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HHS/NIH | RIN: 0925-AA53 | Publication ID: Spring 2010 |
Title: Amendment of Regulation of the Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought and Responsible Prospective Contractors | |
Abstract: On behalf of the Department of Health and Human Services (HHS) and the Public Health Service (PHS), a component of HHS, the National Institutes of Health (NIH), proposes to issue a Notice of Proposed Rulemaking (NPRM) to seek comments from the public on whether HHS should amend the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought (42 CFR part 50 subpart F) and Responsible Prospective Contractors (45 CFR part 94). The existing regulations provide standards to ensure that there is no reasonable expectation that the design, conduct, and reporting of PHS-funded research will be biased by a conflicting financial interest of an investigator. Since the regulations' publication in 1995, biomedical research has progressively become more complex, the Federal Government, PHS-funded institutions and researchers, and the private sector have increasingly interacted in an effort to meet common public health goals, and recent public scrutiny has raised the question of whether a more rigorous approach to investigator disclosure, management of conflicts, and Federal oversight is required. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 45 CFR 94 | |
Legal Authority: 42 USC 216 42 USC 289b-1 42 USC 299c-4 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Jerry Moore NIH Regulations Officer Department of Health and Human Services 6011 Executive Boulevard, Room 601, MSC 7669, Rockville, MD 20852 Phone:301 496-4607 Fax:301 402-0169 Email: jm40z@nih.gov |