Department of Health and Human Services April 2015 – Federal Register Recent Federal Regulation Documents

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 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 document corrects technical errors that appeared in the final rule published in the Federal Register on August 22, 2014 entitled ``Medicare Program; FY 2015 Hospice Wage Index and Payment Rate Update; Hospice Quality Reporting Requirements and Process and Appeals for Part D Payment for Drugs for Beneficiaries Enrolled in Hospice.''

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance finalizes several questions and answers (Q&As) from the draft guidance entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'' issued February 15, 2012.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.'' This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application through an abbreviated licensure pathway. This guidance gives an overview of FDA's approach to determining biosimilarity.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or ``we'') is announcing the availability of a risk assessment entitled ``Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.'' The risk assessment is a tool to assist with reevaluating which animal drug residues should be included in milk testing programs. We undertook this project in response to a request from the National Conference on Interstate Milk Shipments (NCIMS).

We are proposing to revise 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 2016. Some of these changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act), the Pathway for Sustainable Growth Reform (SGR) Act of 2013, the Protecting Access to Medicare Act of 2014, and other legislation. We also are addressing the update of 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 2016. We also are proposing to update 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 2016 and implement certain statutory changes to the LTCH PPS under the Affordable Care Act and the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 and the Protecting Access to Medicare Act of 2014. In addition, we are proposing to establish new requirements or to revise existing requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs) that are participating in Medicare, including related proposals for eligible hospitals and critical access hospitals participating in the Medicare Electronic Health Record (EHR) Incentive Program. We also are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.

The Food and Drug Administration is correcting a notice entitled ``Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop'' that appeared in the Federal Register of April 17, 2015 (80 FR 21248). The document announced a public workshop. The document was published with the incorrect title. This document corrects that error.

The Food and Drug Administration (FDA) has determined the regulatory review period for Xience Xpedition Everolimus Eluting Coronary Stent System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

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 (the PRA), federal agencies are required to publish 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. seq.), which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0014, titled, ``IHS Loan Repayment Program (LRP).'' This previously approved information collection project was last published in the Federal Register (77 FR 27467) on May 10, 2012, and allowed 30 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit this collection, which expires May 31, 2015, to OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS-2015-0003). Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension of currently approved information collection, 0917-0014, ``Indian Health Service Loan Repayment Program.'' The LRP application is available in an electronically fillable and fileable format. Form(s): The IHS LRP Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS LRP identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract through which the IHS agrees to repay part or all of their indebtedness in exchange for an initial two-year service commitment to practice fulltime at an eligible Indian health program. This program is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS LRP. A two-year contract obligation is signed by both parties, and the individual agrees to work at an eligible Indian health program location and provide health services to American Indian and Alaska Native individuals. The information collected via the on-line application from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant accepts employment at a location, the applicant in turn ``picks-up'' the score of that location. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).

The Indian Health Service published a document in the Federal Register on February 20, 2015, for the FY 2015 Office of Tribal Self- Governance Program, Planning Cooperative Agreement. The notice contained incorrect guidance.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``M8 Electronic Common Technical Document (eCTD) v4.0 Draft Implementation Guide v2.0'' (the M8 eCTD draft implementation guidance) and a related document entitled ``eCTD v4.0 Implementation Package Draft Specification for Submission Formats v2.0'' (the draft specifications document). The M8 eCTD draft implementation guidance and the draft specifications document were prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The M8 eCTD draft implementation guidance provides instructions for creating the eCTD v4.0 Health Level 7 Regulated Product Submission (RPS) message for Modules 2 through 5 of the eCTD. The draft specifications document provides specifications for creating files for inclusion in the eCTD. These draft documents represent major updates to the eCTD specifications.