[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54343-54344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22167]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0436]
Center for Biologics Evaluation and Research eSubmitter Pilot
Evaluation Program for Blood Establishments That Collect Whole Blood
and Blood Components
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research (CBER) is announcing an invitation to
participate in a pilot evaluation program for CBER's eSubmitter Program
(eSubmitter). CBER's eSubmitter has been customized as an automated
biologics license application (BLA) and BLA supplement (BLS) submission
system for blood and blood components. Participation in the pilot
program is open to blood establishments that collect Whole Blood and
blood components. The pilot program is intended to provide industry and
CBER regulatory review staff the opportunity to evaluate the eSubmitter
system and determine if it facilitates the BLA/BLS submission process.
The purpose of this notice is to invite blood establishments that
collect Whole Blood and blood components to submit a request to CBER if
they are interested in participating in this pilot program.
DATES: Submit a written or electronic request for participation in this
program by October 7, 2010.
ADDRESSES: If you are interested in participating in this program, you
should submit a request to participate in the program to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic requests
to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lore Fields, Center for Biologics
Evaluation and Research (HFM-375), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6143,
FAX: 301-827-3534, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates certain biological products, including blood and
blood products, and is committed to advancing the public health through
innovative activities that help ensure the safety, effectiveness and
timely delivery of these products to patients. Further, CBER seeks to
continuously enhance and update review efficiency and quality, and the
quality of its regulatory efforts and interactions, by providing CBER
staff and industry with improved processes. In support of this goal,
CBER has participated in the FDA development of a computer-assisted
automated BLA/BLS submission program called eSubmitter to improve the
process for providing certain regulatory submissions to FDA. eSubmitter
will include programs to submit applications for licensure, supplements
to an approved license, and amendments to pending applications or
supplements.
II. The eSubmitter Pilot Evaluation Program Expectations
The eSubmitter pilot evaluation program is expected to last
approximately 12 months. During this period of time, participants will
complete BLA/BLS regulatory submissions using the eSubmitter template
developed at CBER for use by blood establishments that collect Whole
Blood and blood components. eSubmitter was developed using the same
review criteria for applications for these products as currently used
in the BLA/BLS review process at CBER. During the BLA/BLS submission
process, the participants will enter the requested information into the
eSubmitter tool and attach requested documents as an Adobe document
(pdf format). This information will be saved onto a CD-ROM and mailed
to CBER for review. Paper copies of submissions will not be required.
CBER will review the information provided on the CD-ROM and the
attachments according to current managed review procedures.
During the BLA/BLS submission process, CBER staff will be available
to answer any questions or concerns that may arise. As each submission
is completed, the users will be asked to comment on the eSubmitter
program. These discussions will assist CBER in the final development
and release of this electronic tool for use by industry.
III. Requests for Participation
Requests to participate in the eSubmitter pilot are to be
identified with the docket number found in brackets in the heading of
this document. You should include the following information in your
request: Contact name, contact phone number, email address, name of the
establishment, address, and license number. Once requests for
participation are received, FDA will contact interested establishments
to discuss the pilot program.
[[Page 54344]]
Dated: August 31, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22167 Filed 9-3-10; 8:45 am]
BILLING CODE 4160-01-S