Department of Health and Human Services June 18, 2015 – Federal Register Recent Federal Regulation Documents
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Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV
The HOPE Act requires the Secretary of Health and Human Services (the Secretary) to develop and publish criteria for research involving transplantation of HIV-infected (HIV+) donor organs in HIV+ recipients. The goals of these criteria are, first, to ensure that research using organs from HIV+ donors is conducted under conditions protecting the safety of research participants and the general public; and second, that the results of this research provide a basis for evaluating the safety of solid organ transplantation (SOT) from HIV+ donors to HIV+ recipients. The National Institutes of Health (NIH), U.S. Department of Health and Human Services, invites the public to submit comments regarding the proposed HOPE Act criteria.
Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.'' The purpose of this workshop is to receive input from stakeholders and discuss approaches to the study of non-microbial biomarkers for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for establishing appropriate comparator methods and clinically relevant performance standards for non-microbial based in vitro diagnostics for infection.
Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).'' The purpose of this draft guidance is to provide greater clarity for FDA staff and IDE sponsors and sponsor- investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). This draft guidance is not final nor is it in effect at this time.
Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Hair Specimen for Drug Testing
This document is a request for information regarding specific aspects of the regulatory policies and standards that may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hair specimen). The original comment close date was June 29, 2015. We are extending the date to July 29, 2015 to allow for additional comments.
Removal of Obsolete Provisions
Much of the information set out in certain regulations regarding HHS's programs and activities is obsolete. Also, electronic resources are now available that did not exist when this part was first codified. This rule removes these obsolete regulations.
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment Medications; Correction
The Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register of December 6, 2012. The document modified the dispensing requirements buprenorphine and buprenorphine combination products approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. In particular, this rule allows opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphine after the assessment and documentation of a patient's responsibility and stability to receive opioid addiction treatment medication. However, an inadvertent removal of paragraphs was made. This correction reinstates the missing paragraphs.
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