58604 Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Notices 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1220. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E8–22437, appearing on page 55114 in 

the Federal Register of Wednesday, 

September 24, 2008, the following 

correction is made: 

1. On page 55114, in the third 

column, in the Procedure section, the 

fourth sentence is corrected to read 

‘‘Oral presentations from the public will 

be scheduled between approximately 2 

p.m. and 3 p.m.’’ 

There are no other changes to the 

document. 

Dated: October 1, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–23718 Filed 10–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0525] 

Draft Guidance for Industry on New 

Contrast Imaging Indication 

Considerations for Devices and 

Approved Drug and Biological 

Products; 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availability of a draft guidance for 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 ‘‘New Contrast 

Imaging Indication Considerations for 

Devices and Approved Drug and 

Biological Products.’’ As part of the 

Medical Device User Fee Amendments 

of 2007 (MDUFA) Commitment for the 

Performance Goals and Procedures, FDA 

agreed to publish draft guidance by 

September 30, 2008, for medical 

imaging devices with ‘‘contrast agents or 

radiopharmaceuticals.’’ FDA intends 

this draft guidance to assist developers 

of medical imaging devices and imaging 

drug/biological products that provide 

image contrast enhancement. 

Particularly this guidance focuses on 

approaches in developing new contrast 

indications for imaging devices for use 

with already approved imaging 

products. FDA intends for the 

recommendations in this guidance to 

promote timely and effective review of, 

and consistent and appropriate 

regulation and labeling for imaging 

drugs and devices. 

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 

written or electronic comments on the 

draft guidance by January 5, 2009. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Y. Love, Office of Combination 

Products (HFG–3), Office of the 

Commissioner, Food and Drug 

Administration, 15800 Crabbs Branch 

Way, Rockville, MD 20855, 301–427– 

1934. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘New Contrast Imaging Indication 

Considerations for Devices and 

Approved Drug and Biological 

Products.’’ This draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance represents 

the agency’s current thinking on New 

Contrast Imaging Indication 

Considerations for Devices and 

Approved Drug and Biological Products. 

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. 

This draft 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 807 have 

been approved under 0910–0120. The 

collections of information in 21 CFR 

part 814 have been approved under 

0910–0231. The collections of 

information in 21 CFR part 314 have 

been approved under 0910–0001. 

II. 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. 

Please note that on January 15, 2008, the 

FDA Division of Dockets Management 

Web site transitioned to the Federal 

Dockets Management System (FDMS). 

FDMS is a Government-wide, electronic 

docket management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: September 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23712 Filed 10–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0281] 

Pilot Program To Evaluate Proposed 

Name Submissions; Concept Paper 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a concept paper entitled 

‘‘PDUFA Pilot Project Proprietary Name 

Review.’’ The concept paper provides 

information to pharmaceutical firms 

about how to evaluate proposed 

propriety names and submit the data 

generated from those evaluations to 

FDA for review under an anticipated 

pilot program. FDA plans to begin 

enrollment in the pilot program in fiscal 

year (FY) 2009. 

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