Department of Health and Human Services May 6, 2014 – Federal Register Recent Federal Regulation Documents

World Trade Center Health Program; Petition 004-Cardiovascular Disease; Finding of Insufficient Evidence
Document Number: 2014-10434
Type: Proposed Rule
Date: 2014-05-06
Agency: Department of Health and Human Services
On March 7, 2014, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 004) to add ``heart attack,'' which the Administrator has interpreted to mean ``cardiovascular disease,'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add cardiovascular disease to the List. The Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2015
Document Number: 2014-10319
Type: Proposed Rule
Date: 2014-05-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2015. In addition, it includes a proposal to adopt the most recent Office of Management and Budget (OMB) statistical area delineations to identify a facility's urban or rural status for the purpose of determining which set of rate tables would apply to the facility and to determine the SNF PPS wage index including a proposed one-year transition with a blended wage index for all providers for FY 2015. It also includes a discussion of the SNF therapy payment research currently underway within CMS. This proposed rule also proposes a revision to policies related to the Change of Therapy (COT) Other Medicare Required Assessment (OMRA). This proposed rule includes a discussion of a provision related to the Affordable Care Act involving Civil Money Penalties. Finally, this proposed rule includes a discussion of observed trends related to therapy utilization among SNF providers and a discussion of accelerating health information exchange in SNFs.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Activators of Human Pyruvate Kinase To Treat Cancer
Document Number: 2014-10309
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-up Exclusive Evaluation Option License Agreement to TeamedOn International, LLC., a company having a place of business in Rockville, MD, to practice the inventions embodied in the following applications:
Submission for OMB Review; Comment Request
Document Number: 2014-10307
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2014 (FY 2015)
Document Number: 2014-10306
Type: Proposed Rule
Date: 2014-05-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs). These changes would be applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2014 through September 30, 2015. This proposed rule would also address implementation of ICD-10-CM and ICD-10-PCS codes; propose a new methodology for updating the cost of living adjustment (COLA), and propose new quality measures and reporting requirements under the IPF quality reporting program.
Administrative Destruction of Certain Drugs Refused Admission to the United States
Document Number: 2014-10304
Type: Proposed Rule
Date: 2014-05-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is proposing a regulation to implement its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), by providing to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to the destruction. The proposed regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once finalized, this proposed regulation will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-10303
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-10302
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-10301
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2014-10300
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD); Notice of Meeting
Document Number: 2014-10299
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-10298
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2014-10297
Type: Notice
Date: 2014-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Patient Safety Organizations: Voluntary Relinquishment From Medical Peer Review Resource, LLC
Document Number: 2014-10279
Type: Notice
Date: 2014-05-06
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Medical Peer Review Resource, LLC of its status as a PSO, and has delisted the PSO accordingly. Medical Peer Review Resource, LLC submitted this request for voluntary relinquishment during revocation proceedings for cause.
Notice of Meeting
Document Number: 2014-10277
Type: Notice
Date: 2014-05-06
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10 (a) (2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-005, Patient Safety Learning Laboratories; Applying Design Innovation and Systems Engineering (P30)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Center for Devices and Radiological Health Guidance Development and Prioritization; Public Workshop; Requests for Comments
Document Number: 2014-10262
Type: Notice
Date: 2014-05-06
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2014-10179
Type: Notice
Date: 2014-05-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2014-10178
Type: Notice
Date: 2014-05-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.