WAIS Document Retrieval[Federal Register: September 5, 1997 (Volume 62, Number 172)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 312
[Docket No. 95N-0138]
Disqualification of a Clinical Investigator
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the investigational new drug regulation that provides for disqualification of clinical investigators who submit false information. The revision is intended to clarify the agency's authority to reach sponsor- investigators under the regulation.
EFFECTIVE DATE: November 4, 1997.
FOR FURTHER INFORMATION CONTACT: Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1046.
- Comments on the Proposed Rule
- Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
- Analysis of Impacts
FDA has examined the impacts of the final rule under Executive Order 12866
and the Regulatory Flexibility Act (5 U.S.C. 601-612). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this regulation does not impose reporting, recordkeeping, or other economic burdens, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.
FDA is amending the regulations governing the disqualification of clinical investigators to clarify that Sec. 312.70 (21 CFR 312.70) reaches sponsor-investigators.
Part 312 (21 CFR part 312) requires sponsors to monitor the progress of clinical investigations, to review and evaluate evidence relating to the safety and effectiveness of the drug under investigation, and to report to FDA information based on these monitoring and review activities. Clinical investigators conduct clinical trials on new drugs and submit the resulting data to individual or corporate sponsors. Data generated by the clinical investigators are the subject of the reports submitted by sponsors to FDA.
In the Federal Register of February 16, 1996 (61 FR 6177), FDA proposed amending Sec. 312.70 by adding language that would clarify that FDA can disqualify clinical investigators, including sponsor- investigators, for submitting to sponsors or to FDA false information in any required report. Under current Sec. 312.70(b), the agency may disqualify an investigator who has ``deliberately or repeatedly submitted false information to the sponsor in any required report.'' However, unlike investigators, sponsor-investigators, who both directly conduct investigations and report data to FDA, submit information directly to FDA and not to a separate sponsor. Because Sec. 312.3(b) specifically states that the ``requirements applicable to a sponsor- investigator under this part include both those applicable to an investigator and a sponsor,'' Sec. 312.70(b) encompasses the disqualification of sponsor-investigators. This has been the agency's long-standing interpretation for clinical investigator disqualifications for drugs, animal drugs, and devices. However, for clarity, the agency is amending this regulation to make specific reference to FDA and to sponsor-investigators. FDA also intends in the near future to review and harmonize the clinical investigator disqualification provisions under device and animal drug regulations (21 CFR 812.119 and 511.1(c)) with the changes made in this final rule.
FDA received one comment on the proposed rule. The comment commended FDA for the proposed amendment to Sec. 312.70, stating that it is imperative that data supporting the safety and efficacy of pharmaceuticals be accurate and reliable. The comment noted that it was in the best interest of patients, investigators, pharmaceutical companies, and the Government that FDA be able to assure the integrity of data. The comment also expressed support for the disqualification of a clinical investigator who has deliberately or repeatedly supplied false information to a sponsor or to FDA.
FDA welcomes comments and suggestions from all persons interested in protecting the integrity of clinical data. The deliberate submission of false information by those directly responsible for administering or dispensing an investigational new drug subverts the integrity of the review process. At worst, such actions may endanger public health and safety and, at a minimum, will challenge public confidence in a review process that is conducted with honesty by the vast majority of investigators and sponsor-investigators.
List of Subjects in 21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical research, Reporting and recordkeeping requirements, Safety.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 312 is amended as follows:
PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION
- The authority citation for 21 CFR part 312 continues to read as follows:
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 371); sec. 351 of the Public Health Service Act (42 U.S.C. 262).
- Section 312.70 is amended by revising the first sentences of paragraphs (a) and (b) to read as follows:
Sec. 312.70 Disqualification of a clinical investigator.
(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50, or part 56 of this chapter, or has submitted to FDA or to the sponsor false information in any required report, the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research will furnish the investigator written notice of the matter complained of and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. * * *
(b) After evaluating all available information, including any explanation presented by the investigator, if the Commissioner determines that the investigator has repeatedly or deliberately failed to comply with the requirements of this part, part 50, or part 56 of this chapter, or has deliberately or repeatedly submitted false information to FDA or to the sponsor in any required report, the Commissioner will notify the investigator and the sponsor of any investigation in which the investigator has been named as a participant that the investigator is not entitled to receive investigational drugs.
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Dated: August 29, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-23587 Filed 9-4-97; 8:45 am]
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