2016-15664. Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.” The guidance document provides investigational new drug application (IND) sponsors with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States. The guidance announced in this notice updates the guidance of the same title dated February 2012 (February 2012 guidance) by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2010-D-0500 for “Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/​regulatoryinformation/​dockets/​default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled “Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.” The guidance provides IND sponsors with recommendations regarding IND submissions for early clinical trials for LBPs in the United States, including LBPs lawfully marketed as conventional foods and dietary supplements in the United States and proposed for clinical uses regulated under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262). The guidance focuses on the CMC information that should be provided in an IND for early clinical trials evaluating LBPs. The guidance is applicable to INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise under part 312 (21 CFR part 312).

In the Federal Register of February 21, 2012 (77 FR 9947), FDA announced the availability of the final guidance of the same title dated February 2012. In the Federal Register of March 31, 2015 (80 FR 17050), FDA published a notice requesting additional comments on the CMC information that a sponsor of an IND should provide in its IND in order to meet regulatory requirements when commercially available conventional foods or dietary supplements containing LBPs are used as investigational new drugs in early phase clinical trials. FDA received a few comments on the notice and in response to the comments, FDA is updating the February 2012 guidance by adding a section to address when the label on commercially available products will be considered adequate to satisfy the purpose of the CMC requirements for INDs under § 312.23(a)(7)(iv)(a)-(b). In addition, editorial changes were made to improve clarity. The guidance announced in this notice updates the guidance of the same title dated February 2012.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2) without seeking additional comments after determining that prior public participation is not feasible or appropriate. FDA notes that we already sought comments on the issues addressed by the revisions in this guidance in the Federal Register of March 31, 2015 under Docket No. FDA-2010-D-0500. Further delay in implementing these revisions could impede the progress of certain investigations of drug use of commercially marketed foods or dietary supplements that are of low risk and may be of benefit to the public health.

The guidance represents the current thinking of FDA on “Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 312 have been approved under OMB control number 0910-0014.

III. Electronic Access

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

Dated: June 27, 2016.

Leslie Kux,

Associate Commissioner for Policy.