Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices 51993 

advise ANDA applicants to submit such 

labeling. 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21245 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0215] 

Draft Guidance for Industry and Food 

and Drug Administration Staff on In 

Vitro Companion Diagnostic Devices; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

October 12, 2011, the comment period 

for the notice that appeared in the 

Federal Register of July 14, 2011 (76 FR 

41506). In the notice, FDA requested 

comments on a draft guidance 

document entitled ‘‘In Vitro Companion 

Diagnostic Devices.’’ The Agency is 

taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: Submit either written or 

electronic comments by October 12, 

2011. 

ADDRESSES: 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comments on the draft guidance to 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. 1601, Rockville, MD 20852. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Mansfield, Center for Devices 

and Radiologic Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 5676, 

Silver Spring, MD 20993–0002, 301– 

796–4664; or 

Christopher Leptak, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5102, 

Silver Spring, MD 20993–0002, 301– 

796–0017; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 14, 

2011 (76 FR 41506), FDA published a 

notice announcing the availability of the 

draft guidance entitled ‘‘In Vitro 

Companion Diagnostic Devices,’’ and 

the opening of a public docket to receive 

comments on the draft guidance 

document. Interested persons were 

invited to submit comments by 

September 12, 2011. At this time the 

Agency is extending the comment 

period until October 12, 2011, to 

continue to receive public comments. 

Comments submitted to the docket will 

assist in identifying issues to be 

addressed in the finalized guidance 

document. 

II. Request for 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. 

Dated: August 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21226 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0586] 

Draft Guidance for Industry on 

Standards for Clinical Trial Imaging 

Endpoints; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Standards for Clinical 

Trial Imaging Endpoints.’’ The purpose 

of this draft guidance is to assist 

sponsors in the use of imaging 

endpoints in clinical trials of 

therapeutic drugs and biological 

products. The draft guidance describes 

standards sponsors can use to ensure 

that clinical trial imaging data are 

obtained in a manner that complies with 

a trial’s protocol, maintains imaging 

data quality, and provides a verifiable 

record of the imaging process. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment 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 October 18, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist the 

office in processing your requests. 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: 

Rafel Dwaine Rieves, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 2354, 

Silver Spring, MD 20993 –0002, 301– 

796–2050; or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Standards for Clinical Trial Imaging 

Endpoints.’’ This draft guidance is 

intended to assist sponsors in the 

standardization of imaging procedures 

when an important imaging endpoint is 

used in a clinical trial of a therapeutic 

drug or biological product, especially 

for an efficacy endpoint. As part of the 

reauthorization of the Prescription Drug 

User Fee Act (PDUFA 4), FDA 

committed to certain performance goals 

(see letters from the Secretary of Health 

and Human Services to the Chairman of 


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