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Office of Information and Regulatory Affairs (OIRA)

Executive Order Submissions Under Review

December 05, 2016


Department of Health and Human Services


AGENCY: HHS-ACF RIN: 0970-AC43 Status: Pending Review
TITLE: Performance Standards for Runaway and Homeless Youth Grantees
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 03/17/2016 LEGAL DEADLINE: Statutory  


AGENCY: HHS-ACF RIN: 0970-AC50 Status: Pending Review
TITLE: Flexibility, Efficiency, and Modernization of Child Support Enforcement Programs
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 07/28/2016 LEGAL DEADLINE: None  


AGENCY: HHS-CDC RIN: 0920-AA59 Status: Pending Review
TITLE: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, Addition of Certain Influenza Strains to the List of Select Agents, and Enhanced Biosafety Requirements
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/18/2016 LEGAL DEADLINE: None  


AGENCY: HHS-CDC RIN: 0920-AA56 Status: Pending Review
TITLE: World Trade Center Health Program: Amendments to Definitions, Appeals, and Other Requirements
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/27/2016 LEGAL DEADLINE: None  


AGENCY: HHS-CDC RIN: 0920-AA63 Status: Pending Review
TITLE: Control of Communicable Diseases
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 11/01/2016 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AS56 Status: Pending Review
TITLE: Pre-Existing Condition Insurance Plan Program Updates (CMS-9995-IFC4)
STAGE: Interim Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 02/03/2015 LEGAL DEADLINE: None  
REVIEW EXTENDED


AGENCY: HHS-CMS RIN: 0938-AR84 Status: Pending Review
TITLE: Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics (CMS-6012-P)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 04/27/2016 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AG81 Status: Pending Review
TITLE: Conditions of Participation for Home Health Agencies (CMS-3819-F)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 05/06/2016 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AS61 Status: Pending Review
TITLE: Medicaid Supplemental Payment and Accountability (CMS-2393-P)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 07/19/2016 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AS84 Status: Pending Review
TITLE: Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-F)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 11/14/2016 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AT11 Status: Pending Review
TITLE: Conditions for Coverage for End-Stage Renal Disease Facilities (CMS-3337-IFC)
STAGE: Interim Final Rule ECONOMICALLY SIGNIFICANT: Yes
** RECEIVED DATE: 12/02/2016 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AH28 Status: Pending Review
TITLE: Direct Food Substances Affirmed as Generally Recognized as Safe; Partially Hydrogenated Menhaden Oil and Rapeseed Oil
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/27/2016 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZA46 Status: Pending Review
TITLE: Tobacco Product Standard for N-nitrosonornicotine Level in Finished Smokeless Tobacco Products
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 08/17/2016 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AH19 Status: Pending Review
TITLE: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/26/2016 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AG96 Status: Pending Review
TITLE: Format and Content of Reports Intended to Demonstrate Substantial Equivalence
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/28/2016 LEGAL DEADLINE: None  


AGENCY: HHS-HRSA RIN: 0906-AB08 Status: Pending Review
TITLE: 340B Program Omnibus Guidelines
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/01/2016 LEGAL DEADLINE: None  


AGENCY: HHS-HRSA RIN: 0906-AB02 Status: Pending Review
TITLE: Definition of Human Organ Under Section 301 of the National Organ Transplant Act of 1984
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/09/2016 LEGAL DEADLINE: Statutory  


AGENCY: HHS-HRSA RIN: 0906-AA89 Status: Pending Review
TITLE: 340(B) Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/21/2016 LEGAL DEADLINE: Statutory  


AGENCY: HHS-IHS RIN: 0917-ZA31 Status: Pending Review
TITLE: Reimbursement Rates for Calendar Year 2017
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 11/30/2016 LEGAL DEADLINE: None  


AGENCY: HHS-OIG RIN: 0936-AA05 Status: Pending Review
TITLE: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/27/2016 LEGAL DEADLINE: None  


AGENCY: HHS-OS RIN: 0991-AC02 Status: Pending Review
TITLE: Medicare Program; Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 11/18/2016 LEGAL DEADLINE: None  


AGENCY: HHS-SAMHSA RIN: 0930-AA23 Status: Pending Review
TITLE: Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/15/2016 LEGAL DEADLINE: None  


AGENCY: HHS-SAMHSA RIN: 0930-AA24 Status: Pending Review
TITLE: Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/15/2016 LEGAL DEADLINE: None  


AGENCY: HHS-SAMHSA RIN: 0930-AA21 Status: Pending Review
TITLE: Confidentiality of Substance Use Disorder Patient Records
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/26/2016 LEGAL DEADLINE: None  



Note: "**" denotes recent change in status.
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