Department of Health and Human Services May 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.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in the following Patent Applications to Dimension Therapeutics, Inc. (``Dimension'') located in Cambridge, Massachusetts, USA:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 1, 2016, page 10640 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute on Drug Abuse (NIDA), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of April 25, 2016. In the proposed rule, FDA requested comments for a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior (SIB or AB). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Health and Nutrition Examination Survey (NHANES). NHANES programs produce descriptive statistics which measure the health and nutrition status of the general population.

HRSA announces the award of an extension in the amount of $150,000 for the Maternal and Child Health Collaborative Office Rounds (MCH-COR) grants. The purpose of the program is to foster joint pediatrics-child psychiatry continuing education in the psychosocial development aspects of child health, utilizing a study group approach that emphasizes the practical challenges confronted by community based practitioners. The extension will permit recipients to continue activities within the scope of the current award while the program is evaluated, during the budget period of 7/1/2016-6/30/2017.