Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Clinical Trials and Human Subject Protection

Clinical Trials and Human Subject Protection

                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries Home
          Science & Research
          Science and Research Special Topics
          Clinical Trials and Human Subject Protection
          Disqualification of a Clinical Investigator (2/16/1996)Clinical Trials and Human Subject Protection Disqualification of a Clinical Investigator (2/16/1996)
  
  	
    Share
    Post
    Linkedin

    Email
    PrintWAIS Document Retrieval[Federal Register: February 16, 1996 (Volume 61, Number 33)]
[Proposed Rules]              
[Page 6177-6178]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe96-21]

Proposed RulesFederal 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.

[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.

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:
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.
    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.
    [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
    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.  * * *  * * * * *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

                                                                                  Content current as of:
      09/17/2015Clinical Trials and Human Subject Protection

          
                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop