[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
