Unified Agenda
21 CFR Ch. I
42 CFR Chs. I-V
45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII
AGENCY:
Office of the Secretary, HHS.
ACTION:
Semiannual agenda.
SUMMARY:
The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the semiannual publication of an inventory of all rulemakings that will be under development or review during the ensuing 12-month period. The purpose of this effort is to encourage more effective public participation in the regulatory process by publicly providing, at an early stage, information about regulatory actions that the Department is working on. All interested members of the public are thus invited to communicate to the Department their views on the rulemakings prospectively outlined below.
FOR FURTHER INFORMATION CONTACT:
Ann Stallion, Department of Health and Human Services, Washington, DC 20201, (202) 690-7449, or the contact person for a specific component of the Department as listed below.
SUPPLEMENTARY INFORMATION:
The regulatory actions capsulized below reflect an effort to present for public scrutiny a realistic forecast of the rulemaking activities that the Department will engage in over the next 12 months. Comments on the policy directions that these rulemakings will take should be sent to the agency representatives listed below, depending on the HHS component and the specific agenda entry that is of interest. Comments may be directed to the Office of the Secretary, if the responsible component of the Department is not apparent, or if a comment covers subjects crossing program lines.
Administration on Aging: Harry Posman, Executive Secretariat, Room 4741, 330 Independence Avenue SW., Washington, DC 20201; Phone (202) 260-0669.
Administration on Children and Families: Madeline Mocko, Director, Division of Policy and Legislation, 7th Floor, 370 L' Enfant Promenade SW., Washington, DC 20447; Phone (202) 401-9223.
Agency for Health Care Policy and Research: Phyllis Zucker, 2101 East Jefferson Street, Suite 603, Rockville, MD; 20852; Phone (301) 594-1455.
Centers for Disease Control and Prevention: Verla Neslund, Director, Executive Secretariat, 1600 Clifton Road, Building 16, Atlanta, GA 30333; Phone (404) 639-7120.
Centers for Medicare & Medicaid Services: Michelle Shorrt, Director, Division of Regulations and Issuances, 7500 Security Boulevard, C4-26-05, Baltimore, MD 21244; Phone (410) 786-4675.
Food and Drug Administration: Ed Dutra, Director, Regulatory Policy and Management Staff, 5600 Fishers Lane, Rockville, MD 20857; Phone (301) 827-3480.
Health Resource Services Administration: Dolores R. Etherith, 5600 Fishers Lane, Room 14-A-08, Rockville, MD 20857; Phone (301) 443-1786.
Indian Health Service: Betty Gould, 12300 Twinbrook Parkway, Suite 450, Rockville, MD 20857; Phone (301) 443-1116.
National Institutes of Health: Jerry Moore, 9000 Rockville Pike, Building 31, Room 1B25, Bethesda, MD 20205; Phone (301) 496-4606.
Office of the Secretary: Ann C. Agnew, Executive Secretary to the Department, Room 603H, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201; Phone (202) 690-7699.
Substance Abuse and Mental Health Services Administration: Joe Faha, 5600 Fishers Lane, Room 12-A-17, Rockville, MD 20857; Phone (301) 443-4640.
We have indicated as "withdrawn" numerous rulemakings mentioned in previous agendas because we do not plan any developmental work on them during the period covered by this agenda. Should work on these rulemakings begin again, appropriate new entries about them will appear in future agendas.
Dated:
April 25, 2002.
Ann C. Agnew, Executive Secretary to the Department.
| Office of the Secretary—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 712 | Safe Harbor for Arrangements Involving Federally Qualified Health Centers | 0991-AB06 |
| 713 | Implementing the Bioterrorism Prevention and Response Act of 2001 | 0991-AB15 |
| Office of the Secretary—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 714 | Shared Risk Exception to the Safe Harbor Provisions | 0991-AA91 |
| 715 | 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 |
|---|---|---|
| 716 | Revisions to 42 CFR Part 1003 | 0991-AB03 |
| 717 | Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums for ESRD Beneficiaries | 0991-AB04 |
| 718 | Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants) | 0991-AB12 |
| 719 | Modifications to Standards for Privacy of Individually Identifiable Health Information | 0991-AB14 |
| Office of the Secretary—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 720 | Safe Harbor for Ambulance Restocking | 0991-AB05 |
| 721 | Revisions and Technical Corrections to 42 CFR Chapter V | 0991-AB09 |
| Substance Abuse and Mental Health Services Administration—Long-Term Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 722 | 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 |
|---|---|---|
| 723 | Community Mental Health Services Block Grant | 0930-AA08 |
| 724 | Substance Abuse and Mental Health Services Administration Mental Health and Substance Abuse Emergency Response Criteria | 0930-AA09 |
| Centers for Disease Control and Prevention—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 725 | Control of Communicable Diseases | 0920-AA03 |
| 726 | Amendments to Quality Assurance and Administrative Provision for Approval of Respiratory Protective Devices | 0920-AA04 |
| Centers for Disease Control and Prevention—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 727 | 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 |
|---|---|---|
| 728 | DHHS Statement of Policy—Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort Under the Energy Employee Occupational Illness Compensation Act of 2000 | 0920-AA07 |
| Centers for Disease Control and Prevention—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 729 | Packaging and Handling of Infectious Substances and Select Agents | 0920-AA02 |
| Departmental Management—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 730 | Implementation of the Equal Access to Justice Act in Agency Proceedings | 0990-AA02 |
| Departmental Management—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 731 | Administrative Wage Garnishment | 0990-AA05 |
| Food and Drug Administration—Prerule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 732 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| Food and Drug Administration—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 733 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 734 | Establishment Registration and Product Listing for Drugs and Biologics | 0910-AA49 |
| 735 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 736 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 737 | Blood Initiative | 0910-AB26 |
| 738 | Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | 0910-AB34 |
| 739 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 740 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements | 0910-AB88 |
| 741 | Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format | 0910-AB91 |
| 742 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 743 | Status Reports of Distribution and Use Information for Antimicrobial Animal Drug Products Used in Food-Producing Animals | 0910-AC04 |
| 744 | Control of Salmonella Enteritidis in Shell Eggs During Production and Retail | 0910-AC14 |
| 745 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 746 | Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 747 | Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products | 0910-AC19 |
| 748 | Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients From Unapproved Sources | 0910-AC20 |
| 749 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 750 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
| 751 | Bar Code Label Requirements for Human Drug Products | 0910-AC26 |
| 752 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| 753 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 754 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
| Food and Drug Administration—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 755 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 756 | Labeling for Human Prescription Drugs; Revised Format | 0910-AA94 |
| 757 | Use of Ozone-Depleting Substances | 0910-AA99 |
| 758 | 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 |
| 759 | Revisions to the General Safety Requirements for Biological Products; Final Rule | 0910-AB51 |
| 760 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 761 | Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims | 0910-AB66 |
| 762 | CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback) | 0910-AB76 |
| 763 | Antibiotic Resistance Labeling | 0910-AB78 |
| 764 | Food Additives: Food Contact Substances Notification System | 0910-AB94 |
| 765 | Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States | 0910-AB95 |
| 766 | Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When Human Studies Are Unethical | 0910-AC05 |
| 767 | Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products | 0910-AC07 |
| 768 | Revocation of Conditions for Marketing Digoxin Products for Oral Use | 0910-AC12 |
| 769 | Postmarket Surveillance | 0910-AC31 |
| 770 | Redacting 510(k) Submissions | 0910-AC33 |
| 771 | Section 17 Best Pharmaceuticals for Children Act | 0910-AC35 |
| Food and Drug Administration—Long-Term Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 772 | Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 773 | Investigational Use New Animal Drug Regulations (Section 610 Review) | 0910-AB02 |
| 774 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | 0910-AB27 |
| 775 | Current Good Tissue Practice for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | 0910-AB28 |
| 776 | Premarket Notice Concerning Bioengineered Foods | 0910-AC15 |
| Food and Drug Administration—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 777 | Exports; Notification and Recordkeeping Requirements | 0910-AB16 |
| 778 | Foreign Establishment Registration and Listing | 0910-AB21 |
| 779 | Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs | 0910-AB39 |
| 780 | State Certification of Mammography Facilities | 0910-AB98 |
| 781 | Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded | 0910-AC22 |
| Food and Drug Administration—Discontinued Entries | Regulation Identification Number | Title | Date Withdrawn | Comments |
|---|---|---|---|
| 0910-AA02 | New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) | 03/20/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA19 | Food Labeling Review | 03/05/2002 | Withdrawn |
| 0910-AA20 | Medical Foods | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA45 | Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA51 | Bioavailability and Bioequivalence Requirements | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA86 | Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA90 | Direct-to-Consumer Promotion Regulations | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA98 | Current Good Manufacturing Practice; Revision of Certain Labeling Controls | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB00 | Radioactive Drugs for Basic Research | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB14 | Administrative Practices and Procedures; Advisory Opinions and Guidelines | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB33 | Antibiotic Drug Approval and Exclusivity | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB37 | Expanded Access to Investigational Therapies | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB42 | Electronic Submission of Postmarketing Safety Reports | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB43 | Distinguishing Marks for Drug Products Containing Insulin | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB44 | Pregnancy Labeling | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB49 | Supplements and Other Changes to Approved New Animal Drug Applications | 03/05/2002 | Withdrawn |
| 0910-AB50 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 03/05/2002 | Withdrawn |
| 0910-AB56 | Natural Rubber-Containing Drugs; User Labeling | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB57 | Bulk Drug Substances for Use in Pharmacy Compounding | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB58 | Pharmacy and Physician Compounding of Drug Products | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB59 | Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB60 | Discontinuation of a Lifesaving Product | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB63 | Positron Emission Tomography Drugs; Current Good Manufacturing Practice | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB68 | Presubmission Conferences | 03/05/2002 | Withdrawn |
| 0910-AB71 | Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 | 03/05/2002 | Withdrawn |
| 0910-AB72 | Mandatory HACCP Regulations for Manufacturers of Rendered Products | 03/05/2002 | Withdrawn |
| 0910-AB73 | Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB74 | Surgeon's and Patient Examination Gloves; Reclassification | 03/13/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB79 | Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB80 | 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications | 03/06/2002 | Withdrawn |
| 0910-AB81 | Repackaging Approval Requirements | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB82 | Stability Testing of Drugs | 03/06/2002 | Withdrawn |
| 0910-AB90 | Substances Prohibited From Use in Animal Food or Feed | 03/05/2002 | Withdrawn |
| 0910-AB92 | Fees Relating to Drugs; Waiver and Reduction of Fees | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB93 | Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB99 | Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment | 03/13/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC00 | Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC01 | Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC02 | Reporting Information Regarding Falsification of Data | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC03 | Examination of Administrative Record and Other Advisory Committee Records | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC08 | Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC09 | Labeling Dietary Supplements for Women Who Are or May Become Pregnant | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC10 | Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC11 | Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC13 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 03/20/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC16 | Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC24 | Requirements for Medical Gas Containers and Closure Systems | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC27 | Promotion and Charging For Investigational Drugs | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| Health Resources and Services Administration—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 782 | National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Medical Malpractice Payments Reporting Requirements | 0906-AA41 |
| 783 | Designation of Medically Underserved Populations and Health Professional Shortage Areas | 0906-AA44 |
| 784 | 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 |
|---|---|---|
| 785 | National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table | 0906-AA55 |
| Health Resources and Services Administration—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 786 | National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table | 0906-AA58 |
| 787 | Adoption of the Interim Final Rule as a Final Rule With Amendments for Ricky Ray Hemophilia | 0906-AA59 |
| Indian Health Service—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 788 | Tribal Self-Governance Amendments | 0917-AA05 |
| Indian Health Service—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 789 | 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 |
|---|---|---|
| 790 | Undergraduate Scholarship Program Regarding Professions Needed by the NIH | 0925-AA10 |
| 791 | National Institutes of Health Loan Repayment Program for Research | 0925-AA18 |
| 792 | NIH Center Grants | 0925-AA24 |
| 793 | NIH Training Grants | 0925-AA28 |
| National Institutes of Health—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 794 | Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects | 0925-AA20 |
| National Institutes of Health—Long-Term Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 795 | Standards for a National Chimpanzee Sanctuary System | 0925-AA31 |
| National Institutes of Health—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 796 | National Institutes of Health AIDS Research Loan Repayment Program | 0925-AA02 |
| 797 | National Cancer Institute Clinical Cancer Education Program | 0925-AA17 |
| 798 | National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repayment Program | 0925-AA19 |
| 799 | National Institutes of Health Clinics Research Loan Repayment Program for Individuals From Disadvantaged Backgrounds | 0925-AA25 |
| 800 | NIH Loan Repayment Program for Minority Health Disparities Research | 0925-AA26 |
| 801 | Pediatric Research Loan Repayment Program | 0925-AA27 |
| 802 | National Institutes of Health Loan Repayment Program for Clinical Researchers | 0925-AA30 |
| Office of Public Health and Science—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 803 | Public Health Services Policies on Research Misconduct | 0940-AA04 |
| Office of Public Health and Science—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 804 | Public Health Service Standards for the Protection of Research Misconduct Whistleblowers | 0940-AA01 |
| Office of Public Health and Science—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 805 | Federal Policy (Common Rule) for the Protection of Human Subjects | 0940-AA03 |
| 806 | Protection of Human Research Subjects | 0940-AA05 |
| Centers for Medicare & Medicaid Services—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 807 | Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-P) | 0938-AH73 |
| 808 | National Standard for Identifiers of Health Plans (CMS-1212-P) | 0938-AH87 |
| 809 | Medicare Hospice Care Amendments (CMS-1022-P) | 0938-AJ36 |
| 810 | End-Stage Renal Disease Bad Debt Payment (CMS-1126-P) | 0938-AK02 |
| 811 | Conditions of Participation of Intermediate Care Facilities for Persons With Mental Retardation (CMS-3046-P) | 0938-AK23 |
| 812 | Review of National Coverage Determinations and Local Coverage Determinations (CMS-3063-P) | 0938-AK60 |
| 813 | Revised Process for Making Medicare Coverage Determinations (NCDs) (CMS-3062-N) | 0938-AK61 |
| 814 | Health Insurance Reform: Claims Attachments Standards (CMS-0050-P) | 0938-AK62 |
| 815 | Health Insurance Reform: Modifications to Standards for Electronic Transactions (CMS-0003-P) | 0938-AK64 |
| 816 | Rate of Reimbursement of Photocopy Expenses for Prospective Payment System Providers (CMS-3055-P) | 0938-AK68 |
| 817 | Modifications to Medicare Managed Care Rules (CMS-4041-P) | 0938-AK71 |
| 818 | Revisions to Transaction and Code Set Standards for Electronic Transactions (CMS-0005-P) | 0938-AK76 |
| 819 | Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-P) | 0938-AK79 |
| 820 | Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates (CMS-1206-P) | 0938-AL19 |
| 821 | Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2003 (CMS-1202-P) | 0938-AL20 |
| 822 | Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 (CMS-1204-P) | 0938-AL21 |
| 823 | Hospital Inpatient Rehabilitation Prospective Payment System for FY 2003 (CMS-1205-N) | 0938-AL22 |
| 824 | Hospital Inpatient Prospective Payment System for FY 2003 (CMS-1203-P) | 0938-AL23 |
| 825 | Payment for Respiratory Assist Devices with Bi-Level Capability and a Back-Up Rate (CMS-1167-P) | 0938-AL27 |
| 826 | Self-Declaration of Citizenship (CMS-2085-P) | 0938-AL33 |
| 827 | Hospice Wage Index for FY 2003 (CMS-1211-N) | 0938-AL41 |
| 828 | Electronic Submission of Cost Reports (CMS-1199-P) | 0938-AL51 |
| 829 | Health Insurance Reform: National Standard for Identifiers of Health Plans (CMS-1212-F) | 0938-AL52 |
| 830 | Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures (CMS-6146-P) | 0938-AL53 |
| 831 | Effect of Change of Ownership on Provider and Supplier Penalties (CMS-2215-P) | 0938-AL72 |
| 832 | Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family and Medical Leave Act (CMS-2158-P) | 0938-AL88 |
| 833 | Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates (CMS-1471-P) | 0938-AL91 |
| Centers for Medicare & Medicaid Services—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 834 | Security Standards (CMS-0049-F) | 0938-AI57 |
| 835 | National Standard Employer Identifier (CMS-0047-F) | 0938-AI59 |
| 836 | External Quality Review of Medicaid Managed Care Organizations (CMS-2015-F) | 0938-AJ06 |
| 837 | Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions, and Establishment of a Quality Assessment and Improvement Program (CMS-1910-F) | 0938-AJ17 |
| 838 | Hospital Conditions of Participation: Laboratory Services (CMS-3014-F) | 0938-AJ29 |
| 839 | Non-Federal Governmental Plans Exempt From Health Insurance Portability Requirements (CMS-2033-IFC) | 0938-AK00 |
| 840 | 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 |
| 841 | Hospital Conditions of Participation: Quality Assessment and Performance Improvements (CMS-3050-F) | 0938-AK40 |
| 842 | Supplementary Medical Insurance Premium Surcharge Agreements (CMS-4007-F) | 0938-AK42 |
| 843 | Payment for Upgraded Durable Medical Equipment; Withdrawal of Proposed Rule (CMS-1084-WN) | 0938-AK50 |
| 844 | Prospective Payment System for Long-Term Care Hospitals for FY 2003 (CMS-1177-P) | 0938-AK69 |
| 845 | Medicare Inpatient Disproportionate Share Hospital (DSH) Adjustment Formula (CMS-1171-IFC) | 0938-AK77 |
| 846 | State Allotments for Payment of Medicare Part B Premiums for Qualified Individuals; Federal Fiscal Year 2001 (CMS-2087-PN) | 0938-AK91 |
| 847 | Medicaid Managed Care; New Provisions (CMS-2104-F) | 0938-AK96 |
| 848 | Modifications to the State Children's Health Insurance Program (CMS-2006-F) | 0938-AL00 |
| 849 | Home Health Prospective Payment System Rate Update for FY 2003 (CMS-1198-NC) | 0938-AL16 |
| 850 | Medicare Program; Medicare-Endorsed Prescription Drug Discount Card Assistance Initiative (CMS-4027-P) | 0938-AL28 |
| 851 | Peer Review Organizations: Name and Other Changes—Technical Amendments (CMS-3088-FC) | 0938-AL38 |
| 852 | End-Stage Renal Disease—Rescission of Waiver of Conditions for Coverage Under a State of Emergency in Houston, Texas Area (CMS-3074-F2) | 0938-AL39 |
| 853 | Prospective Payment System for Inpatient Rehabilitation Hospital; Correcting Amendment (CMS-1069-F2) | 0938-AL40 |
| 854 | Physician Fee Schedule for CY 2002: Correction Notice (CMS-1169-CN) | 0938-AL48 |
| 855 | Notice of Modification of Beneficiary Assessment Requirements for Skilled Nursing Facilities (CMS-1209-N) | 0938-AL55 |
| 856 | Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year 2003 (CMS-8013-N) | 0938-AL56 |
| 857 | Revision of the Procedures for Requesting Exceptions to Cost Limits for Skilled Nursing Facilities and Elimination of Reclassifications; Correction (CMS-1883-F3) | 0938-AL61 |
| 858 | Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate Beginning January 1, 2003 (CMS-8014-N) | 0938-AL63 |
| 859 | Request for Information on Benefit-Specific Waiting Periods (CMS-2150-N) | 0938-AL64 |
| 860 | Part A Premiums for 2003 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8015-N) | 0938-AL69 |
| 861 | Medicaid Managed Care: Withdrawal (CMS-2001-F4) | 0938-AL83 |
| 862 | FY 1999 SCHIP Reallocation Notice (CMS-2137-N) | 0938-AL86 |
| Centers for Medicare & Medicaid Services—Long-Term Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 863 | "Without Fault" and Beneficiary Waiver of Recovery As It Applies to Medicare Overpayment Liability (CMS-6007-F) | 0938-AD95 |
| 864 | Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F) | 0938-AG79 |
| 865 | Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-FC) | 0938-AG81 |
| 866 | End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 Review) | 0938-AG82 |
| 867 | Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas, and Intestinal Transplants (CMS-3835-P) | 0938-AH17 |
| 868 | Hospice Care—Conditions of Participation (CMS-3844-P) | 0938-AH27 |
| 869 | Medicare and Medicaid Programs; Terms, Definitions, and Addresses: Technical Amendments (CMS-9877-F) | 0938-AH53 |
| 870 | Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F) | 0938-AH99 |
| 871 | Medical Child Support and Health Insurance Coverage of Dependent Children (CMS-2081-P) | 0938-AI21 |
| 872 | Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for Medicare Billing Privileges (CMS-6003-F) | 0938-AI49 |
| 873 | Coverage of Religious Non-Medical Health Care Institutions (CMS-1909-F) | 0938-AI93 |
| 874 | Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the Conditions of Participation for Home Health Agencies (CMS-3006-F) | 0938-AJ10 |
| 875 | Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F) | 0938-AJ96 |
| 876 | Application of Inherent Reasonableness to All Medicare Part B Services (Other than Physician Services) (CMS-1908-F) | 0938-AJ97 |
| 877 | Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy, and Consignment Closets (CMS-6010-P) | 0938-AJ98 |
| 878 | Clinical Lab Requirements—Revisions to Regulations Implementing CLIA (CMS-2226-F) | 0938-AK24 |
| 879 | Improvements to the Medicare+Choice Appeals and Grievance Procedures (CMS-4024-F) | 0938-AK48 |
| 880 | Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships—Phase II (CMS-1810-FC) | 0938-AK67 |
| 881 | Organ Procurement Organization Condition for Coverage (CMS-3064-IFC) | 0938-AK81 |
| 882 | Modifications to Managed Care Rules Based on Payment Provisions in BIPA and Technical Corrections (CMS-4040-F) | 0938-AK90 |
| 883 | Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity (CMS-4018-P) | 0938-AK94 |
| 884 | 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 |
| 885 | Update Interest Assessment on Medicare Overpayment and Underpayment (CMS-6014-P) | 0938-AL14 |
| 886 | Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-P) | 0938-AL18 |
| 887 | Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities that Provide Inpatient or Residential Care (CMS-2130-P) | 0938-AL26 |
| 888 | Medicare-Endorsed Prescription Drug Discount Card Assistance Initiative for State Sponsors (CMS-4032-P) | 0938-AL30 |
| 889 | State Children's Health Insurance Program; Eligibility for Unborn Children (CMS-2127-F) | 0938-AL37 |
| 890 | Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers (CMS-2151-F) | 0938-AL43 |
| 891 | Interim Final Amendment for Mental Health Parity (CMS-2152-IFC) | 0938-AL44 |
| 892 | Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans (CMS-1208-P) | 0938-AL49 |
| 893 | Prospective Payment System for Psychiatric Hospitals (CMS-1213-P) | 0938-AL50 |
| 894 | Provider Reimbursement Determinations and Appeals (CMS-1727-P) | 0938-AL54 |
| 895 | Definition of Severe Medically Determinable Impairment (CMS-2143-P) | 0938-AL57 |
| 896 | Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-IFC) | 0938-AL59 |
| 897 | SCHIP; Purchase of Family Coverage—Benefit Flexibility in Parent Coverage (CMS-2148-P) | 0938-AL62 |
| 898 | Revisions to Medicaid Cost-Sharing Regulations (CMS-2144-P) | 0938-AL66 |
| 899 | Revisions to the Medicare Appeals Process (CMS-4004-P) | 0938-AL67 |
| 900 | Notice of Intent to Conduct Negotiated Rulemaking for Special Payment Provisions and Standards for Suppliers of Custom-Fabricated Orthotics and Prosthetics (CMS-6012-N) | 0938-AL68 |
| 901 | DMERC Service Areas and Related Matters (CMS-1219-P) | 0938-AL76 |
| 902 | State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals; Federal Fiscal Year 2002 (CMS-2136-PN) | 0938-AL79 |
| 903 | Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P) | 0938-AL80 |
| 904 | Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and Intermediate Care Facilities for the Mentally Retarded (CMS-2004-F) | 0938-AL81 |
| 905 | 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-F) | 0938-AL84 |
| 906 | Medicaid Coverage Rules for Inmates of Public Institutions (CMS-2077-P) | 0938-AL85 |
| 907 | Targeted Case Management (CMS-2061-P) | 0938-AL87 |
| 908 | Changes to the Hospital Inpatient Prospective Payment System and FY 2004 Rates (CMS-1470-P) | 0938-AL89 |
| 909 | Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2004 (CMS-1469-P) | 0938-AL90 |
| 910 | Prospective Payment System for Long-Term Care Hospitals: FY 2004 (CMS-1472-P) | 0938-AL92 |
| 911 | Prospective Payment System for Psychiatric Hospitals (CMS-1477-P) | 0938-AL93 |
| 912 | Home Health Prospective Payment System Rate Update for FY 2004 (CMS-1473-NC) | 0938-AL94 |
| 913 | Prospective Payment System for Inpatient Rehabilitation Hospitals (CMS-1474-P) | 0938-AL95 |
| 914 | Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004 (CMS-1476-P) | 0938-AL96 |
| Centers for Medicare & Medicaid Services—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 915 | Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests (CMS-3250-F) | 0938-AI92 |
| 916 | Fee Schedule for Payment of Ambulance Services and Revisions to the Physician's Certification Requirements for Coverage of Nonemergency Ambulance Services (CMS-1002-FC) | 0938-AK30 |
| 917 | Medicare Program; Reporting and Repayment of Overpayments (CMS-6011-P) | 0938-AK45 |
| 918 | Prospective Payment System for Hospital Outpatient Services: Criteria for Establishing New Pass-Through Categories for Medical Devices (CMS-1179-IFC) | 0938-AK59 |
| 919 | Qualification Requirements for Directors of Laboratories Performing High Complexity Testing (CMS-2094-P) | 0938-AK83 |
| 920 | Medicaid Upper Payment Limit for Non-State Government-Owned or -Operated Hospitals (CMS-2134-F) | 0938-AL05 |
| 921 | Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships; Delay of Effective Date of the "Set in Advance" Provision (CMS-1809-IFC) | 0938-AL29 |
| 922 | Deductible Amount for Medigap High Deductible Options for Calendar Year 2002 (CMS-2135-N) | 0938-AL34 |
| 923 | Prospective Payment System for Hospital Outpatient Services; Delay in Effective Date of Calendar Year 2002 Payment Rates and the Pro Rata Reduction on Transitional Pass-Through Payment (CMS-1159-F3) | 0938-AL35 |
| 924 | Disapproval of Alcon Laboratories Request for an Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers (CMS-3061-FN) | 0938-AL36 |
| 925 | Correction of Certain Calendar Year 2003 Payment Rates Under the Hospital Outpatient Prospective Payment System and the Pro Rata Reduction on Transitional Pass-Through Payment (CMS-1159-F4) | 0938-AL42 |
| 926 | Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Correction Notice (CMS-1163-CN) | 0938-AL47 |
| Centers for Medicare & Medicaid Services—Discontinued Entries | Regulation Identification Number | Title | Date Withdrawn | Comments |
|---|---|---|---|
| 0938-AH81 | Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical Procedures for Ambulatory Surgical Centers (CMS-1885-FC) | 03/03/2002 | Withdrawn |
| 0938-AI48 | Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities, Rehabilitation Agencies (CMS-6005-P) | 03/06/2002 | Withdrawn |
| 0938-AI75 | Advance Refunding of Debt and Methodology for Repayment of Loan (CMS-1777-P) | 03/20/2002 | Withdrawn |
| 0938-AI89 | Medicare Coverage of, and Payment for, Bone Mass Measurements (CMS-3004-F) | 03/06/2002 | Withdrawn |
| 0938-AJ39 | Emergency Medical Treatment and Labor Act (EMTALA) (CMS-1063-P) | 03/03/2002 | Withdrawn |
| 0938-AJ44 | Protection for Women Who Elect Reconstruction After a Mastectomy (CMS-2040-IFC) | 03/04/2002 | Withdrawn |
| 0938-AJ64 | Surety Bonds Requirements for Suppliers of Durable Medical Equipment (CMS-6006-P) | 03/14/2002 | Withdrawn |
| 0938-AJ81 | Surety Bond Requirements for Home Health Agencies (HHAS) (CMS-6001-P) | 03/14/2002 | Withdrawn |
| 0938-AK15 | Payment for Clinical Psychology Training Programs (CMS-1089-F) | 03/03/2002 | Withdrawn |
| 0938-AK39 | Medicare Provider and Supplier Hearing Procedures (CMS-2093-P) | 03/06/2002 | Withdrawn |
| 0938-AK43 | Medical Devices Coverage Decisions Related to Health Care Technology (CMS-3059-P) | 03/20/2002 | Withdrawn |
| 0938-AK53 | Recognition of the American Osteopathic Association for Ambulatory Surgical Center Programs (CMS-2079-FN) | 03/04/2002 | Withdrawn |
| 0938-AK63 | Health Insurance Reform: Standards for Electronic Signatures (CMS-0051-F) | 03/03/2002 | Withdrawn |
| 0938-AK87 | Hospital Reference Laboratory and Medicare Secondary Payer (CMS-1187-P) | 03/03/2002 | Withdrawn |
| 0938-AK88 | Portability in the Group Health Insurance Market—Shared HHS Provisions (CMS-2048-F) | 03/20/2002 | Withdrawn |
| 0938-AK92 | Extended Medicaid for Certain Families Who Lose Medicaid Eligibility Because of Earned Income and the Residency of Minor Parents and Pregnancy (CMS 2026-F) | 03/04/2002 | Withdrawn |
| 0938-AK93 | Home Health Prospective Payment System Refinements (CMS-1161-P) | 03/20/2002 | Withdrawn |
| 0938-AK99 | Relief From Medicare Part A Late Enrollment Penalty for Group Buy-In for State and Local Retirees (CMS-4022-P) | 03/20/2002 | Withdrawn |
| 0938-AL06 | 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) | 03/06/2002 | Withdrawn |
| 0938-AL45 | Requirements for Long-term Care Facilities (CMS-3096-P) | 03/06/2002 | Withdrawn |
| Administration for Children and Families—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 927 | Program Performance Standards for the Operation of Head Start Programs | 0970-AB99 |
| 928 | Safeguarding Child Support and Expanded FPLS Information | 0970-AC01 |
| 929 | Developmental Disabilities and Bill of Rights Act | 0970-AC07 |
| Administration for Children and Families—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 930 | Construction and Major Renovation of Head Start and Early Head Start Facilities | 0970-AB54 |
| 931 | Child Support Enforcement for Indian Tribes | 0970-AB73 |
| 932 | Child Support Enforcement Program Omnibus Conforming Regulation | 0970-AB81 |
| 933 | Family Child Care Program Option for Head Start Programs | 0970-AB90 |
| 934 | Technical Revision of Head Start Regulations To Make Them Conform to Recent Statutory Revisions | 0970-AC00 |
| Administration for Children and Families—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 935 | High Performance Bonus Awards Under the TANF Program | 0970-AC06 |
| Administration on Aging—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 936 | 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 |
712. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH CENTERS
Agency:
Department of Health and Human Services (HHS)/Office of the Secretary (OS)
Priority:
Substantive, Nonsignificant
Legal Authority:
PL 100-93, sec 14(a)
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
42 CFR 1001
Legal Deadline:
None
Abstract:
This rule would set forth a new anti-kickback safe harbor addressing remuneration between Federal Qualified Health Centers and certain service providers where a significant community benefit exists.
| Action | Date | FR Cite |
| NPRM | 10/00/02 | |
| NPRM Comment Period End | 12/00/02 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
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
Related RIN:
Related To 0991-AA91
RIN:
0991-AB06
713. IMPLEMENTING THE BIOTERRORISM PREVENTION AND RESPONSE ACT OF 2001
Agency:
Department of Health and Human Services (HHS)/Office of the Secretary (OS)
Priority:
Other Significant
Legal Authority:
Not Yet Determined
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
None
Legal Deadline:
None
Abstract:
A variety of regulations will be required once the Bioterrorism Prevention and Response Act has been signed into law. These regulations would implement provisions that address, among other things, biological agents that have the potential to pose a national security threat, provisions relating to foods including recordkeeping regarding foods, food-shipment importation procedures and related matters.
| Action | Date | FR Cite |
| NPRM | 09/00/02 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State, Tribal, Federal
Agency Contact:
Alex Azar, General Counsel, Department of Health and Human Services, Office of the Secretary
Phone: 202 690-7741
RIN:
0991-AB15
714. 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.
| 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 | 10/00/02 |
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Additional Information:
Interim final regulations were published on November 19, 1999 (64 FR 63504) and are currently in effect. See 42 CFR 1001.952(t) and (u).
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
Related RIN:
Related To 0991-AB06
RIN:
0991-AA91
715. 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
Agency:
Department of Health and Human Services (HHS)/Office of the Secretary (OS)
Priority:
Other Significant
Legal Authority:
PL 100-259, Civil Rights Restoration Act of 1987
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 90; 45 CFR 91
Legal Deadline:
None
Abstract:
The Secretary proposes to amend the Department's regulations implementing title VI of the Civil Rights Act of 1964, as amended, section 504 of the Rehabilitation Act of 1973, as amended, title IX of the Education Amendments of 1972, and the Age Discrimination Act of 1975, as amended. The principal proposed conforming change is to amend the regulations to add the definitions of "program or activity" or "program" that correspond to the statutory definitions enacted under the Civil Rights Restoration Act of 1987.
| Action | Date | FR Cite |
| NPRM | 12/06/00 | 65 FR 76460 |
| NPRM Comment Period End | 01/05/01 | |
| Final Action | 08/00/02 | |
| Final Action Effective | 09/00/02 |
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses, Governmental Jurisdictions, Organizations
Government Levels Affected:
State, Local, Federal, Tribal
Agency Contact:
Robinsue Frohboese, Acting Director, Office for Civil Rights, Department of Health and Human Services, Office of the Secretary
Phone: 202 619-0403
RIN:
0991-AB10
716. REVISIONS TO 42 CFR PART 1003
Agency:
Department of Health and Human Services (HHS)/Office of the Secretary (OS)
Priority:
Substantive, Nonsignificant
Legal Authority:
42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396b; 42 USC 1396u-2
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
42 CFR 1003
Legal Deadline:
None
Abstract:
This proposed rule would revise part 1003, addressing the Office of Inspector General's authority to propose the imposition of civil money penalties and assessments, by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; modify the current definition for the term "claim;" update various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems or names through Internet and e-mail communications.
| Action | Date | FR Cite |
| NPRM | To Be Determined |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
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-AB03
717. 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, visit the Code of Federal Regulations.)
42 CFR 1003
Legal Deadline:
None
Abstract:
The proposed final rule would set forth in the OIG's civil money penalty provisions in 42 CFR part 1003 a new safe harbor for unlawful inducements to beneficiaries to provide protection for independent dialysis facilities that pay, in whole or in part, premiums for Supplementary Medical Insurance (Medicare part B) or Medicare Supplemental Health Insurance policies (Medigap) for financially needy Medicare beneficiaries with end-stage renal disease (ESRD). The safe harbor would specifically establish various standards that, if met, would result in the particular arrangement being protected from civil penalties under section 1128A(a)(5) of the Social Security Act.
| Action | Date | FR Cite |
| Final Rule | To Be Determined |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
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-AB04
718. 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