80 FR 17050 - Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

The Food and Drug Administration (FDA) is announcing a request for additional comments on the chemistry, manufacturing, and control (CMC) information that a sponsor of an investigational new drug application (IND) should provide in its IND in order to meet regulatory requirements when commercially available foods or dietary supplements containing live biotherapeutic products (LBPs) are used as investigational new drugs in early phase clinical trials. The request for additional comments on the CMC information is related to the guidance entitled, ``Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry,'' dated February 2012 (February 2012 guidance).

[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17050-17051]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07273]


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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; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; requests for comments.

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[[Page 17051]]

SUMMARY: The Food and Drug Administration (FDA) is announcing a request 
for additional comments on the chemistry, manufacturing, and control 
(CMC) information that a sponsor of an investigational new drug 
application (IND) should provide in its IND in order to meet regulatory 
requirements when commercially available foods or dietary supplements 
containing live biotherapeutic products (LBPs) are used as 
investigational new drugs in early phase clinical trials. The request 
for additional comments on the CMC information is related to the 
guidance entitled, ``Early Clinical Trials with Live Biotherapeutic 
Products: Chemistry, Manufacturing, and Control Information; Guidance 
for Industry,'' dated February 2012 (February 2012 guidance).

DATES: Submit either electronic or written comments on the requested 
CMC information by May 29, 2015.

ADDRESSES: Submit written requests for single copies of the February 
2012 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 240-402-7800. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the requested CMC information 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: 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 a request for additional comments on the CMC 
information that a sponsor of an IND should provide in its IND in order 
to meet the requirements under Sec.  312.23 (21 CFR 312.23), when 
commercially available foods or dietary supplements containing LBPs are 
subject to study as investigational new drugs in early phase clinical 
trials.
    In the Federal Register of February 21, 2012 (77 FR 9947), FDA 
announced the publication of a final guidance entitled ``Early Clinical 
Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and 
Control Information; Guidance for Industry,'' dated February 2012. The 
guidance provides IND sponsors with recommendations regarding CMC 
information that should be included in IND submissions for early 
clinical trials with LBPs, including LBPs lawfully marketed as foods or 
dietary supplements in the United States and proposed for clinical uses 
regulated under section 351 of the Public Health Service Act (42 U.S.C. 
262). The guidance also outlines the Drug Substance and Drug Product 
information that should be provided in the CMC section of an IND to 
meet the requirements under Sec.  312.23 and to support proceeding to 
clinical evaluation of an LBP in human subjects.

II. CMC Information

    FDA is considering modifying the February 2012 guidance to address 
the CMC information that should be provided in an IND, under certain 
conditions. Specifically, FDA is considering whether to revise the 
guidance to address when the label on the commercially available 
product(s) would be considered adequate to satisfy the requirement for 
CMC information under Sec.  312.23. For example, we are considering 
whether the label would be adequate to satisfy the CMC information when 
the following conditions are met: (1) The LBP product that is proposed 
for investigational use is a commercially available food or dietary 
supplement; (2) the investigation does not involve a route of 
administration, dose, patient population, or other factor that 
significantly increases the risk (or decreases the acceptability of 
risk) associated with the use of the food or dietary supplement; (3) 
the investigation is not intended to support a marketing application 
for a drug claim for the food or dietary supplement; and (4) the 
investigation is conducted in compliance with the requirements for INDs 
(part 312), the requirements for review by an institutional review 
board (21 CFR part 56), and with the requirements for informed consent 
(21 CFR part 50). FDA is seeking public comment on this issue.

III. Comments

    Interested persons may submit either electronic comments regarding 
the requested CMC information to http://www.regulations.gov or written 
comments to the Division of Dockets Management (see ADDRESSES). It is 
only necessary to send one set of 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, and will be posted to 
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the February 2012 
guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07273 Filed 3-30-15; 8:45 am]
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