Document ID: FDA-2013-N-0842-0001
Agency: fda
Document Type: Notice
Title: Consolidation of Wound Care Products Containing Live Cells
Posted Date: 2013-08-14T04:00Z

[Federal Register Volume 78, Number 157 (Wednesday, August 14, 2013)]
[Notices]
[Pages 49528-49529]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19685]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0842]

Consolidation of Wound Care Products Containing Live Cells

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is transferring 
oversight responsibilities for certain wound care products containing 
live cells from the Center for Devices and Radiological Health (CDRH) 
to the Center for Biologics Evaluation and Research (CBER). This 
consolidation initiative provides the opportunity to further develop 
and coordinate scientific and regulatory activities between CDRH and 
CBER. FDA believes that as more wound care products containing live 
cells are developed such consolidation is necessary for both efficient 
and consistent Agency action.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of 
Combination Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, rm. 5130, Silver Spring, MD 20993, 301-796-8930, 
hhs.gov">john.weiner@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Consolidation of Approved Wound Care Products Containing Live Cells 
in CBER

    On August 14, 2013, primary responsibility for regulating the 
following approved products: P950032, P960007, P000036, P010016, (all 
with product code MGR); H990013 (product code PBD); and H990002 
(product code OCE), and all supplements included therein, was 
transferred from the Office of Device Evaluation, CDRH, to the Office 
of Cellular, Tissue and Gene Therapies, CBER. The jurisdictional 
assignment of these products to CBER is

[[Page 49529]]

in accordance with section 503(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(g)) and 21 CFR 3.4. This will consolidate 
primary responsibility for regulating wound care products containing 
live cells in CBER.

II. Web page Listing CDRH Applications Transferred to CBER and Contact 
Information

    FDA has created a Web page listing the premarket approval 
applications and humanitarian device exemptions in CDRH that are being 
transferred to CBER. Sponsors of these products are encouraged to 
consult the Web page to find new contact information. The Web page 
address is: http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm356173.htm.
    Commencing immediately, submitters should send submissions to: 
Document Control Center, HFM-99, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448. Contact for questions on submissions: 
Patrick Riggins, Office of Cellular, Tissue and Gene Therapy, Center 
for Biologics Evaluation and Research, WOC1, Rm. 234N (HFM-705), 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-5366, 
patrick.riggins@fda/hhs.gov.

    Dated: August 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19685 Filed 8-13-13; 8:45 am]
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