Department of Health and Human Services August 14, 2017 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee. This meeting is open to the public. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number, 1-877- 492-3517 and the passcode is 2576415. The phone line has 75 ports available for teleconference participants. The meeting room will only accommodate 50 people. There will be 15 minutes allotted on Wednesday, September 27, 2017 from 11:30 a.m.-11:45 a.m. for public comments. The public is welcome to submit written comment in advance of the meeting, to the contact person listed below. Written comments received in advance of the meeting will be included in the official record of the meeting.

The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).

Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the final adoption of such changes no less than 30 days before such changes become effective. In accordance with notice requirements of NAPA, ANA herein describes proposed interpretive rules and general statements of policy that relate to ANA's funding opportunities beginning in Fiscal Year (FY) 2018. Changes to FY 2018 Funding Opportunity Announcements (FOAs) will be based on the following previously published programs: Environmental Regulatory Enhancement (ERE) HHS-2017-ACF-ANA-NR-1221, Native American Language Preservation and Maintenance-Esther Martinez Immersion (EMI) HHS-2017-ACF-ANA-NB- 1226, Native American Language Preservation and Maintenance (P&M) HHS- 2017-ACF-ANA-NL-1235, Social and Economic Development Strategies (SEDS) HHS-2017-ACF-ANA-NA-1236, Social and Economic Development Strategies- Alaska (SEDS-AK) HHS-2015-ACF-ANA-NK-0960, and Native Youth Initiative for Leadership, Empowerment, and Development (ILEAD) HHS-2017-ACF-ANA-NC-1263. This notice of public comment also provides additional information about ANA's plan for administering grant programs.

This notice announces a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. The meeting is open to the public, and registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/ 32822.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these changes implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making changes relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the market basket update that will apply to the rate- of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.