WAIS Document Retrieval[Federal Register: February 16, 1996 (Volume 61, Number 33)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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.
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.
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.
- 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 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.
- 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.
- 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.
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
- 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.
- 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. * * *
- 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. * * * * * * * *
- The authority citation for 21 CFR part 312 continues to read as follows:
Dated: February 9, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-3384 Filed 2-15-96; 8:45 am]
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