Proposed Rules. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2010-25850 · Docket No. FDA-2010-D-0500

Summary

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information” dated September 2010. The draft guidance provides investigational new drug application (IND) sponsors with recommendations on the submission of INDs for early clinical trials with live biotherapeutic products (LBPs).

Dates

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comment on any guidance at any time (21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 13, 2010.

Supplementary Information

I. Background FDA is announcing the availability of a draft document entitled “Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information” dated September 2010. The draft guidance provides IND sponsors with recommendations on the submission of INDs for early clinical trials with LBPs. Regulations in part 312 (21 CFR part 312) require sponsors who wish to study LBPs in humans to submit an IND to FDA, unless the sponsor falls into one of the exemptions for clinical investigations found under § 312.2(b). The general principles underlying the IND submission and the general requirements for an IND's content and format are contained in §§ 312.22 and 312.23, respectively. This draft guidance focuses on the chemistry, manufacturing, and control information that should be provided in an IND in order to meet the requirements under § 312.23 for early clinical trials evaluating LBPs. This draft guidance is applicable to all INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise (§ 312.2). The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 312 have been approved under the Office of Management and Budget (OMB) control number 0910-0014. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management ( see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of 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 draft guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: October 7, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-25850 Filed 10-13-10; 8:45 am]