Document ID: FDA-2010-D-0500-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products; Chemistry, Manufacturing, and Control Information
Posted Date: 2010-10-14T04:00Z

[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]               
[Page 63188-63189]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc10-81]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Industry: Early Clinical Trials With Live 
Biotherapeutic Products: Chemistry, Manufacturing, and Control 
Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 63189]]

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draft guidance provides investigational new drug application (IND) 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 13, 2010.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 301-827-1800. 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit electronic comments on the draft guidance to http://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: Benjamin A. Chacko, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

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 Sec.  312.2(b). The general principles underlying the IND 
submission and the general requirements for an IND's content and format 
are contained in Sec. Sec.  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 Sec.  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 (Sec.  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]
BILLING CODE 4160-01-P