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

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Document Number: 2014-25318
Type: Notice
Date: 2014-10-24
Agency: Department of Health and Human Services
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and Human Services (HHS), through the Office for Human Research Protections (OHRP) is announcing the availability of a draft guidance for the research community entitled ``Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.''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 This draft guidance represents OHRP's current thinking on this topic.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.
Document Number: 2014-25304
Type: Notice
Date: 2014-10-23
Agency: Department of Education, Department of Health and Human Services
On August 18, 2014, the Departments of Education and Health and Human Services published in the Federal Register (79 FR 48854 and 79 FR 48874) notices inviting applications for new awards for fiscal year 2014 for the Preschool Development GrantsDevelopment and Preschool Development GrantsExpansion Grants programs. The notices established October 14, 2014, as the deadline date for eligible applicants to apply for funding under the programs. On October 9, 2014, the Departments published in the Federal Register (79 FR 61065) a notice extending the deadline for submission to October 15, 2014, after learning that the Grants.gov Web site would be unavailable to applicants on October 11-12, 2014. It appears that some applicants may have encountered technical difficulties in the submission of their applications on October 15, 2014. Therefore, we are extending, to October 24, 2014, the deadline for transmittal of applications.
Document Number: 2014-25261
Type: Proposed Rule
Date: 2014-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Document Number: 2014-25258
Type: Notice
Date: 2014-10-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25257
Type: Proposed Rule
Date: 2014-10-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Document Number: 2014-25251
Type: Notice
Date: 2014-10-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25250
Type: Notice
Date: 2014-10-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25248
Type: Notice
Date: 2014-10-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This notice provides public announcement of CDC's intent to award Ebola appropriations to AFENET for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH10-1006 Strengthening the Development of Applied Epidemiology and Sustainable Public Health Capacity through Collaboration, Program Development and Implementation, Communication and Information Sharing.''
Document Number: 2014-25218
Type: Notice
Date: 2014-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-25217
Type: Proposed Rule
Date: 2014-10-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception'' dated October 2014. The draft guidance document is intended for tissue establishments and healthcare professionals and discusses one of the exceptions for establishments from certain regulatory requirements.
Document Number: 2014-25214
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Document Number: 2014-25210
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Document Number: 2014-25205
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2014-25200
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2014-25199
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2014-25198
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Document Number: 2014-25181
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25177
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25176
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25175
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25155
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services (HHS) is hereby announcing that the charters have been renewed for the following federal advisory committees for which the Office of the Assistant Secretary for Health provides management support: Chronic Fatigue Syndrome Advisory Committee (CFSAC); President's Council on Fitness, Sports, and Nutrition (PCFSN); Secretary's Advisory Committee on Human Research Protections (SACHRP); and Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). Functioning as federal advisory committees, these committees are governed by the provisions of the Federal Advisory Committee Act (FACA). Under FACA, it is stipulated that the charter for a federal advisory committee must be renewed every two years in order for the committee to continue to operate.
Document Number: 2014-25024
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services, Administration for Children and Families
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.
Document Number: 2014-24637
Type: Notice
Date: 2014-10-23
Agency: Department of Health and Human Services
This notice announces the second Office of Medicare Hearings and Appeals (OMHA) Medicare Appellant Forum. The purpose of this event is to provide updates to OMHA appellants on the status of OMHA operations and to relay information on a number of OMHA and CMS initiatives designed to reduce the backlog in the processing of Medicare appeals at the OMHA level and lower levels of the administrative appeals process.
Document Number: 2014-25133
Type: Notice
Date: 2014-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.''
Document Number: 2014-25106
Type: Notice
Date: 2014-10-22
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.
Document Number: 2014-25105
Type: Notice
Date: 2014-10-22
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.
Document Number: 2014-25095
Type: Notice
Date: 2014-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25094
Type: Notice
Date: 2014-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-25089
Type: Proposed Rule
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.
Document Number: 2014-25068
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
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.
Document Number: 2014-25067
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-25053
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-25049
Type: Rule
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Document Number: 2014-25048
Type: Notice
Date: 2014-10-22
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 ``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.
Document Number: 2014-25046
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25045
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25044
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25043
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25042
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25041
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25040
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25039
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25038
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25037
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25036
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-25033
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Document Number: 2014-25032
Type: Notice
Date: 2014-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for CARBON DIOXIDE LASER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the United States Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that food additive.
Document Number: 2014-25030
Type: Notice
Date: 2014-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-24962
Type: Proposed Rule
Date: 2014-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by EMD Millipore Corp., proposing that the color additive regulations be amended to expand the safe use of mica-based pearlescent pigments in alcoholic beverages to include cordials, liqueurs, cocktails, and certain other alcoholic beverages, and non-alcoholic mixers and mixes.