Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 9947 

finalized, will represent the Agency’s 

current thinking on conducting drug 

interaction studies during drug 

development to support marketing 

approval. 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This revised draft guidance refers to 

previously approved collections of 

information that 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 

201.57 have been approved under OMB 

control number 0910–0572. 

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 document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances or http:// 

www.regulations.gov. 

Dated: February 15, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3958 Filed 2–17–12; 8:45 am] 

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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. 

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/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/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] 

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