[Federal Register Volume 62, Number 80 (Friday, April 25, 1997)]
[Notices]
[Pages 20189-20190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0137]


Cellpro, Inc.; Premarket Approval of CEPRATE SC Stem 
Cell Concentration System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by CellPro, Inc., Bothell, WA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the CEPRATE SC Stem Cell Concentration System 
(CEPRATE SC System). FDA's Center for Biologics Evaluation 
and Research (CBER) notified the applicant, by letter of December 6, 
1996, of the approval of the application.

DATES: Petitions for administrative review by May 27, 1997.Q02
ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Keith O. Webber, Center for Biologics 
Evaluation and Research (HFM-594), 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-5103.

SUPPLEMENTARY INFORMATION: On January 3, 1994, CellPro, Inc., Bothell, 
WA 98021, submitted to CBER an application for premarket approval of 
the CEPRATE SC System. The device is indicated for the 
processing of autologous bone marrow to obtain a cell population 
enriched with cells displaying the CD34 surface marker (CD34+). Such 
cells are intended for hematopoietic support after myeloablative 
chemotherapy. Infusion of CD34+ enriched cell populations results in a 
lower incidence of dimethyl sulfoxide infusion-associated complications 
compared with infusion of unselected bone marrow cells. The 
CEPRATE SC System consists of an instrument and a single-use, 
sterile, prepackaged kit containing disposable components which 
includes: (1) An avidin column, (2) a precolumn, (3) a tubing set, (4) 
a vial of anti-CD34+ biotinylated monoclonal antibody, (5) a blood 
filter, and (6) wash and culture media. The CEPRATE SC System 
concentrates CD34+ cells using a

[[Page 20190]]

proprietary, continuous flow immunoadsorption technique. Bone marrow 
cells are harvested, fractionated for recovery of the buffy-coat and 
incubated with biotinylated murine anti-CD34 monoclonal antibody which 
selectively binds CD34+ cells. After incubation, the cells are washed 
to remove excess, unbound antibody and then processed through the 
CEPRATE SC System. After processing through the 
CEPRATE SC System, the CD34+ enriched population of 
autologous bone marrow cells are reinfused into the patient.
    On December 6, 1996, CBER approved the application by a letter to 
the applicant from the Director of the Office of Therapeutics Research 
and Review, CBER.
    In the December 6, 1996, approval letter the expiration dating 
period for the anti-human CD34 biotinylated antibody (murine) was 
approved at 18 months when stored at -70  deg.C. An expiration dating 
period for all other components of the CEPRATE SC Disposables 
Kit was approved for 12 months when stored at the appropriate 
temperatures. FDA received a submission from CellPro, Inc., dated 
December 12, 1996, in support of extending the expiration dating period 
for the remaining components of the CEPRATE SC System from 12 
months to 18 months. On February 19, 1997, FDA approved the 18-month 
expiration dating period for all components of the CEPRATE SC 
System except for the Roswell Park Memorial Institute cell culture 
medium, which has an approved expiration dating period of 16 months.
    FDA has determined that the sale, distribution, and use of the 
CEPRATE SC System is restricted to prescription use in 
accordance with 21 CFR 801.109 within the meaning of section 520(e) of 
the act (21 U.S.C. 360j(e)) under the authority of section 
515(d)(1)(B)(ii) of the act (21 U.S.C. 360e(d)(1)(B)(ii)). FDA has also 
determined that to ensure the safe and effective use of the device, the 
CEPRATE SC System is further restricted within the meaning of 
section 520(e) of the act under the authority of section 
515(d)(1)(B)(ii) of the act insofar as: (1) The labeling specifies the 
requirements that apply to the training of practitioners who may use 
the device; and (2) the sale, distribution, and use must not violate 
section 502(q) and (r) of the act (21 U.S.C. 352(q) and (r)).
    A summary of the safety and effectiveness data on which CBER based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act authorizes any interested person to 
petition, under section 515(g) of the act, for administrative review of 
CBER's decision to approve this application. A petitioner may request 
either a formal hearing under 21 CFR part 12 of FDA's administrative 
practices and procedures regulations or a review of the application and 
CBER's action by an independent advisory committee of experts. A 
petition is to be in the form of a petition for reconsideration under 
21 CFR 10.33(b). A petitioner shall identify the form of review 
requested (hearing or independent advisory committee) and shall submit 
with the petition supporting data and information showing that there is 
a genuine and substantial issue of material fact for resolution through 
administrative review. After reviewing the petition, FDA will decide 
whether to grant or deny the petition and will publish a notice of its 
decision in the Federal Register. If FDA grants the petition, the 
notice will state the issue to be reviewed, the form of review to be 
used, the persons who may participate in the review, the time and place 
where the review will occur, and other details.
    Petitioners may, at any time on or before May 27, 1997, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Biologics Evaluation and 
Research (21 CFR 5.53).

    Dated: April 17, 1997.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-10720 Filed 4-24-97; 8:45 am]
BILLING CODE 4160-01-F