Department of Health and Human Services October 2014 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) is announcing the availability of a draft guidance for the research community entitled ``Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.'' OHRP is specifically addressing what risks to subjects are presented by research evaluating or comparing risks associated with standards of care, and which of these risks are reasonably foreseeable and should be disclosed to prospective research subjects as part of their informed consent. OHRP is soliciting written comments from all interested parties, including, but not limited to IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, the regulated community, and the public at large. This draft guidance represents OHRP's current thinking on this topic. Certain treatments and procedures that are commonly used in health care for a given type of disease or condition have come to be known as ``standards of care.'' Multiple ``standards of care'' involving widely differing treatments and risks may be available for the same disease or medical condition. Where multiple ``standard of care'' options are available for a given disease or condition, the use of the term does not imply that the options will produce similar benefits or incur similar risks. Furthermore, patients may not find those options equally acceptable, nor do physicians always use them interchangeably. Importantly there is not necessarily a limit on how different the risks from two versions of a standard of care might be. For example, it may already be known that one of those versions imposes a significantly higher risk of death than the other. Adequate knowledge about the effectiveness and risks of standards of care and how these standards compare to each other is sometimes lacking. In recent years research studies designed to evaluate such treatments and procedures have become commonplace. These studies are often called ``comparative effectiveness research'' or ``standard of care research.'' As this type of research has become more common, so too have questions about how the HHS human subject protection regulations (45 CFR part 46) apply to such research. There is uncertainty in the research community about which risks of the research should be determined to be reasonably foreseeable risks of research and how they should be described to prospective subjects in the process of informed consent. OHRP's interpretation of the HHS research regulations has been that if people are being asked to undergo procedures in a research study that involve risks that they would not otherwise be exposed to, these are `research risks' that people must be informed about. Only in that way are they able to make a truly informed decision about whether they are willing to participate. For comparative effectiveness or standard of care research, OHRP's general position is that the reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research when the risks being evaluated are different from the risks subjects would be exposed to outside of the study. This guidance addresses these issues in the form of frequently asked questions. OHRP will consider comments received before issuing the final guidance document.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed revisions to four rules originally proposed in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In response to the comments received on these foundational FSMA proposed rules, FDA issued supplemental notices of proposed rulemaking that propose significant changes to four of the proposed rules including: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food); Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety); Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Animal Food); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs). The purpose of the public meeting is to solicit oral stakeholder and public comments on the new content of the supplemental proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the supplemental proposed rules.

This document provides the methodology and data sources necessary to determine federal payment amounts made in program year 2016 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.

The Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement requests public comments to inform its upcoming Report to Congress. The Report to Congress (``Report'') is required to be submitted no later than June 30, 2015 under Title III, Section 305 of H.R. 4980 (Pub. L. 113-183), Preventing Sex Trafficking and Strengthening Families Act of 2014. The legislation was signed into law on September 29, 2014. This Request for Information offers the opportunity for interested individuals and organizations to provide input on specific Report requirements or other information that would be valuable to the Report development.

This notice provides public announcement of CDC's intent to award Ebola appropriations to select Ministries of Health and their bona fide agents for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1418, ``Protecting and Strengthening Public Health Impact, Systems, Capacity, and Security.''

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.

Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Eye Institute will host a meeting to enable public discussion of the Institute's proposal to rename its Division of Extramural Research to the Division of Extramural Science and establish a new Division of Extramural Activities. The proposal seeks to clearly delineate functions and streamline the services provided by adding focus to scientific programs and extramural operations. This proposed change aligns NEI with the structure of other NIH Institutes and Centers.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine. This guidance is intended to serve as a focus for continued discussions among the Division of Neurology Products, pharmaceutical sponsors, the academic community, and the public.