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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Acknowledgment Letter, July 6, 2012 - HPC, Cord Blood BLA 125432

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 LifeSouth Community Blood Centers, Inc.
Attention:  Nancy Eckert  
4039 Newberry Road
Gainesville, Florida 32607

 

Dear Ms. Eckert

We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:

Our Submission Tracking Number (STN):  BLA 125432/0

Name of Biological Product:  HPC, Cord Blood  

Indication:  For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patient disorders affecting the hematopoietic system.

Date of Application:  May 14, 2012

Date of Receipt:  May 18, 2012

Action Due Date:  March 18, 2013

US License Number and Manufacturing Site(s):  1647

Please note that you are also responsible for complying with the applicable provisions of sections 402(i) and (j) of the Public Health Service Act (PHS Act) (42 U.S.C. §§ 282(i) and (j), which was recently amended by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law No. 110-85, 121 Stat.904).

FDAAA amended the PHS Act by adding new section 402(j) (U.S.C. 282 (j)) which expanded the current database known as Clinical Trials.gov to include mandatory registration and reporting of results for applicable clinical trials of human drugs (including biological products) and devices.  FDAAA requires that, at the time of submission of an application under sections 505, 515 or 520(m) of the FD&C Act (21 U.S.C. 355, 360e or 360j(m)), or under section 351 of the PHS Act (21 U.S.C. 262), or submission of a report under section 510(k) or the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements or 42 U.S.C. 282(j) have been met.  Where available, such certification must include the appropriate National Clinical Trial (NCT) control numbers (42 U.S.C. 282(j)(5)(B)).  You did not submit such certification when you submitted the BLA referenced in this letter.  You may use Form FDA 3674, “Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank” to comply with the certification requirement.

In completing Form FDA 3674, you should review 42 U.S.C. 282(j) to determine whether the requirements of FDAAA apply to any clinical trials referenced in this application.  Additional information on registering your clinical trials is available at the Protocol Registration System (PRS) Information Site http://prsinfo.clinicaltrials.gov/.

We request that you submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number.  Send all correspondence to the following address:

Director, Celia Witten, Ph.D., M.D.
Center for Biologics Evaluation and Research
Attn:  Office of Cellular, Tissue and Gene Therapies
Document Control Center, HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD  20852-1448

Applicants who sent applications via the Food and Drug Administration Electronic Submissions Gateway (ESG) should continue to use those procedures.  The ESG is an Agency-wide solution for accepting electronic regulatory submissions that enables the secure submission of regulatory information for review.  Instructions for setting up an ESG account can be found at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm

We will notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review.

If you have any questions, please contact the Regulatory Project Manager, Candace Jarvis, at (301) 827-6536.

Sincerely yours,

 

Raj K. Puri, Ph.D., M.D.
Director
Division of Cellular and Gene Therapies
Center for Biologics Evaluation and Research