Notice: Draft Guidance for Industry on New Contrast Imaging Indication 
Considerations for Devices and Approved Drug and Biological Products; 
Availability

Federal Register: October 7, 2008 (Volume 73, Number 195)              
                  Page 58604

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availability of a draft guidance for industry entitled ``New Contrast 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Procedures, FDA agreed to publish draft guidance by September 30, 2008, 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 FDA intends this draft guidance to assist 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm 
or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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