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Office of Information and Regulatory Affairs (OIRA)

Executive Order Submissions Under Review

August 29, 2014


Department of Health and Human Services


AGENCY: HHS-ACF RIN: 0970-AC61
TITLE: Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Violence Against Women Reauthorization Act of 2013
STAGE: Interim Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 01/01/2014 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AC47
TITLE: Adoption and Foster Care Analysis and Reporting System (AFCARS)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 03/01/2014 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AC46
TITLE: Head Start Eligibility Determination
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 05/30/2014 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AG81
TITLE: Home Health Agency Conditions of Participation (CMS-3819-P)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 05/22/2014 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AS29
TITLE: Revisions to Patient's Rights Conditions for Participation and Conditions for Coverage (CMS-3302-P)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/13/2014 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AS06
TITLE: Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-P)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/26/2014 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AR43
TITLE: Medicare Secondary Payer and "Future Medicals" (CMS-6047-P)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/01/2013 LEGAL DEADLINE: None  
REVIEW EXTENDED


AGENCY: HHS-CMS RIN: 0938-AS30
TITLE: Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs for 2014 and Health Information Technology: Revisions to the CEHRT Definition (CMS-0052-F)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/08/2014 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AP01
TITLE: Requirements for the Medicare Incentive Reward Program and Provider Enrollment (CMS-6045-F)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 08/12/2014 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AS32
TITLE: Annual Eligibility Determinations for Exchange Participation and Insurance Affordability Programs; Health Insurance Issuer Standards Under the Affordable Care Act (CMS-9941-F)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/20/2014 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AG56
TITLE: Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 04/03/2014 LEGAL DEADLINE: None  
REVIEW EXTENDED


AGENCY: HHS-FDA RIN: 0910-AG57
TITLE: Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 04/03/2014 LEGAL DEADLINE: None  
REVIEW EXTENDED


AGENCY: HHS-FDA RIN: 0910-AF97
TITLE: Proposed Revisions To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other Changes
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 04/10/2013 LEGAL DEADLINE: None  
REVIEW EXTENDED


AGENCY: HHS-FDA RIN: 0910-AG35
TITLE: Produce Safety Regulation
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 05/07/2014 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-AG36
TITLE: Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 06/13/2014 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-AG64
TITLE: Foreign Supplier Verification Program
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/23/2014 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-AG10
TITLE: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/26/2014 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-AG18
TITLE: Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/03/2013 LEGAL DEADLINE: None  
REVIEW EXTENDED


AGENCY: HHS-HRSA RIN: 0906-AB04
TITLE: 340B Drug Pricing Program Regulations
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 04/09/2014 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-AA55
TITLE: Clinical Trials Registration and Results Submission
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 03/11/2014 LEGAL DEADLINE: Statutory  
REVIEW EXTENDED


AGENCY: HHS-OIG RIN: 0936-AA06
TITLE: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 05/15/2014 LEGAL DEADLINE: None  
REVIEW EXTENDED


AGENCY: HHS-OS RIN: 0991-AB92
TITLE: 2014 Edition, Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/01/2014 LEGAL DEADLINE: None  


AGENCY: HHS-SAMHSA RIN: 0930-ZA06
TITLE: Mandatory Guidelines for Federal Workplace Drug Testing Programs -- Oral
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/23/2014 LEGAL DEADLINE: None  


AGENCY: HHS-SAMHSA RIN: 0930-ZA05
TITLE: Mandatory Guidelines for Federal Workplace Drug Testing Programs
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/25/2014 LEGAL DEADLINE: None  



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