Department of Health and Human Services May 25, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing a final order to reclassify external cardiac compressors (ECC) (under FDA product code DRM), a preamendments class III device, into class II (special controls). FDA is also creating a separate classification regulation for a subgroup of devices previously included within this classification regulation, to be called cardiopulmonary resuscitation (CPR) aids, and reclassifying these devices from class III to class II for CPR aids with feedback and to class I for CPR aids without feedback.

The HIV/AIDS Bureau (HAB) is requesting a class deviation from the competition requirements in order to provide one-year extensions with funds to 346 Ryan White HIV/AIDS Program (RWHAP) Part C HIV Early Intervention Services Program Existing Geographic Service Area (EISEGA) recipients. The purpose of the Part C EISEGA program is to provide HIV primary care in the outpatient setting to targeted low income, underinsured people living with HIV. HAB is finalizing an evaluation of the Part C EISEGA program and development of a new data-driven methodology. This methodology is aimed at ensuring that awards are based on a consistent approach to promote a rational and sustainable allocation of resources while ensuring responsiveness to geographic and healthcare financing considerations, indicators of need, and results along the HIV care continuum. HAB expects to re-compete the entire program in fiscal year (FY) 2018. One-year extensions with funds for all 346 Part C EISEGA recipients enables HAB to finalize the evaluation and methodology development and engage recipients and relevant stakeholders with regard to this new approach prior to implementation and without disrupting the provision of critical HIV primary medical care services to the current RWHAP clients served by these recipients. Pending the availability of funds, the amount of each FY 2017 award will be based on a proportion of the FY 2016 Part C EISEGA award to each of the 346 recipients, respectively.

In accordance with the Grants Policy and Administration Manual (GPAM) Part F: Chapter 2.b.34, the Bureau of Primary Health Care (BPHC) has been granted a class deviation from the requirements for competition contained in the GPAM Part F: Chapter 2.b.4 to award funds to bridge 52 PCAs three months. This extension, from March 31, 2017, to June 30, 2017, will extend the project and budget period end dates for the 52 PCAs which will result in alignment with other BPHC cooperative agreements.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.