Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 47805 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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/default.htm or http:// 

www.regulations.gov. 

Dated: September 10, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22380 Filed 9–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0293] 

Guidance for Industry: Considerations 

for Allogeneic Pancreatic Islet Cell 

Products; 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: Considerations 

for Allogeneic Pancreatic Islet Cell 

Products’’ dated September 2009. The 

guidance document provides 

recommendations to manufacturers, 

sponsors, and clinical investigators 

involved in the transplantation of 

allogeneic pancreatic islet cell products 

for clinical investigations of the 

treatment of type 1 diabetes mellitus. 

The guidance identifies the types of data 

and information obtained during 

investigational new drug studies that 

may be helpful in establishing the 

safety, purity, and potency of a 

biological product in a biologics license 

application (BLA). The guidance 

announced in this notice finalizes the 

draft guidance of the same title, dated 

May 2008. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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 written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Valerie A. Butler, 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: Considerations for Allogeneic 

Pancreatic Islet Cell Products’’ dated 

September 2009. The guidance 

document provides recommendations to 

manufacturers, sponsors, and clinical 

investigators involved in the 

transplantation of allogeneic pancreatic 

islet cell products for clinical 

investigations of the treatment of type 1 

diabetes mellitus. The guidance 

identifies the types of data and 

information that may be obtained during 

investigational new drug studies to 

assist in establishing the safety, purity, 

and potency of a biological product in 

a BLA. However, the guidance is not 

intended to identify all of the product, 

preclinical, and clinical data that may 

be needed to successfully support a 

BLA. 

In the Federal Register of May 22, 

2008 (73 FR 29760), FDA announced the 

availability of the draft guidance of the 

same title, dated May 2008. FDA 

received a few comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. The guidance announced in 

this notice finalizes the draft guidance 

dated May 2008. 

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 211 has been approved 

under 0910–0139; the collections of 

information in 21 CFR part 312 has been 

approved under 0910–0014; the 

collections of information in 21 CFR 

parts 601 and 610 have been approved 

under 0910–0338; and the collections of 

information in 21 CFR part 1271 has 

been approved under 0910–0543 and 

0910–0559. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination 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/ 

GuidanceComplianceRegulatory

Information/default.htm or http:// 

www.regulations.gov. 

Dated: September 11, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22426 Filed 9–16–09; 8:45 am] 

BILLING CODE 4160–01–S 


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