Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Blood Establishments That Collect Whole Blood and Blood Components, 54343-54344 [2010-22167]
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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
Nonprofit Capacity Building Program Performance Progress Report (PPR) ....................................................................................
Government Capacity Building Program PPR .................................
Estimated Total Annual Burden
Hours: 336.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
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comments and recommendations for the
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E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: August 31, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–22132 Filed 9–3–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[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.
The Food and Drug
Administration (FDA), Center for
Biologics Evaluation and Research
(CBER) is announcing an invitation to
participate in a pilot evaluation program
SUMMARY:
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Number of
responses per
respondent
Number of
respondents
Instrument
35
49
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 https://
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: lore.fields@fda.hhs.gov.
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
PO 00000
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Average burden
hours per
response
4
4
Total burden
hours
1
1
140
196
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.
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54344
Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0048]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EFFIENT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
EFFIENT and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
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SUMMARY:
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the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product EFFIENT
(Prasugrel Hydrochloride). EFFIENT is a
platelet inhibitor indicated for the
reduction of thrombotic cardiovascular
events (including stent thrombosis) in
patients with acute coronary syndrome
who are to be managed with
percutaneous coronary intervention.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
EFFIENT (U.S. Patent No. 5,288,726)
from Daiichi Sankyo Co. Ltd., and UBE
Industries, Ltd., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated March 24, 2010, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of EFFIENT
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
EFFIENT is 2,795 days. Of this time,
2,232 days occurred during the testing
phase of the regulatory review period,
while 563 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: November 16,
2001. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on November 16, 2001.
2. The date the application was
initially submitted with respect to the
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human drug product under section
505(b) of the act: December 26, 2007.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
EFFIENT (NDA 22–307) was submitted
on December 26, 2007.
3. The date the application was
approved: July 10, 2009. FDA has
verified the applicant’s claim that NDA
22–307 was approved on July 10, 2009.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,679 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by November 8,
2010. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by March 7, 2011. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–22234 Filed 9–3–10; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54343-54344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22167]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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: lore.fields@fda.hhs.gov.
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
