Department of Health and Human Services December 10, 2013 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; National Survey of Older Americans Act Participants
Document Number: 2013-29436
Type: Notice
Date: 2013-12-10
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the information collection requirements contained in consumer assessment surveys that are used by ACL to measure program performance for programs funded under Title III of the Older Americans Act.
Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability
Document Number: 2013-29395
Type: Notice
Date: 2013-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets intended to be swallowed intact. FDA is concerned that these characteristics of generic drugs are too varied compared to the originator drug and could affect patient outcomes.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices Current Good Manufacturing Practice Quality System Regulation
Document Number: 2013-29394
Type: Notice
Date: 2013-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
Document Number: 2013-29393
Type: Notice
Date: 2013-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the submission of periodic safety reports as described in the guidance entitled ``Periodic Benefit-Risk Evaluation Report (PBRER) (E2C(R2)).'' The guidance was prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, and describes the format, content, and timing of a PBRER for an approved drug or biologic. This notice also solicits comments on the information collection associated with the submission of waiver-related materials as described in the draft guidance entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format.'' The draft guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an ICH E2C(R2) PBRER in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations.
Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive Petitions; Reopening of the Comment Period
Document Number: 2013-29392
Type: Notice
Date: 2013-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice published in the Federal Register of Wednesday, September 11, 2013 (78 FR 55727), announcing the availability of the draft guidance for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food Additive Petitions.''
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Hospital Value-Based Purchasing Program; Organ Procurement Organizations; Quality Improvement Organizations; Electronic Health Records (EHR) Incentive Program; Provider Reimbursement Determinations and Appeals
Document Number: 2013-28737
Type: Rule
Date: 2013-12-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2014 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Hospital Value-Based Purchasing (VBP) Program. In the final rules in this document, we are finalizing changes to the conditions for coverage (CfCs) for organ procurement organizations (OPOs); revisions to the Quality Improvement Organization (QIO) regulations; changes to the Medicare fee-for-service Electronic Health Record (EHR) Incentive Program; and changes relating to provider reimbursement determinations and appeals.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014
Document Number: 2013-28696
Type: Rule
Date: 2013-12-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major final rule with comment period addresses changes to the physician fee schedule, clinical laboratory fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule with comment period also includes a discussion in the Supplementary Information regarding various programs. (See the Table of Contents for a listing of the specific issues addressed in the final rule with comment period.)