2010-25851. Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.” This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND requirements.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 12, 2011. Submit either electronic or written comments concerning proposed collection of information by December 13, 2010.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Sandy Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993-0002, 301-796-1077, or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.” FDA receives frequent inquiries from external constituents, in particular the academic research community (e.g., clinical investigators, Institutional Review Boards (IRBs)) and the pharmaceutical industry, concerning whether various types of human research studies can be conducted without an IND. Because of the volume and nature of the inquiries, this guidance is intended to be a resource to assist potential sponsors and clinical investigators in determining whether an IND should be submitted for their planned research. Generally, clinical investigations in which a drug is administered to study subjects must be conducted under an IND as required by part 312 (21 CFR part 312). This guidance explains the general requirements for when an IND is needed, describes the types of clinical studies that are exempt by regulation from the IND requirements, and addresses a range of issues that commonly arise in inquiries to FDA concerning the application of the IND requirements.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on determining whether human research studies can be conducted without an IND. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comment on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Draft Guidance for Industry on Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.

Description: The draft guidance would assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an IND as described in part 312, Investigational New Drug Application. The draft guidance describes the basic criteria for when an IND is required, specific situations in which an IND is not required, and a range of issues that have been the source of confusion or misperceptions about the application of the IND regulations. Section VIII of the draft guidance, “Process for Addressing Inquiries Concerning the Application of the IND Requirements,” provides a process for seeking advice from FDA concerning the application of the IND regulations to a planned clinical investigation. Under § 312.2(e), FDA, on request, will advise on the applicability of part 312 to a planned clinical investigation.

Part 312 contains an information collection that has been approved by OMB under OMB control number 0910-0014, and this approval would extend to the recommendations in the draft guidance. However, requests for FDA advice, under § 312.2(e), on the application of the IND regulations to a planned clinical investigation has not been part of this approval by OMB. Therefore, we are requesting OMB approval of the information collection in Section VIII of the draft guidance. As indicated in table 1 of this document, based on FDA's experience with the requests it has received for advice on the application of the IND regulations to planned clinical investigations, we estimate that we will receive annually approximately 45 formal inquiries as described in Section VIII of the draft guidance from approximately 20 sponsors and/or investigators, and approximately 110 informal inquiries as described in Section VIII from approximately 40 sponsors and/or investigators. We also estimate that it will take approximately 8 hours to prepare and submit each formal inquiry and approximately 30 minutes to prepare and submit each informal inquiry.

FDA requests comments on this analysis of information collection burdens:

Table 1—Estimated Annual Reporting Burden ¹

	Number of respondents	Number of responses per respondent	Total annual responses	Hours per response	Total hours
Formal Inquiry	20	2.25	45	8 hours	360
Informal Inquiry	40	2.75	110	30 minutes	55
Total					415
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding the draft guidance, including comments regarding proposed collection of information. It is only necessary to send one set of comments. It is no longer necessary to send two copies of any mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, or http://www.regulations.gov.

Dated: October 6, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.