[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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
20 CFR Ch. III
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 April 25, 1994.
FOR FURTHER INFORMATION CONTACT: For further inquiries or comments
related to specific regulations listed in the agenda, the public is
encouraged to contact the appropriate responsible individual. Questions
or comments on the overall agenda should be sent to: Ann White,
Regulations Coordinator, Office of the Secretary, Department of Health
and Human Services, 200 Independence Avenue SW., Washington, DC 20201;
telephone: (202) 690-6824.
SUPPLEMENTARY INFORMATION:
Department of Health and Human Services Regulatory Plan
For this edition of the Department of Health and Human
Services' 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.
Health Care Financing Administration
Please note that many of the Health Care Financing
Administration entries use acronyms and public law citations that
refer to popular titles of well-known laws. As an aid to readers,
we offer the following cross-reference guide:
COBRA '85--Consolidated Omnibus Budget Reconciliation Act of
1985 (PL 99-272).
OBRA '86--Omnibus Budget Reconciliation Act of 1986 (PL 99-
509).
OBRA '87--Omnibus Budget Reconciliation Act of 1987 (PL 100-
93).
MCAA '88--Medicare Catastrophic Coverage Act of 1988 (PL 100-
360).
FSA '88--Family Support Act of 1988 (PL 100-485).
CLIA '88--Clinical Laboratory Improvement Amendments of 1988
(PL 100-578).
TMRA '88--Technical and Miscellaneous Revenue Act of 1988 (PL
100-647).
OBRA '89--Omnibus Budget Reconciliation Act of 1989 (PL 101-
239).
OBRA '90--Omnibus Budget Reconciliation Act of 1990 (PL 101-
508).
OBRA '93--Omnibus Budget Reconciliation Act of 1993 (PL 103-
66).
Jacquelyn Y. White,
Deputy Executive Secretary to the Department.
Office of the Secretary--Proposed Rule Stage
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1339 Nondiscrimination Requirements (Including on the Basis of Sex or Religion) Applicable
to Block Grants and Standard Nondiscrimination Procedures Applicable to Certain Other
Programs.............................................................................. 0991-AA02
1340 Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans........... 0991-AA45
1341 Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental
Policies.............................................................................. 0991-AA53
1342 Amendment to Grants Management Common Rule To Raise Threshold for Simplified Small
Purchases............................................................................. 0991-AA77
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Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1343 Civil Money Penalties and Exclusions for Assistants at Cataract Surgery............... 0991-AA37
1344 Block Grant Programs.................................................................. 0991-AA55
1345 Uniform Administrative Requirements for Grants and Cooperative Agreements............. 0991-AA56
1346 Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care
Entities.............................................................................. 0991-AA65
1347 Additional Safe Harbor Provisions Under the Anti-Kickback Statute..................... 0991-AA66
1348 Safe Harbors for Protecting Health Plans.............................................. 0991-AA69
1349 Governmentwide Guidance for New Restrictions on Lobbying; Interim Final Guidance...... 0991-AA70
1350 Revisions to the PRO Sanctions Process................................................ 0991-AA73
1351 Clarification of the OIG Safe Harbor Anti-Kickback Provisions......................... 0991-AA74
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Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1352 Civil Money Penalties and Intermediate Sanctions for HMOs and Competitive Medical
Plans................................................................................. 0991-AA44
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Departmental Management--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1353 Implementation of the Equal Access to Justice Act in Agency Proceedings............... 0990-AA02
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Social Security Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1354 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Adjustments in SSI Benefits on Account of Retroactive Benefits Under Title
II (061P)............................................................................. 0960-AB38
1355 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Evaluation Guides for Determining Substantial Gainful Activity (SGA) (147P). 0960-AB73
1356 Old-Age, Survivors, and Disability Insurance Program; Nonpayment of Benefits to
Prisoners, Vocational Rehabilitation Exception (166P)................................. 0960-AC16
1357 Old-Age, Survivors and Disability Insurance and Supplemental Security Income Programs;
Vocational Factors Regulations Restructuring and Clarification (207P)................. 0960-AC61
1358 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Interim Disability Benefits (215P).......................................... 0960-AC76
1359 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Appeals Council Notice Requirements (235P).................................. 0960-AC93
1360 Supplemental Security Income Program; Augmented Benefits (271P)....................... 0960-AD07
1361 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Fees for Representation of Claimants (296P)................ 0960-AD23
1362 OASDI and SSI for the Aged, Blind and Disabled; Continuation of Benefits on Account of
Participation in a Non-State VR Program (299P)........................................ 0960-AD26
1363 Supplemental Security Income for the Aged, Blind, and Disabled; Exclusion From Income
and Resources of Victims' Compensation Payments and State Relocation Assistance (311F) 0960-AD36
1364 Supplemental Security Income for the Aged, Blind, and Disabled; Reimbursement for VR
Services Furnished During Certain Months of Non-payment (315P)........................ 0960-AD39
1365 Code of Conduct for Administrative Law Judges and Administrative Appeals Judges of the
Social Security Administration (341P)................................................. 0960-AD54
1366 Election of Benefits Based on Age by Disabled Widow, Widower, and Surviving Divorced
Spouse Beneficiaries (343P)........................................................... 0960-AD56
1367 Against Equity and Good Conscience (348P)............................................. 0960-AD62
1368 Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for
Determination of Disability; Hemic and Lymphatic System, and Malignant Neoplastic
Diseases (399P) (Reg Plan Seq. No. 33)................................................ 0960-AD67
1369 Procedures for Handling Earnings Reports (418F)....................................... 0960-AD70
1370 Conduct of Representatives Under Title II or Title XVI (431P)......................... 0960-AD73
1371 Statement of Earnings and Benefit Estimate (415P)..................................... 0960-AD74
1372 Fees for Federal Administration of State Supplementary Payments in the SSI Program
(376P)................................................................................ 0960-AD75
1373 Who May Protect a Potential Claimant's Filing Date or Application for Supplemental
Security Income Benefits (408P)....................................................... 0960-AD76
1374 Reliable Information Which is Currently Available for Determining Benefit Amounts in
the Supplemental Security Income Program (NEWMAN) (434P).............................. 0960-AD77
1375 Revised Medical Criteria for Determination of Disability, Endocrine System and Obesity
and Related Criteria (436P) (Reg Plan Seq. No. 34).................................... 0960-AD78
1376 Revised Medical Criteria for Determination of Disability, Growth Impairments (444P)
(Reg Plan Seq. No. 35)................................................................ 0960-AD80
1377 Valuation of Certain In-Kind Support and Maintenance (ISM) Where There is a Cost-of-
Living Adjustment in SSI Benefits (454P).............................................. 0960-AD82
1378 Relationship/Coverage Actions Note Initial Determinations/SSI Corrections (455P)...... 0960-AD83
1379 Prevention of Adverse Effects on Eligibility and Benefit Amount When Spouse or Parent
Absent Due to Active Military Service (462P).......................................... 0960-AD86
1380 Extension of Time Period for Not Counting as Resources, Funds Received for Repair or
Replacement of Damaged or Destroyed Excluded Resources in the SSI Program (486P)...... 0960-AD87
1381 Federal OASDI and SSI for the Aged, Blind, and Disabled; Signature Requirements for
State Agency Medical and Psychological Consultants in Disability Determinations (465P) 0960-AD88
1382 Federal Old-Age, Survivors, and Disability Insurance and Supplemental Security Income,
Acceptable Medical Sources (469P)..................................................... 0960-AD91
1383 Old-Age, Survivors, and Disability Insurance Program; Contributions for Support (475P) 0960-AD92
1384 Computation of SSI Benefits for the First Three Months of Payment (476P).............. 0960-AD93
1385 Definition of ``Largest Benefit Amount'' for Purposes of Determining the Earnings
Record on Which a Person Who Is Simultaneously Entitled to Child's Insurance Benefits
(481P)................................................................................ 0960-AD95
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References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Social Security Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1386 Supplemental Security Income Program; Suspensions, Terminations, and Advance Notice of
Adverse Determinations (031F)......................................................... 0960-AA22
1387 Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for
Determination of Disability; Musculoskeletal System (143F) (Reg Plan Seq. No. 36)..... 0960-AB01
1388 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income Program;
Continued Payment of Benefits to Persons in Vocational Rehabilitation Programs (131F). 0960-AB05
1389 Supplemental Security Income Program; Proceeds of a Loan, Payment of Pro Rata Share of
Household Operating Expenses (180F)................................................... 0960-AC42
1390 Old-Age, Survivors, and Disability Insurance Program; Applicability of Government
Pension to Certain Federal Employees (188F)........................................... 0960-AC46
1391 Supplemental Security Income Program; Continuation of Full Benefit Standard for
Certain Persons Temporarily Institutionalized (198F).................................. 0960-AC55
1392 Old-Age, Survivors, and Disability Insurance Program; Medical Criteria for Evaluating
Mental Disorders for Adults (222F) (Reg Plan Seq. No. 37)............................. 0960-AC74
1393 Supplemental Security Income Program; Treatment of Augmented Veterans' Benefits (231F) 0960-AC82
1394 Supplemental Security Income Program; Waiver of SSI Rule for Deeming to Children the
Income and Resources of Their Parents for Certain Disabled Children (252F)............ 0960-AC96
1395 SSI Program; Reduction in Time When Income and Resources of Separated Couples Must Be
Treated as Jointly Available for Purposes of SSI Eligibility and Benefits (254F)...... 0960-AC98
1396 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Updating Nomenclature (264F)............................... 0960-AD11
1397 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the
Aged, Blind, and Disabled; Representative Payee Reforms (295F) (Reg Plan Seq. No. 38). 0960-AD22
1398 Organization and Procedures; Procedures of the Office of Hearings and Appeals;
Authority of Appeals Officers to Deny a Request for Appeals Council Review (334F)..... 0960-AD45
1399 OASDI and SSI; Testing Modifications to the Disability Determination Procedures (359F)
(Reg Plan Seq. No. 39)................................................................ 0960-AD63
1400 Reliable Information Which Is Currently Available for Determining Benefit Amounts in
the Supplemental Security Income Program (382F)....................................... 0960-AD65
1401 Compensation of Qualified Organizations Serving as Representative Payees Under Title
II and Title XVI (423F)............................................................... 0960-AD71
1402 Federal OASDI and SSI; Computing Benefit Amounts, Disposing of Underpayments,
Resolving Overpayments, and Payment Restriction (428F)................................ 0960-AD72
1403 Federal Old-Age, Survivors, and Disability Insurance; Evidence Required to Presume a
Person Is Dead (443F)................................................................. 0960-AD79
1404 Temporary Increase in Sponsorship Period for Aliens Under the SSI Program (457F)...... 0960-AD84
1405 Replacement of Lost, Damaged or Stolen Excluded Resources (Hurricane Andrew) (458I)... 0960-AD85
1406 Technical Changes to Title XVI (466F)................................................. 0960-AD89
1407 Supplemental Security Income for the Aged, Blind or Disabled; Evidence of Lawful
Admission for Permanent Residence in the United States (486F)......................... 0960-AD90
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Social Security Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1408 Supplemental Security Income Program; What Is Not Income (121F)....................... 0960-AB09
1409 Supplemental Security Income Program; Continuation of Benefits and Special Eligibility
for Certain Severely Impaired Recipients Who Work (171F).............................. 0960-AC22
1410 Old-Age, Survivors, and Disability Insurance and Supplemental Security Income
Programs; Deemed Application Date Based on Misinformation (267F)...................... 0960-AD05
1411 Supplemental Security Income Program; Financial Institution Accounts in the SSI
Program (278F)........................................................................ 0960-AD10
1412 Supplemental Security Income for the Aged, Blind, and Disabled; Treatment of Certain
Royalties and Honoraria (310F)........................................................ 0960-AD35
1413 Supplemental Security Income Program; Treatment of Promissory Notes in Home
Replacement Situations (182F)......................................................... 0960-AD61
1414 Appeal Rights Following State-Initiated Mass Change in Federally Administered State
Supplementary Payments Resulting in Reduction, Suspension, or Termination of State
Supplementary Payments (383F)......................................................... 0960-AD66
1415 Eligibility for Children of Armed Forces Personnel Residing Outside the United States
Other Than in Foreign Countries (452F)................................................ 0960-AD81
1416 Federal Old-Age, Survivors and Disability Insurance; Determining Disability and
Blindness; Extension of Expiration Date for the Listing of Impairments, Mental
Disorders in Adults (477F)............................................................ 0960-AD94
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Public Health Service--Office of Assistant Secretary for Health (OASH)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1417 Public Health Service Policies on Research Misconduct................................. 0905-AE02
1418 Standards of Compliance for Abortion-Related Services in Family Planning Service
Projects.............................................................................. 0905-AE03
----------------------------------------------------------------------------------------------------------------
Public Health Service--Office of Assistant Secretary for Health (OASH)--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1419 Privacy Act; Exempt System............................................................ 0905-AD31
----------------------------------------------------------------------------------------------------------------
Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1420 Confidentiality of Substance Abuse Patient Records.................................... 0905-AD97
1421 Protection and Advocacy for Individuals With Mental Illness........................... 0905-AD99
1422 Community Mental Health Services Block Grants......................................... 0905-AE24
----------------------------------------------------------------------------------------------------------------
Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1423 Block Grants for Prevention and Treatment of Substance Abuse.......................... 0905-AD98
1424 Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions) (Reg
Plan Seq. No. 45)..................................................................... 0905-AE05
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Public Health Service--Centers for Disease Control and Prevention (CDC)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1425 Respiratory Protective Devices (Reg Plan Seq. No. 46)................................. 0905-AB58
1426 Interstate Shipment of Biological Material That Contains or May Contain Infectious
Substances............................................................................ 0905-AC89
1427 Medical Examination of Aliens......................................................... 0905-AD29
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Public Health Service--Food and Drug Administration (FDA)--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1428 Medical Foods......................................................................... 0905-AD91
1429 Sunglasses; Labeling; Ultraviolet Radiation........................................... 0905-AE35
1430 Investigational Device Exemption: Cost Recovery....................................... 0905-AE36
1431 Development of Hazard Analysis Critical Control Points for the Food Industry; Request
for Comments (Reg Plan Seq. No. 40)................................................... 0905-AE60
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Public Health Service--Food and Drug Administration (FDA)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1432 Over-the-Counter (OTC) Drug Review.................................................... 0905-AA06
1433 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug
and Patent Term Restoration Act....................................................... 0905-AA96
1434 Infant Formula Act.................................................................... 0905-AC46
1435 Reporting of Errors and Accidents Relating to Blood Safety and Withdrawal of
Previously Proposed Rule.............................................................. 0905-AD67
1436 Proposed Labeling for Drug Products Based on False or Fraudulent Data................. 0905-AD71
1437 Review of Warnings, Use Instructions, and Precautionary Information Under Section 314
of the National Childhood Vaccine Injury Act of 1986.................................. 0905-AD72
1438 Performance Standard for the Infant Apnea Monitor..................................... 0905-AD83
1439 Mammography Quality Standards Act of 1992 (Reg Plan Seq. No. 41)...................... 0905-AE19
1440 Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of
Drugs Composed Wholly or Partly of Insulin............................................ 0905-AE28
1441 Adverse Experience Reporting Requirements for Human Drug and Licensed Biological
Products.............................................................................. 0905-AE29
1442 Electronic Signatures................................................................. 0905-AE31
1443 Financial Disclosure by Clinical Investigators........................................ 0905-AE32
1444 Effective Date of Requirement for Submission of Premarket Approval Applications....... 0905-AE34
1445 Latex Condoms/Gloves: Expiration Date Labeling........................................ 0905-AE37
1446 Amalgam Ingredient Labeling........................................................... 0905-AE39
1447 Latex Warning......................................................................... 0905-AE40
1448 Premarket Approval of Medical Devices; Supplemental Applications...................... 0905-AE41
1449 Medical Devices; Restricted Devices................................................... 0905-AE42
1450 Prescription Drug Product Labeling; Medication Guide (Reg Plan Seq. No. 42)........... 0905-AE43
1451 Hearing Aids; Professional and Patient Labeling; Conditions for Sale.................. 0905-AE46
1452 Human Tissue Intended for Transplantation: Proposed Rule.............................. 0905-AE49
1453 Foods Derived from New Plant Varieties; Premarket Notification (Reg Plan Seq. No. 43). 0905-AE50
1454 Classification of Computer Software Programs That Are Medical Devices................. 0905-AE58
1455 Iron Containing Drugs and Supplements................................................. 0905-AE59
1456 New Drug and Biological Product License Applications; Regulations Implementing the
Prescription Drug User Fee Act of 1992 and Clarifying Existing Regulations............ 0905-AE61
1457 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding
of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals..... 0905-AE63
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Public Health Service--Food and Drug Administration (FDA)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1458 Policies Concerning Uses of Sulfiting Agents.......................................... 0905-AB52
1459 Abbreviated New Drug Application Regulations (Title I of the ``Drug Price Competition
and Patent Term Restoration Act of 1984'')............................................ 0905-AB63
1460 Current Good Manufacturing Practice for Blood and Blood Components; Notification of
Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV
Infection............................................................................. 0905-AC90
1461 Lead in Foods......................................................................... 0905-AC91
1462 Expediting Approval for Drugs Intended To Treat Life-Threatening and Severely
Debilitating Illnesses................................................................ 0905-AC94
1463 Fees for Certification Services; Insulin and Color Additive Certification Programs.... 0905-AD34
1464 Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and
Clarifications........................................................................ 0905-AD44
1465 Implementation of the Safe Medical Devices Act of 1990................................ 0905-AD59
1466 Mandatory HACCP Seafood Inspection Program............................................ 0905-AD60
1467 Bottled Water......................................................................... 0905-AD65
1468 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;
Revision of ``Pediatric Use'' Subsection in the Labeling.............................. 0905-AD76
1469 Recordkeeping and Reporting: Electronic Products...................................... 0905-AD78
1470 General Biological Product Standards; Alternative Procedures and Exceptions........... 0905-AD82
1471 Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket
Notification Procedures and Current Good Manufacturing Practices Regulations.......... 0905-AD84
1472 Threshold of Regulation Policy for Components of Food Contact Articles................ 0905-AD86
1473 Food Labeling Review.................................................................. 0905-AD89
1474 Levo-Alpha-Methadol (LAAM) in Maintenance; Joint Proposed Revision of Conditions for
Use................................................................................... 0905-AD92
1475 Temporomandibular Joint Implant Classification........................................ 0905-AD93
1476 Disqualification of Clinical Investigators............................................ 0905-AD94
1477 Investigational Device Exemption; Intraocular Lenses.................................. 0905-AD95
1478 Dietary Supplement Label Review....................................................... 0905-AD96
1479 Adverse Experience Reporting Required for Licensed Biological Products................ 0905-AE18
1480 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;
Addition of ``Geriatric Use'' Subsection in the Labeling.............................. 0905-AE26
1481 Tamper-Evident Packaging Requirements for Over-The-Counter Human Drug Products........ 0905-AE27
1482 Substances Prohibited for Use in Ruminant Feed........................................ 0905-AE45
----------------------------------------------------------------------------------------------------------------
Public Health Service--Food and Drug Administration (FDA)--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1483 Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act.. 0905-AD15
----------------------------------------------------------------------------------------------------------------
Public Health Service--Health Resources and Services Administration (HRSA)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1484 National Health Service Corps Loan Repayment Program; Grants for State Loan Repayment
Programs.............................................................................. 0905-AC65
1485 Organ Procurement and Transplantation Network Rules (Reg Plan Seq. No. 44)............ 0905-AD26
1486 Health Education Assistance Loan (HEAL) Program: Lenders'/ Holders' Performance
Standards............................................................................. 0905-AD87
1487 National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine
Injury Table - II..................................................................... 0905-AE52
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Public Health Service--Health Resources and Services Administration (HRSA)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1488 National Vaccine Injury Compensation Program (VICP): Revisions to the Vaccine Injury
Table................................................................................. 0905-AD64
1489 Grants for Faculty Training Projects in Geriatric Medicine and Dentistry.............. 0905-AE13
1490 Grants for the Establishment of Departments of Family Medicine........................ 0905-AE17
1491 Medical Facility Construction and Modernization Requirements for Provision of Services
to Persons Unable to Pay (Nursing Homes).............................................. 0905-AE33
1492 National Practitioner Data Bank for Adverse Information on Physicians and Other Health
Care Practitioners: Amendment to Data Bank Regulations To Comply With Court Order..... 0905-AE38
1493 Federally Supported Health Centers Assistance Act of 1992............................. 0905-AE48
1494 National Practitioner Data Bank for Adverse Information on Physicians, Dentists, and
Other Health Care Practitioners: Debt Collection Methods.............................. 0905-AE53
1495 Technical Amendments to the Health Professions, Nursing, and Allied Health Training
Grant Programs Under 42 CFR Parts 57 and 58........................................... 0905-AE54
----------------------------------------------------------------------------------------------------------------
Public Health Service--Health Resources and Services Administration (HRSA)--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1496 Maternal and Child Health (MCH) Project Grants........................................ 0905-AD88
1497 Medical Facility Construction and Modernization; Requirements for Provision of
Services to Persons Unable To Pay (Charitable Facilities)............................. 0905-AE06
1498 Grants for Nurse Practitioner and Nurse-Midwifery Programs............................ 0905-AE11
----------------------------------------------------------------------------------------------------------------
Public Health Service--Indian Health Service (IHS)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1499 Indian Health Service Loan Repayment Program Regulations.............................. 0905-AC96
1500 Indian Health Service Catastrophic Health Emergency Fund Program...................... 0905-AC97
1501 Revision of Urban Indian Health Regulations........................................... 0905-AD20
1502 Acquisition Under the Buy Indian Act.................................................. 0905-AE09
----------------------------------------------------------------------------------------------------------------
Public Health Service--Indian Health Service (IHS)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1503 Revision of Indian Self-Determination Regulations (Reg Plan Seq. No. 47).............. 0905-AC98
1504 Review of the Determination of an Indian Tribe's Resource Deficiency Level............ 0905-AD21
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Public Health Service--National Institutes of Health (NIH)--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1505 Grants for Research Projects.......................................................... 0905-AC02
1506 National Institutes of Health AIDS Research Loan Repayment Program.................... 0905-AD18
1507 Hazardous Substances Basic Research and Training Grants............................... 0905-AD46
1508 National Institutes of Health Construction Grants..................................... 0905-AD49
1509 Standards for Bone Marrow Registries and Centers...................................... 0905-AD51
1510 Training Grants....................................................................... 0905-AD56
1511 National Institutes of Health Center Grants........................................... 0905-AE00
1512 Grants for National Alcohol Research Centers.......................................... 0905-AE08
1513 National Institutes of Health Clinical Research Loan Repayment Program for Individuals
from Disadvantaged Backgrounds........................................................ 0905-AE56
1514 Undergraduate Scholarship Program Regarding Professions Needed by the NIH............. 0905-AE57
1515 Traineeships (Termination Policies)................................................... 0905-AE62
----------------------------------------------------------------------------------------------------------------
Public Health Service--National Institutes of Health (NIH)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1516 Traineeships.......................................................................... 0905-AD28
1517 National Institute of Environmental Health Sciences Hazardous Waste Worker Training... 0905-AD69
1518 Responsibilities of Public Health Service-Funded Institutions for Promoting
Objectivity in Research (Reg Plan Seq. No. 48)........................................ 0905-AE01
1519 National Heart, Lung, and Blood Institute Grants for Prevention and Control Projects.. 0905-AE25
1520 National Library of Medicine Grants................................................... 0905-AE55
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Public Health Service--National Institutes of Health (NIH)--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1521 Health and Human Services Policy for Protection of Human Subjects..................... 0905-AE47
----------------------------------------------------------------------------------------------------------------
Public Health Service--Agency for Health Care Policy and Research (AHCPR)--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1522 Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer
Review of Grants and Contracts........................................................ 0905-AD30
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1523 Hospice Services (MB-7-P)............................................................. 0938-AC52
1524 Transfer of Resources for Less Than Fair Market Value (MB-10-P)....................... 0938-AD18
1525 Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P)............. 0938-AD32
1526 Revisions to the Freedom of Information Regulations (OPA-1-P)......................... 0938-AD60
1527 New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........ 0938-AD82
1528 Fee Schedule for Payment of Clinical Psychologist Services (BPD-495-P)................ 0938-AD84
1529 Clarification of ``Without Fault'' as It Applies to Physician Provider and Supplier
Liability (BPD-719-P)................................................................. 0938-AD95
1530 Protection of Income and Resources for Community Spouse (MB-23-P)..................... 0938-AE12
1531 Physician Certification and Plan of Care Requirements and Inspection of Care Reviews
(HSQ-178-P)........................................................................... 0938-AE17
1532 Medicaid Payment of Medicare Cost Sharing for Qualified Medicare Beneficiaries and
Qualified Disabled and Working Individuals and Specified Low-Income Medicare
Beneficiaries (MB-031-P).............................................................. 0938-AE38
1533 Coverage of Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist
Services (BPD-708-P).................................................................. 0938-AF00
1534 Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)............... 0938-AF28
1535 Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)........................... 0938-AF32
1536 Medicaid Payment for Obstetrical and Pediatric Services--Adequate Payment Level
Provision (MB-036-P).................................................................. 0938-AF62
1537 Clarification of Coverage of Inpatient Psychiatric Services (MB-060-P)................ 0938-AF73
1538 Federally Qualified Health Center Services (Medicaid) (MB-043-P)...................... 0938-AF90
1539 Minimum Physician Qualifications for Certain Services (MB-059-P)...................... 0938-AF92
1540 Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................ 0938-AF97
1541 Conditions of Participation for Rural Health Clinics (BPD-764-P)...................... 0938-AG05
1542 Income and Eligibility Verification System (MB-66-P).................................. 0938-AG12
1543 Medicare Appeals of Individual Claims (BPD-453-P)..................................... 0938-AG18
1544 End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs
(BPD-763-P)........................................................................... 0938-AG20
1545 Appointment of Representatives for Appeal (BPO-120-P)................................. 0938-AG30
1546 Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P).................... 0938-AG31
1547 Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P).......... 0938-AG33
1548 Community Supported Living Arrangements Services (MB-070-P)........................... 0938-AG35
1549 Telephone Requests for Review of Initial Determinations (BPO-121-P)................... 0938-AG48
1550 Conditions for Payment for Physicians' Services in Teaching Settings (BPD-792-P)...... 0938-AG53
1551 New Look Behind for Intermediate Care Facilities for the Mentally Retarded (ICFs/MR)
(HSQ-214-P)........................................................................... 0938-AG58
1552 Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and
Overpayments (HSQ-215-P).............................................................. 0938-AG59
1553 Institutional Plan Amendment Findings (MB-078-P) (Reg Plan Seq. No. 49)............... 0938-AG60
1554 Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-PN)... 0938-AG65
1555 Effects of Generally Accepted Accounting Principles (GAAP) on Reasonable Costs
Determinations (BPD-800-P)............................................................ 0938-AG66
1556 Expansion of the Definition of Eye and Ear Specialty Hospitals (BPD-804-P)............ 0938-AG67
1557 Salary Equivalency Guidelines for Physical and Respiratory Therapy Services Furnished
Under Arrangements (BPD-808-PN)....................................................... 0938-AG70
1558 Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with
Tuberculosis (MB-082-P)............................................................... 0938-AG72
1559 Proposed Payments to Disproportionate Share Hospitals for FY 1995 (MB-089-N).......... 0938-AG75
1560 Revision of Medicare Hospital Conditions of Participation (BPD-745-P) (Reg Plan Seq.
No. 50)............................................................................... 0938-AG79
1561 Physicians' Referrals to Health Care Entities With Which They Have Financial
Relationships--Expanded to Designated Health Services (BPD-809-P) (Reg Plan Seq. No.
51)................................................................................... 0938-AG80
1562 Home Health Agency (HHA) Conditions of Participation (BPD-819-P) (Reg Plan Seq. No.
52)................................................................................... 0938-AG81
1563 End Stage Renal Disease (ESRD) Conditions of Coverage (BPD-818-P) (Reg Plan Seq. No.
53)................................................................................... 0938-AG82
1564 Distinct Parts and Costing for Skilled Nursing Facilities and Nursing Facilities (BPD-
815-P)................................................................................ 0938-AG84
1565 Extension of Certain Effective Dates for Clinical Laboratory Requirements and
Personnel Requirements for Cytologists (HSQ-217-FC)................................... 0938-AG86
1566 Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-FC)........... 0938-AG87
1567 Approval of the American Society for Histocompatibility and Immunogenetics for the
Specialty of Histocompatibility (HSQ-220-N)........................................... 0938-AG88
1568 Medicaid: Coverage of Rehabilitation Services (MB-076-P).............................. 0938-AG89
1569 Medicaid: Nominal Copayments for Institutional Services for Medicaid Recipients (MB-
090-FC)............................................................................... 0938-AG90
1570 Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare
Program (BPD-820-N)................................................................... 0938-AG93
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1571 Payment for Clinical Diagnostic Laboratory Services (BPD-309-F)....................... 0938-AB50
1572 Home and Community-Based Services and Respiratory Care for Ventilator-Dependent
Individuals (MB-8-FC)................................................................. 0938-AC55
1573 Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge
Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-FC)............ 0938-AC58
1574 Denial of Payment for Substandard Quality Care (HSQ-132-F)............................ 0938-AC84
1575 Revised Effective Date of Medicare/Medicaid Provider Agreement and Supplier
Participation (HSQ-139-F)............................................................. 0938-AC88
1576 Changes Concerning Suspension of Medicare Payments and Determinations of Allowable
Interest Expense (BPO-118-FC)......................................................... 0938-AC99
1577 Changes Concerning the Definition of Accrual Basis of Accounting (BPD-366-FC)......... 0938-AD01
1578 Optional Payment System for Low Medicare Volume Skilled Nursing Facilities (BPD-409-F) 0938-AD02
1579 Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to
Health Care Technology (BPD-432-F).................................................... 0938-AD07
1580 Revisions to Conditions of Participation for Hospitals and Conditions for Coverage of
Suppliers of End-Stage Renal Disease Services (BPD-421-F)............................. 0938-AD11
1581 Medicaid Eligibility of Poverty Level Groups and Extended Coverage of Services (MB-13-
F).................................................................................... 0938-AD17
1582 Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F) (Reg Plan Seq.
No. 54)............................................................................... 0938-AD33
1583 Changes to Peer Review Organization Regulations (HSQ-135-F)........................... 0938-AD38
1584 Payment for Durable Medical Equipment and Orthotic and Prosthetic Devices (BPD-494-F). 0938-AD65
1585 Medicare Secondary Payer for Disabled Individuals (BPD-482-FC)........................ 0938-AD73
1586 Medicare Coverage of Home Health Services, Medicare Conditions of Participation and
Home Health Aide Supervision (BPD-469-F).............................................. 0938-AD78
1587 Appeals for Enrollees of Prepaid Health Care Plans (OMC-008-F)........................ 0938-AD79
1588 Omnibus Nursing Home Reform Requirements (BPD-488-FC)................................. 0938-AD81
1589 Survey and Certification of Skilled Nursing Facilities and Nursing Facilities and
Enforcement Procedures (HSQ-156-F) (Reg Plan Seq. No. 55)............................. 0938-AD94
1590 HMO Organizational Structure and Services (OMC-007-F)................................. 0938-AE25
1591 ''Confined to the Home'' Requirements for Home Health Services (BPD-626-F)............ 0938-AE34
1592 Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F).... 0938-AE39
1593 Hospital Standard for HIV Infectious Blood (BPD-633-F)................................ 0938-AE40
1594 Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-202-F) (Reg Plan Seq. No.
56)................................................................................... 0938-AE47
1595 Conditions of Coverage for Organ Procurement Organizations (BPD-646-FC)............... 0938-AE48
1596 Preadmission Screening and Annual Resident Review (BPD-661-F)......................... 0938-AE49
1597 Extended Medicaid Eligibility for Certain Individuals (MB-026-F)...................... 0938-AE51
1598 Resident Assessment in Long-Term Care Facilities (HSQ-180-F).......................... 0938-AE61
1599 Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................ 0938-AE63
1600 Conforming Provisions for 1988 HMO Amendments (OMC-004-F)............................. 0938-AE64
1601 Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)
(Reg Plan Seq. No. 57)................................................................ 0938-AE72
1602 Payment for Nursing and Allied Health Science Education (BPD-685-F)................... 0938-AE79
1603 Uniform Electronic Cost Reporting System for Hospitals (BPD-689-F).................... 0938-AE80
1604 Medicare Coverage of Prescription Drugs Used in Immunosuppressive Therapy (BPD-424-F). 0938-AE94
1605 Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care
Facilities for the Mentally Retarded (BPD-650-F)...................................... 0938-AE97
1606 Coverage of Screening Pap Smears (BPD-705-F).......................................... 0938-AE98
1607 Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social
Worker Services--Medicare (BPD-706-F)................................................. 0938-AE99
1608 Allowing Certifications and Recertifications by Nurse Practitioners and Clinical Nurse
Specialists for Certain Services (BPD-709-F).......................................... 0938-AF01
1609 Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC).................... 0938-AF02
1610 Case Management (MB-27-F)............................................................. 0938-AF07
1611 Medicaid Third Party Liability: Cost Effectiveness Waivers (MB-39-F).................. 0938-AF11
1612 Required Coverage of Nurse Practitioner Services--Medicaid (MB-41-F).................. 0938-AF12
1613 Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F)............. 0938-AF14
1614 OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-FC)............. 0938-AF15
1615 Criteria for the Determination of Reasonable Costs for Medicare --Contracting Prepaid
Health Plans (OMC-006-F).............................................................. 0938-AF16
1616 Physician Ownership of and Referrals to Health Care Facilities That Furnish Clinical
Laboratory Services and Financial Relationship Reporting Requirements (BPD-674-FC)
(Reg Plan Seq. No. 58)................................................................ 0938-AF40
1617 Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-IFC).... 0938-AF42
1618 Medicare and Medicaid Programs; Advance Directives (BPD-718-F)........................ 0938-AF50
1619 Partial Hospitalization Services in Community Mental Health Centers (BPD-736-F)....... 0938-AF53
1620 Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer Based
Group Health Plans (MB-047-F)......................................................... 0938-AF64
1621 Referral to Child Support Enforcement Agencies of Medicaid Families With an Absent
Parent (MB-051-F)..................................................................... 0938-AF68
1622 Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants
and Children (MB-052-IFC)............................................................. 0938-AF69
1623 Optional Spenddown (MB-055-IFC)....................................................... 0938-AF72
1624 Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid
Health Care Organizations (OMC-010-F) (Reg Plan Seq. No. 59).......................... 0938-AF74
1625 National Coverage Decisions: Rules for Risk Contracting HMOs and CMPs (OMC-019-F)..... 0938-AF76
1626 Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or
Services Under Medicare Part B (BPO-105-F)............................................ 0938-AF85
1627 Application of Interest Charges to Medicare Secondary Payer Recoveries (BPO-108-GN)... 0938-AF87
1628 Retroactive Enrollment (OMC-015-F).................................................... 0938-AF98
1629 Payment for Preadmission Services (BPD-731-F)......................................... 0938-AG00
1630 Change in Provider Agreement Regulations Related to Federal Employee Health Benefits
(BPD-748-F)........................................................................... 0938-AG03
1631 Payment for Extracorporeal Shock Wave Lithotripsy Services Furnished by Ambulatory
Surgical Centers (BPD-762-FN)......................................................... 0938-AG04
1632 Intermediary and Carrier Functions (BPO-111-N)........................................ 0938-AG06
1633 Revised Medicaid Management Information Systems (MB-38-FN)............................ 0938-AG10
1634 Revisions to the Definition of End-Stage Renal Disease and Resumption of Entitlement
(BPD-738-F)........................................................................... 0938-AG19
1635 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
1636 Medicare Program: Proposed Additions to and Deletions From the Current List of Covered
Surgical Procedures for Ambulatory Surgical Centers (BPD-776-FN)...................... 0938-AG27
1637 Medicare Program: Special Payment Limits for Home Blood Glucose Monitors (BPD-778-FN). 0938-AG28
1638 General Evaluation Criteria and Standards for Evaluating Performance of Contract (HSQ-
207-GNC).............................................................................. 0938-AG32
1639 Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence
Testing) (BPD-780-FN)................................................................. 0938-AG43
1640 Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure
Breathing Machine Therapy (BPD-781-FN)................................................ 0938-AG44
1641 Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia
(Dry Mouth) (BPD-782-FN).............................................................. 0938-AG45
1642 Part A Premium for 1995 for the Uninsured Aged and for Certain Disabled Individuals
Who Have Exhausted Other Entitlement (OACT-046-N)..................................... 0938-AG49
1643 Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance
Premium Rates Beginning January 1, 1995 (OACT-047-N).................................. 0938-AG50
1644 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance
Amounts for 1995 (OACT-048-N)......................................................... 0938-AG51
1645 Revisions to Geographic Practice Cost Indices, Payment Policies and Adjustments to the
Relative Value Units Under the Physician Fee Schedule for CY 1995 (BPD-789-FC) (Reg
Plan Seq. No. 60)..................................................................... 0938-AG52
1646 Reductions in Payments for HHA Services (BPD-793-NC).................................. 0938-AG54
1647 Date for Filing Medicare Cost Reports (BPD-794-F)..................................... 0938-AG55
1648 Freedom of Choice Waiver; Conforming Changes (OMC-021-F).............................. 0938-AG63
1649 Payment to Swing Bed Hospitals (BPD-805-FC)........................................... 0938-AG68
1650 Physician Performance Standard Rates of Increase for FY 1995 and Physician Fee
Schedule Update for CY 1995 (BPD-807-FNC)............................................. 0938-AG69
1651 Categorization of CLIA Tests and Personnel Modifications (HSQ-216-FC)................. 0938-AG71
1652 Medicaid Program: Nurse-Midwife Services (MB-085-P)................................... 0938-AG73
1653 Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program
(MB-084-NC) (Reg Plan Seq. No. 61).................................................... 0938-AG77
1654 Criteria for Medicare Coverage of Lung Transplants (BPD-812-NC)....................... 0938-AG83
1655 Information, Counseling, and Assistance Grants Programs: Medicare Program (OBS-001-FC) 0938-AG91
1656 Qualified Health Maintenance Organizations: Technical Amendments (OMC-009-FC)......... 0938-AG92
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.
Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1657 Medicaid Eligibility and Coverage Requirements (MB-001-F)............................. 0938-AA58
1658 Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F)......................... 0938-AB07
1659 Home and Community-Based Services for the Elderly (MB-019-F).......................... 0938-AD55
1660 Payment Adjustments for Hospitals That Serve a Disproportionate Number of Low-Income
Patients (MB-017-IFC)................................................................. 0938-AE35
1661 Utilization and Quality Control Peer Review Organizations (PRO): Confidential
Information (HSQ-190-P)............................................................... 0938-AF03
1662 Day Habilitation and Related Services (MB-37-P)....................................... 0938-AF10
1663 Medicare Coverage of Screening Mammography (BPD-724-F)................................ 0938-AF26
1664 Medicare, Medicaid, and CLIA Programs: Inspection and Certification Procedures for
Laboratories (HSQ-193-P).............................................................. 0938-AF33
1665 Medicaid Drug Use Review Program and Electronic Claims Management System for
Outpatient Drug Claims (MB-050-F)..................................................... 0938-AF67
1666 Intermediary and Carrier Checks That Are Lost, Stolen, Defaced, Mutilated, Destroyed,
or Paid on Forged Endorsements (BPO-114-FC)........................................... 0938-AG16
1667 Changes in Physician Attestation Requirements (BPD-769-F)............................. 0938-AG34
1668 Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and
Fiscal Year 1995 Rates (BPD-802-F).................................................... 0938-AG46
1669 Reductions in Payments for SNF Services (BPD-795-NC).................................. 0938-AG56
1670 Limitations on Revisions to Final Administrative Cost Proposals (BPO-122-P)........... 0938-AG57
1671 Required Laboratory Procedures for Rural Health Clinics (BPD-783-F)................... 0938-AG62
1672 Self-Implementing Coverage and Payment Provisions: 1993 Legislation (BPD-791-F)....... 0938-AG64
1673 Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal
Fiscal Year 1994 (MB-088-N)........................................................... 0938-AG74
1674 Small Business Innovation Research Grants for FY 95 (ORD-068-N)....................... 0938-AG76
1675 Medicare and Medicaid Programs; Medicare-Medicaid Coverage Data Bank Requirements:
Preliminary Guidance (BPO-125-N)...................................................... 0938-AG78
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1676 Foster Care, Adoption Assistance, and Child Welfare Services.......................... 0970-AA97
1677 Amendments to Developmental Disabilities Rules........................................ 0970-AB11
1678 Standards for Safe Transportation..................................................... 0970-AB24
1679 Title IV-E Training................................................................... 0970-AB25
1680 Standards for Purchase of Facilities.................................................. 0970-AB31
1681 National Voter Registration Act of 1993 Provisions Affecting Public Assistance
Agencies.............................................................................. 0970-AB32
1682 Family Preservation and Support....................................................... 0970-AB34
1683 Notice of Proposed Rulemaking for the Administration of Native Americans 45 CFR Part
1336.................................................................................. 0970-AB37
1684 Interstate Case Closure............................................................... 0970-AB41
1685 Direct Payments to Indian Tribes and Tribal Organizations under Title IV-B, Subpart 1. 0970-AB44
1686 Repatriation - Advance Approval of Costs.............................................. 0970-AB45
1687 Reduction of Reporting Requirements for the State Systems Advance Planning Document
(APD) Process......................................................................... 0970-AB46
1688 Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and
FY 1996 Provisions.................................................................... 0970-AB47
1689 Automobile Resource Limit (Reg Plan Seq. No. 62)...................................... 0970-AB48
1690 Administrative Flexibility Rule....................................................... 0970-AB49
1691 Head Start Initiative on Families With Infants and Toddlers (Reg Plan Seq. No. 63).... 0970-AB50
1692 Flexibility in the Utilization of Information Obtained through the Income Eligibility
Verification System................................................................... 0970-AB51
1693 Designation of Alternative Agency to Serve Indian Tribal Children..................... 0970-AB52
1694 Income Eligibility Criteria for Indian Tribes......................................... 0970-AB53
1695 Construction of Head Start Facilities................................................. 0970-AB54
1696 Quality Standards for Head Start Programs............................................. 0970-AB55
1697 Head Start Fellowships Program........................................................ 0970-AB56
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1698 Aid to Families With Dependent Children Program; Extension of Medicaid Eligibility
When Support Collections Result in Termination of AFDC Eligibility.................... 0970-AA07
1699 Block Grant Programs (Low-Income Home Energy Assistance Program --LIHEAP) FY 91 and FY
92 Provisions......................................................................... 0970-AB15
1700 Block Grant Programs (Low-Income Home Energy Assistance Program--LIHEAP)--FY 93 and FY
94 Provisions......................................................................... 0970-AB16
1701 Family Violence Prevention and Services............................................... 0970-AB18
1702 Child Abuse and Neglect State Grant Program........................................... 0970-AB23
1703 State Legalization Impact Assistance Grant............................................ 0970-AB28
1704 Child Care--Revised Regulations....................................................... 0970-AB33
1705 Statewide Automated Child Welfare Information System.................................. 0970-AB38
1706 Child Support Enforcement Program: Paternity Establishment and Revision of Child
Support Enforcement Program and Audit Regulations..................................... 0970-AB40
1707 Refugee Resettlement Program: Miscellaneous Changes................................... 0970-AB42
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1708 Revisions of Child Support Enforcement Program and Audit Regulations.................. 0970-AA74
1709 Head Start Performance Standards for Infants, Toddlers, and Pregnant Women............ 0970-AB04
1710 Technical Changes to the AFDC Program as Required by OBRA 90.......................... 0970-AB14
1711 Automatic Data Processing Equipment and Services; Conditions for Federal Financial
Participation and General Administration - Public Assistance Programs................. 0970-AB39
----------------------------------------------------------------------------------------------------------------
Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1712 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)
_______________________________________________________________________
1339. NONDISCRIMINATION REQUIREMENTS (INCLUDING ON THE BASIS OF SEX OR
RELIGION) APPLICABLE TO BLOCK GRANTS AND STANDARD NONDISCRIMINATION
PROCEDURES APPLICABLE TO CERTAIN OTHER PROGRAMS
Legal Authority: 42 USC 9906; 42 USC 300x-7; 42 USC 708; 42 USC 8625;
42 USC 9821; 42 USC 9849; 42 USC 1397; 42 USC 300w-7
CFR Citation: 45 CFR 94
Legal Deadline: None
Abstract: To implement the nondiscrimination requirements applicable to
block grants authorized by the Omnibus Budget Reconciliation Act of
1981, P.L. 97-35, as amended by the Omnibus Budget Reconciliation Act
of 1990, P.L. 101-508.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/21/86 51 FR 2806
NPRM Comment Period End 03/24/86
Second NPRM 11/00/94
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local
Agency Contact: Marcella Haynes, Director, Policy & Special Projects
Staff, Office for Civil Rights, Department of Health and Human
Services, Office of the Secretary, 330 Independence Ave., SW., Rm.
5034, Washington, DC 20201, 202 619-0671
RIN: 0991-AA02
_______________________________________________________________________
1340. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN
INCENTIVE PLANS
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 proposed rule would 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 10/00/94
NPRM Comment Period End 12/00/94
Small Entities Affected: Undetermined
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, 202
619-3270
RIN: 0991-AA45
_______________________________________________________________________
1341. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO
MEDICARE SUPPLEMENTAL POLICIES
Legal Authority: PL 100-360, Sec 428(b); PL 101-508, Sec 4351; PL 101-
508, Sec 4353(a); PL 101-508, Sec 4354; PL 101-508, Sec 4355(a); PL
101-508, Sec 4357
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This proposed rule would authorize the imposition of CMPs
against individuals or entities who knowingly and willfully use
misleading and 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 meet Medigap policy loss-ratio requirements, failure to
comply with policy simplification standards, and failure to obtain
Secretarial certification of Medigap policies in States with non-
approved regulatory programs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: State
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, 202
619-3270
RIN: 0991-AA53
_______________________________________________________________________
1342. AMENDMENT TO GRANTS MANAGEMENT COMMON RULE TO RAISE
THRESHOLD FOR SIMPLIFIED SMALL PURCHASES
Legal Authority: 5 USC 301
CFR Citation: 45 CFR 92
Legal Deadline: None
Abstract: This proposal would raise the threshold for simplified small
purchase procedures for grantees from $25,000 to $100,000.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
NPRM Comment Period End 12/00/94
Final Action 05/00/95
Final Action Effective 05/00/95
Small Entities Affected: None
Government Levels Affected: State, Local, Tribal
Additional Information: OMB Circular A-102
Agency Contact: Charles Gale, Director, Division of Grants Policy and
Oversight, Department of Health and Human Services, Office of the
Secretary, Room 517-D, 200 Independence Avenue SW., Washington, DC
20301, 202 690-6377
RIN: 0991-AA77
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
1343. CIVIL MONEY PENALTIES AND EXCLUSIONS FOR ASSISTANTS AT CATARACT
SURGERY
Legal Authority: PL 99-272, Sec 9307; PL 99-514, Sec 1895(b)(16)
CFR Citation: 42 CFR 1001; 42 CFR 1003
Legal Deadline: None
Abstract: These final regulations provide for the imposition of civil
money penalties and exclusions against physicians billing the Medicare
program or program beneficiaries for services of an assistant at
surgery for cataract operations where prior approval has not been
granted. This rule specifically responds to various comments raised as
a result of the interim final, and makes a number of technical
corrections to those final regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 04/10/87 52 FR 11649
Final Action 12/00/94
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, 202
619-3270
RIN: 0991-AA37
_______________________________________________________________________
1344. BLOCK GRANT PROGRAMS
Legal Authority: PL 100-485; PL 100-607; PL 100-690
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: Recent legislation modified technical, administrative and
reporting requirements for several of the Department's block grants.
This notice would propose regulatory changes to reflect these statutory
changes and to clarify certain other block grant regulatory provisions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/17/92 57 FR 31682
Next Action Undetermined
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Terrance Tychan, Department of Health and Human
Services, Office of the Secretary, 200 Independence Avenue SW.,
Washington, DC 20201, 202 690-6901
RIN: 0991-AA55
_______________________________________________________________________
1345. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE
AGREEMENTS
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:
45 CFR 74 Interim Final Rule 08/25/94 (59 FR 43754) Comment Period
End 10/24/94 Final Action 05/00/95
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, 202 690-6377
RIN: 0991-AA56
_______________________________________________________________________
1346. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL TO
CERTAIN HEALTH CARE ENTITIES
Legal Authority: PL 101-239, Sec 6204; PL 101-508, Sec 4207(e); PL
101-508, Sec 4207(m)(2); PL 103-66, Sec 13562
CFR Citation: 42 CFR 1003
Legal Deadline: Final, Statutory, October 1, 1991.
Abstract: This rule will implement new civil money penalty authorities
regarding prohibited physician ownership and referral arrangements as
set forth in Section 1877 of the Social Security Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/20/93 58 FR 54096
NPRM Comment Period End 12/20/93
Final Action 11/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: This rulemaking is being developed in
conjunction with RIN 0938-AF40 and will be amended in accordance with
OBRA 1993 and the inclusion of designated health services.
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,
202 619-3270
RIN: 0991-AA65
_______________________________________________________________________
1347. ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-KICKBACK STATUTE
Legal Authority: PL 100-93, Sec 2; PL 100-93, Sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This final rule will set forth additional ``safe harbor''
provisions, as authorized by section 14 of PL 100-93. The final rule
delineates business and payment practices relating to the Medicare and
State health care programs that will be immunized from either criminal
or civil prosecution in accordance with the Medicare/Medicaid anti-
kickback statute.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/21/93 58 FR 49008
NPRM Comment Period End 11/22/93
Final Action 01/00/95
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,
202 619-3270
RIN: 0991-AA66
_______________________________________________________________________
1348. SAFE HARBORS FOR PROTECTING HEALTH PLANS
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 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: The OIG is currently assessing the public
comments received and will be issuing a revised final rule.
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,
202 619-3270
RIN: 0991-AA69
_______________________________________________________________________
1349. GOVERNMENTWIDE GUIDANCE FOR NEW RESTRICTIONS ON LOBBYING; INTERIM
FINAL GUIDANCE
Legal Authority: 31 USC 1352
CFR Citation: 45 CFR 93
Legal Deadline: None
Abstract: This interim final rule is in response to section 319 of P.L.
101-121. Section 319 generally prohibits recipients of Federal
contracts, grants, and loans from using appropriated funds for lobbying
the Executive or Legislative Branches of the Federal Government in
connection with a specific contract, grant, or loan. Section 319 also
requires that each person who requests or receives a Federal contract,
grant, cooperative agreement, loan or a Federal commitment to insure or
guarantee a loan, must disclose lobbying activities.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 02/26/90 55 FR 6736
Next Action Undetermined
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, 202 690-6574
RIN: 0991-AA70
_______________________________________________________________________
1350. REVISIONS TO THE PRO SANCTIONS PROCESS
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 01/00/95
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, 202
619-3270
RIN: 0991-AA73
_______________________________________________________________________
1351. CLARIFICATION OF THE OIG SAFE HARBOR ANTI-KICKBACK PROVISIONS
Legal Authority: PL 100-93, sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This rule will clarify various aspects of the original set of
safe harbor provisions that were published on July 29, 1991 (56 FR
35952) and that are currently set forth in 42 CFR 1001.952(a)-(k). This
clarifying rule will modify the final safe harbor provisions to give
greater clarity to their original intent.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/21/94 59 FR 37202
NPRM Comment Period End 09/21/94
Final Action 03/00/95
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 the
Inspector General, OMP, 330 Independence Avenue SW., Washington, DC
20201, 202 619-3270
RIN: 0991-AA74
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
1352. CIVIL MONEY PENALTIES AND INTERMEDIATE SANCTIONS FOR HMOS AND
COMPETITIVE MEDICAL PLANS
CFR Citation: 42 CFR 1003; 42 CFR 417; 42 CFR 431; 42 CFR 434
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/15/94 59 FR 36072
Final Action Effective 09/13/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, 202 619-3270
RIN: 0991-AA44
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Departmental Management (HHSDM)
_______________________________________________________________________
1353. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY
PROCEEDINGS
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 01/00/95
Final Action Effective 01/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Timothy M. White, 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, 202 619-0150
RIN: 0990-AA02
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1354. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; ADJUSTMENTS IN SSI BENEFITS ON ACCOUNT OF
RETROACTIVE BENEFITS UNDER TITLE II (061P)
Legal Authority: 42 USC 405; 42 USC 1320a-6; 42 USC 1302; 42 USC 1383;
PL 98-369, Sec 2615; 42 USC 1383b; 42 USC 1327
CFR Citation: 20 CFR 404.408b; 20 CFR 416.1123; 20 CFR 416.1402(m); 20
CFR 416.1123a; 20 CFR 404.902
Legal Deadline: None
Abstract: Sec. 2615 of Pub. L. 98-369 amended sec. 1127 of the Social
Security Act to eliminate windfalls that permitted some people who were
paid Old-Age, Survivors and Disability Insurance (OASDI) and
Supplemental Security Income (SSI) benefits retroactively to receive
more in total benefits for the same period than if they had been paid
the benefits when regularly due. The two main changes are: (1) SSI
benefits will be reduced where retroactive OASDI benefits have been
paid before the SSI benefits. Under prior law, reductions could be made
only in retroactive OASDI benefits and only when the retroactive SSI
had been paid first. (2) OASDI or SSI benefits payable upon
reinstatement following a period of suspension or termination will be
reduced by the amount of SSI benefits that would not have been paid if
the OASDI benefits had been paid when regularly due. We will amend our
regulations to conform to the statutory changes. Any costs/savings are
associated with the legislation being implemented and not with the
regulations themselves.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, Maryland 21235, 410
965-8471
RIN: 0960-AB38
_______________________________________________________________________
1355. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; EVALUATION GUIDES FOR DETERMINING SUBSTANTIAL
GAINFUL ACTIVITY (SGA) (147P)
Legal Authority: PL 98-460, Sec 10; PL 99-643; PL 100-203; PL 101-508
CFR Citation: 20 CFR 404; 20 CFR 416
Legal Deadline: None
Abstract: These proposed changes will clarify how the Social Security
Administration evaluates a person's work activity. These regulations
also will increase the monthly earnings amount that constitutes
services for trial work period purposes and change the rules to allow
the value of any subsidy or impairment-related work expenses to be
deducted in determining that monthly earnings amount. These regulations
also reflect statutory changes with respect to the trial work period
and the re-entitlement period.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra Bond, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794
RIN: 0960-AB73
_______________________________________________________________________
1356. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; NONPAYMENT OF
BENEFITS TO PRISONERS, VOCATIONAL REHABILITATION EXCEPTION (166P)
Legal Authority: 42 USC 402(x)(1); 42 USC 405
CFR Citation: 20 CFR 404.468; 20 CFR 404.469 (New)
Legal Deadline: None
Abstract: Existing regulations at 20 CFR 404.468(d) provide a
vocational rehabilitation exception to the nonpayment of benefits to
prisoners provision described at 20 CFR 404.468(a). Under the
exception, the nonpayment provision does not apply if a prisoner who is
entitled to benefits on the basis of disability is actively and
satisfactorily participating in a rehabilitation program which has been
specifically approved for the individual by a court of law. In
addition, the Secretary must determine that the program is expected to
result in the individual being able to do substantial gainful activity
upon release and within a reasonable time. No benefits will be paid to
the prisoner for any month prior to the approval of the program. The
proposed regulations would set out more definitive criteria for
applying the exception and would define terms, such as ``rehabilitation
program,'' ``court of law,'' and ``reasonable time,'' for purposes of
applying the exception.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Blvd., Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC16
_______________________________________________________________________
1357. OLD-AGE, SURVIVORS AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; VOCATIONAL FACTORS REGULATIONS RESTRUCTURING
AND CLARIFICATION (207P)
Legal Authority: 42 USC 405; 42 USC 421; 42 USC 423; 42 USC 1302; 42
USC 1382c; 42 USC 1383
CFR Citation: 20 CFR 404.1520; 20 CFR 404.1550 to 404.1567; 20 CFR
416.920; 20 CFR 416.950 to 416.967
Legal Deadline: None
Abstract: Based upon adjudicative experience, we are proposing
clarifications and a restructuring of the disability vocational
evaluation regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-6243
RIN: 0960-AC61
_______________________________________________________________________
1358. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; INTERIM DISABILITY BENEFITS (215P)
Legal Authority: 42 USC 423(h); 42 USC 1383(a); PL 100-647, Sec 8001
CFR Citation: 20 CFR 404; 20 CFR 416
Legal Deadline: None
Abstract: These regulations implement a section of Pub. L. 100-647 that
authorizes interim benefit payments whenever an Administrative Law
Judge (ALJ) decides that a claimant is entitled to benefits based on
disability or blindness and the Secretary has not issued his final
decision within 110 days after the date of the ALJ's determination.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AC76
_______________________________________________________________________
1359. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; APPEALS COUNCIL NOTICE REQUIREMENTS (235P)
Legal Authority: 42 USC 401(g); 42 USC 405(a); 42 USC 405(b); 42 USC
405(d) to 405(h); 42 USC 421(d); 42 USC 1302; 42 USC 1383; 42 USC 1383b
CFR Citation: 20 CFR 404.973; 20 CFR 416.1473
Legal Deadline: None
Abstract: These proposed regulations amend the existing regulations to
clarify the requirements that the Appeals Council (AC) notify the
parties of its reasons for reviewing a case and the issues to be
decided. The proposed regulations clarify the AC's procedures with
regard to providing the notice required by the regulations and do not
represent any change in policy. These regulations are intended to
remove any ambiguities in the current regulations concerning the
circumstances and the manner in which the AC provides notice to the
parties.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-6243
RIN: 0960-AC93
_______________________________________________________________________
1360. SUPPLEMENTAL SECURITY INCOME PROGRAM; AUGMENTED BENEFITS (271P)
Legal Authority: 42 USC 1382a
CFR Citation: 20 CFR 416.1121; 20 CFR 416.1122
Legal Deadline: None
Abstract: These proposed regulations will state how benefits from other
programs that have been augmented to provide for dependents are treated
under the Supplemental Security Income program. Our current regulations
only explain the treatment of the primary beneficiary's portion of an
augmented Department of Veterans Affairs benefit.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AD07
_______________________________________________________________________
1361. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; FEES FOR
REPRESENTATION OF CLAIMANTS (296P)
Legal Authority: PL 101-508, Sec 5106
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: We propose to amend the regulations to reflect section
5106(a) of Pub. L. 101-508 which modifies the manner in which past-due
benefits are calculated and the process by which SSA approves fees
charged by persons representing claimants before the Agency.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AD23
_______________________________________________________________________
1362. OASDI AND SSI FOR THE AGED, BLIND AND DISABLED; CONTINUATION OF
BENEFITS ON ACCOUNT OF PARTICIPATION IN A NON-STATE VR PROGRAM (299P)
Legal Authority: PL 101-508, Sec 5113
CFR Citation: 20 CFR 404.316; 20 CFR 404.337; 20 CFR 404.352; 20 CFR
404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20 CFR 404.1597; 20 CFR
416.1321; 20 CFR 416.1338; 20 CFR 416.1402
Legal Deadline: None
Abstract: These regulations will implement section 5113 of Pub. L. 101-
508, which amends sections 225(b) and 1631(a)(6) of the Act to extend
eligibility for continuation of benefits under these sections to
persons who are participating in a non-State VR program. Prior to these
amendments, the law only provided for continuation of benefits when a
person was participating in a State VR Program. These regulatory
changes will bring our regulations into conformity with the amendments
to the law.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD26
_______________________________________________________________________
1363. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED;
EXCLUSION FROM INCOME AND RESOURCES OF VICTIMS' COMPENSATION PAYMENTS AND
STATE RELOCATION ASSISTANCE (311F)
Legal Authority: PL 101-508, sec 5031; PL 101-508, sec 5035; PL 103-
66, sec 13732
CFR Citation: 20 CFR 416.1124; 20 CFR 416.1161(a); 20 CFR 416.1204(a);
20 CFR 416.1210; 20 CFR 416.1229 (New); 20 CFR 416.1239 (New)
Legal Deadline: None
Abstract: These regulations will provide for the exclusion from income
and from resources (for nine months) in the Supplemental Security
Income Program payments received by a person from a State established
fund to aid victims of crime and payments received as State or local
government relocation assistance.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/26/94 59 FR 44093
NPRM Comment Period End 10/25/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Additional Information: RIN 0960-AD37 has been merged with this action.
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1753
RIN: 0960-AD36
_______________________________________________________________________
1364. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED;
REIMBURSEMENT FOR VR SERVICES FURNISHED DURING CERTAIN MONTHS OF NON-
PAYMENT (315P)
Legal Authority: PL 101-508, Sec 5037
CFR Citation: 20 CFR 416.1321; 20 CFR 416.1331; 20 CFR 416.1338; 20
CFR 416.1402; 20 CFR 416.2201
Legal Deadline: None
Abstract: These regulations reflect section 5037 of Pub. L. 101-508,
which amends section 1615 of the Act, to provide for reimbursement for
VR services furnished during certain months of nonpayment of
Supplemental Security Income benefits. Prior to these amendments there
was no provision in the law for such reimbursement.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD39
_______________________________________________________________________
1365. CODE OF CONDUCT FOR ADMINISTRATIVE LAW JUDGES AND ADMINISTRATIVE
APPEALS JUDGES OF THE SOCIAL SECURITY ADMINISTRATION (341P)
Legal Authority: EO 12674 as modified by EO 12731;; 42 USC 405
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: These regulations would establish a Code of Conduct for OHA
Administrative Law Judges and Administrative Appeals Judges.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Office of
Regulations, Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
8471
RIN: 0960-AD54
_______________________________________________________________________
1366. ELECTION OF BENEFITS BASED ON AGE BY DISABLED WIDOW, WIDOWER, AND
SURVIVING DIVORCED SPOUSE BENEFICIARIES (343P)
Legal Authority: 42 USC 405
CFR Citation: 20 CFR 404.335; 20 CFR 404.336; 20 CFR 404.337
Legal Deadline: None
Abstract: We propose to amend our regulations to permit the election of
benefits based on age by widows, widowers and surviving divorced
spouses (hereinafter, collectively widows) who are at least age 60 and
who are already entitled to widow's benefits based on disability. This
proposal would allow the widow to choose which of the two types of
widow's benefits is more advantageous. The estimated increase in
benefit payments is less than $500,000 per year for fiscal years 1992-
1995.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra Bond, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
1794
RIN: 0960-AD56
_______________________________________________________________________
1367. AGAINST EQUITY AND GOOD CONSCIENCE (348P)
Legal Authority: 30 USC 923; 42 USC 404; 42 USC 1383
CFR Citation: 20 CFR 404.509; 20 CFR 410.561d; 20 CFR 416.554
Legal Deadline: None
Abstract: These proposed regulations amend the existing regulations to
change how we determine when recovery of an overpayment would be
against equity and good conscience. Currently, regulations permit
determinations that recovery of an overpayment would be against equity
and good conscience under three specific conditions. The proposed
regulations will provide for the ``against equity and good conscience''
determination to be based on an examination and consideration of a
variety of factors such as cause and result of overpayment and fairness
as they affect both the beneficiary and the Social Security
Administration.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
8470
RIN: 0960-AD62
_______________________________________________________________________
1368. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; HEMIC AND LYMPHATIC
SYSTEM, AND MALIGNANT NEOPLASTIC DISEASES (399P)
Regulatory Plan: This entry is Seq. No. 33 in Part II of this issue of
the Federal Register.
RIN: 0960-AD67
_______________________________________________________________________
1369. PROCEDURES FOR HANDLING EARNINGS REPORTS (418F)
Legal Authority: 42 USC 405(a); 42 USC 1302(a); 42 USC 1320b-1
CFR Citation: 20 CFR 422.115; 20 CFR 422.120
Legal Deadline: None
Abstract: These regulations will update our current regulations to
reflect the procedures we use for handling employers' wage reports that
lack a correct social security number. Additionally, the regulations
will include our requirements for employers to file corrections of
erroneous wage reports. The regulations will also include a description
of our process for providing pension plan information under the
Employee Retirement Income Security Act of 1974. There are no
significant costs.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/30/94 59 FR 44674
NPRM Comment Period End 10/31/94
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: Local, Federal
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD70
_______________________________________________________________________
1370. CONDUCT OF REPRESENTATIVES UNDER TITLE II OR TITLE XVI (431P)
Legal Authority: 42 USC 405(a); 42 USC 406; 42 USC 1302(a); 42 USC
1383(d)(1); 42 USC 1383(d)(2)
CFR Citation: 20 CFR 404.1700ff; 20 CFR 416.1500ff
Legal Deadline: None
Abstract: These regulations explain who may serve as a representative,
how claimants appoint and discharge representatives, the necessary
qualifications which representatives must possess, and rules of conduct
and standards of responsibility that a representative must follow.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-6243
RIN: 0960-AD73
_______________________________________________________________________
1371. STATEMENT OF EARNINGS AND BENEFIT ESTIMATE (415P)
Legal Authority: 42 USC 405; 42 USC 1302; 42 USC 1320b-13
CFR Citation: 20 CFR 404.811; 20 CFR 404.812 (New); 20 CFR 422.125
Legal Deadline: None
Abstract: Section 1143(c) of the Social Security Act requires that by
not later than September 30, 1995, we must furnish a social security
account statement to each eligible individual who has attained age 60
by October 1, 1994, is not receiving social security benefits, and for
whom we can determine a current mailing address. During fiscal year
1995 through 1999, we must furnish such a statement to eligible
individuals attaining age 60 in the fiscal year they turn age 60.
Similarly, beginning no later than October 1, 1999, we must provide
such a statement annually to eligible individuals age 25 or over. In
these regulations, we provide who will be sent a statement, who will
not be sent a statement, how we will determine addresses, and the
contents of the statements. We have not yet compiled all the costs.
These regulations will benefit the public by implementing section
1143(c) which will help individuals verify that we have entered their
correct earnings into our records and by showing the benefits to which
such individuals may become entitled.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD74
_______________________________________________________________________
1372. FEES FOR FEDERAL ADMINISTRATION OF STATE SUPPLEMENTARY PAYMENTS IN
THE SSI PROGRAM (376P)
Legal Authority: 42 USC 1302; 42 USC 1382(e); 42 USC 1383; PL 93-66,
sec 212
CFR Citation: 20 CFR 416.2010; 20 CFR 416.2090
Legal Deadline: None
Abstract: Section 13731 of Pub. L. 103-66 (the Omnibus Budget
Reconciliation Act of 1993) enacted August 10, 1993, requires the
Secretary to assess each State an administration fee for processing the
State's mandatory and optional supplementary payments. The fee will be
charged for all State supplementary payments issued on or after October
1, 1993. Also, the Secretary may charge a State an additional services
fee if, at the request of the State, the Secretary provides services
beyond the level customarily provided in the administration of such
payments.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD75
_______________________________________________________________________
1373. WHO MAY PROTECT A POTENTIAL CLAIMANT'S FILING DATE OR APPLICATION
FOR SUPPLEMENTAL SECURITY INCOME BENEFITS (408P)
Legal Authority: 42 USC 1302; 42 USC 1382; 42 USC 1383(a); 42 USC
1383(d); 42 USC 1383(e)
CFR Citation: 20 CFR 416.315ff
Legal Deadline: None
Abstract: These proposed regulations would make protecting a filing
date easier and protect potential claimants from losing SSI benefits if
an application is filed.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AD76
_______________________________________________________________________
1374. RELIABLE INFORMATION WHICH IS CURRENTLY AVAILABLE FOR DETERMINING
BENEFIT AMOUNTS IN THE SUPPLEMENTAL SECURITY INCOME PROGRAM (NEWMAN)
(434P)
Legal Authority: 42 USC 1302; 42 USC 1382(a) to 1382(c); 42 USC 1383
CFR Citation: 20 CFR 416.420
Legal Deadline: None
Abstract: The Social Security Act (the Act) provides that if the
Secretary of Health and Human Services (the Secretary) determines that
reliable information is currently available concerning the income of an
individual, the Secretary may use that information to determine an
individual's current month's supplemental security income (SSI) benefit
amount. This method of determining SSI benefit amounts is an exception
to the use of income from a prior month, known as retrospective monthly
accounting (RMA). The Secretary has determined that no reliable
information exists which is currently available for determining SSI
benefit amounts for a current month using any method other than RMA.
These rules are applicable only in California pursuant to a court order
issued in Newman v. Shalala.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD77
_______________________________________________________________________
1375. REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY, ENDOCRINE
SYSTEM AND OBESITY AND RELATED CRITERIA (436P)
Regulatory Plan: This entry is Seq. No. 34 in Part II of this issue of
the Federal Register.
RIN: 0960-AD78
_______________________________________________________________________
1376. REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY, GROWTH
IMPAIRMENTS (444P)
Regulatory Plan: This entry is Seq. No. 35 in Part II of this issue of
the Federal Register.
RIN: 0960-AD80
_______________________________________________________________________
1377. VALUATION OF CERTAIN IN-KIND SUPPORT AND MAINTENANCE (ISM) WHERE
THERE IS A COST-OF-LIVING ADJUSTMENT IN SSI BENEFITS (454P)
Legal Authority: PL 103-66, sec 13735
CFR Citation: 20 CFR 416.420; 20 CFR 416.1130(a)
Legal Deadline: None
Abstract: These proposed regulation would reflect the amendment to
section 1611(c) of the Act, effective January 1, 1995, that the current
Federal benefit rate be used in determining the value of certain in-
kind support and maintenance for the first 2 months after there is a
cost-of-living adjustment in SSI benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AD82
_______________________________________________________________________
1378. RELATIONSHIP/COVERAGE ACTIONS NOTE INITIAL DETERMINATIONS/SSI
CORRECTIONS (455P)
Legal Authority: 42 USC 402; 42 USC 403(a); 42 USC 403(b); 42 USC
405(a); 42 USC 405(b); 42 USC 416; 42 USC 423; 42 USC 428(a); 42 USC
428(b); 42 USC 428(c); 42 USC 428(d); 42 USC 428(e); 42 USC 1302; 42
USC 401(j); 42 USC 405(a)
CFR Citation: 20 CFR 404.331; 20 CFR 404.332; 20 CFR 404.341; 20 CFR
404.357; 20 CFR 404.361; 20 CFR 404.366; 20 CFR 404.903; 20 CFR
416.1180
Legal Deadline: None
Abstract: This regulation will make technical changes to several
sections. Most of the changes correct problems with wording which
occurred during the 1980 recodification. One change corrects an obvious
clerical error in the wording of section 416.1180. Another change
expands section 404.903 to clarify that extending social security or
medical coverage in accordance with section 218 of the Act is a matter
between the individual and the State and is not subject to SSA's
administrative review process.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Lois Berg, Paralegal Specialist, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713
RIN: 0960-AD83
_______________________________________________________________________
1379. PREVENTION OF ADVERSE EFFECTS ON ELIGIBILITY AND BENEFIT AMOUNT
WHEN SPOUSE OR PARENT ABSENT DUE TO ACTIVE MILITARY SERVICE (462P)
Legal Authority: PL 103-66, sec 13733
CFR Citation: 20 CFR 416.1160ff
Legal Deadline: None
Abstract: These proposed regulations reflect the provisions of section
13733 of Pub. L. 103-66 which allows us to consider, absent evidence to
the contrary, an ineligible parent or spouse who is absent from a
deeming household due solely to an active duty military assignment, to
be living in the same household as the eligible individual for deeming
purposes. This will prevent possible adverse SSI effects which could
otherwise result when a military deemor is absent from the household.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AD86
_______________________________________________________________________
1380. EXTENSION OF TIME PERIOD FOR NOT COUNTING AS RESOURCES,
FUNDS RECEIVED FOR REPAIR OR REPLACEMENT OF DAMAGED OR DESTROYED EXCLUDED
RESOURCES IN THE SSI PROGRAM (486P)
Legal Authority: 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 416.1232
Legal Deadline: None
Abstract: In the past several years, portions of the United States have
experienced natural disasters that have had unprecedented effects on
supplemental security income (SSI) recipients. In August 1992,
Hurricane Andrew devastated south Florida causing damage estimated in
excess of $18 billion. Because of the extent of the devastation, many
SSI recipients in the area were unable to use insurance payments to
repair or replace their damaged property within the timeframes provided
by regulations at that time. With the expiration of existing
timeframes, the payments would have counted as a resource for SSI
purposes. On March 17, 1994, the Social Security Administration (SSA)
published interim-final regulations which provided victims of Hurricane
Andrew with an additional 12-month time period if needed in which to
repair or replace their property. We are proposing regulations which
provide SSA with the flexibility to consider these types of occurrences
and provide individuals with additional time to repair or replace
damaged or destroyed excluded resources when certain criteria are met.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM Comment Period End 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD87
_______________________________________________________________________
1381. FEDERAL OASDI AND SSI FOR THE AGED, BLIND, AND DISABLED;
SIGNATURE REQUIREMENTS FOR STATE AGENCY MEDICAL AND PSYCHOLOGICAL
CONSULTANTS IN DISABILITY DETERMINATIONS (465P)
Legal Authority: 42 USC 405(a); 42 USC 421; 42 USC 1302; 42 USC 1382c;
42 USC 1383; 42 USC 1383b
CFR Citation: 20 CFR 404.1615; 20 CFR 416.1015
Legal Deadline: None
Abstract: We propose to revise sections 404.1615 and 416.1015 of the
current regulations regarding the certifications required on disability
determination forms. Current regulations require that, unless the
disability determination is made by a State agency disability hearing
officer, disability hearing officer, disability determinations will be
made by a team consisting of a State agency medical or psychological
consultant and a State agency disability examiner, even when the
determination is made on technical, nonmedical grounds. We propose to
remove the requirement that a medical or psychological consultant make
the determination jointly with the disability examiner when there is no
medical evidence to be evaluated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harry J. Short, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, 410 965-6243
RIN: 0960-AD88
_______________________________________________________________________
1382. FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND
SUPPLEMENTAL SECURITY INCOME, ACCEPTABLE MEDICAL SOURCES (469P)
Legal Authority: 42 USC 1302; 42 USC 1383; 42 USC 405
CFR Citation: 20 CFR 404.1513; 20 CFR 416.913
Legal Deadline: None
Abstract: We propose to add speech and language pathologists to the
list of acceptable medical sources in our current regulations. These
sources will assist us in establishing the existence of speech and
language impairments. We also propose to make other changes in our
regulations to clarify what we mean by an acceptable medical source.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1758
RIN: 0960-AD91
_______________________________________________________________________
1383. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM;
CONTRIBUTIONS FOR SUPPORT (475P)
Legal Authority: 42 USC 402(d)(3); 42 USC 416(b)(3); 42 USC 405(a); 42
USC 1302
CFR Citation: 20 CFR 404.366
Legal Deadline: None
Abstract: To provide more uniformity in our decision making, we are
amending our rules on the contributions for support that must be
provided by the insured to certain categories of claimants for child's
benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD92
_______________________________________________________________________
1384. COMPUTATION OF SSI BENEFITS FOR THE FIRST THREE MONTHS OF
PAYMENT (476P)
Legal Authority: 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 416.320
Legal Deadline: None
Abstract: SSI eligibility and payment are calculated by taking into
account income received by the applicant/recipient. Two calculations
must be made for each month. The first is the eligibility computation
and is based on the current (payment) month's income. The second is the
eligibility computation, which, under retrospective monthly accounting,
is based (usually) on the income of a prior month called the budget
month. Generally the budget month is 2 months prior to the payment
month. The transitional computation for the first 3 months of ssi
payment is an exception to the general rule described above. While the
eligibility computation continues to apply to the current month's
income, the budget month on which each of the first 3 months' payments
are based is the first month of eligibility. This policy was intended
to facilitate the transition into 2 month retrospective accounting
cycle and to avoid penalizing the recipient for income received prior
to initial SSI eligibility. However, the policy also has the effect of
counting income which is only received in one month more than one time.
In Jones v. Shalala the Ninth Circuit Court of Appeals ruled
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD93
_______________________________________________________________________
1385. DEFINITION OF ``LARGEST BENEFIT AMOUNT'' FOR PURPOSES OF
DETERMINING THE EARNINGS RECORD ON WHICH A PERSON WHO IS SIMULTANEOUSLY
ENTITLED TO CHILD'S INSURANCE BENEFITS (481P)
Legal Authority: 42 USC 402(d); 42 USC 402(k); 42 USC 1302; 42 USC
405(a)
CFR Citation: 20 CFR 404.304; 20 CFR 404.353b; 20 CFR 404.407d
Legal Deadline: None
Abstract: Section 202(k)(2)(A) of the Act (42 U.S.C. 402(k)(2)(A))
contains the statutory requirements for determining the earnings record
on which SSA will pay a person, who is simultaneously entitled to
child's insurance benefits on the earnings records of more than one
worker. Generally, the child's benefits will be paid on the earnings
record that yields the highest primary insurance amount (PIA). However,
under certain circumstances, the child's benefits will be paid on the
earnings record that yields a lower PIA if that record produces the
``largest benefit'' to which the child could be entitled under section
202(d) without the application of the reduction under the ``family
maximum'' provisions. In implementing section 202(k)(2)(A), SSA has
determined the ``largest benefit'' under section 202(k)(2)(A) by
comparing the original benefit amount (i.e., 50 percent of the PIA of a
living worker and 75 percent of the PIA of a deceased worker)
calculated on the dependent and/or survivor claim of the child on the
earnings record of each worker without applying any reductions or
deductions. The United States District Court for the Northern District
of Alabama in Agee v. Sullivan rejected
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lois Berg, Paralegal Specialist, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713
RIN: 0960-AD95
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Social Security Administration (SSA)
_______________________________________________________________________
1386. SUPPLEMENTAL SECURITY INCOME PROGRAM; SUSPENSIONS, TERMINATIONS,
AND ADVANCE NOTICE OF ADVERSE DETERMINATIONS (031F)
Legal Authority: 42 USC 1382; 42 USC 1382a; 42 USC 1382b; 42 USC
1382c; 42 USC 1382d; 42 USC 1383; PL 99-643, sec 3; PL 99-643, sec 4;
PL 100-203, sec 9103; PL 100-203, sec 9112; PL 100-203, sec 9115; PL
101-239, sec 8009; PL 101-508, sec 5038; PL 101-508, sec 5105
CFR Citation: 20 CFR 416B; 20 CFR 416G; 20 CFR 416M
Legal Deadline: None
Abstract: This regulation reorganizes, revises, and clarifies the rules
on stopping, reducing, suspending, and terminating an SSI beneficiary's
SSI benefits. This regulation's purpose is to make these rules easier
to read and understand. These rules also reflect the following
statutory enactments: (1) section 3 of Pub. L. 99-643, (2) section 4 of
Pub. L. 99-643, (3) section 9103 of Pub. L. 100-203, (4) section 9112
of Pub. L. 100-203, (5) section 9115 of Pub. L. 100-203, (6) section
8009 of Pub. L. 101-239, (7) section 5038 of Pub. L. 101-508, and (8)
section 5105 of Pub. L. 101-508.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice of Decision to Develop
Regs 06/19/79 44 FR 35241
NPRM 05/08/86 51 FR 17057
NPRM Comment Period End 07/07/86
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759
RIN: 0960-AA22
_______________________________________________________________________
1387. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; MUSCULOSKELETAL SYSTEM
(143F)
Regulatory Plan: This entry is Seq. No. 36 in Part II of this issue of
the Federal Register.
RIN: 0960-AB01
_______________________________________________________________________
1388. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAM; CONTINUED PAYMENT OF BENEFITS TO PERSONS IN
VOCATIONAL REHABILITATION PROGRAMS (131F)
Legal Authority: 42 USC 405; 42 USC 425; 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 404.316; 20 CFR 404.337; 20 CFR 404.352; 20 CFR
404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20 CFR 404.1597; 20 CFR
416.1321; 20 CFR 416.1338; 20 CFR 416.1331; 20 CFR 416.1402
Legal Deadline: None
Abstract: These changes permit the continued payment of disability
benefits to persons who medically recover while participating in a
vocational rehabilitation (VR) program, without regard to whether the
person was expected at the onset of the VR program to medically recover
before the scheduled completion date of the program and without regard
to whether the person has any residual functional limitation. These
changes bring the regulations into conformity with certain court
decisions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 05/14/86 51 FR 17616
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-8471
RIN: 0960-AB05
_______________________________________________________________________
1389. SUPPLEMENTAL SECURITY INCOME PROGRAM; PROCEEDS OF A LOAN, PAYMENT
OF PRO RATA SHARE OF HOUSEHOLD OPERATING EXPENSES (180F)
Legal Authority: 42 USC 1302
CFR Citation: 20 CFR 416.1103; 20 CFR 416.1133
Legal Deadline: None
Abstract: Money borrowed (a loan) is not income for SSI purposes and
therefore has no effect on a person's SSI benefits. These regulations
will state that only cash transactions may be considered loans. These
regulations will also provide that the one-third reduction rule which
applies when a person who lives in another's household and receives in-
kind support and maintenance will not apply if the SSI recipient pays
his or her pro rata share in cash and no later than the month under
consideration. No additional costs or savings are anticipated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/20/90 55 FR 33922
NPRM Comment Period End 10/19/90
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Blvd., Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC42
_______________________________________________________________________
1390. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; APPLICABILITY
OF GOVERNMENT PENSION TO CERTAIN FEDERAL EMPLOYEES (188F)
Legal Authority: 42 USC 402(b); 42 USC 402(c); 42 USC 402(e); 42 USC
402(f); 42 USC 402(g); PL 100-203, Sec 9007; PL 100-647, Sec 8014
CFR Citation: 20 CFR 404.408a
Legal Deadline: None
Abstract: This final rule would reflect provisions of the Omnibus
Budget Reconciliation Act of 1987 (PL 100-203, sec 9007) on the
Government pension offset and provisions of the Technical and
Miscellaneous Revenue Act of 1988 (PL 100-647), which also contained
new rules on the government pension offset.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/12/89 54 FR 51036
NPRM Comment Period End 02/12/90
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-8471
RIN: 0960-AC46
_______________________________________________________________________
1391. SUPPLEMENTAL SECURITY INCOME PROGRAM; CONTINUATION OF FULL BENEFIT
STANDARD FOR CERTAIN PERSONS TEMPORARILY INSTITUTIONALIZED (198F)
Legal Authority: PL 100-203, Sec 9115; PL 99-643, Sec 3
CFR Citation: 20 CFR 416.211; 20 CFR 416.413; 20 CFR 416.414; 20 CFR
416.1149; 20 CFR 416.1167; 20 CFR 416.1325; 20 CFR 416.2040; 20 CFR
416.410; 20 CFR 416.412; 20 CFR 416.640; 20 CFR 416.1147
Legal Deadline: None
Abstract: These regulations conform to statutory amendments which
require continued payment for up to three months based on the full
payment rate to certain persons eligible for SSI payments under
sections 1619 or 1611 of the Social Security Act who enter certain
medical or psychiatric institutions. Without the provisions, SSI
benefits would be reduced or suspended.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/28/92 57 FR 44519
NPRM Comment Period End 11/27/92
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-1759
RIN: 0960-AC55
_______________________________________________________________________
1392. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; MEDICAL
CRITERIA FOR EVALUATING MENTAL DISORDERS FOR ADULTS (222F)
Regulatory Plan: This entry is Seq. No. 37 in Part II of this issue of
the Federal Register.
RIN: 0960-AC74
_______________________________________________________________________
1393. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF AUGMENTED
VETERANS' BENEFITS (231F)
Legal Authority: 42 USC 1382a
CFR Citation: 20 CFR 416.1123
Legal Deadline: None
Abstract: These regulations describe the treatment of the dependent's
portion of an augmented Department of Veterans Affairs benefit as
income to the dependent by the SSI program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/18/90 55 FR 20612
NPRM Comment Period End 07/17/90
Final Action 11/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC82
_______________________________________________________________________
1394. SUPPLEMENTAL SECURITY INCOME PROGRAM; WAIVER OF SSI RULE FOR
DEEMING TO CHILDREN THE INCOME AND RESOURCES OF THEIR PARENTS FOR CERTAIN
DISABLED CHILDREN (252F)
Legal Authority: 42 USC 1382c(f)(2)
CFR Citation: 20 CFR 416.415; 20 CFR 416.1148; 20 CFR 416.1165; 20 CFR
416.1202
Legal Deadline: None
Abstract: These proposed regulations reflect the provisions of section
8010 of Pub. L. 101-239 which waive the SSI income and resource deeming
rules (which deem the income and resources of a disabled child's
parents to the child if the child is living at home) for disabled
children who were eligible for SSI benefits while in a medical
institution and who qualify for Medicaid under a State home care plan
authorized under title XIX when deeming parental income and resources
would make the disabled child ineligible for SSI benefits or eligible
for a payment of less than the personal needs allowance. This was
effective June 1, 1990.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/22/93 58 FR 49249
NPRM Comment Period End 11/22/93
Final Action 01/00/95
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Cassandra Bond, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794
RIN: 0960-AC96
_______________________________________________________________________
1395. SSI PROGRAM; REDUCTION IN TIME WHEN INCOME AND RESOURCES OF
SEPARATED COUPLES MUST BE TREATED AS JOINTLY AVAILABLE FOR PURPOSES OF
SSI ELIGIBILITY AND BENEFITS (254F)
Legal Authority: 42 USC 1382c(b)
CFR Citation: 20 CFR 416.120(c); 20 CFR 416.305; 20 CFR 416.430; 20
CFR 416.432; 20 CFR 416.532(c); 20 CFR 416.554; 20 CFR 416.1130(c); 20
CFR 416.1147; 20 CFR 416.1801(c); 20 CFR 416.1802(b); 20 CFR 416.1806;
20 CFR 416.1811; 20 CFR 416.1830(a); 20 CFR 416.1832(c); 20 CFR
416.1832(d)
Legal Deadline: None
Abstract: This proposed regulation requires that a married couple be
treated as separate individuals for purposes of SSI eligibility and
benefit determination beginning with the month after the month they
begin living apart. This change is effective October 1, 1990.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/08/94 59 FR 10766
NPRM Comment Period End 05/09/94
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AC98
_______________________________________________________________________
1396. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; UPDATING NOMENCLATURE
(264F)
Legal Authority: 42 USC 405; 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 404; 20 CFR 410; 20 CFR 416; 20 CFR 422
Legal Deadline: None
Abstract: This regulation amends current regulations to replace
outdated nomenclature and terminology, to eliminate little used rules
and provisions which are no longer in effect, and to correct technical
errors such as misspellings and incorrect cross-references.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Cassandra Bond, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794
RIN: 0960-AD11
_______________________________________________________________________
1397. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; REPRESENTATIVE PAYEE
REFORMS (295F)
Regulatory Plan: This entry is Seq. No. 38 in Part II of this issue of
the Federal Register.
RIN: 0960-AD22
_______________________________________________________________________
1398. ORGANIZATION AND PROCEDURES; PROCEDURES OF THE OFFICE OF HEARINGS
AND APPEALS; AUTHORITY OF APPEALS OFFICERS TO DENY A REQUEST FOR APPEALS
COUNCIL REVIEW (334F)
Legal Authority: 42 USC 405; 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 422.205
Legal Deadline: None
Abstract: We propose to amend our regulations to give Appeals Officers
of the Appeals Council authority to deny requests for review of hearing
decisions. Presently, this authority rests only with members of the
Appeals Council.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/10/94 59 FR 1363
NPRM Comment Period End 03/11/94
Final Action 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lois Berg, Legal Assistant, Office of Regulations,
Department of Health and Human Services, Social Security
Administration, 6401 Security Boulevard, Baltimore, Maryland 21235, 410
965-1713
RIN: 0960-AD45
_______________________________________________________________________
1399. OASDI AND SSI; TESTING MODIFICATIONS TO THE DISABILITY
DETERMINATION PROCEDURES (359F)
Regulatory Plan: This entry is Seq. No. 39 in Part II of this issue of
the Federal Register.
RIN: 0960-AD63
_______________________________________________________________________
1400. RELIABLE INFORMATION WHICH IS CURRENTLY AVAILABLE FOR DETERMINING
BENEFIT AMOUNTS IN THE SUPPLEMENTAL SECURITY INCOME PROGRAM (382F)
Legal Authority: 42 USC 1302; 42 USC 1382(a) to 1382(c); 42 USC
1382(e); 42 USC 1382a; 42 USC 1382f; 42 USC 1383
CFR Citation: 20 CFR 416.420
Legal Deadline: NPRM, Judicial, March 16, 1993.
Abstract: Pursuant to the Court order in Gould, et al. v. Sullivan, No.
C2-87-964 (S.D. Ohio, October 2, 1992), we proposed a rule for
determining benefits in the SSI program. Under section 1611(c)(4)(A) of
the Social Security Act, if the Secretary determines that reliable
information is currently available concerning the income and other
circumstances of an individual for a month, the Secretary may use that
information to determine an individual's SSI benefit amount for that
month. This discretionary method of determining SSI benefit amounts is
an exception to the use of information from a prior month, known as
retrospective monthly accounting (RMA), as provided in section
1611(c)(1) of the Act. The proposed rule explained that the Secretary
has determined that no information exists which is reliable and
currently available to use in computing SSI benefit amounts pursuant to
section 1611(c)(4).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/16/93 58 FR 14191
NPRM Comment Period End 05/17/93
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD65
_______________________________________________________________________
1401. COMPENSATION OF QUALIFIED ORGANIZATIONS SERVING AS REPRESENTATIVE
PAYEES UNDER TITLE II AND TITLE XVI (423F)
Legal Authority: 42 USC 405(a); 42 USC 405(j); 42 USC 1302; 42 USC
1383(a)(2)
CFR Citation: 20 CFR 404.2040; 20 CFR 404.2040a; 20 CFR 416.640; 20
CFR 416.640a
Legal Deadline: None
Abstract: These additional changes to the final regulations which were
published on June 1, 1992 will require a representative payee to set
aside a personal needs allowance for all institutionalized
beneficiaries; preclude a qualified organization that serves as
representative payee from taking a fee from the personal needs
allowance of all institutionalized beneficiaries; and allow a qualified
organization to collect its fee for services from conserved benefits in
certain limited circumstances.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD71
_______________________________________________________________________
1402. FEDERAL OASDI AND SSI; COMPUTING BENEFIT AMOUNTS, DISPOSING OF
UNDERPAYMENTS, RESOLVING OVERPAYMENTS, AND PAYMENT RESTRICTION (428F)
Legal Authority: 42 USC 405(a); 42 USC 415(a)(7); 42 USC 1302(a)
CFR Citation: 20 CFR 404.213; 20 CFR 404.460; 20 CFR 404.503; 20 CFR
404.510
Legal Deadline: None
Abstract: Current regulations on the windfall elimination provision do
not explain how SSA will treat the purchase of noncovered retroactive
service, e.g., the purchase of coverage for military service. The
regulations will state that we will accept such service in determining
whether an insured individual is exempt from the windfall provision
because he or she became eligible before 1986 for a pension based on
noncovered employment. The regulations will also include three
technical amendments. First, we will delete a cross reference which
erroneously indicates that a person otherwise eligible for an
underpayment of benefits must be the parent of an insured individual.
Second, we will change age 72 to age 70 regarding deductions for net
earnings from self-employment. Third, we will delete the German
Democratic Republic and Albania from the list of countries to which
payment of benefits is restricted.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/20/94 59 FR 37000
NPRM Comment Period End 09/19/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, Legal Assistant, Department of Health
and Human Services, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235, 410 965-8471
RIN: 0960-AD72
_______________________________________________________________________
1403. FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE; EVIDENCE
REQUIRED TO PRESUME A PERSON IS DEAD (443F)
Legal Authority: 42 USC 405(a); 42 USC 1102
CFR Citation: 20 CFR 404.720
Legal Deadline: None
Abstract: These proposed regulations reflect a new proposed policy
providing that the presumption of death arises when the claimant
establishes an individual has been absent from his or her residence and
not heard from for 7 years. Once the presumption is made, the burden
then shifts to us to rebut the presumption either by presenting
evidence that the missing individual is still alive or by providing an
explanation to account for the individual's absence in a manner
consistent with continued life rather than death. Policy concerning the
rebuttal of a presumption of death will also be provided in a new
section to the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/20/94 59 FR 37002
NPRM Comment Period End 09/19/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD79
_______________________________________________________________________
1404. TEMPORARY INCREASE IN SPONSORSHIP PERIOD FOR ALIENS UNDER THE SSI
PROGRAM (457F)
Legal Authority: PL 103-152, sec 7
CFR Citation: 20 CFR 416.1160; 20 CFR 416.1204
Legal Deadline: None
Abstract: Section 7 of Pub. L. 103-152 amended section 1621 of the
Social Security Act to temporarily increase the sponsorship period for
aliens under the SSI program from 3 years to 5 years following the
alien's date of lawful admission to the U.S. The increase in the
sponsorship period is effective January 1, 1994. Beginning October 1,
1996, the 3-year sponsorship period will be reinstated. We will amend
our regulations to conform to the statutory changes. Any costs/savings
are associated with the legislation and not with the regulations
themselves.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 06/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lois Berg, Paralegal Specialist, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713
RIN: 0960-AD84
_______________________________________________________________________
1405. REPLACEMENT OF LOST, DAMAGED OR STOLEN EXCLUDED RESOURCES
(HURRICANE ANDREW) (458I)
Legal Authority: 42 USC 1302; 42 USC 1383
CFR Citation: 20 CFR 416.1232
Legal Deadline: None
Abstract: Some supplemental security income (SSI) recipients who were
victims of Hurricane Andrew in south Florida have not been able to
replace or repair their damaged homes and other excluded resources due
to circumstances beyond their control. This means that some SSI
recipients will be holding assets (insurance money) in amounts that
will disqualify them for SSI benefits if held for periods exceeding the
maximum 18-month period currently in regulations at section 416.1232.
Since Hurricane Andrew occurred in August 1992, SSI recipients could
become ineligible as early as March 1994. We are codifying in
regulations, interim final rules which provide additional time for
victims of Hurricane Andrew to replace or repair their damaged excluded
resources without suffering loss or interruption of their SSI benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 03/17/94 59 FR 12544
NPRM Comment Period End 05/17/94
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762
RIN: 0960-AD85
_______________________________________________________________________
1406. TECHNICAL CHANGES TO TITLE XVI (466F)
Legal Authority: 42 USC 1382; 42 USC 1382a; 42 USC 1382b; 42 USC 1382j
CFR Citation: 20 CFR 416.1236; 20 CFR 416 app
Legal Deadline: None
Abstract: We are amending the supplemental security income regulations
by making technical changes to update the appendix at the end of
Subpart K which lists exclusions from income in statutes other than the
Social Security Act and to update the lists of statutory exclusions
from resources contained in Subpart L.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, Legal Assistant, Department of Health and
Human Services, Social Security Administration, Office of Regulations,
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470
RIN: 0960-AD89
_______________________________________________________________________
1407. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND OR
DISABLED; EVIDENCE OF LAWFUL ADMISSION FOR PERMANENT RESIDENCE IN THE
UNITED STATES (486F)
Legal Authority: 42 USC 1302; 42 USC 1382c(a)(1)(B); 42 USC 1382c(e);
42 USC 1383
CFR Citation: 20 CFR 416.1615
Legal Deadline: None
Abstract: On September 20, 1993, the Immigration and Naturalization
Service (INS) published a regulatory change concerning the documents
which certify the alien status of a lawful permanent resident within
the United States. The change which establishes INS Form I-551, Alien
Registration Receipt Card, as the definitive evidence of lawful
permanent resident status is effective September 20, 1994. Since aliens
who apply for SSI benefits as lawful permanent residents must submit
evidence of this status, we are revising the title XVI regulations to
reflect the change in the INS regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lois Berg, Paralegal Specialist, Department of Health
and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713
RIN: 0960-AD90
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Social Security Administration (SSA)
_______________________________________________________________________
1408. SUPPLEMENTAL SECURITY INCOME PROGRAM; WHAT IS NOT INCOME (121F)
CFR Citation: 20 CFR 416.1103(a)
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/01/94 59 FR 33906
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, 410 965-8470
RIN: 0960-AB09
_______________________________________________________________________
1409. SUPPLEMENTAL SECURITY INCOME PROGRAM; CONTINUATION OF BENEFITS AND
SPECIAL ELIGIBILITY FOR CERTAIN SEVERELY IMPAIRED RECIPIENTS WHO WORK
(171F)
CFR Citation: 20 CFR 416.260; 20 CFR 416.261; 20 CFR 416.262; 20 CFR
416.265; 20 CFR 416.268; 20 CFR 416.269; 20 CFR 416.1112; 20 CFR
416.1402; 20 CFR 416.264; 20 CFR 416.1403
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/12/94 59 FR 41400
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, 410 965-1758
RIN: 0960-AC22
_______________________________________________________________________
1410. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL
SECURITY INCOME PROGRAMS; DEEMED APPLICATION DATE BASED ON MISINFORMATION
(267F)
CFR Citation: 20 CFR 404.612; 20 CFR 404.614; 20 CFR 404.615; 20 CFR
404.633 (New); 20 CFR 404.902; 20 CFR 404.903; 20 CFR 416.310; 20 CFR
416.325; 20 CFR 416.351 (New); 20 CFR 416.1402; 20 CFR 416.1403
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/31/94 59 FR 44918
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, 410 965-1762
RIN: 0960-AD05
_______________________________________________________________________
1411. SUPPLEMENTAL SECURITY INCOME PROGRAM; FINANCIAL INSTITUTION
ACCOUNTS IN THE SSI PROGRAM (278F)
CFR Citation: 20 CFR 416.1201(b); 20 CFR 416.1208 (New)
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/31/94 59 FR 27985
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, 410 965-1762
RIN: 0960-AD10
_______________________________________________________________________
1412. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED;
TREATMENT OF CERTAIN ROYALTIES AND HONORARIA (310F)
CFR Citation: 20 CFR 416.1110; 20 CFR 416.1111; 20 CFR 416.1121
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/24/94 59 FR 43470
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Duane Heaton, 410 965-8470
RIN: 0960-AD35
_______________________________________________________________________
1413. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF PROMISSORY NOTES
IN HOME REPLACEMENT SITUATIONS (182F)
CFR Citation: 20 CFR 416.1212
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/23/94 59 FR 43283
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry Lerner, 410 965-1762
RIN: 0960-AD61
_______________________________________________________________________
1414. APPEAL RIGHTS FOLLOWING STATE-INITIATED MASS CHANGE IN FEDERALLY
ADMINISTERED STATE SUPPLEMENTARY PAYMENTS RESULTING IN REDUCTION,
SUSPENSION, OR TERMINATION OF STATE SUPPLEMENTARY PAYMENTS (383F)
CFR Citation: 20 CFR 416.1401; 20 CFR 416.1402; 20 CFR 416.1403
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/22/94 59 FR 43035
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jack Schanberger, 410 965-8471
RIN: 0960-AD66
_______________________________________________________________________
1415. ELIGIBILITY FOR CHILDREN OF ARMED FORCES PERSONNEL RESIDING OUTSIDE
THE UNITED STATES OTHER THAN IN FOREIGN COUNTRIES (452F)
CFR Citation: 20 CFR 416.215
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/12/94 59 FR 41399
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Henry D. Lerner, 410 965-1762
RIN: 0960-AD81
_______________________________________________________________________
1416. FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE;
DETERMINING DISABILITY AND BLINDNESS; EXTENSION OF EXPIRATION DATE FOR
THE LISTING OF IMPAIRMENTS, MENTAL DISORDERS IN ADULTS (477F)
Legal Authority: 42 USC 1302; 42 USC 1383; 42 USC 405
CFR Citation: 20 CFR 404.1500
Legal Deadline: None
Abstract: The Social Security Administration issues listings of
impairments to evaluate disability and blindness under the Social
Security and Supplemental security income (SSI) programs. This rule
would extend the expiration date for the adult mental disorders
listings. We propose no revisions to the medical criteria in the
listings; they would remain the same as they now appear in the Code of
Federal Regulations. This extension will ensure that we continue to
have medical evaluation criteria in the listings to adjudicate claims
for disability based on mental impairments at step three of our
sequential evaluation process.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 08/16/94 59 FR 41974
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Richard M. Bresnick, Legal Assistant, Department of
Health and Human Services, Social Security Administration, Office of
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1758
RIN: 0960-AD94
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health
(OASH)
_______________________________________________________________________
1417. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
Legal Authority: 42 USC 289b; 42 USC 290aa
CFR Citation: 42 CFR 93
Legal Deadline: None
Abstract: The proposed regulation will revise the definition of
research misconduct, identify responsibilities of institutions
receiving allegations of research misconduct involving PHS-supported
research, provide a hearing opportunity for persons found to have
engaged in research misconduct, and set forth other policies of the
Department of Health and Human Services related to research integrity.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/28/94 59 FR 33242
NPRM Comment Period End 08/29/94 59 FR 33242
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Dr. Lawrence Rhoades, Director, Division of Policy and
Education, Office of Research Integrity, Department of Health and Human
Services, Public Health Service, 5515 Security Lane, Suite 700,
Rockville, MD 20852, 301 443-5300
RIN: 0905-AE02
_______________________________________________________________________
1418. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY
PLANNING SERVICE PROJECTS
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
Agency Contact: Gerald Bennett, Acting Deputy Assistant Secretary for
Population Affairs, Department of Health and Human Services, Public
Health Service, East West Towers, Suite 200, West Bldg., 5600 Fishers
Lave, Rockville, MD 20857, 301 594-4000
RIN: 0905-AE03
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Office of Assistant Secretary for Health
(OASH)
_______________________________________________________________________
1419. PRIVACY ACT; EXEMPT SYSTEM
CFR Citation: 45 CFR 5b
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/19/94 59 FR 36717
Final Action Effective 08/18/94 59 FR 36717
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Dr. Lawrence Rhoades, 301 443-5300
RIN: 0905-AD31
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services
Administration (SAMHSA)
_______________________________________________________________________
1420. CONFIDENTIALITY OF SUBSTANCE ABUSE PATIENT RECORDS
Legal Authority: 42 USC 290dd-2, as amended by PL 102-321; 42 USC
290dd-3, as amended by PL 102-321
CFR Citation: 42 CFR 2
Legal Deadline: None
Abstract: This action modifies rules at 42 CFR part 2 to clarify
coverage of general medical facilities in light of U.S. v. Eide, 875
F.2d 1429, 1438 (9th Cir. 1989).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/18/94 59 FR 42561
NPRM Comment Period End 10/17/94
Final Action 03/00/95
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Tribal, Federal
Additional Information: 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, Public Health Service, 5600 Fishers Lane,
Room 12C-15, Rockville, MD 20857, 301 443-4640
RIN: 0905-AD97
_______________________________________________________________________
1421. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS
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 10/00/94
NPRM Comment Period End 01/00/95
Final Action 04/00/95
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Local
Additional Information: 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, Public Health Service, 5600 Fishers Lane,
Room 12C-15, Rockville, MD 20857, 301 443-4640
RIN: 0905-AD99
_______________________________________________________________________
1422. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANTS
Legal Authority: 42 USC 300X-1, PL 102-321, ADAMHA Reorganization Act
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: States and territories must submit annual applications which
include State plans and implementation reports for services delivery to
adults with serious mental illness and children with serious emotional
disturbance under the Community Mental Health Services Block Grant
statute. Regulatory action is necessary to establish uniform
application format and to institute requirements with regard to
addressing and reporting on the statutory criteria the Secretary must
use to determine if applications comply with legislative mandates
(sections 1911, 1920 and 1941-1954 of the Public Health Service Act, as
amended by P.L. 102-321), thus meeting approval for grant award.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/95
NPRM Comment Period End 04/00/95
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Tribal
Agency Contact: Joseph Faha, Director, Div. of Legislation and External
Affairs, Department of Health and Human Services, Public Health
Service, Room 12C-15, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857, 301 443-4640
RIN: 0905-AE24
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services
Administration (SAMHSA)
_______________________________________________________________________
1423. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
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 are effective immediately. However,
States have 90 days from the effective date to bring previously
submitted FY 1993 applications into substantial compliance and need to
submit applications in the prescribed format beginning only with 1994
applications.
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 12/00/94
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Tribal
Additional Information: 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, Public Health Service, 5600 Fishers Lane,
Room 12C-15, Rockville, MD 20857, 301 443-4640
RIN: 0905-AD98
_______________________________________________________________________
1424. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
(TOBACCO PROVISIONS)
Regulatory Plan: This entry is Seq. No. 45 in Part II of this issue of
the Federal Register.
RIN: 0905-AE05
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Centers for Disease Control and Prevention
(CDC)
_______________________________________________________________________
1425. RESPIRATORY PROTECTIVE DEVICES
Regulatory Plan: This entry is Seq. No. 46 in Part II of this issue of
the Federal Register.
RIN: 0905-AB58
_______________________________________________________________________
1426. INTERSTATE SHIPMENT OF BIOLOGICAL MATERIAL THAT CONTAINS OR MAY
CONTAIN INFECTIOUS SUBSTANCES
Legal Authority: 42 USC 216; 42 USC 264; 42 USC 271
CFR Citation: 42 CFR 72
Legal Deadline: None
Abstract: The revised regulation will clarify and expand the
requirements for proper packaging and handling of infectious substances
during interstate shipment. The revised regulation will ensure that all
biological material that could contain infectious substances is
packaged in a manner for interstate shipment that minimizes the
potential for leakage and possible contamination of the environment and
minimizes direct physical contact with the contents by package
handlers. The revised regulation is not expected to have a major impact
on the cost of shipping these materials.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/02/90 55 FR 7678
NPRM Comment Period End 05/09/90 55 FR 7678
Final Action 10/00/94
Final Action Effective 01/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jonathan Y. Richmond, Ph.D., Director, Office of Health
and Safety, Centers for Disease Control and Prevention, Department of
Health and Human Services, Public Health Service, 1600 Clifton Road
NE., Mailstop F-05, Atlanta, GA 30333, 404 639-2453
RIN: 0905-AC89
_______________________________________________________________________
1427. MEDICAL EXAMINATION OF ALIENS
Legal Authority: 8 USC 1182; 8 USC 1224; 8 USC 1225; 42 USC 216; 42
USC 249; 42 USC 252; PL 101-649
CFR Citation: 42 CFR 34
Legal Deadline: None
Abstract: This is a proposed revision in the regulations for the
medical examination of aliens. The regulations were developed to
provide for the physical and mental examination of aliens within the
United States or in other countries as required by the Immigration and
Nationality Act. This revision would update the regulations in
accordance with current epidemiologic concepts and medical diagnostic
standards.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 05/31/91 56 FR 25000
Interim Final Comment Period End08/02/91 56 FR 25000
Final Action 00/00/00
Final Action Effective 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Federal
Agency Contact: Charles R. McCance, Director, Division of Quarantine,
Department of Health and Human Services, Public Health Service, Centers
for Disease Control and Prevention, 1600 Clifton Road, Mailstop E-04,
Atlanta, GA 30333, 404 639-8100
RIN: 0905-AD29
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1428. MEDICAL FOODS
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
ANPRM Comment Period End 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Agency Contact: Carol Lang, 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,
202 205-5372
RIN: 0905-AD91
_______________________________________________________________________
1429. SUNGLASSES; LABELING; ULTRAVIOLET RADIATION
Legal Authority: 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: The failure of sunglasses to block the transmittance of a
sufficient amount of UV rays may result in macular degeneration, a
condition affecting vision significantly. Not all sunglasses provide
adequate protection for those at high risk. FDA believes that consumers
should be aware of the degree of protection provided. FDA is publishing
the ANPRM to gather additional information on the extent of the problem
and to seek potential solutions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE35
_______________________________________________________________________
1430. INVESTIGATIONAL DEVICE EXEMPTION: COST RECOVERY
Legal Authority: 21 USC 360j (g)
CFR Citation: 21 CFR 812.7
Legal Deadline: None
Abstract: FDA is considering revising its regulation concerning
recovering costs from patients for devices being investigated for
safety and effectiveness information before commercial marketing.
Presently, 21 CFR 812.7(b) prohibits investigators from charging
subjects a price larger than that necessary to recover costs of
manufacture, research, development and handling. FDA believes that this
may encourage more widespread use of investigational devices than is
appropriate. FDA is publishing this ANPRM to gather information on the
nature and extent of the problem.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 03/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE36
_______________________________________________________________________
1431. DEVELOPMENT OF HAZARD ANALYSIS CRITICAL CONTROL POINTS FOR
THE FOOD INDUSTRY; REQUEST FOR COMMENTS
Regulatory Plan: This entry is Seq. No. 40 in Part II of this issue of
the Federal Register.
RIN: 0905-AE60
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1432. OVER-THE-COUNTER (OTC) DRUG REVIEW
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'' to be included in revised NPRM (cont)
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 03/00/95
Alcohol (Topical) Products (To be merged w/other rulemkg) ANPRM 05/21/
82 (47 FR 22324)
Amendment (DPH Combinations) Cough/Cold (Comb.) Products NPRM 03/00/95
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)
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)
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 12/00/94
Antidiarrheal Products ANPRM 03/21/75 (40 FR 12924) NPRM 04/30/86 (51
FR 16138) Final Action 02/00/95
Antidotes, Toxic Ingestion Prdts (Now 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)
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)
Cough/Cold (Combination) Products ANPRM 09/09/76 (41 FR 38312) NPRM
08/12/88 (53 FR 30522) NPRM (Amendment)(DPH Combinations) 03/00/
95 Final Action 00/00/00
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)
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 03/00/95
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)
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)
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 03/00/95
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 (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
12/00/94
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)
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 02/
00/95
Reporting of Adverse Reactions NPRM 12/00/94
Skin Bleaching Products ANPRM 11/03/78 (43 FR 51546) NPRM 09/03/82
(47 FR 39108) NPRM (Reproposed) 03/00/95
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 03/00/95
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 03/00/95
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) Second NPRM 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 11/
00/94
Vaginal Contraceptive Products ANPRM 12/12/80 (45 FR 82014) NPRM 10/
00/94
Vaginal Drug Products ANPRM 10/13/83 (48 FR 46694) Withdrawal
Published 02/03/94 (59 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)
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/
95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: ABSTRACT CONT: for ``Antimicrobial Products.''
NPRM for ``Alcohol (Topical) Products'' to be included in revised NPRM
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products''
is being revised because it is being 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.
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, 301 594-
5000
RIN: 0905-AA06
_______________________________________________________________________
1433. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I OF THE
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT
Legal Authority: 21 USC 360b; 21 USC 371
CFR Citation: 21 CFR 514
Legal Deadline: Final, Statutory, November 5, 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 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 approved after 1962.
Timetable:
New Animal Drug Approval Process NPRM 12/17/91 (56 FR 65544) NPRM 03/
00/95
Reporting Requirements for Marketed Animal Drugs NPRM 12/17/91 (56 FR
65581) Final Action 03/00/95
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: 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 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, 301 594-1620
RIN: 0905-AA96
_______________________________________________________________________
1434. INFANT FORMULA ACT
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 the Infant Formula Act of 1986. The rule establishes
infant formula record and record retention requirements. The agency is
also 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:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule 12/24/91 56 FR 66566
NPRM 07/00/95
NPRM Comment Period End 10/00/95
Current Good Mfg. Practices; Qual Control Proc NPRM 07/00/95
Infant Form Cons Comp, Micro Test & Recd Retention Req NPRM 01/26/89
(54 FR 3783) NPRM (Comment Period End) 03/27/89 Second NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: None
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, 202 205-5372
RIN: 0905-AC46
_______________________________________________________________________
1435. REPORTING OF ERRORS AND ACCIDENTS RELATING TO BLOOD SAFETY AND
WITHDRAWAL OF PREVIOUSLY PROPOSED RULE
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
effect 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. (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/95
NPRM Comment Period End 12/00/95
Small Entities Affected: Businesses, Organizations
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: ABSTRACT CONT: 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 transfusions services is expected to be
minimal.
Agency Contact: Jean M. Olson, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Biologics
Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AD67
_______________________________________________________________________
1436. PROPOSED LABELING FOR DRUG PRODUCTS BASED ON FALSE OR FRAUDULENT
DATA
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355
to 358; 21 USC 360 to 360b; 21 USC 371; 21 USC 374; 21 USC 376; 42 USC
216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n; 42 USC 264
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The agency proposes to revise its regulations pertaining to
human drug product labeling. The proposed revisions would subject drug
products whose labeling was based in whole or in part on false or
fraudulent data or information to the statutory requirements in section
502(f)(1) of the Federal Food, Drug, and Cosmetic Act. The proposal
would also interpret the term ``false or fraudulent labeling.''
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Anne Kirchner, 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, 301 594-1049
RIN: 0905-AD71
_______________________________________________________________________
1437. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION
UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY ACT OF 1986
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 06/00/95
Small Entities Affected: None
Government Levels Affected: State
Additional Information: 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-635), 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AD72
_______________________________________________________________________
1438. PERFORMANCE STANDARD FOR THE INFANT APNEA MONITOR
Legal Authority: 21 USC 360d
CFR Citation: 21 CFR 800
Legal Deadline: None
Abstract: FDA is proposing a mandatory standard for infant apnea
monitors which are intended for use on infants to detect cessation of
breathing. The standard includes requirements for infant apnea monitors
in four areas: Patient monitoring, electrical, mechanical and
environmental, and labeling. FDA considered reliance upon voluntary
standards to address risks presented by these devices but determined
that a mandatory standard is necessary.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 07/08/83 48 FR 31392
NPRM 10/00/94
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: James J. McCue, Jr., Chief, Operations 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, 301 594-4765
RIN: 0905-AD83
_______________________________________________________________________
1439. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992
Regulatory Plan: This entry is Seq. No. 41 in Part II of this issue of
the Federal Register.
RIN: 0905-AE19
_______________________________________________________________________
1440. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN; FEES
FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN
Legal Authority: 21 USC 352; 21 USC 356; 21 USC 371
CFR Citation: 21 CFR 429.40; 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 announce that it will no
longer routinely perform tests and assays on insulin samples prior to
certification where there is a testing and marketing history sufficient
to establish that precertification testing is no longer necessary. The
interim rule will also revise the fee schedule for insulin
certification services to reflect the change in FDA's certification
policy.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/95
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, 301 594-1049
RIN: 0905-AE28
_______________________________________________________________________
1441. ADVERSE EXPERIENCE REPORTING REQUIREMENTS FOR HUMAN DRUG AND
LICENSED BIOLOGICAL PRODUCTS
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 agency proposes to amend its 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 proposed
regulations would also revise certain definitions and reporting periods
and formats as recommended by the International Conference on
Harmonisation 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 proposal would amend the regulations governing the design
of, and the analysis and reporting of data from, clinical studies.
These proposed amendments are intended to provide more complete and
accurate information that would enable sponsors, investigators, and FDA
to determine early on the toxicity of investigational drugs during
clinical studies.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: None
Government Levels Affected: None
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, 301 594-1049
RIN: 0905-AE29
_______________________________________________________________________
1442. ELECTRONIC SIGNATURES
Legal Authority: 21 USC 301 et seq; 21 USC 201 et seq
CFR Citation: 21 CFR 11
Legal Deadline: None
Abstract: FDA is proposing 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 is being 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 (cont)
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: ABSTRACT CONT: that preserves the integrity of
the agency's enforcement activities.
Agency Contact: Paul J. Motise, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research (HFD-323), 7500 Standish Place, Rockville, MD 20855, 301 594-
1089
RIN: 0905-AE31
_______________________________________________________________________
1443. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
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 proposed 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 proposed rule are well below the $100
million threshold that defines a significant (cont)
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: ABSTRACT CONT: regulatory action. The proposed
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 proposed rule will strengthen the FDA
review process.
Agency Contact: John S. Ensign, Department of Health and Human
Services, Food and Drug Administration, Office of Health Affairs (HFY-
20), 5600 Fishers Lane, Rockville, MD 20857, 301 443-1382
RIN: 0905-AE32
_______________________________________________________________________
1444. EFFECTIVE DATE OF REQUIREMENT FOR SUBMISSION OF PREMARKET APPROVAL
APPLICATIONS
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 and 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 commercially viable. FDA is
providing an opportunity for manufacturers to petition for
reclassification before premarket approval is required.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice 05/06/94 59 FR 23731
NPRM 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE34
_______________________________________________________________________
1445. LATEX CONDOMS/GLOVES: EXPIRATION DATE LABELING
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 product and to place that date on their
labeling.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE37
_______________________________________________________________________
1446. AMALGAM INGREDIENT LABELING
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 03/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE39
_______________________________________________________________________
1447. LATEX WARNING
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 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE40
_______________________________________________________________________
1448. PREMARKET APPROVAL OF MEDICAL DEVICES; SUPPLEMENTAL APPLICATIONS
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 for a change in a device approval
application (PMA) was not submitted 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 03/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE41
_______________________________________________________________________
1449. MEDICAL DEVICES; RESTRICTED DEVICES
Legal Authority: 21 USC 351; 21 USC 360j(e)
CFR Citation: 21 CFR 801; 21 CFR 899
Legal Deadline: None
Abstract: The proposal would designate certain categories of devices as
``restricted devices.'' Restricted devices are defined by the statute
as devices that must be restricted in their sale, distribution or use
because of their potential for harmful effect or collateral measures
necessary to their use. FDA would propose to include in this category
devices such as those that pierce or penetrate the skin, implantable
devices, devices that introduce medicinal gas or energy into the body
and devices that are used for diagnosis that must be interpreted or
analyzed by a qualified health professional. Restricted devices are
subject to certain limitations on distribution and to special labeling
requirements. FDA also may regulate the advertising of restricted
devices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE42
_______________________________________________________________________
1450. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE
Regulatory Plan: This entry is Seq. No. 42 in Part II of this issue of
the Federal Register.
RIN: 0905-AE43
_______________________________________________________________________
1451. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR
SALE
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 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
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, 301 594-4765
RIN: 0905-AE46
_______________________________________________________________________
1452. HUMAN TISSUE INTENDED FOR TRANSPLANTATION: PROPOSED RULE
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 amending the regulations to require the registration
of those establishments engaged in procurement, processing, storage, or
distribution of human tissue intended for transplantation. It is also
intended to clarify those requirements previously promulgated by the
interim rule.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Rule; Opport. for
Comment 12/14/93 58 FR 65514
Interim Rule; Comment Period End03/14/94
NPRM 02/00/95
NPRM Comment Period End 05/00/95
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Paula McKeever, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AE49
_______________________________________________________________________
1453. FOODS DERIVED FROM NEW PLANT VARIETIES; PREMARKET
NOTIFICATION
Regulatory Plan: This entry is Seq. No. 43 in Part II of this issue of
the Federal Register.
RIN: 0905-AE50
_______________________________________________________________________
1454. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE
MEDICAL DEVICES
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. In so doing, the agency
anticipates promulgating relevant exemptions by using a risk-based
approach as required under the Medical Device Amendments to the act.
Under this approach all medical software devices will be subject to the
adulteration and misbranding provisions of the act. Moderate risk
devices will 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 seeking comment on potential criteria
related to the intended uses of medical software devices that might be
used in determining the level of risk as part of this document. FDA is
also clarifying the manner in which FDA's current statutory authorities
govern medical software devices under the act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AE58
_______________________________________________________________________
1455. IRON CONTAINING DRUGS AND SUPPLEMENTS
Legal Authority: 21 USC 343; 21 USC 348; 21 USC 351; 21 USC 352
CFR Citation: 21 CFR 101; 21 CFR 170; 21 CFR 310
Legal Deadline: None
Abstract: FDA is 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/06/94 59 FR 51030
NPRM Comment Period End 12/20/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: John Hathcock, Director, Division of Applied Science
and Technology, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-465),
200 C Street SW., Washington, DC 20204, 202 205-5365
RIN: 0905-AE59
_______________________________________________________________________
1456. NEW DRUG AND BIOLOGICAL PRODUCT LICENSE APPLICATIONS;
REGULATIONS IMPLEMENTING THE PRESCRIPTION DRUG USER FEE ACT OF 1992 AND
CLARIFYING EXISTING REGULATIONS
Legal Authority: 21 USC 379(e); 21 USC 379(g) to 379(h)
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
Legal Deadline: None
Abstract: FDA is proposing new regulations and amendments to current
regulations governing the submission of applications for marketing
approval for human drug and biological products to specify what must be
submitted as a separate original marketing application, what may be
combined in a single application, what changes to an approved
application may be submitted as a supplement, and when applicants
should respond to FDA action letters. FDA is taking this action to
provide clear regulatory policy to industry and to assure fair and
consistent implementation of the provisions of the Prescription Drug
User Fee Act of 1992 (PDUFA). The new regulations codify longstanding
policies as well as specific definitions and policies that have been
developed and used to implement the PDUFA.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/94
Small Entities Affected: None
Government Levels Affected: State, Federal
Agency Contact: Thomas Hassall, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-5), 5600 Fishers Lane, Rockville, MD
20857, 301 594-6740
RIN: 0905-AE61
_______________________________________________________________________
1457. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; PROPOSED AMENDMENT OF CERTAIN
REQUIREMENTS FOR FINISHED PHARMACEUTICALS
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 11/00/94
Small Entities Affected: None
Government Levels Affected: Federal
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, 301 594-1046
RIN: 0905-AE63
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1458. POLICIES CONCERNING USES OF SULFITING AGENTS
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 (cont)
Timetable:
Food Labeling; Declaration of Sulfiting Agents NPRM 04/03/85 (50 FR
13306) Final Action 07/09/86 (51 FR 25012) Effective Date 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 10/00/94
Revoking Use of Sulfiting Agents on Fruits & Vegetables, Etc. NPRM 08/
14/85 (50 FR 32836) Final Action 07/09/86 (51 FR 25021) Effective
date 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 02/00/95
Status of Use of Sulfit Agents on Minimally Procd & Froz Potatoes NPRM
02/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: 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 affirmed, by an equally divided vote and without
opinion, 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.
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, 202 254-9528
RIN: 0905-AB52
_______________________________________________________________________
1459. ABBREVIATED NEW DRUG APPLICATION REGULATIONS (TITLE I OF THE ``DRUG
PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984'')
Legal Authority: 21 USC 355 title I
CFR Citation: 21 CFR 10; 21 CFR 310; 21 CFR 314; 21 CFR 320
Legal Deadline: None
Abstract: Until the passage of title I of the Drug Price Competition
and Patent Term Restoration Act of 1984, abbreviated new drug
application (ANDA) procedures were only available for generic products
equivalent to pioneer drugs approved before 1962. Title I opened up the
ANDA policy to generic copies of products approved after 1962. On July
10, 1989 (54 FR 28872), FDA proposed regulations to implement Title I.
The proposal provides for the submission of abbreviated new drug
applications for generic versions of drug products first approved after
1962. These new provisions will benefit consumers by making generic
drug products available more quickly.
The agency is preparing the final rule in two segments. The final rule
for the first segment, which establishes requirements for the format
and content of an ANDA, suitability petitions, and certain
administrative actions, published in the Federal Register of April 28,
1992 (57 FR 17950). The agency is reviewing the public comments
submitted in response to the proposed requirements for patent
certification and exclusivity and preparing a final rule on the
segment.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/10/89 54 FR 28872
NPRM Comment Period End 10/10/89
NPRM Extension of Comment Period10/11/89 54 FR 41629
NPRM Public Comment Period End 01/09/90
NPRM Extension of Comment Period01/16/90 55 FR 1471
NPRM Public Comment Period End 04/09/90
Final Action Effective 11/02/94
Content and Format, Suitability Petitions Final Action 04/28/92 (57 FR
17950)
Patent Certification and Exclusivity Final Action 10/03/94 (59 FR
50338)
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, 301 594-1049
RIN: 0905-AB63
_______________________________________________________________________
1460. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS;
NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD COMPONENTS AT
INCREASED RISK FOR TRANSMITTING HIV INFECTION
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 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 (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/30/93 58 FR 34962
Final Action 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: 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 of
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.
Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AC90
_______________________________________________________________________
1461. LEAD IN FOODS
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. FDA has identified several potential sources of
dietary lead exposure that it intends to address in proposed rules in
its initiatives to reduce exposure to lead in the diet.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/01/89 54 FR 23485
NPRM Comment Period End 07/31/89
Prohibit Use of Lead-Soldered Food Cans NPRM 06/21/93 (58 FR
33860) Final Action 12/00/94
Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles NPRM 11/
25/92 (57 FR 55485) Final Action 02/00/95
Small Entities Affected: None
Government Levels Affected: None
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, 202 205-4681
RIN: 0905-AC91
_______________________________________________________________________
1462. EXPEDITING APPROVAL FOR DRUGS INTENDED TO TREAT LIFE-THREATENING
AND SEVERELY DEBILITATING ILLNESSES
Legal Authority: 21 USC 351 to 357; 21 USC 371; 42 USC 262
CFR Citation: 21 CFR 312
Legal Deadline: None
Abstract: In the Federal Register of October 21, 1988 (53 FR 41561),
FDA issued an interim rule, effective upon date of publication, with
opportunity for public comment, that set forth procedures designed to
speed the availability of new therapies to desperately ill patients,
while preserving appropriate guarantees for safety and effectiveness.
These procedures are intended to facilitate the development,
evaluation, and marketing of such products, especially where no
satisfactory alternative therapies exist. These procedures reflect the
recognition that physicians and patients are generally willing to
accept greater risks or side effects from products that treat life-
threatening and severely debilitating illnesses. These procedures also
reflect the recognition that the benefits of the drug need to be
evaluated in light of the severity of the disease being treated. The
procedures apply to life-threatening or severely debilitating
illnesses. The agency is reviewing the public comments submitted in
response to the interim rule and preparing a Federal Register document
that will respond to these comments. The (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 10/21/88 53 FR 41561
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Additional Information: ABSTRACT CONT: agency is also considering the
recommendations contained in the report of the ``National Committee to
Review Current Procedures for Approval of New Drugs for Cancer and
AIDS.''
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, 301 594-1049
RIN: 0905-AC94
_______________________________________________________________________
1463. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE
CERTIFICATION PROGRAMS
Legal Authority: 21 USC 502; 21 USC 506; 21 USC 701; 21 USC 706
CFR Citation: 21 CFR 80.10; 21 CFR 429.55
Legal Deadline: None
Abstract: 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 also considering similar amendments to the regulations
governing fees for the color additive certification program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule (Insulin) 10/04/91 56 FR 50248
Interim Final Rule (Color
Additives) 11/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: David R. Petak, Chief, Accounting Branch, Department of
Health and Human Services, Food and Drug Administration, Office of
Management (HFA-120), 5600 Fishers Lane, Rockville, MD 20857, 301 443-
1766
RIN: 0905-AD34
_______________________________________________________________________
1464. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION,
GUIDANCE, AND CLARIFICATIONS
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 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
proposed rule would provide (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/14/94 59 FR 11842
NPRM Comment Period End 08/01/94
Final Action 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: information, guidance, and
clarification of those sections of PDMA that are not related to State
licensing of wholesale distributors.
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, 301 594-1049
RIN: 0905-AD44
_______________________________________________________________________
1465. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990
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, November 28, 1992, 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. (cont)
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 12/00/
95
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) Final Action 00/00/00
Exemption of Humanitarian Devices NPRM 12/21/92 (57 FR 60491) Final
Action 02/00/95
Medical Device Recall Authority NPRM 06/14/94 (59 FR 30656) NPRM
(Correction) 06/23/94 (59 FR 32489) Final Action 00/00/00
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 12/00/94
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 00/00/00
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 10/00/94
Temporary Suspension of a Premarket Approval Application NPRM 10/12/93
(58 FR 52729) Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: ABSTRACT CONT: Summaries of Safety and
Effectiveness for Premarket Notification--A final rule will set forth
information to be included in data summaries on which substantial
equivalence determinations are made. Recall of Medical Devices--FDA
will propose procedures for using its authority to order device recalls
and notifications. Reports of Removal and Corrections--FDA will propose
procedures for manufacturers to report to FDA health-related market
removals and corrections of devices. Civil Money Penalties--FDA
proposed regulations to establish 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.
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, 301 594-4765
RIN: 0905-AD59
_______________________________________________________________________
1466. MANDATORY HACCP SEAFOOD INSPECTION PROGRAM
Legal Authority: 21 USC 342 Federal Food, Drug, and Cosmetic Act; 21
USC 371 Federal Food, Drug, and Cosmetic Act; 21 USC 374 Federal Food,
Drug, and Cosmetic Act; 42 USC 264 Public Health Service Act; 21 USC
321; 21 USC 343; 21 USC 346; 21 USC 348; 21 USC 379e; 21 USC 381; 42
USC 241; 42 USC 242l; 42 USC 300u-l; 42 USC 216; 42 USC 243
CFR Citation: 21 CFR 123; 21 CFR 1240
Legal Deadline: None
Abstract: The Food and Drug Administration intends to issue
requirements for the safe processing and importing of fish and fishery
products in keeping with Hazard Analysis Critical Control Point (HACCP)
principles. HACCP involves the identification and monitoring of
``critical control points'' in a processing or other operation the
failure of which can render a product adulterated. HACCP has been
strongly endorsed by the National Academy of Sciences for use by the
seafood industry.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/28/94 59 FR 4142
NPRM Comment Period End 03/29/94
Final Action 06/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: 42 USC 264; 42 USC 271
Agency Contact: Philip Spiller, Deputy Director, Office of Seafood,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition (HFS-401), 200 C Street
SW., Washington, DC 20204, 202 254-3885
RIN: 0905-AD60
_______________________________________________________________________
1467. BOTTLED WATER
Legal Authority: 21 USC 341; 21 USC 343(h); 21 USC 349; 21 USC 371(a)
CFR Citation: 21 CFR 103
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 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 04/
00/95
Microbiological Quality Standard NPRM 10/06/93 (58 FR 25042) Final
Action 04/00/95
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 11/00/95
Quality Standards for 39 Contaminants NPRM 01/05/93 (58 FR 382) Final
Action 10/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 202 205-4681
RIN: 0905-AD65
_______________________________________________________________________
1468. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN
PRESCRIPTION DRUGS; REVISION OF ``PEDIATRIC USE'' SUBSECTION IN THE
LABELING
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355
to 358; 21 USC 360 to 360b; 21 USC 371; 21 USC 374; 21 USC 376; 42 USC
216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n; 42 USC 264
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: In the Federal Register of October 16, 1992 (57 FR 47423),
the agency proposed to amend its regulations pertaining to the specific
content and format of prescription drug labeling by revising the
current ``Pediatric Use'' subsection of professional labeling to
provide for the inclusion of more complete information about use of a
drug in children and about hazards associated with this use. This
regulatory action is intended to respond to concerns in FDA and
elsewhere that current prescription drug labeling does not contain
adequate information about the use of drugs in children. 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 10/16/92 57 FR 47423
NPRM Comment Period End 12/15/92
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Erica L. Keys, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research (HFD-362), 7500 Standish Place, Rockville, MD
20855, 301 594-1049
RIN: 0905-AD76
_______________________________________________________________________
1469. RECORDKEEPING AND REPORTING: ELECTRONIC PRODUCTS
Legal Authority: 21 USC 360hh; 21 USC 360ii; 21 USC 360jj; 21 USC
360kk; 21 USC 360ll; 21 USC 360mm; 21 USC 360nn; 21 USC 360oo
CFR Citation: 21 CFR 1000; 21 CFR 1002
Legal Deadline: None
Abstract: The Final Rule would amend FDA regulations on Recordkeeping
and Reporting of adverse events and other information relating to
radiation emitting electronic products. The timing and content of
certain reports will be revised to enhance the usefulness of the
information. This action will result in improved protection of the
public health while reducing the regulatory burden on manufacturers and
distributors.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
ANPRM 07/02/82 47 FR 29004
ANPRM 11/16/82 47 FR 51706
ANPRM 07/01/85 50 FR 27024
NPRM 10/25/90 55 FR 43066
NPRM Comment Period End 01/22/91
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AD78
_______________________________________________________________________
1470. GENERAL BIOLOGICAL PRODUCT STANDARDS; ALTERNATIVE PROCEDURES AND
EXCEPTIONS
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 06/00/95
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Stephen Ripley, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AD82
_______________________________________________________________________
1471. MEDICAL DEVICES; PROTECTIVE RESTRAINTS; REVOCATION OF EXEMPTIONS
FROM 510(K) PREMARKET NOTIFICATION PROCEDURES AND CURRENT GOOD
MANUFACTURING PRACTICES REGULATIONS
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 exempting 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. (cont)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/19/92 57 FR 27397
NPRM Comment Period End 08/18/92
Final Action 12/00/94
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Additional Information: ABSTRACT CONT: These costs will be offset by
the saving of lives and reduced product liability exposure.
Agency Contact: Patricia Dubill, Department of Health and Human
Services, Food and Drug Administration, Center for Devices and
Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, MD 20850,
301 594-4765
RIN: 0905-AD84
_______________________________________________________________________
1472. THRESHOLD OF REGULATION POLICY FOR COMPONENTS OF FOOD CONTACT
ARTICLES
Legal Authority: 21 USC 321; 21 USC 341; 21 USC 342; 21 USC 346a; 21
USC 348; 21 USC 371
CFR Citation: 21 CFR 170; 21 CFR 171; 21 CFR 174
Legal Deadline: None
Abstract: FDA is establishing a policy for determining when the
likelihood/extent of migration of a component of a food contact article
is so trivial as not to require regulation as a food additive. A
substance considered under this Threshold of Regulation Policy would
undergo an abbreviated review by FDA, as opposed to the extensive
review and formal issuance of a regulation required for other food
additives. This final rule lists the criteria which must be met for a
food-contact material to be reviewed under this policy and identifies
the types of data that FDA will need for its review. This policy will
reduce regulatory cost and delays and thereby bring important and
innovative products to market faster.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/12/93 58 FR 52719
Final Action 06/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Edward J. Machuga, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-216), 200 C Street SW.,
Washington, DC 20204, 202 254-9528
RIN: 0905-AD86
_______________________________________________________________________
1473. FOOD LABELING REVIEW
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. In developing the
final rules that were published on January 6, 1993, the agency
identified three areas that should be the subject of additional
rulemaking: a definition for the nutrient content claim ``healthy''; a
definition for ``nonfunctional slack-fill''; and requirements for the
identification of certain ingredients on food labels. Proposed
regulations addressing these issues were published on January 6, 1993.
On May 12, 1993, FDA announced that, in accordance with the NLEA, the
regulation it proposed on January 6, 1993, on nonfunctional slack-fill
was considered a final rule. Subsequently, on December 6, 1993, FDA
issued a final rule responding to the comments received to the January
6, 1993, proposal. FDA also proposed on June 15, 1993, to amend its
January 6, 1993, final rules on nutrient content and health claims to
have 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 (cont)
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 03/00/95
Nutrient Content, Definition of the Term, Healthy NPRM 01/06/93 (58 FR
2944) Final Action 05/10/94 (59 FR 24232)
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 04/00/
95
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: ABSTRACT CONT: small restaurant firms for one
year. Finally, 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. These
actions were proposed following reconsideration of the provisions in
question.
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, 202 205-4561
RIN: 0905-AD89
_______________________________________________________________________
1474. LEVO-ALPHA-METHADOL (LAAM) IN MAINTENANCE; JOINT PROPOSED REVISION
OF CONDITIONS FOR USE
Legal Authority: 21 USC 355; 21 USC 371; 21 USC 823; 42 USC 241(d); 42
USC 290ee-3; 42 USC 257a
CFR Citation: 21 CFR 291
Legal Deadline: None
Abstract: The Food and Drug Administration and the National Institute
on Drug Abuse are reviewing comments on an interim rule that revised
the conditions for the treatment of narcotic addiction to provide for
the use of LAAM in the maintenance treatment of narcotic addicts. The
interim rule allows narcotic treatment programs to provide an
additional treatment drug for use in the maintenance treatment of
narcotic addicts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 07/20/93 58 FR 38704
Interim Final Rule Comment
Period End 09/20/93
Final Action 03/00/95
Small Entities Affected: None
Government Levels Affected: State, Local
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, 301 594-1046
RIN: 0905-AD92
_______________________________________________________________________
1475. TEMPOROMANDIBULAR JOINT IMPLANT CLASSIFICATION
Legal Authority: 21 USC 360c; 21 USC 360e
CFR Citation: 21 CFR 872.3940; 21 CFR 872.3950; 21 CFR 872.3960; 21
CFR 872.3970
Legal Deadline: None
Abstract: The final rule would classify into class III (Premarket
approval) certain temporomandibular joint (TMJ) prostheses including
the interarticular disc prosthesis (the interpositional implant), the
mandibular condyle prosthesis, and the glenoid fossa prosthesis. This
action would allow FDA to require manufacturers of these devices to
submit premarket approval applications demonstrating the safety and
effectiveness of these devices. The devices present a risk of implant
loosening or displacement; foreign body reaction; degenerative changes
to the natural articulating surfaces; infection; and loss of implant
integrity.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/18/92 57 FR 43165
NPRM Comment Period End 12/08/92 57 FR 56876
Reproposal 02/14/94 59 FR 6935
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AD93
_______________________________________________________________________
1476. DISQUALIFICATION OF CLINICAL INVESTIGATORS
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 02/00/95
Small Entities Affected: Businesses
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AD94
_______________________________________________________________________
1477. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES
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 02/00/95
Small Entities Affected: None
Government Levels Affected: None
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, 301 594-4765
RIN: 0905-AD95
_______________________________________________________________________
1478. DIETARY SUPPLEMENT LABEL REVIEW
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 (cont)
Timetable:
Health Claims and Label Statements; Dietary Supplements NPRM Folic
Acid and Neural Tube Def 10/14/93 (58 FR 53254) Final Action 00/00/00
Health Claims; Diet. Fiber/Cancer, CHD; Antioxidant/CVD; Omega-3 NPRM
10/14/93 (58 FR 53296)
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)
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: ABSTRACT CONT: 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.
Agency Contact: John Hathcock, Director, Divisions of Science and
Applied Technology, Office of Special Nutritionals, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-465), 200 C Street SW.,
Washington, DC 20204, 301 594-6006
RIN: 0905-AD96
_______________________________________________________________________
1479. ADVERSE EXPERIENCE REPORTING REQUIRED FOR LICENSED BIOLOGICAL
PRODUCTS
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42
USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25
CFR Citation: 21 CFR 600
Legal Deadline: None
Abstract: FDA is amending the regulations to require manufacturers,
packers, and distributors (hereafter referred to as LICENSED
MANUFACTURERS) of licensed biological products to report to FDA within
15 working days all adverse experiences associated with the use of a
biological product that are both serious and unexpected; any
significant increase in the frequency of a serious, but expected
adverse experience; periodically all other adverse experiences; and
product distribution and disposition data. FDA is taking this action to
provide a mechanism under which LICENSED MANUFACTURERS would inform the
agency, on a timely basis, of any unanticipated safety problems with
marketed biological products.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/29/90 55 FR 11611
NPRM Comment Period End 05/29/90
Final Action 11/00/94
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Paula McKeever, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448, 301 594-3074
RIN: 0905-AE18
_______________________________________________________________________
1480. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN
PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN THE
LABELING
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 11/00/94
Small Entities Affected: Undetermined
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, 301 594-1046
RIN: 0905-AE26
_______________________________________________________________________
1481. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER HUMAN
DRUG PRODUCTS
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 requirements 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 tamper 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 proposed 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 06/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
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, 301 594-1049
RIN: 0905-AE27
_______________________________________________________________________
1482. SUBSTANCES PROHIBITED FOR USE IN RUMINANT FEED
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 589.2000
Legal Deadline: None
Abstract: The Food and Drug Administration is considering a proposal to
ban the feeding of certain materials to ruminants. Epidemiological
evidence developed in the United Kingdom suggests increased vigilance
and precautionary practices are necessary to assure that Bovine
Spongiform Encephalopathy (BSE) is not introduced among cattle herds in
the United States. This same evidence has suggested that the feeding of
certain animal derived materials caused the BSE epidemic in the United
Kingdom.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/29/94 59 FR 44584
Final Action 04/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: John P. Honstead, Veterinary Medical Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine (HFV-222), 7500 Standish Place,
Rockville, MD 20855, 301 594-1728
RIN: 0905-AE45
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
_______________________________________________________________________
1483. IMPLEMENTATION OF TITLE I OF THE GENERIC ANIMAL DRUG AND PATENT
TERM RESTORATION ACT
CFR Citation: 21 CFR 514
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Merged With RIN 0905-AA96 07/15/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lonnie W. Luther, 301 594-1623
RIN: 0905-AD15
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1484. NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT PROGRAM; GRANTS FOR
STATE LOAN REPAYMENT PROGRAMS
Legal Authority: PL 100-177; PL 101-597
CFR Citation: 42 CFR 62.21 to 62.30; 42 CFR 62.51 to 62.58
Legal Deadline: None
Abstract: The National Health Service Corps (NHSC) Revitalization
Amendments of 1990, PL 101-597, amends Section 338B of the PHS Act
which authorizes the NHSC Loan Repayment Program. These Amendments also
revise the State Loan Repayment Program at Section 338I of the PHS Act.
The interim rule relating to both these programs as published April 3,
1989, will be revised to reflect the 1990 amendments. Regulations
governing the Special Repayment Program established under PL 100-177
were published on 11/6/91 in final form under RIN 0905-AD58, separate
from this NPRM (RIN 0905-AC65). The amended NHSC Loan Repayment Program
(RIN 0905-AD57) removes the provision which limits the Secretary's loan
repayment to one month in advance of services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 04/03/89 56 FR 13458
NPRM 01/00/95
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Rhoda Abrams, Director, Office of Program and Policy
Development, Bureau of Primary Health Care, Department of Health and
Human Services, Public Health Service, East-West Tower Bldg., 4350
East-West Highway, 7th Floor, Bethesda, MD 20814, 301 594-4060
RIN: 0905-AC65
_______________________________________________________________________
1485. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES
Regulatory Plan: This entry is Seq. No. 44 in Part II of this issue of
the Federal Register.
RIN: 0905-AD26
_______________________________________________________________________
1486. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: LENDERS'/ HOLDERS'
PERFORMANCE STANDARDS
Legal Authority: 42 USC 216; 42 USC 292 to 292o
CFR Citation: 42 CFR 60
Legal Deadline: NPRM, Statutory, October 13, 1993.
Abstract: This Notice of Proposed Rulemaking proposes to amend 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 10/00/94
Small Entities Affected: None
Government Levels Affected: None
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 Building, Room 8-48, Rockville, Maryland 20857,
301 443-1173
RIN: 0905-AD87
_______________________________________________________________________
1487. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS
AND ADDITIONS TO THE VACCINE INJURY TABLE - II
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 03/00/95
Small Entities Affected: None
Government Levels Affected: None
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, Maryland 20857, 301
443-6593
RIN: 0905-AE52
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1488. NATIONAL VACCINE INJURY COMPENSATION PROGRAM (VICP): REVISIONS TO
THE VACCINE INJURY TABLE
Legal Authority: 42 USC 216; 42 USC 300aa-14; 42 USC 300aa-1 note.
CFR Citation: 42 CFR 100
Legal Deadline: NPRM, Statutory, December 22, 1990.
Section 312 of PL 99-660 requires the Secretary to propose regulations
to amend the Vaccine Injury Table, based on the findings of the
Institute of Medicine (IOM) study, (cont)
Abstract: The National Vaccine Injury Compensation Program (VICP),
administered by the Secretary, and governed by subtitle 2 of title XXI
of the Public Health Service Act, as enacted by the National Childhood
Vaccine Injury Act of 1986 (the Act), provides a system of no-fault
compensation for certain individuals who have been injured by specific
childhood vaccines. The nature of the injuries, disabilities,
illnesses, conditions, and deaths which will be presumed to result from
the administration of specific vaccines, and the time period in which
the first symptom or manifestation of onset must occur for this
presumption to apply, are outlined in section 2114 of the Act in what
is known as the Vaccine Injury Table. This Final Rule makes refinements
to the Vaccine Injury Table to more accurately reflect current
scientific knowledge about the conditions that result from vaccines
which will result in appropriate compensation for injuries related to
vaccines.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/14/92 57 FR 36878
Public Hearing 10/29/92 57 FR 49055
NPRM Comment Period End 02/11/93
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: LEGAL DEADLINE CONT: within 3 years of the
effective date of title III (12/22/87). Since the IOM study was not
completed until August 1991, it was not possible to meet this legal
deadline. This section also requires the Final regulation to be
published 6 months after the NPRM. Given the 180-day comment period,
the 6-month requirement is an impossibility.
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, 5600 Fishers
Lane, Parklawn Building, Room 8A35, Rockville, Maryland 20857, 301 443-
6593
RIN: 0905-AD64
_______________________________________________________________________
1489. GRANTS FOR FACULTY TRAINING PROJECTS IN GERIATRIC MEDICINE AND
DENTISTRY
Legal Authority: 42 USC 216; 42 USC 294o
CFR Citation: 42 CFR 57, subpart PP
Legal Deadline: None
Abstract: This final amends the Grants for Faculty Training Projects in
Geriatric Medicine and Dentistry regulations to bring the existing
regulations into conformity with technical amendments made by the
Health Professions Extension Amendments of 1992 (Pub. L. 102-408); to
propose two new definitions for ``relevant advanced training or
experience'' and ``geriatric psychiatry''; and to remove a section
regarding the period of time for fellowship appointments for more
flexibility in implementing the program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/03/94 59 FR 10104
NPRM Comment Period End 04/04/94
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Neil H. Sampson, Director, Division of Associated,
Dental & Public Health Professions, BHPr, Department of Health and
Human Services, Health Resources and Services Administration, Room 8-
101, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, 301
443-6853
RIN: 0905-AE13
_______________________________________________________________________
1490. GRANTS FOR THE ESTABLISHMENT OF DEPARTMENTS OF FAMILY MEDICINE
Legal Authority: 42 USC 216; 42 USC 293k
CFR Citation: 42 CFR 57, subpart R
Legal Deadline: None
Abstract: This final amends the Grants for the Establishment of
Departments of Family Medicine regulations to expand the definition of
``academic administrative unit'' to clarify which academic
administrative units are eligible for support under the authority of
section 747 of the Public Health Service Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/19/94 59 FR 36733
NPRM Comment Period End 08/18/94 59 FR 36733
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marc L. Rivo, M.D., Director, Division of Medicine,
Bureau of Health Professions, Department of Health and Human Services,
Health Resources and Services Administration, Room 4C-25, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-6190
RIN: 0905-AE17
_______________________________________________________________________
1491. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION REQUIREMENTS FOR
PROVISION OF SERVICES TO PERSONS UNABLE TO PAY (NURSING HOMES)
Legal Authority: 42 USC 291 et seq; 42 USC 300q et seq
CFR Citation: 42 CFR 124 subpart F
Legal Deadline: None
Abstract: The current regulations stipulate that an indigent is
ineligible for Hill-Burton uncompensated services if the individual is
covered under a third-party insurance or governmental program. This
requirement has created major compliance problems for many Hill-Burton
obligated nursing homes. In most of these nursing homes, the only
individuals who meet the income eligibility requirements for receipt of
Hill-Burton uncompensated services (Category A and B eligibility) are
also covered by their State's Medicaid program; hence, they are by
definition ineligible for Hill-Burton uncompensated services. The
proposed regulations would address this problem by establishing a third
income-eligibility level (Category C) for nursing homes, which would
allow individuals whose annual incomes are greater than those under
Category A and B to be eligible for nursing home services. This would
result in a limit substantially above the Medicaid income eligibility
limit, thus allowing more individuals to be eligible for services in
Hill-Burton nursing homes.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/04/94 59 FR 15693
NPRM Comment Period End 06/03/94 59 FR 15693
Final Action 10/00/94
Small Entities Affected: Organizations
Government Levels Affected: None
Agency Contact: Charlotte G. Pascoe, Director, Division of Facilities
Compliance, Bureau of Health Resources Development, Department of
Health and Human Services, Public Health Service, 5600 Fishers Lane,
Room 11-19, Parklawn Building, Rockville, Maryland 20857, 301 443-5656
RIN: 0905-AE33
_______________________________________________________________________
1492. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: AMENDMENT TO DATA BANK
REGULATIONS TO COMPLY WITH COURT ORDER
Legal Authority: 42 USC 11101 et seq
CFR Citation: 45 CFR 60
Legal Deadline: None
Abstract: These regulations amend the current regulations under section
60.7(a) and (c) to require reporting of medical malpractice payments
only by entities which make these payments on behalf of physicians and
other health care practitioners, deleting the requirement of reporting
by persons who make such payments.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 11/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas C. Croft, Director, Division of Quality
Assurance, Bureau of Health Professions, Department of Health and Human
Services, Health Resources and Services Administration, Room 8-67,
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, 301
443-2300
RIN: 0905-AE38
_______________________________________________________________________
1493. FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT OF 1992
Legal Authority: 42 USC 216; 42 USC 233
CFR Citation: 42 CFR 6
Legal Deadline: None
Abstract: These regulations clarify that the range of health care
services provided by eligible entities and individuals would be covered
under the Federal Tort Claims Act (FTCA). As a result, health centers
would not have to purchase private insurance policies to cover gaps of
malpractice liability exposure. The intended effect of this proposed
rule is to save funds for PHS grantees and invest such savings into
providing additional health services to the medically underserved
populations of covered health centers and their health professionals.
The Domestic Policy Council staff requested the publication of these
rules in an expeditious manner to facilitate full implementation of the
1992 legislation.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/19/94 59 FR 42790
NPRM Comment Period End 09/19/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Libby Merrill, Legislative Analyst, Office of Program
and Policy Development, Bureau of Primary Health Care, Department of
Health and Human Services, Public Health Service, East-West Tower
Bldg., 4350 East-West Highway, 7th Floor, Bethesda, MD 20814, 301 594-
4060
RIN: 0905-AE48
_______________________________________________________________________
1494. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS, DENTISTS, AND OTHER HEALTH CARE PRACTITIONERS: DEBT
COLLECTION METHODS
Legal Authority: 42 USC 11101 et seq
CFR Citation: 45 CFR 60
Legal Deadline: None
Abstract: This final rule would modify section 60.12(c), ``Assessing
and collecting fees,'' of the Data Bank regulations to provide Data
Bank customers several alternative ways to pay the fee(s) associated
with querying the Data Bank. The regulation currently prescribes that
``fees must be paid by check or money order made payable to 'U.S.
Department of Health and Human Services' or to the unit stated in the
billing.'' Those options would be expanded to include payment by credit
card and other electronic means (e.g., automated clearinghouse).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas C. Croft, Director, Division of Quality
Assurance, Bureau of Health Professions, Department of Health and Human
Services, Health Resources and Services Administration, Room 8-67,
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, 301
443-2300
RIN: 0905-AE53
_______________________________________________________________________
1495. TECHNICAL AMENDMENTS TO THE HEALTH PROFESSIONS, NURSING,
AND ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58
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 title 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 03/00/95
Small Entities Affected: None
Government Levels Affected: None
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 8A-55, Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, 301 443-1590
RIN: 0905-AE54
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--Health Resources and Services
Administration (HRSA)
_______________________________________________________________________
1496. MATERNAL AND CHILD HEALTH (MCH) PROJECT GRANTS
CFR Citation: 42 CFR 51a
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/19/94 59 FR 36703
Final Action Effective 08/18/94 59 FR 36703
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Federal
Agency Contact: Lynn Squire, 301 443-2778
RIN: 0905-AD88
_______________________________________________________________________
1497. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION; REQUIREMENTS FOR
PROVISION OF SERVICES TO PERSONS UNABLE TO PAY (CHARITABLE FACILITIES)
CFR Citation: 42 CFR 124 subpart F
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/30/94 59 FR 44634
Final Action Effective 08/30/94
Small Entities Affected: Organizations
Government Levels Affected: None
Agency Contact: Charlotte G. Pascoe, 301 443-5656
RIN: 0905-AE06
_______________________________________________________________________
1498. GRANTS FOR NURSE PRACTITIONER AND NURSE-MIDWIFERY PROGRAMS
CFR Citation: 42 CFR 57, subpart Y
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn Pending nursing
reauthorizing legislation 07/06/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marla E. Salmon, ScD. RN, 301 443-5786
RIN: 0905-AE11
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1499. INDIAN HEALTH SERVICE LOAN REPAYMENT PROGRAM REGULATIONS
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: Public Law 100-713, enacted November 23, 1988, authorized a
program in which health professionals would have their health
professions education loans repayed in amounts up to a maximum of
$25,000 per year in exchange for service in an Indian health program.
The Secretary is directed to implement some provisions by regulations,
i.e., waiver provision. P. L. 102-573 raised the maximum to $35,000 for
repayment of educational loans.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/94
NPRM Comment Period End 02/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Linus Everling, Chief, Scholarship Branch, Indian
Health Service, Department of Health and Human Services, Public Health
Service, 12300 Twinbrook Parkway, Suite 100, Rockville, MD 20852, 301
443-6197
RIN: 0905-AC96
_______________________________________________________________________
1500. INDIAN HEALTH SERVICE CATASTROPHIC HEALTH EMERGENCY FUND PROGRAM
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: Public Law 100-713, enacted November 23, 1988, authorized a
new program establishing a catastrophic health emergency fund. The
Secretary is directed to establish the program by regulations
consistent with provisions of the Law including a definition of a
catastrophic disease.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
NPRM Comment Period End 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Betty J. Penn, Chief, Regulations Branch, DLR, Indian
Health Service, Department of Health and Human Services, Public Health
Service, 12300 Twinbrook Parkway., Suite 450, Rockville, MD 20852, 301
443-1116
RIN: 0905-AC97
_______________________________________________________________________
1501. REVISION OF URBAN INDIAN HEALTH REGULATIONS
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: P.L. 100-713, enacted November 23, 1988, requires the
Secretary to prescribe, by regulation, the criteria for selecting urban
Indian organizations to enter into contracts.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
NPRM Comment Period End 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Betty J. Penn, Chief, Regulations Branch, DLR, Indian
Health Service, OPEL, Department of Health and Human Services, Public
Health Service, 12300 Twinbrook Parkway, Suite 450, Rockville, MD
20852, 301 443-1116
RIN: 0905-AD20
_______________________________________________________________________
1502. ACQUISITION UNDER THE BUY INDIAN ACT
Legal Authority: 25 USC 47
CFR Citation: 48 CFR ch 3, app A
Legal Deadline: None
Abstract: This regulation will update and standardize existing
regulations for the Buy Indian Act to coincide with the Department of
Interior regulations at 48 CFR Chapter 14. There are no costs
associated with these revised regulations. These revisions will
increase competition among Indian economic enterprises and facilitate
economic development of Indian reservations by increasing opportunities
for Indian businesses.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
NPRM Comment Period End 03/00/95
Small Entities Affected: None
Government Levels Affected: Tribal
Procurement: This is a procurement-related action for which there is a
statutory requirement. The agency has not yet determined whether there
is a paperwork burden associated with this action.
Agency Contact: Myrna Mooney, Small and Disadvantaged Business
Utilization, Specialist, Department of Health and Human Services,
Public Health Service, 12300 Twinbrook Parkway - Suite 450, Rockville,
MD 20852, 301 443-1480
RIN: 0905-AE09
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
_______________________________________________________________________
1503. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS
Regulatory Plan: This entry is Seq. No. 47 in Part II of this issue of
the Federal Register.
RIN: 0905-AC98
_______________________________________________________________________
1504. REVIEW OF THE DETERMINATION OF AN INDIAN TRIBE'S RESOURCE
DEFICIENCY LEVEL
Legal Authority: PL 100-713
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: P.L. 100-713, enacted November 23, 1988, requires the
Secretary to establish, by regulation, procedures which would allow any
Indian tribe to petition the Secretary for a review of any
determination of the health resources deficiency level of such tribe.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/10/91 56 FR 51189
NPRM Comment Period End 12/09/91 56 FR 51189
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Betty J. Penn, Chief, Regulations Branch, DLR, Indian
Health Service, OPEL, Department of Health and Human Services, Public
Health Service, 12300 Twinbrook Parkway, Suite 450, Rockville, MD
20852, 301 443-1116
RIN: 0905-AD21
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1505. GRANTS FOR RESEARCH PROJECTS
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 the Food and Drug Administration
previously omitted from the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: John J. Migliore, 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,
301 496-4606
RIN: 0905-AC02
_______________________________________________________________________
1506. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM
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 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Marc Horowitz, Director, NIH AIDS Research Loan
Repayment Program, Department of Health and Human Services, Public
Health Service, Office of AIDS Research, National Institutes of Health,
9000 Rockville Pike, Bethesda, MD 20892, 301 496-0357
RIN: 0905-AD18
_______________________________________________________________________
1507. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS
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 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Dr. William A. Suk, Program Administrator, Division of
Extramural Research and Training, Department of Health and Human
Services, Public Health Service, NIEHS, P.O. Box 12233, Research
Triangle Park, NC 27709, 919 541-0797
RIN: 0905-AD46
_______________________________________________________________________
1508. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS
Legal Authority: 42 USC 216; 42 USC 285a-2; 42 USC 285a-3; 42 USC
285a-4; 42 USC 285b-3; 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 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg. 31, Rm 1B25, Center DR
MSC 2075, Bethesda, MD 20892-2075, 301 496-4606
RIN: 0905-AD49
_______________________________________________________________________
1509. STANDARDS FOR BONE MARROW REGISTRIES AND CENTERS
Legal Authority: 42 USC 216; 42 USC 274k
CFR Citation: 42 CFR 122
Legal Deadline: Final, Statutory, May 14, 1991.
Abstract: Regulations will be proposed to implement title I of PL 101-
616, Transplant Amendments Act of 1990, which added section 379 to the
Public Health Service Act. Section 379 authorizes the Secretary to
establish and maintain a National Bone Marrow Donor Registry, and
further provides that the Secretary shall establish and enforce
criteria, standards, and procedures for entities participating in the
National Bone Marrow Donor Program, including the National Registry.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul R. McCurdy, MD, Special Assistant for Clinical
Hematology, Div. of Blood Diseases and Resources, NHLBI, Department of
Health and Human Services, Public Health Service, Federal Building,
Room 516, 7550 Wisconsin Avenue, Bethesda, MD 20892, 301 496-8387
RIN: 0905-AD51
_______________________________________________________________________
1510. TRAINING GRANTS
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 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg. 31, Rm 1B25, Center DR
MSC 2075, Bethesda, MD 20892-2075, 301 496-4606
RIN: 0905-AD56
_______________________________________________________________________
1511. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS
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)(b); 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Additional Legal Authorities: 42 USC 286a-
7(c)(1)(G)
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR
MSC 2075, Bethesda, MD 20892-2075, 301 496-4606
RIN: 0905-AE00
_______________________________________________________________________
1512. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS
Legal Authority: 42 USC 216, 285n-2
CFR Citation: 42 CFR 54a
Legal Deadline: None
Abstract: Regulations governing grants for alcohol abuse and alcoholism
prevention, treatment, and rehabilitation services, and National
Alcohol Research Centers will be amended to set forth changes
necessitated by enactment of the Alcohol, Drug Abuse, and Mental Health
Administration (ADAMHA) Reorganization Act, Public Law 102-321, and
other changes necessary to update the regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, Bldg. 31, Rm. 3B-11, 9000 Rockville Pike,
Bethesda, MD 20892, 301 496-2832
RIN: 0905-AE08
_______________________________________________________________________
1513. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN
REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS
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 payments under the NIH Clinical Research Loan
Repayment Program for Individuals from Disadvantaged Background
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 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marc Horowitz, Dir., Clinical Research Loan Repayment
Prog., Individuals from Disadvantaged Backgrounds, Department of Health
and Human Services, Public Health Service, Office of AIDS Research,
9000 Rockville Pike, Bethesda, MD 20892, 301 402-0852
RIN: 0905-AE56
_______________________________________________________________________
1514. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS
NEEDED BY THE NIH
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 ten consecutive weeks of service (employment) at the NIH
during which the individual is attending the institution and receiving
the NIH scholarship. The proposed new regulations will cover this
program.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marc Horowitz, Dir., NIH AIDS Research Loan Repayment,
Program, Department of Health and Human Services, Public Health
Service, Office of AIDS Research, NIH, 9000 Rockville Pike, Bethesda,
MD 20892, 301 402-0852
RIN: 0905-AE57
_______________________________________________________________________
1515. TRAINEESHIPS (TERMINATION POLICIES)
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 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Migliore, NIH Regulations Officer, Department of
Health and Human Services, Public Health Service, National Institutes
of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR MSC 2075,
Bethesda, MD 20892-2075, 301 496-4606
RIN: 0905-AE62
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1516. TRAINEESHIPS
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 concerning National Institutes of Health, and
National Library Medicine traineeships will be revised in their
entirety to cover traineeships awarded under sections 404 E(d)(2),
405(b)(1)(C), 472, and 485B of the PHS act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/06/93 58 FR 42039
NPRM Comment Period End 10/05/93
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Migliore, NIH Regulations Officer, Department of
Health and Human Services, Public Health Service, National Institutes
of Health, 9000 Rockville Pike, Bldg. 31, Rm. 1B25, Center DR MSC 2075,
Bethesda, MD 20892-2075, 301 496-4606
RIN: 0905-AD28
_______________________________________________________________________
1517. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS WASTE
WORKER TRAINING
Legal Authority: 42 USC 9660a; 42 USC 1816
CFR Citation: 42 CFR 65
Legal Deadline: None
Abstract: Regulations concerning the NIEHS Hazardous Waste Worker
Training Program will be amended to make them applicable to grants
administered under the Hazardous Materials Employee Training Grant
Program. The grants are authorized under section 118 of the Hazardous
Materials Transportation Act (HMTA), 49 USC App. 1816, as amended by
the Hazardous Materials Transportation Uniform Safety Act (HMTUSA) of
1990, P.L. 101-615.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/29/93 58 FR 50897
NPRM Comment Period End 11/29/93
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR
MSC 2075, Bethesda, MD 20892-2075, 301 496-4606
RIN: 0905-AD69
_______________________________________________________________________
1518. RESPONSIBILITIES OF PUBLIC HEALTH SERVICE-FUNDED INSTITUTIONS FOR
PROMOTING OBJECTIVITY IN RESEARCH
Regulatory Plan: This entry is Seq. No. 48 in Part II of this issue of
the Federal Register.
RIN: 0905-AE01
_______________________________________________________________________
1519. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION AND
CONTROL PROJECTS
Legal Authority: 42 USC 216; 42 USC 285b-1
CFR Citation: 42 CFR 52e
Legal Deadline: None
Abstract: Regulations governing NHLBI grants for prevention and control
projects will be amended to conform them to changes in PHS Act section
419 made by the NIH Revitalization Act of 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR
MSC 2075, Bethesda, MD 20892-2075, 301 496-2832
RIN: 0905-AE25
_______________________________________________________________________
1520. NATIONAL LIBRARY OF MEDICINE GRANTS
Legal Authority: 42 USC 216; 42 USC 286b-5
CFR Citation: 42 CFR 59a
Legal Deadline: None
Abstract: Regulations governing National Library of Medicine grants for
establishing, expanding, and improving basic medical library resources
are being amended to reflect the change in the maximum award amount
from $750,000 to $1,000,000 as authorized by the National Institutes of
Health Revitalization Act of 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John J. Migliore, NIH Regulations Officer, Department
of Health and Human Services, Public Health Service, National
Institutes of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR
MSC 2075, Bethesda, MD 20892-2075, 301 496-4606
RIN: 0905-AE55
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
_______________________________________________________________________
1521. HEALTH AND HUMAN SERVICES POLICY FOR PROTECTION OF HUMAN
SUBJECTS
Legal Authority: 5 USC 301; 42 USC 289
CFR Citation: 45 CFR 46
Legal Deadline: None
Abstract: HHS is amending its Human Subjects Protection regulations to
rescind the provision requiring prior review and advice from an Ethical
Advisory Board for research applications and proposals involving in
vitro fertilization of human ova as a prerequisite to funding by HHS
and its components. The provision was nullified by the National
Institutes of Health Revitalization Act of 1993. The regulations are
being amended to reflect this statutory nullification.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 06/01/94 59 FR 28276
Final Action Effective 06/01/94 59 FR 28276
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: F. William Dommel, Jr., J.D., Office of Protection from
Research Risks, NIH, Department of Health and Human Services, Public
Health Service, NIH, Bldg. 31, Room 5B63, 9000 Rockville Pike,
Bethesda, MD 20892-001, 301 496-7005
RIN: 0905-AE47
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Public Health Service (PHS)--Agency for Health Care Policy and Research
(AHCPR)
_______________________________________________________________________
1522. HEALTH SERVICES RESEARCH, EVALUATION, DEMONSTRATION, AND
DISSEMINATION PROJECTS; PEER REVIEW OF GRANTS AND CONTRACTS
Legal Authority: 42 USC 299c-1(e)
CFR Citation: 42 CFR 67
Legal Deadline: None
Abstract: This final rule revises the regulations under 42 CFR part 67
governing grants for health services research and grants for health
services research centers made by the former National Center for Health
Services Research and Health Care Technology Assessment (NCHSR). Public
Law 101-239, enacted on December 19, 1989, established the Agency for
Health Care Policy and Research to replace the NCHSR, and in title IX
of the PHS Act and section 1142 of the Social Security Act provided the
new agency with a much expanded role in health services research. The
final rule will reflect applicable provisions of these statutes, as
amended by P.L. 102-410.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/16/93 58 FR 60510
NPRM Comment Period End 01/18/94
Final Action 01/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Linda K. Demlo, Ph.D., Director, Office of Program
Development, Agency for Health Care Policy and Research, Department of
Health and Human Services, Public Health Service, Suite 603, 2101 East
Jefferson Street, Rockville, MD 20852, 301 594-2453
RIN: 0905-AD30
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1523. HOSPICE SERVICES (MB-7-P)
Legal Authority: 42 USC 1396d(a)(18); 42 USC 1396d(o); 42 USC
1396a(a)(13)(D); 42 USC 1396o(a)(2)(E)
CFR Citation: 42 CFR 418.32; 42 CFR 435.218; 42 CFR 435.231; 42 CFR
440.185; 42 CFR 447.53; 42 CFR 447.327; 42 CFR 447.381 to 447.384; 42
CFR 435.726; 42 CFR 435.735; 42 CFR 436.231
Legal Deadline: None
Abstract: This regulation would implement section 9505 of PL 99-272 by
establishing eligibility and coverage requirements, payment procedures
and conditions of participation for optional Medicaid coverage of
hospice care. It would also implement section 9435(b) of PL 99-509
regarding payment for hospice care for individuals residing in a
nursing facility or intermediate care facility in a State that has not
elected to cover hospice services. It also would implement sections
4705 and 4717 of PL 101-508 which further clarifies conditions for
payment and the scope of benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Organizations
Government Levels Affected: State
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 400 EHR, 6325 Security Blvd., Baltimore, MD 21207,
410 966-5659
RIN: 0938-AC52
_______________________________________________________________________
1524. TRANSFER OF RESOURCES FOR LESS THAN FAIR MARKET VALUE (MB-10-P)
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) of the Social Security Act, which was extensively
revised by section 303(b) of MCCA '88 (PL 100-360) as amended by
section 608(d)(16)(B) of FSA '88 (PL 100-485) and section 6411(e)(1) of
based services with no time limit on the penalty if these individuals
or their spouses made transfers of assets (including establishing
trusts under certain conditions) for less than fair market value during
a prohibited period. The period of ineligibility applies if the
individual or spouse made a transfer of assets for less than fair
market value at any time during or after the 36-month period
immediately before a date established according to a formula
established in the law.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/95
Small Entities Affected: None
Government Levels Affected: State, Local
Additional Information: ABSTRACT CONT: This rule will also reflect
statutory revisions mandated by OBRA '93.
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323 EHR, 6325 Security Blvd., Baltimore, MD 21207,
410 966-4451
RIN: 0938-AD18
_______________________________________________________________________
1525. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES (BPD-
425-P)
Legal Authority: 42 USC 1395x(g); 42 USC 1395x(p); 42 USC 1395x(w)(1)
CFR Citation: 42 CFR 400.202; 42 CFR 410; 42 CFR 424; 42 CFR 484; 42
CFR 485; 42 CFR 489
Legal Deadline: None
Abstract: This rule would implement section 9337 of PL 99-509 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 PL 101-239 which increased the payment limit for
outpatient occupational therapy services provided by independent
practitioners. This proposed rule would also redesignate current
subpart Q of part 405 of the Medicare rules as new part 485.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marsha Klamner, Health Insurance Specialist, Health
Organizations Branch, Department of Health and Human Services, Health
Care Financing Administration, Rm. 401, EHR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-4632
RIN: 0938-AD32
_______________________________________________________________________
1526. REVISIONS TO THE FREEDOM OF INFORMATION REGULATIONS (OPA-1-P)
Legal Authority: 5 USC 552; EO 12600
CFR Citation: 42 CFR 401.101 to 401.104; 42 CFR 401.110 to 401.112; 42
CFR 401.120 to 401.125; 42 CFR 401.130 to 401.138; 42 CFR 401.140 to
401.145; 42 CFR 401.150 to 401.154
Legal Deadline: None
Abstract: This rule proposes changes to the regulations implementing
the Freedom of Information Act (FOIA). The regulations are being
revised based on HCFA's experience with the FOIA in administering the
Medicare and Medicaid programs. This rule would also conform HCFA's
FOIA regulations to regulations published by the Department of Health
and Human Services, as well as to guidance issued by the Office of
Management and Budget, the Department of Justice, Presidential
Executive Order 12600, and to the Freedom of Information Reform Act of
1986.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Martha DiSario, Acting Director, Office of Public
Affairs, Department of Health and Human Services, Health Care Financing
Administration, Room 435-H HHH Building, 200 Independence Avenue SW.,
Washington, DC 20201, 202 690-6113
RIN: 0938-AD60
_______________________________________________________________________
1527. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) POLICIES
(BPD-491-P)
Legal Authority: 42 USC 1395u; 42 USC 1395ss
CFR Citation: 42 CFR 403.200; 42 CFR 403.201; 42 CFR 403.205; 42 CFR
403.206; 42 CFR 403.210; 42 CFR 403.211 to 403.220; 42 CFR 403.222; 42
CFR 403.224; 42 CFR 403.226; 42 CFR 403.228; 42 CFR 403.229; 42 CFR
403.231; 42 CFR 403.332; 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, and
1990. 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 and the Medicare Catastrophic
Coverage Repeal Act of 1989.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Julie Walton, Health Insurance Specialist, Long Term
Care Branch, Div. of Provider Services Coverage Policy, Department of
Health and Human Services, Health Care Financing Administration, Room
401, EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-
4622
RIN: 0938-AD82
_______________________________________________________________________
1528. FEE SCHEDULE FOR PAYMENT OF CLINICAL PSYCHOLOGIST SERVICES (BPD-
495-P)
Legal Authority: 42 USC 1395k(a)(2)(B)(iii); 42 USC 1395x(gg); 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 410
Legal Deadline: None
Abstract: This interim final rule with comment period establishes fee
schedules for payment for therapeutic and miscellaneous diagnostic
services furnished under Medicare Part B by clinical psychologists or
incident to the services of a clinical psychologist. It implements a
portion of section 4077(b) of OBRA '87 as amended.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Elisa Tunanidas, Health Insurance Specialist, Division
of Medical Services Payment, Department of Health and Human Services,
Health Care Financing Administration, 1-H-5, ELR, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-4505
RIN: 0938-AD84
_______________________________________________________________________
1529. CLARIFICATION OF ``WITHOUT FAULT'' AS IT APPLIES TO PHYSICIAN
PROVIDER AND SUPPLIER LIABILITY (BPD-719-P)
Legal Authority: 42 USC 1395gg
CFR Citation: 42 CFR 405.350 to 405.355; 42 CFR 405.356 to 405.361; 20
CFR 404.506 to 510
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
incorporate in HCFA regulations pertinent portions of Social Security
Administration regulations dealing with ``without fault.''
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Paul Olenick, Director, Division of Medicare
Eligibility Policy, Department of Health and Human Services, Health
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4472
RIN: 0938-AD95
_______________________________________________________________________
1530. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSE (MB-23-P)
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)(A) of the FSA (PL 100-485), section
6411(e)(3) of OBRA '89 (PL 101-239) and section 4714 of OBRA '90 (PL
101-508). 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 12/00/94
Small Entities Affected: Undetermined
Government Levels Affected: State, Local
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4451
RIN: 0938-AE12
_______________________________________________________________________
1531. PHYSICIAN CERTIFICATION AND PLAN OF CARE REQUIREMENTS AND
INSPECTION OF CARE REVIEWS (HSQ-178-P)
Legal Authority: 42 USC 1396b(g); 42 USC 1396a(a)(30); 42 USC
1396a(a)(44)
CFR Citation: 42 CFR 400; 42 CFR 440; 42 CFR 441; 42 CFR 456; 42 CFR
483
Legal Deadline: None
Abstract: This proposed rule would make the requirements for physician
certification and development of a plan of care general State plan
requirements. States would no longer be required to make quarterly
showings that they had determined compliance with those requirements or
with utilization review. A quarterly demonstration to the Secretary of
an effective program of medical review as demonstrated by a
satisfactory utilization control program would be limited to
Inspections of Care (IOCs) in participating Intermediate Care
Facilities/Mentally Retarded (ICFs/MR) and psychiatric hospitals. This
rule will establish review criteria specifically for ICFs/MRs that
ensure essential client protections and focus on the provision of
active treatment. This rule will also clarify utilization control
requirements included in 42 CFR part 456, Subpart S.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Helene Fredeking, Director, Division of Long Term Care
Services, Department of Health and Human Services, Health Care
Financing Administration, 2-D-2, ME, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-6807
RIN: 0938-AE17
_______________________________________________________________________
1532. MEDICAID PAYMENT OF MEDICARE COST SHARING FOR QUALIFIED MEDICARE
BENEFICIARIES AND QUALIFIED DISABLED AND WORKING INDIVIDUALS AND
SPECIFIED LOW-INCOME MEDICARE BENEFICIARIES (MB-031-P)
Legal Authority: 42 USC 1396a(a)(10)(E); Clause VIII of the matter
following 42 USC 1396a(a)(10)(F); 42 USC 1396a(e)(8); 42 USC
1396a(m)(4); 42 USC 1396a(n); 42 USC 1396b(f)(4); 42 USC 1396d(a); 42
USC 1396d(p); 42 USC 1302
CFR Citation: 42 CFR 431.625; 42 CFR 435; 42 CFR 436; 42 CFR 441.256;
42 CFR 447.600 to 447.620; 42 CFR 447.51; 42 CFR 447.53
Legal Deadline: None
Abstract: These rules would propose to require States to include in
their State plans payment of Medicare cost-sharing for specified low-
income Medicare beneficiaries (SLMBS), Qualified Medicare Beneficiaries
(QMB) and Qualified Disabled and Working Individuals (QDWI). The
territories have the option to do the same. We would define cost-
sharing, specify criteria for determining QMB status, propose
requirements and options for payment amounts and limitations, and
provide for Federal financial participation in State payments for
Medicare cost-sharing on behalf of QMBs. For QDWIs Federal financial
participation would be limited to Medicare, Part A premium. The changes
would implement provisions of MCCA '88 as modified by the FSA '88, TMRA
'88, OBRA '89, and OBRA '90. Many of these provisions went into effect
January 1, 1989.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Local
Additional Information: TIMETABLE: Pending consultation with outside
groups and resolution of complex issues.
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323, EHR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-4451
RIN: 0938-AE38
_______________________________________________________________________
1533. COVERAGE OF PHYSICIAN ASSISTANT, NURSE PRACTITIONER, AND CLINICAL
NURSE SPECIALIST SERVICES (BPD-708-P)
Legal Authority: 42 USC 1395x(s)(2)(K); 42 USC 1395u(b)(12); 42 USC
1395x(aa)
CFR Citation: 42 CFR 405; 42 CFR 410
Legal Deadline: None
Abstract: This proposed rule would conform Medicare regulations to the
provisions in sections 9338 of OBRA '86, 4076(a) of OBRA '87, 6114 of
OBRA '89, and 4155 of OBRA '90. These sections amended portions of the
Social Security Act (the Act) concerning the coverage of and payment
for certain services described in section 1861(s)(2)(K) of the Act that
are performed by physician assistants, nurse practitioners, and
clinical nurse specialists.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: TIMETABLE: Pending publication of 0938-AF01
(BPD-709-F).
Agency Contact: William Larson, Program Analyst, Office of Coverage &
Eligibility Policy, Department of Health and Human Services, Health
Care Financing Administration, Room 401, EHR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-4639
RIN: 0938-AF00
_______________________________________________________________________
1534. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS (BPD-
727-P)
Legal Authority: 42 USC 1395oo
CFR Citation: 42 CFR 405
Legal Deadline: None
Abstract: This regulation would update and clarify regulations
governing the Provider Reimbursement Review Board and would deal with
such issues as the parties to a Board hearing, jurisdiction of the
Board, time periods for filing appeals, and the definition of ``good
cause'' for late filings. The Board has authority to adjudicate
disputes between providers and intermediaries under section 1878 of the
Social Security Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul Olenick, Director, Division of Medicare &
Eligibility Policy, Department of Health and Human Services, Health
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4472
RIN: 0938-AF28
_______________________________________________________________________
1535. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-P)
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 (PL 101-239) and section 4755 of OBRA
'90 (PL 101-508).
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 07/00/95
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, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-7089
RIN: 0938-AF32
_______________________________________________________________________
1536. MEDICAID PAYMENT FOR OBSTETRICAL AND PEDIATRIC SERVICES--ADEQUATE
PAYMENT LEVEL PROVISION (MB-036-P)
Legal Authority: 42 USC 1396a(a)(30)(A); 42 USC 1396a(s); 42 USC
1396r-7
CFR Citation: 42 CFR 430.12; 42 CFR 430.16; 42 CFR 447.204; 42 CFR
447.300; 42 CFR 447.301; 42 CFR 447.393; 42 CFR 447.397
Legal Deadline: None
Abstract: This rule would implement section 1902(a)(30)(A) of the
Social Security Act, which requires that Medicaid payment rates be
established at a level to ensure access to services for Medicaid
recipients is at least equal to the access available to the general
population in the geographic area. It would also implement section 1926
of the Social Security Act by establishing State plan requirements
concerning obstetrical and pediatric services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: State
Additional Information:
TIMETABLE: Pending resolution of complex policy issues.
Agency Contact: Bernard Truffer, Director, Division of Payment Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 291 EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-0691
RIN: 0938-AF62
_______________________________________________________________________
1537. CLARIFICATION OF COVERAGE OF INPATIENT PSYCHIATRIC SERVICES (MB-
060-P)
Legal Authority: 42 USC 1396d(h)(l)(A)
CFR Citation: 42 CFR 440; 42 CFR 441
Legal Deadline: None
Abstract: This rule would establish settings, other than psychiatric
hospitals, in which inpatient psychiatric services may be covered under
State Medicaid plans. It would implement section 4755(a)(1) of OBRA
'90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/00/94
Small Entities Affected: Undetermined
Government Levels Affected: State
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 400 EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-5659
RIN: 0938-AF73
_______________________________________________________________________
1538. FEDERALLY QUALIFIED HEALTH CENTER SERVICES (MEDICAID) (MB-043-P)
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 (PL 101-239) and
section 4704 of OBRA '90 (PL 101-508) and reflect statutory revisions
mandated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 04/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Additional Information:
TIMETABLE: Pending resolution of complex policy and operational issues.
Agency Contact: Bernard Truffer, Director, Division of Payment Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 291, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-1357
RIN: 0938-AF90
_______________________________________________________________________
1539. MINIMUM PHYSICIAN QUALIFICATIONS FOR CERTAIN SERVICES (MB-059-P)
Legal Authority: 42 USC 1396b(i)
CFR Citation: 42 CFR 441
Legal Deadline: None
Abstract: This rule would establish qualifications that physicians must
meet as a condition for payment under Medicaid for services furnished
to children under 21 and to pregnant women (and women during the 60
days following termination of pregnancy). Section 4752(e) of PL 101-508
establishes these requirements for services furnished on or after
January 1, 1992. The regulation and legislation are intended to assure
that high quality services are furnished to women and children.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/06/93 58 FR 42041
NPRM Comment Period End 10/06/93 58 FR 42042
Second NPRM 04/00/95
Small Entities Affected: Undetermined
Government Levels Affected: State
Agency Contact: Bob Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 400, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-5659
RIN: 0938-AF92
_______________________________________________________________________
1540. REVISIONS TO RULES ON HEALTH CARE PREPAYMENT PLANS (OMC-016-P)
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 03/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Tracy Jensen, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, Room
4360, Cohen Building, 330 Independence Avenue SW., Washington, DC
20201, 202 619-2158
RIN: 0938-AF97
_______________________________________________________________________
1541. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-764-P)
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
1395(a)(13)
CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 491
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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Jacqueline Sheridan, Chief, Health Organizations
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4635
RIN: 0938-AG05
_______________________________________________________________________
1542. INCOME AND ELIGIBILITY VERIFICATION SYSTEM (MB-66-P)
Legal Authority: 42 USC 1320b-7
CFR Citation: 42 CFR 435.940; 42 CFR 435.945; 42 CFR 435.948; 42 CFR
435.952; 42 CFR 435.953; 42 CFR 435.955; 42 CFR 435.960; 42 CFR 435.965
Legal Deadline: None
Abstract: This rule would amend our regulations to allow States more
flexibility to limit their income and eligibility verification system
data match requests to only those matches that are productive or
useful. States would be required to submit plans of alternative income
and eligibility verification system procedures for approval by HCFA.
The flexibility offered by this change would afford States the freedom
to design more efficient data matches.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: State
Additional Information:
TIMETABLE: Pending publication of AFDC regulation (RIN 0970-AB13).
Agency Contact: Donna Jarosinski, Program Analyst, Medicaid Bureau,
Department of Health and Human Services, Health Care Financing
Administration, Room 273, EHR, 6325 Security Boulevard, Baltimore, MD
21207, 410 966-5928
RIN: 0938-AG12
_______________________________________________________________________
1543. MEDICARE APPEALS OF INDIVIDUAL CLAIMS (BPD-453-P)
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 implement sections 9313(a)(1) and 9341 of PL
99-509. Section 9313(a)(1) permits providers, physicians or suppliers
to represent beneficiaries, with certain limitations, in pursuing
appeals of adverse determinations regarding claims for benefits under
Medicare Part A or Part B. 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 judicial review,
provided the amount in controversy is at least $1000. Section 9341 also
limits the review of national coverage determinations 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 05/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul Olenick, Director, Division of Medicare
Eligibility Policy, BPD, Department of Health and Human Services,
Health Care Financing Administration, Room 401, EHR Building, 6325
Security Boulevard, Baltimore, Maryland 21207, 410 966-4472
RIN: 0938-AG18
_______________________________________________________________________
1544. END-STAGE RENAL DISEASE (ESRD) PAYMENT EXCEPTION REQUESTS AND ORGAN
PROCUREMENT COSTS (BPD-763-P)
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 would 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. We are
proposing to compute the acquisition costs of hearts and livers using
the same method we now use to pay for the acquisition costs of kidneys.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/26/94
NPRM Comment Period End 10/25/94 59 FR 44097
Final Action 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Michael Powell, Health Insurance Specialist, Division
of Special Payment Programs, BPD, Department of Health and Human
Services, Health Care Financing Administration, Room 1-A-5, EHR
Building, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-
4557
RIN: 0938-AG20
_______________________________________________________________________
1545. APPOINTMENT OF REPRESENTATIVES FOR APPEAL (BPO-120-P)
Legal Authority: 42 USC 1395ff
CFR Citation: 42 CFR 405.870; 42 CFR 405.701(c)
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 07/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Betsy Horne, Chief Appeals Branch, Bureau of Program
Operations, Department of Health and Human Services, Health Care
Financing Administration, G-C-1 Meadows East Building, 6325 SEcurity
Boulevard, Baltimore, Maryland 21207, 410 966-4292
RIN: 0938-AG30
_______________________________________________________________________
1546. ENFORCEMENT REQUIREMENTS FOR RENAL DIALYSIS FACILITIES (HSQ-204-P)
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) 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Debbie Schoenemann, Chief, Survey and Certification
Procedures Branch, HSQ, Department of Health and Human Services, Health
Care Financing Administration, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-6771
RIN: 0938-AG31
_______________________________________________________________________
1547. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH PURPOSES
(HSQ-208-P)
Legal Authority: 42 USC 1320c-9
CFR Citation: 42 CFR 1320c-9
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 00/00/00
Small Entities Affected: Organizations
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, Room 2-D-3,
Meadows East Building, 6325 Security Boulevard, Baltimore, Maryland
21207, 410 966-6759
RIN: 0938-AG33
_______________________________________________________________________
1548. COMMUNITY SUPPORTED LIVING ARRANGEMENTS SERVICES (MB-070-P)
Legal Authority: 42 USC 1395u
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
Legal Deadline: None
Abstract: This rule would specify requirements that must be met in
order for a State to be eligible to provide community supported living
arrangements services to individuals with developmental disabilities as
an optional Medicaid service.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/95
Small Entities Affected: Undetermined
Government Levels Affected: State
Additional Information:
TIMETABLE: Pending resolution of Complex Policy Issues.
Agency Contact: Mary Jean Duckett, Chief, Home and Community Based
Waivers Branch, MB, Department of Health and Human Services, Health
Care Financing Administration, Room 400, EHR Building, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-5640
RIN: 0938-AG35
_______________________________________________________________________
1549. TELEPHONE REQUESTS FOR REVIEW OF INITIAL DETERMINATIONS (BPO-121-P)
Legal Authority: 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Rosalind Little, Appeals Branch, Division of Appeals
and Communication, Department of Health and Human Services, Health Care
Financing Administration, G-C-1 Meadows East Building, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-6972
RIN: 0938-AG48
_______________________________________________________________________
1550. CONDITIONS FOR PAYMENT FOR PHYSICIANS' SERVICES IN TEACHING
SETTINGS (BPD-792-P)
Legal Authority: 42 USC 1302; 42 USC 1395w
CFR Citation: 42 CFR 405; 42 CFR 415
Legal Deadline: None
Abstract: This rule would establish in regulations current coverage and
payment policy concerning teaching physicians' services. It would also
establish in regulations certain policies relating to the coverage and
payment of the services of residents in settings other than hospitals.
This proposed rule will supersede the proposed rule published on
February 7, 1989 (54 FR 5946).
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information:
TIMETABLE: Pending resolution of complex policy issues.
Agency Contact: William Morse, Program Analyst, Physician and
Practitioner Payment Branch, Department of Health and Human Services,
Health Care Financing Administration, 1-H-5, ELR, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-4520
RIN: 0938-AG53
_______________________________________________________________________
1551. NEW LOOK BEHIND FOR INTERMEDIATE CARE FACILITIES FOR THE MENTALLY
RETARDED (ICFS/MR) (HSQ-214-P)
Legal Authority: 42 USC 1396i
CFR Citation: 42 CFR 442.116
Legal Deadline: None
Abstract: The rule would add regulations to delineate HCFA/DHHS
authority to cancel the Medicaid approval of an intermediate care
facility for the mentally retarded (ICF/MR) if HCFA determines that the
facility has failed to meet Medicaid certification requirements. The
rule would also eliminate the current regulatory policy by which States
are entitled to up to 120 days of FFP for ICFs/MR having been
terminated from the Medicaid program, while their appeals are pending.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/00/95
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Pamela V. Vocke, Director, Division of Program
Operations, Health Standards and Quality Bureau, Department of Health
and Human Services, Health Care Financing Administration, Room 2-D-2,
ME Building, 6325 Security Boulevard, Baltimore, Maryland 21207, 410
966-7089
RIN: 0938-AG58
_______________________________________________________________________
1552. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES,
SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)
Legal Authority: 42 USC 1395hh
CFR Citation: 42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 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 and suppliers. It would state that all
Medicare penalties and sanctions are automatically assigned to a new
owner unless otherwise stated in the change of ownership. It would also
extend the same principle to overpayments; i.e., we would amend the
regulations on provider overpayments to require the new owner of a
provider or a supplier to be liable for any Medicare overpayments paid
to the previous owner unless otherwise stated in the change of
ownership. Finally, we would clarify the effect of a leasing
arrangement has on a provider agreement and on supplier approval.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/00/95
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Pamela V. Vocke, Director of Program Operations, Health
Standards and Quality Bureau, Department of Health and Human Services,
Health Care Financing Administration, Room 2-D-2, ME Building, 6325
Security Boulevard, Baltimore, Maryland 21207, 410 966-7089
RIN: 0938-AG59
_______________________________________________________________________
1553. INSTITUTIONAL PLAN AMENDMENT FINDINGS (MB-078-P)
Regulatory Plan: This entry is Seq. No. 49 in Part II of this issue of
the Federal Register.
RIN: 0938-AG60
_______________________________________________________________________
1554. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF CATARACT
SURGERY (BPD-797-PN)
Legal Authority: 42 USC 1395x; 42 USC 1395y
CFR Citation: None
Legal Deadline: None
Abstract: This notice would announce the Medicare program's proposal to
adopt certain recommendations set forth by the Agency for Health Care
Policy and Research and the Guidelines for Cataract Practice in order
to define medical necessity with respect to Medicare coverage of
cataract surgery and Nd:YAG capsulotomy. This would reinforce our
policy of noncoverage for most preoperative testing for cataract
surgery, as set forth in the Medicare Coverage Issues Manual.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 02/00/95
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Karen Fink, Health Insurance Specialist, Office of
Coverage and Eligibility Policy, Department of Health and Human
Services, Health Care Financing Administration, Room 401, EHR, 6325
Security Boulevard, Baltimore, Maryland 21297, 410 966-4643
RIN: 0938-AG65
_______________________________________________________________________
1555. EFFECTS OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (GAAP) ON
REASONABLE COSTS DETERMINATIONS (BPD-800-P)
Legal Authority: 42 USC 1395x(v)
CFR Citation: 42 CFR 413.20; 42 CFR 413.24
Legal Deadline: None
Abstract: This proposed rule would clarify our policy on the
application of generally accepted accounting principles (GAAP) for
Medicare reimbursement purposes. We would specify that the use of GAAP
is required for cost reporting purposes but that the Secretary is not
required to follow GAAP in determining Medicare reimbursement.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: John Eppinger, Program Analyst, Department of Health
and Human Services, Health Care Financing Administration, Room 1-F-5,
ELR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-4518
RIN: 0938-AG66
_______________________________________________________________________
1556. EXPANSION OF THE DEFINITION OF EYE AND EAR SPECIALTY HOSPITALS
(BPD-804-P)
Legal Authority: 42 USC 1395(l)(i)(4)
CFR Citation: 42 CFR 413
Legal Deadline: None
Abstract: Hospitals designated as eye or eye and ear hospitals receive
a blended payment for the facility costs of ambulatory surgical
procedures based on 75 percent of costs and 25 percent of the
ambulatory surgical center rate for cost reporting periods beginning
before January 1, 1995. In accordance with section 13532 of OBRA '93,
this proposed rule would expand the definition of eye or eye and ear
hospitals. The expanded definition would extend eligibility for
designation as an eye or eye and ear hospital to hospitals meeting
specified criteria.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Carolyn Muller, Payment Policy Branch, Department of
Health and Human Services, Health Care Financing Administration, Room
1-F-5, ELR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410
966-4589
RIN: 0938-AG67
_______________________________________________________________________
1557. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL AND RESPIRATORY THERAPY
SERVICES FURNISHED UNDER ARRANGEMENTS (BPD-808-PN)
Legal Authority: 42 USC 1395x(v)(5)
CFR Citation: 42 CFR 413.106
Legal Deadline: None
Abstract: This notice proposes revisions for the salary equivalency
guidelines for Medicare payment for the reasonable costs of physical
and respiratory therapy services and other therapy services furnished
by providers under arrangements with an outside contractor. The
guidelines are used by Medicare fiscal intermediaries to determine the
maximum allowable costs of those services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 10/00/95
Small Entities Affected: Undetermined
Government Levels Affected: None
Agency Contact: Jacqueline Gordon, Program Analyst, Payment Policy
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 1-F-5, ELR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4517
RIN: 0938-AG70
_______________________________________________________________________
1558. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS
INFECTED WITH TUBERCULOSIS (MB-082-P)
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
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 01/00/95
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Joe Dulany, Program Analyst, Department of Health and
Human Services, Health Care Financing Administration, Room 400, EHR,
6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-0665
RIN: 0938-AG72
_______________________________________________________________________
1559. PROPOSED PAYMENTS TO DISPROPORTIONATE SHARE HOSPITALS FOR FY 1995
(MB-089-N)
Legal Authority: 42 USC 1396r-4(f)
CFR Citation: 42 CFR 447.297; 42 CFR 447.298; 42 CFR 447.299
Legal Deadline: Other, Statutory, October 1, 1994.
The Social Security Act requires publication of preliminary amounts by
the beginning of each Federal fiscal year.
Abstract: This notice will contain the preliminary Fiscal Year 1995
national target and each State's allotment for disproportionate share
hospital (DSH) payments. DSH payments are payment adjustments made to
Medicaid participating hospitals that serve a large number of Medicaid
recipients and other low-income individuals with special needs.
Implementing regulations require that a notice be published before the
start of each FFY with the preliminary amounts for the FFY.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 10/00/94
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Richard Strauss, Analyst, Division of Financial
Management, Department of Health and Human Services, Health Care
Financing Administration, Room 273, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-2019
RIN: 0938-AG75
_______________________________________________________________________
1560. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION
(BPD-745-P)
Regulatory Plan: This entry is Seq. No. 50 in Part II of this issue of
the Federal Register.
RIN: 0938-AG79
_______________________________________________________________________
1561. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH
THEY HAVE FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES
(BPD-809-P)
Regulatory Plan: This entry is Seq. No. 51 in Part II of this issue of
the Federal Register.
RIN: 0938-AG80
_______________________________________________________________________
1562. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-
819-P)
Regulatory Plan: This entry is Seq. No. 52 in Part II of this issue of
the Federal Register.
RIN: 0938-AG81
_______________________________________________________________________
1563. END STAGE RENAL DISEASE (ESRD) CONDITIONS OF COVERAGE
(BPD-818-P)
Regulatory Plan: This entry is Seq. No. 53 in Part II of this issue of
the Federal Register.
RIN: 0938-AG82
_______________________________________________________________________
1564. DISTINCT PARTS AND COSTING FOR SKILLED NURSING FACILITIES
AND NURSING FACILITIES (BPD-815-P)
Legal Authority: 42 USC 1395i-3; 42 USC 1395r
CFR Citation: 42 CFR 409; 42 CFR 483
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. This rule also proposes 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/95
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: William Ullman, Health Insurance Specialist, Department
of Health and Human Services, Health Care Financing Administration,
Room 401, EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 401
966-5667
RIN: 0938-AG84
_______________________________________________________________________
1565. EXTENSION OF CERTAIN EFFECTIVE DATES FOR CLINICAL
LABORATORY REQUIREMENTS AND PERSONNEL REQUIREMENTS FOR CYTOLOGISTS (HSQ-
217-FC)
Legal Authority: 42 USC 263a
CFR Citation: 42 CFR 493.855; 42 CFR 493.1201; 42 CFR 493.1202; 42 CFR
493.1203; 42 CFR 493.1213; 42 CFR 493.1215; 42 CFR 493.1217; 42 CFR
493.1218; 42 CFR 493.1223; 42 CFR 493.1443
Legal Deadline: None
Abstract: This rule will extend the date by which a laboratory must
enroll in an HHS-approved cytology proficiency testing program. It also
extends the date by which an individual with a doctoral degree must
possess board certification to qualify as a director of a laboratory
that performs high complexity testing. In addition, we are extending
the phase-in for minimum quality control requirements for unmodified,
moderate complexity testing cleared through the Food and Drug
Administration premarket notification on premarket approval processes.
The date extensions do not reduce current requirements for quality test
performance. Rather, they take into account more realistic timeframes
based on actual experience.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Kathleen Kremann, Health Insurance Specialist,
Department of Health and Human Services, Health Care Financing
Administration, Meadowwood East Building, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 597-5906
RIN: 0938-AG86
_______________________________________________________________________
1566. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE
SCHEDULES (HSQ-219-FC)
Legal Authority: PL 100-578
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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Ed Mortimore, Health Insurance Specialist, Department
of Health and Human Services, Health Care Financing Administration,
Meadowwood East Building, 6325 Security Boulevard, Baltimore, Maryland
21207, 410 597-2140
RIN: 0938-AG87
_______________________________________________________________________
1567. APPROVAL OF THE AMERICAN SOCIETY FOR HISTOCOMPATIBILITY
AND IMMUNOGENETICS FOR THE SPECIALTY OF HISTOCOMPATIBILITY (HSQ-220-N)
Legal Authority: 42 USC 263a
CFR Citation: 42 CFR 493.501
Legal Deadline: None
Abstract: This notice announces HCFA's approval of the American Society
for Histocompatibility and Immunogenetics as an accrediting
organization for clinical laboratories under the Clinical Laboratory
Improvement Amendments at 1988 for the specialty of histocompatibility.
The effect of this notice is to exempt laboratories accredited by the
American Society for Histocompatibility from having to be surveyed by
Medicare surveyors for that specialty, except for validation and
complaint investigation surveys.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Anthony Tirone, Director, Office of Survey and
Certification, HSQB, Department of Health and Human Services, Health
Care Financing Administration, 2-D-2, Meadows East Building, 6325
Security Boulevard, Baltimore, Maryland 21207, 410 966-6763
RIN: 0938-AG88
_______________________________________________________________________
1568. MEDICAID: COVERAGE OF REHABILITATION SERVICES (MB-076-P)
Legal Authority: 42 USC 1396d(a)(13)
CFR Citation: 42 CFR 440.130; 42 CFR 440.110; 42 CFR 440.90
Legal Deadline: None
Abstract: The rule would amend the Medicaid regulations to redefine
rehabilitation services furnished as medical assistance under the
Medicaid program. The rule also would clarify the limitations on and
conditions for providing rehabilitation services in various settings.
These amendments incorporate and interpret a statutory change to the
definition of rehabilitation services made by section 4719 of OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Organizations
Government Levels Affected: State
Agency Contact: Linda Sizelove, Chief, Medicaid Coverage Policy Branch,
Department of Health and Human Services, Health Care Financing
Administration, Room 400, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4626
RIN: 0938-AG89
_______________________________________________________________________
1569. MEDICAID: NOMINAL COPAYMENTS FOR INSTITUTIONAL SERVICES
FOR MEDICAID RECIPIENTS (MB-090-FC)
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 01/00/95
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Marinos Svolos, Office Director, Medicaid Eligibility
Policy, Medicaid Bureau, Department of Health and Human Services,
Health Care Financing Administration, Room 323, EHR, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-4451
RIN: 0938-AG90
_______________________________________________________________________
1570. WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE
SERVICES UNDER THE MEDICARE PROGRAM (BPD-820-N)
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 that we use to adjust
payment rates in different areas of the country, which reflect local
differences in area wage levels. We are considering development of this
proposed rule through a ``negotiated rulemaking'' proceeding under the
Negotiated Rulemaking Act of 1990. The next step will be to publish a
notice of intent to form an advisory committee to negotiate the wage
index.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice of Intent 10/00/94
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Randal S. Ricktor, Health Insurance Specialist,
Department of Health and Human Services, Health Care Financing
Administration, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-
5650
RIN: 0938-AG93
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1571. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES (BPD-309-F)
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 405.501; 42 CFR 405.502; 42 CFR 405.505; 42 CFR
405.506; 42 CFR 405.511; 42 CFR 405.556; 42 CFR 405.1310; 42 CFR
413.170; 42 CFR 414.350 to 414.378; 42 CFR 424.55; 42 CFR 424.64; 42
CFR 431.54; 42 CFR 447.10; 42 CFR 447.300; 42 CFR 447.321
Legal Deadline: None
Abstract: This regulation will incorporate provisions of Public Laws
98-369, 99-272, 99-509, 100-203, 100-647, 101-239 and 101-508 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 the
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 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Additional Information:
TIMETABLE: Pending publication of RIN 0938-AF40.
Agency Contact: Ron Wren, Health Insurance Specialist, Department of
Health and Human Services, Health Care Financing Administration, Room
1-H-5 ELR, 6325 Security Blvd., Baltimore, MD 21207, 410 966-4506
RIN: 0938-AB50
_______________________________________________________________________
1572. HOME AND COMMUNITY-BASED SERVICES AND RESPIRATORY CARE FOR
VENTILATOR-DEPENDENT INDIVIDUALS (MB-8-FC)
Legal Authority: 42 USC 1396n(c)
CFR Citation: 42 CFR 435.726; 42 CFR 435.735; 42 CFR 440.180; 42 CFR
441.301; 42 CFR 441.302; 42 CFR 441.303; 42 CFR 441.304; 42 CFR
441.305; 42 CFR 441.306; 42 CFR 441.307; 42 CFR 441.308; 42 CFR
441.310; 42 CFR 440.185; 42 CFR 440.250
Legal Deadline: None
Abstract: This rule revises the regulations for home and community
based services as required by section 9502 of PL 99-272, sections 9408
and 9411 of PL 99-509, sections 4102 and 4118 of PL 100-203, sections
411(k)(10)(A) and 411(k)(10)(H) of PL 100-360, section 8427 of PL 100-
647, and sections 4741 and 4742 of PL 101-508.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/01/88 53 FR 19950
NPRM Comment Period End 07/31/88 53 FR 19950
Final Rule With Comment Period 07/25/94 59 FR 37702
Effective Date 08/24/94 59 FR 37702
Comment Period End 09/23/94 59 FR 37702
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 400 EHR, 6325 Security Blvd., Baltimore, MD 21207,
410 966-5659
RIN: 0938-AC55
_______________________________________________________________________
1573. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR
EMERGENCY CARE (BPD-393-FC)
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 formally implements statutory requirements
that require 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 PL 99-272, 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 PL 99-509, 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 59 FR 32086
Comment Period End 08/22/94 59 FR 32086
Final Rule 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Jacqueline Sheriden, Chief, Health Organizations
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401 EHR Bldg., 6325 Security Blvd., Baltimore, MD
21207, 410 966-4635
RIN: 0938-AC58
_______________________________________________________________________
1574. DENIAL OF PAYMENT FOR SUBSTANDARD QUALITY CARE (HSQ-132-F)
Legal Authority: 42 USC 1320c-3(a); 42 USC 1395cc(a)(1)(K); 42 USC
1395u; 42 USC 1395pp(b)
CFR Citation: 42 CFR 462.105; 42 CFR 466; 42 CFR 473; 42 CFR 476; 42
CFR 489.21
Legal Deadline: None
Abstract: This final rule implements section 9403 of PL 99-272; section
9353(c) of PL 99-509; section 4096(a) of PL 100-203; and section 4205
of PL 101-508. In accordance with these statutory provisions, Peer
Review Organizations (PROs) are authorized to deny Medicare payment to
a physician or hospital for services furnished that are of substandard
quality. Beneficiaries are protected from liability for the cost of the
services where payment is denied because services were of substandard
quality.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/08/89 54 FR 1956
NPRM Comment Period End 03/20/89 54 FR 1956
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information:
TIMETABLE: Pending review in light of the Health Care Quality
Improvement Initiative under the PRO program.
Agency Contact: Harvey Brook, Office of Peer Review, Department of
Health and Human Services, Health Care Financing Administration, 2-D-2
Meadows East Bldg., 6300 Security Blvd., Baltimore, MD 21207, 410 966-
6853
RIN: 0938-AC84
_______________________________________________________________________
1575. REVISED EFFECTIVE DATE OF MEDICARE/MEDICAID PROVIDER AGREEMENT AND
SUPPLIER PARTICIPATION (HSQ-139-F)
Legal Authority: 42 USC 1395cc; 42 USC 1396i
CFR Citation: 42 CFR 440.10; 42 CFR 440.70; 42 CFR 442.13; 42 CFR
488.11; 42 CFR 489.13; 42 CFR 498.3
Legal Deadline: None
Abstract: This rule will establish uniform rules for determining the
effective date of participation for all providers and suppliers whose
Medicare or Medicaid approval requires onsite surveys by the State
survey agency. Also, it provides criteria for determining the effective
date of participation for those providers and suppliers who are deemed
to meet the conditions by an accreditation. It would also specify that
those dissatisfied with a decision on their effective date of
participation under Medicare are entitled to a Medicare reconsideration
and hearing on the decision.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/08/92 57 FR 46362
NPRM Comment Period End 12/07/92
Final Action 04/00/95
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State, 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, Room 2-D-2 Meadows East
Bldg., 6300 Security Blvd., Baltimore, MD 21207, 410 966-7089
RIN: 0938-AC88
_______________________________________________________________________
1576. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)
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 413.153; 42 CFR 405.370; 42 CFR 413.5(c)(3); 42
CFR 405.371; 42 CFR 405.372; 42 CFR 405.373; 42 CFR 405.375
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 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Additional Information:
TIMETABLE: Pending resolution of complex administrative issues.
Agency Contact: Sam Guida, Director, Div. of Acct Managmt &
Collections, Division of Payment and Reporting Policy, Department of
Health and Human Services, Health Care Financing Administration, 1-E-6
Meadows East Building, 6325 Security Blvd., Baltimore, MD 21207, 410
966-7495
RIN: 0938-AC99
_______________________________________________________________________
1577. CHANGES CONCERNING THE DEFINITION OF ACCRUAL BASIS OF ACCOUNTING
(BPD-366-FC)
Legal Authority: 42 USC 1395x(v)(1)(A)
CFR Citation: 42 CFR 413.24
Legal Deadline: None
Abstract: This rule will revise the Medicare regulations to clarify the
definition of ``accrual basis of accounting'' to indicate that expenses
must be incurred by a provider of health care services before Medicare
will pay its share of those expenses. This change is intended to
incorporate into the regulations Medicare's longstanding policy
regarding the circumstances under which we recognize, for the purposes
of program payment, a provider's claim for costs for which it has not
actually expended funds during the current cost reporting period.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/09/91 56 FR 50834
NPRM Comment Period End 12/09/91 56 FR 50834
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Eppinger, Payment Policy Branch, Department of
Health and Human Services, Health Care Financing Administration, Room
1-F-5 ELR, 6325 Security Blvd., Baltimore, MD 21207, 410 966-4518
RIN: 0938-AD01
_______________________________________________________________________
1578. OPTIONAL PAYMENT SYSTEM FOR LOW MEDICARE VOLUME SKILLED NURSING
FACILITIES (BPD-409-F)
Legal Authority: 42 USC 1395yy(d)
CFR Citation: 42 CFR 413.200; 42 CFR 413.202; 42 CFR 413.204; 42 CFR
413.208; 42 CFR 413.210; 42 CFR 413.212; 42 CFR 413.214; 42 CFR
413.216; 42 CFR 413.220; 42 CFR 413.221; 42 CFR 413.1; 42 CFR 413.24
Legal Deadline: None
Abstract: This rule will allow skilled nursing facilities (SNFs) that
provide fewer than 1,500 days of care to Medicare beneficiaries in a
cost reporting period to have the option of receiving prospective
payments in the following cost reporting period. The prospective
payments would be based on components of SNF costs such as routine
operating costs, capital-related costs, and a return on equity for
proprietary facilities for routine services furnished before October 1,
1993. This rule will also specify that the return on equity provision
for proprietary SNFs is eliminated effective October 1, 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/08/94 59 FR 29578
NPRM Comment Period End 08/08/94 59 FR 29578
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: William Goeller, Director, Division of Payment and
Reporting Policy, Department of Health and Human Services, Health Care
Financing Administration, Room 1-F-5 ELR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-4513
RIN: 0938-AD02
_______________________________________________________________________
1579. CRITERIA AND PROCEDURES FOR MAKING MEDICAL SERVICES COVERAGE
DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY (BPD-432-F)
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
Additional Information:
TIMETABLE: Pending resolution of complex policy issues.
Agency Contact: Walter Rutemueller, Chief, Special Coverages Isues
Branch, Department of Health and Human Services, Health Care Financing
Administration, 401 East High Rise Bldg., 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-5395
RIN: 0938-AD07
_______________________________________________________________________
1580. REVISIONS TO CONDITIONS OF PARTICIPATION FOR HOSPITALS AND
CONDITIONS FOR COVERAGE OF SUPPLIERS OF END-STAGE RENAL DISEASE SERVICES
(BPD-421-F)
Legal Authority: 42 USC 1395x(e)(6)(B); 42 USC 1395x(ee); PL 99-509,
Sec 9339(d)
CFR Citation: 42 CFR 405; 42 CFR 482
Legal Deadline: None
Abstract: This final rule will require hospitals, as a condition of
participation, to provide a discharge planning process for patients in
accordance with section 9305(c) of PL 99-509. Revisions will also
implement section 6025 of PL 101-239 to allow a doctor of dental
surgery or dental medicine to be a hospital medical director if the
laws of the State in which the hospital is located permit. The preamble
to this final rule withdraws proposed regulations for the
qualifications of laboratory directors under section 9339(d) of PL 99-
509. The information collection burden of several end-stage renal
disease regulations is reduced.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/16/88 53 FR 22506
NPRM Comment Period End 08/15/88 53 FR 22506
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jacqueline Sheridan, Chief, Health Organizations
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401 EHR, 6325 Security Blvd., Baltimore, MD 21207,
410 966-4635
RIN: 0938-AD11
_______________________________________________________________________
1581. MEDICAID ELIGIBILITY OF POVERTY LEVEL GROUPS AND EXTENDED COVERAGE
OF SERVICES (MB-13-F)
Legal Authority: 42 USC 1396a(a)(10); 42 USC 1396a(l); 42 USC
1396a(f); 42 USC 1396a(m); 42 USC 1396b(f); 42 USC 1396r-1; 42 USC
1396a(a)(47); 42 USC 1396a(e)(6); 42 USC 1396a(e)(7); 42 USC
1396a(a)(17)
CFR Citation: 42 CFR 431; 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR
447
Legal Deadline: None
Abstract: This rule will amend the Medicaid regulations to incorporate
changes relating to Medicaid eligibility groups and coverage of
services made by the Medicare Catastrophic Coverage Act of 1988 (PL
100-360), OBRAs '90, '89, '87, and '86 (PL 101-508, PL 101-239, PL 100-
203 and PL 99-509), and the Homeless Eligibility Clarification Act of
the Anti-Drug Abuse Act of 1986 (PL 99-570). This rule will add
eligibility groups of pregnant women, infants and children, and aged
and disabled individuals with incomes up to specified percentage of the
Federal poverty line; clarify eligibility of homeless individuals; and
add provisions for the presumptive eligibility period for pregnant
women who, based on preliminary information, appear to meet income
requirements under Medicaid.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/23/94 59 FR 13666
NPRM Comment Period End 05/23/94
Final Action 06/00/95
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Medicaid Bureau, Department of Health and Human Services,
Health Care Financing Administration, Room 323 East High Rise, 6325
Security Blvd., Baltimore, MD 21207, 410 966-4451
RIN: 0938-AD17
_______________________________________________________________________
1582. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES (BPD-426-
F)
Regulatory Plan: This entry is Seq. No. 54 in Part II of this issue of
the Federal Register.
RIN: 0938-AD33
_______________________________________________________________________
1583. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HSQ-135-F)
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 66.1; 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 (PL 99-272) and OBRA '86 (PL 99-503). 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 03/00/95
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: Harvey Brook, Office of Peer Review, Department of
Health and Human Services, Health Care Financing Administration, Rm. 2-
D-2 Meadows East Bldg., 6325 Security Blvd., Baltimore, MD. 21207, 410
966-6853
RIN: 0938-AD38
_______________________________________________________________________
1584. PAYMENT FOR DURABLE MEDICAL EQUIPMENT AND ORTHOTIC AND PROSTHETIC
DEVICES (BPD-494-F)
Legal Authority: 42 USC 1395m(a); 42 USC 1395x(n)
CFR Citation: 42 CFR 405.501; 42 CFR 405.514; 42 CFR 414.200; 42 CFR
414.202; 42 CFR 414.210; 42 CFR 414.220; 42 CFR 414.222; 42 CFR
414.226; 42 CFR 414.228; 42 CFR 414.229; 42 CFR 410.36; 42 CFR 410.38;
42 CFR 414.232
Legal Deadline: None
Abstract: This final rule responds to comments received in response to
the final rule with comment period (57 FR 57675) implementing section
4062 of PL 100-203 and sections 4152 and 4153 of PL 101-508. That rule
established fee schedules and payment methodologies that govern
payments for six categories of durable medical equipment and orthotic
and prosthetic devices. If changes are warranted based on our
evaluation of comments, they will be incorporated in this final rule.
It will also reflect statutory revisions mandated by OBRA '93.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 12/07/92 57 FR 57675
Effective Date 01/06/93 57 FR 57675
Public Comment Period End 02/05/93 57 FR 57675
Final Action 03/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: William Long, Program Analyst, Division of Medical
Services Payment, Department of Health and Human Services, Health Care
Financing Administration, Room 1-H-5 ELR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-5655
RIN: 0938-AD65
_______________________________________________________________________
1585. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (BPD-482-FC)
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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/08/90 55 FR 8491
NPRM Comment Period End 05/08/90 55 FR 8491
Final Action 01/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Herbert Pollock, Chief, Medicare Benefit Coordination
Policy Branch, Department of Health and Human Services, Health Care
Financing Administration, Room 401, EHR, 6325 Security Blvd.,
Baltimore, Maryland 21207, 410 966-4474
RIN: 0938-AD73
_______________________________________________________________________
1586. MEDICARE COVERAGE OF HOME HEALTH SERVICES, MEDICARE CONDITIONS OF
PARTICIPATION AND HOME HEALTH AIDE SUPERVISION (BPD-469-F)
Legal Authority: 42 USC 1395x(m); 42 USC 1395x(o); 42 USC 1395x(f); 42
USC 1395x(n); 42 USC 1395f(dd)
CFR Citation: 42 CFR 409; 42 CFR 413; 42 CFR 418; 42 CFR 484
Legal Deadline: None
Abstract: These regulations establish home health aide supervision and
duty requirements applicable to all home health agencies and hospices
that provide home health aide services under the Medicare program. In
addition, these regulations codify longstanding policies concerning the
limitations and exclusions applicable to home health services covered
under the Medicare program. The rule also clarifies policies concerning
exclusions for drugs and biological and prosthetic devices.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 09/27/91 56 FR 49154
NPRM Comment Period End 11/26/91 56 FR 49154
Final Action 11/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Thomas, Health Insurance Specialist, Div. of
Provider Services Coverage Policy, Department of Health and Human
Services, Health Care Financing Administration, Room 401 EHR, 6325
Security Blvd., Baltimore, Md. 21207, 410 966-4623
RIN: 0938-AD78
_______________________________________________________________________
1587. APPEALS FOR ENROLLEES OF PREPAID HEALTH CARE PLANS (OMC-008-F)
Legal Authority: 42 USC 1395mm; 42 USC 1395l(a)(1)(A)
CFR Citation: 42 CFR 405; 42 CFR 417; 42 CFR 482
Legal Deadline: None
Abstract: This rule will amend or establish regulations relating to
appeal rights and procedures for Medicare beneficiaries who are
enrolled in health maintenance organizations (HMOs), competitive
medical plans (CMPs), and health care prepayment plans (HCPPs).
Specifically, the rule will extend to HMO and CMP members the right to
request review by a PRO of early hospital discharges; impose a 60-day
limit for HMOs and CMPs to process requests by beneficiaries for
reconsideration of decisions on denied services or claims; and require
HCPPs to establish appeal procedures for enrollees who are Medicare
beneficiaries. These changes are aimed at improving efficiency and at
providing beneficiaries equitable appeal rights, regardless of their
enrollment status.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/07/92 57 FR 46119
NPRM Comment Period End 12/07/92 57 FR 46119
Final Action 11/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Maureen Miller, Program Analyst, Office of Managed
Care, Department of Health and Human Services, Health Care Financing
Administration, Room 4360 Cohen Building, 330 Independence Ave. SW.,
Washington, DC 20201, 202 619-0129
RIN: 0938-AD79
_______________________________________________________________________
1588. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-FC)
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
Legal Deadline: None
Abstract: This rule will implement several provisions of OBRA '87 other
than those implemented through the rules published on February 2, 1989,
and September 26, 1991, governing long term care facility participation
in the Medicare and Medicaid programs effective October 1, 1990, and
State requirements for Federal financial participation. The provisions
include Federal standards for evaluating State waivers of nursing
facility nurse staffing requirements, use of physical and chemical
restraints in nursing facilities, qualifications of nursing home
administrators, notices of Medicaid rights to be given to persons
admitted to nursing facilities, and other technical changes.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/05/92 57 FR 4516
NPRM Comment Period End 04/06/92 57 FR 4516
Final Rule With Comment Period 05/00/95
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Agency Contact: Bill Ullman, Health Insurance Specialist Long Term Care
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-5667
RIN: 0938-AD81
_______________________________________________________________________
1589. SURVEY AND CERTIFICATION OF SKILLED NURSING FACILITIES AND NURSING
FACILITIES AND ENFORCEMENT PROCEDURES (HSQ-156-F)
Regulatory Plan: This entry is Seq. No. 55 in Part II of this issue of
the Federal Register.
RIN: 0938-AD94
_______________________________________________________________________
1590. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OMC-007-F)
Legal Authority: 42 USC 300e(a); 42 USC 300e(b)(1); 42 USC
300e(b)(3)(A); 42 USC 300e(c)
CFR Citation: 42 CFR 417.100; 42 CFR 417.101; 42 CFR 417.103; 42 CFR
417.104; 42 CFR 417.107
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
NPRM Comment Period End 09/13/93 58 FR 38170
Final Action 06/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Maureen Miller, Analyst, Office of Managed Care,
Department of Health and Human Services, Health Care Financing
Administration, Room 4360, Cohen Bldg., 330 Independence Avenue SW.,
Washington, DC 20201, 202 619-0129
RIN: 0938-AE25
_______________________________________________________________________
1591. ``CONFINED TO THE HOME'' REQUIREMENTS FOR HOME HEALTH SERVICES
(BPD-626-F)
Legal Authority: 42 USC 1395f(a)(2)(C); 42 USC 1395n(a)(2)(A)
CFR Citation: 42 CFR 409.42
Legal Deadline: None
Abstract: This rule clarifies when a home health patient is considered
``confined to the home'' in order to receive home health benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/07/91 56 FR 50542
NPRM Comment Period End 12/06/91
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: John Thomas, Health Insurance Specialist, Long Term
Care Branch, Department of Health and Human Services, Health Care
Financing Administration, Room 401 EHR, 6325 Security Blvd., Baltimore,
MD 21207, 410 966-4623
RIN: 0938-AE34
_______________________________________________________________________
1592. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH
AGENCIES (HSQ-169-F)
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 03/00/95
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, Room 2-D-2 Meadows
East, 6300 Security Boulevard, Baltimore, MD 21207, 410 966-7089
RIN: 0938-AE39
_______________________________________________________________________
1593. HOSPITAL STANDARD FOR HIV INFECTIOUS BLOOD (BPD-633-F)
Legal Authority: 42 USC 1395x(e)(9)
CFR Citation: 42 CFR 482
Legal Deadline: None
Abstract: This final rule will require hospitals to notify either each
recipient or each recipient's physician whenever potentially HIV
infectious blood has been administered, and to provide each recipient
with information to obtain testing and counseling. 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 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joanne Sinsheimer, Chief, Long Term Care Branch, Div.
of Provider Services Coverage Policy, Department of Health and Human
Services, Health Care Financing Administration, Room 401 EHR, 6325
Security Blvd, Baltimore, MD 21207, 410 966-4620
RIN: 0938-AE40
_______________________________________________________________________
1594. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS IMPLEMENTING THE
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA '88) (HSQ-202-F)
Regulatory Plan: This entry is Seq. No. 56 in Part II of this issue of
the Federal Register.
RIN: 0938-AE47
_______________________________________________________________________
1595. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS (BPD-
646-FC)
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 sets forth changes to the conditions of
coverage for organ procurement organizations (OPOs). It deals with the
definition of an OPO service area, expansion of the qualifications for
the Board of Directors, OPO assistance to be provided to hospitals in
establishing and implementing protocols governing organ procurement
activity, establishing criteria for allocating organs, and organ
testing for AIDS.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/21/91 56 FR 28513
NPRM Comment Period End 08/21/91 56 FR 28513
Final Rule With Comment Period 09/08/94 59 FR 46500
Effective Date 10/11/94 59 FR 46500
Comment Period End 11/07/94 59 FR 46500
Final Action 00/00/00
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, 401,
EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-5666
RIN: 0938-AE48
_______________________________________________________________________
1596. PREADMISSION SCREENING AND ANNUAL RESIDENT REVIEW (BPD-661-F)
Legal Authority: 42 USC 1395r
CFR Citation: 42 CFR 483
Legal Deadline: NPRM, Statutory, March 19, 1990.
Abstract: The final rule with comment period published November 30,
1992, (57 FR 56450) implemented sections 4211 of OBRA '87, section 6901
of OBRA '89, and section 4801 of OBRA '90. The provisions included: (1)
State requirements for preadmission screening and annual resident
review of individuals with mental illness or mental retardation who are
applicants to or residents of nursing facilities that are certified for
Medicaid; and (2) appeals systems for persons who may be transferred or
discharged from facilities or who wish to dispute a determination made
in the preadmission screening and annual review process. The changes in
this rule included OBRA '90 provisions defining ``severe mental
illness'' and ``specialized services'' which will reduce State review
workloads and clarify Medicaid matching payment for the States.
Following analysis of the public comments, we may issue a final
rulemaking document.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/23/90 55 FR 10951
NPRM Comment Period End 05/22/90 55 FR 10951
Final Rule With Comment Period 11/30/92 57 FR 56450
Public Comment Period End 01/29/93 57 FR 56450
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Jan Earle, Program Analyst, Medicaid Bureau, Department
of Health and Human Services, Health Care Financing Administration,
Room 401, EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410
966-0103
RIN: 0938-AE49
_______________________________________________________________________
1597. EXTENDED MEDICAID ELIGIBILITY FOR CERTAIN INDIVIDUALS (MB-026-F)
Legal Authority: 42 USC 1396r-6; 42 USC 1396r(b)
CFR Citation: 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 447
Legal Deadline: None
Abstract: This regulation will revise current regulations to reflect
that participants in work supplement programs are deemed to be AFDC
recipients under the State plan and make Medicaid eligibility mandatory
for those individuals; to provide extended Medicaid benefits to certain
families when they become ineligible for AFDC solely because of
increased earnings from, or hours of, employment; and to revise certain
conditions of eligibility that minor parents and pregnant minors must
meet before receiving Medicaid benefits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/14/93 58 FR 65312
NPRM Comment Period End 02/11/94 58 FR 65312
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Federal
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323 EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4451
RIN: 0938-AE51
_______________________________________________________________________
1598. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)
Legal Authority: 42 USC 1395i-3; 42 USC 1396r
CFR Citation: 42 CFR 483
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 06/00/95
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Sue Nonemaker, Program Analyst, Division of Long Term
Care, Department of Health and Human Services, Health Care Financing
Administration, 2-D-2, ME, 6325 Security Boulevard, Baltimore, Maryland
21207, 410 966-6825
RIN: 0938-AE61
_______________________________________________________________________
1599. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS (OMC-
003-F)
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 08/00/95
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, Room
4360 Cohen Building, 330 Independence Ave. SW., Washington, DC 20201,
202 619-2158
RIN: 0938-AE63
_______________________________________________________________________
1600. CONFORMING PROVISIONS FOR 1988 HMO AMENDMENTS (OMC-004-F)
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 employee health plan
contributions.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 07/05/91 56 FR 30723
Public Comment Period End 09/03/91 56 FR 30723
Final Action 04/00/95
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, Room
4360, Cohen Building, 330 Independence Ave. SW., Washington, DC 20201,
202 205-9582
RIN: 0938-AE64
_______________________________________________________________________
1601. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT)
SERVICES (MB-28-F)
Regulatory Plan: This entry is Seq. No. 57 in Part II of this issue of
the Federal Register.
RIN: 0938-AE72
_______________________________________________________________________
1602. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-685-F)
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.
Section 6205(b)(2) of PL 101-239 required that a proposed rule be
published before July 1, 1990 and that a final rule not be effective
before 10/01/90.
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 PL 101-239. 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 PL 101-508, 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 07/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Nancy Edwards, Chief, Payment Limitations and
Exclusions Branch, Department of Health and Human Services, Health Care
Financing Administration, 1-H-1 ELR, 6325 Security Blvd., Baltimore,
Maryland 21207, 410 966-4531
RIN: 0938-AE79
_______________________________________________________________________
1603. UNIFORM ELECTRONIC COST REPORTING SYSTEM FOR HOSPITALS (BPD-689-F)
Legal Authority: 42 USC 1395ww(f)(1)(B)
CFR Citation: 42 CFR 413.20; 42 CFR 413.24; 42 CFR 413.40; 42 CFR
412.52
Legal Deadline: None
Abstract: This rule will implement section 1886(f)(1)(B) of the Social
Security Act, which requires the Secretary to place into effect a
standardized electronic cost reporting format and allows the Secretary
to waive the requirement where such implementation would result in a
financial hardship for a hospital. Under this rule, all hospitals are
required to submit their cost reports, for hospital cost reporting
periods beginning on or after October 1, 1989, in a uniform electronic
format.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/19/91 56 FR 41110
Comment Period End 10/18/91 56 FR 41110
Final Rule With Comment Period 05/25/94 59 FR 26960
Effective Date 06/24/94 59 FR 26960
Comment Period End 07/25/94 59 FR 26960
Final Action 00/00/00
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Federal
Agency Contact: William Goeller, Director, Division of Payment and
Reporting Policy, Department of Health and Human Services, Health Care
Financing Administration, Room 1-F-5, ELR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-4513
RIN: 0938-AE80
_______________________________________________________________________
1604. MEDICARE COVERAGE OF PRESCRIPTION DRUGS USED IN IMMUNOSUPPRESSIVE
THERAPY (BPD-424-F)
Legal Authority: 42 USC 1395x(s)(2)(J)
CFR Citation: 42 CFR 410
Legal Deadline: None
Abstract: This final rule amends the regulations to reflect section
9335(c) of OBRA '86 and section 4075 of OBRA '87. These statutory
provisions provide Medicare coverage for prescription drugs used in
immunosuppressive therapy furnished to an individual who receives an
organ transplant for which Medicare payment is made for a period of one
year after the transplant procedure. The final rule will also reflect
statutory revisions mandated by OBRA 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/19/88 53 FR 1383
NPRM Comment Period End 03/21/88 53 FR 1383
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Walter Rutemueller, Chief, Special Coverage Issues
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-5395
RIN: 0938-AE94
_______________________________________________________________________
1605. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE FACILITIES, AND
INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED (BPD-650-F)
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)
Legal Deadline: None
Abstract: This rule amends the fire safety standards for hospitals,
long term care facilities, and intermediate care facilities for the
mentally retarded and affects only those facilities. It deletes
references to the 1967 and 1973 editions of the Life Safety Code of the
National Fire Protection Association and requires compliance with
either the 1981 or 1985 editions depending on the date when the
facility was first certified to participate in Medicare or Medicaid.
This rule creates a uniform policy for all types of facilities that
participate in the Medicare and Medicaid programs. The rescission of
the 1967 and 1973 editions of the Life Safety Code is intended to
ensure that Medicare and Medicaid beneficiaries and recipients have the
benefit of the most current fire protection standards.
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: Joanne Sinsheimer, Chief, Long Term Care Branch, Div.
of Provider Services Coverage Policy, Department of Health and Human
Services, Health Care Financing Administration, Room 401, EHR, 6325
Security Blvd., Baltimore, MD 21207, 410 966-4620
RIN: 0938-AE97
_______________________________________________________________________
1606. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)
Legal Authority: 42 USC 1395x(s)(14); 42 USC 1395x(nn)
CFR Citation: 42 CFR 410.10; 42 CFR 411.15; 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 07/00/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: William Larson, Program Analyst, Medical Services
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-4639
RIN: 0938-AE98
_______________________________________________________________________
1607. MEDICARE COVERAGE OF CLINICAL PSYCHOLOGIST, OTHER PSYCHOLOGIST, AND
CLINICAL SOCIAL WORKER SERVICES--MEDICARE (BPD-706-F)
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 08/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Regina Walker, Program Analyst, Office of Coverage &
Eligibility Policy, Department of Health and Human Services, Health
Care Financing Administration, Room 401, EHR, 6325 Security Blvd.,
Baltimore, MD 21207, 410 966-6735
RIN: 0938-AE99
_______________________________________________________________________
1608. ALLOWING CERTIFICATIONS AND RECERTIFICATIONS BY NURSE PRACTITIONERS
AND CLINICAL NURSE SPECIALISTS FOR CERTAIN SERVICES (BPD-709-F)
Legal Authority: 42 USC 1395f(a)
CFR Citation: 42 CFR 424
Legal Deadline: None
Abstract: This final regulation implements section 6028 of OBRA '89. It
allows nurse practitioners and clinical nurse specialists working in
collaboration with a physician to certify and recertify that extended
care services are needed or continue to be needed.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/28/91 56 FR 29609
NPRM Comment Period End 08/27/91 56 FR 29609
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joanne Sinsheimer, Chief, Long Term Care Branch, Div.
of Provider Services Coverage Policy, Department of Health and Human
Services, Health Care Financing Administration, Room 401 EHR, 6325
Security Blvd., Baltimore, MD 21207, 410 966-4620
RIN: 0938-AF01
_______________________________________________________________________
1609. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HSQ-175-FC)
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
_________________________________________________________________________
Final Rule With Comment Period 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Local, Federal
Additional Information:
TIMETABLE: Pending court ruling.
Agency Contact: Pam Vocke, Director, Division of Program Operations,
Department of Health and Human Services, Health Care Financing
Administration, 2-D-2, ME, 6325 Security Blvd., Baltimore, MD 21207,
410 966-7089
RIN: 0938-AF02
_______________________________________________________________________
1610. CASE MANAGEMENT (MB-27-F)
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 would 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 06/00/95
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State, Local
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 400, EHR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-5659
RIN: 0938-AF07
_______________________________________________________________________
1611. MEDICAID THIRD PARTY LIABILITY: COST EFFECTIVENESS WAIVERS (MB-39-
F)
Legal Authority: 42 USC 1396a(a)(25)
CFR Citation: 42 CFR 433.138; 42 CFR 433.139
Legal Deadline: None
Abstract: This rule will provide States with the opportunity to request
waivers of certain third party liability requirements if the State has
more cost effective methods than those required to be used under
current regulations. These requirements relate to methods and
procedures for determining liability of third parties to pay for
services furnished under Medicaid and for paying claims. The waivers
will apply to administratively imposed requirements, not statutory
requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/02/94 59 FR 4880
NPRM Comment Period End 04/03/94 59 FR 4880
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Richard Friedman, Director, Division of Payment
Systems, Department of Health and Human Services, Health Care Financing
Administration, 273, EHR, 6325 Security Blvd., Baltimore, MD 21207, 410
966-3292
RIN: 0938-AF11
_______________________________________________________________________
1612. REQUIRED COVERAGE OF NURSE PRACTITIONER SERVICES--MEDICAID (MB-41-
F)
Legal Authority: 42 USC 1396d(a)(21)
CFR Citation: 42 CFR 440
Legal Deadline: None
Abstract: This regulation will require direct payment to certified
pediatric and family nurse practitioners to the extent that these
providers are authorized to practice under State laws. It would
implement section 6405 of OBRA '89 (PL 101-239) which became effective
July 1, 1990.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/23/91 56 FR 66392
NPRM Comment Period End 02/22/92 56 FR 66392
Final Action 01/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Department of Health and Human Services, Health Care Financing
Administration, 400, EHR, 6325 Security Blvd., Baltimore, MD 21207, 410
966-5659
RIN: 0938-AF12
_______________________________________________________________________
1613. PAYMENT FOR FEDERALLY QUALIFIED HEALTH CENTER (FQHC) SERVICES (BPD-
728-F)
Legal Authority: 42 USC 1395x(s)(2)(E); 42 USC 1395x(aa)(3); 42 USC
1395x(aa)(4); 42 USC 1395k(a)(2)(D)(ii); 42 USC 1395l(b)(5)
CFR Citation: 42 CFR 405; 42 CFR 491
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 4704 of PL 101-
508. 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
Public Comment Period End 08/11/92 57 FR 24961
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch,
Department of Health and Human Services, Health Care Financing
Administration, Room 441, EHR, 6325 Security Blvd., Baltimore, MD
21207, 410 966-4635
RIN: 0938-AF14
_______________________________________________________________________
1614. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS (OMC-
018-FC)
Legal Authority: 42 USC 1396b(m); 42 USC 1396a(e)(2)(A)
CFR Citation: 42 CFR 434.21 to 44; 42 CFR 447.361; 42 CFR 447.362
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: Businesses, Organizations
Government Levels Affected: State, Local
Agency Contact: Jane McClard, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, Room
233, ELR, 6325 Security Blvd., Baltimore, MD 21207, 410 966-5321
RIN: 0938-AF15
_______________________________________________________________________
1615. CRITERIA FOR THE DETERMINATION OF REASONABLE COSTS FOR MEDICARE --
CONTRACTING PREPAID HEALTH PLANS (OMC-006-F)
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 remove the absolute payment limit that is to
be applied to Prepaid Health Organizations with cost contracts under
section 1876 of the Social Security Act. This regulation will also set
forth the revised criteria that HCFA will use in determining claimed
costs that are reasonable and therefore reimbursable for prepaid health
organizations with cost contracts under section 1876 and agreements
under section 1833.
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, 1-G-2
Oak Meadows, 6325 Security Boulevard, Baltimore, Maryland 21207, 410
966-7610
RIN: 0938-AF16
_______________________________________________________________________
1616. PHYSICIAN OWNERSHIP OF AND REFERRALS TO HEALTH CARE FACILITIES THAT
FURNISH CLINICAL LABORATORY SERVICES AND FINANCIAL RELATIONSHIP REPORTING
REQUIREMENTS (BPD-674-FC)
Regulatory Plan: This entry is Seq. No. 58 in Part II of this issue of
the Federal Register.
RIN: 0938-AF40
_______________________________________________________________________
1617. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE
AGREEMENTS (MB-046-IFC)
Legal Authority: 42 USC 1396a(a); 42 USC 1396b(i); 42 USC 1396r-8; 42
USC 1396b(a)
CFR Citation: 42 CFR 447
Legal Deadline: None
Abstract: This rule will incorporate section 4401 of OBRA '90 which
concern reimbursement for prescribed drugs. Section 4401 amended title
XIX of the Social Security Act to add specific requirements for payment
for covered outpatient drugs. In general, 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 12/00/94
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Larry Reed, Chief, Medicaid Noninstitutional Payment
Policy Branch, Department of Health and Human Services, Health Care
Financing Administration, Room 273 EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-0830
RIN: 0938-AF42
_______________________________________________________________________
1618. MEDICARE AND MEDICAID PROGRAMS; ADVANCE DIRECTIVES (BPD-718-F)
Legal Authority: 42 USC 1395cc
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
Legal Deadline: None
Abstract: The final rules will make minor changes in the interim rule,
which implemented statutory provisions effective in December, 1991.
They will amend the Medicare and Medicaid regulations governing
provider agreements and contracts to establish requirements for States,
hospitals, nursing facilities, skilled nursing facilities, providers of
home health care or personal care services, hospice programs and
prepaid health plans concerning advance directives. An advance
directive is a written instruction, such as a living will or durable
power of attorney for health care, recognized under State law, relating
to the provision of health care when an individual's condition makes
him or her unable to express his or her wishes. The intent of these
provisions is to enhance an individual's control over medical treatment
decisions. These rules implement sections 4206 and 4751 of OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule With Comment
Period 03/06/92 57 FR 8194
Public Comment Period End 05/05/92 57 FR 8194
Final Action 04/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jacqueline Sheridan, Chief, Health Organizations
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4635
RIN: 0938-AF50
_______________________________________________________________________
1619. PARTIAL HOSPITALIZATION SERVICES IN COMMUNITY MENTAL HEALTH CENTERS
(BPD-736-F)
Legal Authority: 42 USC 1395k(a)(2)(J); 42 USC 1395x(ff)(3); 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 interim
final rule sets forth the coverage criteria and payment methodology for
partial hospitalization services furnished in community mental health
centers. It also specifies the requirements a community mental health
center must meet in order to enter into a Medicare provider agreement
to furnish partial hospitalization services.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 02/11/94 59 FR 6570
Interim Final Rule Effective 03/13/94 59 FR 6570
Comment Period End 04/12/94 59 FR 6570
Final Action 08/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch,
Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4635
RIN: 0938-AF53
_______________________________________________________________________
1620. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST
EFFECTIVE EMPLOYER BASED GROUP HEALTH PLANS (MB-047-F)
Legal Authority: 42 USC 1396a(a)(10); 42 USC 1396a(u)(l); 42 USC
1396d(a); 42 USC 1396a(a)(25); 42 USC 1396a(e); 42 USC 1396e
CFR Citation: 42 CFR 435.2; 42 CFR 435.3; 42 CFR 435.10; 42 CFR
435.186; 42 CFR 435.188
Legal Deadline: None
Abstract: This rule will amend our regulations to provide for
continuation of payment of health insurance premiums for individuals
who are entitled to elect COBRA continuation coverage under a group
health plan provided by an employer with 75 or more employees; require
Medicaid recipients to apply for enrollment in employer-based cost
effective group health plans as a condition of Medicaid eligibility;
require State agencies to pay for premiums, deductibles, coinsurances
and other cost sharing obligations under employer-based cost effective
group health plans, and define ``COBRA continuation coverage'' and
``COBRA beneficiaries.''
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/20/94 59 FR 31569
NPRM Comment Period End 08/19/94 59 FR 31569
Final Action 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: State, Federal
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323 EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4451
RIN: 0938-AF64
_______________________________________________________________________
1621. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID FAMILIES
WITH AN ABSENT PARENT (MB-051-F)
Legal Authority: 42 USC 1396k
CFR Citation: 42 CFR 433.160
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 06/00/95
Small Entities Affected: None
Government Levels Affected: None
Additional Information: MB-041-F will incorporate response to public
comments made on 0938-AF65, MB-048-F.
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323 EHR, 6325 Security Boulevard, Baltimore, MD
21207, 410 966-4451
RIN: 0938-AF68
_______________________________________________________________________
1622. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME
PREGNANT WOMEN, INFANTS AND CHILDREN (MB-052-IFC)
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
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 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
Comment Period End 11/22/94 59 FR 48805
Effective Date 11/24/94 59 FR 48805
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323 EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4451
RIN: 0938-AF69
_______________________________________________________________________
1623. OPTIONAL SPENDDOWN (MB-055-IFC)
Legal Authority: 42 USC 1396b(f)(2); 42 USC 1396a(a)(17)
CFR Citation: 42 CFR 435; 42 CFR 436
Legal Deadline: None
Abstract: This rule would allow States to choose the option of a
variation of the spenddown for medically needy individuals. Under the
regular spenddown program a medically needy individual becomes eligible
for Medicaid by spending down income in excess of the medically needy
income standard until the standard is reached. Under the optional
program, an applicant could choose to pay an amount equal to their
excess income to the State instead of becoming eligible only after
incurring expenses. This option was provided by section 4723 of OBRA
'90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule With Comment
Period 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Local
Additional Information: TIMETABLE: Pending consultation with outside
organizations.
Agency Contact: Marinos Svolos, Director, Division of Eligibility
Policy, Department of Health and Human Services, Health Care Financing
Administration, Room 323 EHR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4451
RIN: 0938-AF72
_______________________________________________________________________
1624. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-F)
Regulatory Plan: This entry is Seq. No. 59 in Part II of this issue of
the Federal Register.
RIN: 0938-AF74
_______________________________________________________________________
1625. NATIONAL COVERAGE DECISIONS: RULES FOR RISK CONTRACTING HMOS AND
CMPS (OMC-019-F)
Legal Authority: 42 USC 1395mm(c)(2)
CFR Citation: 42 CFR 417
Legal Deadline: None
Abstract: Under this rule, Health Maintenance Organizations (HMOs) and
Competitive Medical Plans (CMPs) that have entered into risk contracts
with HCFA will be protected against large unanticipated cost increases
that will result from having to furnish a new or increased Medicare
benefit established by a national coverage decision. When the Secretary
estimates that the new or increased benefit will result in a
significant change in the HMO's or CMP's costs, the organization will
not be required to furnish the service to its Medicare enrollees until
the cost has been taken into account in determining the monthly per
capita amounts that HCFA pays the HMO or CMP. This rule would implement
section 4204(c) of OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/22/94 59 FR 8429
Public Comment Period End 04/25/94 59 FR 8429
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Tracy Jensen, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, Room
4360, Cohen Building, 330 Independence Avenue SW., Washington, DC
20201, 202 619-2158
RIN: 0938-AF76
_______________________________________________________________________
1626. PART B ADVANCE PAYMENTS TO PHYSICIANS/SUPPLIERS OR OTHER ENTITIES
FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (BPO-105-F)
Legal Authority: 42 USC 1395u(c)
CFR Citation: 42 CFR 421.212
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 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Samuel Guida, Director, Division of Account Management
& Collection, Department of Health and Human Services, Health Care
Financing Administration, Room 1-E-6, ME Building, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-7495
RIN: 0938-AF85
_______________________________________________________________________
1627. APPLICATION OF INTEREST CHARGES TO MEDICARE SECONDARY PAYER
RECOVERIES (BPO-108-GN)
Legal Authority: 31 USC 3711; 31 USC 3717
CFR Citation: 42 CFR 401.601; 42 CFR 405.376; 45 CFR 30.16; 45 CFR
30.13
Legal Deadline: None
Abstract: This notice announces that HCFA is proceeding under its
authority to charge interest on secondary payer payments overdue to
HCFA. Experience has shown that parties owing monies to HCFA are not
motivated to make timely payments and require followup efforts to
collect the payments. The existing regulation at 42 CFR 401.607, which
authorizes claims collection (including interest), and other
authorities are being invoked to stimulate prompt payment.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice 04/00/95
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: John Albert, Program Analyst, Div. of Entitlement &
Benefit Coordination, Department of Health and Human Services, Health
Care Financing Administration, Room 3-E-5 ME Building, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-7457
RIN: 0938-AF87
_______________________________________________________________________
1628. RETROACTIVE ENROLLMENT (OMC-015-F)
Legal Authority: 42 USC 1395mm
CFR Citation: 42 CFR 417
Legal Deadline: None
Abstract: This regulation 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 the Omnibus Budget Reconciliation Act of 1990, PL 101-508.
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
Public Comment Period End 02/25/94 58 FR 68366
Final Action 07/00/95
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, Room
4360, Cohen Building, 330 Independence Avenue SW., Washington, DC
20201, 202 619-2158
RIN: 0938-AF98
_______________________________________________________________________
1629. PAYMENT FOR PREADMISSION SERVICES (BPD-731-F)
Legal Authority: 42 USC 1395ww(a)(4)
CFR Citation: 42 CFR 412.2(c); 42 CFR 413.40
Legal Deadline: None
Abstract: This rule implements 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. Included are services (other than ambulance
services) by a hospital (or by an entity wholly owned or operated by
the hospital) to the patient during the three days immediately
preceding the date of the patient's admission if the services are
diagnostic services (including clinical diagnostic laboratory tests),
or are other services related to the admission (as defined by the
Secretary).
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
Public Comment Period End 03/14/94 59 FR 1654
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Bill Ullman, Health Insurance Specialist Div. of
Provider Services Coverage Policy, Department of Health and Human
Services, Health Care Financing Administration, 401 East High Rise
Building, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-5667
RIN: 0938-AG00
_______________________________________________________________________
1630. CHANGE IN PROVIDER AGREEMENT REGULATIONS RELATED TO FEDERAL
EMPLOYEE HEALTH BENEFITS (BPD-748-F)
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 enrolled in a Federal Employee
Health Benefits (FEHB) plan but who are not entitled to receive
hospital benefits under Medicare Part A (Hospital Insurance) may not
exceed the hospital payments established for Medicare purposes for
inpatient hospital services. 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/10/94 59 FR 6228
NPRM Comment Period End 04/11/94 59 FR 6228
Final Action 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch,
Department of Health and Human Services, Health Care Financing
Administration, 401 EHR, 6325 Security Boulevard, Baltimore, MD 21207,
410 966-4635
RIN: 0938-AG03
_______________________________________________________________________
1631. PAYMENT FOR EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY SERVICES
FURNISHED BY AMBULATORY SURGICAL CENTERS (BPD-762-FN)
Legal Authority: 42 USC 1395l(i)(2)
CFR Citation: 42 CFR 416.120; 42 CFR 416.125; 42 CFR 416.130
Legal Deadline: None
Abstract: This notice complies with the court order by the U.S.
District Court for the District of Columbia on March 12, 1992, in The
American Lithotripsy Society v. Louis W. Sullivan, M.D. The court order
stays implementation of the Medicare payment rate announced on December
31, 1991 (56 FR 67666) for Extracorporeal Shock Wave Lithotripsy
Services furnished in Medicare Participating Ambulatory Surgical
Centers and use of the payment rate in determining the Medicare
allowance in hospital out-patient departments until the Secretary
publishes certain information relevant to the setting of the
Extracorporeal Shock Wave Lithotripsy Rate, receives comments, and
publishes a final notice.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 10/01/93 58 FR 51355
Public Comment Period End 12/30/93 58 FR 6128
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joan H. Sanow, Health Insurance Specialist, Division of
Special Payment Programs, Department of Health and Human Services,
Health Care Financing Administration, Room 1-A-5, ELR, 6325 Security
Boulevard, Baltimore, MD 21207-5187, 410 966-5723
RIN: 0938-AG04
_______________________________________________________________________
1632. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-N)
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.
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 59 FR 35664
Final Action 00/00/00
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Alan Bromberg, Program Analyst, Div. of Contractor
Planning & Managemt, BPO, Department of Health and Human Services,
Health Care Financing Administration, 3-F-1 ME Building, 6325 Security
Boulevard, Baltimore, MD 21207, 410 966-7441
RIN: 0938-AG06
_______________________________________________________________________
1633. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)
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. (Systems concepts without prescribing a particular
system design or solution.)
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 11/22/93 58 FR 61692
Public Comment Period End 01/21/94 58 FR 61692
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Richard Friedman, Director, Division of Payment
Systems, Medicaid Bureau, Department of Health and Human Services,
Health Care Financing Administration, Room 273, ELR, 6325 Security
Boulevard, Baltimore, MD 21207, 410 966-3292
RIN: 0938-AG10
_______________________________________________________________________
1634. REVISIONS TO THE DEFINITION OF END-STAGE RENAL DISEASE AND
RESUMPTION OF ENTITLEMENT (BPD-738-F)
Legal Authority: 42 USC 426-1
CFR Citation: 42 CFR 406.13
Legal Deadline: None
Abstract: This rule revises the definition of end-stage renal disease
to clarify that only those individuals whose kidneys have failed and
for whom the disease is expected to be a life-long affliction are
eligible for Medicare and end-stage renal disease benefits. This rule
also specifies that Medicare enrollment resumes for individuals who
again begin a regular course of renal dialysis treatments after a
previous course is terminated (with or without kidney transplant) and
include the same considerations for those who have a second transplant.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/06/94 59 FR 714
NPRM Comment Period End 03/07/94 59 FR 714
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Paul Olenick, Director, Division of Medicare
Eligibility Policy, BPD, Department of Health and Human Services,
Health Care Financing Administration, Room 401, EHR Building, 6325
Security Boulevard, Baltimore, Maryland 21207, 410 966-4472
RIN: 0938-AG19
_______________________________________________________________________
1635. 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)
Legal Authority: 42 USC 1395rr
CFR Citation: 42 CFR 405.2140; 42 CFR 405.2150
Legal Deadline: None
Abstract: This rule incorporates by reference, in our regulations, the
Association for the Advancement of Medical Instrumentation (AAMI)
guidelines for monitoring the quality of water used in dialysis as
published in ``Hemodialyzers System, Second Edition.'' It also updates
an existing incorporation by reference to reflect the 1992 edition AAMI
voluntary guidelines and standards on ``Recommended Practice for Reuse
of Hemodialyzers.'' These guidelines clarify certain issues and reflect
current medically acceptable dialysis standards and techniques.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 02/14/94 59 FR 6937
NPRM Comment Period End 04/15/94 59 FR 6937
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch,
BPD, Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR Building, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4635
RIN: 0938-AG21
_______________________________________________________________________
1636. MEDICARE PROGRAM: PROPOSED ADDITIONS TO AND DELETIONS FROM THE
CURRENT LIST OF COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL
CENTERS (BPD-776-FN)
Legal Authority: 42 USC 1395i(1)
CFR Citation: None
Legal Deadline: None
Abstract: This notice implements sections 1833(i)(l) of the Social
Security Act, which requires, in part, that the list of covered
ambulatory surgical center (ASC) procedures be reviewed and updated at
least every 2 years. The last update was published December 31, 1991.
This notice announces specific proposed additions to, and deletions
from, the list of surgical procedures for which facility services are
covered when the procedures are performed in a Medicare participating
ASC. The notice also announces changes to our criteria for deleting
procedures from the ASC list. Additionally, it announces the assignment
of payment groups for each addition. Finally, it reflects statutory
revisions mandated by OBRA '93.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 12/14/93 58 FR 65357
Public Comment Period End 02/14/94 58 FR 65357
Final Action 01/00/95
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Jacqueline Sheridan, Chief, Health Organizations
Branch, BPD, Department of Health and Human Services, Health Care
Financing Administration, 6325 Security Boulevard, Baltimore, Maryland
21207, 410 966-4635
RIN: 0938-AG27
_______________________________________________________________________
1637. MEDICARE PROGRAM: SPECIAL PAYMENT LIMITS FOR HOME BLOOD GLUCOSE
MONITORS (BPD-778-FN)
Legal Authority: 42 USC 1395l; 42 USC 1395u(b)
CFR Citation: None
Legal Deadline: None
Abstract: This notice establishes special payment limits for standard
home blood glucose monitors, identified as code EO607 of the HCFA
common procedure coding system. The notice is intended to prevent
excessive payment for these items.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Proposed Notice 01/06/94 59 FR 755
Comment Period End 03/07/94 59 FR 755
Final Action 02/00/95
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Joel Kaiser, Health Insurance Specialist, Medical
Services Payment Branch, BPD, Department of Health and Human Services,
Health Care Financing Administration, Room 1-H-5, ELR, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-4499
RIN: 0938-AG28
_______________________________________________________________________
1638. GENERAL EVALUATION CRITERIA AND STANDARDS FOR EVALUATING
PERFORMANCE OF CONTRACT (HSQ-207-GNC)
Legal Authority: 42 USC 1320c-2(h)(2)
CFR Citation: 42 CFR 462
Legal Deadline: None
Abstract: The notice provides general criteria and standards that will
be used to evaluate the effective and efficient performance of
Utilization 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 02/00/95
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Nancy Lafferty, Program Analyst, Department of Health
and Human Services, Health Care Financing Administration, Room 2-D-2,
Meadows East Building, 6325 Security Boulevard, Baltimore, Maryland
21207, 410 966-6783
RIN: 0938-AG32
_______________________________________________________________________
1639. WITHDRAWAL OF COVERAGE OF DIAGNOSTIC NOCTURNAL PENILE TUMESCENCE
TESTING (IMPOTENCE TESTING) (BPD-780-FN)
Legal Authority: 42 USC 1395y
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces the Medicare program's intent to
withdraw coverage for diagnostic nocturnal 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
Public Comment Period End 03/07/94 59 FR 309
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Maxine Hormats, Special Coverage Issues Branch,
Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR Building, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4630
RIN: 0938-AG43
_______________________________________________________________________
1640. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT
POSITIVE PRESSURE BREATHING MACHINE THERAPY (BPD-781-FN)
Legal Authority: 42 USC 1395x; 42 USC 1395y
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 59 FR 33520
Final Action 00/00/00
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Walter Rutenmueller, Chief, Special Coverage Issues
Branch, Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR Building, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-5395
RIN: 0938-AG44
_______________________________________________________________________
1641. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-FN)
Legal Authority: 42 USC 1395y
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 59 FR 26653
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Francina Spencer, Special Coverage Issues Branch,
Department of Health and Human Services, Health Care Financing
Administration, Room 401, EHR Building, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4614
RIN: 0938-AG45
_______________________________________________________________________
1642. PART A PREMIUM FOR 1995 FOR THE UNINSURED AGED AND FOR CERTAIN
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-046-N)
Legal Authority: 42 USC 1395i-2; 42 USC 1395i-2a
CFR Citation: None
Legal Deadline: Other, Statutory, September 30, 1994.
Other deadline is for publication of Notice.
Abstract: This notice announces the hospital insurance premium for
calendar year 1995 under 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 10/00/94
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, 1705 Whitehead Building, 6325 Security
Boulevard, Baltimore, Maryland 21207, 410 966-6389
RIN: 0938-AG49
_______________________________________________________________________
1643. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY
MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1995 (OACT-047-N)
Legal Authority: 42 USC 1395r
CFR Citation: None
Legal Deadline: Other, Statutory, September 30, 1994.
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, 1995. It also announces the monthly SMI premium
rate to be paid by all enrollees during the 12 months beginning January
1, 1995.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice 10/00/94
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, Room M-1, 1705 Whitehead Bulding, 6325
Security Boulevard, Baltimore, Maryland 21207, 410 966-6396
RIN: 0938-AG50
_______________________________________________________________________
1644. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE
SERVICES COINSURANCE AMOUNTS FOR 1995 (OACT-048-N)
Legal Authority: 42 USC 1395e
CFR Citation: None
Legal Deadline: Other, Statutory, September 15, 1994.
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 1995 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 10/00/94
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, Room M-l, 1705 Whitehead Building, 6325
Security Boulevard, Baltimore, Maryland 21207, 410 966-6389
RIN: 0938-AG51
_______________________________________________________________________
1645. REVISIONS TO GEOGRAPHIC PRACTICE COST INDICES, PAYMENT POLICIES AND
ADJUSTMENTS TO THE RELATIVE VALUE UNITS UNDER THE PHYSICIAN FEE SCHEDULE
FOR CY 1995 (BPD-789-FC)
Regulatory Plan: This entry is Seq. No. 60 in Part II of this issue of
the Federal Register.
RIN: 0938-AG52
_______________________________________________________________________
1646. REDUCTIONS IN PAYMENTS FOR HHA SERVICES (BPD-793-NC)
Legal Authority: 42 USC 1302; 42 USC 1395x(r)(1); 42 USC 1395hh; PL
103-66, Sec 13564
CFR Citation: 42 CFR None
Legal Deadline: None
Abstract: This notice in accordance with PL 103-66, provides that there
be no changes in home health services cost limits for cost reporting
periods beginning on or after July 1, 1994 and before July 1, 1996.
This notice also requires the Secretary, when granting or extending
exceptions to cost limits, to limit any exception to the amount that
would have been granted if there were no restrictions on changes in the
cost limits.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice With Comment Period 11/00/94
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Robert Kuhl, Division of Payment and Reporting Policy,
Department of Health and Human Services, Health Care Financing
Administration, Room 1-F-5, ELR, 6325 Security Boulevard, Baltimore,
Maryland 21207, 410 966-4597
RIN: 0938-AG54
_______________________________________________________________________
1647. DATE FOR FILING MEDICARE COST REPORTS (BPD-794-F)
Legal Authority: 42 USC 1395g
CFR Citation: 42 CFR 405.376; 42 CFR 413.24
Legal Deadline: None
Abstract: This rule will extend the time frame providers have to file
cost reports from no later than 3 months after the close of the period
covered by the report to no later than 5 months after the close of that
period. This change is necessary to ensure that providers have an
adequate amount of time to file complete and accurate cost reports. We
would define what HCFA considers to be an ``acceptable'' cost report
submission.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/25/94 59 FR 26998
Public Comment Period End 07/25/94 59 FR 26998
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Katie Walker, Payment Policy Branch, Department of
Health and Human Services, Health Care Financing Administration, Room
1-F-5, ELR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410
966-7278
RIN: 0938-AG55
_______________________________________________________________________
1648. FREEDOM OF CHOICE WAIVER; CONFORMING CHANGES (OMC-021-F)
Legal Authority: 42 USC 1302
CFR Citation: 42 CFR 431.55; 42 CFR 431.57
Legal Deadline: None
Abstract: This rule amends existing Medicaid regulations on freedom of
choice waivers granted under section 1915(b) of the Social Security Act
(Act) to conform them to the amendments made to the Act by sections
4604 and 4742 of OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule With Public
Comment Period End 02/01/94 59 FR 4597
Effective Date 03/03/94 59 FR 4597
Comment Period End 04/04/94 59 FR 4597
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Tracy Jensen, Office of Managed Care, Department of
Health and Human Services, Health Care Financing Administration, Room
4360 Cohen Building, 330 Independence Ave. SW., Washington, DC 20201,
202 619-2158
RIN: 0938-AG63
_______________________________________________________________________
1649. PAYMENT TO SWING BED HOSPITALS (BPD-805-FC)
Legal Authority: 42 USC 1395tt
CFR Citation: 42 CFR 413.53; 42 CFR 413.114
Legal Deadline: None
Abstract: This final rule with comment period would implement section
4008(j) of PL 101-508 by setting forth a new methodology for payment of
routine extended care services provided in a swing bed hospital.
Medicare payment for such services is determined 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. These rates will be determined
prospectively based on the most recent SNF cost reporting data
available. In accordance with PL 101-508, this rule also provides 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.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule With Comment Period 05/00/95
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Katie Walker, Director, Division of Payment and
Reporting Policy, Department of Health and Human Services, Health Care
Financing Administration, Room 1-F-5, ELR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-7278
RIN: 0938-AG68
_______________________________________________________________________
1650. PHYSICIAN PERFORMANCE STANDARD RATES OF INCREASE FOR FY 1995 AND
PHYSICIAN FEE SCHEDULE UPDATE FOR CY 1995 (BPD-807-FNC)
Legal Authority: 42 USC 1302; 42 USC 1395w-4; 42 USC 1395hh
CFR Citation: None
Legal Deadline: Final, Statutory, October 31, 1994.
Abstract: This notice announces the calendar year (CY) 1995 updates to
the Medicare physician fee schedule and the Federal fiscal year (FY)
1995 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),
respectively, of the Social Security Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Notice With Comment Period10/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Bernard Patashnik, Director, Division of Medical
Services Payment, Department of Health and Human Services, Health Care
Financing Administration, Room 1-H-5, ELR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-4497
RIN: 0938-AG69
_______________________________________________________________________
1651. CATEGORIZATION OF CLIA TESTS AND PERSONNEL MODIFICATIONS (HSQ-216-
FC)
Legal Authority: 42 USC 263a; 42 USC 1302; 42 USC 1395
CFR Citation: 42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.7;
42 CFR 493.9; 42 CFR 493.17; 42 CFR 493.18; 42 CFR 493.19; 42 CFR
493.20; 42 CFR 493.21; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 493.37; 42
CFR 493.39; 42 CFR 493.43; ...
Legal Deadline: None
Abstract: This final rule with comment period responds to comments
received concerning two previously published rules (57 FR 7002 and 58
FR 5215) for implementing CLIA. In this rule, we expand personnel
requirements so that more people are qualified to perform high
complexity tests and physician performed (now called provider-
performed) microscopy procedures and to supervise high complexity
testing.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule With Comment Period 10/00/94
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Judith Yost, Chief Laboratory & Home Health Services
Branch, HSQB, Department of Health and Human Services, Health Care
Financing Administration, Room 1-C-2 MWE, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 597-5907
RIN: 0938-AG71
_______________________________________________________________________
1652. MEDICAID PROGRAM: NURSE-MIDWIFE SERVICES (MB-085-P)
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 36479
NPRM Comment Period End 09/16/94 59 FR 36479
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Wardwell, Director, Division of Coverage Policy,
Medicaid Bureau, Department of Health and Human Services, Health Care
Financing Administration, Room 400, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-5659
RIN: 0938-AG73
_______________________________________________________________________
1653. MEDICAID PROGRAM: FEES FOR VACCINE ADMINISTRATION UNDER PEDIATRIC
IMMUNIZATION PROGRAM (MB-084-NC)
Regulatory Plan: This entry is Seq. No. 61 in Part II of this issue of
the Federal Register.
RIN: 0938-AG77
_______________________________________________________________________
1654. CRITERIA FOR MEDICARE COVERAGE OF LUNG TRANSPLANTS (BPD-
812-NC)
Legal Authority: 42 USC 1395y
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces Medicare criteria for coverage of lung
transplants under certain circumstances. We have determined, based on
results of an assessment conducted by the Public Health Service, that
lung transplants are a medically reasonable and necessary service when
furnished to patients with progressive end-stage pulmonary or
cardiopulmonary disease and when furnished by participating facilities
that meet specific criteria. Facilities electing to seek Medicare
coverage will be required to submit information establishing that the
criteria are met for evaluation by HCFA.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Notice With Comment Period 10/00/94
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Claude Mone, Health Insurance Specialist, Department of
Health and Human Services, Health Care Financing Administration, Room
400, EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-
4671
RIN: 0938-AG83
_______________________________________________________________________
1655. INFORMATION, COUNSELING, AND ASSISTANCE GRANTS PROGRAMS:
MEDICARE PROGRAM (OBS-001-FC)
Legal Authority: 42 USC 1302; 42 USC 1395hh
CFR Citation: 42 CFR 403
Legal Deadline: None
Abstract: This rule establishes, for fiscal years 1994 and beyond, a
minimum level of funding for grants made to States to provide Medicare
beneficiaries with information, counseling, and assistance related to
obtaining adequate and appropriate health insurance coverage. It also
establishes in regulations the condition for eligibility for these
grants, limitations on the use of grant funds in certain circumstances,
and annual reporting requirements. This grant program is in accordance
with OBRA '90.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Effective Date 10/07/94
Final Rule With Comment Period 10/07/94 59 FR 51125
Comment Period End 12/06/94
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: Eric Lang, Health Insurance Specialist, Office of
Beneficiary Services, Department of Health and Human Services, Health
Care Financing Administration, Room 600, EHR, 6325 Security Boulevard,
Baltimore, Maryland 21207, 410 966-3193
RIN: 0938-AG91
_______________________________________________________________________
1656. QUALIFIED HEALTH MAINTENANCE ORGANIZATIONS: TECHNICAL
AMENDMENTS (OMC-009-FC)
Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 300e; 42 USC 300e-
5; 42 USC 300e-9; 31 USC 9701
CFR Citation: 42 CFR 417
Legal Deadline: None
Abstract: This rule clarifies and updates portions of the HCFA
regulations that pertain to Federal qualification of health maintenance
organizations (HMOs), continued regulation of qualified HMOs, inclusion
of qualified HMOs in employee health benefits plans offered by
employers, and administration of outstanding loans and loan guarantees
that were awarded before October 1, l986, under the Public Health
Service Act.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Rule With Comment Period 10/03/94 59 FR 49834
Effective Date 10/31/94 59 FR 49834
Comment Period End 11/29/94 59 FR 49834
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Tracy Jensen, Health Insurance Specialist, Office of
Managed Care, Department of Health and Human Services, Health Care
Financing Administration, Room 4360, Cohen Building, 200 Independence
Avenue SW., Washington, DC 20201, 202 619-2158
RIN: 0938-AG92
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Health Care Financing Administration (HCFA)
_______________________________________________________________________
1657. MEDICAID ELIGIBILITY AND COVERAGE REQUIREMENTS (MB-001-F)
CFR Citation: 42 CFR 435; 42 CFR 436
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 08/22/94 59 FR 43050
Final Action Effective 08/18/94
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Marinos Svolos, 410 966-4451
RIN: 0938-AA58
_______________________________________________________________________
1658. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (MB-020-F)
CFR Citation: 42 CFR 435.732; 42 CFR 435.831; 42 CFR 436.831
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn No further action
needed. 07/26/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Marinos Svolos, 410 966-4451
RIN: 0938-AB07
_______________________________________________________________________
1659. HOME AND COMMUNITY-BASED SERVICES FOR THE ELDERLY (MB-019-F)
CFR Citation: 42 CFR 435.3; 42 CFR 435.217; 42 CFR 435.726; 42 CFR
435.735; 42 CFR 436.2; 42 CFR 436.217; 42 CFR 440.250; 42 CFR 441.10;
42 CFR 441.350 to 441.357; 42 CFR 441.360; 42 CFR 441.365; 42 CFR
400.203; 42 CFR 440.1; 42 CFR 440.181
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 07/26/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Wardwell, 410 966-5659
RIN: 0938-AD55
_______________________________________________________________________
1660. PAYMENT ADJUSTMENTS FOR HOSPITALS THAT SERVE A DISPROPORTIONATE
NUMBER OF LOW-INCOME PATIENTS (MB-017-IFC)
CFR Citation: 42 CFR 412; 42 CFR 440; 42 CFR 447
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 07/26/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Bernard Truffer, 410 966-1357
RIN: 0938-AE35
_______________________________________________________________________
1661. UTILIZATION AND QUALITY CONTROL PEER REVIEW ORGANIZATIONS (PRO):
CONFIDENTIAL INFORMATION (HSQ-190-P)
CFR Citation: 42 CFR 476
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/18/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Harvey Brook, 410 966-6853
RIN: 0938-AF03
_______________________________________________________________________
1662. DAY HABILITATION AND RELATED SERVICES (MB-37-P)
CFR Citation: 42 CFR 440
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Combined with 0938-
AF89 (MB-076-P) 04/01/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Wardwell, 410 966-5659
RIN: 0938-AF10
_______________________________________________________________________
1663. MEDICARE COVERAGE OF SCREENING MAMMOGRAPHY (BPD-724-F)
CFR Citation: 42 CFR 405.534; 42 CFR 405.535; 42 CFR 410.1; 42 CFR
410.10; 42 CFR 411.15; 42 CFR 413.123; 42 CFR 494.50
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 09/30/94 59 FR 49826
Final Action Effective 10/01/94 59 FR 49826
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: William Larson, 410 966-4639
RIN: 0938-AF26
_______________________________________________________________________
1664. MEDICARE, MEDICAID, AND CLIA PROGRAMS: INSPECTION AND CERTIFICATION
PROCEDURES FOR LABORATORIES (HSQ-193-P)
CFR Citation: 42 CFR 493
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn by HCFA - no further
action anticipated 09/19/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Pam Vocke, 410 966-7089
RIN: 0938-AF33
_______________________________________________________________________
1665. MEDICAID DRUG USE REVIEW PROGRAM AND ELECTRONIC CLAIMS MANAGEMENT
SYSTEM FOR OUTPATIENT DRUG CLAIMS (MB-050-F)
CFR Citation: 42 CFR 456
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 09/23/94 59 FR 48811
Final Action Effective 10/24/94 59 FR 48811
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Al Beachley, 410 966-3325
RIN: 0938-AF67
_______________________________________________________________________
1666. INTERMEDIARY AND CARRIER CHECKS THAT ARE LOST, STOLEN, DEFACED,
MUTILATED, DESTROYED, OR PAID ON FORGED ENDORSEMENTS (BPO-114-FC)
CFR Citation: 42 CFR 424.350; 42 CFR 424.352; 42 CFR 424.354
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 07/26/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Samuel Guida, 410 966-7495
RIN: 0938-AG16
_______________________________________________________________________
1667. CHANGES IN PHYSICIAN ATTESTATION REQUIREMENTS (BPD-769-F)
CFR Citation: 42 CFR 412.46(c)
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/09/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jackie Sheridan, 410 966-4635
RIN: 0938-AG34
_______________________________________________________________________
1668. MEDICARE PROGRAM: CHANGES TO THE INPATIENT HOSPITAL PROSPECTIVE
PAYMENT SYSTEMS AND FISCAL YEAR 1995 RATES (BPD-802-F)
CFR Citation: 42 CFR 412; 42 CFR 413
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 09/01/94 59 FR 45330
Final Action Effective 10/01/94 59 FR 45330
Small Entities Affected: Businesses, Organizations
Government Levels Affected: State, Federal
Agency Contact: Lana Price, 410 966-4529
RIN: 0938-AG46
_______________________________________________________________________
1669. REDUCTIONS IN PAYMENTS FOR SNF SERVICES (BPD-795-NC)
CFR Citation: 42 CFR 413.30
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn by HCFA - no further
action necessary. 09/01/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Robert Kuhl, 410 966-4597
RIN: 0938-AG56
_______________________________________________________________________
1670. LIMITATIONS ON REVISIONS TO FINAL ADMINISTRATIVE COST PROPOSALS
(BPO-122-P)
CFR Citation: 42 CFR 421.10
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 06/30/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Don Posen, 410 966-7533
RIN: 0938-AG57
_______________________________________________________________________
1671. REQUIRED LABORATORY PROCEDURES FOR RURAL HEALTH CLINICS (BPD-783-F)
CFR Citation: 42 CFR 491.9
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 04/21/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Jacqueline Sheridan, 410 966-4635
RIN: 0938-AG62
_______________________________________________________________________
1672. SELF-IMPLEMENTING COVERAGE AND PAYMENT PROVISIONS: 1993 LEGISLATION
(BPD-791-F)
CFR Citation: 42 CFR 405.2137; 42 CFR 405.2163; 42 CFR 405.2401; 42
CFR 406.32; 42 CFR 408.20; 42 CFR 410.10; 42 CFR 410.52; 42 CFR 410.60;
42 CFR 413.157; 42 CFR 413.124; 42 CFR 413.130; 42 CFR 418.306
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
No comments received on 05/25/94
rule; no action necessary. 10/06/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Matt Plonski, 410 966-4662
RIN: 0938-AG64
_______________________________________________________________________
1673. FINAL LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE SHARE
HOSPITALS: FEDERAL FISCAL YEAR 1994 (MB-088-N)
CFR Citation: 42 CFR 447.297; 42 CFR 447.298
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/02/94
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: State
Agency Contact: Richard Strauss, 410 966-2019
RIN: 0938-AG74
_______________________________________________________________________
1674. SMALL BUSINESS INNOVATION RESEARCH GRANTS FOR FY 95 (ORD-068-N)
CFR Citation: None
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Notice 10/03/94 59 FR 50246
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Carl Hackerman, 410 966-6644
RIN: 0938-AG76
_______________________________________________________________________
1675. MEDICARE AND MEDICAID PROGRAMS; MEDICARE-MEDICAID COVERAGE
DATA BANK REQUIREMENTS: PRELIMINARY GUIDANCE (BPO-125-N)
Legal Authority: 42 USC 1320b-14
CFR Citation: None
Legal Deadline: None
Abstract: This notice informs the public about section 1144 of the
Social Security Act, which is self-implementing, and provides
preliminary guidance to employers who are required to report
information about all individuals covered by group health plans to a
newly established Medicare-Medicaid Coverage Data Bank. Information in
the data bank will be used to help identify situations where employer
group health plans are responsible for making primary payments for
services received by Medicare or Medicaid beneficiaries. This notice
provides: information on the background and legislative authority for
the data bank; definitions of key terms; reporting requirements; the
identity of entities that are required to, or may, report; reporting
dates; penalties for noncompliance; and methods of reporting.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Final Action 05/10/94 59 FR 24167
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Tribal, Federal
Agency Contact: William Zavoina, Department of Health and Human
Services, Health Care Financing Administration, Bureau of Program
Operations, 1445 Meadows East Bldg., Baltimore, MD 21207, 410 966-7461
RIN: 0938-AG78
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________
1676. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES
Legal Authority: 42 USC 627
CFR Citation: 45 CFR 1355; 45 CFR 1356; 45 CFR 1357
Legal Deadline: None
Abstract: This NPRM will propose criteria the Department will use to
verify that a State has met statutory requirements and is eligible to
receive additional funds under section 427 of the Social Security Act.
The proposed rule will contain the specific criteria by which State
performance in meeting the requirements of section 427 is determined,
the percentage levels and other standards for case record compliance,
and procedures for conducting compliance reviews.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 06/00/95
Small Entities Affected: None
Government Levels Affected: State
Additional Information: This action was previously reported under RIN
0980-AA08.
Agency Contact: Daniel H. Lewis, Associate Commissioner, Children's
Bureau, Admin. on Children, Youth, and Families, Department of Health
and Human Services, Administration for Children and Families, P.O. Box
1182, Washington, DC 20013, 202 205-8618
RIN: 0970-AA97
_______________________________________________________________________
1677. AMENDMENTS TO DEVELOPMENTAL DISABILITIES RULES
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.
Abstract: This NPRM will propose to update 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 01/00/95
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, 202 690-
5504
RIN: 0970-AB11
_______________________________________________________________________
1678. STANDARDS FOR SAFE TRANSPORTATION
Legal Authority: 42 USC 9801 et seq
CFR Citation: 45 CFR 1310
Legal Deadline: None
Abstract: The NPRM will propose 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 01/00/95
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, 202
205-8569
RIN: 0970-AB24
_______________________________________________________________________
1679. TITLE IV-E TRAINING
Legal Authority: 42 USC 674
CFR Citation: 45 CFR 235; 45 CFR 1356.60
Legal Deadline: None
Abstract: Section 474 of the Social Security Act authorizes Federal
matching for training personnel employed or preparing for employment by
the State or local child welfare agency at 75 percent instead of 50
percent as for other administrative costs. This NPRM will clarify what
is included in the higher reimbursement rate.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
Small Entities Affected: Undetermined
Government Levels Affected: State
Agency Contact: Daniel H. Lewis, Deputy Associate Commissioner,
Children's Bureau, Admin. on Children, Youth & Families, Department of
Health and Human Services, Administration for Children and Families,
P.O. Box 1182, Washington, DC 20013, 202 205-8618
RIN: 0970-AB25
_______________________________________________________________________
1680. STANDARDS FOR PURCHASE OF FACILITIES
Legal Authority: 42 USC 9801 et seq
CFR Citation: 45 CFR 1309
Legal Deadline: None
Abstract: This regulation will propose standards for the purchase of
facilities as required by the Head Start Improvement Act of 1992.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
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, 202
205-8569
RIN: 0970-AB31
_______________________________________________________________________
1681. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING PUBLIC
ASSISTANCE AGENCIES
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 10/00/94
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, 202
401-9289
RIN: 0970-AB32
_______________________________________________________________________
1682. FAMILY PRESERVATION AND SUPPORT
Legal Authority: 42 USC 430 to 435
CFR Citation: 45 CFR 1355; 45 CFR 1356; 45 CFR 1357
Legal Deadline: None
Abstract: This NPRM will propose to amend the requirements under title
IV-B subpart 1 for the Child Welfare 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
welfare 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
NPRM Comment Period End 12/05/94
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 1187, Washington, DC
20013, 202 205-8618
RIN: 0970-AB34
_______________________________________________________________________
1683. NOTICE OF PROPOSED RULEMAKING FOR THE ADMINISTRATION OF NATIVE
AMERICANS 45 CFR PART 1336
Legal Authority: 42 USC 2991
CFR Citation: 45 CFR 1336
Legal Deadline: None
Abstract: The regulations propose to amend 45 CFR part 1336 to
implement new 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 recent amendments to the statute.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 03/00/95
Final Action 03/00/96
Small Entities Affected: Organizations
Government Levels Affected: None
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, 020 690-
5780
RIN: 0970-AB37
_______________________________________________________________________
1684. INTERSTATE CASE CLOSURE
Legal Authority: 42 USC 1102
CFR Citation: 45 CFR 303
Legal Deadline: None
Abstract: This regulation proposes to make critical changes to aid
States in converting their caseloads to automated systems by 1995. Its
scope is limited to interstate case closure issues, and should provide
helpful guidance to States in eliminating from their caseloads cases
which can no longer be worked. States have been requesting such
criteria for the past several years. The intent of this regulation is
to lessen State burdens, rather than to create new ones. This measure
would complement welfare reform efforts by helping States to streamline
their caseloads as they move to automated systems, thus preparing them
for changes in the welfare system.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: None
Government Levels Affected: State, Local, Federal
Agency Contact: Susan Notar, Program Specialist, Office of Child
Support Enforcement, Department of Health and Human Services,
Administration for Children and Families, 370 L'Enfant Promenade SW.,
Washington, DC 20447, 202 401-4606
RIN: 0970-AB41
_______________________________________________________________________
1685. DIRECT PAYMENTS TO INDIAN TRIBES AND TRIBAL ORGANIZATIONS UNDER
TITLE IV-B, SUBPART 1
Legal Authority: 42 USC 628
CFR Citation: 45 CFR 1357.40
Legal Deadline: None
Abstract: This NPRM will propose to amend the regulations governing
direct payments to Indian Tribes and Indian Tribal Organizations (ITOs)
for child welfare services under title IV-B, subpart 1. It will
eliminate the requirement that to be eligible, Indian Tribes and ITOs
must provide services under contract (or grant) with the Secretary of
the Interior under section 102 of the Indian Self-Determination Act. It
will also add a description of the formula used to calculate the amount
of Federal funds available to eligible Tribes and ITOs under title IV-
B, subpart 1.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 10/00/94
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: State, Tribal
Agency Contact: Michael Ambrose, Director, Division of Child Welfare,
Children's Bureau, ACYF, Department of Health and Human Services,
Administration for Children and Families, P.O. Box 1182, Washington, DC
20013, 202 205-8618
RIN: 0970-AB44
_______________________________________________________________________
1686. REPATRIATION - ADVANCE APPROVAL OF COSTS
Legal Authority: 42 USC 1313
CFR Citation: 45 CFR 212
Legal Deadline: None
Abstract: This document proposes to amend the regulations concerning
the U.S. Repatriate Program. The proposal is to require agencies
providing assistance to groups of United States citizens who are
returned from foreign countries to the United States by the Department
of State due to war, threat of war, civil disorder, or natural disaster
to request advance approval from the Administration of Children and
Families to incur expenses for planning receptions for such groups, for
implementing such plans. This action is necessary in order for the
Department to control the limited funding available for such
activities.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/19/94 59 FR 42795
NPRM Comment Period End 10/18/94
Final Action 08/00/95
Small Entities Affected: None
Government Levels Affected: Undetermined
Agency Contact: David B. Smith, Director, Division of State
Legalization and, Repatriation, Department of Health and Human
Services, Administration for Children and Families, 370 L'Enfant
Promenade SW., Washington, DC 20447, 202 401-9255
RIN: 0970-AB45
_______________________________________________________________________
1687. REDUCTION OF REPORTING REQUIREMENTS FOR THE STATE SYSTEMS
ADVANCE PLANNING DOCUMENT (APD) PROCESS
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 95.600
Legal Deadline: None
Abstract: These proposed rules will 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 01/00/95
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, 202 401-6404
RIN: 0970-AB46
_______________________________________________________________________
1688. BLOCK GRANT PROGRAMS (LOW INCOME HOME ENERGY ASSISTANCE
PROGRAM --LIHEAP)--FY 1995 AND FY 1996 PROVISIONS
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: -- Inclusion of new Assurance 16, to require grantees
to submit as a part of their annual application a description of their
annual application a description of their ``self-sufficiency''
activities and to submit a report to DHHS on the effect of these
activities; -- Inclusion of allowable uses of DOE rules for
weatherization services provided with LIHEAP funds; -- 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: -- Consideration of different
weighting of factors under the allocation formula for the leveraging
incentive program; -- Hearing requirements for adult disallowances; --
Allotments for territories; and, -- Standards for reviewing grantee
interpretations of -- statutory requirements.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
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, 202 401-9351
RIN: 0970-AB47
_______________________________________________________________________
1689. AUTOMOBILE RESOURCE LIMIT
Regulatory Plan: This entry is Seq. No. 62 in Part II of this issue of
the Federal Register.
RIN: 0970-AB48
_______________________________________________________________________
1690. ADMINISTRATIVE FLEXIBILITY RULE
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 earnings.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
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, 202
401-9289
RIN: 0970-AB49
_______________________________________________________________________
1691. HEAD START INITIATIVE ON FAMILIES WITH INFANTS AND
TODDLERS
Regulatory Plan: This entry is Seq. No. 63 in Part II of this issue of
the Federal Register.
RIN: 0970-AB50
_______________________________________________________________________
1692. FLEXIBILITY IN THE UTILIZATION OF INFORMATION OBTAINED
THROUGH THE INCOME ELIGIBILITY VERIFICATION SYSTEM
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 205.55; 45 CFR 205.56; 45 CFR 205.60; 45 CFR
205.62
Legal Deadline: None
Abstract: States will be given the flexibility to eliminate certain
data matches and/or to selectively match only certain categories of
recipients or applicants. In addition, States can also adjust the
timeframes for follow-up of match ``hits''. States must demonstrate
that their proposed changes will result in a more efficient and cost
effective matching operation.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 12/00/94
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, 202
401-9289
RIN: 0970-AB51
_______________________________________________________________________
1693. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL
CHILDREN
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 serves the tribe is terminated.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 01/00/95
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, 370 L'Enfant Promenade SW.,
Washington, DC 20013, 202 205-8569
RIN: 0970-AB52
_______________________________________________________________________
1694. INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES
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 01/00/95
Small Entities Affected: Organizations
Government Levels Affected: Tribal
Agency Contact: Douglas Klafehan, Deputy Associate Commissioner, Heat
Start, Bureau, Department of Health and Human Services, Administration
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202
205-8569
RIN: 0970-AB53
_______________________________________________________________________
1695. CONSTRUCTION OF HEAD START FACILITIES
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 03/00/95
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, 202
205-8569
RIN: 0970-AB54
_______________________________________________________________________
1696. QUALITY STANDARDS FOR HEAD START PROGRAMS
Legal Authority: 42 USC 9801
CFR Citation: 45 CFR 1301; 45 CFR 1304; 45 CFR 1309
Legal Deadline: NPRM, Statutory, May 18, 1995.
Legal deadline only pertains to performance standards.
Abstract: The NPRM will establish performance standards with respect to
services provided by Head Start Programs including health, education,
parent involvement, nutritional, social and transitional services,
administrative and financial management standards and standards
relating to the condition and location of facilities used to carry out
Head Start activities.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/00/95
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, 202
205-8569
RIN: 0970-AB55
_______________________________________________________________________
1697. HEAD START FELLOWSHIPS PROGRAM
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 12/00/94
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, 202
205-8569
RIN: 0970-AB56
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________
1698. AID TO FAMILIES WITH DEPENDENT CHILDREN PROGRAM; EXTENSION OF
MEDICAID ELIGIBILITY WHEN SUPPORT COLLECTIONS RESULT IN TERMINATION OF
AFDC ELIGIBILITY
Legal Authority: 42 USC 606; 42 USC 1302; PL 98-378, Sec 20; PL 100-
485, Sec 303(e)
CFR Citation: 42 CFR 435; 42 CFR 436; 45 CFR 233
Legal Deadline: None
Abstract: This final rule, which implements section 20 of the Child
Support Enforcement Amendments of 1984 (Pub. L. 98-378), specifies that
in any case where the collection or increased collection of support
under title IV-D of the Social Security Act contributes in whole or
part to a family's ineligibility for AFDC, the family is deemed, but
only for the purpose of Medicaid eligibility, to be receiving AFDC for
a period of four calendar months after the last month of AFDC
eligibility. This applies only to families who receive AFDC in three of
the six months immediately preceding the month of ineligibility.
``Received'' includes those individuals denied an AFDC payment solely
because of a payment under $10, the recoupment of an overpayment, or
because the payment is determined to be zero as a result of rounding.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/27/92 57 FR 56294
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Mack A. 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, 202
401-9289
RIN: 0970-AA07
_______________________________________________________________________
1699. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE PROGRAM --
LIHEAP) FY 91 AND FY 92 PROVISIONS
Legal Authority: 42 USC 8621 et seq
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: This final rule amends the Department's regulations governing
the administration of block grant programs; this rule applies to the
Low-Income Home Energy Assistance Program (LIHEAP). The rule revises
provisions included in an interim final rule published 01/16/92, that
amended the block grant regulations and implemented changes to the
LIHEAP statute which were made by the Augustus F. Hawkins Human
Services Reauthorization Act of 1990 (Pub. L. 101-501). These changes
involve the Department's response to formal complaints, a reduction in
the percent of LIHEAP funds that grantees may carry forward from one
fiscal year to the next, waiver authority to increase the percent of
LIHEAP funds that grantees may use for weatherization from 15% to 25%,
a requirement for additional outreach and intake services under certain
circumstances, and a new leveraging incentive program. This final rule
also makes several related, largely technical amendments to the block
grant regulations.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 01/16/92 57 FR 1960
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: State
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, 202 401-9351
RIN: 0970-AB15
_______________________________________________________________________
1700. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE PROGRAM--
LIHEAP)--FY 93 AND FY 94 PROVISIONS
Legal Authority: 42 USC 8621 et seq
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: The final rule 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 Augustus F. Hawkins Services
Reauthorization Act (HRSA) of 1990 (Pub. L. 101-501) and language in
the fiscal year 1993 appropriations statute (Pub. L. 102-394) that will
affect grantee administration of the LIHEAP program in fiscal years
1993 and 1994. The major changes effective FY 93 and FY 94 is: --
Ending of authority to transfer LIHEAP funds to other block grant
programs. This rule also contains proposed requirements for an
application completion date in order for Indian tribes and tribal
organizations to receive Community Service Block Grant program funds.
The rule includes certain submission and completion dates for States
applying for Community Services, Social Services and LIHEAP block grant
funds to cover requirements under the Cash Management Improvement Act
of 1990, P.L. 101-453. Finally, this final rule includes changes
proposed
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/16/93 58 FR 60498
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: State
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, 202 401-9351
RIN: 0970-AB16
_______________________________________________________________________
1701. FAMILY VIOLENCE PREVENTION AND SERVICES
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 01/00/95
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, 202 401-2333
RIN: 0970-AB18
_______________________________________________________________________
1702. CHILD ABUSE AND NEGLECT STATE GRANT PROGRAM
Legal Authority: 42 USC 5101
CFR Citation: 45 CFR 1340
Legal Deadline: None
Abstract: The primary purpose of this NPRM will be to propose revisions
to 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 03/00/95
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: David W. Lloyd, 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, 202 205-8586
RIN: 0970-AB23
_______________________________________________________________________
1703. STATE LEGALIZATION IMPACT ASSISTANCE GRANT
Legal Authority: PL 99-603; PL 102-394
CFR Citation: 45 CFR 402
Legal Deadline: None
Abstract: This rule amends the SLIAG regulations to implement the
amendment to IRCA that directs the Secretary to reallocate any SLIAG
funds not expended by States by December 30, 1994 to States which had
expended their entire allocations, based on each State's percentage
share of total unreimbursed legalization alien costs in all States. The
reallocated funds will be available until June 30, 1995.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 05/31/94 59 FR 28038
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: State
Agency Contact: David B. Smith, Director, Division of State
Legalization and Repatriation, Department of Health and Human Services,
Administration for Children and Families, 370 L'Enfant Promenade SW.,
Washington, DC 20447, 202 401-9255
RIN: 0970-AB28
_______________________________________________________________________
1704. CHILD CARE--REVISED REGULATIONS
Legal Authority: 42 USC 1302
CFR Citation: Not yet determined
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 12/00/94
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, 202 205-8572
RIN: 0970-AB33
_______________________________________________________________________
1705. STATEWIDE AUTOMATED CHILD WELFARE INFORMATION SYSTEM
Legal Authority: PL 103-66
CFR Citation: 45 CFR 1355; 45 CFR 1356
Legal Deadline: None
Abstract: These interim final rules implement section 13713 of the
Omnibus Budget Reconciliation Act of 1993, Public Law 103-66 signed by
the President on August 10, 1993.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
Interim Final Rule 12/22/93 58 FR 87939
Final Action 12/00/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Naomi B. Marr, Director, Office of Information Systems
Mgmt, Department of Health and Human Services, Administration for
Children and Families, 300 E Hubert Humphrey Building, 200 Independence
Ave. SW., Washington, DC 20201, 202 401-6960
RIN: 0970-AB38
_______________________________________________________________________
1706. CHILD SUPPORT ENFORCEMENT PROGRAM: PATERNITY ESTABLISHMENT AND
REVISION OF CHILD SUPPORT ENFORCEMENT PROGRAM AND AUDIT REGULATIONS
Legal Authority: 42 USC 663(h); 42 USC 604(d); 42 USC 652(a)(1); 42
USC 652(a)(4)
CFR Citation: 45 CFR 301; 45 CFR 302; 45 CFR 303; 45 CFR 305
Legal Deadline: Other, Statutory, October 1, 1993.
Statutory effective date; the law allows for a later effective date in
States needing to enact State laws.
Abstract: This final rule contains provisions regarding both paternity
establishment and the audit. The paternity establishment provisions
which implement the requirements of section 13721 of the Omnibus Budget
Reconciliation Act of 1993 (OBRA'93) require States to adopt a variety
of procedures designed to streamline the paternity establishment
process. These include the use of default orders, a presumption of
paternity based on genetic test results, conditions for admission of
genetic test results as evidence, and expedited decision-making process
for paternity cases in which title IV-D services are being provided. In
addition, this final regulation amends regulations governing the audit
of State Child Support Enforcement (IV-D) programs and the imposition
of financial penalties for failure to substantially comply with the
requirements of title IV-D of the Act. This regulation specifies how
audits will evaluate State compliance with the requirements set forth
in title IV-D of the Act and Federal regulations, including
requirements resulting from the Family Support Act
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 11/29/93 58 FR 62599
Final Action 10/00/94
Small Entities Affected: None
Government Levels Affected: State, Local, Federal
Additional Information: This regulation includes RIN 0970-AA74 which is
hereby withdrawn.
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, 202 401-5373
RIN: 0970-AB40
_______________________________________________________________________
1707. REFUGEE RESETTLEMENT PROGRAM: MISCELLANEOUS CHANGES
Legal Authority: 8 USC 1522
CFR Citation: 45 CFR 400
Legal Deadline: None
Abstract: We are proposing to make miscellaneous changes to existing
regulations at 45 CFR Part 400.
Timetable:
_________________________________________________________________________
Action Date FR Cite
_________________________________________________________________________
NPRM 08/12/94 59 FR 41417
Interim Final Rule 08/00/95
Small Entities Affected: None
Government Levels Affected: State, Local
Agency Contact: Toyo A. Biddle, Deputy Director, Division of Policy
Analysis, Department of Health and Human Services, Administration for
Children and Families, 370 L'Enfant Promenade SW., Washington, D.D.
20447, 202 401-9250
RIN: 0970-AB42
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Administration for Children and Families (ACF)
_______________________________________________________________________
1708. REVISIONS OF CHILD SUPPORT ENFORCEMENT PROGRAM AND AUDIT
REGULATIONS
CFR Citation: 45 CFR 301; 45 CFR 305
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn - Combined With RIN
0970-AB40 08/19/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Lourdes Henry, 202 401-5440
RIN: 0970-AA74
_______________________________________________________________________
1709. HEAD START PERFORMANCE STANDARDS FOR INFANTS, TODDLERS, AND
PREGNANT WOMEN
CFR Citation: 45 CFR 1307
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Withdrawn 08/19/94
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Douglas Klafehn, 202 205-8569
RIN: 0970-AB04
_______________________________________________________________________
1710. TECHNICAL CHANGES TO THE AFDC PROGRAM AS REQUIRED BY OBRA 90
CFR Citation: 45 CFR 205; 45 CFR 233
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 05/19/94 59 FR 26141
Small Entities Affected: None
Government Levels Affected: State, Local, Federal
Agency Contact: Mack A. Storrs, 202 401-9289
RIN: 0970-AB14
_______________________________________________________________________
1711. AUTOMATIC DATA PROCESSING EQUIPMENT AND SERVICES; CONDITIONS FOR
FEDERAL FINANCIAL PARTICIPATION AND GENERAL ADMINISTRATION - PUBLIC
ASSISTANCE PROGRAMS
CFR Citation: 45 CFR 95; 45 CFR 205
Completed:
_________________________________________________________________________
Reason Date FR Cite
_________________________________________________________________________
Final Action 06/15/94 59 FR 30707
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: William Davis, 202 401-6404
RIN: 0970-AB39
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Administration on Aging (AOA)
_______________________________________________________________________
1712. 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
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)(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: NPRM, Statutory, April 1, 1993. Final, Statutory, June
1, 1993.
Abstract: The Administration on Aging (AoA) is proposing to revise the
current rules governing State agencies, area agencies on aging, Indian
tribes, organizations serving older individuals who are Hawaiian
Natives, and service providers providing services and advocating on
behalf of older individuals who are eligible for supportive and
nutrition services under the Older Americans Act of 1965, as amended.
The purpose of these revisions is to provide a structure for the
operation of the Act's Title VII program for vulnerable elder rights
protection activities under a new 45 CFR part 1327 of these
regulations; establish competitive guidelines and procedures for the
making of Title IV grants and contracts, under a new 45 CFR part 1324
of these regulations; and clarify new program and policy directions in
the development of intrastate funding formulas, as well as past
omissions, under 45 CFR parts 1321, 1326, and 1328 of these current
regulations. We believe that these additions and revisions will assist
State agencies, area agencies on aging, Indian tribes, organizations
serving older individuals who are Hawaiian Natives, and service (cont)
Timetable:
Balance of OAA Amendments NPRM 11/00/94
Elder Rights Protection NPRM 10/00/94
Intrastate Funding Formulas NPRM 03/17/94 (59 FR 12728) NPRM Comment
Period End 05/16/94 Final Action 10/00/94
Small Entities Affected: Organizations
Government Levels Affected: State, Tribal
Additional Information: ABSTRACT CONT: providers in the development and
provision of community-based services.
Agency Contact: William F. Benson, Deputy Assistant Secretary for
Aging, Department of Health and Human Services, Administration on
Aging, 330 Independence Avenue SW., Room 4760, Cohen Bldg., Washington,
DC 20201, 202 619-0556
RIN: 0985-AA00
[FR Doc. 94-23418 Filed 11-10-94; 8:45 am]
BILLING CODE 4150-04-F