
[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Page 9947]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: Early 
Clinical Trials With Live Biotherapeutic Products: Chemistry, 
Manufacturing, and Control Information '' dated February 2012. The 
guidance provides certain Investigational New Drug Application (IND) 
sponsors with recommendations in connection with the submission of INDs 
for early clinical trials with live biotherapeutic products (LBPs). The 
guidance announced in this notice finalizes the draft guidance of the 
same title dated September 2010.

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

ADDRESSES: Submit written requests for single copies of this 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 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 guidance document.
    Submit electronic comments on the 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 document entitled 
``Guidance for Industry: Early Clinical Trials With Live Biotherapeutic 
Products: Chemistry, Manufacturing, and Control Information'' dated 
February 2012. The guidance provides certain IND sponsors with 
recommendations in connection with IND submissions for early clinical 
trials for LBPs in the United States. The guidance focuses on the 
chemistry, manufacturing, and control 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.
    In the Federal Register of October 14, 2010 (75 FR 63188), FDA 
announced the availability of the draft guidance of the same title 
dated September 2010. FDA received a few comments on the draft guidance 
and those comments were considered as the guidance was finalized. In 
response to comments, changes incorporated in the final guidance 
include the addition of text related to the scope, definitions and 
background section of the guidance. In addition, editorial changes were 
made to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated September 2010.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 
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 21 CFR part 312 have been approved under 
0910-0014.

III. Comments

    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. 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 guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3957 Filed 2-17-12; 8:45 am]
BILLING CODE 4160-01-P


