[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] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97N-0137] Cellpro, Inc.; Premarket Approval of CEPRATESC Stem Cell Concentration System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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