Office of Assistant Secretary for Health--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1296 Standards of Compliance for Abortion-Related Services in Family Planning Service
Projects.............................................................................. 0937-AA00
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1297 Ambulance Services (BPD-813-P)........................................................ 0938-AH13
1298 Changes in Coverage and Payment Policies for Physician Assistant Services (BPD-829-P). 0938-AH26
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1299 New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........ 0938-AD82
1300 ''Without Fault'' and Beneficiary Waiver of Recovery as It Applies to Medicare
Overpayment Liability (BPD-719-P)..................................................... 0938-AD95
1301 Protection of Income and Resources for Community Spouses of Institutionalized
Individuals (MB-023-P)................................................................ 0938-AE12
1302 Coverage of Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist
Services (BPD-708-P).................................................................. 0938-AF00
1303 Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)........................... 0938-AF32
1304 Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-F)...... 0938-AF42
1305 Federally Qualified Health Center Services (Medicaid) (MB-043-P)...................... 0938-AF90
1306 Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................ 0938-AF97
1307 Conditions of Participation for Rural Health Clinics (BPD-764-P)...................... 0938-AG05
1308 Medicare Appeals of Individual Claims (BPD-453-P)..................................... 0938-AG18
1309 Appointment of Representatives for Medicare Appeals (BPO-120-P)....................... 0938-AG30
1310 Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P).................... 0938-AG31
1311 Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P).......... 0938-AG33
1312 Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and
Overpayments (HSQ-215-P).............................................................. 0938-AG59
1313 Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-PN)... 0938-AG65
1314 New Payment Methodology for Routine Extended Care Services Provider in a Swing Bed
Hospital (BPD-805-P).................................................................. 0938-AG68
1315 Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech
Pathology, and Occupational Therapy (BPD-808-PN)...................................... 0938-AG70
1316 Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with
Tuberculosis (MB-082-P)............................................................... 0938-AG72
1317 Physicians' Referrals to Health Care Entities With Which They Have Financial
Relationships--Expanded to Designated Health Services (BPD-809-P)..................... 0938-AG80
1318 Home Health Agency (HHA) Conditions of Participation (BPD-819-P) (Reg Plan Seq. No.
38)................................................................................... 0938-AG81
1319 End-Stage Renal Disease (ESRD) Conditions of Coverage (BPD-818-P) (Reg Plan Seq. No.
39)................................................................................... 0938-AG82
1320 Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening of
Applicants for Nursing Home Admission (BPD-815-P)..................................... 0938-AG84
1321 Medicaid: Nominal Copayments for Institutional Services for Medicaid Recipients (MB-
090-P)................................................................................ 0938-AG90
1322 Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare
Program (BPD-820-P)................................................................... 0938-AG93
1323 Categorization and Certification Requirements for a New Subcategory of Moderate
Complexity Testing (HSQ-222-P) (Reg Plan Seq. No. 40)................................. 0938-AG98
1324 CLIA Program: Categorization of Waived Tests (HSQ-225-P) (Reg Plan Seq. No. 41)....... 0938-AG99
1325 Medicaid Coverage of Personal Care Services (MB-071-P)................................ 0938-AH00
1326 Liability for Third Parties to Pay for Care and Services (MB-080-P)................... 0938-AH01
1327 Medicare Program: Coverage of Certified Nurse-Midwife Services (BPD-496-P)............ 0938-AH02
1328 Medicare Program: Uniform Electronic Cost Reporting for Skilled Nursing Facilities and
Home Health Agencies (BPD-788-P)...................................................... 0938-AH12
1329 Adjustment in Payment Amounts for New Technology Intraocular Lenses (BPD-831-P)....... 0938-AH15
1330 Schedule of Limits for Skilled Nursing Facility Inpatient Routine Service Costs (BPD-
837-NC)............................................................................... 0938-AH18
1331 Additional Supplier Standards (BPD-838-P)............................................. 0938-AH19
1332 Delegation of Civil Money Penalties (BPO-135-FC)...................................... 0938-AH22
1333 State Plan Amendment (SPA) Reconsideration Process (MB-096-P)......................... 0938-AH24
1334 Evidence of Lawful Permanent Residence (MB-097-P)..................................... 0938-AH25
1335 Hospice Care - Conditions of Participation (BPD-844-P)................................ 0938-AH27
1336 Limitations on Payment for Home Oxygen Therapy Based on Inherent Reasonableness
Criteria (BPD-845-PN)................................................................. 0938-AH28
1337 Medicaid: Limitations on Aggregate Payments to Disproportionate Share Hospitals;
Federal Fiscal Year 1997 (MB-098-N)................................................... 0938-AH30
1338 Medicaid Eligibility Quality Control, Staffing and Training, and Utilization Control:
Removal of Obsolete and Restrictive Requirements (MB-099-P)........................... 0938-AH31
1339 Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1997
Rates (BPD-847-P) (Reg Plan Seq. No. 42).............................................. 0938-AH34
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1340 Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F)......................... 0938-AB07
1341 Payment for Clinical Diagnostic Laboratory Tests (BPD-309-F).......................... 0938-AB50
1342 Effective Dates for Provider Agreements and Supplier Approvals (HSQ-139-F)............ 0938-AC88
1343 Changes Concerning Suspension of Medicare Payments and Determinations of Allowable
Interest Expense (BPO-118-FC)......................................................... 0938-AC99
1344 Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F)................. 0938-AD33
1345 Changes to Peer Review Organization Regulations (HSQ-135-F)........................... 0938-AD38
1346 Revisions to the Freedom of Information Regulations (OPA-001-P)....................... 0938-AD60
1347 Omnibus Nursing Home Reform Requirements (BPD-488-F).................................. 0938-AD81
1348 HMO Organizational Structure and Services (OMC-007-F)................................. 0938-AE25
1349 Hospital Standard for HIV Infectious Blood and Blood Products (BPD-633-F)............. 0938-AE40
1350 Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-226-F) (Reg Plan Seq. No.
43)................................................................................... 0938-AE47
1351 Conditions of Coverage for Organ Procurement Organizations (BPD-646-F)................ 0938-AE48
1352 Resident Assessment in Long-Term Care Facilities (HSQ-180-F).......................... 0938-AE61
1353 Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................ 0938-AE63
1354 Employer Contributions to HMOs (OMC-004-F)............................................ 0938-AE64
1355 Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F).... 0938-AE72
1356 Payment for Nursing and Allied Health Science Education (BPD-685-F)................... 0938-AE79
1357 Coverage of Screening Pap Smears (BPD-705-F).......................................... 0938-AE98
1358 Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social
Worker Services--Medicare (BPD-706-F)................................................. 0938-AE99
1359 Case Management (MB-27-F)............................................................. 0938-AF07
1360 Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F)............. 0938-AF14
1361 Partial Hospitalization Services in Community Mental Health Centers (BPD-736-IFC)..... 0938-AF53
1362 Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants
and Children Under Age 19 (MB-052-F).................................................. 0938-AF69
1363 Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid
Health Care Organizations (OMC-010-FC)................................................ 0938-AF74
1364 Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or
Services Under Medicare Part B (BPO-105-F)............................................ 0938-AF85
1365 Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and
Competitive Medical Plans (OMC-015-F)................................................. 0938-AF98
1366 Payment for Preadmission Services (BPD-731-F)......................................... 0938-AG00
1367 Change in Provider Agreement Regulations Related to Federal Employee Health Benefits
(BPD-748-F)........................................................................... 0938-AG03
1368 Intermediary and Carrier Functions (BPO-111-F)........................................ 0938-AG06
1369 Revised Medicaid Management Information Systems (MB-38-FN)............................ 0938-AG10
1370 End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs
(BPD-763-F)........................................................................... 0938-AG20
1371 Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure
Breathing Machine Therapy (BPD-781-FN)................................................ 0938-AG44
1372 Telephone and Electronic Requests for Review of Part B Initial Claim Determinations
(BPO-121-P)........................................................................... 0938-AG48
1373 Schedule of Limits on Home Health Agency Costs Per Visit (BPD-793-N).................. 0938-AG54
1374 Medicaid Program: Nurse-Midwife Services (MB-085-F)................................... 0938-AG73
1375 Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program
(MB-084-FN)........................................................................... 0938-AG77
1376 Revision of Medicare Hospital Conditions of Participation (BPD-745-P) (Reg Plan Seq.
No. 44)............................................................................... 0938-AG79
1377 Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and
Fiscal Year 1996 Rates (BPD-825-FC)................................................... 0938-AG95
1378 Medicare Program: Revisions to Payment Policies and Adjustments to the Relative Value
Units (RVUs) Under the Physician Fee Schedule for Calendar Year 1996 (BPD-827-FC) (Reg
Plan Seq. No. 45)..................................................................... 0938-AG96
1379 Medicare Program: Physician Fee Schedule Update for Calendar Year 1996 & Physician
Volume Performance Standard Rates of Increase for Federal Fiscal Year 1996 (BPD-828-
FN)................................................................................... 0938-AH03
1380 Part A Premium for 1996 for the Uninsured Aged and for Certain Disabled Individuals
Who Have Exhausted Other Entitlement (OACT-051-N)..................................... 0938-AH06
1381 Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance
Premium Rates Beginning January 1, 1996 (OACT-050-N).................................. 0938-AH07
1382 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance
Amounts for 1996 (OACT-049-N)......................................................... 0938-AH08
1383 Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal Fiscal
Year 1995 (Medicaid Program) (MB-094-N)............................................... 0938-AH09
1384 Reporting of Interest From Zero Coupon Bonds (BPD-647-F).............................. 0938-AH11
1385 Update of the Reasonable Compensation Equivalent Limits for Services Furnished by
Physicians (BPD-816-N)................................................................ 0938-AH14
1386 Criteria and Procedures for Extending Coverage to Certain Devices and Related Services
(BPD-841-FC) (Reg Plan Seq. No. 46)................................................... 0938-AH21
1387 CLIA Program; Granting and Withdrawal of Authority to Private Nonprofit Accreditation
Organizations and of CLIA Exemption Under State Laboratory Programs; Technical
Corrections........................................................................... 0938-AH32
1388 Medicare Program; Special Enrollment Periods and Waiting Periods (BPD-752-FC)......... 0938-AH33
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1389 Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge
Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-F)............. 0938-AC58
1390 Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to
Health Care Technology (BPD-432-F).................................................... 0938-AD07
1391 Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P)............. 0938-AD32
1392 Medicare Secondary Payer for Disabled Individuals (BPD-482-FC)........................ 0938-AD73
1393 Fee Schedule for Payment of Clinical Psychologist Services (BPD-495-P)................ 0938-AD84
1394 Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F).... 0938-AE39
1395 Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care
Facilities for the Mentally Retarded (BPD-650-FC)..................................... 0938-AE97
1396 Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC).................... 0938-AF02
1397 OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-FC)............. 0938-AF15
1398 Presumptive Limits on Payments to HMOs, CMPs, and HCPPs (OMC-006-F)................... 0938-AF16
1399 Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)............... 0938-AF28
1400 Referral to Child Support Enforcement Agencies of Medicaid Families (MB-051-F)........ 0938-AF68
1401 Assessing Interest Against Medicare Secondary Payer (MSP) Debts (BPO-108-P)........... 0938-AF87
1402 General Criteria and Standards for Evaluating Performance of Contract Obligations (HSQ-
207-NC)............................................................................... 0938-AG32
1403 Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence
Testing) (BPD-780-FN)................................................................. 0938-AG43
1404 Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia
(Dry Mouth) (BPD-782-FN).............................................................. 0938-AG45
1405 Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-FC)........... 0938-AG87
1406 Mandatory Medigap Crossover Claims Transmittal Requirements (BPD-811-P)............... 0938-AG94
1407 Definition of Skilled Nursing Facility (SNF) and Home Health Agency (HHA) for Coverage
of Durable Medical Equipment (DME) (BPD-834-P)........................................ 0938-AH16
1408 Medicare Coverage of Liver Transplantation (BPD-835-PN)............................... 0938-AH17
1409 Provisions That Allow Rural Primary Care Hospitals (RPCHs) to Enter Into Swing-Bed
Agreements (BPD-839-P)................................................................ 0938-AH20
1410 Transfer of Assets for Less Than Fair Market Value: Medicaid Program (MB-095-P)....... 0938-AH23
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1411 Clarifications of Medicare's Accrual Basis of Accounting Policy (BPD-366-F)........... 0938-AD01
1412 Optional Payment System for Low Medicare Volume Skilled Nursing Facilities (BPD-409-F) 0938-AD02
1413 Transfer of Resources for Less Than Fair Market Value (MB-10-P)....................... 0938-AD18
1414 Payment for Durable Medical Equipment and Orthotic and Prosthetic Devices (BPD-494-F). 0938-AD65
1415 Uniform Electronic Cost Reporting System for Hospitals (BPD-689-F).................... 0938-AE80
1416 Allowing Certifications and Recertifications by Nurse Practitioners and Clinical Nurse
Specialists for Certain Services (BPD-709-FC)......................................... 0938-AF01
1417 Medicaid Third Party Liability: Cost Effectiveness Waivers (MB-39-F).................. 0938-AF11
1418 Required Coverage of Nurse Practitioner Services--Medicaid (MB-41-F).................. 0938-AF12
1419 Physician Ownership of and Referrals to Health Care Facilities That Furnish Clinical
Laboratory Services and Financial Relationship Reporting Requirements (BPD-674-FC).... 0938-AF40
1420 Medicare and Medicaid Programs; Advance Directives (BPD-718-F)........................ 0938-AF50
1421 Clarification of Resumption of Entitlement Rules for Medicare Patients with End-Stage
Renal Disease (BPD-738-F)............................................................. 0938-AG19
1422 Standards for Quality of Water Used in Dialysis and Revised Guidelines on Reuse of
Hemodialyzer Filters for End-Stage Renal Disease Patients (BPD-766-F)................. 0938-AG21
1423 Community Supported Living Arrangements Services (MB-070-P)........................... 0938-AG35
1424 Conditions for Payment for Physicians' Services in Teaching Settings (BPD-792-P)...... 0938-AG53
1425 Date for Filing Medicare Cost Reports (BPD-794-F)..................................... 0938-AG55
1426 Expansion of the Definition of Eye and Ear Specialty Hospitals (BPD-804-P)............ 0938-AG67
1427 Categorization of CLIA Tests and Personnel Modifications (HSQ-216-FC)................. 0938-AG71
1428 Criteria for Medicare Coverage of Lung Transplants (BPD-812-FN)....................... 0938-AG83
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1429 Foster Care, Adoption Assistance, and Child Welfare Services.......................... 0970-AA97
1430 Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and
FY 1996 Provisions.................................................................... 0970-AB47
1431 Administrative Flexibility Rule....................................................... 0970-AB49
1432 Designation of Alternative Agency To Serve Indian Tribal Children..................... 0970-AB52
1433 Construction of Head Start Facilities................................................. 0970-AB54
1434 Quality Standards for Head Start Programs (Reg Plan Seq. No. 47)...................... 0970-AB55
1435 Head Start Fellowships Program........................................................ 0970-AB56
1436 Reporting Overdue Support Information to Consumer Reporting Agencies.................. 0970-AB57
1437 On-Site Foster Care Eligibility Reviews............................................... 0970-AB60
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1438 Amendments to Developmental Disabilities Rules........................................ 0970-AB11
1439 Family Violence Prevention and Services............................................... 0970-AB18
1440 Child Abuse and Neglect State Grant Program........................................... 0970-AB23
1441 Standards for Safe Transportation..................................................... 0970-AB24
1442 Standards for Purchase of Facilities.................................................. 0970-AB31
1443 National Voter Registration Act of 1993 Provisions Affecting Public Assistance
Agencies.............................................................................. 0970-AB32
1444 Child Care--Revised Regulations....................................................... 0970-AB33
1445 Family Preservation and Support....................................................... 0970-AB34
1446 Administration of Native Americans 45 CFR Part 1336................................... 0970-AB37
1447 Reduction of Reporting Requirements for the State Systems Advance Planning Document
(APD) Process......................................................................... 0970-AB46
1448 Income and Resource Disregards Related to Interests of Individual Indians in Trust or
Restricted Lands...................................................................... 0970-AB59
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1449 Income Eligibility Criteria for Indian Tribes......................................... 0970-AB53
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1450 Block Grant Programs (Low-Income Home Energy Assistance Program --LIHEAP) FY 91 and FY
92 Provisions......................................................................... 0970-AB15
1451 Block Grant Programs (Low-Income Home Energy Assistance Program--LIHEAP)--FY 93 and FY
94 Provisions......................................................................... 0970-AB16
1452 Statewide Automated Child Welfare Information System.................................. 0970-AB38
1453 Refugee Resettlement Program: Miscellaneous, Comprehensive Changes.................... 0970-AB42
1454 Direct Payments to Indian Tribes and Tribal Organizations Under Title IV-B, Subpart 1. 0970-AB44
1455 Repatriation - Advance Approval of Costs.............................................. 0970-AB45
1456 AFCARS Data Element on Foster Care Payments........................................... 0970-AB58
1457 Removal of Keys Amendment Regulations................................................. 0970-AB61
1458 Removal of Obsolete Family Assistance Regulation...................................... 0970-AB62
1459 Elimination of Obsolete Block Grant Rules............................................. 0970-AB63
----------------------------------------------------------------------------------------------------------------
Administration on Aging--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1460 Grants for State and Community Programs on Aging, Intrastate Funding Formulas;
Training, Research and Discretionary 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)
_______________________________________________________________________
1192. REVISIONS TO THE CIVIL MONEY PENALTY PROVISIONS RELATING TO
THE MISUSE OF CERTAIN SYMBOLS AND EMBLEMS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1320b-10; PL 103-296, Sec 312
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This final rule will make a number of technical revisions to
the civil money penalty authority relating to the misuse of certain
symbols, emblems and names as a result of amendments to section 1140 of
the Social Security Act. Among other revisions, this rule (1)
eliminates the annual penalty cap, (2) includes the words and letters
of the Department and Medicaid under the prohibition, and (3) redefines
a violation with regard to bulk mailings and solicitations. In
addition, this rule serves to remove references to Social Security and
its programs from 42 CFR 1003. Sepearte rulemaking addressing
violations of the SSA symbols, emblems and names are being developed in
conjunction with this final rule.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General,OMP, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270
RIN: 0991-AA81
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1193. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN
INCENTIVE PLANS
Priority: Substantive, Nonsignificant
Legal Authority: PL 99-509, Sec 9313(c); PL 101-239, Sec 6003(g)(3);
PL 101-508, Sec 4204(a)(3); PL 101-508, Sec 4731(b)(1)
CFR Citation: 42 CFR 1001; 42 CFR 1003
Legal Deadline: None
Abstract: This final rule will prohibit a hospital from knowingly
making incentive payments to a physician as an inducement to reduce or
limit services provided to Medicare or Medicaid beneficiaries who are
under the direct care of that physician. The rule would also set forth
standards governing the imposition of CMPs for each such individual for
whom payments are made.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/01/94 59 FR 61571
NPRM Comment Period End 01/30/95
Final Action 06/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270
RIN: 0991-AA45
_______________________________________________________________________
1194. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND
COOPERATIVE AGREEMENTS
Priority: Substantive, Nonsignificant
Legal Authority: 5 USC 301
CFR Citation: 45 CFR 74
Legal Deadline: None
Abstract: On 11/29/93 OMB revised circular A-110 which contains
administrative requirements for grants to universities, hospitals, and
nonprofit organizations. 45 CFR Part 74 is being revised to implement
the circular.
Timetable:
Interim Final Rule 08/25/94 (59 FR 43754) Comment Period End 10/24/94
Final Action 10/00/95
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Charles Gale, Director, Division of Grants Policy and
Oversight, Department of Health and Human Services, Office of the
Secretary, Rm. 517D, HHH Bldg., 200 Independence Avenue SW.,
Washington, DC 20201
Phone: 202 690-6377
RIN: 0991-AA56
_______________________________________________________________________
1195. CLARIFICATION OF THE INITIAL OIG SAFE HARBOR PROVISIONS AND
ESTABLISHMENT OF ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-
KICKBACK STATUTE
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: PL 100-93, Sec 2; PL 100-93, Sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This final rule serves both to clarify various aspects of the
original safe harbor provisions and to add new safe harbors as
authorized under section 14 of PL 100-93. Specifically, this rule
modifies the original set of final safe harbor provisions (56 FR 35952,
7/9/91) to give greater clarity to that rulemaking's original intent.
In addition, this rule sets forth an expanded listing of safe harbor
provisions designed to protect additional payment and business
practices from criminal prosecution and civil sanctions under the anti-
kickback statute.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/21/93 58 FR 49008
NPRM Comment Period End 11/22/93
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Additional Information: This final rule incorporates the safe harbor
clarification provisions previously addressed in RIN 0991-AA74 and set
forth in proposed rulemaking (59FR37202, July 21, 1994).
Agency Contact: Joel Jay Schaer, Regulations Officer, Office of
Inspector General, OMP, Department of Health and Human Services, Office
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270
RIN: 0991-AA66
_______________________________________________________________________
1196. SAFE HARBORS FOR PROTECTING HEALTH PLANS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: PL 100-93, Sec 2; PL 100-93, Sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This rule establishes additional ``safe harbor'' provisions,
as authorized by section 14 of PL 100-93. This rule protects certain
health care plans, such as health maintenance organizations, that offer
incentives to enrollees or that enter into negotiated price reduction
agreements with contract health care providers.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule With Comment Period 11/05/92 57 FR 52723
Extension of Public Comment
Period 01/07/93 58 FR 2989
Interim Final Rule 11/05/93 57 FR 52723
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Office of the
Inspector General, OMP, Department of Health and Human Services, Office
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270
RIN: 0991-AA69
_______________________________________________________________________
1197. REVISIONS TO THE PRO SANCTIONS PROCESS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1302; 42 USC 1320c-5; PL 100-93, sec 6; PL
100-93, sec 8; PL 100-93, sec 10; PL 100-203, sec 4095; PL 101-508, sec
4205
CFR Citation: 42 CFR 1004
Legal Deadline: None
Abstract: This rule will revise and update the procedures governing the
imposition and adjudication of sanctions predicated on recommendations
of State Peer Review Organizations. These changes are necessitated by
statutory revisions resulting from PL 100-93, PL 100-203, and PL 101-
508. This rule will also set forth new appeal and reinstatement
procedures that are presently codified in 42 CFR part 1004.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/28/94 59 FR 9452
NPRM Comment Period End 04/29/94
Final Action 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270
RIN: 0991-AA73
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Office of the Secretary (OS)
_______________________________________________________________________
1198. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING
TO MEDICARE SUPPLEMENTAL POLICIES
Priority: Substantive, Nonsignificant
Legal Authority: PL 100-360, Sec 428(b); PL 101-508, Sec 4204(g)(1);
PL 101-508, Sec 4351; PL 101-508, Sec 4354(a)(1)(E); PL 101-508, Sec
4354(a)(2); PL 101-508, Sec 4355(a); PL 101-508, Sec 4357
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This rule would authorize CMPs against any individual or
entity who knowingly and willfully use misleading or fraudulent
practices in the advertisement, solicitation, offering for sale or
delivery of Medicare supplemental health insurance (Medigap) policies.
Penalties would also be established for failure to (1) meet Medigap
policy loss-ratio requirements, (2) comply with policy simplification
standards, or (3) obtain Secretarial certification of Medigap policies
in States with non-approved regulatory programs. In addition, this rule
would also set forth CMPs for the failure of sellers or issuers to
solicit information, and to provide notice, about Medicaid status and
eligibility before selling or issuing Medigap policies.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AA53
_______________________________________________________________________
1199. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL
TO CERTAIN HEALTH CARE ENTITIES
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: PL 101-239, Sec 6204; PL 101-508, Sec 4207(e); PL
101-508, Sec 4207(m)(a); PL 103-66, Sec 13562
CFR Citation: 42 CFR 1001; 42 CFR 1003
Legal Deadline: None
Abstract: This revised final rule is designed to implement civil money
penalty authority for prohibited physician ownership and referral
arrangements set forth in section 1877 of the Social Security Act. This
rule addresses comments raised as a result of the final rule with
comment period (60 FR 16580), and several technical changes to 42 CFR
1001 and 1003 resulting from Government reinvention efforts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/20/93 58 FR 54096
NPRM Comment Period End 12/20/93
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Office of
Inspector General, OMP, Department of Health and Human Services, Office
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AA65
_______________________________________________________________________
1200. CIVIL MONEY PENALTIES FOR NOTIFYING A HOME HEALTH AGENCY, OR
A HOME OR COMMUNITY-BASED HEALTH CARE CENTER OR PROVIDER, OF A STANDARD
SURVEY
Priority: Substantive, Nonsignificant
Legal Authority: PL 100-203, Sec 4022(a); PL 100-360, Sec
411(d)(2)(A); PL 100-485, Sec 608(d)(20)(A); PL 101-508, Sec 4711(b)(a)
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This proposed rule would set forth civil money penalties
against any individual or entity that notifies, or causes to notify, a
home health agency, or a home or community- based health care center or
provider, of the time or date on which a standard survey is scheduled
to be conducted by a State or local agency.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OMP, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270
RIN: 0991-AA79
_______________________________________________________________________
1201. CIVIL MONEY PENALTIES FOR FALSE INFORMATION ON DRUG
MANUFACTURER PRICE SURVEYS AND REBATE AGREEMENTS
Priority: Substantive, Nonsignificant
Legal Authority: PL 101-508, Sec 4401(a)(3)
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This proposed rule would set forth civil money penalties
against any wholesaler, manufacturer or seller of outpatient drugs that
fails to respond to a request for information about charges or prices,
or to knowingly provide false information, in a survey by the Secretary
to verify manufacturers' reported prices. In addition, this rule would
set forth civil money penalties against any drug manufacturer doing
business with Medicaid that, in accordance with section 1927(b)(3)(A)
of the Social Security Act, fails to provide rebate agreement price
information on a timely basis, and for knowingly providing false
information.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270
RIN: 0991-AA80
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
1202. AMENDMENT TO GRANTS MANAGEMENT COMMON RULE TO RAISE THRESHOLD
FOR SIMPLIFIED SMALL PURCHASES
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 92
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 04/19/95 60 FR 19645
Final Action Effective 05/19/95
Small Entities Affected: None
Government Levels Affected: State, Local, Tribal
Agency Contact: Charles Gale
Phone: 202 690-6377
RIN: 0991-AA77
_______________________________________________________________________
1203. PROPOSED AMENDMENTS TO NONPROCUREMENT DEBARMENT AND
SUSPENSION COMMON RULE TO ACHIEVE RECIPROCITY WITH PROCUREMENT
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 76
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/26/95 60 FR 33037
Final Action Effective 08/25/95
Small Entities Affected: None
Government Levels Affected: None
Procurement: This is a procurement-related action for which there is a
statutory requirement. There is no paperwork burden associated with
this action.
Agency Contact: Neil Steyskal
Phone: 202 690-5729
RIN: 0991-AA78
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
1204. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 10801 et seq, as amended by PL 102-173
CFR Citation: 45 CFR 51
Legal Deadline: Final, Statutory, May 27, 1992.
Section 9 of P.L. 102-173, enacted on 11/27/91, sets this deadline.
Abstract: Sets requirements for funding State and State-designated
systems for protecting and advocating for individuals with mental
illness. By law, these requirements must be set out in regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/14/94 59 FR 64367
NPRM Comment Period End 02/13/95
Final Action 04/00/96
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Local
Additional Information: Previously reported under RIN 0905-AD99.
Alternate Contact: Sue Martone, DLEA, SAMHSA, PHS; Room 12C-15, 5600
Fishers Lane, Rockville, MD 20857; 301-443-4640
Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration, 5600 Fishers Lane, Room 12C-15, Rockville, MD 20857
Phone: 301 443-4640
RIN: 0930-AA02
_______________________________________________________________________
1205. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
(TOBACCO PROVISIONS)
Regulatory Plan: This entry is Seq. No. 26 in Part II of this issue of
the Federal Register.
RIN: 0930-AA03
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
1206. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
Priority: Other Significant
Legal Authority: 42 USC 300-x et seq, as amended by PL 102-321
CFR Citation: 45 CFR 96
Legal Deadline: Final, Statutory, August 25, 1992.
Awards to States after January 1, 1993 cannot be made until
implementing regulations are published.
Abstract: Sets requirements for block grants for prevention and
treatment of substance abuse. The requirements include criteria for
approval of State plans which must by statute be prescribed in
regulations. These provisions would replace the existing interim final
rule published March 31, 1993. Given the pending reauthorization of
SAMHSA and the current Administration's FY 1996 legislative proposal to
turn the block grant into a ``Performance Partnership,'' publication of
this regulation has been put on hold.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 03/31/93 58 FR 17062
Interim Final Rule Comment
Period End 06/01/93
Final Action 00/00/00
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Tribal
Additional Information: Previously reported under RIN 0905-AD98.
Alternate Contact: Sue Martone, DLEA, SAMHSA, PHS, 5600 Fishers Lane,
Room 12C-15, Rockville, MD 20852; 301-443-4640
Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration, 5600 Fishers Lane, Room 12C-15, Rockville, MD 20857
Phone: 301 443-4640
RIN: 0930-AA01
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
1207. CONFIDENTIALITY OF SUBSTANCE ABUSE PATIENT RECORDS
Priority: Other Significant
CFR Citation: 42 CFR 2
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/05/95 60 FR 22296
Final Action Effective 06/05/95
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Tribal, Federal
Agency Contact: Joseph D. Faha
Phone: 301 443-4640
RIN: 0930-AA00
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
1208. RESPIRATORY PROTECTIVE DEVICES
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
CFR Citation: 30 CFR 11; 42 CFR 84
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/08/95 60 FR 30336
Final Action Effective 07/10/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard Metzler
Phone: 304 284-5713
RIN: 0920-AA00
_______________________________________________________________________
1209. NATIONAL CENTER FOR HEALTH STATISTICS, SPECIAL STATISTICAL
SERVICES; GRANTS FOR HEALTH EDUCATION/RISK REDUCTION; VACCINES
INFORMATION AND EDUCATION--REPEAL
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
CFR Citation: 42 CFR 3; 42 CFR 51g; 42 CFR 110
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/13/95 60 FR 36072
Final Action Effective 07/13/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Gaylon Morris
Phone: 404 639-3243
RIN: 0920-AA01
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Departmental Management (HHSDM)
_______________________________________________________________________
1210. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY
PROCEEDINGS
Priority: Substantive, Nonsignificant
Legal Authority: 5 USC 504(c)(1)
CFR Citation: 45 CFR 13
Legal Deadline: None
Abstract: The Equal Access to Justice Act generally requires agencies
to pay attorney fees to parties prevailing against the Government in
certain types of administrative proceedings. It requires each agency to
issue rules implementing the Act as it applies to these proceedings. As
originally enacted, the Act had a sunset clause. A statutory amendment
eliminated the sunset provision and made other changes in the Act. The
instant regulation would amend 45 CFR part 13 (HHS's regulation
implementing the Act) to eliminate the corresponding sunset provision
and to make other changes conforming with the statutory changes.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/19/87 52 FR 23311
NPRM Comment Period End 08/17/87
Final Action 02/00/96
Final Action Effective 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Leslie L. Clune, Acting Associate General Counsel,
Business and Administrative Law Division, Department of Health and
Human Services, Room 5362, HHS Cohen Building, 330 Independence Avenue
SW., Washington, DC 20201
Phone: 202 619-0150
RIN: 0990-AA02
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
1211. REINVENTING FDA FOOD REGULATIONS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 101; 21 CFR 102; 21 CFR 103; 21 CFR 131; 21 CFR
133; 21 CFR 135; 21 CFR 136; 21 CFR 137; 21 CFR 139; 21 CFR 145; 21 CFR
146; 21 CFR 150; 21 CFR 152; 21 CFR 155; 21 CFR 156; ...
Legal Deadline: None
Abstract: In response to President Clinton's memorandum to heads of
departments, and agencies entitled ``Regulatory Reinvention
Initiative,'' FDA will be initiating rulemaking to retain, revise, or
revoke certain of its regulations for food. FDA will be proposing: (1)
to establish a notification procedure for companies to use for
independent GRAS determinations; (2) to request information on the need
to retain, revise, or revoke its food standards of identity regulations
and its common or usual name regulations; (3) to coordinate the food
additive, GRAS, and color additive approval process with USDA when meat
and poultry product uses are petitioned for; and (4) to increase the
number of categorical exclusions from the requirements for
environmental review.
Timetable:
Additional categorical exclusions for environmental impact NPRM 09/00/
96
Food Additives, Color Additives, and GRAS Petition Review NPRM 03/00/
96
Food Standards and Other Regulations for Food ANPRM 10/00/95
Notification Procedures for Independent GRAS Determinations NPRM 02/
00/96
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: L. Robert Lake, Director, Office of Policy, Planning
and Strategic Initiatives, Department of Health and Human Services,
Food and Drug Administration, Center for Food Safety and Applied
Nutrition (HFS-150), 200 C Street SW. Washington, DC 20204
Phone: 202 205-4561
Fax: 202 401-7739
RIN: 0910-AA58
_______________________________________________________________________
1212. FOOD STANDARDS OF IDENTITY, QUALITY, AND FILL OF
CONTAINER; COMMON OR USUAL NAME REGULATIONS: REQUEST FOR COMMENTS ON
EXISTING REGULATIONS
Regulatory Plan: This entry is Seq. No. 27 in Part II of this issue of
the Federal Register.
RIN: 0910-AA67
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
1213. OVER-THE-COUNTER (OTC) DRUG REVIEW
Priority: Routine and Frequent
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 21 USC 321p; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 360a; 21 USC 371a
CFR Citation: 21 CFR 310; 21 CFR 330; 21 CFR 333; 21 CFR 334; 21 CFR
335; 21 CFR 336; 21 CFR 337; 21 CFR 338; 21 CFR 339; 21 CFR 340; 21 CFR
341; 21 CFR 342; 21 CFR 343; 21 CFR 344; 21 CFR 345; ...
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. NOTE: NPRM for
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for
``Emetic Products'' and reproposed as ``Poison Treatment Products.''
NPRM for ``Astringent (Wet Dressings) Products'' was included in the
NPRM for ``Skin Protectant Products.'' NPRM for ``Diaper Rash
Products'' was included in NPRMs for ``Antifungal,'' ``Antimicrobial,''
``External Analgesic'' and ``Skin Protectant Products.'' NPRM for
``Fever Blister/Cold Sore Products (External)'' was included in NPRMs
for ``External Analgesic'' and ``Skin Protectant Products.'' NPRM for
``Insect Bites and Stings (Relief) Products'' was included in NPRMs for
``External Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/
Oak/Sumac Prevention'' was included in NPRMs for ``External Analgesic''
and ``Skin Protectant Products.'' NPRM for ``Mercurial (Topical)
Products'' was included in revised NPRM for ``Antimicrobial Products.''
NPRM for ``Alcohol (Topical) Products'' was included in revised NPRM
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products''
was updated and split into two sections: first aid products and health
care products.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the
individual rulemaking. However, the Agency anticipates that the rules
would not have a significant economic impact on a substantial number of
small entities as defined by the Regulatory Flexibility Act.
Timetable:
Acne (Topical) Products ANPRM 03/23/82 (47 FR 12430) NPRM 01/15/85
(50 FR 2172) NPRM (Amendment) 08/07/91 (56 FR 37622) Final Action 08/
16/91 (56 FR 41008)
Alcohol (Oral) in OTC Drug Products NPRM 10/21/93 (58 FR 54466) Final
Action 03/13/95 (60 FR 13590)
Alcohol (Topical) Products (To be merged w/other rulemkg) ANPRM 05/21/
82 (47 FR 22324)
Anorectal Products ANPRM 05/27/80 (45 FR 35576) NPRM 08/15/88 (53 FR
30756) Final Action 08/03/90 (55 FR 31776) Final Action (LYCD) 09/02/
93 (58 FR 46746) Final Action (Witch Hazel) 06/03/94 (59 FR 28766)
Antacid Drug Products ANPRM 04/05/73 (38 FR 8714) NPRM 11/12/73 (38
FR 31260) Final Action 06/04/74 (39 FR 9862) NPRM (Amendment)
(Overindulgence) 12/24/91 (56 FR 66754) Final Action (Amendment)
(Warning) 08/26/93 (58 FR 45204) NPRM (Amendment) (Testing) 09/23/93
(58 FR 49826) NPRM (Amendment)(Sodium Bicarb.) 02/02/94 (59 FR
5060) Final Action (Technical Amendment) 11/25/94 (59 FR 60555) Final
Action (Amendment) (Testing) 11/00/95
Anthelmintic Products ANPRM 09/09/80 (45 FR 59541) NPRM 08/24/82 (47
FR 37062) Final Action 08/01/86 (51 FR 27756)
Antibiotic First Aid Products ANPRM 04/01/77 (42 FR 17642) NPRM 07/
09/82 (47 FR 29986) Final Action 12/11/87 (52 FR 47312) NPRM
(Amendment) 08/18/89 (54 FR 34188) Final Action 03/15/90 (55 FR
9721) NPRM (Amendment) 05/11/90 (55 FR 19868) NPRM (Amendment) 06/08/
90 (55 FR 23450) Final Action (Amendment) 10/03/90 (55 FR
40379) Final Action (Amendment) 12/05/90 (55 FR 50171) NPRM
(Amendment) (Warning) 11/00/95
Anticaries Products ANPRM 03/28/80 (45 FR 20666) NPRM 09/30/85 (50 FR
39854) NPRM 06/15/88 (53 FR 22430) Final Action 10/06/95 (60 FR
52474)
Antidiarrheal Products ANPRM 03/21/75 (40 FR 12924) NPRM 04/30/86 (51
FR 16138) Final Action 12/00/95
Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts) ANPRM
01/05/82 (47 FR 444)
Antiemetic Products ANPRM 03/21/75 (40 FR 12934) NPRM 07/13/79 (44 FR
41064) Final Action 04/30/87 (52 FR 15886) NPRM (Amendment) 08/26/93
(58 FR 45216) Final Action 04/11/94 (59 FR 16981)
Antiflatulent Drug Products NPRM 11/12/73 (38 FR 31260) Final Action
06/04/74 (39 FR 19877) NPRM (Amendment) 01/29/88 (53 FR 2716) Final
Action (Amendment) 12/00/95
Antifungal (Topical) Products ANPRM 03/23/82 (47 FR 12480) NPRM 12/
12/89 (54 FR 51136) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR
25240) Final Action (Amdt.)(Diaper Rash) 12/18/92 (57 FR 60430) Final
Action (Partial) 09/02/93 (58 FR 46744) Final Action 09/23/93 (58 FR
49890)
Antimicrobial Products ANPRM 09/13/74 (39 FR 33103) NPRM 01/06/78 (43
FR 1210) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 25246)
Antiperspirant Products ANPRM 10/10/78 (43 FR 46694) NPRM 08/20/82
(47 FR 36492) Final Action 00/00/00
Antiseptic First Aid ANPRM 09/13/74 (39 FR 33103) NPRM 01/06/78 (43
FR 1210) NPRM (Revised) 07/22/91 (56 FR 33644) Final Action 00/00/00
Antiseptic Products (Professional Use) ANPRM 09/13/74 (39 FR
33103) NPRM 01/06/78 (43 FR 1210) NPRM (Revised) 06/17/94 (59 FR
31402)
Aphrodisiac Products ANPRM 10/01/82 (47 FR 43572) NPRM 01/15/85 (50
FR 2168) Final Action 07/07/89 (54 FR 28780)
Aspirin (Heart Labeling) NPRM 10/20/93 (58 FR 54224)
Aspirin (Reye Syndrome) NPRM 10/20/93 (58 FR 54228)
Astringent (Wet Dressings) Prdts (Merged w/other rulemkg) ANPRM 09/07/
82 (47 FR 39436)
Benign Prostatic Hypertrophy Products ANPRM 10/01/82 (47 FR
43566) NPRM 02/20/87 (52 FR 5406) Final Action 02/27/90 (55 FR 6926)
Boil Ointments ANPRM 06/29/82 (47 FR 28306) NPRM 01/26/88 (53 FR
2198) Final Action 11/15/93 (58 FR 60332)
Camphorated Oil Drug Products ANPRM 09/26/80 (45 FR 63869) Final
Action 09/21/82 (47 FR 41716)
Cholecystokinetic Products ANPRM 02/12/80 (45 FR 9286) NPRM 08/24/82
(47 FR 37068) Final Action 06/10/83 (48 FR 27004) NPRM (Amendment)
08/15/88 (53 FR 30786) Final Action (Amendment) 02/28/89 (54 FR 8320)
Corn and Callus Remover Products ANPRM 01/05/82 (47 FR 522) NPRM 02/
20/87 (52 FR 5412) Final Action 08/14/90 (55 FR 33258)
Cough/Cold (Anticholinergic) Products ANPRM 09/09/76 (41 FR
38312) NPRM 07/09/82 (47 FR 30002) Final Action 11/08/85 (50 FR
46582)
Cough/Cold (Antihistamine) Products ANPRM 09/09/76 (41 FR 38312) NPRM
01/15/85 (50 FR 2200) NPRM (Amendment) 08/24/87 (52 FR 31892) Final
Action 12/09/92 (57 FR 58356) Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)
Cough/Cold (Antitussive) Products ANPRM 09/09/76 (41 FR 38312) NPRM
10/19/83 (48 FR 48576) Final Action 08/12/87 (52 FR 30042) NPRM
(Amendment) 07/06/89 (54 FR 28442) NPRM (Amendment) 10/02/89 (54 FR
40412) Final Action (Amendment) 07/06/90 (55 FR 27806) Final Action
(Amendment) 10/03/90 (55 FR 40381) NPRM (Amendment)(Warning) 06/19/92
(57 FR 27666) NPRM (Amendment)(Ingredients) 12/09/92 (57 FR
58378) Final Action (Amendment)(Warning) 10/20/93 (58 FR 54232) Final
Action (Amdt.)(Ingredients) 06/03/94 (59 FR 29172)
Cough/Cold (Bronchodilator) Products ANPRM 09/09/76 (41 FR
38312) NPRM 10/26/82 (47 FR 47520) Final Action 10/02/86 (51 FR
35326) NPRM (Amendment)(Warning) 06/19/92 (57 FR 27662) Final Action
(Amendment)(Warning) 10/20/93 (58 FR 54238) NPRM (Amendment)(MDI) 03/
09/95 (60 FR 13014) NPRM (Amendment)(Ephedrine) 07/27/95 (60 FR
38643) Final Action (Amendment) (MDI) 02/00/96
Cough/Cold (Combination) Products ANPRM 09/09/76 (41 FR 38312) NPRM
08/12/88 (53 FR 30522) NPRM (Amendment)(DPH Combinations) 02/23/95 (60
FR 10286) Final Action Theophylline 07/27/95 (60 FR 38636) Final
Action 03/00/96
Cough/Cold (Diphenhydramine) Products Final Action/Enforcement Policy
12/00/95
Cough/Cold (Expectorant) Products ANPRM 09/09/76 (41 FR 38312) NPRM
07/09/82 (47 FR 30002) Final Action 02/28/89 (54 FR 8494) Final
Action (Technical Changes) 06/30/92 (57 FR 29176)
Cough/Cold (Expectorant/Ipecac) Products Final Action 09/14/92 (57 FR
41857)
Cough/Cold (Nasal Decongestant) Products ANPRM 09/09/76 (41 FR
38312) NPRM 01/15/85 (50 FR 2220) NPRM (Amendment) 06/19/92 (57 FR
27658) Final Action 08/23/94 (59 FR 43386) NPRM (Phenylpropanolamine)
03/00/96
Dandruff, Seborrheic Dermatitis and Psoriasis Control Products ANPRM
12/03/82 (47 FR 54646) NPRM 07/30/86 (51 FR 27346) Final Action 12/
04/91 (56 FR 63554) NPRM (Amendment) 04/05/93 (58 FR 17554) Final
Action 01/28/94 (59 FR 4000)
Daytime Sedatives ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/78 (43 FR
25544) Final Action 06/22/79 (44 FR 36378)
Diaper Rash Products (Merged w/other rulemkg) ANPRM 09/07/82 (47 FR
39406)
Digestive Aid Products ANPRM 01/05/82 (47 FR 454) NPRM 01/29/88 (53
FR 2706) Final Action 10/21/93 (58 FR 54450)
Emetic Products ANPRM 03/21/75 (40 FR 12939) NPRM 09/05/78 (43 FR
39544)
Exocrine Pancreatic Insufficiency Products ANPRM 12/21/79 (44 FR
75666) NPRM 11/08/85 (50 FR 46594) NPRM (Reproposed) 07/15/91 (56 FR
32282) Final Action 04/24/95 (60 FR 20162)
External Analgesic Products ANPRM 12/04/79 (44 FR 69768) NPRM 02/08/
83 (48 FR 5852) NPRM (Amendment) (Dandruff) 07/30/86 (51 FR
27360) NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592) NPRM
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818) NPRM (Amendment) (Fvr
Blister/Ext) 01/31/90 (55 FR 3370) NPRM (Amendment) (1%Hydrocortisone)
02/27/90 (55 FR 6932) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR
25234) Final Action (Diaper Rash) 12/18/92 (57 FR 60426) Final Action
00/00/00
Fever Blister Products (Internal) ANPRM 01/05/82 (47 FR 502) NPRM 06/
17/85 (50 FR 25156) Final Action 06/30/92 (57 FR 29166)
Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other
rulemkg) ANPRM 09/07/82 (47 FR 39436)
Hair Grower and Hair Loss Prevention Products ANPRM 11/07/80 (45 FR
73955) NPRM 01/15/85 (50 FR 2190) Final Action 07/07/89 (54 FR 28772)
Hormone (Topical) Products ANPRM 01/05/82 (47 FR 430) NPRM 10/02/89
(54 FR 40618) Final Action 09/09/93 (58 FR 57608)
Hypo/Hyperphosphatemia Products ANPRM 12/09/80 (45 FR 81154) NPRM 01/
15/85 (50 FR 2160) Final Action 05/11/90 (55 FR 19852)
Ingrown Toenail Relief Products ANPRM 10/17/80 (45 FR 69128) NPRM 09/
03/82 (47 FR 39120) Final Action 09/09/93 (58 FR 47602)
Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg) ANPRM 09/
07/82 (47 FR 39412)
Insect Repellent Drug Products (Internal) ANPRM 01/05/82 (47 FR
424) NPRM 06/10/83 (48 FR 26986) Final Action 06/17/85 (50 FR 25170)
Internal Analgesic Products ANPRM 07/08/77 (42 FR 35346) NPRM 11/16/
88 (53 FR 46204) NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR
66762) NPRM (Amdt.)(Sodium Bicarbonate) 02/02/94 (59 FR 5068) NPRM
(Amendment)(Alcohol Warning) 12/00/95 Final Action (Cardio/
Cerebrvasclar) 02/00/96 NPRM (Labeling-revised indications) 03/00/
96 NPRM (Prof. Labeling)(Acute MI) 03/00/96
Internal Analgesic Products (Overindulgence) Final Action 00/00/00
Internal Deodorant Products ANPRM 01/05/82 (47 FR 512) NPRM 06/17/85
(50 FR 25162) Final Action 05/11/90 (55 FR 19862)
Labeling of Drug Products for OTC Use NPRM 04/05/93 (58 FR
17553) Final Action 01/28/94 (59 FR 3998) NPRM (Do not mix drugs) 08/
03/94 (59 FR 39499) NPRM (Amendment) (Do not mix drugs) 10/04/95 (60
FR 52058) NPRM (Unless a doctor tells you) 11/00/95 NPRM (Format/
Examples) 02/00/96 NPRM (Calcium/Magnesium/Potassium) 03/00/96
Laxative Products ANPRM 03/21/75 (40 FR 12902) NPRM 01/15/85 (50 FR
2124) NPRM (Amendment) 10/01/86 (51 FR 35136) NPRM (Amendment) 09/02/
93 (58 FR 46589) Final Action 03/00/96
Leg Muscle Cramps (Nocturnal Relief) Products ANPRM 10/01/82 (47 FR
43562) NPRM 11/08/85 (50 FR 46588) Final Action 08/22/94 (59 FR
43234)
Male Genital Desensitizer Products ANPRM 09/07/82 (47 FR 39412) NPRM
10/02/85 (50 FR 40260) Final Action 06/19/92 (57 FR 27654)
Menstrual Products ANPRM 12/07/82 (47 FR 55075) NPRM 11/16/88 (53 FR
46194)
Mercurial (Topical) Products (To be merged w/other rulemkg) ANPRM 01/
05/82 (47 FR 436)
Nailbiting/Thumbsucking Deterrent Products ANPRM 10/17/80 (45 FR
69122) NPRM 09/03/82 (47 FR 39096) Final Action 09/02/93 (58 FR
46749)
Nighttime Sleep Aid Products ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/
78 (43 FR 25544) Final Action 02/14/89 (54 FR 6814) NPRM (Amendment)
08/26/93 (58 FR 45217) Final Action (Amendment) 04/11/94 (59 FR 16982)
NDA Labeling Exclusivity NPRM 11/09/93 (58 FR 59622)
Ophthalmic Products ANPRM 05/06/80 (45 FR 30002) NPRM 06/28/83 (48 FR
29788) Final Action 03/04/88 (53 FR 7076) Final Action (Anti-
infective) 12/18/92 (57 FR 60416)
Oral Discomfort (Relief) Products ANPRM 05/25/82 (47 FR 22712) NPRM
09/24/91 (56 FR 48302)
Oral Health Care Products ANPRM 05/25/82 (47 FR 22760) NPRM 01/27/88
(53 FR 2436) NPRM (Amendment) (Antimicrobials) 02/09/94 (59 FR
6084) Final Action 00/00/00
Oral Mucosal Injury Products (Merged w/Oral Health Care) ANPRM 11/02/
79 (44 FR 63270) NPRM 07/26/83 (48 FR 33984)
Oral Wound Healing Products ANPRM 11/02/79 (44 FR 63270) NPRM 07/26/
83 (48 FR 33984) Final Action 07/18/86 (51 FR 26112)
Otic Products (Dry Water-Clogged Ears) NPRM (Amendment) 02/00/96
Otic Products (Earwax) NPRM 07/09/82 (47 FR 30012) Final Action 08/
08/86 (51 FR 28656)
Otic Products (Swimmers Ear) NPRM 07/30/86 (51 FR 27366) Final Action
02/15/95 (60 FR 8916) Final Action Partial Stay 08/16/95 (60 FR 42435)
Overindulgence Remedies ANPRM 10/01/82 (47 FR 43540) NPRM 12/24/91
(56 FR 66742) NPRM (Amendment)(Warning) 05/05/93 (58 FR 26886)
Overindulgence Remedies/Prevention of Inebriation ANPRM 10/01/82 (47
FR 43540) Final Action 07/19/83 (48 FR 32872)
Pediculicide Products ANPRM 06/29/82 (47 FR 28312) NPRM 04/03/89 (54
FR 13480) Final Action 12/14/93 (58 FR 65452)
Phenylpropanolamine Products (Labeling) NPRM 01/00/96
Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg) ANPRM 09/07/
82 (47 FR 39412)
Poison Treatment Products NPRM 01/15/85 (50 FR 2244) Final Action 03/
00/96
Quinine for Malaria NPRM 04/19/95 (60 FR 19650)
Reporting of Adverse Reactions NPRM 12/00/95
Skin Bleaching Products ANPRM 11/03/78 (43 FR 51546) NPRM 09/03/82
(47 FR 39108) NPRM (Reproposed) 03/00/96
Skin Protectant Products ANPRM 08/04/78 (43 FR 34628) NPRM 02/15/83
(48 FR 6820) NPRM (Amendment) (Astringent) 04/03/89 (54 FR
13490) NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808) NPRM
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362) NPRM (Amendment)
(Diaper Rash) 06/20/90 (55 FR 25204) Final Action (Astringent) 10/21/
93 (58 FR 54466) Final Action (Witch Hazel) 06/03/94 (59 FR
28767) Final Action (Poison Ivy) 03/00/96 Final Action 03/00/96
Smoking Deterrent Products ANPRM 01/05/82 (47 FR 490) NPRM 07/03/85
(50 FR 27552) Final Action 06/01/93 (58 FR 31236)
Sodium Labeling NPRM 04/25/91 (56 FR 19222) Final Action 12/00/95
Status of Certain Category II and III Ingredients NPRM 05/16/90 (55 FR
20434) Final Action 11/07/90 (55 FR 46914) NPRM 08/25/92 (57 FR
38568) Final Action 05/10/93 (58 FR 27636)
Stimulant (Overindulgence) Products NPRM (Amendment) 12/24/91 (56 FR
66758)
Stimulant Products ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/78 (43 FR
25544) Final Action 02/29/88 (53 FR 6100)
Stomach Acidifier Products ANPRM 10/19/79 (44 FR 60316) NPRM 01/15/85
(50 FR 2184) Final Action 08/17/88 (53 FR 31270)
Sunscreen Products ANPRM 08/25/78 (43 FR 38206) NPRM 05/12/93 (58 FR
28194) NPRM (Amendment) 06/08/94 (59 FR 29706)
Sweet Spirits of Nitre ANPRM 02/22/80 (45 FR 11846) Final Action 06/
27/80 (45 FR 43400)
Topical Drug Products Containing Benzoyl Peroxide (Labeling) NPRM 02/
17/95 (60 FR 9554)
Vaginal Contraceptive Products ANPRM 12/12/80 (45 FR 82014) NPRM 02/
03/95 (60 FR 6892)
Vaginal Drug Products ANPRM 10/13/83 (48 FR 46694) Withdrawal 02/03/
95 (60 FR 5226)
Vitamin/Mineral Products ANPRM 03/16/79 (44 FR 16126) Withdrawal 11/
27/81 (46 FR 57914)
Wart Remover Products ANPRM 10/03/80 (45 FR 65609) NPRM 09/03/82 (47
FR 39102) NPRM (Amendment) 03/27/87 (52 FR 9992) Final Action 08/14/
90 (55 FR 33246) NPRM (Amendment)(Directions) 01/28/94 (59 FR
4015) Final Action (Amdt.)(Directions) 11/23/94 (59 FR 60315)
Water Soluble Gums NPRM 10/30/90 (55 FR 45782) Final Action 08/26/93
(58 FR 45194)
Weight Control Products ANPRM 02/26/82 (47 FR 8466) NPRM 10/30/90 (55
FR 45788) Final Action 08/08/91 (56 FR 37792) NPRM (Amendment) 01/00/
96
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AA06.
NOTE: Reinventing government applies only to the Antacid Drug Products
final action.
Agency Contact: William E. Gilbertson, Director, Monograph Review
Staff, Office of OTC Drug Evaluation, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research (HFD-810), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-5000
RIN: 0910-AA01
_______________________________________________________________________
1214. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND
REPORTS
Priority: Other Significant
Legal Authority: 21 USC 350a
CFR Citation: 21 CFR 107; 21 CFR 106
Legal Deadline: None
Abstract: The agency published on December 24, 1991, a final rule
implementing certain aspects of the Infant Formula Act of 1986. The
rule establishes infant formula record and record retention
requirements. The agency is preparing a proposed rule that will
establish current good manufacturing practice regulations, quality
control procedures, quality factors, notification requirements, and
reports for the production of infant formulas.
Timetable:
Current Good Mfg. Practices; Qual Control Proc NPRM 05/00/96 NPRM
(Comment Period End) 08/00/96
Infant Form Cons Comp, Micro Test & Recd Retention Req NPRM 01/26/89
(54 FR 3783) NPRM (Comment Period End) 03/27/89 Final Rule 12/24/91
(56 FR 66566)
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AC46.
Agency Contact: Carolyn W. Miles, Nutritionist, Regulatory Branch,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition (HFS-456), 200 C Street
SW., Washington, DC 20204
Phone: 202 205-5372
RIN: 0910-AA04
_______________________________________________________________________
1215. REPORTING OF ERRORS AND ACCIDENTS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42
USC 262 to 264
CFR Citation: 21 CFR 600; 21 CFR 606
Legal Deadline: None
Abstract: All licensed manufacturers are required to notify FDA
promptly of errors or accidents in the manufacture of products that may
affect the safety, purity, or potency of any distributed biological
product (21 CFR 600.14). The reporting of certain errors or accidents
occurring in the manufacture of blood and blood components is necessary
so that FDA can respond where the public health may be endangered and
provide added assurance as to the continued safety, identity, quality,
purported quality, and purity of blood and blood components. FDA has
determined that errors and accidents that are detected and corrected
before a finished unit is removed from the unprocessed inventory and
made available for release and distribution do not affect the safety of
the blood supply and need not be reported to the Agency. The proposed
rule would require licensed establishments, unlicensed establishments,
and transfusion services to report and keep records. The cost to
licensed establishments would be minimal. Since they already are
required to report, licensed establishments would only have to make
some changes in standard operating procedures. Unlicensed
establishments are already required to keep records and conduct
investigations. Under the proposed rule they would have to establish
reporting procedures and report to FDA. The transfusion services would
have to assure their recordkeeping and investigation procedures are
sufficient and establish reporting procedures. Reporting by transfusion
services is expected to be minimal.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/96
NPRM Comment Period End 08/00/96
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD67.
Agency Contact: Jean M. Olson, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Biologics
Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448
Phone: 301 594-3074
RIN: 0910-AA12
_______________________________________________________________________
1216. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992
Regulatory Plan: This entry is Seq. No. 28 in Part II of this issue of
the Federal Register.
RIN: 0910-AA24
_______________________________________________________________________
1217. EFFECTIVE DATE OF REQUIREMENT FOR SUBMISSION OF PREMARKET
APPROVAL APPLICATIONS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360e
CFR Citation: 21 CFR 868; 21 CFR 870; 21 CFR 872; 21 CFR 878; 21 CFR
882; 21 CFR 888
Legal Deadline: Final, Statutory, December 1, 1995.
Abstract: Class III devices which were on the market before 1976 were
exempt from premarket approval until FDA issues a rule requiring the
submission of premarket approval applications. The Safe Medical Devices
Act of 1990 directed FDA to review the classification of pre-1976 class
III devices for which premarket approval is not yet required, and
either reclassify them into class I or class II or require premarket
approval for those devices remaining in class III. There are
approximately 125 pre-1976 class III devices not yet addressed. The
devices covered by this proposal are devices which FDA believes may no
longer be commercialy viable. FDA is providing an opportunity for
manufactureres to petition for reclassification before premarket
approval is required.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice 05/06/94 59 FR 23731
NPRM 09/07/95 60 FR 46718
NPRM Comment Period End 01/05/96
Final Action 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE34.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20857
Phone: 301 594-4765
RIN: 0910-AA31
_______________________________________________________________________
1218. LATEX CONDOMS/GLOVES: EXPIRATION DATE LABELING
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 351; 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: Latex patient examination and surgeon gloves and latex
condoms are used as a barrier to transmission of diseases through
bodily fluids, including AIDS. Latex deteriorates over time, reducing
its utility as a barrier. The proposed rule would require manufacturers
of these products to perform testing to establish an appropriate
expiration date for their products and to place that date on their
labeling.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE37.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA32
_______________________________________________________________________
1219. LATEX WARNING
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: Certain persons may be subject to severe adverse reaction
upon contact with latex. Therefore, FDA would propose to require that
devices containing latex have a warning in the labeling concerning the
presence of latex and the potential risk. This will enable health
professionals and consumers to make an informed choice concerning the
use of a device.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/96
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE40.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA34
_______________________________________________________________________
1220. PREMARKET APPROVAL OF MEDICAL DEVICES; SUPPLEMENTAL
APPLICATIONS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 360e
CFR Citation: 21 CFR 814.39
Legal Deadline: None
Abstract: FDA has become aware of several situations in which a
supplement to an approved premarket approval application (PMA) was not
submitted for a change to the device even though FDA believed that a
supplement was required. Therefore, FDA would propose to revise its
regulation to clarify when a supplement is required. This would result
in fewer unapproved changes in devices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE41.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA35
_______________________________________________________________________
1221. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS
FOR SALE
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360d; 21 USC 371; 21
USC 360j(e)
CFR Citation: 21 CFR 801.420; 21 CFR 801.421
Legal Deadline: None
Abstract: FDA is considering revising its present regulation governing
the labeling and conditions for sale of hearing aids. The present rule
requires an examination by a physician before purchase of a hearing
aid, but permits an informed adult to waive that requirement. There is
some evidence that this waiver provision is being misused. FDA is
reconsidering which types of health professionals are competent to
perform hearing evaluations. FDA is also considering revisions to its
professional and patient labeling to require updated information.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 11/10/93 58 FR 59695
ANPRM Comment Period End 01/10/94
NPRM 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AE46.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA39
_______________________________________________________________________
1222. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; PROPOSED AMENDMENT OF CERTAIN
REQUIREMENTS FOR FINISHED PHARMACEUTICALS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 351 to 352; 21 USC 355 to 357; 21
USC 360b; 21 USC 371; 21 USC 374
CFR Citation: 21 CFR 210.3; 21 CFR 211.22; 21 CFR 211.68; 21 CFR
211.82; 21 CFR 211.84; 21 CFR 211.101; 21 CFR 211.103; 21 CFR 211.110;
21 CFR 211.111; 21 CFR 211.113; 21 CFR 211.115; 21 CFR 211.160; 21 CFR
211.166; 21 CFR 211.192; 21 CFR 211.220; ...
Legal Deadline: None
Abstract: FDA is proposing revisions to the current good manufacturing
practice (CGMP) regulations at 21 CFR parts 210 and 211 regarding
finished pharmaceuticals. The new regulations either codify current
agency policies or current industry practices. Among other things, the
proposal would create or clarify requirements for process and methods
validation, appropriate laboratory testing procedures, and protection
against contamination. The proposal is designed to update the CGMP
regulations in response to technological changes and the Agency's
experience with the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: None
Government Levels Affected: Federal
Additional Information: Previously reported under RIN 0905-AE63.
Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1046
RIN: 0910-AA45
_______________________________________________________________________
1223. ANIMAL DRUG AMENDMENTS OF 1994, EXTRA-LABEL USE;
IMPLEMENTATION
Priority: Substantive, Nonsignificant
Legal Authority: PL 103-396
CFR Citation: None
Legal Deadline: Final, Statutory, October 22, 1996.
Two years after bill was signed into law (10/22/94).
Abstract: Upon promulgation of regulations, the Animal Drug Amendments
of 1994 allow licensed veterinarians to prescribe off-label use of
animal and human drugs for animals under certain circumstances within
limits set by FDA. If the Secretary finds there is a reasonable
probability that a use may present a risk to the public, the Secretary
may establish a safe level for residues of such use by order and
require the development of analytical methods for detection of
resultant residues. If the Secretary finds, after affording an
opportunity for public comment, that a use presents a risk to public
health or if no analytical method is developed, when called for, the
Secretary may prohibit such use. The Secretary may also, by regulation,
provide access to veterinarian records to ascertain any use or intended
extra-label use that may present a risk to public health. The proposed
rule will implement the statute by providing policies, procedures, and
limitations on extra-label use and by setting the circumstances and
conditions for Agency examination of veterinarian records.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Final Action 10/00/96
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE66.
Agency Contact: Richard L. Arkin, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Veterinary Medicine (HFV-238), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1737
RIN: 0910-AA47
_______________________________________________________________________
1224. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF
CIGARETTES AND SMOKELESS TOBACCO PRODUCTS TO PROTECT CHILDREN AND
ADOLESCENTS
Regulatory Plan: This entry is Seq. No. 29 in Part II of this issue of
the Federal Register.
RIN: 0910-AA48
_______________________________________________________________________
1225. REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF
DRUGS IN COMMERCIAL DISTRIBUTION
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21
USC 356; 21 USC 357; 21 USC 360; 21 USC 371
CFR Citation: 21 CFR 207
Legal Deadline: None
Abstract: Revises and clarifies these regulations to reduce burden to
manufacturers, packers, distributors, and to consolidate and streamline
the requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Howard Muller, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901
RIN: 0910-AA49
_______________________________________________________________________
1226. HABIT FORMING DRUGS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 371
CFR Citation: 21 CFR 329
Legal Deadline: None
Abstract: Revise and clarify these regulations and to be consistent
with the Drug Enforcement Administration regulation and the Controlled
Substances Act; to streamline requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901
RIN: 0910-AA50
_______________________________________________________________________
1227. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21
USC 357; 21 USC 371
CFR Citation: 21 CFR 320
Legal Deadline: None
Abstract: Revisions and clarification of these requirements to
eliminate duplication and inconsistencies and streamline requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Erica L. Keys, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 827-0901
RIN: 0910-AA51
_______________________________________________________________________
1228. CONSOLIDATION OF REGULATIONS
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 21 USC 371
CFR Citation: 21 CFR 200.30; 21 CFR 200.31; 21 CFR 250.10; 21 CFR
250.103; 21 CFR 250.106; 21 CFR 310.502; 21 CFR 310.504-510; 21 CFR
310.513; 21 CFR 310.525; 21 CFR 310.526
Legal Deadline: None
Abstract: FDA is proposing to consolidate into one section a list of
drugs previously determined to be new drugs. This document would also
remove the section now providing for these drugs. This action, which
will make the regulations more concise and efficient, is being taken in
response to the President's regulatory reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Mary E. Catchings, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-366),
7500 Standish Place Rockville, MD 20855
Phone: 301 594-2041
Fax: 301 827-0901
RIN: 0910-AA53
_______________________________________________________________________
1229. REVOCATION OF CERTAIN REGULATIONS
Regulatory Plan: This entry is Seq. No. 30 in Part II of this issue of
the Federal Register.
RIN: 0910-AA54
_______________________________________________________________________
1230. NAME OF SELLING AGENT OR DISTRIBUTOR
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42
USC 262 to 264
CFR Citation: 21 CFR 610
Legal Deadline: None
Abstract: This proposed rule proposes to allow distributors' and
selling agents' names to be prominently displayed on biological product
containers, package labels, and labeling, while retaining current
product manufacturer labeling information. The proposed rule modifies
the current requirement giving precedence to the name of the
manufacturer by deleting the requirement for prominence of the name of
the manufacturer. The proposed rule is intended to remove an impediment
to flexible manufacturing, packaging, and distribution arrangements and
to harmonize with the drug regulations (21 CFR 201).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/96
NPRM Comment Period End 09/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Jean M. Olson and Tracey Forfa, Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research (HFM-630), 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 594-3074
RIN: 0910-AA56
_______________________________________________________________________
1231. STREAMLINING PROCEDURES FOR CHANGES IN PRODUCTION OF
BIOLOGICS
Regulatory Plan: This entry is Seq. No. 31 in Part II of this issue of
the Federal Register.
RIN: 0910-AA57
_______________________________________________________________________
1232. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA
Priority: Routine and Frequent
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 351; 21 USC 352; 21
USC 355; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: On January 4, 1994, FDA published final rules relative to
nutrition labeling, nutrient content claims and health claims for
dietary supplements. The Dietary Supplement Health and Education Act
(DSHEA) was enacted on October 25, 1995, modifying the provisions for
labeling of dietary supplements. FDA is initiating rulemaking to modify
its regulations for dietary supplements accordingly. One proposal would
modify the nutrition labeling and ingredient declaration requirements.
A second proposal would modify the provisions for nutrient content
claims and health claims for the disclaimer to accompany statements of
nutritional support. A third proposal would define the terms high
potency and antioxident.
Timetable:
High Potency and Antioxident terms; Dietary Supplements NPRM 12/00/95
Nutrition Content and Health Claims; Dietary Supplements NPRM 12/00/95
Nutrition Labeling and Ingredient Labeling; Dietary Supplements NPRM
12/00/95
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Agency Contact: F. Edward Scarbrough, Director, Office of Food
Labeling, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-150),
200 C Street SW. Washington, DC 20204
Phone: 202 205-4561
Fax: 202 205-4594
RIN: 0910-AA59
_______________________________________________________________________
1233. PROTECTION OF HUMAN SUBJECTS; INFORMED CONSENT
Regulatory Plan: This entry is Seq. No. 32 in Part II of this issue of
the Federal Register.
RIN: 0910-AA60
_______________________________________________________________________
1234. OTC DRUG LABELING REVIEW
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321P; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 360a; 21 USC 371a
CFR Citation: 21 CFR 200
Legal Deadline: None
Abstract: As part of the Food and Drug Administration's ongoing process
to improve the labeling of over-the counter (OTC) drug products, the
agency will seek public comment on a standardized uniform format for
OTC labeling. This action is intended to improve the communication of
important information about OTC products to consumers.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Ilisa B. G. Bernstein, Department of Health and Human
Services, Food and Drug Administration, Office of Policy (HF-23) 5600
Fishers Lane, Rm. 15-74 Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
RIN: 0910-AA63
_______________________________________________________________________
1235. MEDICAL DEVICE EXEMPTIONS FROM PREMARKET
NOTIFICATION
Regulatory Plan: This entry is Seq. No. 33 in Part II of this issue of
the Federal Register.
RIN: 0910-AA65
_______________________________________________________________________
1236. SUBSTANCES APPROVED FOR USE IN THE PREPARATION OF
MEAT AND POULTRY PRODUCTS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 348; 21 USC 355 to
357; 21 USC 360; 21 USC 360b to 360f; 21 USC 360h to 360j; 21 USC 361;
21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 262
CFR Citation: 21 CFR 71; 21 CFR 170; 21 CFR 171
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing the review of petitions for the approval of
food and color additives and substances generally recognized as safe
(GRAS) to provide for simultaneous review of such petitions by the Food
Safety and Inspection Service (FSIS), U.S. Department of Agriculture
(USDA), when meat or poultry product uses are proposed. By agreement
between USDA and FDA, such listings would eliminate the need for a
separate FSIS rulemaking to allow the use in meat and poultry products
of FDA-approved substances.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/95
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: Federal
Agency Contact: George Pauli, Department of Health and Human Services,
Food and Drug Administration, Center for Food Safety and Applied
Nutrition (HFS-200) 200 C Street SW., Washington, DC 20204
Phone: 202 418-3090
RIN: 0910-AA66
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
1237. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I
OF THE GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 360b; 21 USC 371
CFR Citation: 21 CFR 514
Legal Deadline: Final, Statutory, November 16, 1989.
The deadline applies to the GADPTRA sections. There is no deadline
relating to the other sections.
Abstract: On December 17, 1991, the Agency published a proposed
revision of the existing regulations that is consistent with the
current procedural regulations for human drugs where appropriate. The
New Animal Drug Application (NADA) revisions articulate general
requirements in regulations containing performance standards and would
complement them through detailed guidelines on, among other matters,
appropriate ways of meeting requirements for submission of chemistry,
pharmacology, and statistical data that would better address the
intricate scientific issues involved. A separate proposed rule for
reporting requirements for marketed animal drugs also was published on
that date. The agency intends to repropose the NADA proposed rule to
incorporate some recent changes in procedure. The Agency also proposes
to amend its regulations to implement Title I of the Generic Animal
Drug and Patent Term Restoration Act, which established new standards
for marketing approval of generic copies of animal drugs approved after
1962.
Timetable:
New Animal Drug Approval Process NPRM 12/17/91 (56 FR 65544) NPRM 08/
00/96
Reporting Requirements for Marketed Animal Drugs NPRM 12/17/91 (56 FR
65581) Final Action 02/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AA96.
For information concerning reporting requirements for marketed animal
drugs, contact William C. Keller, Director, Division of Surveillance,
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, (301) 594-1722. For further
information concerning generic animal drugs, contact Lonnie W. Luther,
Chief, Generic Animal Drug and Quality Control Staff, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855, (301) 594-1623.
Agency Contact: Andrew J. Beaulieu, Deputy Director, Office of New
Animal Drug Evaluation, Department of Health and Human Services, Food
and Drug Administration, Center for Veterinary Medicine (HFV-101), 7500
Standish Place, Rockville, MD 20855
Phone: 301 594-1620
RIN: 0910-AA02
_______________________________________________________________________
1238. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS; NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD
COMPONENTS AT INCREASED RISK FOR TRANSMITTING HIV INFECTION
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 351 to 360k; 21 USC 374; 42 USC 262 to 264
CFR Citation: 21 CFR 606; 21 CFR 610
Legal Deadline: None
Abstract: The agency currently requires that all blood and blood
components intended for transfusion or for the manufacture of any
product be tested for antibody to human immunodeficiency virus (HIV).
In instances when the blood of a donor is found to contain antibodies
to HIV, some blood centers have initiated a program of voluntary
``look-back'' to determine the suitability of previous donations and to
notify consignees of blood and blood components obtained from the
donor's prior donations. Consignees may withdraw or destroy such blood
and blood products, and may trace and notify recipients. A well-
conducted look-back program can provide an effective mechanism for
quarantine of products and for identifying, testing, and counseling
recipients of transfusions determined to be at increased risk of HIV
infection--those who receive blood from a donor later found to be
infected with HIV. The agency is publishing a final rule to establish a
mandatory look-back program. The final rule will require blood
collection facilities to develop a procedure to identify and quarantine
products from prior collections and to notify consignees promptly
whenever a blood donor who has previously donated blood or source
plasma is found to be positive for the antibody to HIV; and to keep
appropriate records when such notification has been made. In addition,
the final rule will require hospital transfusion services to notify
recipients of blood products at increased risk for transmitting HIV and
to keep appropriate records of the notification process. The purpose of
the rulemaking is to ensure the notification of consignees and blood
transfusion recipients and that prompt and appropriate action is taken.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/30/93 58 FR 34962
Final Action 12/00/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AC90.
Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 594-3074
RIN: 0910-AA05
_______________________________________________________________________
1239. LEAD IN FOODS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 336; 21 USC 342(a); 21 USC 346; 21
USC 346a; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 109; 21 CFR 182; 21 CFR 189
Legal Deadline: None
Abstract: In light of the public health concerns raised by continuing
findings concerning the effects of low levels of exposure to lead,
particularly exposure by pregnant women, infants, and children, the
agency is undertaking a comprehensive effort to further reduce lead
levels in food where controllable or avoidable sources of lead addition
to food can be identified. The goal of FDA is to reduce consumers'
exposure to lead in the diet to the lowest level that can be
practicably obtained.
Timetable:
Lead From Ceramic Pitchers NPRM 06/01/89 (54 FR 23485) NPRM Comment
Period End 07/31/89 Withdrawal of NPRM 00/00/00
Prohibit Use of Lead-Soldered Food Cans NPRM 06/21/93 (58 FR
33860) Final Action 06/27/95 (60 FR 33106)
Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles NPRM 11/
25/92 (57 FR 55485) Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AC91.
Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-306),
200 C Street SW., Washington, DC 20204
Phone: 202 205-4681
RIN: 0910-AA06
_______________________________________________________________________
1240. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE
CERTIFICATION PROGRAMS
Priority: Routine and Frequent
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 356; 21 USC 379e(e)
CFR Citation: 21 CFR 80; 21 CFR 429
Legal Deadline: None
Abstract: Insulin Certification Program:
In the Federal Register of October 4, 1991 (56 FR 50248), FDA issued an
interim rule effective on November 4, 1991 with opportunity for public
comment, revising the fee schedule for insulin certification services.
The fees are intended to recover the full costs of operation of FDA's
insulin certification program, including the unfunded liability of the
Civil Service Retirement Fund and appropriate overhead costs of the
Public Health Service and Department of Health and Human Services. FDA
is publishing a new interim rule lowering the fees, to reflect lower
costs involved in administering the insulin certification program.
Color Certification Program:
In the Federal Register of November 29, 1994, FDA issued an interim
rule effective December 29, 1994, which amended the color additive
regulations by increasing the fees for certification services. The
change in fees will allow FDA to continue to maintain an adequate color
certification program as required by the Federal Food, Drug, and
Cosmetic Act.
On February 13, 1995, FDA received comments from only one interested
party, the International Association of Color Manufacturers (IACM).
Those comments, which stated IACM's opposition to an automatic annual
escalator provision in the interim rule, will be incorporated into a
final rule. The final rule is expected to be published in the Federal
Register by early 1996. FDA expects to eliminate the automatic annual
escalator provision in response to IACM's concerns.
Timetable:
Color Additives Interim Final Rule 11/29/94 (59 FR 60898) Final
Action 11/00/95
Insulin Interim Final Rule 10/04/91 (56 FR 50248) Interim Final Rule
11/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD34.
Agency Contact: David R. Petak, Director, Division of Accounting,
Department of Health and Human Services, Food and Drug Administration,
Office of Management (HFA-120), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-1766
Fax: 301 443-6242
RIN: 0910-AA07
_______________________________________________________________________
1241. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION,
GUIDANCE, AND CLARIFICATIONS
Priority: Substantive, Nonsignificant
Legal Authority: PL 100-293 Prescription Drug Marketing Act of 1987
CFR Citation: 21 CFR 203
Legal Deadline: None
Abstract: The Prescription Drug Marketing Act of 1987 (PDMA) amended
the Federal Food, Drug, and Cosmetic Act to: (1) require State
licensing of wholesale distributors of prescription human drugs under
Federal guidelines including minimum standards for storage, handling,
and recordkeeping; (2) ban the reimportation of prescription human
drugs produced in the United States, except when reimported by the
manufacturer or for emergency use; 3) ban the sale, trade, or purchase
of drug samples; (4) ban trafficking in or counterfeiting of drug
coupons; (5) mandate storage, handling, and recordkeeping requirements
for drug samples; (6) require licensed practitioners to request drug
samples in writing; (7) prohibit, with certain exceptions, the resale
of prescription human drugs purchased by hospitals or health care
facilities; and (8) set forth criminal and civil penalties for
violations of these provisions. In the Federal Register of September
14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal
guidelines for State licensing of wholesale drug distributors. This
final rule would provide information, guidance, and clarification of
those sections of PDMA that are not related to State licensing of
wholesale distributors.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/14/94 59 FR 11842
NPRM Comment Period End 08/01/94
Final Action 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AD44.
Agency Contact: Lee D. Korb, Regulatory Counsel, Division of Regulatory
Affairs, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-362), 7500
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
RIN: 0910-AA08
_______________________________________________________________________
1242. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990
Priority: Other Significant
Legal Authority: PL 101-629 Safe Medical Devices Act of 1990
CFR Citation: 21 CFR 860; 21 CFR 820; 21 CFR 807; 21 CFR 803; 21 CFR
17; 21 CFR 812; 21 CFR 7; 21 CFR 814; 21 CFR 821; 21 CFR 861; 21 CFR
895
Legal Deadline:
NPRM, Statutory, August 28, 1991, for Medical Device Tracking.
Final, Statutory, November 28, 1991, for Exemption ofHumanitarian
Devices, etc.
Other, Statutory, December 1, 1991, for Classification ofTransitional
Devices Notice.
Final, Statutory, August 28, 1993, for Medical Device Tracking.
Abstract: The Safe Medical Devices Act of 1990 (SMDA), enacted November
28, 1990, was intended to assure marketed devices are safe and
effective, FDA learns quickly of device problems, and has authority to
remove defective devices from the market. The act directs or authorizes
FDA to develop these regulations: Medical Device Reporting--This rule
will require healthcare facilities and distributors to report deaths
and serious injuries/illnesses related to medical devices. Medical
Device Tracking--This regulation requires manufacturers to track
certain devices to the user. Classification of Transitional Devices--
FDA issued a notice to require submission of adverse safety and
effectiveness data on transitional devices. FDA will now propose to
keep each device in class III, or reclassify it in class I or II. Good
Manufacturing Practices for Medical Devices--FDA proposed to add
preproduction design validation in existing CGMP regulations. Exemption
of Humanitarian Devices--The proposed rule gives procedures for
applications for certain premarket review exemptions for humanitarian
devices.
Summaries of Safety and Effectiveness for Premarket Notification--The
final rule sets forth information to be included in data summaries on
which substantial equivalence determinations are made. Recall of
Medical Devices--A proposed rule sets forth procedures for using its
authority to order device recalls and notifications. Reports of Removal
and Corrections--FDA proposed procedures for manufacturers to report to
FDA health-related market removals and corrections of devices. Civil
Money Penalties--A final rule established procedures for a hearing to
which persons are entitled before the imposition of civil money
penalties. Procedural Changes in Medical Device Regulations--This final
rule made revisions in regulations necessary because of procedural
changes made by the SMDA. Premarket Review of Combination Products--FDA
published a final rule establishing procedures for determining which
FDA center will review premarket approval applications for products
that are a combination of a device and a drug or biologic.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Assignment of Agency Component for Review of Premarket Applctns Notice
(Public Hearing) 07/12/91 (56 FR 31951) Final Action 11/21/91 (56 FR
31951)
Civil Money Penalties NPRM 05/26/93 (58 FR 30680) Final Action 07/27/
95 (60 FR 38612)
Classification of Transitional Devices Notice 11/14/91 (56 FR
57960) Notice(Extension of Comment Period) 03/10/92 (57 FR
8462) Notice (Extension of Deadline) 11/30/92 (57 FR 56586) Final
Rule (Contact Lenses) 03/04/94 (59 FR 10283)
CGMPs for Medical Devices ANPRM (Revisions;Request for Cmnts) 06/15/90
(55 FR 24544) ANPRM (Suggested Changes;Availblty) 11/30/90 (55 FR
49644) ANPRM (Extension of Comment Period) 02/14/91 (56 FR
5965) Notice (Open Public Advsy Cmte Mtg) 04/17/91 (56 FR 15626) NPRM
11/23/93 (58 FR 61952) NPRM 07/24/95 (60 FR 37856) Final Action 03/
00/96
Exemption of Humanitarian Devices NPRM 12/21/92 (57 FR 60491) Final
Action 12/00/95
Medical Device Recall Authority NPRM 06/14/94 (59 FR 30656) NPRM
(Correction) 06/23/94 (59 FR 32489) Final Action 12/00/95
Medical Device Reporting Notice (Public Conf ;Rqst for Info) 03/28/91
(56 FR 12934) NPRM 11/26/91 (56 FR 60024) Final Rule (Distributor
Reporting) 09/01/93 (58 FR 46514) Final Action 11/00/95
Medical Device Tracking NPRM 03/27/92 (57 FR 10702) NPRM 05/29/92 (57
FR 22971) Final Action 05/29/92 (57 FR 22966) Final Action (Not Stat
Eff Date 08/16/93 (58 FR 43442)
Miscellaneous Procedural Changes in Medical Device Regulations Final
Action 12/10/92 (57 FR 58400)
Pre-Amendment Class III Devices (merged with 0905-AE34) Notice 05/06/
94 (59 FR 23731)
Reports of Removals and Corrections of Medical Devices NPRM 06/04/94
(59 FR 13828) Final Action 12/00/95
Safe Medical Devices Act of 1990; Implementation Plans Notice 04/05/91
(56 FR 14111)
Summaries of Safety & Effectiveness for Premarket Notification Final
Action 04/28/92 (57 FR 18062) Notice (Stay of Effective Date) 06/01/92
(57 FR 23059) Final Action 12/14/94 (59 FR 64287)
Temporary Suspension of a Premarket Approval Application NPRM 10/12/93
(58 FR 52729) Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD59.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA09
_______________________________________________________________________
1243. FINAL REGULATION TO ESTABLISH PROCEDURES FOR THE SAFE AND
SANITARY PROCESSING AND IMPORTING OF FISH AND FISHERY PRODUCTS
Regulatory Plan: This entry is Seq. No. 34 in Part II of this issue of
the Federal Register.
RIN: 0910-AA10
_______________________________________________________________________
1244. BOTTLED WATER
Priority: Routine and Frequent
Legal Authority: 21 USC 341; 21 USC 343(g); 21 USC 343(h); 21 USC 349;
21 USC 371(a)
CFR Citation: 21 CFR 103; 21 CFR 165
Legal Deadline: Other, Statutory.
Other deadline is for publication of NPRM or Notice within 180 days of
EPA final action.
Abstract: In fulfillment of its mandate under the Safe Drinking Water
Act, EPA is currently in the midst of reviewing and establishing
standards for contaminants in public drinking water such as pathogenic
bacteria, pesticides, and organic chemicals. When EPA establishes such
standards for public drinking water, FDA is required to take
appropriate action to amend its regulations for bottled drinking water
or to state its reasons for not doing so. FDA also establishes identity
standards for a food when it has determined that the standard will
promote honesty and fair dealing in the interest of consumers.
Timetable:
Beverages; Bottled Water NPRM 01/05/93 (58 FR 393) Final Action 11/
00/95
Microbiological Quality Standard NPRM 10/06/93 (58 FR 25042) Final
Action 00/00/00
Quality Standard for Lead and Copper NPRM 01/05/93 (58 FR 389) Final
Action 05/25/94 (59 FR 26933)
Quality Standards for 24 Contaminants NPRM 08/04/93 (58 FR
41612) Final Action 02/00/96
Quality Standards for 35 Contaminants NPRM 01/05/93 (58 FR 382) Final
Action 12/01/94 (59 FR 61529)
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD65.
Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety
Officer, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-306),
200 C Street SW., Washington, DC 20204
Phone: 202 205-4681
RIN: 0910-AA11
_______________________________________________________________________
1245. MEDICAL DEVICES; PROTECTIVE RESTRAINTS; REVOCATION OF
EXEMPTIONS FROM 510(K) PREMARKET NOTIFICATION PROCEDURES AND CURRENT GOOD
MANUFACTURING PRACTICES REGULATIONS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 351; 21 USC 360; 21 USC 360c; 21 USC 360e; 21
USC 360y; 21 USC 371
CFR Citation: 21 CFR 880.6760; 21 CFR 890.3910
Legal Deadline: None
Abstract: FDA has become aware through various sources of numerous
reports of complications including permanent physical injuries, severe
psychological disabilities, other serious injuries and deaths that have
been attributed to incorrect supervision, handling or application of
protective restraint devices by medical or paramedical personnel.
Complications associated with protective restraint devices frequently
result from misuse of the devices. To address potential misuse,
manufacturers should include specific directions for use, to the extent
that such directions are not currently available or not attached to or
kept with the garment. Revocation of the premarket notification
exemptions will allow FDA to collect information about the current
availability and actual employment of directions for use and to monitor
the introduction into commerce of new and changed protective
restraints. Revocation of the exemption from the current good
manufacturing practice regulation will allow FDA to require the
necessary controls over labeling. FDA is also considering educational
programs to address this problem. FDA anticipates total first year
costs of $930,000 for this regulation. These costs will be offset by
the saving of lives and reduced product liability exposure.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/19/92 57 FR 27397
NPRM Comment Period End 08/18/92
Final Action 12/00/95
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AD84.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA17
_______________________________________________________________________
1246. FOOD LABELING REVIEW
Priority: Routine and Frequent
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 100; 21 CFR 101; 21 CFR 102; 21 CFR 161
Legal Deadline: None
Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA)
requires that most foods bear nutrition labeling. The agency issued
final rules implementing most of the provisions contained in the NLEA
on January 6, 1993. Subsequently, however, the agency has identified
additional areas that should be the subject of rulemaking. FDA issued a
proposal on January 6, 1993, to establish requirements for the
identification of certain ingredients on food labels. FDA proposed on
June 15, 1993, to amend its January 6, 1993, final rules on nutrient
content and health claims to remove the provisions that exempted
restaurant menus from the requirements for how nutrient content claims
and health claims are to be made. FDA also proposed to modify the
provisions that delay the effective date of these regulations for small
restaurant firms for one year. The agency proposed January 4, 1994, to
establish reference daily intakes based on the 9th and 10th editions of
the National Research Council's Recommended Dietary Allowances. On
March 14, 1994, FDA published a proposal describing the provisions for
exemptions for low-volume food products of small businesses that were
established by the Nutrition Labeling and Education Act Amendments of
1993. On August 18, 1993, FDA published a proposal concerning the
placement of the nutrition facts panel on food labels. Finally, on July
18, 1994, FDA published proposed revised guidelines for the voluntary
declaration of nutrition labeling for raw produce and fish. A final
rule concerning the placement of the nutrition facts panel published on
April 5, 1995.
Timetable:
Misleading Containers; Nonfunctional Slack Fill NPRM 01/06/93 (58 FR
2957) Final Action 12/06/93 (58 FR 64123)
Nutrient Content Claims and Health Claims; Restaurant Foods NPRM 06/
15/93 (58 FR 33055) Final Action 00/00/00
Nutrient Content, Definition of the Term, Healthy NPRM 01/06/93 (58 FR
2944) Final Action 05/10/94 (59 FR 24232)
Placement of Nutrition Facts Panel NPRM 08/18/93 (58 FR 44091) Final
Action 04/05/95 (60 FR 17202) Final Action Effective 05/05/95 Final
Action Correction 06/12/95 (60 FR 30788)
Protein Hydrolysates; Broth in Tuna; and/or Labeling NPRM (Declaration
of Ingredients) 01/06/93 (58 FR 2950) Final Action (Dec. of
Ingredients) 00/00/00
Reference Daily Intakes NPRM 01/04/94 (59 FR 427) Final Action 02/00/
96
Small Business Exemption, Nutrition Labeling NPRM 03/14/94 (59 FR
11872) Final Action 11/00/95
Voluntary Guidelines for Nutrition Labeling Produce NPRM 07/18/94 (59
FR 36379) Final Action 01/00/96
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AD89.
Agency Contact: F. Edward Scarbrough, Director, Office of Food
Labeling, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-150),
200 C Street SW., Washington, DC 20204
Phone: 202 205-4561
Fax: 202 205-4594
RIN: 0910-AA19
_______________________________________________________________________
1247. DISQUALIFICATION OF CLINICAL INVESTIGATORS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360j(g)
CFR Citation: 21 CFR 812
Legal Deadline: None
Abstract: The rule would amend the investigational device exemption
(IDE) regulations to provide for a procedure for disqualification of
clinical investigators in cases of fraud or other serious violations of
the regulations. Persons whose disqualification is proposed would be
entitled to an opportunity for hearing.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/06/93 58 FR 52144
Final Action 12/00/95
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD94.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA21
_______________________________________________________________________
1248. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 21 USC 360j(g)
CFR Citation: 21 CFR 813; 21 CFR 812
Legal Deadline: None
Abstract: The rule would revoke the separate investigational device
exemption regulation for intraocular lenses (IOL's). IOL's would then
be subject to the same IDE regulation (21 CFR Part 812) as all other
devices. The IOL-IDE regulation was originally created as an interim
measure.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/06/93 58 FR 52142
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD95.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA22
_______________________________________________________________________
1249. DIETARY SUPPLEMENT LABEL REVIEW
Priority: Routine and Frequent
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21
USC 342; 21 USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: NPRM, Statutory, June 15, 1993. Final, Statutory,
December 31, 1993.
If final regulations on labeling of Dietary Supplements are not
published by 12/31/93, the proposed regulations shall be considered the
final regulations.
Abstract: With the publication of various final rules on January 6,
1993, the Agency completed action on its food labeling initiative under
the Nutrition Labeling and Education Act of 1990. Rulemaking on
nutrition labeling of dietary supplements was delayed due to
requirements of the Dietary Supplement Act of 1992 (DSA), which amended
the law to provide that the Agency would issue proposed regulations for
dietary supplements by June 15, 1993, and final regulations by December
31, 1993. Three proposed regulations were developed and published on
June 18, 1993: Health Claims for Dietary Supplements, Nutrient Content
Claims for Dietary Supplements, and Mandatory Nutrition Labeling for
Dietary Supplements. On October 14, 1993, FDA published a proposal to
not authorize health claims on the labels of dietary supplements of 5
nutrient/disease relationships: (1) Dietary fiber and cancer (2)
Dietary Fiber and CVD, (3) Antioxidants and Cancer, (4) Omega-3 fatty
acids and CHD, (5) Zinc and immune function in the elderly. In
addition, FDA also published a proposed rule to authorize the use of
health claims about the relationship of folates and neural tube
defects. On January 4, 1994, FDA published notices stating that it
considered the proposals to be final regulations by operational
statute. However, the notices also stated that FDA considers the
October 14, 1993, rulemakings to be ongoing. The Agency intends to
continue rulemaking with respect to folates and to issue a final rule
as quickly as possible. FDA is also considering new scientific
information that may support health claims for some of the nutrient-
disease relationships given above. If this information is sufficient to
support claims, the Agency will repropose to allow those claims.
Timetable:
Health Claims and Label Statements; Dietary Supplements NPRM Folic
Acid and Neural Tube Def 10/14/93 (58 FR 53254) Final Action 01/04/94
(59 FR 433) Final Action Effective 07/01/94 Final Action 03/00/96
Health Claims; Diet. Fiber/Cancer, CHD; Antioxidant/CVD; Omega-3 NPRM
10/14/93 (58 FR 53296) Final Action 00/00/00
Health Claims; Dietary Supplements NPRM 06/18/93 (58 FR 33700) Final
Action 01/04/94 (59 FR 395)
Nutrient Content Claims; Dietary Supplements NPRM 06/18/93 (58 FR
33731) Final Action 01/04/94 (59 FR 378)
Nutrition Labeling; Dietary Supplements NPRM 06/18/93 (58 FR
33715) Final Action 01/04/94 (59 FR 354)
Regulation of Diet. Supp. ANPRM 06/18/93 (58 FR 33690) Withdrawal 12/
06/94 (59 FR 62644)
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AD96.
Agency Contact: F. Edward Scarbrough, Director, Office of Food
Labeling, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-150),
200 C Street SW., Washington, DC 20204
Phone: 202 205-4561
RIN: 0910-AA23
_______________________________________________________________________
1250. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR
HUMAN PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN THE
LABELING
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 352; 21 USC 355; 42 USC 262
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: On November 1, 1990 (55 FR 46134), the Agency proposed to
amend its regulations governing the content and format of labeling for
human prescription drug products to require a subsection in the
labeling that would include information on the use of a drug in the
elderly. This proposal reflects growing recognition by FDA and others
of the special concerns associated with prescription drug use in this
age group. FDA believes that providing access to this information is
necessary for the safe and effective use of prescription drugs in older
populations. The Agency is reviewing the public comments submitted in
response to the proposed rule and preparing a final rule.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/01/90 55 FR 46134
NPRM Comment Period End 12/31/90
Final Action 01/00/96
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE26.
Agency Contact: Erica L. Keys, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1046
RIN: 0910-AA25
_______________________________________________________________________
1251. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER
HUMAN DRUG PRODUCTS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 371
CFR Citation: 21 CFR 211
Legal Deadline: None
Abstract: On January 18, 1994 (59 FR 2542), the Agency proposed to
amend its tamper-resistant packaging regulations to require that all
over-the-counter (OTC) human drug products marketed in two-piece, hard
gelatin capsules be sealed. The proposal also solicited public comments
on whether additional regulatory changes, such as packaging performance
standards, may be necessary. FDA has required tamper-resistant
packaging features for OTC drug products since 1982. The tamper-
resistant packaging regulations were revised in 1989 in response to
continuing tampering incidents. Despite the regulatory protection
provided by the regulations, two-piece, hard gelatin capsules remain
vulnerable to malicious tampering and were implicated in tampering
incidents in 1991. This regulatory action is in response to the 1991
tampering incidents.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/18/94 59 FR 2542
NPRM Comment Period End 03/21/94
Final Action 01/00/96
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE27.
Agency Contact: Tamar S. Nordenberg, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1049
RIN: 0910-AA26
_______________________________________________________________________
1252. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN;
FEES FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 356; 21 USC 371
CFR Citation: 21 CFR 429.55
Legal Deadline: None
Abstract: The Food and Drug Administration intends to issue an interim
rule, with opportunity for public comment, to revise the fee schedule
for insulin certification services to reflect lower agency costs for
the program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 10/00/95
NPRM 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE28.
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1049
RIN: 0910-AA27
_______________________________________________________________________
1253. ELECTRONIC SIGNATURES; ELECTRONIC RECORDS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 301 et seq; 21 USC 201 et seq
CFR Citation: 21 CFR 11
Legal Deadline: None
Abstract: FDA is preparing regulations to set forth criteria for agency
acceptance of electronic records and electronic signatures in lieu of
paper records and handwritten signatures. The new rules would apply to
any records requirements in Chapter I of Title 21 (all program areas
and industries), unless specifically exempted by future regulations.
For documents required to be maintained, but not submitted to FDA,
persons could use electronic records and signatures upon the effective
date of a final rule. For documents submitted to FDA, persons could use
electronic records and signatures if FDA has stated, in a public docket
to be maintained for that purpose, that the intended receiving
organization is prepared to accept the submission in electronic form.
(The proposed rule does not require use of electronic records and
signatures, but permits their use under certain circumstances.) This
action was taken as a follow-up to the Agency's 7/21/92 advance notice
of proposed rulemaking. The intended effect is to permit and foster use
of new technologies in a manner that is consistent with FDA's overall
mission and that preserves the integrity of the Agency's enforcement
activities.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 07/21/92 57 FR 32185
ANPRM Comment Period End 10/19/92
NPRM 08/31/94 59 FR 45160
NPRM Comment Period End 11/29/94
Final Action 05/00/96
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: Federal
Additional Information: Previously reported under RIN 0905-AE31.
Agency Contact: Paul J. Motise, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-323), 7500 Standish Place, Rockville,
MD 20855
Phone: 301 594-1089
Fax: 301 594-2202
Email: [email protected]
RIN: 0910-AA29
_______________________________________________________________________
1254. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Priority: Other Significant
Legal Authority: 42 USC 262; 21 USC 321; 21 USC 331; 21 USC 351; 21
USC 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 360; 21
USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; ...
CFR Citation: 21 CFR 54; 21 CFR 312.53; 21 CFR 312.57; 21 CFR 312.64;
21 CFR 314.50; 21 CFR 314.60; 21 CFR 314.94; 21 CFR 314.200; 21 CFR
314.300; 21 CFR 320.36; 21 CFR 330.10; 21 CFR 601.2; 21 CFR 807.31; 21
CFR 807.87; 21 CFR 807.100; ...
Legal Deadline: None
Abstract: This final regulation addresses the problem of certain
financial arrangements and interests of clinical investigators that
have the potential to bias the outcome of clinical trials. The problem
is significant because clinical research data provide the basis for
FDA's evaluation of drugs, biologics and devices for marketing. The
regulation requires the sponsor of a product that is the subject of a
marketing application to submit either a statement certifying that the
clinical investigator is not a party to any problematic financial
interests and arrangements or a statement disclosing problematic
interests and arrangements to which the investigator is a party. This
information would enable FDA to subject the relevant clinical research
data to an appropriate level of scrutiny to test its reliability.
Alternatives are to prohibit investigators from holding certain
financial interests altogether or to require divestiture by the
investigator of a prohibited interest. The estimated costs to industry
associated with preparation, submission, and retention of the
information required by this final rule are well below the $100 million
threshold that defines a significant regulatory action. The final rule
is not expected to impose a significant resource burden on FDA because
the submission of statements is limited to clinical data submitted in
support of marketing applications, ruling out data from the large
number of studies that do not lead to applications, and FDA estimates
that sponsors will be able to certify for the majority of their
clinical investigators, so that most submitted data will not require
intensified scrutiny. The final rule will strengthen the FDA review
process.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/22/94 59 FR 47807
NPRM Comment Period End 12/21/94
Final Action 04/00/96
Small Entities Affected: None
Government Levels Affected: None
Procurement: This is a procurement-related action for which there is no
statutory requirement. There is a paperwork burden associated with this
action.
Additional Information: Previously reported under RIN 0905-AE32.
Agency Contact: Mary Gross, Department of Health and Human Services,
Food and Drug Administration, Office of External Affairs (HF-24) 5600
Fishers Lane, Rockville, MD 20857
Phone: 301 827-3440
Fax: 301 594-0113
RIN: 0910-AA30
_______________________________________________________________________
1255. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE
Regulatory Plan: This entry is Seq. No. 35 in Part II of this issue of
the Federal Register.
RIN: 0910-AA37
_______________________________________________________________________
1256. HUMAN TISSUE INTENDED FOR TRANSPLANTATION: PROPOSED RULE
Priority: Other Significant
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 264; 42 USC 271
CFR Citation: 21 CFR 1270
Legal Deadline: None
Abstract: FDA is issuing a final rule requiring certain infectious
disease testing, donor screening, and recordkeeping to help prevent the
transmission of AIDS and hepatitis through human tissue used in
transplantation. FDA is also clarifying and modifying those
requirements previously promulgated by the interim rule. In addition,
FDA is amending the regulations to require the registration of those
establishments engaged in procurement, processing, storage, or
distribution of human tissue intended for transplantation. Also, FDA
will be proposing regulations to govern the recovery, processing,
storage, or distribution of human reproductive tissue.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Rule; Opport. for
Comment 12/14/93 58 FR 65514
Interim Rule; Comment Period End03/14/94
Final Action 01/00/96
NPRM 04/00/96
NPRM Comment Period End 07/00/96
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AE49.
Agency Contact: Paula McKeever, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 594-3074
RIN: 0910-AA40
_______________________________________________________________________
1257. IRON CONTAINING DRUGS AND SUPPLEMENTS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 342; 21 USC 343; 21 USC 351; 21 USC 352
CFR Citation: 21 CFR 101; 21 CFR 111; 21 CFR 310
Legal Deadline: None
Abstract: On October 6, 1994, FDA published a proposal responding to
three citizen petitions that were submitted in response to an increase
in deaths and poisonings in small children due to accidental ingestion
of iron containing drugs and dietary supplements. The petitions
requested that FDA require label warning statements for these products
and special packaging to ensure the safe use of these products. Because
of recent changes in the laws regulating dietary supplements brought
about by the Dietary Supplement Health and Education Act (Pub. L. 103-
417), FDA published a supplemental proposal on February 16, 1995, that
set forth its revised legal authority a supplemental proposal that sets
forth its revised legal authority.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/06/94 59 FR 51030
NPRM Correction 11/14/94 59 FR 56573
NPRM Comment Period End 12/20/94
Supplemental NPRM 02/16/95 60 FR 8989
Supplemental NPRM Comment Period
End 04/17/95
Final Action 04/00/96
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE59.
Agency Contact: Linda Kahl, Acting Director, Division of Programs and
Enforcement Policy, Department of Health and Human Services, Food and
Drug Administration, Center for Food Safety and Applied Nutrition (HFS-
455), 200 C Street SW., Washington, DC 20204
Phone: 202 205-5365
RIN: 0910-AA42
_______________________________________________________________________
1258. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN
GOVERNMENT OFFICIALS
Priority: Other
Legal Authority: 5 USC 552; 18 USC 1905; 19 USC 2531 to 2582; 21 USC
321 to 393; 42 USC 241; 42 USC 242; 42 USC 242a; 42 USC 242l; 42 USC
242n; 42 USC 243; 42 USC 262; 42 USC 263; 42 USC 263b to 263n; 42 USC
264; 42 USC 265
CFR Citation: 21 CFR 20
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing communications with officials of State and
foreign governments. This proposal will permit FDA to disclose to, and
receive from, these officials certain nonpublic information without
being compelled to disclose the information to the public generally.
This proposal addresses the nonpublic exchange of two types of
information. First, it allows the disclosure of nonpublic safety,
effectiveness, or quality information concerning FDA-regulated products
to State government officials. Second, it allows the disclosure of
draft proposed rules and other nonpublic predecisional documents
concerning regulatory requirements or activities between FDA and either
State or foreign government officials. This action is necessary to
enhance cooperation in regulatory activities, to eliminate unfounded
contradictory regulatory requirements, and to minimize redundant
application of similar requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/27/95 60 FR 5530
NPRM Comment Period End 04/27/95
Final Action 01/00/96
Small Entities Affected: None
Government Levels Affected: State, Local, Federal
Additional Information: Previously reported under RIN 0905-AE65.
42 USC 300u-300u-5 42 USC 300aa-1
Agency Contact: Linda Horton, Director, International Policy Staff,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy (HF-23), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3344
Fax: 301 443-6906
Email: [email protected]
RIN: 0910-AA46
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
1259. POLICIES CONCERNING USES OF SULFITING AGENTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 342; 21
USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 182.3616; 21 CFR 182.3637; 21 CFR 182.3739; 21
CFR 182.3766; 21 CFR 182.3798; 21 CFR 182.3862; 21 CFR 100; 21 CFR
130.9
Legal Deadline: None
Abstract: Acceptable evidence and information exist to show that a
subgroup of asthmatics is at moderate to severe risk for a severe
reaction upon exposure to sulfites. The agency's primary tool for
handling a situation where population subgroups may be at increased
risk from a food ingredient that is safe for most people is to use
labeling to inform those persons who need or want to avoid the
ingredient. The agency issued a final rule, effective January 7, 1987,
that requires that when a sulfiting agent is present in a finished food
at 10 parts per million or greater, the sulfiting agent must be
declared on the label. In addition, FDA issued a final rule, effective
August 8, 1986, prohibiting the use of sulfiting agents on raw fruits
and vegetables intended to be served or sold raw to consumers (e.g., in
salad bars). On December 10, 1987, FDA announced its tentative
conclusion that there is no longer a basis to find that the use of
sulfiting agents on ``fresh'' potatoes served or sold unpackaged to
consumers is GRAS. On December 19, 1988, FDA proposed to affirm, with
specific limitations, that certain other uses of sulfiting agents are
GRAS and to establish labeling requirements for sulfiting agents in
standardized foods.
On March 15, 1990 (55 FR 9826), FDA issued a final rule prohibiting the
use of sulfiting agents on ``fresh'' potatoes (55 FR 9826) and
requested data and information concerning the use of sulfiting agents
on frozen potatoes (55 FR 9834).
On August 3, 1990, the United States District Court for the Middle
District of Pennsylvania declared the final rule concerning fresh
potatoes to be ``null and void'' based on perceived procedural defects
in the rulemaking proceeding. The Government appealed the district
court's decision. On May 22, 1991, the U.S. Court of Appeals for the
Third Circuit en banc split equally. Therefore, the decision of the
district court invalidating on procedural grounds FDA's final rule
revoking the GRAS status of the use of sulfiting agents on fresh
potatoes.
FDA's reproposed rule will include the GRAS status of sulfiting agents
on both minimally processed (formerly fresh) and frozen potatoes was
left in place.
Timetable:
Food Labeling; Declaration of Sulfiting Agents NPRM 04/03/85 (50 FR
13306) Final Action 07/09/86 (51 FR 25012) Final Action Effective 01/
09/87 (51 FR 25012)
GRAS Status of the Use of Sulfiting Agents on Fresh Potatoes NPRM-To
be Merged w/Frozen Potatoes 12/10/87 (52 FR 46968) Final Action 03/15/
90 (55 FR 9826)
GRAS Status of Certain Other Food Uses of Sulfiting Agents, Etc. NPRM
12/19/88 (53 FR 51065) Final Action 00/00/00
Revoking Use of Sulfiting Agents on Fruits & Vegetables, Etc. NPRM 08/
14/85 (50 FR 32836) Final Action 07/09/86 (51 FR 25021) Final Action
Effective 08/09/86 (51 FR 25021)
Status of the Use of Sulfiting Agents on Shrimp NPRM 12/19/88 (53 FR
51065) Tentative Final Rule 00/00/00
Status of Use of Sulfit Agents on Minimally Procd & Froz Potatoes NPRM
00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AB52.
Agency Contact: JoAnn Ziyad, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-207), 200 C Street SW.,
Washington, DC 20204
Phone: 202 254-3116
RIN: 0910-AA03
_______________________________________________________________________
1260. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY
INFORMATION UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY
ACT OF 1986
Priority: Other Significant
Legal Authority: PL 99-660, sec 314
CFR Citation: None
Legal Deadline: Final, Statutory, June 22, 1989.
Abstract: Section 314 of the National Childhood Vaccine Injury Act of
1986 mandated that the warnings, use instructions, and precautionary
information of specified childhood vaccines be reviewed and that their
adequacy in warning health care professionals of the nature and extent
of dangers posed by such vaccines be determined. This precautionary
information is contained in the package insert of each vaccine licensed
by the agency. FDA held a public meeting to receive public comment on
the adequacy of these package inserts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice of Public Meeting; Public
Comment on Package Inserts 07/31/92 57 FR 33915
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Additional Information: Previously reported under RIN 0905-AD72.
A public meeting was held on 9/18/92 on section 314 Labeling Review.
Presentations were made by FDA, CDC, manufacturers, parents groups, and
the public on the adequacy of the current labeling.
Agency Contact: Tracey Forfa, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Biologics
Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448
Phone: 301 594-3074
RIN: 0910-AA14
_______________________________________________________________________
1261. GENERAL BIOLOGICAL PRODUCT STANDARDS; ALTERNATIVE PROCEDURES
AND EXCEPTIONS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 262
CFR Citation: 21 CFR 610; 21 CFR 640; 21 CFR 630
Legal Deadline: None
Abstract: The Food and Drug Administration is amending its regulations
governing biological products. This amendment would authorize the
Director, Center for Biologics Evaluation and Research, to approve an
exception or alternative to any regulation in 21 CFR governing
biological products. The regulation will provide flexibility needed to
accommodate rapid changes in biotechnology and to assure the continued
availability of biological products.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 12/00/96
Small Entities Affected: None
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AD82.
Agency Contact: Stephen Ripley, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 594-3074
RIN: 0910-AA16
_______________________________________________________________________
1262. MEDICAL FOODS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 341; 21 USC 342; 21 USC 343; 21
USC 348; 21 USC 350; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360ee;
21 USC 371
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: The Food and Drug Administration is considering development
of regulations for medical foods, as defined by the Orphan Drug Act
Amendments of 1988 (21 USC 360ee(b)(3)) to assure, among other things,
the safety and effectiveness of these products, proper labeling of the
nutrient content and purported uses, including adequate and appropriate
directions for use, and quality control and good manufacturing
practices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AD91.
Agency Contact: Robert Moore, Regulatory Branch, Division of Programs
and Enforcement Policy, Office of Spec Nut., Department of Health and
Human Services, Food and Drug Administration, Center for Food Safety
and Applied Nutrition (HFS-456), 200 C Street SW., Washington, DC 20204
Phone: 202 205-5372
RIN: 0910-AA20
_______________________________________________________________________
1263. ADVERSE EXPERIENCE REPORTING REQUIREMENTS FOR HUMAN DRUG AND
LICENSED BIOLOGICAL PRODUCTS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355
to 357; 21 USC 371; 21 USC 374; 21 USC 216; 21 USC 262; 21 USC 263; 21
USC 263a; 21 USC 264; 21 USC 300aa-25
CFR Citation: 21 CFR 20; 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR
600
Legal Deadline: None
Abstract: The final rule will amend the adverse experience reporting
regulations for human drug products and licensed biological products to
make the requirements consistent with a new single unified form (FDA
Form 3500A) and require the use of this new reporting form. The new
form was announced as part of FDA's MedWatch program. The final rule
will also revise certain definitions and reporting periods and formats
as recommended by the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH) and the World Health Organization's Council for International
Organizations of Medical Sciences (CIOMS). In addition, the rule will
amend the regulations governing the reporting of data from clinical
studies.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/27/94 59 FR 54046
NPRM Comment Period End 01/25/95
Final Action 12/00/96
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE29.
Agency Contact: Howard P. Muller, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1049
RIN: 0910-AA28
_______________________________________________________________________
1264. AMALGAM INGREDIENT LABELING
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: Certain dental amalgams may contain ingredients which may
cause some persons severe adverse reactions. Therefore, FDA would
propose that labeling for dental amalgams must include the ingredients
so that health professionals may choose the appropriate amalgam for the
patient.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE39.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville,
MD 20850
Phone: 301 594-4765
RIN: 0910-AA33
_______________________________________________________________________
1265. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL
DEVICES
Priority: Other Significant
Legal Authority: 21 USC 321(h); 21 USC 351; 21 USC 352; 21 USC 360(c)
CFR Citation: None
Legal Deadline: None
Abstract: FDA is announcing its intention to classify stand-alone
computer software products that fit the definition of a medical device
under the Federal Food, Drug, and Cosmetic Act. The Agency anticipates
classifying these devices by using a risk-based approach as required
under the Medical Device Amendments to the act. Under this approach low
risk medical software devices would be subject only to the adulteration
and misbranding provisions of the act. Moderate risk devices would
additionally be subject to the registration, listing, and good
manufacturing practice requirements for adverse events and complaints.
High risk devices would be the only products to require premarket
submissions. FDA is also seeking comment on potential criteria related
to the intended uses of medical software devices that might be used in
determining the level of risk.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE58.
Agency Contact: Chuck Furfine, Regulatory Review Scientist/Software
Expert, Department of Health and Human Services, Food and Drug
Administration, Center for Devices and Radiological Health (HFZ-84),
2098 Gaither Road, Rockville, MD 20850
Phone: 301 594-4765
RIN: 0910-AA41
_______________________________________________________________________
1266. DEVELOPMENT OF HAZARD ANALYSIS CRITICAL CONTROL POINTS FOR
THE FOOD INDUSTRY; REQUEST FOR COMMENTS
Priority: Other Significant
Legal Authority: 21 USC 321 et seq; 21 USC 342(a)(4); 21 USC 371(a);
42 USC 264
CFR Citation: None
Legal Deadline: None
Abstract: FDA announced on April 4, 1994, its plans to consider
developing regulations that would establish requirements for a new
comprehensive food safety assurance program for both domestically
produced and imported foods that would be based on the principles of
Hazard Analysis Critical Control Points (HACCP). The new food safety
program would respond to new challenges, such as new food processing
and packaging technologies, new food distribution and consumption
patterns, exposure to industrial chemicals and chemical waste, the
increasing importation of foods, new microbial pathogens, and resource
constraints. The most serious of these challenges is presented by food
pathogens. The number of recognized food-borne pathogens has broadened
considerably, as has awareness of long-term complications from certain
food-borne illnesses--such as arthritis, heart disease, and kidney and
neurological damage. To meet such challenges, FDA intends to shift the
focus of its food safety assurance program away from periodic visual
inspection and end-product testing and toward prevention of food safety
risks and problems, utilizing the HACCP state-of-the-art preventive
approach.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 08/04/94 59 FR 39888
ANPRM Comment Period End 12/02/94
NPRM 00/00/00
NPRM Comment Period End 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AE60.
Agency Contact: John E. Kvenberg, Strategic Manager, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-10), 200 C Street SW.,
Washington, DC 20204
Phone: 202 205-4010
RIN: 0910-AA43
_______________________________________________________________________
1267. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 355; 21 USC 371; 42 USC 241; 42 USC 257; 42
USC 290; 42 USC 300
CFR Citation: 21 CFR 291
Legal Deadline: None
Abstract: Revise these regulations to reduce burden, to streamline
requirements, to consolidate various sections.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/97
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Division of
Regulatory Affairs, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-362),
7500 Standish Place Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901
RIN: 0910-AA52
_______________________________________________________________________
1268. EXPORT REQUIREMENTS FOR DRUGS FOR INVESTIGATIONAL
USE IN OTHER COUNTRIES
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 331; 21 USC 351 to 352; 21 USC 355 to 357; 21
USC 360; 21 USC 360b; 21 USC 360aa to 360dd; 21 USC 371 to 372; 21 USC
374; 21 USC 379e; 21 USC 379g; 21 USC 381 to 382; 21 USC 393; 42 USC
216; 42 USC 241; 42 USC 242l
CFR Citation: 21 CFR 312.110
Legal Deadline: None
Abstract: FDA is considering whether to amend its regulations on
investigational new drugs to streamline requirements for exports of
unapproved drugs for investigational use in other countries. FDA is
considering whether to exempt, or reduce requirements for exports of
such drugs to highly developed countries such as Australia, Canada,
Japan, and countries that are members of the European Union or the
European Free Trade Area. The proposal carries out the President's and
Vice President's ``National Performance Review'' for drugs and devices
and is consistent with recent Congressional initiatives.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Linda Horton, Director, International Policy Staff,
Office of Policy (HF-23), Department of Health and Human Services, Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3344
RIN: 0910-AA61
_______________________________________________________________________
1269. EXPORT REQUIREMENTS FOR MEDICAL DEVICES
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355 to 357; 21
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC
372; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 393; 42 USC 216; 42
USC 241; 42 USC 2421; ...
CFR Citation: 21 CFR 812.18
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its regulations for investigational devices to describe streamlined
requirements for exports of unapproved medical devices. Under the
proposed rule, an approved investigational device exemption (IDE) would
constitute an agency determination that the export of the unapproved
device is not contrary to the public health or safety. Countries could
notify FDA that they do not object to the importation of unapproved
devices with an approved IDE into their countries. Thus, for devices
with an FDA-approved IDE, the proposal would eliminate the need for FDA
to make independent determinations either that exportation is not
contrary to the public health or safety or that an importing country
does not object to the importation of a specific device. The proposed
rule is intended to codify and to simplify export requirements for
certain unapproved devices pursuant to the President's and Vice-
President's ``National Performance Review,'' as reflected in the April
1995 report titled, ``Reinventing Drug & Medical Device Regulations.''
It is also consistent with recent Congressional initiatives.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Linda Horton, Director, International Policy Staff,
Office of Policy (HF-23), Department of Health and Human Services, Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3344
RIN: 0910-AA62
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
1270. PROPOSED LABELING FOR DRUG PRODUCTS BASED ON FALSE OR
FRAUDULENT DATA
Priority: Substantive, Nonsignificant
CFR Citation: 21 CFR 201
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 08/14/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Howard Muller
Phone: 301 594-1049
RIN: 0910-AA13
_______________________________________________________________________
1271. RECORDKEEPING AND REPORTING: ELECTRONIC PRODUCTS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
CFR Citation: 21 CFR 1000; 21 CFR 1002
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 09/19/95 60 FR 48374
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan
Phone: 301 594-4765
RIN: 0910-AA15
_______________________________________________________________________
1272. THRESHOLD OF REGULATION POLICY FOR COMPONENTS OF FOOD CONTACT
ARTICLES
Priority: Substantive, Nonsignificant
CFR Citation: 21 CFR 170; 21 CFR 171; 21 CFR 174
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/17/95 60 FR 36582
Final Action Effective 08/16/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Edward J. Machuga
Phone: 202 418-3085
RIN: 0910-AA18
_______________________________________________________________________
1273. MEDICAL DEVICES; RESTRICTED DEVICES
Priority: Other Significant
CFR Citation: 21 CFR 801; 21 CFR 899
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 08/16/95
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan
Phone: 301 594-4765
RIN: 0910-AA36
_______________________________________________________________________
1274. SUBSTANCES PROHIBITED FOR USE IN RUMINANT FEED
Priority: Substantive, Nonsignificant
CFR Citation: 21 CFR 589.2000
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - No action planned in
the next 12 months. 08/08/95
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: John P. Honstead
Phone: 301 594-1728
RIN: 0910-AA38
_______________________________________________________________________
1275. NEW DRUG AND BIOLOGICAL PRODUCT LICENSE APPLICATIONS;
REVISIONS TO EXISTING REGULATIONS
Priority: Other Significant
CFR Citation: 21 CFR 314.51; 21 CFR 314.60; 21 CFR 314.61; 21 CFR
314.71; 21 CFR 314.100; 21 CFR 314.110; 21 CFR 314.120; 21 CFR 600.3;
21 CFR 601.2; 21 CFR 601.3; 21 CFR 611
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 08/14/95
Small Entities Affected: None
Government Levels Affected: State, Federal
Agency Contact: Thomas Hassall
Phone: 301 594-6740
RIN: 0910-AA44
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
1276. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS AND
ADDITIONS TO THE VACCINE INJURY TABLE - II
Priority: Other Significant
Legal Authority: 42 USC 216; 42 USC 300aa-14; 42 USC 300aa-1 note.
CFR Citation: 42 CFR 100
Legal Deadline: None
Abstract: The Secretary has made findings as to the illnesses and
conditions that can reasonably be determined in some circumstances to
be caused or significantly aggravated by certain vaccines. Based on
these findings, the Secretary proposes to amend the Vaccine Injury
Table by regulation pursuant to section 313 of the National Childhood
Vaccine Injury Act of 1986 and section 2114(c) of the Public Health
Service Act. These proposed regulations would have effect only for
petitions for compensation under the National Vaccine Injury
Compensation Program (VICP) filed after the new regulations become
effective.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE52.
Agency Contact: Thomas E. Balbier, Jr., Director, Division of Vaccine
Injury Compensation Program, BHPr, Department of Health and Human
Services, Health Resources and Services Administration, Room 8A-35,
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-6593
RIN: 0906-AA36
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
1277. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES
Regulatory Plan: This entry is Seq. No. 36 in Part II of this issue of
the Federal Register.
RIN: 0906-AA32
_______________________________________________________________________
1278. TECHNICAL AMENDMENTS TO THE HEALTH PROFESSIONS, NURSING, AND
ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 42 USC 293; 42 USC 293c; 42 USC 293d; 42 USC 293j; 42
USC 293k; 42 USC 293l; 42 USC 293m; 42 USC 293n; 42 USC 294; 42 USC
294b; 42 USC 294i; 42 USC 294o
CFR Citation: 42 CFR 57; 42 CFR 58
Legal Deadline: None
Abstract: This final rule amends various Public Health Service (PHS)
health professions, nursing, and allied health training grant
regulations, codified at 42 CFR parts 57 and 58, to bring these
programs into conformity with statutory amendments made by the Health
Professions Extension Amendments of 1992 to the various sections of the
PHS Act under titles VII and VIII. Technical changes being made to the
regulations are: (1) the renumbering of PHS section numbers and their
corresponding United States Code numbers within the regulations; (2)
the removal of the reference to the National Advisory Council on Health
Professions Education and the requirements for the Council's review of
title VII grants; (3) the removal of the reference to section 705 of
the PHS Act concerning audit and inspection requirements, which is
redundant to the requirements that are covered under 45 CFR part 74;
(4) the removal of repealed and inactive title VII and VIII health
professions, nursing, and allied health training grant program
regulations; and (5) other technical changes which are clarifying or
editorial changes in nature.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE54.
Agency Contact: Betty B. Hambleton, Chief, Planning, Evaluation and
Legislation Branch, Office of Research & Planning/BHPr, Department of
Health and Human Services, Health Resources and Services
Administration, Room 8-67, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 443-1590
RIN: 0906-AA38
_______________________________________________________________________
1279. REMOVAL OF OBSOLETE REGULATIONS OF THE TITLE VII
GRANT FOR THE CONSTRUCTION OF TEACHING FACILITIES FOR HEALTH PROFESSIONS
PERSONNEL
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 42 USC 292 et seq
CFR Citation: 42 CFR 57.101 to 57.108; 42 CFR 57.110 to 57.112
Legal Deadline: None
Abstract: The purpose of this action is to remove regulations rendered
obsolete by P.L. 102-408, which rescinded the authority for a health
professions training facilities construction grant program that the now
obsolete regulations governed.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 04/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Charlotte Pascoe, Chief, Division of Acilities
Compliance and, Recovery, Department of Health and Human Services,
Health Resources and Services Administration, Room 7-31 Parklawn Bldg.,
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-6512
RIN: 0906-AA39
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
1280. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: LENDERS'/
HOLDERS' PERFORMANCE STANDARDS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 292 to 292o
CFR Citation: 42 CFR 60
Legal Deadline: NPRM, Statutory, October 13, 1993.
Abstract: This Final rule amends the existing regulations governing the
HEAL Program to establish standards for lenders and holders as required
by the Health Professions Education Extension Amendments of 1992 (Pub.
L. 102-408). These standards would provide lenders and holders a
greater incentive to work to maintain low HEAL default rates and, thus,
improve the long-term solvency of the Student Loan Insurance Fund.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/16/94 59 FR 50103
NPRM Comment Period End 12/16/94
Next Action Undetermined
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD87.
Agency Contact: Michael Heningburg, Director, Division of Student
Assistance, Bureau of Health Professions, Department of Health and
Human Services, Health Resources and Services Administration, 5600
Fishers Lane, Parklawn Bldg. Room 8-48, Rockville, MD 20857
Phone: 301 443-1173
RIN: 0906-AA33
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
1281. GRANTS FOR THE ESTABLISHMENT OF DEPARTMENTS OF FAMILY
MEDICINE
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 57, subpart R
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action Correction Notice -
7/31/95, 60 FR 38970 05/30/95 60 FR 28065
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Enrique Fernandez, M.D., M.Ed.
Phone: 301 443-6190
RIN: 0906-AA34
_______________________________________________________________________
1282. FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT OF 1992
Priority: Other Significant
CFR Citation: 42 CFR 6
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/08/95 60 FR 22530
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Libby Merrill, Legislative Analyst
Phone: 301 594-4060
RIN: 0906-AA35
_______________________________________________________________________
1283. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS, DENTISTS, AND OTHER HEALTH CARE PRACTITIONERS: PAYMENT OF
FEES
Priority: Other
CFR Citation: 45 CFR 60
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/26/95 60 FR 27898
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas C. Croft
Phone: 301 443-2300
RIN: 0906-AA37
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________
1284. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT
PROGRAM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 288-1
CFR Citation: 42 CFR 68
Legal Deadline: None
Abstract: Section 634 of PL 100-607 creates a new program through which
health professionals can obtain federally funded repayment of
educational loans by conducting AIDS research as NIH employees. The new
regulations will cover this program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AD18.
Agency Contact: Marc Horowitz, Director, NIH AIDS Research Loan
Repayment Program, Department of Health and Human Services, National
Institutes of Health, Office of AIDS Research, 9000 Rockville Pike,
Bethesda, MD 20892
Phone: 301 496-0357
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA02
_______________________________________________________________________
1285. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN
REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 288-5
CFR Citation: 42 CFR 68a
Legal Deadline: None
Abstract: Regulations would be issued to govern the awarding of
educational loan repayments under the NIH Clinical Research Loan
Repayment Program for Individuals From Disadvantaged Backgrounds
authorized by section 487E of the Public Health Service Act, as added
by provisions of the NIH Revitalization Act of 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE56.
Agency Contact: Marc Horowitz, Dir., Clinical Research Loan Repayment
Prog., Individuals from Disadvantaged Backgrounds, Department of Health
and Human Services, National Institutes of Health, Office of AIDS
Research, 9000 Rockville Pike, Bethesda, MD 20892
Phone: 301 402-0852
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA09
_______________________________________________________________________
1286. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS
NEEDED BY THE NIH
Priority: Other
Legal Authority: 42 USC 288-4; 42 USC 216
CFR Citation: 42 CFR 68b
Legal Deadline: None
Abstract: Section 487D of the PHS Act, as added by the NIH
Revitalization Act of 1993, creates a program offering scholarships, in
an amount not to exceed $20,000 per year of academic study, to
individuals from disadvantaged backgrounds who are enrolled as full-
time students at accredited institutions pursuing academic programs
appropriate for careers in professions needed by the NIH. For each year
of scholarship support, the recipient agrees to service (employment),
after graduation at the NIH, for one year. Additionally, the individual
agrees to at least ten consecutive weeks of service (employment) at the
NIH during which the individual is attending the institution and
receiving the NIH scholarshipl The proposed new regulations will cover
this program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE57.
Agency Contact: Marc Horowitz, Dir., NIH AIDS Research Loan Repayment
Program, Department of Health and Human Services, National Institutes
of Health, Office of AIDS Research, NIH, 9000 Rockville Pike, Bethesda,
MD 20892
Phone: 301 402-0852
RIN: 0925-AA10
_______________________________________________________________________
1287. TRAINEESHIPS (TERMINATION POLICIES)
Priority: Other
Legal Authority: 42 USC 216; 42 USC 283g(d); 42 USC 284(b)(1)(C); 42
USC 286b-3; 42 USC 287c(b)
CFR Citation: 42 CFR 63
Legal Deadline: None
Abstract: Regulations governing NIH traineeships will be amended to set
forth additional conditions under which awards may be terminated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE62.
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, 9000
Rockville Pike, Bldg 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD
20892-2075
Phone: 301 496-4606
RIN: 0925-AA11
_______________________________________________________________________
1288. ADDITIONAL DHHS PROTECTION FOR PREGNANT WOMEN AND
HUMAN FETUSES INVOLVED AS SUBJECTS FOR RESEARCH, AND PERTAINING TO HUMAN
IN VITRO FERTILIZATION
Priority: Other
Legal Authority: 5 USC 301; 42 USC 289
CFR Citation: 45 CFR 46, supart B
Legal Deadline: None
Abstract: Current regulations which have been in effect for two decades
will be revised to reflect provisions of Public Law 103-43 and recent
changes in NIH and FDA policies on the involvement of women in
research.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: F. William Dommel, Jr., J.D., Senior Policy Advisor,
Department of Health and Human Services, National Institutes of Health,
Office for Protection from Research Risks, 6100 Executive Blvd., Ste.
3801, MSC 7507, Rockville, MD 20892-7507
Phone: 301 496-7005
Fax: 301 402-2071
Email: [email protected]
RIN: 0925-AA14
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________
1289. GRANTS FOR RESEARCH PROJECTS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 216
CFR Citation: 42 CFR 52
Legal Deadline: None
Abstract: Regulations covering grants for research projects will be
amended to show changes necessitated by enactment of Public Laws 99-
158, 99-660, 100-607, 101-549, 101-613, 102-222, 102-321, and 102-588,
and to show their applicability to various programs administered by the
Centers for Disease Control and Prevention and the Food and Drug
Administration previously omitted from the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/02/94 59 FR 39312
NPRM Comment Period End 10/03/94
Final Action 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AC02.
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, 9000
Rockville Pike, Room 1B25, Center DR MSC 2075, Bethesda, MD 20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA01
_______________________________________________________________________
1290. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS
Priority: Other
Legal Authority: 42 USC 9660; 42 USC 216
CFR Citation: 42 CFR 65a
Legal Deadline: None
Abstract: Regulations will be promulgated concerning grants for
research and training made for the purpose of understanding, assessing,
and reducing the adverse effect on human health of exposure to
hazardous substances. The grants are authorized by section 311(a) of
the Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA) of 1980, as added by section 209 of the Superfund
Amendments and Reauthorization Act (SARA) of 1986, P.L. 99-499.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/07/95 60 FR 12525
NPRM Comment Period End 05/08/95 60 FR 12525
Final Action 10/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD46.
Agency Contact: Dr. William A. Suk, Program Administrator, Division of
Extramural Research and Training, Department of Health and Human
Services, National Institutes of Health, NIEHS, P.O. Box 12233,
Research Triangle Park, NC 27709
Phone: 919 541-0797
RIN: 0925-AA03
_______________________________________________________________________
1291. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 216; 42 USC 285a-2; 42 USC 285a-3; 42 USC
285b-3; 42 USC 285b-4; 42 USC 285d-6; 42 USC 285i; 42 USC 285m-3; 42
USC 287a-2; 42 USC 287a-3; 42 USC 300cc-41
CFR Citation: 42 CFR 52b
Legal Deadline: None
Abstract: Regulations concerning NCI construction grants will be
amended to more clearly show their general applicability to all NIH
extramural programs with construction grant authority. Additionally,
the regulations will be amended to show new administrative and
technical requirements, add new procedures for the recovery of grant
funds for facilities no longer used for biomedical research, show new
PHS Act section numbers, and update the listing of other HHS
regulations relevant to construction grants.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/06/95 60 FR 35266
NPRM Comment Period End 09/05/95 60 FR 35266
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD49.
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, 9000
Rockville Pike, Bldg. 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD
20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA04
_______________________________________________________________________
1292. TRAINING GRANTS
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 216; 42 USC 242l(b)(3); 42 USC 284(b)(1)(C);
42 USC 287c(b); 42 USC 300cc-15(a)(1); 42 USC 300cc-41(a)(3)(C); 42 USC
7403(h)(2)
CFR Citation: 42 CFR 63a
Legal Deadline: None
Abstract: New regulations concerning non-NRSA training grants
authorized by various PHS Act sections and training activities
authorized by section 103(h)(2) of the Clean Air Act, as amended by
section 901 of the Clean Air Act Amendments of 1990, P.L. 101-549. The
regulations are intended to serve as a standing set of regulations that
could be adapted for future training grant programs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/24/95 60 FR 4742
NPRM Comment Period End 03/27/95 60 FR 4742
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD56.
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, 9000
Rockville Pike, Bldg. 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD
20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA05
_______________________________________________________________________
1293. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 216; 42 USC 285a-3; 42 USC 285b-4; 42 USC
285c-5; 42 USC 285d-6; 42 USC 285e-2; 42 USC 285e-3; 42 USC 285f-1; 42
USC 285g-5; 42 USC 285g-7; 42 USC 285m-3; 42 USC 285o-2; 42 USC 300cc-
16; 42 USC 285a-6(c)(1)(E); 42 USC 285c-8
CFR Citation: 42 CFR 52a
Legal Deadline: None
Abstract: NIH Center Grants regulations will be amended to show their
applicability to the Drug Abuse Research Centers Program authorized by
PHS Act, section 464N, as added by section 123 of the ADAMHA
Reorganization Act, P.L. 102-321, and several new centers authorized
under the NIH Revitalization Act of 1993. Additionally, in accordance
with the President's Reinventing Government effort, NIH is merging the
regulations governing Grants for National Alcohol Research Centers
codified at 42 CFR Part 54a with the Center Grants regulations and
removing 42 CFR Part 54a from the CFR.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/17/95 60 FR 9560
NPRM Comment Period End 04/18/95 60 FR 9560
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE00. NIH
plans to modify the National Alcohol Research Centers regulations to
set forth changes necessitated by enactment of the ADAMHA
Reorganization Act, Public Law 102-321, and other changes to update the
regulations previously reported under RIN 0905-AE08. Additional Legal
Authorities: 42 USC 286a-7(c)(1)(G)
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, 9000
Rockville Pike, Bldg 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD
20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA06
_______________________________________________________________________
1294. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 42 USC 216; 42 USC 285n-2
CFR Citation: 42 CFR 54a
Legal Deadline: None
Abstract: In accordance with the President's Reinventing Government
effort, regulations governing grants for alcohol abuse and alcoholism
prevention, treatment, and rehabilitation services, and National
Alcohol Research Centers are being merged with the regulations
governing NIH center grants codified at 42 CFR Part 52. Part 54a is
being removed from the CFR.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/19/94 59 FR 42793
NPRM Comment Period End 10/18/94 59 FR 42793
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE08.
Merging of the National Alcohol Research Center grants regulations with
the NIH center grant regulations is also reported under RIN 0925-AA06.
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Bldg. 31, Rm.
3B-11, 9000 Rockville Pike, Bethesda, MD 20892
Phone: 301 496-2832
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA08
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
National Institutes of Health (NIH)
_______________________________________________________________________
1295. RESPONSIBILITIES OF PUBLIC HEALTH SERVICE-FUNDED INSTITUTIONS
FOR PROMOTING OBJECTIVITY IN RESEARCH
Priority: Other Significant
CFR Citation: 42 CFR 50, subpart F; 42 CFR 94
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/11/95 60 FR 35810
Final Action Effective 10/01/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Dr. George J. Galasso
Phone: 301 496-5356
RIN: 0925-AA07
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Office of Assistant Secretary for Health (OASH)
_______________________________________________________________________
1296. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN
FAMILY PLANNING SERVICE PROJECTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 300a-4
CFR Citation: 42 CFR 59
Legal Deadline: None
Abstract: This rule would return the Family Planning Service Program,
funded under Title X of the Public Health Service Act, to the
compliance standards operative prior to February 2, l988, with regard
to the statutory provision prohibiting abortion as a method of family
planning in projects funded under that title.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/05/93 58 FR 7464
NPRM Comment Period End 08/09/93 58 FR 34024
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Additional Information: Previously reported under RIN 0905-AE03.
Agency Contact: Felicia Stewart, M.D., Deputy Assistant Secretary for
Population Affairs, Department of Health and Human Services, Office of
Assistant Secretary for Health, East-West Towers, Suite 200, West
Bldg., 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-4000
RIN: 0937-AA00
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1297. AMBULANCE SERVICES (BPD-813-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1861(s)(7)
CFR Citation: 42 CFR 410.40
Legal Deadline: None
Abstract: This proposed rule would revise HCFA's policy on Medicare
coverage of ambulance services. It focuses on the medical necessity for
ambulance service, redefines an ambulance as an ``emergency vehicle''
and revises the policy on coverage of non-emergency ambulance
transportation for beneficiaries with end-stage renal disease. These
changes would prevent use of non-emergency vehicles and the use of
ambulance transportation in non-emergency situations where the medical
need has not clearly been determined. These changes require the use of
emergency vehicles as ambulances and would focus on the medical
treatment rather than transportation as the primary concern for
furnishing ambulance services, as required by Title XVIII, Section
1861(s)(7) of the Social Security Act. This rule is part of HCFA's
regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Margot Blige, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-02-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4642
RIN: 0938-AH13
_______________________________________________________________________
1298. CHANGES IN COVERAGE AND PAYMENT POLICIES FOR
PHYSICIAN ASSISTANT SERVICES (BPD-829-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395k; 42 USC 1395u(b)(2); 42 USC
1395u(b)(12); 42 USC 1395x(s)
CFR Citation: 42 CFR 410.10; 42 CFR 410.74; 42 CFR 410.150; 42 CFR
414.1; 42 CFR 414.52; 42 CFR 491.2
Legal Deadline: None
Abstract: This proposed rule concerns the coverage and payment policies
for services performed by physician assistants and services furnished
as incident to these services. It would conform Medicare regulations to
the provisions in section 6114 of the Omnibus Budget Reconciliation Act
of 1989. It would provide consistent qualification requirements for
physician assistants.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 04/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Pat Moore, Bureau of Policy Development, Department of
Health and Human Services, Health Care Financing Administration, C4-02-
26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-8090
RIN: 0938-AH26
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1299. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP)
POLICIES (BPD-491-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395ss
CFR Citation: 42 CFR 403.200; 42 CFR 403.205; 42 CFR 403.206; 42 CFR
403.210; 42 CFR 403.215; 42 CFR 403.216; 42 CFR 403.220; 42 CFR
403.222; 42 CFR 403.232; 42 CFR 403.239; 42 CFR 403.250 to 403.258
Legal Deadline: None
Abstract: This rule would organize and codify in regulations the
statutory changes to Medigap provisions made in 1987, 1988, 1989, 1990
and 1994. It will contain specific procedures for review of State
regulatory plans (and individual policies) as required in OBRA '90. The
new standards were enacted by OBRA '87, and '90, the Medicare
Catastrophic Coverage Act of 1988, the Medicare Catastrophic Coverage
Repeal Act of 1989, and the Social Security Act Amendments of 1994.
This rule is part of HCFA's regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Julie Walton, Office of Chronic Care & Insurance
Policy, Bureau of Policy Development, Department of Health and Human
Services, Health Care Financing Administration, C4-08-18, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-4622
RIN: 0938-AD82
_______________________________________________________________________
1300. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT
APPLIES TO MEDICARE OVERPAYMENT LIABILITY (BPD-719-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395gg
CFR Citation: 42 CFR 405; 42 CFR 401; 42 CFR 466.94; 42 CFR 411.23; 42
CFR 411.28; 42 CFR 466.86; 42 CFR 473.14; 42 CFR 413.20; 42 CFR 413.153
Legal Deadline: None
Abstract: This rule would amend the Medicare regulations to clarify our
interpretation of ``without fault'' as it applies to physician,
provider, supplier and beneficiary liability for overpayments. This
definition would result in greater uniformity of determinations by
carriers and intermediaries. Additionally, this proposed rule would
amend the Medicare regulations governing liability for overpayments to
eliminate application of certain regulations of the Social Security
Administration and to replace them with HCFA regulations more specific
to circumstances involving Medicare overpayments. This rule is part of
HCFA's regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: David Walczak, Health Insurance Specialist, Office of
Chronic Care & Insurance Policy, Department of Health and Human
Services, Health Care Financing Administration, C4-07-07, 7500 Security
Blvd., Baltimore, MD 21244
Phone: 410 786-4475
RIN: 0938-AD95
_______________________________________________________________________
1301. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF
INSTITUTIONALIZED INDIVIDUALS (MB-023-P)
Priority: Other Significant
Legal Authority: 42 USC 1396r-5
CFR Citation: 42 CFR 435.630; 42 CFR 435.632; 42 CFR 435.634; 42 CFR
435.636; 42 CFR 435.638; 42 CFR 435.640; 42 CFR 435.642; 42 CFR
435.644; 42 CFR 435.646; 42 CFR 435.648
Legal Deadline: None
Abstract: These regulations would interpret section 303(a) of MCCA '88,
as amended by section 608(d)(16) of the FSA (PL 100-485), section
6411(e)(3) of OBRA '89 and section 4714 of OBRA '90. Section 303(a)
allocates income and resources between a spouse who is
institutionalized and the spouse remaining in the community. It also
provides special post-eligibility rules for institutionalized
individuals who have spouses in the community. The revision would allow
the community spouse to retain more income to meet living expenses.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/96
Small Entities Affected: Undetermined
Government Levels Affected: State, Local
Agency Contact: Jennifer Ryan, Medicaid Bureau, Department of Health
and Human Services, Health Care Financing Administration, C4-23-07,
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4459
RIN: 0938-AE12
_______________________________________________________________________
1302. COVERAGE OF PHYSICIAN ASSISTANT, NURSE PRACTITIONER, AND
CLINICAL NURSE SPECIALIST SERVICES (BPD-708-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302; 42 USC 1395x(s)(2)(K); 42 USC 1396(d)(1)
CFR Citation: 42 CFR 410; 42 CFR 413; 42 CFR 414; 42 CFR 491
Legal Deadline: None
Abstract: This proposed rule concerns the coverage of payment for
services performed by nurse practitioners and clinical nurse
specialists and services furnished as an incident to those services. It
would conform Medicare regulations to the provisions in section 6114 of
OBRA '89, section 4155 of OBRA '90, and section 147(e) of SSA '94. In
addition, under the authority of sections 1861(aa) and 1905(l) of the
Social Security Act, it would revise our existing definition of ``nurse
practitioner'' for purposes of the conditions rural health clinics must
meet to qualify for payment under Medicare and Medicaid and that
Federally qualified health clinics must meet to qualify for payment
under Medicare.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Roberta Epps, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4503
RIN: 0938-AF00
_______________________________________________________________________
1303. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395cc; 42 USC 1396a
CFR Citation: 42 CFR 488
Legal Deadline: None
Abstract: These regulations would provide an alternative to terminating
a psychiatric hospital's participation in the Medicare and Medicaid
programs for facilities found to be out of compliance with
participation requirements. These alternative sanctions could be
imposed instead of terminating a psychiatric hospital's participation
in the Medicare and Medicaid programs where deficiencies do not present
immediate jeopardy to the health and safety of psychiatric hospital
patients.
These amendments are necessary to conform HCFA regulations to changes
made by section 6020 of OBRA '89 and section 4755 of OBRA '90.
The purpose of the legislation is to encourage correction of
deficiencies that do not jeopardize patient health and safety before
termination becomes necessary.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/95
Small Entities Affected: Undetermined
Government Levels Affected: State, Federal
Agency Contact: Pam Vocke, Director, Division of Program Operations,
Department of Health and Human Services, Health Care Financing
Administration, Room 2-D-2, ME, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-7089
RIN: 0938-AF32
_______________________________________________________________________
1304. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE
AGREEMENTS (MB-046-F)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1396a(a); 42 USC 1396b(i); 42 USC 1396r-8; 42
USC 1396b(a)
CFR Citation: 42 CFR 447; 42 CFR 441
Legal Deadline: None
Abstract: This rule will incorporate section 4401 of OBRA '90 to add
specific requirements for Medicaid payment for covered outpatient
drugs. The requirements concern: denial of Federal financial
participation unless rebate agreements and drug use review are in
effect; prohibiting some State plan drug access limitations for drugs
covered under a rebate agreement; and the content of the rebate
agreements. The drug rebate agreement was previously published in the
Federal Register on February 21, 1991 (56 FR 7049). This rule will also
reflect statutory revisions mandated by the Veteran's Health Care Act
of 1992 and OBRA '93. The revision of the drug rebate dispute
resolution process is part of the Department's regulatory reinvention
initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/19/95 60 FR 48442
NPRM Comment Period End 11/20/95 60 FR 48442
Interim Final Rule 03/01/96
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Estelle Chisholm, Health Insurance Specialist,
Department of Health and Human Services, Health Care Financing
Administration, C4-15-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3286
RIN: 0938-AF42
_______________________________________________________________________
1305. FEDERALLY QUALIFIED HEALTH CENTER SERVICES (MEDICAID) (MB-
043-P)
Priority: Other Significant
Legal Authority: 42 USC 1396a(a)(13); 42 USC 1396b(m); 42 USC
1396d(l); 42 USC 1396n(b)
CFR Citation: 42 CFR 440; 42 CFR 447
Legal Deadline: None
Abstract: These regulations would establish a new category of
facilities known as federally Qualified Health Centers (FQHCs) and a
new category of Medicaid services known as FQHC services. This new type
of facility includes community health centers, migrant health centers
and health care for the homeless programs, which are receiving or are
eligible to receive certain grants from the Public Health Service, and
health programs or facilities operated by an Indian tribe or tribal
organization. These regulations would establish requirements for
coverage and payment of FQHC services under the Medicaid program. These
regulations would implement section 6404 of OBRA '89 and section 4704
of OBRA '90 and reflect statutory revisions mandated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: David Worgo, Office of Medical Services, Department of
Health and Human Services, Health Care Financing Administration, C4-15-
18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5919
RIN: 0938-AF90
_______________________________________________________________________
1306. REVISIONS TO RULES ON HEALTH CARE PREPAYMENT PLANS (OMC-016-
P)
Priority: Other Significant
Legal Authority: 42 USC 1395l; 31 USC 9701
CFR Citation: 42 CFR 417
Legal Deadline: None
Abstract: This regulation would impose a range of requirements on
Health Care Prepayment Plans corresponding to certain provisions for
prepaid health plans under section 1876 of the Social Security Act. The
expanded regulatory requirements would increase beneficiary protections
and strengthen Federal oversight of the HCFA program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/96
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Tim Love, Health Insurance Specialist, Office of
Managed Care, Department of Health and Human Services, Health Care
Financing Administration, S-3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-1094
RIN: 0938-AF97
_______________________________________________________________________
1307. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-
764-P)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395l(a); 42 USC 1395l(b); 42 USC 1395l(d); 42
USC 1395x(aa); 42 USC 1395oo(j); 42 USC 1395ww(a)(4); 42 USC
1396a(a)(13)(E)
CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 486
Legal Deadline: None
Abstract: This rule would update our regulations to incorporate several
health care coverage and payment provisions contained in Public Laws
100-203, 101-239, and 101-508 (the OBRAs '87, '89, and '90) and would
propose administrative changes that clarify policy related to sharing
space between rural health centers and other entities, such as
physician offices, the replacement of the provider-based cost basis
system with the all-inclusive rate payment system, and the allowance of
separate payment under Part B for more complex laboratory services.
This rule is part of HCFA's regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Helen Klein, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-06-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4641
RIN: 0938-AG05
_______________________________________________________________________
1308. MEDICARE APPEALS OF INDIVIDUAL CLAIMS (BPD-453-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395ff
CFR Citation: 42 CFR 405.732; 42 CFR 405.801; 42 CFR 405.837; 42 CFR
405.838; 42 CFR 405.839; 42 CFR 405.840
Legal Deadline: None
Abstract: This rule would conform the regulation to section 9341 of
OBRA '86. Section 9341 extends to Medicare Part B claimants the right
to a hearing before an Administrative Law Judge if the amount in
controversy is at least $500 and to judical review, provided the amount
in controversy is at least $1000. Section 9341 also limits the review
of national coverage determination and prohibits judicial review of any
regulation or instruction, initially issued before January 1, 1981,
relating to a method of determining the amount of payment under Part B.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul Olenick, Director, Division of Beneficiary and
Insurance Issues, Department of Health and Human Services, Health Care
Financing Administration, C4-07-07, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4472
RIN: 0938-AG18
_______________________________________________________________________
1309. APPOINTMENT OF REPRESENTATIVES FOR MEDICARE APPEALS (BPO-120-
P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395ff; 42 USC 405(a); 42 USC 406; 42 USC
1395ii
CFR Citation: 42 CFR 405.870; 42 CFR 405.701(c); 42 CFR 405.801(c); 42
CFR 405.871; 42 CFR 405.872
Legal Deadline: None
Abstract: This rule would clarify current regulations concerning: who
can be appointed as representatives at Medicare appeal proceedings; the
appointment procedure for representatives; whether a representative may
be paid for his or her services; and the representative's specific
responsibilities. These changes would improve the administration of the
claims appeal process.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Betsy Horn, Bureau of Program Operations, Department of
Health and Human Services, Health Care Financing Administration, S-1-
05-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0973
RIN: 0938-AG30
_______________________________________________________________________
1310. ENFORCEMENT REQUIREMENTS FOR RENAL DIALYSIS FACILITIES (HSQ-
204-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395rr(h)
CFR Citation: 42 CFR 405; 42 CFR 405.2181; 42 CFR 405.2182; 42 CFR
405.2184
Legal Deadline: None
Abstract: This rule would implement section 12 of PL 100-93, which
amended section 1881 of the Social Security Act by adding a new
paragraph (h). Paragraph (h) (redesignated as (g) by OBRA '87) broadens
the Secretary's authority to impose alternative sanctions on suppliers
of end-stage renal disease services when the noncompliance of the
supplier does not immediately jeopardize patient health and safety.
Alternative sanctions provide HCFA with a more flexible response to
facility deficiencies short of termination. This rule is part of HCFA's
regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Debbie Schoenemann, Office of Survey & Certification,
Department of Health and Human Services, Health Care Financing
Administration, S-2-19-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6771
RIN: 0938-AG31
_______________________________________________________________________
1311. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH
PURPOSES (HSQ-208-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1320c-9
CFR Citation: 42 CFR 476.144
Legal Deadline: None
Abstract: This rule would allow Peer Review Organizations (PROs) to
disclose confidential information to researchers without the consent of
the individuals who would be identified. Currently, PROs can only
disclose to the public nonconfidential aggregate data where no one is
specifically identified. The statute, however, provides for limited
disclosure in case there are circumstances the Secretary shall by
regulations provide to assure adequate protection of the rights and
interest of patients, health care practitioners, or providers. HCFA is
now emphasizing the sharing of PRO data for educational and research
purposes as evidenced by the implementation of the Uniform Clinical
Data Set and the Health Care Quality Improvement Initiative. This
regulatory revision will make confidential PRO information accessible
to researchers while still protecting the identities of beneficiaries
and practitioners from unwarranted disclosure. PRO flexibility to share
information with researchers is comparable with the revised
requirements in the PRO's Fourth Scope of Work contract.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: State, Federal
Agency Contact: Mike Rappaport, Director, Division of Systems
Management, Health Standards Quality Bureau, Department of Health and
Human Services, Health Care Financing Administration, S-1-09-26, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6759
RIN: 0938-AG33
_______________________________________________________________________
1312. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER
PENALTIES, SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395hh
CFR Citation: 42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 42
CFR 405.1843; 42 CFR 405.1805; 42 CFR 483.151; 42 CFR 484.36; 42 CFR
489.2; 42 CFR 489.18
Legal Deadline: None
Abstract: This rule would amend regulations on provider agreements to
clarify the effect a change of ownership has on penalties and sanctions
incurred by Medicare providers. It would state that all Medicare
penalties and sanctions are automatically assigned to a new owner. It
would also extend the same principle to suppliers; i.e., we would
require the new owner of a supplier to be liable for any Medicare
overpayments, penalties, and sanctions incurred by or imposed the
previous owner.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/96
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Irene Gibson, Deputy Director, Office of Survey &
Certification, Department of Health and Human Services, Health Care
Financing Administration, S-2-14-17, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-6768
RIN: 0938-AG59
_______________________________________________________________________
1313. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF
CATARACT SURGERY (BPD-797-PN)
Priority: Other Significant
Legal Authority: 42 USC 1395x(s)(1); 42 USC 1395y(a)(1)(A)
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces the Medicare program's proposal to
define medical necessity with respect to Medicare coverage of
preoperative testing for cataracts, cataract surgery, and Nd:YAG
capsulotomy.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 10/06/95 60 FR 52396
NPRM Comment Period End 12/05/95
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Karen McVearry, Technology & Special Analysis Staff,
Department of Health and Human Services, Health Care Financing
Administration, C4-10-07, 7500 Security Boulevard, Baltimore, MD 21297
Phone: 410 786-4643
RIN: 0938-AG65
_______________________________________________________________________
1314. NEW PAYMENT METHODOLOGY FOR ROUTINE EXTENDED CARE SERVICES
PROVIDER IN A SWING BED HOSPITAL (BPD-805-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395tt
CFR Citation: 42 CFR 413.53; 42 CFR 413.114
Legal Deadline: None
Abstract: This proposed rule would revise the regulations governing the
methodology for payment of routine extended care services provided in a
swing bed hospital. Medicare payment for such services would be
determined prospectively based on the average rate per patient day paid
by Medicare for routine care services provided in a free standing
skilled nursing facility (SNF) in the region where the hospital is
located. This rule would also provide that payment for these services
will be the higher of the payment cost rate in effect for the current
calendar year or for the payment rate received by the swing-bed
hospital for the prior calendar year. In addition, this rule would
revise the regulations concerning the method used to allocate hospital
general routine inpatient service costs for purposes of determining
payment to swing-bed hospitals.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Katie Walker, Office of Hospital Policy, Department of
Health and Human Services, Health Care Financing Administration, C5-03-
03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7278
RIN: 0938-AG68
_______________________________________________________________________
1315. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL THERAPY,
RESPIRATORY THERAPY, SPEECH PATHOLOGY, AND OCCUPATIONAL THERAPY (BPD-808-
PN)
Priority: Other Significant
Legal Authority: 42 USC 1395x(v)(5)
CFR Citation: 42 CFR 413.106
Legal Deadline: None
Abstract: This notice proposes revisions to the salary equivalency
guidelines for Medicare payment for the reasonable costs of physical
and respiratory therapy services furnished by providers under
arrangements with an outside contractor. The notice also proposes
initial salary equivalency guidelines for speech language pathology and
occupational therapy services furnished by providers under arrangements
with an outside contractor. The guidelines would be used by Medicare
fiscal intermediaries to determine the maximum allowable costs of those
services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 04/00/96
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Jacqueline Gordon, Health Insurance Specialist,
Division of Home Care and Therapy, Department of Health and Human
Services, Health Care Financing Administration, C4-07-14, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-4517
RIN: 0938-AG70
_______________________________________________________________________
1316. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR
INDIVIDUALS INFECTED WITH TUBERCULOSIS (MB-082-P)
Priority: Other Significant
Legal Authority: 42 USC 1396a(a)(10)(A)(ii); PL 103-66, Sec 13603; 42
USC 1396a
CFR Citation: 42 CFR 435.219; 42 CFR 435.201; 42 CFR 440.250; 42 CFR
436.201; 42 CFR 436.219; 42 CFR 440.164
Legal Deadline: None
Abstract: This rule would amend the existing Medicaid regulations to
provide for optional Medicaid coverage of low-income individuals
infected with tuberculosis (TB). These individuals would be eligible
only for specified TB-related services.
The rule would incorporate and interpret provisions of section 13603 of
OBRA '93.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Jennifer Ryan, Medicaid Bureau, Department of Health
and Human Services, Health Care Financing Administration, C4-20-14,
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4459
RIN: 0938-AG72
_______________________________________________________________________
1317. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY
HAVE FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES
(BPD-809-P)
Priority: Other Significant
Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 1395nn
CFR Citation: 42 CFR 411
Legal Deadline: None
Abstract: This proposed rule would provide that a physician who has (or
has a family member who has) a financial relationship with a health
care entity may not make referrals to that entity for certain services
(designated health services) under the Medicare program, except under
specified circumstances. This proposed rule would also deny payment to
a State for expenditures for designated health services furnished on
the basis of a physician referral that, all things being equal, would
result in denial of payment under Medicare. The provisions of the
proposed rule are based on sections 13562 and 13624 of the OBRA '93, as
amended by SSA '94.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Betty Burrier, Office of Chronic Care Insurance Policy,
Bureau of Policy Development, Department of Health and Human Services,
Health Care Financing Administration, C4-11-23, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-0191
RIN: 0938-AG80
_______________________________________________________________________
1318. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-
819-P)
Regulatory Plan: This entry is Seq. No. 38 in Part II of this issue of
the Federal Register.
RIN: 0938-AG81
_______________________________________________________________________
1319. END-STAGE RENAL DISEASE (ESRD) CONDITIONS OF COVERAGE (BPD-
818-P)
Regulatory Plan: This entry is Seq. No. 39 in Part II of this issue of
the Federal Register.
RIN: 0938-AG82
_______________________________________________________________________
1320. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION
OF FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (BPD-815-
P)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395i-3; 42 USC 1396r
CFR Citation: 42 CFR 409; 42 CFR 483; 42 CFR 413
Legal Deadline: None
Abstract: In this proposed rule we would define ``distinct part'' by
specifying that a distinct part is a physically identifiable unit of an
institution (that is, an entire ward wing, floor, or building)
including all beds in the unit. In conjunction with this change we also
propose an alternative approach for calculating medicare payments to a
skilled nursing facility (SNF). This new ``distinct costing'' procedure
would enable a participating SNF to establish a distinct costing area
within the SNF for its relatively high intensity residents so that it
can isolate and fully capture the routine cost of their care without
resorting to the use of arbitrary certification boundaries to achieve
this result. This proposed rule would also prohibit nursing homes from
financially screening private pay applicants for admission. Instead,
nursing homes would be permitted to charge up to a 2-month deposit
before admission to ensure that sufficient funds are available to pay
for care to which the individual may be entitled.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: William Ullman, Health Insurance Specialist, Bureau of
Policy Development, Department of Health and Human Services, Health
Care Financing Administration, C4-13-15, 7500 Security Blvd, Baltimore,
MD 21244
Phone: 401 786-5667
RIN: 0938-AG84
_______________________________________________________________________
1321. MEDICAID: NOMINAL COPAYMENTS FOR INSTITUTIONAL SERVICES FOR
MEDICAID RECIPIENTS (MB-090-P)
Priority: Other Significant
Legal Authority: 42 USC 1396a(a)(14); 42 USC 1396o
CFR Citation: 42 CFR 447.54; 42 CFR 447.55
Legal Deadline: None
Abstract: This final rule with comment period redefines the nominal
maximum deductible, coinsurance, or copayment charge that a State may
impose on certain Medicaid recipients for each admission for inpatient
hospital services. This revision of the copayment amount will help
prevent undue hardships on Medicaid recipients who have low or no
income by limiting the impact of rising health care costs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Ingrid Osburne, Health Care Specialist, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, C4-19-24, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4461
RIN: 0938-AG90
_______________________________________________________________________
1322. WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE SERVICES
UNDER THE MEDICARE PROGRAM (BPD-820-P)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395f(i); 5 USC 561 to 590
CFR Citation: 42 CFR 418
Legal Deadline: None
Abstract: The Medicare hospice benefit has been in effect since 1983.
This proposed rule would update the wage index used to adjust payment
rates to reflect local differences in area wage levels. We are
undertaking development of this proposed rule through a ``negotiated
rulemaking'' proceeding under the Negotiated Rulemaking Act of 1990.
This proposed rule is part of the Department's regulatory reinvention
initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice of Intent 10/14/94 59 FR 52129
NPRM 05/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Janice Flaherty, Director, Division of Home Care &
Therapy, Department of Health and Human Services, Health Care Financing
Administration, C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4637
RIN: 0938-AG93
_______________________________________________________________________
1323. CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A NEW
SUBCATEGORY OF MODERATE COMPLEXITY TESTING (HSQ-222-P)
Regulatory Plan: This entry is Seq. No. 40 in Part II of this issue of
the Federal Register.
RIN: 0938-AG98
_______________________________________________________________________
1324. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HSQ-225-P)
Regulatory Plan: This entry is Seq. No. 41 in Part II of this issue of
the Federal Register.
RIN: 0938-AG99
_______________________________________________________________________
1325. MEDICAID COVERAGE OF PERSONAL CARE SERVICES (MB-071-P)
Priority: Other Significant
Legal Authority: 42 USC 1396d(a)(24)
CFR Citation: 42 CFR 440.70; 42 CFR 440.167; 42 CFR 440.170
Legal Deadline: None
Abstract: This rule would revise the Medicaid regulations to
incorporate the provisions of OBRA '93 relating to coverage of personal
care services. Personal care services furnished to an individual who is
not an inpatient or resident of a hospital, nursing facility,
intermediate care facility for the mentally retarded or an institution
for mental disease is an optional Medicaid benefit, effective October
1, 1994. The services may be furnished both in the home and in other
locations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/95
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Mary Jean Duckett, Office of Long Term Care Services,
Medicaid Bureau, Department of Health and Human Services, Health Care
Financing Administration, C4-25-02, 7500 Security Blvd., Baltimore, MD
21244
Phone: 410 786-3294
RIN: 0938-AH00
_______________________________________________________________________
1326. LIABILITY FOR THIRD PARTIES TO PAY FOR CARE AND SERVICES (MB-
080-P)
Priority: Other Significant
Legal Authority: 42 USC 1396a(a)(25)(A); 42 USC 1396b(o)
CFR Citation: 42 CFR 433.135 to 152
Legal Deadline: None
Abstract: This rule would amend the regulations governing third party
liability as required by OBRA '93. It would add ERISA plans, service
benefit plans and health maintenance organizations to the definition of
liable third parties. It would require States to prohibit any health
insurer from taking into account when enrolling or making payments,
that an individual is eligible for or receiving Medicaid. It would also
require States to enact a law under which the State is deemed to have
acquired a recipient's right to payment by a third party.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: Undetermined
Government Levels Affected: State, Federal
Agency Contact: Robert Nakielny, Health Insurance Specialist, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, C4-21-01, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4466
RIN: 0938-AH01
_______________________________________________________________________
1327. MEDICARE PROGRAM: COVERAGE OF CERTIFIED NURSE-MIDWIFE
SERVICES (BPD-496-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 13951; 42 USC 1395x(s); 42 USC 1395x(gg)
CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 486
Legal Deadline: None
Abstract: This rule would specify that Medicare part B coverage
includes the services of a certified nurse-midwife furnished
independent of the supervision of a physician (if that practice is
allowed under the State law of the State in which the service is
furnished). Section 4073 of the OBRA '87, as amended by section 411(h)
of the MCCA '88, established separate Medicare Part B coverage of
certified nurse-midwife services furnished after June 30, 1988. Section
13554 of OBRA '93 eliminates the limitation on coverage of certified-
nurse midwife services. Services provided by a certified nurse-midwife
outside the maternity cycle will now be covered under this provision.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Roberta Epps, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 419 786-4503
RIN: 0938-AH02
_______________________________________________________________________
1328. MEDICARE PROGRAM: UNIFORM ELECTRONIC COST REPORTING
FOR SKILLED NURSING FACILITIES AND HOME HEALTH AGENCIES (BPD-788-P)
Priority: Other Significant
Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 1395x(v)
CFR Citation: 42 CFR 413.24
Legal Deadline: None
Abstract: This proposed rule would add the requirement that, for cost
reporting periods beginning on or after October 1, 1995 all skilled
nursing facilities and home health agencies must submit cost reports
currently required under Medicare regulations in a uniform electronic
format. This proposed rule would also allow a delay or waiver of this
requirement where implementation would result in financial hardship for
a provider.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas Talbott, Auditor, Bureau of Policy Development,
Department of Health and Human Services, Health Care Financing
Administration, C5-03-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4592
RIN: 0938-AH12
_______________________________________________________________________
1329. ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY
INTRAOCULAR LENSES (BPD-831-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395k(a)(2); 42 USC 1395l; 42 USC 1395z; 42
USC 1395aa; 42 USC 2630
CFR Citation: 42 CFR 416
Legal Deadline: NPRM, Statutory, October 31, 1995.
Abstract: This rule would establish in regulations a process under
which interested parties may request a review of the appropriateness of
the current payment amount for IOLs furnished by Medicare participating
ASCs. This rule is part of HCFA's regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cathaleen Ahern, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-09-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4515
RIN: 0938-AH15
_______________________________________________________________________
1330. SCHEDULE OF LIMITS FOR SKILLED NURSING FACILITY
INPATIENT ROUTINE SERVICE COSTS (BPD-837-NC)
Priority: Other Significant
Legal Authority: 42 USC 1395f(b); 42 USC 1395x(v)(1); 42 USC 1395yy
CFR Citation: 42 CFR 413
Legal Deadline: Final, Statutory, October 1, 1995.
Abstract: This final notice with comment period sets forth an updated
schedule of limits on skilled nursing facility routine service costs
for which payment may be made under the Medicare program. Section
1888(a) of the Social Security Act requires that for cost reporting
periods, beginning on or after October 1, 1995 and every 2 years
thereafter, the Secretary update the per diem cost limits for skilled
nursing facility routine service costs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/95
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Robert Kuhl, Technical Advisor, Bureau of Policy
Development, Department of Health and Human Services, Health Care
Financing Administration, C4-11-06, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4597
RIN: 0938-AH18
_______________________________________________________________________
1331. ADDITIONAL SUPPLIER STANDARDS (BPD-838-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395f; 42 USC 1395g(c); 42 USC 1395n; 42 USC
1495u(b)and(p); 42 USC 1395cc(d); 42 USC 1395gg(e)and(f)
CFR Citation: 42 CFR 424.57
Legal Deadline: NPRM, Statutory, January 1, 1996.
Abstract: This rule would establish additional standards for entities
seeking to qualify as Medicare suppliers for purposes of submitting
claims for medical equipment and supplies. This rule is part of HCFA's
regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Larry Bonander, Bureau of Policy Development,
Department of Health and Human Services, Health Care Financing
Administration, C4-11-24, 7500 Security Boulevard, Baltimore, MD 21214
Phone: 410 786-4479
RIN: 0938-AH19
_______________________________________________________________________
1332. DELEGATION OF CIVIL MONEY PENALTIES (BPO-135-FC)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 405(a); 42 USC 1302; 42 USC 1395x(aa); 42 USC
1395cc; 42 USC 1395ff(c); 42 USC 1395hh; 42 USC 1395ii
CFR Citation: None
Legal Deadline: None
Abstract: This rule would outline the processes and procedures to be
undertaken in the imposition of civil money penalties and the appeals
process.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Cohen, Bureau of Program Operations, Department of
Health and Human Services, Health Care Financing Administration, S-03-
14-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3345
RIN: 0938-AH22
_______________________________________________________________________
1333. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS
(MB-096-P)
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1396a(a)
CFR Citation: 42 CFR 430.18; 42 CFR 430.60
Legal Deadline: None
Abstract: This proposed rule would revise and streamline the State Plan
Amendment (SPA) reconsideration process. Currently, when a State
requests reconsideration of a denied SPA, a hearing is held in all
cases, even when the only dispute is over the interpretation of the
statute. Under the proposed regulation, the State and HCFA could avoid
the cost and delay of the hearing process by agreeing that the only
issue is interpretation of the statute and permit the State to take the
issue directly to court. The reconsidered decision would than be made
without a hearing. This rule is part of the Department's regulatory
reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/96
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Robert Tomlinson, Office of Beneficiary Services,
Medicaid Bureau, Department of Health and Human Services, Health Care
Financing Administration, C4-23-07, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4463
RIN: 0938-AH24
_______________________________________________________________________
1334. EVIDENCE OF LAWFUL PERMANENT RESIDENCE (MB-097-P)
Priority: Other
Legal Authority: 42 USC 1396b(v)
CFR Citation: 42 CFR 435.406; 42 CFR 435.408
Legal Deadline: None
Abstract: This proposed rule would revise HCFA regulations concerning
documents which are required to determine proof of satisfactory
immigration status for Medicaid eligibility. It would specify that
lawful permanent residence be verified by whatever document is
currently in use by the Immigration and Naturalization Services (INS)
for that purpose. Currently, HCFA does not specify in regulations the
current documents used by INS for determining proof of lawful permanent
residence. HCFA needs to publish companion regulations to conform to
final SSA regulations for the supplemental security income (SSI)
program to ensure consistency among INS, HCFA, and SSA.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Robert Tomlinson, Office of Beneficiary Services,
Medicaid Bureau, Department of Health and Human Services, Health Care
Financing Administration, C4-20-21, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4463
RIN: 0938-AH25
_______________________________________________________________________
1335. HOSPICE CARE - CONDITIONS OF PARTICIPATION (BPD-844-
P)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395x(dd)
CFR Citation: 42 CFR 418
Legal Deadline: None
Abstract: This proposed rule would revise the Medicare conditions of
participation for hospices to held ensure the provision of quality care
through an emphasis on patient-centered outcomes. Areas of change would
include, among others, assessment of patient needs, clarification of
physician roles, coordination of care for hospice patients residing in
nursing homes, clarification of nursing roles, patient rights, and
provision of services. This rule is part of the Department's regulatory
reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/30/96
Small Entities Affected: Businesses
Government Levels Affected: State, Local
Agency Contact: Thomas Saltz, Bureau of Policy Development, Department
of Health and Human Services, Health Care Financing Administration, C4-
05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4480
RIN: 0938-AH27
_______________________________________________________________________
1336. LIMITATIONS ON PAYMENT FOR HOME OXYGEN THERAPY BASED
ON INHERENT REASONABLENESS CRITERIA (BPD-845-PN)
Priority: Economically Significant
Legal Authority: 42 USC 1395m(a); 42 USC 1395u(b)(8) and (9)
CFR Citation: 42 CFR 405.502(g); 42 CFR 414.210(d)
Legal Deadline: None
Abstract: This proposed notice sets forth our rationale for determining
that Medicare's Part B payment allowances for home oxygen are grossly
excessive and specifies the proposed change in our charge or
methodology for determining home oxygen payment amounts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/95
Proposed Notice 10/00/95
Small Entities Affected: Businesses
Government Levels Affected: Federal
Agency Contact: William J. Long, Health Insurance Specialist,
Department of Health and Human Services, Health Care Financing
Administration, C4-04-05, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5655
RIN: 0938-AH28
_______________________________________________________________________
1337. MEDICAID: LIMITATIONS ON AGGREGATE PAYMENTS TO
DISPROPORTIONATE SHARE HOSPITALS; FEDERAL FISCAL YEAR 1997 (MB-098-N)
Priority: Other Significant
Legal Authority: 42 USC 1395r-4
CFR Citation: 42 CFR 447.297; 42 CFR 447.298
Legal Deadline: Other, Statutory, October 1995.
Abstract: This notice announces the preliminary Federal fiscal year
1997 national target and individual State allotments for Medicaid
payment made to hospitals that serve a disproportionate number of
Medicaid recipients and low-income patients with special needs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Richard Strauss, Health Insurance Specialist, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, Room C-4-18-26, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-2019
RIN: 0938-AH30
_______________________________________________________________________
1338. MEDICAID ELIGIBILITY QUALITY CONTROL, STAFFING AND
TRAINING, AND UTILIZATION CONTROL: REMOVAL OF OBSOLETE AND RESTRICTIVE
REQUIREMENTS (MB-099-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 42 USC 1302; 42 USC 1396a(a)(4); 42 USC 1396a(a)(26);
42 USC 1396b(g) and (i); 42 USC 1396b(u); 42 USC 1396d(a)(16); 42 USC
1396d(h)
CFR Citation: 42 CFR 431.861; 42 CFR 431.862; 42 CFR 431.863; 42 CFR
431.864; 42 CFR 432.10; 42 CFR 456
Legal Deadline: None
Abstract: This rule would remove several obsolete sections of the
Medicaid regulations that specify rules and procedures for disallowing
Federal financial participation for erroneous medical assistance
payments due to eligibility and beneficiary liability errors as
detected through the Medicaid eligibility quality control (MEQC)
program for assessment periods from 1980 through June 1990. The rule
also would eliminate certain regulations that specify Federal standards
for personnel administration and training programs to allow States more
flexibility and reduce burden. In addition, the rule would remove most
of the regulations that prescribe requirements concerning control of
the utilization of all Medicaid services, including specific
requirements for control of utilization in institutions. The statutory
requirements for utilization control remain in effect. This effort is
part of our initiative to reinvent health care regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/96
Small Entities Affected: Businesses, Organizations
Government Levels Affected: State, Local
Agency Contact: William Hickman, Medicaid Bureau, Department of Health
and Human Services, Health Care Financing Administration, Room C-4-24-
27A, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3235
RIN: 0938-AH31
_______________________________________________________________________
1339. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE
PAYMENT SYSTEM AND FISCAL YEAR 1997 RATES (BPD-847-P)
Regulatory Plan: This entry is Seq. No. 42 in Part II of this issue of
the Federal Register.
RIN: 0938-AH34
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1340. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (MB-020-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302
CFR Citation: 42 CFR 435.831; 42 CFR 436.831
Legal Deadline: None
Abstract: This final rule amends and responds to comments on a final
rule with comment period published in the Federal Register on January
12, 1994. That final rule permits States flexibility to revise the
process by which incurred medical expenses are considered to reduce an
individual's or a family's income in order for the individual or family
to become Medicaid eligible. Only States that cover the medically
needy, and States that use more restrictive criteria to determine
eligibility of the aged, blind, and disabled than the criteria used to
determine eligibility for Supplemental Security Income (SSI) benefits,
have a spenddown.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/02/83 48 FR 39959
NPRM Comment Period End 11/16/83 48 FR 39959
Interim Final Rule 01/12/94 59 FR 1659
Final Rule With Comment Period 01/12/94 59 FR 1659
Comment Period End 03/14/94
Effective Date 03/14/94
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Roy Trudel, Health Insurance Specialist, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3417
RIN: 0938-AB07
_______________________________________________________________________
1341. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (BPD-309-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395l(a)(1)(D); 42 USC 1395l(a)(2)(D); 42 USC
1395l(b)(3); 42 USC 1395l(h); 42 USC 1395cc(a)(2)(A); 42 USC
1396b(i)(7)
CFR Citation: 42 CFR 414.1; 42 CFR 414.2; 42 CFR 414.5; 42 CFR
405.556; 42 CFR 431.54; 42 CFR 447.342
Legal Deadline: None
Abstract: This rule will incorporate provisions of DEFRA, COBRA, OBRA
'86, OBRA '87, the Technical and Miscellaneous Revenue Act of 1988,
OBRA '89, and OBRA '90 regarding payment and ``assignment'' for
diagnostic clinical laboratory tests establishing in regulations the
methods for implementing fee schedules. This rule would set forth the
methods by which the fee schedules would be updated and would allow
certain adjustments for exceptions to the fee schedule. It will also
reflect a statutory revision mandated by OBRA '93.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/18/93 58 FR 43156
NPRM Comment Period End 10/18/93 58 FR 43156
Final Action 06/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Charles Spalding, Director, Division of Ambulatory Care
Services, Department of Health and Human Services, Health Care
Financing Administration, C-4-05-24, 7500 Security Blvd., Baltimore, MD
21244
Phone: 410 786-4496
RIN: 0938-AB50
_______________________________________________________________________
1342. EFFECTIVE DATES FOR PROVIDER AGREEMENTS AND SUPPLIER
APPROVALS (HSQ-139-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302; 42 USC 1395hh
CFR Citation: 42 CFR 431; 42 CFR 442; 42 CFR 488; 42 CFR 489; 42 CFR
498
Legal Deadline: None
Abstract: This rule establishes uniform criteria for determining the
effective dates of Medicare and Medicaid provider agreements and of the
approval of Medicare suppliers when the provider or supplier is subject
to survey as a basis for determining participation in those programs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/08/92 57 FR 46362
NPRM Comment Period End 12/07/92
Final Action 06/00/96
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Agency Contact: Irene Givson, Deputy Director, Office of Survey and
Certification, Department of Health and Human Services, Health Care
Financing Administration, S-02-14-17, 7500 Security Blvd., Baltimore,
MD 21244
Phone: 410 786-6768
RIN: 0938-AC88
_______________________________________________________________________
1343. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1320b-4; 42 USC 1395g; 42 USC 1395x(v)(1)(A);
42 USC 1395l; 42 USC 1395gg
CFR Citation: 42 CFR 405.370 to 405.377; 42 CFR 413.5; 42 CFR 413.153
Legal Deadline: None
Abstract: This rule will change the Medicare regulations to provide for
the following: (1) elimination of the requirement that in case of
overpayments to health care providers, the contractor makes a
determination that a suspension of payment is needed to protect the
program against financial loss before the payment can be suspended; (2)
clarification of procedures and roles of contractors, HCFA, and the
Office of Inspector General relating to suspension of payment; (3)
elimination of the requirement that investment income of providers from
gifts, grants, and endowments be offset against allowable interest
expenses if that investment income is commingled with other funds; and
(4) extension of the list of exceptions to the interest expense
investment income offset provision to include investment income from
deferred compensation plans and self-insurance funds.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/22/88 53 FR 31888
NPRM Comment Period End 10/21/88 53 FR 31888
Final Rule With Comment Period 06/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Sam Guida, Director, Div. of Acct. Mgmnt. &
Collections, Division of Payment and Reporting Policy, Department of
Health and Human Services, Health Care Financing Administration, S-2-
08-28, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-7495
RIN: 0938-AC99
_______________________________________________________________________
1344. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES
(BPD-426-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395y(a)(14); 42 USC 1395cc(a)(1)(H); 42 USC
1395cc(g); 42 USC 1395x(w)(1)
CFR Citation: 42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 412; 42 CFR
489; 42 CFR 1003
Legal Deadline: None
Abstract: This final rule, issued jointly by HCFA and the OIG,
prohibits Medicare payment for nonphysician services furnished to a
hospital outpatient by a provider or supplier other than the hospital,
unless the services are furnished under an arrangement with the
hospital. The hospital is obligated by its provider agreement to
furnish the services directly or under an arrangement. These
regulations also authorize the OIG to impose a civil money penalty, not
to exceed $2,000, against any individual who knowingly and willfully
presents, or causes to be presented, a bill or request for payment, for
items or services furnished under Medicare, that is inconsistent with
an arrangement under section 1866(a)(1)(H) of the Social Security Act
or is in violation of the requirements for an arrangement. These
regulations implement section 9343(c) of OBRA '86, section 4085(i)(17)
of OBRA '87, and section 4157 of OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/05/88 53 FR 29486
NPRM Comment Period End 10/04/88 53 FR 29486
Final Action 04/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Carolyn Mullen, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C-4-11-16, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4589
RIN: 0938-AD33
_______________________________________________________________________
1345. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HSQ-135-F)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395y(a); 42 USC 1320c; 42 USC 1396a(a)(30);
42 USC 1395cc(a)
CFR Citation: 42 CFR 400.200; 42 CFR 411.15; 42 CFR 431.630; 42 CFR
433.15; 42 CFR 462.1; 42 CFR 462.101; 42 CFR 462.102; 42 CFR 462.106;
42 CFR 462.107; 42 CFR 466.1; 42 CFR 466.71; 42 CFR 466.76; 42 CFR
466.78; 42 CFR 466.83
Legal Deadline: None
Abstract: This rule will set forth several changes to regulations that
govern Peer Review Organizations (PROs) and is based on statutory
changes contained in COBRA '85 and OBRA '86. In addition, several
technical changes will be included as a result of experience gained
with the PRO program by HCFA. This rule also implements the new quality
review requirements for certain Medicaid Health Maintenance
Organization contracts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/16/88 53 FR 8654
NPRM Comment Period End 05/16/88 53 FR 8654
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Harvey Brook, Deputy Director, Office of Quality
Improvement Programs, Department of Health and Human Services, Health
Care Financing Administration, S-1-09-26, 7500 Security Blvd.,
Baltimore, MD 21244
Phone: 410 786-6853
RIN: 0938-AD38
_______________________________________________________________________
1346. REVISIONS TO THE FREEDOM OF INFORMATION REGULATIONS (OPA-001-
P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 5 USC 552(b)(4); EO 12600; PL 99-570, Sec 1801; PL
99-570, Sec 1802; PL 99-570, Sec 1803; PL 99-570, Sec 1804
CFR Citation: 42 CFR 401.101 to 401.102; 42 CFR 401,110; 42 CFR
401.120 to 401.123; 42 CFR 401.124 to 401.125; 42 CFR 401.105 to
401.108; 42 CFR 401.115 to 401.116
Legal Deadline: None
Abstract: This proposed rule would supplement the existing Department
of Health and Human Services (HHS) Freedom of Information Act (FOIA)
regulations by establishing rules specific to HCFA. The rule would also
revise existing HCFA regulations to delete language that reiterates or
conflicts with HHS-FOIA regulations or that pertains to SSA. This
proposed rule is part of the Department's regulatory reinvention
initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 01/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Melody Hardy, Freedom of Information & Privacy Office,
Department of Health and Human Services, Health Care Financing
Administration, C2-01-11, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5358
RIN: 0938-AD60
_______________________________________________________________________
1347. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-F)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395i-3; 42 USC 1395x; 42 USC 1396r
CFR Citation: 42 CFR 418; 42 CFR 440; 42 CFR 441; 42 CFR 482; 42 CFR
483; 42 CFR 488; 42 CFR 431
Legal Deadline: None
Abstract: This final rule responds to public comments on the February
5, 1992, proposed rule that will implement several provisions of OBRA
'87 that concern services to residents of nursing homes. This rule will
implement provisions that include Federal standards for evaluating
State waivers of nursing facility nurse staffing requirements, use of
physical and chemical restraints in nursing facilities, qualifications
of facility administrators, notice of Medicaid rights to be given to
persons admitted to nursing facilities, and other technical changes.
This rule is part of the Department's regulatory reinvention
initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/05/92 57 FR 4516
NPRM Comment Period End 04/06/92 57 FR 4516
Final Action 04/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Bill Ullman, Health Insurance Specialist, Bureau of
Policy Development, Department of Health and Human Services, Health
Care Financing Administration, C4-11-06, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-5667
RIN: 0938-AD81
_______________________________________________________________________
1348. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OMC-007-F)
Priority: Other Significant
Legal Authority: 42 USC 1395mm
CFR Citation: 42 CFR 417.100; 42 CFR 417.101; 42 CFR 417.103; 42 CFR
417.104; 42 CFR 417.107; 42 CFR 417.120; 42 CFR 417.122; 42 CFR
417.123; 42 CFR 417.124; 42 CFR 417.126; 42 CFR 417.143; 42 CFR 417.152
Legal Deadline: None
Abstract: This regulation will provide organizations which operate
health maintenance organizations (HMOs) that are federally qualified
under title XIII of the Public Health Service Act with greater
flexibility in operating other health benefit plans. It will also
authorize, with certain limitations, federally qualified HMOs to offer
out-of-plan physician services and require a reasonable deductible for
those services. Further, this regulation would permit the HMO to use
assets of the parent organization to meet fiscal soundness and
insolvency protection requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/15/93 58 FR 38170
Correction Notice 09/03/93 58 FR 46925
NPRM Comment Period End 09/13/93 58 FR 38170
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Maureen Miller, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, S-3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1097
RIN: 0938-AE25
_______________________________________________________________________
1349. HOSPITAL STANDARD FOR HIV INFECTIOUS BLOOD AND BLOOD PRODUCTS
(BPD-633-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395x(e)(9)
CFR Citation: 42 CFR 482
Legal Deadline: None
Abstract: This final rule will require hospitals to notify the
patient's attending physician whenever potentially HIV infectious blood
has been administered, and to ask the physician to inform the patient
of the need for HIV testing and counseling. If the physician is
unavailable or declines to inform the patient, the hospital must notify
the patient. This rule implements a recommendation of the President's
Commission on AIDS.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/30/93 58 FR 34977
NPRM Comment Period End 08/30/93 58 FR 34977
Final Action 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Janet Samen, Office of Chronic Care & Insurance Policy,
Bureau of Policy Development, Department of Health and Human Services,
Health Care Financing Administration, C5-13-07, 7500 Security Blvd.,
Baltimore, MD 21244
Phone: 410 786-5244
RIN: 0938-AE40
_______________________________________________________________________
1350. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS
IMPLEMENTING THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA
'88) (HSQ-226-F)
Regulatory Plan: This entry is Seq. No. 43 in Part II of this issue of
the Federal Register.
RIN: 0938-AE47
_______________________________________________________________________
1351. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS
(BPD-646-F)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395x
CFR Citation: 42 CFR 485; 42 CFR 405; 42 CFR 482
Legal Deadline: Final, Statutory, November 16, 1991.
Abstract: This final rule will respond to comments on the final rule
with comment period which set forth changes to the conditions of
coverage for organ procurement organizations (OPOs). It deals with the
definition of an OPO service area; qualifications of the board of
directors; establishment of performance criteria for OPOs; clarify
operational policy for certification and recertification of OPOs,
competition for open areas, and, appeals of the Secretary's decisions.
This rule contains provisions that are part of the Department's
regulatory reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/21/91 56 FR 28513
NPRM Comment Period End 08/21/91 56 FR 28513
Interim Final Rule With Comment
Period 09/08/94 59 FR 46500
Effective Date 10/11/94
Comment Period End 11/07/94
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Claude Mone, Health Insurance Specialist, Department of
Health and Human Services, Health Care Financing Administration, C5-05-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5666
RIN: 0938-AE48
_______________________________________________________________________
1352. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395i-3; 42 USC 1396r; 42 USC 1302
CFR Citation: 42 CFR 483; 42 CFR 456.1; 42 CFR 456.600; 42 CFR
456.601; 42 CFR 456.602; 42 CFR 456.603; 42 CFR 456.608; 42 CFR
456.609; 42 CFR 456.610; 42 CFR 456.612; 42 CFR 456.651; 42 CFR
456.654; 42 CFR 483.20; 42 CFR 483.315
Legal Deadline: Final, Statutory, January 1, 1989.
Abstract: Sections 1819(b)(3) and 1919(b)(3) of the Social Security
Act, as amended by PL 100-203, require skilled nursing facilities in
the Medicare program and before October 1, 1990, as nursing facilities
in the Medicaid program, to conduct a comprehensive, standardized
assessment of each resident's capability to perform daily life
functions. The assessment must also describe significant impairments in
the resident's functional capacity and be based on a uniform minimum
data set specified by the Secretary. Sections 1819(f)(6)(A) and 1919
(f)(6)(A) of the Act require the Secretary to specify a minimum data
set of core elements and common definitions for use by nursing
facilities in conducting the assessments. This rule would specify this
minimum data set and establish guidelines for using it.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/28/92 57 FR 61614
NPRM Comment Period End 02/26/93 57 FR 61614
Final Action 04/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Sue Nonemaker, Health Standards Quality Bureau,
Department of Health and Human Services, Health Care Financing
Administration, S-2-19-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6825
RIN: 0938-AE61
_______________________________________________________________________
1353. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS
(OMC-003-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395mm
CFR Citation: 42 CFR 417
Legal Deadline: None
Abstract: This rule will provide Medicare beneficiaries with certain
coverage for pre-existing conditions under supplemental insurance after
non-renewal or termination of a Medicare health maintenance
organization (HMO) or competitive medical plan (CMP) contract; provide
a 30-day open enrollment period for individuals who would otherwise
lose prepaid Medicare coverage as a result of termination, non-renewal
or reduction in service area of a risk contract; accelerate the
deadline for risk contracting HMOs and CMPs to submit adjusted
community rate proposals; require all HMOs and CMPs to furnish a copy
of an executed enrollment application form to Medicare applicants, and
require HCPPs to comply with HMO/CMP beneficiary application
procedures.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/11/94 59 FR 11230
NPRM Comment Period End 05/09/94
Final Action 01/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Tracy Jensen, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, S-3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1096
RIN: 0938-AE63
_______________________________________________________________________
1354. EMPLOYER CONTRIBUTIONS TO HMOS (OMC-004-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 300e(c); 42 USC 300e-1(l); 42 USC 300e-9
CFR Citation: 42 CFR 417
Legal Deadline: None
Abstract: This rule would conform existing regulations to sections 5(b)
and 7 of the Health Maintenance Organization (HMO) Amendments of 1988
(PL 100-517). It would prohibit employers from financially
discriminating against HMO enrollees in setting the contributions the
employers make to employees' health plans.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/05/91 56 FR 30723
Comment Period End 09/03/91 56 FR 30723
Final Action 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marty Abeln, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1096
RIN: 0938-AE64
_______________________________________________________________________
1355. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT
(EPSDT) SERVICES (MB-28-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1396a(a)(43); 42 USC 1396d(r)
CFR Citation: 42 CFR 441.50; 42 CFR 440.40
Legal Deadline: None
Abstract: Section 6403 of OBRA '89 defines in new section 1905(r) of
the Social Security Act the following EPSDT services: screening
services, vision services, dental services and hearing services. It
also extends EPSDT services to include such other necessary health
care, diagnostic services, treatment, and other measures described in
section 1905(a) of the Act to correct or ameliorate defects and
illnesses and conditions discovered by the screening services whether
or not the services are covered under the State plan. Section 6403 also
amended section 1902(a)(43) of the Act to require States to report to
the Secretary certain information about EPSDT services provided under
the plan during each fiscal year. This rule would set forth
requirements to implement these statutory provisions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/01/93 58 FR 51288
NPRM Comment Period End 11/30/93 58 FR 51288
Final Action 04/00/96
Small Entities Affected: Undetermined
Government Levels Affected: State, Local
Agency Contact: Robert Wardwell, Director, Office of Medical and
Remedial Care Services, Department of Health and Human Services, Health
Care Financing Administration, C4-14-17, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-3254
RIN: 0938-AE72
_______________________________________________________________________
1356. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-
685-F)
Priority: Substantive, Nonsignificant
Legal Authority: PL 101-239, Sec 6205; PL 101-508, Sec 4004; PL 101-
508, Sec 4159; 42 USC 1395x note
CFR Citation: 42 CFR 413
Legal Deadline: NPRM, Statutory, July 1, 1990.
Abstract: This rule will set forth our policy for the payment of the
costs of approved nursing and allied health science programs, an action
directed by section 6205(b)(2) of OBRA '89. For the most part, the
provisions set forth in this rule restate or clarify our current
policies governing these costs, which have been previously set forth in
the provider reimbursement manual and other documents, but have never
been included in the regulations. In addition, we are amending the list
of approved programs and clarify payment rules for certified registered
nurse anesthetist programs. This rule will also implement section 4004
of OBRA '90 which provides that, effective with cost reporting periods
beginning on or after October 1, 1990, under certain conditions, costs
incurred by a hospital or educational institution related to the
hospital for clinical training are treated as pass-through costs and
paid on the basis of reasonable cost even though the hospital does not
operate the education programs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/22/92 57 FR 43659
NPRM Comment Period End 11/23/92 57 FR 43659
Final Action 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Tzvi Hefter, Director, Division of Hospital Services,
Department of Health and Human Services, Health Care Financing
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1850
RIN: 0938-AE79
_______________________________________________________________________
1357. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395x(s)(14); 42 USC 1395x(nn)
CFR Citation: 42 CFR 410.10; 42 CFR 410.15; 42 CFR 410.56
Legal Deadline: None
Abstract: This rule will establish regulations under section 6115 of
OBRA '89 to govern Medicare Part B coverage of screening pap smears and
related medically necessary services (including a physician's
interpretation of the test results) provided to a woman for the early
detection of cervical cancer.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/26/93 58 FR 62312
NPRM Comment Period End 01/24/94 58 FR 62312
Final Action 04/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joyce Eng, Office of Physician Ambulatory Care Policy,
Bureau of Policy Development, Department of Health and Human Services,
Health Care Financing Administration, C-4-02-26, 7500 Security Blvd.,
Baltimore, MD 21244
Phone: 410 786-4619
RIN: 0938-AE98
_______________________________________________________________________
1358. MEDICARE COVERAGE OF CLINICAL PSYCHOLOGIST, OTHER
PSYCHOLOGIST, AND CLINICAL SOCIAL WORKER SERVICES--MEDICARE (BPD-706-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395l(c); 42 USC 1395x(hh)(2); 42 USC
1395x(ii)
CFR Citation: 42 CFR 410; 42 CFR 417; 42 CFR 424
Legal Deadline: None
Abstract: This rule will address provisions of section 6113 of OBRA '89
and section 4157 of OBRA '90. Section 6113 of OBRA '89 provides
coverage for the services of clinical psychologists (CPs) and clinical
social workers. It requires CPs to agree to consult with the patient's
primary care or attending physician. Also, it eliminates the dollar
limitation that previously applied to mental health services although
the 62.5 percent limitation still applies. OBRA '89 also provides
coverage for clinical social worker services, but places two
limitations on separate payment, which apply to services provided to
inpatients of hospitals and skilled nursing facilities that are
Medicare participating. Section 4157 of OBRA '90 unbundled CP services
from the definition of ``inpatient hospital services.''
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/29/93 58 FR 68829
NPRM Comment Period End 02/28/94 58 FR 68829
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Regina Walker, Office of Chronic Care & Insurance
Policy, Bureau of Policy Development, Department of Health and Human
Services, Health Care Financing Administration, C-4-08-16, 7500
Security Blvd., Baltimore, MD 21244
Phone: 410 786-6735
RIN: 0938-AE99
_______________________________________________________________________
1359. CASE MANAGEMENT (MB-27-F)
Priority: Other Significant
Legal Authority: 42 USC 1396d; 42 USC 1396n
CFR Citation: 42 CFR 431.51(c); 42 CFR 440.169; 42 CFR 440.250; 42 CFR
441.10; 42 CFR 441.18; 42 CFR 447.327; 42 CFR 431.54
Legal Deadline: None
Abstract: This rule will place into our regulations provisions of COBRA
'85, OBRA '86, TEFRA '86, TMRA '88 and OBRA '87 dealing with case
management services. These regulations will provide for optimal
Medicaid coverage of case management services furnished to specific
groups in specific geographic areas or political subdivisions within a
State.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/15/93 58 FR 53481
NPRM Comment Period End 12/14/93
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Robert Wardwell, Director, Office of Medical and
Remedial Care Services, Department of Health and Human Services, Health
Care Financing Administration, C4-25-07, 7500 Security Blvd.,
Baltimore, MD 21244
Phone: 410 786-5659
RIN: 0938-AF07
_______________________________________________________________________
1360. PAYMENT FOR FEDERALLY QUALIFIED HEALTH CENTER (FQHC) SERVICES
(BPD-728-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395x(aa); 42 USC 13951
CFR Citation: 42 CFR 405.2401; 42 CFR 405.2430; 42 CFR 405.2446; 42
CFR 405.2448; 42 CFR 405.2450; 42 CFR 405.2463; 42 CFR 405.2466; 42 CFR
405.2468; 42 CFR 491.5; 42 CFR 491.8
Legal Deadline: None
Abstract: This final rule will respond to comments received as a result
of our publication of a final rule with comment period (57 FR 24961)
which established a new category of facility known as an FQHC, the
services of which are covered under the Medicare program. Those
regulations also established requirements for coverage and payment of
FQHC services under Medicare. They implemented section 4161(a) of PL
101-508 and section 13556 of PL 103-66. This final rule will clarify or
change policy, as appropriate, based on our evaluation of public
comments.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Effective Date 06/12/92 57 FR 24961
Final Rule with Comment Period 06/12/92 57 FR 24961
Comment Period End 08/11/92
Final Action 01/00/96
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Bernadette Schumaker, Acting Director, Office of
Physician and Ambulatory Care Policy, Department of Health and Human
Services, Health Care Financing Administration, C4-11-16, 7500 Security
Blvd., Baltimore, MD 21244
Phone: 410 786-0309
RIN: 0938-AF14
_______________________________________________________________________
1361. PARTIAL HOSPITALIZATION SERVICES IN COMMUNITY MENTAL HEALTH
CENTERS (BPD-736-IFC)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395k(a)(2)(J); 42 USC 1395x(ff); 42 USC
1395cc(e)(2)
CFR Citation: 42 CFR 400; 42 CFR 410; 42 CFR 413; 42 CFR 489; 42 CFR
498
Legal Deadline: None
Abstract: In accordance with section 4162 of OBRA '90, this rule sets
forth the coverage criteria and payment methodology for partial
hospitalization services furnished in community mental health centers.
It also specified the requirements a community mental health center
must meet in order to enter into a Medicare provider agreement to
furnish partial hospitalization services. This interim final rule will
respond to public comments.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 02/11/94 59 FR 6570
Effective Date 03/13/94 59 FR 6570
Comment Period End 04/12/94
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Susan Levy, Office of Chronic Care & Insurance Policy,
Bureau of Policy Development, Department of Health and Human Services,
Health Care Financing Administration, C4-05-27, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-9364
RIN: 0938-AF53
_______________________________________________________________________
1362. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-
INCOME PREGNANT WOMEN, INFANTS AND CHILDREN UNDER AGE 19 (MB-052-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1396a(a)(55)
CFR Citation: 42 CFR 435.901; 42 CFR 435.902; 42 CFR 435.903; 42 CFR
435.904; 42 CFR 435.907; 42 CFR 436.2; 42 CFR 435.3
Legal Deadline: None
Abstract: This rule implements a statutory requirement that State
Medicaid agencies must provide for receipt and initial processing of
Medicaid applications filed by certain low-income pregnant women,
infants, and children under age 19, at locations which are other than
those used for receipt and processing of Aid to Families with Dependent
Children (AFDC) applications. The statutory requirement also provides
that the application form for these individuals must not be the AFDC
application form.
The rule is based on section 1902(a)(55) of the Social Security Act as
added by section 4602 of OBRA '90, PL 101-508.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule With Comment
Period 08/23/94 59 FR 48805
Interim Final Rule 09/23/94 59 FR 48805
Comment Period End 11/22/94 59 FR 48805
Effective Date 11/24/94
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Tomlinson, Health Insurance Specialist,
Department of Health and Human Services, Health Care Financing
Administration, C4-07-22, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4531
RIN: 0938-AF69
_______________________________________________________________________
1363. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-FC)
Priority: Other Significant
Legal Authority: 42 USC 1395mm(i); 42 USC 1396b
CFR Citation: 42 CFR 417.01; 42 CFR 417.409; 42 CFR 417.495; 42 CFR
434.67; 42 CFR 1003.100 to 1003.103
Legal Deadline: None
Abstract: This rule would amend the regulations governing federally
qualified health maintenance organizations (HMOs) and competitive
medical plans (CMPs) contracting with the Medicare program, and certain
HMOs and health insuring organizations (HIOs) contracting with States
under the Medicaid program, by implementing changes made by sections
4204(a) and 4731(a) of OBRA '90 concerning physician incentive plans.
The changes are intended to allow HMOs, CMPs, and HIOs the flexibility
to provide reasonable financial incentives to their physicians and
physician groups in order to eliminate unnecessary care while still
protecting enrollees from reduced quality of care or reduced access to
care.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/14/92 57 FR 59024
Comment Period End 04/13/93 58 FR 8568
Final Action 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Tony Hausner, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, S-3-
23-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1093
RIN: 0938-AF74
_______________________________________________________________________
1364. PART B ADVANCE PAYMENTS TO PHYSICIANS/SUPPLIERS OR OTHER
ENTITIES FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (BPO-105-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395u
CFR Citation: 42 CFR 421.214
Legal Deadline: None
Abstract: This rule would amend Medicare regulations to provide advance
payment to physicians, suppliers, or entities that furnish items or
services under Medicare Part B. These payments could be made only when
claims processing is so delayed that interest payments alone are
insufficient to adequately compensate the provider, in light of cash
flow needs. This change is intended to result in more efficient and
economical administration of the Medicare program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/18/94 59 FR 36415
NPRM Comment Period End 09/16/94 59 FR 36415
Final Action 12/00/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Bob Shaw, Bureau of Program Operations, Department of
Health and Human Services, Health Care Financing Administration, S-2-
01-23, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7671
RIN: 0938-AF85
_______________________________________________________________________
1365. RETROACTIVE ENROLLMENT AND DISENROLLMENT IN RISK HEALTH
MAINTENANCE ORGANIZATIONS AND COMPETITIVE MEDICAL PLANS (OMC-015-F)
Priority: Other Significant
Legal Authority: 42 USC 1395mm
CFR Citation: 42 CFR 417.448; 42 CFR 417.450; 42 CFR 417.456; 42 CFR
417.460; 42 CFR 417.461; 42 CFR 417.462; 42 CFR 417.464; 42 CFR 417.584
Legal Deadline: None
Abstract: This rule will allow retroactive enrollment of up to 90 days
for individuals enrolling with an eligible organization (which has a
risk-sharing contract under section 1876 of the Social Security Act)
under a health benefit plan operated, sponsored, or contributed to, by
the individual's employer or former employer (or the employer or former
employer of the individual's spouse). The regulation implements section
4204(e) of OBRA '90. In addition, the rule will permit the Secretary to
authorize retroactive disenrollment in specific cases.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/27/93 58 FR 68366
Comment Period End 02/25/94 58 FR 68366
Final Action 05/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Anne Manley, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, S-3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1096
RIN: 0938-AF98
_______________________________________________________________________
1366. PAYMENT FOR PREADMISSION SERVICES (BPD-731-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395ww(a)(4)
CFR Citation: 42 CFR 412.2(c); 42 CFR 413.40
Legal Deadline: None
Abstract: This rule confirms the provisions published in an interim
final rule with comment period on January 12, 1994. In addition, this
final rule responds to comments received on the interim final rule with
comment period. The interim final rule implemented section 4003 of OBRA
'90, entitled ``Expansion of DRG Payment Window,'' which amended the
statutory definition of ``inpatient operating cost'' to include certain
preadmission services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Effective Date 01/12/94 59 FR 1654
Interim Final Rule With Comment
Period 01/12/94 59 FR 1654
Comment Period End 03/14/94
Final Action 03/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Nancy Edwards, Director, Division of Prospective
Payment System, Department of Health and Human Services, Health Care
Financing Administration, C5-06-27, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4531
RIN: 0938-AG00
_______________________________________________________________________
1367. CHANGE IN PROVIDER AGREEMENT REGULATIONS RELATED TO FEDERAL
EMPLOYEE HEALTH BENEFITS (BPD-748-F)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 5 USC 8904(b)
CFR Citation: 42 CFR 489
Legal Deadline: None
Abstract: This rule will amend current Medicare regulations to require
that payment for inpatient hospital services furnished to retired
Federal workers age 65 and older who are enrolled in a Federal Employee
Health Benefits (FEHB) plan but who are not covered under Medicare Part
A (Hospital Insurance) must accept as payment in full an amount that
approximates as closely as possible the inpatient hospital Medicare
prospective payment rate. The rule will also amend current Medicare
regulations to authorize HCFA to consider termination or nonrenewal of
a hospital's Medicare provider agreement for knowingly and willfully
failing to accept, on a repeated basis, the Medicare rate as payment in
full from an FEHB plan. This rule will implement section 7002(f) of
OBRA '90, enacted November 5, 1990. This rule is part of the
Department's regulatory initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/10/94 59 FR 6228
NPRM Comment Period End 04/11/94 59 FR 6228
Final Action 02/00/96
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Paul Olenick, Director, Division of Beneficiary and
Insurance Issues, Department of Health and Human Services, Health Care
Financing Administration, C4-07-07, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4472
RIN: 0938-AG03
_______________________________________________________________________
1368. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-F)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395h; 42 USC 1395u
CFR Citation: 42 CFR 421.100; 42 CFR 421.200
Legal Deadline: None
Abstract: Current regulations list functions that intermediaries and
carriers must perform. All intermediaries and all carriers must perform
all the enumerated functions. This rule changes the regulations to
bring them into greater conformance with the Medicare statute, which
gives the Health Care Financing Administration flexibility to move some
functions from one contractor to another to reduce inefficiency, lower
cost or achieve better program administration. This rule is part of
HCFA's regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/22/94 59 FR 8446
NPRM Comment Period End 04/25/94 59 FR 8446
Notice to Reopen Comment Period 07/17/94 59 FR 35664
Comment Period End 10/11/94
Final Action 02/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Alan Bromberg, Bureau of Program Operations, Department
of Health and Human Services, Health Care Financing Administration, S-
2-01-23, 2300 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7441
RIN: 0938-AG06
_______________________________________________________________________
1369. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1396b(r)
CFR Citation: 42 CFR 433.1; 42 CFR 431.17; 42 CFR 447.10; 42 CFR
447.45; 42 CFR 74.20; 42 CFR 74.21
Legal Deadline: None
Abstract: This notice sets forth revised general functional
requirements for the Medicaid Management Information System (MMIS). The
MMIS consists of software and hardware used to process Medicaid claims
and to retrieve and produce utilization and management information
about services that are required by the Medicaid agency or Federal
Government for administrative or audit purposes. The revised
requirements allow States more flexibility to exercise variations in
the implementation.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 11/22/93 58 FR 61692
Comment Period End 01/21/94
Final Action 12/00/95
Final Action 01/00/96
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Richard Friedman, Director, Div. of Systems Data and
Analysis, Medicaid Bureau, Department of Health and Human Services,
Health Care Financing Administration, C4-17-07, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-3292
RIN: 0938-AG10
_______________________________________________________________________
1370. END-STAGE RENAL DISEASE (ESRD) PAYMENT EXCEPTION REQUESTS AND
ORGAN PROCUREMENT COSTS (BPD-763-F)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395rr
CFR Citation: 42 CFR 413.170; 42 CFR 413.172; 42 CFR 413.174; 42 CFR
413.176; 42 CFR 413.178; 42 CFR 413.179; 42 CFR 413.180; 42 CFR
413.182; 42 CFR 413.184; 42 CFR 413.186; 42 CFR 413.188; 42 CFR
413.190; 42 CFR 413.192; 42 CFR 413.194; 42 CFR 413.196; ...
Legal Deadline: None
Abstract: These regulations specify the criteria HCFA will use to
determine if a facility furnishing dialysis services to patients with
end-stage renal disease qualifies for a higher payment under an
exception to the prospectively determined payment rate; and the
procedures used to evaluate ESRD payment exceptions requests. The rule
also revised the way HCFA computes acquisition costs for organs that
are transplanted into Medicare beneficiaries. The rule is part of the
Department's regulatory reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/26/94 59 FR 44097
NPRM Comment Period End 10/25/94 59 FR 44097
Final Action 12/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Michael Powell, Health Insurance Specialist, Division
of End-Stage Renal Disease, Department of Health and Human Services,
Health Care Financing Administration, C5-05-27, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-4557
RIN: 0938-AG20
_______________________________________________________________________
1371. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF
INTERMITTENT POSITIVE PRESSURE BREATHING MACHINE THERAPY (BPD-781-FN)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395x(n); 42 USC 1395y(a)(1)(A)
CFR Citation: None
Legal Deadline: None
Abstract: Intermittent positive pressure breathing (IPPB) machine
therapy is currently covered under Medicare as durable medical
equipment for patients whose ability to breathe is severally impaired.
Based on a Public Health Service recommendation, we propose to place
limitations on Medicare coverage of IPPB machine therapy.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 06/29/94 59 FR 33520
Comment Period End 08/29/94
Final Action 04/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Francine Spencer, Office of Chronic Care & Insurance
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-04-05, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4614
RIN: 0938-AG44
_______________________________________________________________________
1372. TELEPHONE AND ELECTRONIC REQUESTS FOR REVIEW OF PART B
INITIAL CLAIM DETERMINATIONS (BPO-121-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395hh; 42 USC 1395ff
CFR Citation: 42 CFR 405.807
Legal Deadline: None
Abstract: Current Medicare regulations allow a Medicare beneficiary to
appeal, in writing, decisions to deny payment for a claim under
supplementary medical insurance. This rule would allow a beneficiary to
appeal an initial payment determination either in writing or by
telephone. This rule is part of HCFA's regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/10/95 60 FR 35544
Final Action 01/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Rosalind Little, Bureau of Program Operations,
Department of Health and Human Services, Health Care Financing
Administration, S-01-05-18, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-6972
RIN: 0938-AG48
_______________________________________________________________________
1373. SCHEDULE OF LIMITS ON HOME HEALTH AGENCY COSTS PER VISIT
(BPD-793-N)
Priority: Other Significant
Legal Authority: 42 USC 1395f(b); 42 USC 1395x(v)(1)(A); 42 USC
1395x(v)(1)(L); 42 USC 1395hh; PL 103-66, Sec 13564(a); 42 USC
1395cc(a)
CFR Citation: None
Legal Deadline: None
Abstract: This notice responds to public comments on the February 14,
1995 notice with comment period (60 FR 8389) that set forth a revised
schedule of limits on home health agency costs that may be paid under
the Medicare program for cost reporting periods beginning on or after
July 1, 1993. The revised limits replaced the per-visit limits that
were set forth in our July 8, 1993 notice with comment period (58 FR
36748). The February 14 notice also provided, in accordance with the
provisions of OBRA '93, that there will be no changes in the home
health agency cost limits for cost reporting periods beginning on or
after July 1, 1994, and before July 1, 1996.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Other Provisions Effective 07/01/93 60 FR 8389
Notice With Comment Period 02/14/95 60 FR 8389
Comment Period End 04/17/95
Final Action 03/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Michael Bussacca, Health Insurance Specialist, Bureau
of Policy Development, Department of Health and Human Services, Health
Care Financing Administration, C4-05-27, 7500 Security Boulevard,
Baltimore, MD 21207
Phone: 410 786-4602
RIN: 0938-AG54
_______________________________________________________________________
1374. MEDICAID PROGRAM: NURSE-MIDWIFE SERVICES (MB-085-F)
Priority: Other Significant
Legal Authority: PL 103-66, Sec 13605
CFR Citation: 42 CFR 440
Legal Deadline: None
Abstract: This rule would expand coverage of nurse-midwife services
under the Medicaid program by including coverage for those services the
nurse-midwives perform outside the maternity cycle as allowed by State
law and regulation. The provisions of this rule conform the regulations
to the legislative provisions of OBRA '93.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/18/94 59 FR 36419
NPRM Comment Period End 09/16/94 59 FR 36419
Final Action 01/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Linda Sizelove, Office of Medical Services, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, C4-24-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3255
RIN: 0938-AG73
_______________________________________________________________________
1375. MEDICAID PROGRAM: FEES FOR VACCINE ADMINISTRATION UNDER
PEDIATRIC IMMUNIZATION PROGRAM (MB-084-FN)
Priority: Other Significant
Legal Authority: PL 103-66, sec 13631; 42 USC 1396a(a)(62); 42 USC
1396s
CFR Citation: None
Legal Deadline: None
Abstract: This notice establishes a regional maximum fee that a
Medicaid provider may charge for the administration of qualified
pediatric vaccines under the Medicaid Pediatric Immunization Program.
It also specifies the methodology used to develop this maximum fee and
allows a State to pay a rate lower than the maximum fee if the State
can ensure federally vaccine-eligible children adequate access to the
vaccines at the lower rate. This notice implements section
1928(c)(2)(C)(ii) of the Social Security Act, as added by section 13631
of OBRA '93.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Effective Date 10/01/94 59 FR 50235
Notice With Comment Period 10/03/94 59 FR 50235
Comment Period End 12/12/94
Final Action 04/00/96
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: State
Agency Contact: Marge Sciulli, Health Insurance Specialist, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, C4-21-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-0691
RIN: 0938-AG77
_______________________________________________________________________
1376. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION
(BPD-745-P)
Regulatory Plan: This entry is Seq. No. 44 in Part II of this issue of
the Federal Register.
RIN: 0938-AG79
_______________________________________________________________________
1377. MEDICARE PROGRAM: CHANGES TO THE INPATIENT HOSPITAL
PROSPECTIVE PAYMENT SYSTEMS AND FISCAL YEAR 1996 RATES (BPD-825-FC)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395ww
CFR Citation: 42 CFR 412; 42 CFR 413
Legal Deadline: NPRM, Statutory, May 1995. Final, Statutory, September
1995.
Abstract: This rule would make revisions to the inpatient hospital
prospective payment systems for operating costs and capital-related
costs. It also would include changes in the methods amounts and factors
used to determine the prospective payment rates applicable to
discharges occurring during FY 1996. In addition, the rule would set
forth the rate of increase limits for hospitals and hospital units
excluded from the prospective payment systems. Finally, this rule would
eliminate the requirement for physicians to sign an ``attestation
form'' for each Medicare patient discharged from a hospital. This rule
includes provisions that are part of HCFA's regulatory reform
initiative and the Department's regulatory reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/02/95 60 FR 29202
NPRM Comment Period End 08/01/95 60 FR 29202
Final Rule With Comment Period 09/01/95 60 FR 45778
Effective Date 10/01/95
Comment Period End 11/01/95
Final Action 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: State, Federal
Agency Contact: Nancy Edwards, Director, Division of Prospective
Payment Systems, Department of Health and Human Services, Health Care
Financing Administration, C5-07-22, 7500 Security Blvd., Baltimore, MD
21244
Phone: 410 786-4531
RIN: 0938-AG95
_______________________________________________________________________
1378. MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES AND
ADJUSTMENTS TO THE RELATIVE VALUE UNITS (RVUS) UNDER THE PHYSICIAN FEE
SCHEDULE FOR CALENDAR YEAR 1996 (BPD-827-FC)
Regulatory Plan: This entry is Seq. No. 45 in Part II of this issue of
the Federal Register.
RIN: 0938-AG96
_______________________________________________________________________
1379. MEDICARE PROGRAM: PHYSICIAN FEE SCHEDULE UPDATE FOR CALENDAR
YEAR 1996 & PHYSICIAN VOLUME PERFORMANCE STANDARD RATES OF INCREASE FOR
FEDERAL FISCAL YEAR 1996 (BPD-828-FN)
Priority: Other Significant
Legal Authority: 42 USC 1395w-4
CFR Citation: None
Legal Deadline: Other, Statutory, October 31, 1995.
Annual update required.
Abstract: This notice announces the calendar year 1996 updates to the
Medicare physician fee schedule and the federal fiscal year 1996
performance standard rates of increase for expenditures and volume of
physicians' services under the Medicare Supplementary Medical Insurance
(Part B) program as required by sections 1848(d) and (f) of the Social
Security Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 10/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Terrence Kay, Director, Division of Physician Services,
Office of Physician & Ambulatory Care Policy, Department of Health and
Human Services, Health Care Financing Administration, C4-10-26, 7500
Security Blvd., Baltimore, MD 21244
Phone: 410 786-4497
RIN: 0938-AH03
_______________________________________________________________________
1380. PART A PREMIUM FOR 1996 FOR THE UNINSURED AGED AND FOR
CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-
051-N)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395i-2; 42 USC 1395i-2a
CFR Citation: None
Legal Deadline: Other, Statutory, September 30, 1995.
Other deadline is for publication of Notice.
Abstract: This notice announces the hospital insurance premium for
calendar year 1996 under the Medicare's hospital insurance program
(Part A) for the uninsured aged and for certain disabled individuals
who have exhausted other entitlement. The uninsured aged are those
individuals who are not insured under the Social Security or Railroad
Retirement Acts and do not otherwise meet the requirements for
entitlement to Medicare Part A. The disabled beneficiaries are those
who lose monthly Social Security cash payments because they returned to
work even though their disability continues. Section 1818(d) of the
Social Security Act specifies the method to be used to determine this
amount.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice 10/16/95 60 FR 53631
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Wandishin, Director, Division of Hospital
Insurance, Department of Health and Human Services, Health Care
Financing Administration, N-3-26-00, 7500 Security Blvd., Baltimore, MD
21244
Phone: 410 786-6389
RIN: 0938-AH06
_______________________________________________________________________
1381. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1996
(OACT-050-N)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395r
CFR Citation: None
Legal Deadline: Other, Statutory, September 1995.
Other deadline is for publication of Notice.
Abstract: This notice announces the monthly actuarial rates for aged
(age 65 and over) and disabled (under age 65) enrollees, in the
Medicare Supplementary Insurance (SMI) program for the 12 months
beginning January 1, 1996. It also announces the monthly SMI premium
rate to be paid by all enrollees during the 12 months beginning January
1, 1996.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice 10/16/95 60 FR 53626
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Carter Warfield, Director, Division of Supplementary
Medical Insurance, Department of Health and Human Services, Health Care
Financing Administration, N-3-26-00, 7500 Security Blvd., Baltimore, MD
21244
Phone: 410 786-6396
RIN: 0938-AH07
_______________________________________________________________________
1382. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE
SERVICES COINSURANCE AMOUNTS FOR 1996 (OACT-049-N)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395e
CFR Citation: None
Legal Deadline: Other, Statutory, September 15, 1995.
Other deadline is for publication of Notice.
Abstract: This notice announces the inpatient hospital deductible and
the hospital and extended care services coinsurance amounts for
services furnished in calendar year 1996 under Medicare's hospital
insurance program (Medicare Part A). The Medicare statute specifies the
formulae to be used to determine these amounts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice 10/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Wandishin, Director, Division of Hospital
Insurance, Department of Health and Human Services, Health Care
Financing Administration, N-3-36-24, 7500 Security Blvd., Baltimore, MD
21244
Phone: 410 786-6389
RIN: 0938-AH08
_______________________________________________________________________
1383. LIMITATIONS ON AGGREGATE PAYMENTS TO
DISPROPORTIONATE SHARE HOSPITALS: FEDERAL FISCAL YEAR 1995 (MEDICAID
PROGRAM) (MB-094-N)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1396r-4(f)
CFR Citation: 42 CFR 447.297; 42 CFR 447.298; 42 CFR 447.299
Legal Deadline: None
Abstract: This notice announces the final Federal fiscal year (FFY)
1995 national target and individual State allotments for Medicaid
payment adjustments made to hospitals that serve a disproportionate
number of Medicaid recipients and low-income patients with special
needs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 11/00/95
Small Entities Affected: None
Government Levels Affected: State, Federal
Agency Contact: Richard Strauss, Health Insurance Specialist, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, C4-18-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2019
RIN: 0938-AH09
_______________________________________________________________________
1384. REPORTING OF INTEREST FROM ZERO COUPON BONDS (BPD-
647-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395x(v)
CFR Citation: 42 CFR 413.153
Legal Deadline: None
Abstract: This final rule requires Medicare providers to report all
interest expense and income from zero coupon bonds in the cost
reporting period in which the interest was accrued.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/13/93 58 FR 65150
Final Action 01/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Ann Pash, Health Insurance Specialist, Bureau of Policy
Development, Department of Health and Human Services, Health Care
Financing Administration, C5-03-17, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4615
RIN: 0938-AH11
_______________________________________________________________________
1385. UPDATE OF THE REASONABLE COMPENSATION EQUIVALENT
LIMITS FOR SERVICES FURNISHED BY PHYSICIANS (BPD-816-N)
Priority: Other Significant
Legal Authority: 42 USC 1395xx
CFR Citation: 42 CFR 405.482(f)
Legal Deadline: None
Abstract: This notice sets forth updated payment limits on the amount
of allowable compensation for services furnished by physicians to
providers that are not covered by the prospective payment system or per
resident payments for graduate medical education. These services are
paid for by Medicare on a reasonable cost basis. The revised reasonable
compensation equivalent limits are based on updated economic index data
and replace the limits that were published in the Federal Register on
February 20, 1985.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 01/00/96
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Ward Pleines, Health Insurance Specialist, Office of
Hospital Policy, Department of Health and Human Services, Health Care
Financing Administration, C5-03-03, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4528
RIN: 0938-AH14
_______________________________________________________________________
1386. CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO
CERTAIN DEVICES AND RELATED SERVICES (BPD-841-FC)
Regulatory Plan: This entry is Seq. No. 46 in Part II of this issue of
the Federal Register.
RIN: 0938-AH21
_______________________________________________________________________
1387. CLIA PROGRAM; GRANTING AND WITHDRAWAL OF AUTHORITY
TO PRIVATE NONPROFIT ACCREDITATION ORGANIZATIONS AND OF CLIA EXEMPTION
UNDER STATE LABORATORY PROGRAMS; TECHNICAL CORRECTIONS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 263a
CFR Citation: 42 CFR 493.501; 42 CFR 493.506; 42 CFR 493.513; 42 CFR
493.515; 42 CFR 493.521
Legal Deadline: None
Abstract: This rule clarifies that a state may obtain approval from
HCFA for exemption of its licensed laboratories from CLIA requirements
given if it does not license all laboratories in the state. We are also
making technical revisions and corrections to the final rule published
July 31, 1992, that include data format requirements, laboratory
performance information to be sent to us by accreditation organizations
and CLIA-exempt states and the right of a state to appeal termination
of its exemption for failure to pay required law.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule With Comment Period 11/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Josephine Simmons, Chief, Laboratory Performance
Branch, HSQB, HCFA, HHS, Department of Health and Human Services,
Health Care Financing Administration, 7500 Security Blvd, Room 52-19-
26, Baltimore, MD 21244
Phone: 410 786-3409
RIN: 0938-AH32
_______________________________________________________________________
1388. MEDICARE PROGRAM; SPECIAL ENROLLMENT PERIODS AND
WAITING PERIODS (BPD-752-FC)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1302; 42 USC 1395
CFR Citation: 42 CFR 406; 42 CFR 407; 42 CFR 408; 42 CFR 416
Legal Deadline: None
Abstract: This rule will reflect statutory changes made by OBRA's 1987,
1989, 1990 and 1993. It will provide an additional way for certain
disabled individuals to qualify for special enrollment periods (SEPs);
extend through 1998 the period during which disabled individuals under
age 65 may take advantage of SEPs if they are covered under large group
health plans; and provide that a second 24-month waiting period is not
required for disability-based reentitlement if the current impairment
is the same as or directly related to the impairment on which the
previous period of entitlement was based.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule with Comment Period 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Margaret Jefferson, Health Insurance Specialist,
Department of Health and Human Services, Health Care Financing
Administration, 7500 Security Blvd., C4-07-22, Baltimore, MD 21244
Phone: 410 786-4482
RIN: 0938-AH33
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1389. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR
EMERGENCY CARE (BPD-393-F)
Priority: Other Significant
Legal Authority: 42 USC 1395x; 42 USC 1395cc; 42 USC 1395dd
CFR Citation: 42 CFR 488.18; 42 CFR 489.20; 42 CFR 489.24; 42 CFR
489.25; 42 CFR 489.26; 42 CFR 489.27; 42 CFR 489.53; 42 CFR 1003
Legal Deadline: None
Abstract: This final rule requires Medicare participating hospitals
with emergency departments to provide upon request medical examinations
and treatments for individuals with emergency medical conditions and
women in labor. A participating hospital that has specialized
capabilities or facilities (such as burn, shock trauma, or neonatal
intensive care units) must accept an appropriate transfer if they have
the capacity to treat the individual. Hospitals failing to meet those
requirements may have their Medicare provider agreements terminated,
and hospitals and responsible physicians may be subject to civil money
penalties. Under section 9122 of COBRA '85, Medicare participating
hospitals are required to accept CHAMPUS and CHAMPVA payment as payment
in full for services provided to CHAMPUS and CHAMPVA beneficiaries.
These regulations also implement section 9305(b) of OBRA '86, which
requires Medicare hospitals to give patients a notice of their
discharge rights.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/16/88 53 FR 22513
NPRM Comment Period End 08/15/88 53 FR 22513
Final Rule With Comment Period 06/22/94 59 FR 32086
Effective Date 07/22/94
Comment Period End 08/22/94
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Tzvi Hefter, Director, Division of Hospital Service,
Department of Health and Human Services, Health Care Financing
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1304
RIN: 0938-AC58
_______________________________________________________________________
1390. CRITERIA AND PROCEDURES FOR MAKING MEDICAL SERVICES COVERAGE
DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY (BPD-432-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395y
CFR Citation: 42 CFR 400.200; 42 CFR 405.201; 42 CFR 405.203; 42 CFR
405.205; 42 CFR 405.207; 42 CFR 405.209
Legal Deadline: None
Abstract: The final rule establishes in regulations generally
applicable criteria and procedures for determining whether a service is
``reasonable and necessary'' under the Medicare program; it sets forth
the coverage decisionmaking process; and it summarizes and provides an
analysis of the public comments that we received in response to the
January 30, 1989 proposed rule (54 FR 4302). The objective of the
criteria and procedures set forth in this rule is to ensure that
Federal funds are expended only for medical services that are
appropriate to meet an individual's medical needs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/30/89 54 FR 4302
NPRM Comment Period End 03/31/89 54 FR 4302
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: David Higbee, Technology & Special Analysis Staff,
Department of Health and Human Services, Health Care Financing
Administration, C4-10-07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4643
RIN: 0938-AD07
_______________________________________________________________________
1391. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES
(BPD-425-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395k; 42 USC 1395l; 42 USC 1395w-4; 42 USC
1395x(s); 42 USC 1395x(p); 42 USC 1395cc(e)
CFR Citation: 42 CFR 410; 42 CFR 485; 42 CFR 486
Legal Deadline: None
Abstract: This rule would implement section 9337 of OBRA '86 which
provides Medicare coverage for outpatient occupational therapy services
furnished by providers and independent practitioners, identical to the
coverage for outpatient physical therapy. It also would implement
section 6133(a) of OBRA '89 which increased the payment limit for
outpatient occupational therapy services provided by independent
practitioners.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Sheridan Gladhill, Bureau of Policy Development,
Department of Health and Human Services, Health Care Financing
Administration, C-4-05-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1782
RIN: 0938-AD32
_______________________________________________________________________
1392. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (BPD-482-
FC)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395y(b)
CFR Citation: 42 CFR 411
Legal Deadline: None
Abstract: This rule implements the Medicare secondary payer (MSP)
provision for disabled individuals who are covered under large group
health plans (LGHPs). Under this provision LGHPs may not take into
account that such individuals are entitled to Medicare. The rule
contains procedures under which a plan can appeal a determination of
nonconformance which could lead to a tax penalty. It reflects statutory
revisions mandated by OBRA '86, OBRA '89, and OBRA '93, some of which
also affect the MSP provisions for persons who are entitled on the
basis of age or end-stage renal disease. This rule is part of HCFA's
regulatory reform initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/08/90 55 FR 8491
NPRM Comment Period End 05/08/90 55 FR 8491
Final Rule With Comment 08/31/95 60 FR 45344
Effective Date 09/29/95
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Herbert Pollock, Office of Chronic Care & Insurance
Policy, Bureau of Policy Development, Department of Health and Human
Services, Health Care Financing Administration, C-4-08-14, 7500
Security Blvd., Baltimore, MD 21244
Phone: 410 786-4474
RIN: 0938-AD73
_______________________________________________________________________
1393. FEE SCHEDULE FOR PAYMENT OF CLINICAL PSYCHOLOGIST SERVICES
(BPD-495-P)
Priority: Other Significant
Legal Authority: 42 USC 1395k(a)(2)(B)(iii); 42 USC 1395x(hh); 42 USC
1395w-4; 42 USC 1395x(b); 42 USC 1395l(a)(1)(L); 42 USC 1395x(s)
CFR Citation: 42 CFR 414
Legal Deadline: None
Abstract: This proposed rule would establish fee schedules for payment
of clinical psychologist services furnished under Medicare Part B. It
implements a portion of section 4077(b) of OBRA '87 as amended. It
further implements section 6113(a) of OBRA '89 and section 4157 of OBRA
'90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Elisa Tunanidas, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4505
RIN: 0938-AD84
_______________________________________________________________________
1394. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH
AGENCIES (HSQ-169-F)
Priority: Other Significant
Legal Authority: 42 USC 1395w-2; 42 USC 1395bbb
CFR Citation: 42 CFR 488; 42 CFR 489; 42 CFR 498
Legal Deadline: None
Abstract: These rules will establish periodic, unannounced surveys of
home health agencies (HHAs) and other survey requirements and also will
specify a number of sanctions that could be used, when an HHA is out of
compliance with Federal requirements, as an alternative or in addition
to terminating an HHA's participation in the Medicare program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/02/91 56 FR 37054
NPRM Comment Period End 10/01/91 56 FR 37054
Final Action 00/00/00
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State, Local, Federal
Agency Contact: Pam Vocke, Director, Division of Program Operations,
Office of Survey and Certification, Department of Health and Human
Services, Health Care Financing Administration, S-2-19-26, 6300
Security Blvd., Baltimore, MD 21244
Phone: 410 786-3487
RIN: 0938-AE39
_______________________________________________________________________
1395. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE
FACILITIES, AND INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED
(BPD-650-FC)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395x; 42 USC 1396d
CFR Citation: 42 CFR 482.41(b)(1); 42 CFR 483.70(a); 42 CFR
483.470(j)(2)(i)(C); 42 CFR 416.44(a); 42 CFR 418.100(d)
Legal Deadline: None
Abstract: This final rule with comment period revises the fire safety
standards for hospitals, long term care facilities participating in
Medicare and Medicaid, intermediate care facilities for the mentally
retarded, ambulatory surgical centers (ASCs) and hospices. It deletes
references to the 1967 and 1973, 1981, and 1985 editions of the Life
Safety Code (LSC) of the National Fire Protection Association (NFPA)
and requires compliance with only the 1994 edition of the LSC. This is
a part of the Department's regulatory reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/01/90 55 FR 31196
NPRM Comment Period End 10/01/90 55 FR 31196
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: James Kenton, Division of Skilled Nursing Care, Bureau
of Policy Development, Department of Health and Human Services, Health
Care Financing Administration, C4-11-06, 7500 Security Blvd.,
Baltimore, MD 21244
Phone: 410 786-5629
RIN: 0938-AE97
_______________________________________________________________________
1396. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HSQ-
175-FC)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: PL 101-239, Sec 6901(a); 42 USC 1395i-3; 42 USC
1395aa(d); 42 USC 1396r
CFR Citation: 42 CFR 442; 42 CFR 488
Legal Deadline: None
Abstract: This final rule with comment period amends the Medicare and
Medicaid regulations by removing obsolete long-term care survey forms,
guidelines, and procedures used by State agencies when they evaluate a
Medicare skilled nursing facility or a Medicaid nursing facility for
compliance with Federal certification requirements. Effective October
1, 1990, the application of new Federal participation requirements for
these facilities with an increased focus on actual or potential
resident outcomes has made the survey forms and process in existing
regulations outdated. Retention of the outdated items could cause
confusion in connection with directions State survey agencies must
follow in determining facility compliance.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule Effective
Date 10/19/94
Interim Final Rule Comment
Period End 11/18/94
Final Rule With Comment Period 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Additional Information:
TIMETABLE: Pending court ruling.
Agency Contact: Pam Vocke, Director, Division of Program Operations,
Office of Survey and Certification, Department of Health and Human
Services, Health Care Financing Administration, S-2-19-26, 6300
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3487
RIN: 0938-AF02
_______________________________________________________________________
1397. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS
(OMC-018-FC)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1396b(m); 42 USC 1396a(e)(2)(A)
CFR Citation: 42 CFR 434.20 to 44; 42 CFR 435.212; 42 CFR 435.362
Legal Deadline: None
Abstract: This rule will require certain health insuring organizations
to be subject to the regulations governing prepaid health plans. This
rule will also allow State-only funds to be paid to Medicaid
contracting entities. These funds will not be considered when computing
the rate at which Federal financial participation is made. Further,
this rule will incorporate several technical amendments from section
4732 of OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/09/94 59 FR 23820
NPRM Comment Period End 07/08/94 59 FR 23820
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jane McClard, Health Insurance Specialist, Office of
Managed Care, Department of Health and Human Services, Health Care
Financing Administration, S-03-02-01, 7500 Security Blvd., Baltimore,
MD 21244
Phone: 410 786-4460
RIN: 0938-AF15
_______________________________________________________________________
1398. PRESUMPTIVE LIMITS ON PAYMENTS TO HMOS, CMPS, AND HCPPS (OMC-
006-F)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1395mm(h); 42 USC 1395x(v)(1)(A)
CFR Citation: 42 CFR 417.532(a)(3); 42 CFR 417.802; 42 CFR 417.800(c)
Legal Deadline: None
Abstract: This rule will establish presumptive limits for Medicare
payments to Health Maintenance Organizations and Competitive Medical
Plans, and to Health Care Prepayment Plans (HCPPs) that furnishes
inpatient hospital care. It will also revise the criteria that HCFA
uses to determine reasonable costs for HCPPs that do not furnish
inpatient hospital care. This rule is part of HCFA's regulatory reform
initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/22/94 59 FR 8435
NPRM Comment Period End 04/25/94 59 FR 8435
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: A. G. D'Alberto, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, S-3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7610
RIN: 0938-AF16
_______________________________________________________________________
1399. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS
(BPD-727-P)
Priority: Other
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1302; 42 USC 1395f(b); 42 USC 1395g(a); 42 USC
1395l; 42 USC 1395x(u); 42 USC 1395hh; 42 USC 1395jj; 42 USC 1395oo; 42
USC 1395ww
CFR Citation: 42 CFR 405.1801; 42 CFR 405.1889
Legal Deadline: None
Abstract: Under section 1878 of the Social Security Act, the Provider
Reimbursement Review Board (PRRB) has the authority to adjudicate
substantial reimbursement disputes between providers and
intermediaries. This proposed rule would revise, update, and clarify
various provisions of the regulations pertaining to provider appeals
before intermediaries and the PRRB. This rule is part of HCFA's
regulatory reform initiative.
Timetable: Next Action Undetermined
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Morty Marcus, Office of Chronic Care & Insurance
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477
RIN: 0938-AF28
_______________________________________________________________________
1400. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID
FAMILIES (MB-051-F)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1396k
CFR Citation: 42 CFR 433.160; 42 CFR 433.135; 42 CFR 433.137; 42 CFR
433.151
Legal Deadline: None
Abstract: This rule will require State Medicaid agencies to refer
Medicaid families with an absent parent to child support enforcement
(CSE) agencies. Section 9142 of OBRA '87 required CSE agencies to
provide all CSE services to such Medicaid families who have assigned to
the State their rights to medical support. The purpose of these rules
is to require States to make this referral to State CSE agencies to
ensure that those recipients requiring CSE services receive them.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/22/93 58 FR 49272
NPRM Comment Period End 11/22/93 58 FR 49272
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Randy Graydon, Director, Division of Benenficiary
Services, Department of Health and Human Services, Health Care
Financing Administration, C4-22-27, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4451
RIN: 0938-AF68
_______________________________________________________________________
1401. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP)
DEBTS (BPO-108-P)
Priority: Substantive, Nonsignificant
Legal Authority: 31 USC 3711; 31 USC 3717; 42 USC 1395y(b)(2)(B)
CFR Citation: 42 CFR 411.40; 42 CFR 405.376
Legal Deadline: None
Abstract: This proposal would establish in HCFA rules provisions
concerning interest charges on amounts owed to the Federal government
when an overpayment occurs because Medicare was billed and made payment
as the primary payer, rather than as the secondary payer. We also
propose to clarify the date of determination that an overpayment has
occurred so that all parties would have a clear understanding of the
period subject to payment of interest charges.
Timetable: Next Action Undetermined
Small Entities Affected: None
Government Levels Affected: None
Additional Information:
TIMETABLE: Pending revisions resulting from PL 103-432.
Agency Contact: John Albert, Health Insurance Spcialist, Bureau of
Program Operations, Department of Health and Human Services, Health
Care Financing Administration, S-03-02-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-7457
RIN: 0938-AF87
_______________________________________________________________________
1402. GENERAL CRITERIA AND STANDARDS FOR EVALUATING PERFORMANCE OF
CONTRACT OBLIGATIONS (HSQ-207-NC)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302; 42 USC 1320c; 42 USC 1320-2
CFR Citation: 42 CFR 462
Legal Deadline: None
Abstract: This notice provides general criteria and standards that will
be used to evaluate the effective and efficient performance of
Utilization and Quality Control Peer Review Organizations (PROs) for
new contracts entered into on or after April 1, 1993, by the 53 PROs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice With Comment Period 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Kathleen Kelso, Health Standards & Quality Bureau,
Department of Health and Human Services, Health Care Financing
Administration, S-1-09-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7214
RIN: 0938-AG32
_______________________________________________________________________
1403. WITHDRAWAL OF COVERAGE OF DIAGNOSTIC NOCTURNAL PENILE
TUMESCENCE TESTING (IMPOTENCE TESTING) (BPD-780-FN)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395y(a)(i)(A)
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces the Medicare program's intent to
withdraw coverage for diagnostic nocturnal penile tumescence (NPT)
testing in the sleep disorder clinic and to exclude coverage for
nocturnal penile tumescence testing by plethysmography and other
monitoring devices in all settings. Public Health Service studies show
that NPT testing is not a reliable index for evaluating impotence.
Therefore, it does not meet HCFA's criteria for effectiveness.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 01/04/94 59 FR 308
Comment Period End 03/07/94 59 FR 309
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Bob Ulikowski, Office of Physician & Ambulatory Care
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-10-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5721
RIN: 0938-AG43
_______________________________________________________________________
1404. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-FN)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395y(a)(1)(A)
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces the Medicare program's intent to
exclude from coverage electrostimulation of the salivary glands in the
treatment of xerostomia secondary to Sjogren's Syndrome. Public Health
Service (PHS) studies show that there is insufficient data to establish
the clinical utility of electrostimulation to evaluate its long-term
effectiveness, or to identify those xerostomia patients who would
benefit from this procedure. Also, PHS reports that electrostimulation
is not widely accepted as a treatment for xerostomia secondary to
Sjogren's Syndrome.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 05/23/94 59 FR 26653
Comment Period End 07/22/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Francina Spencer, Office of Chronic Care & Insurance
Policy, Department of Health and Human Services, Health Care Financing
Administration, C4-040-05, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4614
RIN: 0938-AG45
_______________________________________________________________________
1405. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE
SCHEDULES (HSQ-219-FC)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 263a(m)
CFR Citation: 42 CFR 493.638; 42 CFR 493.649
Legal Deadline: None
Abstract: The preamble to this final rule with comment period announces
updated fees that laboratories must pay as required by CLIA '88. Fee
increases are necessary to meet the costs of program administration,
which are to be borne by the laboratories. In addition, technical
conforming changes are made to the regulations to ensure consistent and
complete references. This rule is part of HCFA's regulatory reform
initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Ed Mortimore, Survey & Certification, Department of
Health and Human Services, Health Care Financing Administration, S-2-
18-14, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3509
RIN: 0938-AG87
_______________________________________________________________________
1406. MANDATORY MEDIGAP CROSSOVER CLAIMS TRANSMITTAL REQUIREMENTS
(BPD-811-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395ss
CFR Citation: 42 CFR 403.206; 42 CFR 403.212; 42 CFR 403.222; 42 CFR
403.232; 42 CFR 403.204; 42 CFR 424.68
Legal Deadline: None
Abstract: This regulation proposes to require Medicare supplemental
issuers to accept from Medicare carriers direct transmittal of claims
submitted for services furnished to Part B Medicare beneficiaries by
participating physicians and suppliers; pay user fees associated with
this claims transmittal requirement; and meet certain other
requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Thomas Hoyer, Director, Office of Chronic Care &
Insurance Policy, Department of Health and Human Services, Health Care
Financing Administration, C4-02-16, 7500 Security Bldg., Baltimore, MD
21244
Phone: 410 786-5661
RIN: 0938-AG94
_______________________________________________________________________
1407. DEFINITION OF SKILLED NURSING FACILITY (SNF) AND
HOME HEALTH AGENCY (HHA) FOR COVERAGE OF DURABLE MEDICAL EQUIPMENT (DME)
(BPD-834-P)
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1495x(n)
CFR Citation: 42 CFR 409; 42 CFR 410
Legal Deadline: None
Abstract: This proposed rule would define skilled nursing facilities
(SNF) (under Medicare and Medicaid) for purposes of Medicare coverage
of DME and home health. A Medicare SNF (as defined under section 1819
of the Act) can not be considered a home under Medicare Part B for DME
and home health coverage. This proposed rule would presume that all
Medicaid NFs are section 1819(a) facilities and this would not be
considered a home for DME and home health coverage. This rule would
identify non- Medicare nursing homes as skilled facilities based upon
the receipt of skilled care by a proportion of their resident
population that is at least comparable to the proportion typically
found in participating Medicare SNFs. This proposed rule is part of the
Department's regulatory reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/00/96
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Thomas Hoyer, Director, Office of Chronic Care and
Insurance Policy, Department of Health and Human Services, Health Care
Financing Administration, C4-02-16, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-4605
RIN: 0938-AH16
_______________________________________________________________________
1408. MEDICARE COVERAGE OF LIVER TRANSPLANTATION (BPD-835-
PN)
Priority: Other Significant
Legal Authority: 42 USC 1395y(a)(1)(A)
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces proposed changes in Medicare's national
coverage policy for liver transplantations. Currently, Medicare
coverage for liver transplantation in adults is limited to seven
diagnosis. This notice proposes to expand the diagnoses for which
Medicare would cover a liver transplant to include all end stage liver
disease except malignancies, hepatitis B, and hemochromatosis. We are
also proposing a change in the criteria for approval of a facility to
perform liver transplants.
Timetable: Next Action Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Lana Price, Director, Division of End Stage Renal
Disease, Bureau of Policy Development, Department of Health and Human
Services, Health Care Financing Administration, C5-05-27, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-4533
RIN: 0938-AH17
_______________________________________________________________________
1409. PROVISIONS THAT ALLOW RURAL PRIMARY CARE HOSPITALS
(RPCHS) TO ENTER INTO SWING-BED AGREEMENTS (BPD-839-P)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1395i-4
CFR Citation: 42 CFR 485.645
Legal Deadline: None
Abstract: This proposed rule would revise the provisions under which
Rural Primary Care Hospitals (RPCHs) are allowed to enter into swing-
bed agreements. These changes are being made to conform the regulations
to changes made by section 102(c) of Public Law 103-432. Changes are
also being made to ensure consistent treatment of similar facilities,
and to protect the health and safety of patients in RPCH swing beds.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Next Action Undetermined
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: George Morey, Office of Hospital Policy, Department of
Health and Human Services, Health Care Financing Administration, C5-08-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4653
RIN: 0938-AH20
_______________________________________________________________________
1410. TRANSFER OF ASSETS FOR LESS THAN FAIR MARKET VALUE:
MEDICAID PROGRAM (MB-095-P)
Priority: Other Significant
Legal Authority: 42 USC 1396p(c)
CFR Citation: 42 CFR 435; 42 CFR 436
Legal Deadline: None
Abstract: These regulations would conform the Medicaid regulations to
section 1917(c) and (d) of the Social Security Act, as amended by
section 13611 of OBRA 1993. Section 1917(c) of the Act addresses the
treatment of transfers of assets for less than fair market value. These
regulations would specify the conditions that would result in the
denial of coverage for certain medical services to otherwise eligible
individuals who transfer assets for less than fair market value. These
regulations would also set forth the rules under which a trust must be
considered in determining eligibility for Medicaid. The provisions
would apply to any individual who established a trust and who is a
Medicaid applicant or recipient.
Timetable: Next Action Undetermined
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Roy Trudel, Division of Eligibility Policy, Medicaid
Bureau, Department of Health and Human Services, Health Care Financing
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3417
RIN: 0938-AH23
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1411. CLARIFICATIONS OF MEDICARE'S ACCRUAL BASIS OF ACCOUNTING
POLICY (BPD-366-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 413.24; 42 CFR 413.100
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/27/95 60 FR 33126
Final Action Effective 07/27/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Eppinger
Phone: 410 786-4518
RIN: 0938-AD01
_______________________________________________________________________
1412. OPTIONAL PAYMENT SYSTEM FOR LOW MEDICARE VOLUME SKILLED
NURSING FACILITIES (BPD-409-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 413.300; 42 CFR 413.302; 42 CFR 413.304; 42 CFR
413.308; 42 CFR 413.310; 42 CFR 413.312; 42 CFR 413.314; 42 CFR
413.316; 42 CFR 413.320; 42 CFR 413.321; 42 CFR 413.1; 42 CFR 413.24
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/21/95 60 FR 37590
Final Action Effective 08/21/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Bob Kuhl
Phone: 410 786-4597
RIN: 0938-AD02
_______________________________________________________________________
1413. TRANSFER OF RESOURCES FOR LESS THAN FAIR MARKET VALUE (MB-10-
P)
Priority: Other Significant
CFR Citation: 42 CFR 435; 42 CFR 436
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn New regulation (MB-
095-P) under development. 01/12/95
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Roy Trudel
Phone: 410 786-3417
RIN: 0938-AD18
_______________________________________________________________________
1414. PAYMENT FOR DURABLE MEDICAL EQUIPMENT AND ORTHOTIC AND
PROSTHETIC DEVICES (BPD-494-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 414.220; 42 CFR 414.222; 42 CFR 414.226; 42 CFR
414.228; 42 CFR 414.229; 42 CFR 414.232
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/10/95 60 FR 35402
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: William Long
Phone: 410 786-5655
RIN: 0938-AD65
_______________________________________________________________________
1415. UNIFORM ELECTRONIC COST REPORTING SYSTEM FOR HOSPITALS (BPD-
689-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 413.24
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/27/95 60 FR 33123
Final Action Effective 07/27/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas Talbott
Phone: 410 786-4592
RIN: 0938-AE80
_______________________________________________________________________
1416. ALLOWING CERTIFICATIONS AND RECERTIFICATIONS BY NURSE
PRACTITIONERS AND CLINICAL NURSE SPECIALISTS FOR CERTAIN SERVICES (BPD-
709-FC)
Priority: Other Significant
CFR Citation: 42 CFR 424
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/26/95 60 FR 38266
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Roberta Epps
Phone: 410 786-4503
RIN: 0938-AF01
_______________________________________________________________________
1417. MEDICAID THIRD PARTY LIABILITY: COST EFFECTIVENESS WAIVERS
(MB-39-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 433.138; 42 CFR 433.139; 42 CFR 433.137
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/10/95 60 FR 35498
Final Action Effective 09/08/95
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Richard Friedman
Phone: 410 786-3292
RIN: 0938-AF11
_______________________________________________________________________
1418. REQUIRED COVERAGE OF NURSE PRACTITIONER SERVICES--MEDICAID
(MB-41-F)
Priority: Other Significant
CFR Citation: 42 CFR 440
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 04/21/95 60 FR 19856
Final Action Effective 05/22/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Wardwell
Phone: 410 786-5659
RIN: 0938-AF12
_______________________________________________________________________
1419. PHYSICIAN OWNERSHIP OF AND REFERRALS TO HEALTH CARE
FACILITIES THAT FURNISH CLINICAL LABORATORY SERVICES AND FINANCIAL
RELATIONSHIP REPORTING REQUIREMENTS (BPD-674-FC)
Priority: Other Significant
CFR Citation: 42 CFR 411
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/14/95 60 FR 41914
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Betty Burrier
Phone: 410 786-0191
RIN: 0938-AF40
_______________________________________________________________________
1420. MEDICARE AND MEDICAID PROGRAMS; ADVANCE DIRECTIVES (BPD-718-
F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 417.436; 42 CFR 417.801; 42 CFR 431.20; 42 CFR
431.107; 42 CFR 434.28; 42 CFR 483.10; 42 CFR 484.10; 42 CFR 489.10; 42
CFR 489.100; 42 CFR 489.104; 42 CFR 498.3; 42 CFR 417.472; 42 CFR
489.102
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/27/95 60 FR 33262
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas Hoyer
Phone: 410 786-5661
RIN: 0938-AF50
_______________________________________________________________________
1421. CLARIFICATION OF RESUMPTION OF ENTITLEMENT RULES FOR MEDICARE
PATIENTS WITH END-STAGE RENAL DISEASE (BPD-738-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 406.13
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/08/95 60 FR 22533
Final Action Effective 06/07/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul Olenick
Phone: 410 786-4472
RIN: 0938-AG19
_______________________________________________________________________
1422. STANDARDS FOR QUALITY OF WATER USED IN DIALYSIS AND REVISED
GUIDELINES ON REUSE OF HEMODIALYZER FILTERS FOR END-STAGE RENAL DISEASE
PATIENTS (BPD-766-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 405.2140; 42 CFR 405.2150
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 09/18/95 60 FR 48039
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jackie Sheridan
Phone: 410 786-4635
RIN: 0938-AG21
_______________________________________________________________________
1423. COMMUNITY SUPPORTED LIVING ARRANGEMENTS SERVICES (MB-070-P)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 435.3; 42 CFR 435.260; 42 CFR 440.1; 42 CFR
440.190; 42 CFR 441.400; 42 CFR 441.402; 42 CFR 441.404; 42 CFR
441.406; 42 CFR 441.408; 42 CFR 441.410; 42 CFR 441.412; 42 CFR 441.414
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Funding ceased to
exist after 9/30/95 03/20/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Mary Jean Duckett
Phone: 410 786-3294
RIN: 0938-AG35
_______________________________________________________________________
1424. CONDITIONS FOR PAYMENT FOR PHYSICIANS' SERVICES IN TEACHING
SETTINGS (BPD-792-P)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 405; 42 CFR 415; 42 CFR 400
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Combined With RIN 0938-AG96 08/15/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: William Morse
Phone: 410 786-4520
RIN: 0938-AG53
_______________________________________________________________________
1425. DATE FOR FILING MEDICARE COST REPORTS (BPD-794-F)
Priority: Other
CFR Citation: 42 CFR 405.376; 42 CFR 413.24
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/27/95 60 FR 33137
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Katie Walker
Phone: 410 786-7278
RIN: 0938-AG55
_______________________________________________________________________
1426. EXPANSION OF THE DEFINITION OF EYE AND EAR SPECIALTY
HOSPITALS (BPD-804-P)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 413
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Sunset date of
legislation has been reached. 08/16/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Carolyn Mullen
Phone: 410 786-4589
RIN: 0938-AG67
_______________________________________________________________________
1427. CATEGORIZATION OF CLIA TESTS AND PERSONNEL MODIFICATIONS
(HSQ-216-FC)
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
CFR Citation: 42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.45;
42 CFR 493.9; 42 CFR 493.47; 42 CFR 493.18; 42 CFR 493.19; 42 CFR
493.20; 42 CFR 493.49; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 493.37; 42
CFR 493.39; 42 CFR 493.43; ...
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 04/24/95 60 FR 20035
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Judith Yost
Phone: 410 786-3531
RIN: 0938-AG71
_______________________________________________________________________
1428. CRITERIA FOR MEDICARE COVERAGE OF LUNG TRANSPLANTS (BPD-812-
FN)
Priority: Other Significant
CFR Citation: None
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Public comments
received did not require
revisions. 08/10/95
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Claude Mone
Phone: 410 786-5666
RIN: 0938-AG83
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________
1429. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES
Priority: Other Significant
Legal Authority: 42 USC 627; 42 USC 671; 42 USC 1320
CFR Citation: 45 CFR 1355; 45 CFR 1356; 45 CFR 1357
Legal Deadline: NPRM, Statutory, July 1, 1995.
Abstract: This NPRM will propose requirements that implement the
statutory provisions of the Social Security Act Amendments of 1994 on
review of State programs under Parts B and E of the Social Security Act
for conformity with State Plan requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: State
Additional Information: This action was previously reported under RIN
0980-AA08.
Agency Contact: Daniel H. Lewis, Deputy Associate Commissioner,
Children's, Bureau, Adm on Children, Youth & Families, Department of
Health and Human Services, Administration for Children and Families,
P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8594
RIN: 0970-AA97
_______________________________________________________________________
1430. BLOCK GRANT PROGRAMS (LOW INCOME HOME ENERGY ASSISTANCE
PROGRAM --LIHEAP)--FY 1995 AND FY 1996 PROVISIONS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 8621
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: This Notice of Proposed Rulemaking will amend the DHHS block
grant regulations to implement changes to the Low Income Home Energy
Assistance Program (LIHEAP) statute which were made by the Human
Services Amendments of 1994 (Pub. L. 103-252). Several of the
provisions in the new law are self-implementing, but a few require
implementing regulations. The major provisions requiring implementing
regulations are: (1) Inclusion of new Assurance 16, to require grantees
to submit as a part of their annual application a description of their
``self-sufficiency'' activities and to submit a report to DHHS on the
effect of these activities; (2) Inclusion of allowable uses of DOE
rules for weatherization services provided with LIHEAP funds; (3)
Inclusion for requirements for submission of data on households served.
In addition, other related amendments to the regulations will be
included, concerning the following issues: (1) Consideration of
different weighting of factors under the allocation formula for the
leveraging incentive program; (2) Hearing requirements for audit
disallowances; and (3) Allotments for territories. requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/96
Small Entities Affected: None
Government Levels Affected: State, Tribal
Agency Contact: Janet M. Fox, Director, Division of Energy Assistance,
Office of Community Services, Department of Health and Human Services,
Administration for Children and Families, 370 L'Enfant Promenade SW.,
Washington, DC 20447
Phone: 202 401-9351
RIN: 0970-AB47
_______________________________________________________________________
1431. ADMINISTRATIVE FLEXIBILITY RULE
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 205.31
Legal Deadline: None
Abstract: This proposed rule adds a new section 205.31 which will
provide a simple administrative process for requesting waivers of
certain AFDC regulatory provisions. Such waivers will give States more
flexibility to devise procedures for the effective and efficient
administration of their AFDC programs. The major provisions for which
waivers will be granted are: (1) the requirements for prospective
budgeting of income; (2) the time period for calculating the total
amount of overpayment and the determination of when the initial
overpayment begins; and (3) other provisions on various disregards and
self-employment business expenses.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Mack Storrs, Director, Division of AFDC Program,
Department of Health and Human Services, Administration for Children
and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9289
RIN: 0970-AB49
_______________________________________________________________________
1432. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL
CHILDREN
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 9801
CFR Citation: 45 CFR 1302
Legal Deadline: None
Abstract: This NPRM will specify a process by which an Indian tribe may
identify and establish an alternative agency to provide Head Start
Services if the agency previously serving the tribe is terminated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/96
Small Entities Affected: Organizations
Government Levels Affected: Tribal
Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head
Start Bureau, Department of Health and Human Services, Administration
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569
RIN: 0970-AB52
_______________________________________________________________________
1433. CONSTRUCTION OF HEAD START FACILITIES
Priority: Other Significant
Legal Authority: 42 USC 9801
CFR Citation: 45 CFR 1309
Legal Deadline: None
Abstract: This NPRM will establish procedures to be used by Head Start
agencies in requesting to use Head Start grant funds to construct or
renovate a Head Start facility.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/96
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: Local, Tribal
Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head
Start, Bureau, Department of Health and Human Services, Administration
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569
RIN: 0970-AB54
_______________________________________________________________________
1434. QUALITY STANDARDS FOR HEAD START PROGRAMS
Regulatory Plan: This entry is Seq. No. 47 in Part II of this issue of
the Federal Register.
RIN: 0970-AB55
_______________________________________________________________________
1435. HEAD START FELLOWSHIPS PROGRAM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 9801
CFR Citation: 45 CFR 1311
Legal Deadline: None
Abstract: This NPRM will establish the policies and procedures to be
used in selecting individuals to be part of the Head Start Fellowship
Program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head
Start Bureau, Department of Health and Human Services, Administration
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569
RIN: 0970-AB56
_______________________________________________________________________
1436. REPORTING OVERDUE SUPPORT INFORMATION TO CONSUMER REPORTING
AGENCIES
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: PL 103-432
CFR Citation: 45 CFR 302; 45 CFR 303
Legal Deadline: None
Abstract: This rule contains provisions regarding required State laws
for reporting information concerning unpaid child support obligations
to consumer reporting agencies. These provisions implement the
requirements of section 212 of the Social Security Act Amendments of
1994, which amend title IV-D of the Social Security Act. These
provisions require States to adopt procedures for periodic reporting of
information to consumer reporting agencies. This regulatory package
will also include technical changes to other child support regulations
to support the President's Regulatory reinvention initiative.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/95
Interim Final Rule 10/00/96
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: State, Local
Agency Contact: Marianne Upton, Branch Chief, Policy Division, Office
of Child Support Enforcement, Department of Health and Human Services,
Administration for Children and Families, 370 L'Enfant Promenade SW.,
Washington, DC 20447
Phone: 202 401-5373
RIN: 0970-AB57
_______________________________________________________________________
1437. ON-SITE FOSTER CARE ELIGIBILITY REVIEWS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 1356
Legal Deadline: None
Abstract: This NPRM will propose requirements that govern on-site
eligibility reviews that the Administration for Children and Families
conducts to assure State agencies' compliance with the statutory
requirements under Title IV-E of the Social Security Act for
eligibility of foster care providers and eligibility of the children in
foster care.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/96
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Daniel H. Lewis, Deputy Associate, Commissioner,
Children's Bureau, Department of Health and Human Services,
Administration for Children and Families, P.O. Box 1182, Washington, DC
20013
Phone: 202 205-8594
RIN: 0970-AB60
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________
1438. AMENDMENTS TO DEVELOPMENTAL DISABILITIES RULES
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 6000 et seq
CFR Citation: 45 CFR 1385; 45 CFR 1386; 45 CFR 1387; 45 CFR 1388
Legal Deadline: Final, Statutory, April 29, 1991.
Final, Statutory, October 3, 1994.
Abstract: This rule updates current rules with clarifications and new
requirements to implement recent changes in the Developmental
Disabilities Assistance and Bill of Rights Act Amendments of 1990 (Pub.
L. 101-496) and 1994 (Pub. L. 103-230).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/18/95 60 FR 26774
Final Action 05/00/96
Small Entities Affected: None
Government Levels Affected: State
Additional Information: This action was previously reported under RIN
0980-AA48.
Agency Contact: John Doyle, Director, Administration and Planning
Staff, Administration on Developmental Disabilities, Department of
Health and Human Services, Administration for Children and Families,
200 Independence Avenue SW., Room 315D, Washington, DC 20201
Phone: 202 690-5504
RIN: 0970-AB11
_______________________________________________________________________
1439. FAMILY VIOLENCE PREVENTION AND SERVICES
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 10407
CFR Citation: 45 CFR 1370
Legal Deadline: NPRM, Statutory, August 26, 1992. Final, Statutory,
September 25, 1992.
Abstract: Would implement the requirements under the Family Violence
Prevention and Services Act which provides various grants related to
domestic violence.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/10/93 58 FR 64920
Final Action 12/00/95
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Local
Agency Contact: Margaret Washnitzer, Director, Division of State
Assistance, Office of Community Services, Department of Health and
Human Services, Administration for Children and Families, 370 L'Enfant
Promenade SW., Washington, DC 20447
Phone: 202 401-2333
RIN: 0970-AB18
_______________________________________________________________________
1440. CHILD ABUSE AND NEGLECT STATE GRANT PROGRAM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 5101
CFR Citation: 45 CFR 1340
Legal Deadline: None
Abstract: The primary purpose of this rule is to revise existing
regulations at 45 CFR 1340 in order to implement recent amendments to
the Child Abuse Prevention and Treatment Act with respect to
confidentiality requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/18/94 59 FR 26046
Final Action 02/00/96
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Emily Cooke, Acting, Director, National Center on
Child, Abuse and Neglect, Department of Health and Human Services,
Administration for Children and Families, P.O. Box 1182, Washington, DC
20013
Phone: 202 205-8586
RIN: 0970-AB23
_______________________________________________________________________
1441. STANDARDS FOR SAFE TRANSPORTATION
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 9801 et seq
CFR Citation: 45 CFR 1310
Legal Deadline: None
Abstract: This rule establishes Head Start Performance Standards for
the safe transportation of Head Start children, including vehicle
requirements, driver qualifications and training and safety rules for
children and staff while enroute and loading and unloading of vehicles.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/15/95 60 FR 31612
Final Action 06/00/96
Small Entities Affected: Organizations
Government Levels Affected: None
Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head
Start Bureau, Department of Health and Human Services, Administration
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569
RIN: 0970-AB24
_______________________________________________________________________
1442. STANDARDS FOR PURCHASE OF FACILITIES
Priority: Other Significant
Legal Authority: 42 USC 9801 et seq
CFR Citation: 45 CFR 1309
Legal Deadline: None
Abstract: This regulation established standards for the purchase of
facilities as required by the Head Start Improvement Act of 1992.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/01/94 59 FR 61575
Final Action 01/00/96
Small Entities Affected: Organizations
Government Levels Affected: None
Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head
Start Bureau, Department of Health and Human Services, Administration
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569
RIN: 0970-AB31
_______________________________________________________________________
1443. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING
PUBLIC ASSISTANCE AGENCIES
Priority: Other Significant
Legal Authority: PL 103-31
CFR Citation: 45 CFR 205.50 (a)(4); 45 CFR 206.10; 42 CFR 431.307 (a);
42 CFR 431.307 (b)
Legal Deadline: None
Abstract: Incorporates general guidance for public assistance agencies
regarding registration procedures to be carried out by State Public
Assistance offices. It removes former prohibitions from distributing
such materials in these offices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/22/94 59 FR 60109
Final Action 12/00/95
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: State, Local
Agency Contact: Mack Storrs, Director, Division of AFDC Program,
Department of Health and Human Services, Administration for Children
and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9289
RIN: 0970-AB32
_______________________________________________________________________
1444. CHILD CARE--REVISED REGULATIONS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 98.255; 45 CFR 98.256; 45 CFR 98.257
Legal Deadline: None
Abstract: The Administration for Children and Families will amend
existing regulations which govern the administration of child care
programs under Title IV-A of the Social Security Act (AFDC Child Care,
Transitional Child Care, At-Risk Child Care) and the Child Care and
Development Block Grant. Based on recent legislative changes, as well
as comments from state and tribal program administrators, child care
advocates and other interested parties, we are examining a number of
specific regulatory provisions. The purpose of this regulatory package
will be to implement legislative changes, reduce program differences,
and promote better program coordination. We do not expect these changes
to result in significant program costs; administrative savings may
result.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/11/94 59 FR 24510
Final Action 02/00/96
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Olivia M. Golden, Commissioner, Administration on
Children, Youth and Families, Department of Health and Human Services,
Administration for Children and Families, P.O. Box 1182, Washington, DC
20013
Phone: 202 205-8572
RIN: 0970-AB33
_______________________________________________________________________
1445. FAMILY PRESERVATION AND SUPPORT
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 430 to 435
CFR Citation: 45 CFR 1355; 45 CFR 1356; 45 CFR 1357
Legal Deadline: None
Abstract: This rule will amend the requirements under title IV-B
subpart 1 for the Child and Family Services State plan and set forth
the requirements the State must adhere to in the development and
submission of its comprehensive five year plan under title IV-B,
subpart 2, family preservation and support services. The submission of
this jointly developed plan is required in order to receive both child
and family services funds under subpart 1 and family preservation and
support services funds under subpart 2 for fiscal years 1995 and
following.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/04/94 59 FR 50646
Final Action 01/00/96
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: State, Tribal
Agency Contact: Daniel H. Lewis, Deputy Associate Commissioner,
Children's Bureau, ACYF, Department of Health and Human Services,
Administration for Children and Families, P.O. Box 1182, Washington, DC
20013
Phone: 202 205-8618
RIN: 0970-AB34
_______________________________________________________________________
1446. ADMINISTRATION OF NATIVE AMERICANS 45 CFR PART 1336
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 2991
CFR Citation: 45 CFR 1336
Legal Deadline: None
Abstract: This regulation amends 45 CFR part 1336 to implement
legislative requirements. It will incorporate an appeals procedure
affording applicants the opportunity to appeal based on organizational
ineligibility or activities deemed ineligible, when determined by the
ANA Commissioner. Native American organizations are expected to welcome
these changes which provide for an appeal of appeals decisions and
comport with amendments to the statute.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/21/95 60 FR 19994
Final Action 11/00/95
Small Entities Affected: Organizations
Government Levels Affected: Tribal
Agency Contact: Sharon McCully, Director, Planning and Support,
Department of Health and Human Services, Administration for Children
and Families, 200 Independence Ave SW., Washington, DC 20201
Phone: 020 690-5780
RIN: 0970-AB37
_______________________________________________________________________
1447. REDUCTION OF REPORTING REQUIREMENTS FOR THE STATE SYSTEMS
ADVANCE PLANNING DOCUMENT (APD) PROCESS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 95.600
Legal Deadline: None
Abstract: These rules decrease the reporting burden on States and
increase their flexibility within the State systems APD process by
increasing the threshold under which APDs and related procurement
documents need not be submitted for Federal approval. Additionally,
States will no longer be required to submit biennial security plans for
Federal review and approval.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/21/95 60 FR 7858
Final Action 07/00/96
Small Entities Affected: Undetermined
Government Levels Affected: None
Procurement: This is a procurement-related action for which there is a
statutory requirement. There is no paperwork burden associated with
this action.
Agency Contact: Bill Davis, Management Analyst, Department of Health
and Human Services, Administration for Children and Families, 370
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-6404
RIN: 0970-AB46
_______________________________________________________________________
1448. INCOME AND RESOURCE DISREGARDS RELATED TO INTERESTS OF
INDIVIDUAL INDIANS IN TRUST OR RESTRICTED LANDS
Priority: Substantive, Nonsignificant
Legal Authority: PL 103-66
CFR Citation: 45 CFR 233
Legal Deadline: None
Abstract: These rules incorporate statutory disregards in the AFDC
program and the Adult Assistance programs in Guam, Puerto Rico and the
Virgin Islands. The first provides that up to $2,000 per year of income
derived from interests of individual Indians in trust or restricted
lands shall not be considered in determining assistance. The second is
a provision requiring that interests of individual Indians in trust or
restricted lands shall not be considered a resource in determining
eligibility for assistance.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/25/94 59 FR 51536
Final Action 02/00/96
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Mack A. Storrs, Director, Division of AFDC Program,
Office of Family Assistance, Department of Health and Human Services,
Administration for Children and Families, 370 L'Enfant Promenade SW.,
Washington, DC 20447
Phone: 202 401-9289
RIN: 0970-AB59
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Administration for Children and Families (ACF)
_______________________________________________________________________
1449. INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES
Priority: Substantive, Nonsignificant
Legal Authority: 45 USC 9801
CFR Citation: 45 CFR 1305
Legal Deadline: None
Abstract: This NPRM will revise the income eligibility criteria used in
enrolling Head Start children and families to allow Indian tribes, in
certain situations, to enroll more children whose families do not meet
Head Start's income criteria than would otherwise be possible.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/96
Small Entities Affected: Organizations
Government Levels Affected: Tribal
Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head
Start Bureau, Department of Health and Human Services, Administration
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569
RIN: 0970-AB53
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Administration for Children and Families (ACF)
_______________________________________________________________________
1450. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE
PROGRAM --LIHEAP) FY 91 AND FY 92 PROVISIONS
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 96
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/01/95 60 FR 21322
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Janet M. Fox
Phone: 202 401-9351
RIN: 0970-AB15
_______________________________________________________________________
1451. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE
PROGRAM--LIHEAP)--FY 93 AND FY 94 PROVISIONS
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 96
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Responsibility is
transferred to ASPE. 10/01/95
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Janet M. Fox
Phone: 202 401-9351
RIN: 0970-AB16
_______________________________________________________________________
1452. STATEWIDE AUTOMATED CHILD WELFARE INFORMATION SYSTEM
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 1355; 45 CFR 1356
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/19/95 60 FR 26829
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Naomi B. Marr
Phone: 202 401-6960
RIN: 0970-AB38
_______________________________________________________________________
1453. REFUGEE RESETTLEMENT PROGRAM: MISCELLANEOUS, COMPREHENSIVE
CHANGES
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
CFR Citation: 45 CFR 400
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/28/95 60 FR 33617
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Toyo A. Biddle
Phone: 202 401-9250
RIN: 0970-AB42
_______________________________________________________________________
1454. DIRECT PAYMENTS TO INDIAN TRIBES AND TRIBAL ORGANIZATIONS
UNDER TITLE IV-B, SUBPART 1
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 1357.40
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/22/95 60 FR 28735
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: State, Tribal
Agency Contact: Michael Ambrose
Phone: 202 205-8618
RIN: 0970-AB44
_______________________________________________________________________
1455. REPATRIATION - ADVANCE APPROVAL OF COSTS
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 212
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 04/21/95 60 FR 19862
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: David B. Smith
Phone: 202 401-9255
RIN: 0970-AB45
_______________________________________________________________________
1456. AFCARS DATA ELEMENT ON FOSTER CARE PAYMENTS
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 1355
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/09/95 60 FR 40505
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Daniel H. Lewis
Phone: 202 205-8619
RIN: 0970-AB58
_______________________________________________________________________
1457. REMOVAL OF KEYS AMENDMENT REGULATIONS
Priority: Routine and Frequent
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 1397
Legal Deadline: None
Abstract: Effective March 31, 1995, the Social Security Administration
has responsibility for the Key Amendments as part of the independent
agency legislations. We are eliminating these Deppartmental rules so
that Social Security can proceed with their own regulations and
guidance.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 05/16/95 60 FR 26000
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Madeline Mocko, Director, Office of Legislation and
Budget, Department of Health and Human Services, Administration for
Children and Families, 370 L'enfant Promenade SW., WWashington, DC
20447
Phone: 202 401-9223
RIN: 0970-AB61
_______________________________________________________________________
1458. REMOVAL OF OBSOLETE FAMILY ASSISTANCE REGULATION
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 205; 45 CFR 224; 45 CFR 233; 45 CFR 238; 45 CFR
239; 45 CFR 240; 45 CFR 282
Legal Deadline: None
Abstract: This notice removes several obsolete provisions from the Code
of Federal Regulations. Most involve work program activities which were
superseded when State welfare agencies began their JOBS programs in
1989 and 1990.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 05/17/95 60 FR 26373
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Maneline Mocko, Director, Office of Legislation and
Budget, Department of Health and Human Services, Administration for
Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9223
RIN: 0970-AB62
_______________________________________________________________________
1459. ELIMINATION OF OBSOLETE BLOCK GRANT RULES
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 42 USC 9912
CFR Citation: 45 CFR 1010; 45 CFR 1050; 45 CFR 1060; 45 CFR 1061; 45
CFR 1064; 45 CFR 1067; 45 CFR 1068; 45 CFR 1069; 45 CFR 1070; 45 CFR
1076
Legal Deadline: None
Abstract: This final rule removes a number of obsolete provisions from
the Code of Federal Regulations. These provisions concern program
activities under the former Community Services Administration (CSA)
which were superseded by Community Services Block Grant Act, enacted as
part of the Omnibus Budget Reconciliation Act of 1981.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 05/17/95 60 FR 26374
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Madeline Mocko, Director, Office of Legislation and
Budget, Department of Health and Human Services, Administration for
Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9223
RIN: 0970-AB63
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Administration on Aging (AOA)
_______________________________________________________________________
1460. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, INTRASTATE
FUNDING FORMULAS; TRAINING, RESEARCH AND DISCRETIONARY PROGRAMS;
VULNERABLE ELDER RIGHTS; AND GRANTS TO INDIANS & NATIVE HAWAIIANS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: PL 102-375, sec 202(a)(10); PL 102-375, sec
202(a)(14); PL 102-375, sec 305(a); PL 102-375, sec 305(a)(1); PL 102-
375, sec 305(a)(2)(c); PL 102-375, sec 305(a)(2); PL 102-375, sec
305(a)(2)(D); PL 102-375, sec 305(a)(1)(E); PL 102-375, sec
305(a)(2)(E); PL 102-375, secs 305(d)(1) to 305(d)(4); PL 102-375, sec
305(a)(A)(i); PL 102-375, sec 306(a)(6)(O)(i); PL 102-375, sec
306(a)(13); PL 102-375, sec 307(a)(1); PL 102-375, sec 307(a)(C)(i)
CFR Citation: 45 CFR 1321; 45 CFR 1324; 45 CFR 1326; 45 CFR 1327; 45
CFR 1328
Legal Deadline: None
Unknown until law is reauthorized.
Abstract: The Administration on Aging (AoA) anticipates revising
current rules to reflect the changes resulting from the pending
reauthorization of the Older Americans Act which incorporates greater
flexibility for the States. PURPOSE: The purpose of these revisions are
to implement the newly enacted law. in the development and provision of
community-based services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Elder Rights Protection NPRM 11/15/94 (59 FR 59056) NPRM Comment
Period End 01/17/95 (59 FR 59056)
Intrastate Funding Formulas NPRM 10/17/94 (59 FR 12728) Final Action
08/01/95
OAA Amdendments in FY '96 NPRM 08/01/96
Next Action Undetermined
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State, Tribal
Agency Contact: Edwin Walker, Director, Office of Program Development
and Operations, Department of Health and Human Services, Administration
on Aging, 330 Independence Avenue SW., Room 4733, Cohen Bldg.,
Washington, DC 20201
Phone: 202 619-0011
RIN: 0985-AA00
[FR Doc. 95-26777 Filed 11-24-95; 8:45 am]
BILLING CODE 4150-04-F