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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.


Fax written comments on the collection of information by July 5, 2013.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to All comments should be identified with the OMB control number 0910-0622. Also include the FDA docket number found in brackets in the heading of this document.

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Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7726,

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application—(OMB Control Number 0910-0622)—Reinstatement

Under § 312.120 (21 CFR 312.120), FDA accepts foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or application for marketing approval for a drug or biological product if the studies are conducted in accordance with good clinical practices (GCP), including review and approval by an independent ethics committee (IEC).

Under § 312.120(a), FDA accepts as support for an IND or application for marketing approval a well-designed and well-conducted foreign clinical study not conducted under an IND if the study is conducted in accordance with GCP, and we are able to validate the data from the study through an onsite inspection if necessary. GCP includes review and Start Printed Page 33848approval by an IEC before initiating a study, continuing review of an ongoing study by an IEC, and obtaining and documenting the freely given informed consent of the subject before initiating a study. Under § 312.120(b), a sponsor of a non-IND foreign study who wants to rely on that study as support for an IND or application for marketing approval must provide the following information to FDA: (1) The investigator's qualifications; (2) a description of the research facilities; (3) a detailed summary of the protocol and results of the study and, should FDA request, case records maintained by the investigator or additional background data such as hospital or other institutional records; (4) a description of the drug substance and drug product used in the study, including a description of the components, formulation, specifications, and, if available, bioavailability of the specific drug product used in the clinical study; (5) if the study is intended to support the effectiveness of a drug product, information showing that the study is adequate and well controlled under § 314.126; (6) the name and address of the IEC that reviewed the study and a statement that the IEC meets the definition in § 312.3; (7) a summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion; (8) a description of how informed consent was obtained; (9) a description of what incentives, if any, were provided to subjects to participate in the study; (10) a description of how the sponsor(s) monitored the study and ensured that the study was carried out consistently with the study protocol; and (11) a description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained.

Section 312.120(c) specifies how sponsors or applicants can request a waiver for any of the requirements under § 312.120(a)(1) and (b). Under § 312.120(c)(1), a waiver request must contain at least one of the following: (1) An explanation why the sponsor's or applicant's compliance with the requirement is unnecessary or cannot be achieved, (2) a description of an alternative submission or course of action that satisfies the purpose of the requirement, or (3) other information justifying a waiver. A waiver request may be submitted in an IND or in an information amendment to an IND, or in an application or in an amendment or supplement to an application submitted under 21 CFR part 314 or 601. Section 312.10 sets forth requirements for sponsors who request waivers from FDA for compliance with any of the provisions in part 312, and § 314.90 sets forth requirements for applicants who request waivers from FDA for compliance with §§ 314.50 through 314.81.

FDA has approval for the submission of these waiver requests under OMB control numbers 0910-0014 for part 312 and 0910-0001 for part 314. In addition to the reporting requirements set forth in table 1 of this document, there is also a recordkeeping provision in § 312.120(d) stating how long sponsors and applicants must retain records required by § 312.120. In addition, § 312.120(b) states that any signed written commitments by investigators must be maintained by the sponsor or applicant and made available for Agency review upon request, and also specifies sponsor recordkeeping of IEC-related information. Under § 312.120(d), if a study is submitted in support of an application for marketing approval, records must be retained for 2 years after an Agency decision on that application; if a study is submitted in support of an IND but not an application for marketing approval, records must be retained for 2 years after the submission of the IND. The retention requirements in § 312.57(c) for records and reports required under part 312 apply to these provisions, and are approved under OMB control number 0910-0014.

We estimate that 237 companies will submit a total of approximately 1,185 non-IND foreign clinical studies in support of an IND or application for marketing approval for a drug or biological product. Hour burden estimates vary due to differences in size, complexity, and duration across studies, and we estimate that complying with § 312.120 would take sponsors between 18 and 32 hours annually for each non-IND foreign clinical trial, totaling 37,920 hours (32 × 1,185).

In the Federal Register of February 26, 2013 (78 FR 13067), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received that pertained to the collection of information.

FDA estimates the burden for this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: May 30, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-13246 Filed 6-4-13; 8:45 am]