Document
42 CFR 50.606(c) or 45 CFR 94.6(c) (Disclosure)
ICR 202512-0925-001 · OMB 0925-0417 · Object 173360500.
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
|---|---|
| File Title | 42 CFR 50.606(c) or 45 CFR 94.6(c) (Disclosure) |
| Author | Currie, Mikia (NIH/OD) [E] |
| Last Modified By | Writer |
| File Modified | 2025-11-24 |
| File Created | 2026-10-03 |
| Conversion State | complete |
Extracted Text
At. 24 Public reporting burden for this collection of information is estimated to average 18/60 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0417). Do not return the completed form to this address. Disclosure 42 CFR § 50.606 Remedies. (c) In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this subpart, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations . 45 CFR § 94.6 Remedies. (c) In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this part, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.