Unified Agenda

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

45 CFR Subtitle A, Chs. II, III, and XIII

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY:

Office of the Secretary, HHS.

ACTION:

Semiannual regulatory agenda.

SUMMARY:

The regulatory agenda set out below provides information to the public about regulatory actions under development within the Department of Health and Human Services (HHS). The Agenda provides an opportunity for all concerned about the potential impact of these actions to participate in their development at an early stage. Semiannual publication of the Agenda is required under provisions of the Regulatory Flexibility Act of 1980 and of Executive Order 12866.

FOR FURTHER INFORMATION CONTACT:

Ann Stallion, U.S. Department of Health and Human Services, Washington, DC 20201, (202) 690-6824.

SUPPLEMENTARY INFORMATION:

The Office of Management and Budget requires that fall editions of the Agenda be augmented by a regulatory plan. The Plan is made up of a statement of the Department's regulatory priorities; this statement sets out the principles that Secretary Thompson has determined will govern the regulation-development process within HHS, and the overarching policy themes which will establish HHS regulatory priorities during fiscal year 2002. There follows amplified descriptions of those discrete regulatory actions under development which will best reflect these principles and policy themes.

As noted above, public commentary is solicited on the Plan as a whole or on specific actions described in either the Plan or the full Agenda. Interested persons should direct specific comments to the contact official cited at the end of the descriptions of specific regulatory actions. Comments of a more generic nature, or comments on subjects which cross-cut the responsibilities of specific HHS agencies, should be sent to: Ann C. Agnew, Executive Secretary to the Department, Room 603H, 200 Independence Avenue SW., Washington, DC 20201.

For this edition of HHS' 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.

Dated:

October 5, 2001.

Ann C. Agnew, Executive Secretary to the Department.

References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Office of the Secretary—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
984 Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants) 0991-AB12

985 Modifications to Standards for Privacy of Individually Identifiable Health Information (Reg Plan Seq No. 25) 0991-AB14

986 Implementing the Bioterrorism Prevention and Response Act of 2001 (Reg Plan Seq No. 26) 0991-AB15

Office of the Secretary—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
984	Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants)	0991-AB12
985	Modifications to Standards for Privacy of Individually Identifiable Health Information (Reg Plan Seq No. 25)	0991-AB14
986	Implementing the Bioterrorism Prevention and Response Act of 2001 (Reg Plan Seq No. 26)	0991-AB15

Office of the Secretary—Final Rule Stage

Sequence Number Title Regulation Identification Number
987 Shared Risk Exception to the Safe Harbor Provisions 0991-AA91

988 Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums for ESRD Beneficiaries 0991-AB04

989 Safe Harbor for Ambulance Restocking 0991-AB05

990 Revisions and Technical Corrections to 42 CFR Chapter V 0991-AB09

991 Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color, National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration Act of 1987 0991-AB10

Office of the Secretary—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
987	Shared Risk Exception to the Safe Harbor Provisions	0991-AA91
988	Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums for ESRD Beneficiaries	0991-AB04
989	Safe Harbor for Ambulance Restocking	0991-AB05
990	Revisions and Technical Corrections to 42 CFR Chapter V	0991-AB09
991	Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color, National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration Act of 1987	0991-AB10

Office of the Secretary—Long-Term Actions

Sequence Number Title Regulation Identification Number
992 Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care Organizations 0991-AB03

993 Safe Harbor for Arrangements Involving Federally Qualified Health Centers 0991-AB06

Office of the Secretary—Long-Term Actions
Sequence Number	Title	Regulation Identification Number
992	Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care Organizations	0991-AB03
993	Safe Harbor for Arrangements Involving Federally Qualified Health Centers	0991-AB06

Office of the Secretary—Completed Actions

Sequence Number Title Regulation Identification Number
994 Reproduction and Sale of Official Forms and Publications 0991-AA83

995 Standards for Privacy of Individually Indentifiable Health Information 0991-AB08

996 Definition of Terms; Substantially in Excess and Usual Charges and Clarification of the Good Cause Exception 0991-AB13

Office of the Secretary—Completed Actions
Sequence Number	Title	Regulation Identification Number
994	Reproduction and Sale of Official Forms and Publications	0991-AA83
995	Standards for Privacy of Individually Indentifiable Health Information	0991-AB08
996	Definition of Terms; Substantially in Excess and Usual Charges and Clarification of the Good Cause Exception	0991-AB13

Substance Abuse and Mental Health Services Administration—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
997 Community Mental Health Services Block Grant 0930-AA08

Substance Abuse and Mental Health Services Administration—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
997	Community Mental Health Services Block Grant	0930-AA08

Substance Abuse and Mental Health Services Administration—Final Rule Stage

Sequence Number Title Regulation Identification Number
998 Substance Abuse and Mental Health Services Administration Mental Health and Substance Abuse Emergency Response Criteria 0930-AA09

999 Seclusion and Restraint for Non-Medical Residential Facilities 0930-AA10

Substance Abuse and Mental Health Services Administration—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
998	Substance Abuse and Mental Health Services Administration Mental Health and Substance Abuse Emergency Response Criteria	0930-AA09
999	Seclusion and Restraint for Non-Medical Residential Facilities	0930-AA10

Substance Abuse and Mental Health Services Administration—Completed Actions

Sequence Number Title Regulation Identification Number
1000 Substance Abuse Prevention and Treatment Block Grant Applications Due Date Change from March 31 to October 1 for FY 2001 and Beyond 0930-AA04

1001 Mandatory Guidelines for Federal Workplace Drug Testing Programs 0930-AA07

Substance Abuse and Mental Health Services Administration—Completed Actions
Sequence Number	Title	Regulation Identification Number
1000	Substance Abuse Prevention and Treatment Block Grant Applications Due Date Change from March 31 to October 1 for FY 2001 and Beyond	0930-AA04
1001	Mandatory Guidelines for Federal Workplace Drug Testing Programs	0930-AA07

References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Centers for Disease Control and Prevention—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1002 Control of Communicable Diseases (Reg Plan Seq No. 27) 0920-AA03

1003 Amendments to Quality Assurance and Administrative Provision for Approval of Respiratory Protective Devices 0920-AA04

1004 Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of Cancer for Energy Employees Occupational Illness Compensation Program 0920-AA05

Centers for Disease Control and Prevention—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1002	Control of Communicable Diseases (Reg Plan Seq No. 27)	0920-AA03
1003	Amendments to Quality Assurance and Administrative Provision for Approval of Respiratory Protective Devices	0920-AA04
1004	Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of Cancer for Energy Employees Occupational Illness Compensation Program	0920-AA05

Centers for Disease Control and Prevention—Long-Term Actions

Sequence Number Title Regulation Identification Number
1005 Packaging and Handling of Infectious Substances and Select Agents 0920-AA02

Centers for Disease Control and Prevention—Long-Term Actions
Sequence Number	Title	Regulation Identification Number
1005	Packaging and Handling of Infectious Substances and Select Agents	0920-AA02

Departmental Management—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1006 Implementation of the Equal Access to Justice Act in Agency Proceedings 0990-AA02

1007 Administrative Wage Garnishment 0990-AA05

Departmental Management—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1006	Implementation of the Equal Access to Justice Act in Agency Proceedings	0990-AA02
1007	Administrative Wage Garnishment	0990-AA05

Food and Drug Administration—Prerule Stage

Sequence Number Title Regulation Identification Number
1008 Natural Rubber-Containing Drugs; User Labeling 0910-AB56

1009 Requirements for Submission of In Vivo Bioequivalence Data 0910-AC23

1010 Requirements for Medical Gas Containers and Closure Systems 0910-AC24

Food and Drug Administration—Prerule Stage
Sequence Number	Title	Regulation Identification Number
1008	Natural Rubber-Containing Drugs; User Labeling	0910-AB56
1009	Requirements for Submission of In Vivo Bioequivalence Data	0910-AC23
1010	Requirements for Medical Gas Containers and Closure Systems	0910-AC24

References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Food and Drug Administration—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1011 Over-the-Counter (OTC) Drug Review 0910-AA01

1012 Establishment Registration and Product Listing for Drugs and Biologics 0910-AA49

1013 Investigational New Drugs: Export Requirements for Unapproved New Drug Products 0910-AA61

1014 Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs 0910-AA86

1015 Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No. 28) 0910-AA97

1016 Radioactive Drugs for Basic Research 0910-AB00

1017 Administrative Practices and Procedures; Advisory Opinions and Guidelines 0910-AB14

1018 Blood Initiative 0910-AB26

1019 Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications 0910-AB34

1020 Expanded Access to Investigational Therapies 0910-AB37

1021 Electronic Submission of Postmarketing Safety Reports 0910-AB42

1022 Distinguishing Marks for Drug Products Containing Insulin 0910-AB43

1023 Pregnancy Labeling 0910-AB44

1024 Positron Emission Tomography Drugs; Current Good Manufacturing Practice 0910-AB63

1025 Current Good Manufacturing Practice for Medicated Feeds 0910-AB70

1026 Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use 0910-AB79

1027 Repackaging Approval Requirements 0910-AB81

1028 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements (Reg Plan Seq No. 29) 0910-AB88

1029 Submission in Electronic Format of Certain Labeling Information 0910-AB91

1030 Fees Relating to Drugs; Waiver and Reduction of Fees 0910-AB92

1031 Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications 0910-AB93

1032 Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food 0910-AB96

1033 Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment 0910-AB99

1034 Reporting Information Regarding Falsification of Data 0910-AC02

1035 Status Reports of Distribution and Use Information for Antimicrobial Animal Drug Products Used in Food-Producing Animals 0910-AC04

1036 Labeling Dietary Supplements for Women Who Are or May Become Pregnant 0910-AC09

1037 Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" 0910-AC13

1038 Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (Reg Plan Seq No. 30) 0910-AC14

1039 Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition 0910-AC18

1040 Use of Materials Derived from Ruminant Animals in FDA Regulated Products 0910-AC19

1041 Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients from Unapproved Sources 0910-AC20

1042 Exception from General Requirements for Informed Consent; Request for Comments and Information (Reg Plan Seq No. 31) 0910-AC25

1043 Bar Code Label Requirements for Human Drug Products (Reg Plan Seq No. 32) 0910-AC26

1044 Promotion and Charging For Investigational Drugs 0910-AC27

Food and Drug Administration—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1011	Over-the-Counter (OTC) Drug Review	0910-AA01
1012	Establishment Registration and Product Listing for Drugs and Biologics	0910-AA49
1013	Investigational New Drugs: Export Requirements for Unapproved New Drug Products	0910-AA61
1014	Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs	0910-AA86
1015	Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No. 28)	0910-AA97
1016	Radioactive Drugs for Basic Research	0910-AB00
1017	Administrative Practices and Procedures; Advisory Opinions and Guidelines	0910-AB14
1018	Blood Initiative	0910-AB26
1019	Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications	0910-AB34
1020	Expanded Access to Investigational Therapies	0910-AB37
1021	Electronic Submission of Postmarketing Safety Reports	0910-AB42
1022	Distinguishing Marks for Drug Products Containing Insulin	0910-AB43
1023	Pregnancy Labeling	0910-AB44
1024	Positron Emission Tomography Drugs; Current Good Manufacturing Practice	0910-AB63
1025	Current Good Manufacturing Practice for Medicated Feeds	0910-AB70
1026	Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use	0910-AB79
1027	Repackaging Approval Requirements	0910-AB81
1028	Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements (Reg Plan Seq No. 29)	0910-AB88
1029	Submission in Electronic Format of Certain Labeling Information	0910-AB91
1030	Fees Relating to Drugs; Waiver and Reduction of Fees	0910-AB92
1031	Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications	0910-AB93
1032	Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food	0910-AB96
1033	Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment	0910-AB99
1034	Reporting Information Regarding Falsification of Data	0910-AC02
1035	Status Reports of Distribution and Use Information for Antimicrobial Animal Drug Products Used in Food-Producing Animals	0910-AC04
1036	Labeling Dietary Supplements for Women Who Are or May Become Pregnant	0910-AC09
1037	Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue"	0910-AC13
1038	Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (Reg Plan Seq No. 30)	0910-AC14
1039	Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition	0910-AC18
1040	Use of Materials Derived from Ruminant Animals in FDA Regulated Products	0910-AC19
1041	Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients from Unapproved Sources	0910-AC20
1042	Exception from General Requirements for Informed Consent; Request for Comments and Information (Reg Plan Seq No. 31)	0910-AC25
1043	Bar Code Label Requirements for Human Drug Products (Reg Plan Seq No. 32)	0910-AC26
1044	Promotion and Charging For Investigational Drugs	0910-AC27

References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Food and Drug Administration—Final Rule Stage

Sequence Number Title Regulation Identification Number
1045 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) 0910-AA02

1046 Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals 0910-AA45

1047 Bioavailability and Bioequivalence Requirements 0910-AA51

1048 Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients 0910-AA89

1049 Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 33) 0910-AA94

1050 Current Good Manufacturing Practice; Revision of Certain Labeling Controls 0910-AA98

1051 Use of Ozone-Depleting Substances 0910-AA99

1052 Exports; Notification and Recordkeeping Requirements 0910-AB16

1053 Foreign Establishment Registration and Listing (Reg Plan Seq No. 34) 0910-AB21

1054 FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export 0910-AB24

1055 Antibiotic Drug Approval and Exclusivity 0910-AB33

1056 Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs 0910-AB39

1057 Supplements and Other Changes to Approved New Animal Drug Applications 0910-AB49

1058 Revisions to the General Safety Requirements for Biological Products; Direct Final Rule 0910-AB51

1059 Discontinuation of a Lifesaving Product 0910-AB60

1060 Supplements and Other Changes to an Approved Application 0910-AB61

1061 Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Reg Plan Seq No. 35) 0910-AB66

1062 Presubmission Conferences 0910-AB68

1063 Surgeon's and Patient Examination Gloves; Reclassification 0910-AB74

1064 CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback) (Reg Plan Seq No. 36) 0910-AB76

1065 Antibiotic Resistance Labeling 0910-AB78

1066 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications 0910-AB80

1067 Food Additives: Food Contact Substances Notification System 0910-AB94

1068 Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States (Reg Plan Seq No. 37) 0910-AB95

1069 State Certification of Mammography Facilities 0910-AB98

1070 Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation 0910-AC00

1071 Examination of Administrative Record and Other Advisory Committee Records 0910-AC03

1072 Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical (Reg Plan Seq No. 38) 0910-AC05

1073 Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products 0910-AC07

1074 Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity 0910-AC11

1075 Revocation of Conditions for Marketing Digoxin Products for Oral Use 0910-AC12

1076 Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded (Reg Plan Seq No. 39) 0910-AC22

Food and Drug Administration—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
1045	New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)	0910-AA02
1046	Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals	0910-AA45
1047	Bioavailability and Bioequivalence Requirements	0910-AA51
1048	Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients	0910-AA89
1049	Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 33)	0910-AA94
1050	Current Good Manufacturing Practice; Revision of Certain Labeling Controls	0910-AA98
1051	Use of Ozone-Depleting Substances	0910-AA99
1052	Exports; Notification and Recordkeeping Requirements	0910-AB16
1053	Foreign Establishment Registration and Listing (Reg Plan Seq No. 34)	0910-AB21
1054	FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export	0910-AB24
1055	Antibiotic Drug Approval and Exclusivity	0910-AB33
1056	Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs	0910-AB39
1057	Supplements and Other Changes to Approved New Animal Drug Applications	0910-AB49
1058	Revisions to the General Safety Requirements for Biological Products; Direct Final Rule	0910-AB51
1059	Discontinuation of a Lifesaving Product	0910-AB60
1060	Supplements and Other Changes to an Approved Application	0910-AB61
1061	Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Reg Plan Seq No. 35)	0910-AB66
1062	Presubmission Conferences	0910-AB68
1063	Surgeon's and Patient Examination Gloves; Reclassification	0910-AB74
1064	CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback) (Reg Plan Seq No. 36)	0910-AB76
1065	Antibiotic Resistance Labeling	0910-AB78
1066	180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications	0910-AB80
1067	Food Additives: Food Contact Substances Notification System	0910-AB94
1068	Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States (Reg Plan Seq No. 37)	0910-AB95
1069	State Certification of Mammography Facilities	0910-AB98
1070	Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation	0910-AC00
1071	Examination of Administrative Record and Other Advisory Committee Records	0910-AC03
1072	Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical (Reg Plan Seq No. 38)	0910-AC05
1073	Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products	0910-AC07
1074	Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity	0910-AC11
1075	Revocation of Conditions for Marketing Digoxin Products for Oral Use	0910-AC12
1076	Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded (Reg Plan Seq No. 39)	0910-AC22

Food and Drug Administration—Long-Term Actions

Sequence Number Title Regulation Identification Number
1077 Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports 0910-AA04

1078 Food Labeling Review 0910-AA19

1079 Medical Foods 0910-AA20

1080 Direct-to-Consumer Promotion Regulations 0910-AA90

1081 Investigational Use New Animal Drug Regulations (Section 610 Review) 0910-AB02

1082 Suitability Determination for Donors of Human Cellular and Tissue-Based Products 0910-AB27

1083 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products 0910-AB28

1084 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed 0910-AB50

1085 Bulk Drug Substances for Use in Pharmacy Compounding 0910-AB57

1086 Pharmacy and Physician Compounding of Drug Products 0910-AB58

1087 Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness 0910-AB59

1088 Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 0910-AB71

1089 Mandatory HACCP Regulations for Manufacturers of Rendered Products 0910-AB72

1090 Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action 0910-AB73

1091 Stability Testing of Drugs 0910-AB82

1092 Substances Prohibited From Use in Animal Food or Feed 0910-AB90

1093 Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness 0910-AC01

1094 Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 0910-AC08

1095 Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers 0910-AC10

1096 Premarket Notice Concerning Bioengineered Foods 0910-AC15

1097 Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures 0910-AC16

1098 Institutional Review Boards: Registration Requirements 0910-AC17

1099 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed Animal Populations 0910-AC21

Food and Drug Administration—Long-Term Actions
Sequence Number	Title	Regulation Identification Number
1077	Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports	0910-AA04
1078	Food Labeling Review	0910-AA19
1079	Medical Foods	0910-AA20
1080	Direct-to-Consumer Promotion Regulations	0910-AA90
1081	Investigational Use New Animal Drug Regulations (Section 610 Review)	0910-AB02
1082	Suitability Determination for Donors of Human Cellular and Tissue-Based Products	0910-AB27
1083	Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products	0910-AB28
1084	Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed	0910-AB50
1085	Bulk Drug Substances for Use in Pharmacy Compounding	0910-AB57
1086	Pharmacy and Physician Compounding of Drug Products	0910-AB58
1087	Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness	0910-AB59
1088	Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996	0910-AB71
1089	Mandatory HACCP Regulations for Manufacturers of Rendered Products	0910-AB72
1090	Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action	0910-AB73
1091	Stability Testing of Drugs	0910-AB82
1092	Substances Prohibited From Use in Animal Food or Feed	0910-AB90
1093	Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness	0910-AC01
1094	Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness	0910-AC08
1095	Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers	0910-AC10
1096	Premarket Notice Concerning Bioengineered Foods	0910-AC15
1097	Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures	0910-AC16
1098	Institutional Review Boards: Registration Requirements	0910-AC17
1099	Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed Animal Populations	0910-AC21

Food and Drug Administration—Completed Actions

Sequence Number Title Regulation Identification Number
1100 Hearing Aids; Professional and Patient Labeling; Conditions for Sale 0910-AA39

1101 Classification of Computer Software Programs That Are Medical Devices 0910-AA41

1102 Reinventing FDA Food Regulations 0910-AA58

1103 Part 600-Biological Products: General (Completion of a Section 610 Review) 0910-AC06

Food and Drug Administration—Completed Actions
Sequence Number	Title	Regulation Identification Number
1100	Hearing Aids; Professional and Patient Labeling; Conditions for Sale	0910-AA39
1101	Classification of Computer Software Programs That Are Medical Devices	0910-AA41
1102	Reinventing FDA Food Regulations	0910-AA58
1103	Part 600-Biological Products: General (Completion of a Section 610 Review)	0910-AC06

Health Resources and Services Administration—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1104 National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Medical Malpractice Payments Reporting Requirements 0906-AA41

1105 Designation of Medically Underserved Populations and Health Professional Shortage Areas 0906-AA44

1106 National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table 0906-AA55

1107 National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Reporting Adverse and Negative Actions. 0906-AA57

Health Resources and Services Administration—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1104	National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Medical Malpractice Payments Reporting Requirements	0906-AA41
1105	Designation of Medically Underserved Populations and Health Professional Shortage Areas	0906-AA44
1106	National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table	0906-AA55
1107	National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Reporting Adverse and Negative Actions.	0906-AA57

Health Resources and Services Administration—Final Rule Stage

Sequence Number Title Regulation Identification Number
1108 National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table 0906-AA58

1109 Adoption of the Interim Final Rule as a Final Rule with Amendments for Ricky Ray Hemophilia 0906-AA59

Health Resources and Services Administration—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
1108	National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table	0906-AA58
1109	Adoption of the Interim Final Rule as a Final Rule with Amendments for Ricky Ray Hemophilia	0906-AA59

Health Resources and Services Administration—Completed Actions

Sequence Number Title Regulation Identification Number
1110 Compliance Alternatives for Provision of Uncompensated Services 0906-AA52

1111 Final Rule for the Health Professions, Nursing, Public Health, and Allied Health Training Grant Programs Under 42 CFR Parts 57 and 58 0906-AA53

Health Resources and Services Administration—Completed Actions
Sequence Number	Title	Regulation Identification Number
1110	Compliance Alternatives for Provision of Uncompensated Services	0906-AA52
1111	Final Rule for the Health Professions, Nursing, Public Health, and Allied Health Training Grant Programs Under 42 CFR Parts 57 and 58	0906-AA53

References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Indian Health Service—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1112 Tribal Self-Governance Amendments (Reg Plan Seq No. 40) 0917-AA05

Indian Health Service—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1112	Tribal Self-Governance Amendments (Reg Plan Seq No. 40)	0917-AA05

Indian Health Service—Final Rule Stage

Sequence Number Title Regulation Identification Number
1113 Indian Child Protection and Family Violence Prevention Act Minimum Standards of Character 0917-AA02

Indian Health Service—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
1113	Indian Child Protection and Family Violence Prevention Act Minimum Standards of Character	0917-AA02

National Institutes of Health—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1114 National Institutes of Health AIDS Research Loan Repayment Program 0925-AA02

1115 Undergraduate Scholarship Program Regarding Professions Needed by the NIH 0925-AA10

1116 National Cancer Institute Clinical Cancer Education Program 0925-AA17

1117 National Institutes of Health Loan Repayment Program for Research 0925-AA18

1118 NIH Center Grants 0925-AA24

1119 National Institutes of Health Clinics Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds 0925-AA25

1120 NIH Loan Repayment Program for Minority Health Disparties Research 0925-AA26

1121 Pediatric Research Loan Repayment Program 0925-AA27

1122 NIH Training Grants 0925-AA28

1123 National Institutes of Health Loan Repayment Program for Clinical Researchers 0925-AA30

1124 Standards for a National Chimpanzee Sanctuary System 0925-AA31

National Institutes of Health—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1114	National Institutes of Health AIDS Research Loan Repayment Program	0925-AA02
1115	Undergraduate Scholarship Program Regarding Professions Needed by the NIH	0925-AA10
1116	National Cancer Institute Clinical Cancer Education Program	0925-AA17
1117	National Institutes of Health Loan Repayment Program for Research	0925-AA18
1118	NIH Center Grants	0925-AA24
1119	National Institutes of Health Clinics Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds	0925-AA25
1120	NIH Loan Repayment Program for Minority Health Disparties Research	0925-AA26
1121	Pediatric Research Loan Repayment Program	0925-AA27
1122	NIH Training Grants	0925-AA28
1123	National Institutes of Health Loan Repayment Program for Clinical Researchers	0925-AA30
1124	Standards for a National Chimpanzee Sanctuary System	0925-AA31

National Institutes of Health—Final Rule Stage

Sequence Number Title Regulation Identification Number
1125 National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repayment Program 0925-AA19

1126 Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects 0925-AA20

National Institutes of Health—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
1125	National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repayment Program	0925-AA19
1126	Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects	0925-AA20

National Institutes of Health—Completed Actions

Sequence Number Title Regulation Identification Number
1127 National Research Service Awards 0925-AA16

National Institutes of Health—Completed Actions
Sequence Number	Title	Regulation Identification Number
1127	National Research Service Awards	0925-AA16

Office of Public Health and Science—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1128 Public Health Services Policies on Research Misconduct 0940-AA04

Office of Public Health and Science—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1128	Public Health Services Policies on Research Misconduct	0940-AA04

Office of Public Health and Science—Final Rule Stage

Sequence Number Title Regulation Identification Number
1129 Public Health Service Standards for the Protection of Research Misconduct Whistleblowers 0940-AA01

1130 Federal Policy (Common Rule) for the Protection of Human Subjects 0940-AA03

1131 Protection of Human Research Subjects 0940-AA05

Office of Public Health and Science—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
1129	Public Health Service Standards for the Protection of Research Misconduct Whistleblowers	0940-AA01
1130	Federal Policy (Common Rule) for the Protection of Human Subjects	0940-AA03
1131	Protection of Human Research Subjects	0940-AA05

References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Centers for Medicare & Medicaid Services—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1132 Medicare and Medicaid Programs; Terms, Definitions, and Addresses: Technical Amendments (CMS-9877-P) 0938-AH53

1133 National Standard for Identifiers of Health Plans (CMS-4145-P) (Reg Plan Seq No. 41) 0938-AH87

1134 End Stage Renal Disease Bad Debt Payment (CMS-1126-P) 0938-AK02

1135 Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term Care Facilities and ICFs for the Mentally Retarded (CMS-3047-P) 0938-AK35

1136 Medical Devices Coverage Decisions Related to Health Care Technology (CMS-3059-P) 0938-AK43

1137 Medicare Program; Reporting and Repayment of Overpayments (CMS-6011-P) 0938-AK45

1138 Health Insurance Reform: Standards for Electronic Claims Attachments (CMS-0050-P) (Reg Plan Seq No. 42) 0938-AK62

1139 Health Insurance Reform: Modifications to Standards for Electronic Transactions (CMS-0003-P) (Reg Plan Seq No. 43) 0938-AK64

1140 Prospective Payment System for Long-Term Care Hospitals for FY 2003 (CMS-1177-P) (Reg Plan Seq No. 44) 0938-AK69

1141 Modifications to Medicare Managed Care Rules Based on Provisions of BIPA and Technical Corrections (CMS-1180-P) (Reg Plan Seq No. 45) 0938-AK71

1142 Revisions to Transaction and Code Set Standards for Electronic Transactions (CMS-0005-P) (Reg Plan Seq No. 46) 0938-AK76

1143 Organ Procurement Organization Condition for Coverage (CMS-3064-IFC) (Reg Plan Seq No. 47) 0938-AK81

1144 Qualification Requirements for Directors of Laboratories Performing High Complexity Testing (CMS-2094-P) 0938-AK83

1145 State Allotments for Payment of Medicare Part B Premiums for Qualified Individuals; Federal Fiscal Year 2002 (CMS-2087-PN) 0938-AK91

1146 Home Health Prospective Payment System Refinements (CMS-1161-P) (Reg Plan Seq No. 48) 0938-AK93

1147 Medicaid Managed Care (CMS-2104-F) (Reg Plan Seq No. 49) 0938-AK96

1148 Medicaid Upper Payment Limit for Non-State Government-Owned or Operated Hospitals (CMS-2134-P) (Reg Plan Seq No. 50) 0938-AL05

1149 Home Health Prospective Payment System Rate Update For FY 2003 (CMS-1198-NC) (Reg Plan Seq No. 51) 0938-AL16

1150 Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-P) (Reg Plan Seq No. 52) 0938-AL18

1151 Hospital Outpatient Prospective Payment System for Calendar Year 2003 (CMS-1206-P) (Reg Plan Seq No. 53) 0938-AL19

1152 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update for FY 2003 (CMS-1202-P) (Reg Plan Seq No. 54) 0938-AL20

1153 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 (CMS-1204-P) (Reg Plan Seq No. 55) 0938-AL21

1154 Hospital Inpatient Rehabilitation Prospective Payment System for FY 2003 (CMS-1205-P) (Reg Plan Seq No. 56) 0938-AL22

1155 Hospital Inpatient Prospective Payment System for FY 2003 (CMS-1203-P) (Reg Plan Seq No. 57) 0938-AL23

1156 Initiative to Endorse Prescription Drug Discount Programs (CMS-4027-P) (Reg Plan Seq No. 58) 0938-AL28

Centers for Medicare & Medicaid Services—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1132	Medicare and Medicaid Programs; Terms, Definitions, and Addresses: Technical Amendments (CMS-9877-P)	0938-AH53
1133	National Standard for Identifiers of Health Plans (CMS-4145-P) (Reg Plan Seq No. 41)	0938-AH87
1134	End Stage Renal Disease Bad Debt Payment (CMS-1126-P)	0938-AK02
1135	Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term Care Facilities and ICFs for the Mentally Retarded (CMS-3047-P)	0938-AK35
1136	Medical Devices Coverage Decisions Related to Health Care Technology (CMS-3059-P)	0938-AK43
1137	Medicare Program; Reporting and Repayment of Overpayments (CMS-6011-P)	0938-AK45
1138	Health Insurance Reform: Standards for Electronic Claims Attachments (CMS-0050-P) (Reg Plan Seq No. 42)	0938-AK62
1139	Health Insurance Reform: Modifications to Standards for Electronic Transactions (CMS-0003-P) (Reg Plan Seq No. 43)	0938-AK64
1140	Prospective Payment System for Long-Term Care Hospitals for FY 2003 (CMS-1177-P) (Reg Plan Seq No. 44)	0938-AK69
1141	Modifications to Medicare Managed Care Rules Based on Provisions of BIPA and Technical Corrections (CMS-1180-P) (Reg Plan Seq No. 45)	0938-AK71
1142	Revisions to Transaction and Code Set Standards for Electronic Transactions (CMS-0005-P) (Reg Plan Seq No. 46)	0938-AK76
1143	Organ Procurement Organization Condition for Coverage (CMS-3064-IFC) (Reg Plan Seq No. 47)	0938-AK81
1144	Qualification Requirements for Directors of Laboratories Performing High Complexity Testing (CMS-2094-P)	0938-AK83
1145	State Allotments for Payment of Medicare Part B Premiums for Qualified Individuals; Federal Fiscal Year 2002 (CMS-2087-PN)	0938-AK91
1146	Home Health Prospective Payment System Refinements (CMS-1161-P) (Reg Plan Seq No. 48)	0938-AK93
1147	Medicaid Managed Care (CMS-2104-F) (Reg Plan Seq No. 49)	0938-AK96
1148	Medicaid Upper Payment Limit for Non-State Government-Owned or Operated Hospitals (CMS-2134-P) (Reg Plan Seq No. 50)	0938-AL05
1149	Home Health Prospective Payment System Rate Update For FY 2003 (CMS-1198-NC) (Reg Plan Seq No. 51)	0938-AL16
1150	Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-P) (Reg Plan Seq No. 52)	0938-AL18
1151	Hospital Outpatient Prospective Payment System for Calendar Year 2003 (CMS-1206-P) (Reg Plan Seq No. 53)	0938-AL19
1152	Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update for FY 2003 (CMS-1202-P) (Reg Plan Seq No. 54)	0938-AL20
1153	Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 (CMS-1204-P) (Reg Plan Seq No. 55)	0938-AL21
1154	Hospital Inpatient Rehabilitation Prospective Payment System for FY 2003 (CMS-1205-P) (Reg Plan Seq No. 56)	0938-AL22
1155	Hospital Inpatient Prospective Payment System for FY 2003 (CMS-1203-P) (Reg Plan Seq No. 57)	0938-AL23
1156	Initiative to Endorse Prescription Drug Discount Programs (CMS-4027-P) (Reg Plan Seq No. 58)	0938-AL28

References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.

Centers for Medicare & Medicaid Services—Final Rule Stage

Sequence Number Title Regulation Identification Number
1157 Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F) (Reg Plan Seq No. 59) 0938-AH99

1158 Security Standards (CMS-0049-F) (Reg Plan Seq No. 60) 0938-AI57

1159 National Standard Employer Identifier (CMS-0047-F) (Reg Plan Seq No. 61) 0938-AI59

1160 Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests (CMS-3250-F) 0938-AI92

1161 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions, and Establishment of a Quality Assessment and Improvement Program (CMS-1910-F) 0938-AJ17

1162 Fee Schedule for Payment of Ambulance Services and Revisions to the Physician's Certification Requirements for Coverage of Nonemergency Ambulance Services (CMS-1002-FC) (Reg Plan Seq No. 62) 0938-AK30

1163 Hospital Conditions of Participation: Quality Assessment and Performance Improvements (CMS-3050-F) 0938-AK40

1164 Payment for Upgraded Durable Medical Equipment (CMS-1084-P) 0938-AK50

1165 Prospective Payment System for Hospital Outpatient Services: Criteria for Establishing New Pass-Through Categories for Medical Devices (CMS-1179-IFC) 0938-AK59

1166 Modifications to Managed Care Rules Based on Payment Provisions in BIPA and Technical Corrections (CMS-1181-F) 0938-AK90

Centers for Medicare & Medicaid Services—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
1157	Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F) (Reg Plan Seq No. 59)	0938-AH99
1158	Security Standards (CMS-0049-F) (Reg Plan Seq No. 60)	0938-AI57
1159	National Standard Employer Identifier (CMS-0047-F) (Reg Plan Seq No. 61)	0938-AI59
1160	Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests (CMS-3250-F)	0938-AI92
1161	Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions, and Establishment of a Quality Assessment and Improvement Program (CMS-1910-F)	0938-AJ17
1162	Fee Schedule for Payment of Ambulance Services and Revisions to the Physician's Certification Requirements for Coverage of Nonemergency Ambulance Services (CMS-1002-FC) (Reg Plan Seq No. 62)	0938-AK30
1163	Hospital Conditions of Participation: Quality Assessment and Performance Improvements (CMS-3050-F)	0938-AK40
1164	Payment for Upgraded Durable Medical Equipment (CMS-1084-P)	0938-AK50
1165	Prospective Payment System for Hospital Outpatient Services: Criteria for Establishing New Pass-Through Categories for Medical Devices (CMS-1179-IFC)	0938-AK59
1166	Modifications to Managed Care Rules Based on Payment Provisions in BIPA and Technical Corrections (CMS-1181-F)	0938-AK90

Centers for Medicare & Medicaid Services—Long-Term Actions

Sequence Number Title Regulation Identification Number
1167 "Without Fault" and Beneficiary Waiver of Recovery As It Applies to Medicare Overpayment Liability (CMS-6007-F) 0938-AD95

1168 Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F) 0938-AG79

1169 Home Health Agency (HHA) Conditions of Participation (HCMS-3819-FC) 0938-AG81

1170 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 Review) 0938-AG82

1171 Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas and Intestinal Transplants (CMS-3835-P) 0938-AH17

1172 Hospice Care-Conditions of Participation (CMS-3844-P) 0938-AH27

1173 Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-P) 0938-AH73

1174 Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical Procedures for Ambulatory Surgical Centers (CMS-1885-FC) 0938-AH81

1175 Medical Child Support and Health Insurance Coverage of Dependent Children (CMS-2081-P) 0938-AI21

1176 Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities, Rehabilitation Agencies (CMS-6005-P) 0938-AI48

1177 Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for Medicare Billing Privileges (CMS-6003-F) 0938-AI49

1178 Advance Refunding of Debt and Methodology for Repayment of Loan (CMS-1777-P) 0938-AI75

1179 Medicare Coverage of, and Payment for, Bone Mass Measurements (CMS-3004-F) 0938-AI89

1180 Coverage of Religious Non-Medical Health Care Institutions (CMS-1909-F) 0938-AI93

1181 External Quality Review of Medicaid Managed Care Organizations (CMS-2015-F) 0938-AJ06

1182 Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the Conditions of Participation for Home Health Agencies (CMS-3006-F) 0938-AJ10

1183 Hospital Conditions of Participation: Laboratory Services (CMS-3014-F) 0938-AJ29

1184 Medicare Hospice Care Amendments (CMS-1022-P) 0938-AJ36

1185 Emergency Medical Treatment and Labor Act (EMTALA) (CMS-1063-P) 0938-AJ39

1186 Protection for Women Who Elect Reconstruction After a Mastectomy (CMS-2040-IFC) 0938-AJ44

1187 Surety Bonds Requirements for Suppliers of Durable Medical Equipment (CMS-6006-P) 0938-AJ64

1188 Surety Bond Requirements for Home Health Agencies (HHAS) (CMS-6001-P) 0938-AJ81

1189 Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F) 0938-AJ96

1190 Application of Inherent Reasonableness to All Medicare Part B Services (Other than Physician Services) (CMS-1908-F) 0938-AJ97

1191 Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy, and Consignment Closets (CMS-6010-P) 0938-AJ98

1192 Non-Federal Governmental Plans Exempt From Health Insurance Portability Requirements (CMS-2033-IFC) 0938-AK00

1193 Payment for Clinical Psychology Training Programs (CMS-1089-F) 0938-AK15

1194 Conditions of Participation of Intermediate Care Facilities for Persons With Mental Retardation (CMS-3046-P) 0938-AK23

1195 Clinical Lab Requirements-Revisions to Regulations Implementing CLIA (CMS-2226-F) 0938-AK24

1196 Medicare Provider and Supplier Hearing Procedures (CMS-2093-P) 0938-AK39

1197 Supplementary Medical Insurance Premium Surcharge Agreements (CMS-4007-P) 0938-AK42

1198 Improvements to the Medicare+Choice Appeals and Grievance Procedures (CMS-4024-F) 0938-AK48

1199 Recognition of the American Osteopathic Association for Ambulatory Surgical Center Programs (CMS-2079-FN) 0938-AK53

1200 Challenges to National Coverage Determinations and Local Coverage Determinations (CMS-3063-P) 0938-AK60

1201 Revised Process for Making Medicare Coverage Decisions (CMS-3062-N) 0938-AK61

1202 Health Insurance Reform: Standards for Electronic Signatures (CMS-0051-F) 0938-AK63

1203 Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships-Phase II (CMS-1810-FC) 0938-AK67

1204 Rate of Reimbursement of Photocopy Expenses for Prospective Payment System Providers (CMS-3055-P) 0938-AK68

1205 Medicare Inpatient Disproportionate Share Hospital Adjustment Calculation (CMS-1171-IFC) 0938-AK77

1206 Statement of Intent (CMS-1185-P) 0938-AK79

1207 Hospital Reference Laboratory and Medicare Secondary Payer (CMS-1187-P) 0938-AK87

1208 Portability in the Group Health Insurance Market—Shared HHS Provisions (CMS-2048-F) 0938-AK88

1209 Extended Medicaid for Certain Families Who Lose Medicaid Eligibility Because of Earned Income and the Residency of Minor Parents and Pregnancy (CMS 2026-F) 0938-AK92

1210 Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity (CMS-4018-P) 0938-AK94

1211 Relief from Medicare Part A Late Enrollment Penalty for Group Buy-In for State and Local Retirees (CMS-4022-P) 0938-AK99

1212 Modifications to the State Children's Health Insurance Program (CMS-2006-IFC) 0938-AL00

1213 Continue to Allow States an Option Under the Medicaid Spousal Impoverishment Provisions to Increase the Community Spouse's Income When Adjusting the Protected Resource Allowance (CMS-2128-P) 0938-AL06

1214 Medicare Limits on the Valuation of a Depreciable Asset Recognized as an Allowance for Depreciation and Interest on Capital Indebtedness After a change of Ownership (CMS-1004-F) 0938-AL12

1215 Update Interest Assessment on Medicare Overpayment and Underpayment (CMS-6014-P) 0938-AL14

1216 Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities that Provide Inpatient or Residential Care (CMS-2130-P) 0938-AL26

1217 Payment for Respiratory Assist Devices with Bi-level Capability and a Back-up Rate (CMS-1167-P) 0938-AL27

Centers for Medicare & Medicaid Services—Long-Term Actions
Sequence Number	Title	Regulation Identification Number
1167	"Without Fault" and Beneficiary Waiver of Recovery As It Applies to Medicare Overpayment Liability (CMS-6007-F)	0938-AD95
1168	Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F)	0938-AG79
1169	Home Health Agency (HHA) Conditions of Participation (HCMS-3819-FC)	0938-AG81
1170	End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 Review)	0938-AG82
1171	Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas and Intestinal Transplants (CMS-3835-P)	0938-AH17
1172	Hospice Care-Conditions of Participation (CMS-3844-P)	0938-AH27
1173	Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-P)	0938-AH73
1174	Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical Procedures for Ambulatory Surgical Centers (CMS-1885-FC)	0938-AH81
1175	Medical Child Support and Health Insurance Coverage of Dependent Children (CMS-2081-P)	0938-AI21
1176	Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities, Rehabilitation Agencies (CMS-6005-P)	0938-AI48
1177	Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for Medicare Billing Privileges (CMS-6003-F)	0938-AI49
1178	Advance Refunding of Debt and Methodology for Repayment of Loan (CMS-1777-P)	0938-AI75
1179	Medicare Coverage of, and Payment for, Bone Mass Measurements (CMS-3004-F)	0938-AI89
1180	Coverage of Religious Non-Medical Health Care Institutions (CMS-1909-F)	0938-AI93
1181	External Quality Review of Medicaid Managed Care Organizations (CMS-2015-F)	0938-AJ06
1182	Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the Conditions of Participation for Home Health Agencies (CMS-3006-F)	0938-AJ10
1183	Hospital Conditions of Participation: Laboratory Services (CMS-3014-F)	0938-AJ29
1184	Medicare Hospice Care Amendments (CMS-1022-P)	0938-AJ36
1185	Emergency Medical Treatment and Labor Act (EMTALA) (CMS-1063-P)	0938-AJ39
1186	Protection for Women Who Elect Reconstruction After a Mastectomy (CMS-2040-IFC)	0938-AJ44
1187	Surety Bonds Requirements for Suppliers of Durable Medical Equipment (CMS-6006-P)	0938-AJ64
1188	Surety Bond Requirements for Home Health Agencies (HHAS) (CMS-6001-P)	0938-AJ81
1189	Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)	0938-AJ96
1190	Application of Inherent Reasonableness to All Medicare Part B Services (Other than Physician Services) (CMS-1908-F)	0938-AJ97
1191	Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy, and Consignment Closets (CMS-6010-P)	0938-AJ98
1192	Non-Federal Governmental Plans Exempt From Health Insurance Portability Requirements (CMS-2033-IFC)	0938-AK00
1193	Payment for Clinical Psychology Training Programs (CMS-1089-F)	0938-AK15
1194	Conditions of Participation of Intermediate Care Facilities for Persons With Mental Retardation (CMS-3046-P)	0938-AK23
1195	Clinical Lab Requirements-Revisions to Regulations Implementing CLIA (CMS-2226-F)	0938-AK24
1196	Medicare Provider and Supplier Hearing Procedures (CMS-2093-P)	0938-AK39
1197	Supplementary Medical Insurance Premium Surcharge Agreements (CMS-4007-P)	0938-AK42
1198	Improvements to the Medicare+Choice Appeals and Grievance Procedures (CMS-4024-F)	0938-AK48
1199	Recognition of the American Osteopathic Association for Ambulatory Surgical Center Programs (CMS-2079-FN)	0938-AK53
1200	Challenges to National Coverage Determinations and Local Coverage Determinations (CMS-3063-P)	0938-AK60
1201	Revised Process for Making Medicare Coverage Decisions (CMS-3062-N)	0938-AK61
1202	Health Insurance Reform: Standards for Electronic Signatures (CMS-0051-F)	0938-AK63
1203	Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships-Phase II (CMS-1810-FC)	0938-AK67
1204	Rate of Reimbursement of Photocopy Expenses for Prospective Payment System Providers (CMS-3055-P)	0938-AK68
1205	Medicare Inpatient Disproportionate Share Hospital Adjustment Calculation (CMS-1171-IFC)	0938-AK77
1206	Statement of Intent (CMS-1185-P)	0938-AK79
1207	Hospital Reference Laboratory and Medicare Secondary Payer (CMS-1187-P)	0938-AK87
1208	Portability in the Group Health Insurance Market—Shared HHS Provisions (CMS-2048-F)	0938-AK88
1209	Extended Medicaid for Certain Families Who Lose Medicaid Eligibility Because of Earned Income and the Residency of Minor Parents and Pregnancy (CMS 2026-F)	0938-AK92
1210	Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity (CMS-4018-P)	0938-AK94
1211	Relief from Medicare Part A Late Enrollment Penalty for Group Buy-In for State and Local Retirees (CMS-4022-P)	0938-AK99
1212	Modifications to the State Children's Health Insurance Program (CMS-2006-IFC)	0938-AL00
1213	Continue to Allow States an Option Under the Medicaid Spousal Impoverishment Provisions to Increase the Community Spouse's Income When Adjusting the Protected Resource Allowance (CMS-2128-P)	0938-AL06
1214	Medicare Limits on the Valuation of a Depreciable Asset Recognized as an Allowance for Depreciation and Interest on Capital Indebtedness After a change of Ownership (CMS-1004-F)	0938-AL12
1215	Update Interest Assessment on Medicare Overpayment and Underpayment (CMS-6014-P)	0938-AL14
1216	Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities that Provide Inpatient or Residential Care (CMS-2130-P)	0938-AL26
1217	Payment for Respiratory Assist Devices with Bi-level Capability and a Back-up Rate (CMS-1167-P)	0938-AL27

Centers for Medicare & Medicaid Services—Completed Actions

Sequence Number Title Regulation Identification Number
1218 Medicaid Drugs Rebate Program (CMS-2046-FC) 0938-AF42

1219 Liability for Third Parties To Pay for Services (CMS-2080-P) 0938-AH01

1220 Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-Based Group Health Plans (CMS-2047-FC) 0938-AH48

1221 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P) 0938-AH83

1222 Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital Services (CMS-1069-F) 0938-AJ55

1223 State Health Insurance Assistance Program (SHIP) (CMS-4005-IFC) 0938-AJ67

1224 Practice Expense Data Collection (CMS-1111-IFC) 0938-AK14

1225 Provisions of the Balanced Budget and Refinement Act of 1999; Hospital Inpatient Payments and Rates and Costs of Graduate Medical Education (CMS-1131-F) 0938-AK20

1226 Requirements for the Recredentialing of Medicare+Choice Organization Providers (CMS-1160-F) 0938-AK41

1227 Medicaid Management Information System Revised Definition of "Mechanized Claims Processing and Information Retrieval System" (CMS-2123-IFC) 0938-AK44

1228 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update (CMS-1163-F) 0938-AK47

1229 Civil Money Penalties, Assessments, and Revised Sanction Authorities (CMS-6145-FC) 0938-AK49

1230 Update to the Prospective Payment System for Home Health Agencies for FY 2002 (CMS-1147-NC) 0938-AK51

1231 Prospective Payment System for Hospital Outpatient Services for Calendar Year 2002 (CMS-1159-F) 0938-AK54

1232 Medicare as Secondary Payer-Recovery of Conditional Payments (CMS-6009-P) 0938-AK55

1233 Five Year Review of Work Relative Value Units Under the Physician Fee Schedule Proposed Notice (CMS-1170-PN) 0938-AK56

1234 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2002 (CMS-1169-F) 0938-AK57

1235 Changes to National Coverage Determinations and Local Coverage Determinations (CMS-4019-FC) 0938-AK58

1236 Replacement of Reasonable Charge Methodology by Fee Schedules for Parenteral and Enteral Nutrients, Equipment, and Supplies (CMS-1010-F) 0938-AK66

1237 Changes to the Hospital Inpatients Prospective Payment System for Fiscal Year 2002 Rates (CMS-1158-F) 0938-AK73

1238 Changes to Inpatient BIPA for Fiscal Year 2001 (CMS-1178-F) 0938-AK74

1239 Medicare+Choice ESRD Rates (CMS-1182-FN) 0938-AK75

1240 Procedures for Public Consultations for Coding and Payment Determinations for New Laboratory Tests (CMS-1186-N) 0938-AK80

1241 Recognition of the American Osteopathic Association for Critical Access Hospitals (CMS-2099-N) 0938-AK84

1242 Protection and Promotion of Resident Rights (CMS-3065-P) 0938-AK85

1243 Standards for Electronic Transactions-Elimination of NDC Coding Standards (CMS-0006-P) 0938-AK86

1244 Modification of the Medicaid Upper Payment Limit Transition Period for Inpatient, Outpatient Hospitals, Nursing and Intermediate Care Facility Services for the Mentally Retarded (CMS-2100-P) 0938-AK89

1245 Hospital Conditions of Participation: Anesthesia Services (CMS-3070-F) 0938-AK95

1246 Medicare Program; Emergency Approval for Coverage of End-Stage Renal Disease Facilities in the Houston, Texas Area (CMS-3074-F) 0938-AK98

1247 Medicare and Medicaid Programs; Change of Agency Name: Technical Amendments (CMS-9010-FC) 0938-AL02

1248 Payments for New Medical Services and New Technologies Under the Acute Care Hospital Inpatient Prospective Payment System (CMS-1176-F) 0938-AL09

Centers for Medicare & Medicaid Services—Completed Actions
Sequence Number	Title	Regulation Identification Number
1218	Medicaid Drugs Rebate Program (CMS-2046-FC)	0938-AF42
1219	Liability for Third Parties To Pay for Services (CMS-2080-P)	0938-AH01
1220	Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-Based Group Health Plans (CMS-2047-FC)	0938-AH48
1221	Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)	0938-AH83
1222	Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital Services (CMS-1069-F)	0938-AJ55
1223	State Health Insurance Assistance Program (SHIP) (CMS-4005-IFC)	0938-AJ67
1224	Practice Expense Data Collection (CMS-1111-IFC)	0938-AK14
1225	Provisions of the Balanced Budget and Refinement Act of 1999; Hospital Inpatient Payments and Rates and Costs of Graduate Medical Education (CMS-1131-F)	0938-AK20
1226	Requirements for the Recredentialing of Medicare+Choice Organization Providers (CMS-1160-F)	0938-AK41
1227	Medicaid Management Information System Revised Definition of "Mechanized Claims Processing and Information Retrieval System" (CMS-2123-IFC)	0938-AK44
1228	Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update (CMS-1163-F)	0938-AK47
1229	Civil Money Penalties, Assessments, and Revised Sanction Authorities (CMS-6145-FC)	0938-AK49
1230	Update to the Prospective Payment System for Home Health Agencies for FY 2002 (CMS-1147-NC)	0938-AK51
1231	Prospective Payment System for Hospital Outpatient Services for Calendar Year 2002 (CMS-1159-F)	0938-AK54
1232	Medicare as Secondary Payer-Recovery of Conditional Payments (CMS-6009-P)	0938-AK55
1233	Five Year Review of Work Relative Value Units Under the Physician Fee Schedule Proposed Notice (CMS-1170-PN)	0938-AK56
1234	Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2002 (CMS-1169-F)	0938-AK57
1235	Changes to National Coverage Determinations and Local Coverage Determinations (CMS-4019-FC)	0938-AK58
1236	Replacement of Reasonable Charge Methodology by Fee Schedules for Parenteral and Enteral Nutrients, Equipment, and Supplies (CMS-1010-F)	0938-AK66
1237	Changes to the Hospital Inpatients Prospective Payment System for Fiscal Year 2002 Rates (CMS-1158-F)	0938-AK73
1238	Changes to Inpatient BIPA for Fiscal Year 2001 (CMS-1178-F)	0938-AK74
1239	Medicare+Choice ESRD Rates (CMS-1182-FN)	0938-AK75
1240	Procedures for Public Consultations for Coding and Payment Determinations for New Laboratory Tests (CMS-1186-N)	0938-AK80
1241	Recognition of the American Osteopathic Association for Critical Access Hospitals (CMS-2099-N)	0938-AK84
1242	Protection and Promotion of Resident Rights (CMS-3065-P)	0938-AK85
1243	Standards for Electronic Transactions-Elimination of NDC Coding Standards (CMS-0006-P)	0938-AK86
1244	Modification of the Medicaid Upper Payment Limit Transition Period for Inpatient, Outpatient Hospitals, Nursing and Intermediate Care Facility Services for the Mentally Retarded (CMS-2100-P)	0938-AK89
1245	Hospital Conditions of Participation: Anesthesia Services (CMS-3070-F)	0938-AK95
1246	Medicare Program; Emergency Approval for Coverage of End-Stage Renal Disease Facilities in the Houston, Texas Area (CMS-3074-F)	0938-AK98
1247	Medicare and Medicaid Programs; Change of Agency Name: Technical Amendments (CMS-9010-FC)	0938-AL02
1248	Payments for New Medical Services and New Technologies Under the Acute Care Hospital Inpatient Prospective Payment System (CMS-1176-F)	0938-AL09

Administration for Children and Families—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1249 Program Performance Standards for the Operation of Head Start Programs 0970-AB99

1250 Safeguarding Child Support and Expanded FPLS Information 0970-AC01

1251 Developmental Disabilities and Bill of Rights Act 0970-AC07

Administration for Children and Families—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1249	Program Performance Standards for the Operation of Head Start Programs	0970-AB99
1250	Safeguarding Child Support and Expanded FPLS Information	0970-AC01
1251	Developmental Disabilities and Bill of Rights Act	0970-AC07

Administration for Children and Families—Final Rule Stage

Sequence Number Title Regulation Identification Number
1252 Construction and Major Renovation of Head Start and Early Head Start Facilities 0970-AB54

1253 Child Support Enforcement for Indian Tribes 0970-AB73

1254 Child Support Enforcement Program Omnibus Conforming Regulation 0970-AB81

1255 Family Child Care Program Option for Head Start Programs 0970-AB90

1256 Technical Revision of Head Start Regulations To Make Them Conform to Recent Statutory Revisions 0970-AC00

1257 High Performance Bonus Awards Under the TANF Program 0970-AC06

Administration for Children and Families—Final Rule Stage
Sequence Number	Title	Regulation Identification Number
1252	Construction and Major Renovation of Head Start and Early Head Start Facilities	0970-AB54
1253	Child Support Enforcement for Indian Tribes	0970-AB73
1254	Child Support Enforcement Program Omnibus Conforming Regulation	0970-AB81
1255	Family Child Care Program Option for Head Start Programs	0970-AB90
1256	Technical Revision of Head Start Regulations To Make Them Conform to Recent Statutory Revisions	0970-AC00
1257	High Performance Bonus Awards Under the TANF Program	0970-AC06

Administration for Children and Families—Completed Actions

Sequence Number Title Regulation Identification Number
1258 Individual Development Accounts 0970-AC08

Administration for Children and Families—Completed Actions
Sequence Number	Title	Regulation Identification Number
1258	Individual Development Accounts	0970-AC08

Administration on Aging—Proposed Rule Stage

Sequence Number Title Regulation Identification Number
1259 Grants for State and Community Programs on Aging, Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants to Indians and Native Hawaiians 0985-AA00

Administration on Aging—Proposed Rule Stage
Sequence Number	Title	Regulation Identification Number
1259	Grants for State and Community Programs on Aging, Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants to Indians and Native Hawaiians	0985-AA00

Administration on Aging—Completed Actions

Sequence Number Title Regulation Identification Number
1260 Grants for State and Community Programs on Aging, Family Caregivers, American Indians, and Native Hawaiians 0985-AA01

Administration on Aging—Completed Actions
Sequence Number	Title	Regulation Identification Number
1260	Grants for State and Community Programs on Aging, Family Caregivers, American Indians, and Native Hawaiians	0985-AA01

Department of Health and Human Services (HHS)

Proposed Rule Stage

Office of the Secretary (OS)

984. GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) AND GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS)

Agency:

Department of Health and Human Services (HHS)/Office of the Secretary (OS)

Priority:

Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined.

Legal Authority:

5 USC 301; 41 USC 701 et seq, sec 2455; PL 103-355; 31 USC 6101 note; EO 12689; EO 12549

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

45 CFR 76; 45 CFR 82

Legal Deadline:

None

Abstract:

This proposed common rule is revised to simplify and streamline nonprocurement debarment and suspension requirements, as well as correspond to procurement regulations where possible. The revision will separate the debarment and suspension and Drug-Free Workplace regulations, and will be written in the plain language format.

Timetable:

Action Date FR Cite

NPRM 02/00/02

Regulatory Flexibility Analysis Required:

Small Entities Affected:

Government Levels Affected:

None

Agency Contact:

Diane Osterhus, Federal Assistance Policy Specialist, Department of Health and Human Services, Office of the Secretary, Room 517D, Office of Grants and Acquisition Management, 200 Independence Avenue SW., Washington, DC 20201
Phone: 202 690-5729
Fax: 202 690-6901
Email: diane.osterhus@hhs.gov

RIN:

0991-AB12

985. � MODIFICATIONS TO STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION

Regulatory Plan:

This entry is Seq. No. 25 in part II of this issue of the Federal Register.

RIN:

0991-AB14

986. � IMPLEMENTING THE BIOTERRORISM PREVENTION AND RESPONSE ACT OF 2001

Regulatory Plan:

This entry is Seq. No. 26 in part II of this issue of the Federal Register.

RIN:

0991-AB15

Department of Health and Human Services (HHS)

Final Rule Stage

Office of the Secretary (OS)

987. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Agency:

Department of Health and Human Services (HHS)/Office of the Secretary (OS)

Priority:

Substantive, Nonsignificant

Legal Authority:

42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104-191, sec 216(b)

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

42 CFR 1001

Legal Deadline:

Final, Statutory, January 1, 1997.

Abstract:

This final rule establishes a new statutory exception for risk-sharing arrangements under the Federal health care programs' anti-kickback provisions. The rule sets forth an exception from liability for remuneration between an eligible organization and an individual or entity providing items or services in accordance with a written agreement between these parties. The rule allows remuneration between an organization and an individual or entity if a written agreement places the individual or entity at "substantial financial risk" for the cost or utilization of the items or services that the individual or entity is obligated to provide.

Timetable:

Action Date FR Cite

ANPRM 05/23/97 62 FR 28410

ANPRM Comment Period End 06/09/97
Interim Final Rule 11/19/99 64 FR 63504

Final Rule 03/00/02

Regulatory Flexibility Analysis Required:

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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN:

0991-AA91

988. CIVIL MONEY PENALTY SAFE HARBOR TO PROTECT PAYMENT OF MEDICARE AND MEDIGAP PREMIUMS FOR ESRD BENEFICIARIES

Agency:

Department of Health and Human Services (HHS)/Office of the Secretary (OS)

Priority:

Substantive, Nonsignificant

Legal Authority:

Social Security Act, sec 1128A(a)(5)

CFR Citation: (To search for a specific CFR,

Action	Date	FR Cite
ANPRM	05/23/97	62 FR 28410
ANPRM Comment Period End	06/09/97
Interim Final Rule	11/19/99	64 FR 63504
Final Rule	03/00/02