[Federal Register Volume 62, Number 172 (Friday, September 5, 1997)]
[Rules and Regulations]
[Pages 46875-46876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23587]


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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.

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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.

SUPPLEMENTARY INFORMATION:

I. Background

    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.

II. Comments on the Proposed 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.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866

[[Page 46876]]

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.

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

    1. 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).

    2. 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. 
* * *
* * * * *

    Dated: August 29, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-23587 Filed 9-4-97; 8:45 am]
BILLING CODE 4160-01-F