federal_register: E9-30390
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| E9-30390 | Submission for OMB Review; Comment Request; Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI) | Notice | In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Cancer Institute (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collected below. This proposed information collection was previously published in the Federal Register on June 10, 2009 (74 FR 27552), and allowed 60-days for public comment. One public comment was received regarding pharmaceutical testing. The submitter responded to the e-mail. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a valid OMB control number. Proposed Collection: Title: Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI). Type of Information Collection Request: Existing Collection in Use without an OMB Number. Need and Use of Information Collection: Food and Drug Administration (FDA) regulations require requires sponsors to obtain information from the investigator before permitting the investigator to begin participation in investigational studies. The National Cancer Institute, (NCI) as a sponsor of investigational drug trials, has the responsibility to assure the FDA that investigators in its clinical trials program are qualified by training and experience as appropriate experts to investigate the drug. In order to fulfill these requirements, a standard Statement of Investigator (FDA Form 1572 modified), Supplemental Investigator Data Form, Financial Disclosure Form and Curriculum vitae (CV) are required. The NCI will accept the investigator's CV in any format. All investigators maintain a CV as part of their academic and professional practice. The data obtained from these forms allows the NCI to evaluate the qualifications of the investigator, identify appropriate personnel to receive shipment of investigational agent, ensure supplies are not diverted for inappropriate protocol or patient use and identify financial conflicts of interest. Comparisons are done with the intention of ensuring protocol, patient safety and drug compliance for patient and drug compliance for patient safety and protections. Frequency of Response: Annually. Affected Public: Public sector, businesses or other for- profit that will include Federal agencies or employees, non-profit institutions and a very small number of private practice physicians. Type of Respondents: Investigators. The annual reporting burden is limited to those physicians who choose to participate in NCI sponsored investigational trials to identify new medicinal agents to treat and relieve those patients suffering from cancer. The annualized respondents' burden for record keeping is estimated to require 8,564 hours (see table below). | 2009-12-22 | 2009 | 12 | https://www.federalregister.gov/documents/2009/12/22/E9-30390/submission-for-omb-review-comment-request-investigator-registration-and-financial-disclosure-for | https://www.govinfo.gov/content/pkg/FR-2009-12-22/pdf/E9-30390.pdf | Health and Human Services Department; National Institutes of Health | 221,353 | In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Cancer Institute (NIH) has... |