[Federal Register Volume 61, Number 33 (Friday, February 16, 1996)]
[Proposed Rules]
[Pages 6177-6178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3384]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 61, No. 33 / Friday, February 16, 1996 /
Proposed Rules
[[Page 6177]]
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: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the investigational new drug regulation that provides for
disqualification of clinical investigators for submitting false
information. It has come to the agency's attention that, as written,
the regulation may be unclear. The proposed amendment would clarify the
agency's authority to reach sponsor-investigators under the existing
regulation.
DATES: Written comments by May 16, 1996. FDA proposes that any final
rule based on this proposal become effective 60 days after its date of
publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Howard P. Muller, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1046.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is proposing to amend the regulations governing
disqualification of clinical investigators to clarify that existing
Sec. 312.70 (21 CFR 312.70) reaches sponsor-investigators. Although the
proposed amendment would not signify a change in policy, it has come to
the agency's attention that, as written, the regulation may be unclear.
Generally, clinical investigators who conduct clinical trials to
investigate new drugs submit their data to individual or corporate
sponsors. Part 312 (21 CFR part 312) requires sponsors to monitor the
progress of clinical investigations and to submit clinical
investigation reports to the agency. Thus, data generated by the
clinical investigator become the subject of reports that are submitted
to the agency.
Sponsor-investigators both directly conduct investigations and
report data to the agency. Section 312.3(b) defines ``sponsor-
investigator'' as ``an individual who both initiates and conducts an
investigation, and under whose immediate direction the investigational
drug is administered or dispensed.'' The definition specifically states
that ``[t]he requirements applicable to a sponsor-investigator under
this part include both those applicable to an investigator and a
sponsor.'' Therefore, existing Sec. 312.70 covers the disqualification
of sponsor-investigators. However, the language of Sec. 312.70, as it
applies to sponsor-investigators, may be confusing.
Under existing 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 submit information directly to FDA
and not to a separate sponsor. Although FDA believes that Sec. 312.70
encompasses the disqualification of sponsor-investigators, because a
sponsor-investigator does not submit information to a sponsor, the
existing regulatory language may be ambiguous. Therefore, the agency is
proposing to amend Sec. 312.70 for clarity.
The proposed rule, if finalized, would clarify that the agency can
disqualify clinical investigators and sponsor-investigators for
submitting to sponsors, or to FDA, false information in any required
report.
II. 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.
III. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
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 proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
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 proposed regulation does not impose
paperwork or recordkeeping burdens, the agency certifies that the
proposed 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.
IV. Effective Date
FDA proposes that any final rule based on this proposal become
effective 60 days after its date of publication in the Federal
Register.
V. Request for Comments
Interested persons may, on or before May 16, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.
[[Page 6178]]
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 312 be 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: February 9, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-3384 Filed 2-15-96; 8:45 am]
BILLING CODE 4160-01-F
