[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]



 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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.
 
 ========================================================================
 

  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