Department of Health and Human Services December 24, 2013 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance)
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 the use of rapid response surveys to obtain data on safety information to support quick turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals, and other user facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
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) and the Administration for Children and Families (ACF) announce 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 and ACF seek comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Rocky Flats Plant in Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Sandia National Laboratories-Livermore in Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Amendments to Excepted Benefits
This document contains proposed rules that would amend the regulations regarding excepted benefits under the Employee Retirement Income Security Act of 1974, the Internal Revenue Code, and the Public Health Service Act. Excepted benefits are generally exempt from the health reform requirements that were added to those laws by the Health Insurance Portability and Accountability Act and the Patient Protection and Affordable Care Act.
Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability
On January 16, 2013, the Food and Drug Administration (FDA) announced the availability of, and requested comment on, a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA). FDA is now announcing the availability of, and requesting comment on, a document entitled ``Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA Appendix). The purpose of the draft RA Appendix is to provide a science-based risk analysis of those foods whose production would be considered low risk with respect to the risk of intentional adulteration caused by acts of terrorism. The appendix supplements the science-based risk analysis already included in the draft RA, which does not consider the risk of intentional adulteration caused by acts of terrorism. FDA conducted this evaluation to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.
Focused Mitigation Strategies To Protect Food Against Intentional Adulteration
The Food and Drug Administration (FDA or we) is proposing to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is proposing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). Further, as part of the proposal, FDA discusses an approach to addressing economically motivated intentional adulteration. We expect the proposed rule, if finalized as proposed, would help to protect food from intentional adulteration caused by acts of terrorism.
Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Public Meeting on Proposed Rule
The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss the proposed rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. FDA is proposing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). The purpose of the public meeting is to inform the public of the provisions of the proposed rule and the rulemaking process (including how to submit comments, data, and other information to the rulemaking docket) as well as solicit oral stakeholder and public comments on the proposed rule and to respond to questions about the rule.
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