Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Source Plasma Establishments, 13210-13211 [E9-6687]
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Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices
Officer) P.O. Box 442, St. Louis,
Missouri 63166–2034:
1. Jerry W. Fuller, individually and
acting in concert with Terry R. Fuller
and Mary S. Fuller, all as co–executors
of the estate of Ray C. Fuller; all of
Poplar Grove, Arkansas, to acquire
control of Helena Bancshares, Inc., and
thereby indirectly acquire control of
Helena National Bank, both of Helena,
Arkansas.
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Board of Governors of the Federal Reserve
System, March 23, 2009.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E9–6765 Filed 3–25–09; 8:45 am]
Sexually Transmitted Disease (STD)
Morbidity Surveillance—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
BILLING CODE 6210–01–S
Background and Brief Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day-09–08AX]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
The CDC is responsible for the
reporting and dissemination of
nationally notifiable STD morbidity
information for prevention and control
purposes in collaboration with state and
local health departments. Recent
changes in sexually transmitted disease
(STD) epidemiology in the United States
indicate that the existing passive
surveillance for STD does not include
all the elements needed in order to
control and prevent STDs in the U.S.
Towards that end, CDC is proposing a
new electronic information collection
called STD Morbidity Surveillance that
will include information on laboratory
confirmation of syphilis infection and
risk behaviors of persons infected with
syphilis and other STDs. Physicians and
other providers collect demographic,
risk, and clinical (including laboratory)
information from persons diagnosed
with notifiable STDs during a clinical
encounter or counseling session. The
respondents will submit the information
electronically, to the state and local
public health departments. Clinical
specimens obtained from case-patients
are submitted to private or public
diagnostic laboratories with laboratory
requisition forms which includes
information on the provider and casepatient. A subset of the information
reported to state health departments
from health care providers or
laboratories is reported electronically as
a case report e-record to CDC’s
Nationally Notifiable Disease
Surveillance System on a weekly basis.
CDC estimates that 57 respondents
spend 20 minutes each week extracting
notifiable STD surveillance information
from their electronic information
system. CDC staff review STD morbidity
data at varying frequencies to identify
population subgroups at increased risk
for STDs. The target evidence-based
intervention strategies, evaluate the
impact of ongoing control efforts, thus
enhancing our understanding of STD
transmission. There is no cost to
respondents other than their time. The
total estimated annual burden hours are
989.
ESTIMATED ANNUALIZED BURDEN HOURS
Types of
respondent
Form
name
State Health Departments ..............................
Territorial Health Agencies .............................
City and county health departments ...............
Electronic STD Case report ...........................
Electronic STD Case report ...........................
Electronic STD Case report ...........................
Dated: March 19, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–6631 Filed 3–25–09; 8:45 am]
No. of
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0134]
BILLING CODE 4163–18–P
Center for Biologics Evaluation and
Research eSubmitter Pilot Evaluation
Program for Source Plasma
Establishments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Biologics Evaluation and Research
(CBER) is announcing an invitation to
participate in a pilot evaluation program
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20:28 Mar 25, 2009
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No. of
responses per
respondent
50
5
2
52
2
52
Average
burden per
response
(in hours)
20/60
20/60
20/60
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 Source Plasma. 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 Source
Plasma to submit a request to CBER if
they are interested in participating in
this pilot program.
E:\FR\FM\26MRN1.SGM
26MRN1
Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices
DATES: Submit a written or electronic
request for participation in this program
by April 27, 2009. You should include
the following information in your
request: contact name, contact phone
number, e-mail address, name of the
establishment, address, and license
number (if applicable).
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, or e-mail: 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. The
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 6 months. During this
period of time, participants will
complete BLA/BLS regulatory
submissions using the eSubmitter
template developed at CBER for use by
Source Plasma establishments. The
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
VerDate Nov<24>2008
20:28 Mar 25, 2009
Jkt 217001
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. Once requests for
participation are received, FDA will
contact interested establishments to
discuss the pilot program.
Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–6687 Filed 3–25–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0137]
Draft Guidance for Industry: Use of
Serological Tests to Reduce the Risk
of Transmission of Trypanosoma cruzi
Infection in Whole Blood and Blood
Components for Transfusion and
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Use of
Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi
Infection in Whole Blood and Blood
Components for Transfusion and
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)’’ dated
March 2009. The draft guidance
document notifies establishments that
manufacture Whole Blood and blood
components intended for use in
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13211
transfusion, and establishments that
make eligibility determinations for
donors of HCT/Ps about FDA approval
of a biologics license application for an
enzyme-linked immunosorbent assay
(ELISA) test system for the detection of
antibodies to Trypanosoma cruzi (T.
cruzi). The draft guidance also notifies
establishments that make donor
eligibility determinations for HCT/P
donors that FDA has determined T.
cruzi to be a relevant communicable
disease under current regulations. In
addition, the guidance provides
recommendations for using a licensed
test for antibodies to T. cruzi to test
individual human donors, including
donors of Whole Blood and blood
components for transfusion and HCT/P
donors (living and cadaveric (non-heart
beating)), for antibodies to T. cruzi in
plasma and serum samples. The
guidance document does not apply to
Source Plasma.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by June 24, 2009. Submit
written comments on the information
collection burden by May 26, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
E:\FR\FM\26MRN1.SGM
26MRN1
]]>Agencies
[Federal Register Volume 74, Number 57 (Thursday, March 26, 2009)]
[Notices]
[Pages 13210-13211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6687]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0134]
Center for Biologics Evaluation and Research eSubmitter Pilot
Evaluation Program for Source Plasma Establishments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) 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 Source Plasma. 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 Source
Plasma to submit a request to CBER if they are interested in
participating in this pilot program.
[[Page 13211]]
DATES: Submit a written or electronic request for participation in
this program by April 27, 2009. You should include the following
information in your request: contact name, contact phone number, e-mail
address, name of the establishment, address, and license number (if
applicable).
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, or e-mail: 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. The
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 6 months. During this period of time, participants will
complete BLA/BLS regulatory submissions using the eSubmitter template
developed at CBER for use by Source Plasma establishments. The
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. Once requests for participation are received, FDA will
contact interested establishments to discuss the pilot program.
Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6687 Filed 3-25-09; 8:45 am]
BILLING CODE 4160-01-S
