Department of Health and Human Services August 28, 2012 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL
The Food and Drug Administration (FDA) has determined the regulatory review period for TORISEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Shane Mayack, Ph.D., Joslin Diabetes Center: Based on the report of an investigation conducted by the Joslin Diabetes Center (Joslin) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Shane Mayack, former postdoctoral fellow, Department of Developmental and Stem Cell Biology, Joslin, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants T32 DK07260-29 and P30 DK036836 and the 2008 NIH Director's New Innovator Award Program grant DP2 OD004345-01. ORI found that Respondent engaged in research misconduct involving two (2) published papers:
Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
This document corrects a technical error in the notice [Document Identifier: CMS-10003] entitled ``Notice of Denial of Medical Coverage (or Payment)'' that was published in the July 6, 2012 (77 FR 40064) Federal Register.
Privacy Act, Exempt Record System
The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.'' HHS/FDA proposes to exempt this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations.
Privacy Act, Exempt Record System
The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.'' HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research Misconduct Proceedings
In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration's (FDA's) regulations for the protection of privacy, FDA is publishing notice of a new Privacy Act system of records entitled ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC'' System No. 09-10-0020. Under the Department of Health and Human Services' (HHS' or the Department's) Public Health Service Policies on Research Misconduct, FDA has responsibilities for addressing research integrity and misconduct issues related to FDA supported activities. This system contains records related to the processing and reviewing of allegations of scientific research misconduct levied against an individual (the respondent) who is an agent of, or affiliated by contract or agreement with, FDA, or an FDA employee involved in intramural research. Research misconduct proceedings include allegation assessments, inquiries, investigations, oversight reviews by HHS' Office of Research Integrity (ORI), hearings, and administrative appeals.
Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, ``NIH Records Related to Research Misconduct Proceedings, HHS/NIH.'' HHS is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. Elsewhere in this issue of the Federal Register, HHS is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. HHS is publishing this companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency publishing this companion proposed rule under the agency's usual procedure for notice- and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws the direct final rule. The direct final rule and this companion proposed rule are substantively identical.
Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, ``NIH Records Related to Research Misconduct Proceedings, HHS/NIH.'' HHS is exempting this system of records from certain provisions of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. HHS is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. Elsewhere in this issue of the Federal Register, HHS is publishing a companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws this direct final rule. The companion proposed rule and this direct final rule are substantively identical.
Privacy Act of 1974; Proposed Exempt New System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act), the National Institutes of Health (NIH) is proposing to establish an exempt new system of records, 09-25-0223, ``NIH Records Related to Research Misconduct Proceedings, HHS/NIH.'' The new system will contain records pertaining to individual respondents who are the subject of research misconduct allegations or proceedings governed by the Public Health Service (PHS) Policies on Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93 (``Part 93''). Because this is a law enforcement investigatory system, NIH has published a Notice of Proposed Rulemaking to exempt the system from certain requirements of the Privacy Act; specifically, the provisions pertaining to providing an accounting of disclosures, access and amendment, notification, and agency procedures and rules.
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