
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43206-43207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0500]


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.

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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

[[Page 43207]]

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 
Sec.  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.
[FR Doc. 2016-15664 Filed 6-30-16; 8:45 am]
BILLING CODE 4164-01-P


