[Federal Register: October 7, 2008 (Volume 73, Number 195)]
[Notices]
[Page 58604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc08-81]
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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Draft Guidance for Industry on New Contrast Imaging Indication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.
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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availability of a draft guidance for industry entitled ``New Contrast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Procedures, FDA agreed to publish draft guidance by September 30, 2008,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 FDA intends this draft guidance to assist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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug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 Submit written comments on the draft guidance to the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