Department of Health and Human Services March 2016 – Federal Register Recent Federal Regulation Documents

The Secretary of the Department of Health and Human Services (HHS) hereby issues this final rule with comment period to implement a methodology and payment rates for the Indian Health Service (IHS) Purchased/Referred Care (PRC), formerly known as the Contract Health Services (CHS), to apply Medicare payment methodologies to all physician and other health care professional services and non-hospital- based services. Specifically, it will allow the health programs operated by IHS, Tribes, Tribal organizations, and urban Indian organizations (collectively, I/T/U programs) to negotiate or pay non-I/ T/U providers based on the applicable Medicare fee schedule, prospective payment system, Medicare Rate, or in the event of a Medicare waiver, the payment amount will be calculated in accordance with such waiver; the amount negotiated by a repricing agent, if applicable; or the provider or supplier's most favored customer (MFC) rate. This final rule will establish payment rates that are consistent across Federal health care programs, align payment with inpatient services, and enable the I/T/U to expand beneficiary access to medical care. A comment period is included, in part, to address Tribal stakeholder concerns about the opportunity for meaningful consultation on the rule's impact on Tribal health programs.

On February 25, 2016, we published a Federal Register notice (81 FR 9483) announcing a new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel), which was scheduled for Wednesday, March 23, 2016. This notice announces the cancellation of the March 23, 2016 meeting.

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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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, 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 Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.

In accordance with the requirements of the Privacy Act of 1974, as amended, this Notice re-establishes a computer matching agreement between CMS and the Department of Defense (DoD). We have provided background information about the proposed matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #234 entitled ``Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications.'' In order to improve the process for submission and review of chemistry, manufacturing, and controls (CMC) information for animal drugs, the Center for Veterinary Medicine (CVM) has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. Termed Question-based Review (QbR), these questions provide a general framework for original CMC submissions to investigational new animal drug (INAD) files, generic investigational new animal drug (JINAD) files, new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), conditional approval of applications for conditional approval (CNADAs), and veterinary master files (VMFs).

The U.S. Department of Health and Human Services (HHS) announces the establishment of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) and invites nominations for membership.

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 ``Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)''. The purpose of BD-STEPS is to identify modifiable maternal exposures in pregnancy that may increase the risk for having a pregnancy affected by certain major, structural birth defects.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), 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 December 1, 2015, page 75120 and allowed 60 days for public comment. A public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director (OD), 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. For Further Information Contact: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Dina Paltoo, Office of Science Policy, 6705 Rockledge Drive or call non-toll-free number (301) 496-9838 or Email your request, including your address to: GDS@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Forms to Support Genomic Data Sharing for Research Purposes, 0925-0670, Expiration Date 03/31/2016REVISION, Office of the Director, OD, National Institutes of Health (NIH). Need and Use of Information Collection: Sharing research data supports the NIH mission and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. The NIH has longstanding policies to make a broad range of research data, including genomic data, publicly available in a timely manner from the research activities that it funds. Genomic research data sharing is an integral element of the NIH mission as it facilitates advances in our understanding of factors that influence health and disease, while also providing opportunities to accelerate research through the power of combining large and information-rich datasets. To promote robust sharing of human and non-human data from a wide range of large-scale genomic research and provide appropriate protections for research involving human data, the NIH issued the NIH Genomic Data Sharing Policy (GDS Policy). Human genomic data submissions and controlled-access are managed through a central data repository, the database of Genotypes and Phenotypes (dbGaP) which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at the NIH. Under the GDS Policy, all investigators who receive NIH funding to conduct large-scale genomic research are expected to register studies with human genomic data in dbGaP, no matter which NIH-designated data repository will maintain the data. As part of the registration process, investigators must provide basic study information such as the type of data that will be submitted to dbGaP, a description of the study, and an institutional assurance (i.e. Institutional Certification) of the data submission which delineates any limitations on the secondary use of the data (e.g., data cannot be shared with for-profit companies, data can be used only for research of particular diseases). Investigators interested in using controlled-access data for secondary research must apply through dbGaP and be granted permission from the relevant NIH Data Access Committee(s). As part of the application process, investigators and their institutions must provide information such as a description of the proposed research use of controlled-access datasets that conforms to any data use limitations, agree to the Genomic Data User Code of Conduct, and agree to the terms of access through a Data Use Certification agreement. Requests to renew data access and reports to close out data use are similar to the initial data access request, requiring sign-off by both the requestor and the institution, but also ask for information about how the data have been used, and about publications, presentations, or intellectual property based on the research conducted with the accessed data as well as any data security issues or other data management incidents. The NIH has developed online forms, available through dbGaP, in an effort to reduce the burden for researchers and their institutional officials to complete the study registration, data submission, data access, and renewal and closeout processes. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,505.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for polio and varicella vaccines.

The Food and Drug Administration (FDA, we) 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 our use of a tracking network to collect and share safety information about animal food from Federal, State, and Territorial Agencies.

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.