[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Pages 37245-37246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0249]


Draft Guidance for Industry: Preparation of Investigational 
Device Exemptions and Investigational New Drug Applications for 
Products Intended to Repair or Replace Knee Cartilage; 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 document entitled ``Guidance for Industry: 
Preparation of IDEs and INDs for Products Intended to Repair or Replace 
Knee Cartilage'' dated July 2007. The draft guidance provides to 
sponsors recommendations about certain information that should be 
included in an investigational device exemption (IDE) or 
investigational new drug application (IND) for a product intended to 
repair or replace knee cartilage. The draft guidance, when finalized, 
will supplement other FDA publications on IDEs and INDs.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 October 9, 2007.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448; or the Division of Small Manufacturers, 
International, and Consumer Assistance (DSMICA) (HFZ-220), Center for 
Devices and Radiological Health (CDRH), Food and Drug Administration, 
1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive 
label to assist the office in processing your requests. The draft 
guidance may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800; or by calling CDRH at 240-276-3150 or by faxing a 
request to CDRH at 240-276-3151. To receive an electronic copy, send an 
e-mail request to [email protected]. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.
    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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:
    Brenda R. Friend, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301-827-6210; or
    Aric D. Kaiser, Center for Devices and Radiological Health (HFZ-
410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3676.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Preparation of IDEs and INDs for Products 
Intended to Repair or Replace Knee Cartilage'' dated July 2007. The 
draft guidance document provides to sponsors recommendations about 
certain information that should be included in an IDE or IND for a 
product intended to repair or replace knee cartilage. For the purposes 
of the draft guidance, a product intended to repair or replace knee 
cartilage, as with other articular cartilage repair or replacement 
products, may include a biologic, device, or combination product whose 
components would be individually regulated by CDRH and CBER.
    FDA prepared this draft guidance to address issues that may arise 
in the development of articular cartilage repair or replacement 
products. The draft guidance also reflects input received from the 
public and the Cellular, Tissue, and Gene Therapies Advisory Committee 
(CTGTAC) at the March 3 to 4, 2005, CTGTAC meeting. The draft guidance, 
when finalized, will supplement other FDA publications on IDEs and 
INDs.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations.

[[Page 37246]]

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 
312 (on INDs) have been approved under OMB control number 0910-0014; 
and those in 21 CFR part 812 (on IDEs) have been approved under OMB 
control number 0910-0078.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft 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 the brackets in 
the heading of this document. A copy of the draft 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 draft guidance 
at either http://www.fda.gov/cber/guidelines.htm, http://www.fda.gov/cdrh/guidance.html, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13162 Filed 7-6-07; 8:45 am]
BILLING CODE 4160-01-S