Statistical Process Controls for Blood Establishments; Public Workshop, 46096-46097 [2012-18854]
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46096
Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices
Kimberly S. Lane,
Deputy Director, Office of Science Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012–18851 Filed 8–1–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors, Office
of Public Health Preparedness and
Response (BSC, OPHPR)
mstockstill on DSK4VPTVN1PROD with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates:
9:30 a.m.–3 p.m., August 21, 2012; 9:30
a.m.–3 p.m., August 22, 2012.
Place: CDC, 1600 Clifton Road NE., Roybal
Campus, Building 19, Auditorium B2,
Atlanta, Georgia 30329.
Status: Open to the public limited only by
the space available. The meeting room will
accommodate up to 30 people. Public
participants should pre-register for the
meeting as described in Additional
Information for Public Participants.
Purpose: This Board is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services (HHS), the Assistant Secretary for
Health (ASH), the Director, Centers for
Disease Control and Prevention (CDC), and
the Director, Office of Public Health
Preparedness and Response (OPHPR),
concerning strategies and goals for the
programs and research within OPHPR,
monitoring the overall strategic direction and
focus of the OPHPR Divisions and Offices,
and administration and oversight of peer
review of OPHPR scientific programs. For
additional information about the Board,
please visit: https://www.cdc.gov/phpr/
science/counselors.htm.
Matters to be Discussed: Agenda items for
this meeting include: (1) Briefings and BSC
deliberation on the following topics: OPHPR
International Activities; National Health
Security Preparedness Index Update; update
on the activities of the joint BSC-National
Biodefense Science Board Strategic National
Stockpile ad hoc working group; CDC’s
response to laboratory biosafety issues;
Public Health Emergency Medical
Countermeasure Enterprise (PHEMCE) and
CDC’s smallpox vaccine program; OPHPR’s
national policy initiatives; history and
overview of the Preparedness and Emergency
Response Learning Centers; update on CDC’s
biosurveillance and situational awareness
activities; (2) BSC liaison representative
updates to the Board highlighting
organizational activities relevant to the
OPHPR mission.
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Agenda items are subject to change as
priorities dictate.
Additional Information for Public
Participants: Members of the public that wish
to attend this meeting should pre-register by
submitting the following information by
email, facsimile, or phone (see Contact
Person for More Information) no later than 12
noon (EDT) on Monday, August 13, 2012:
• Full Name,
• Organizational Affiliation,
• Complete Mailing Address,
• Citizenship, and
• Phone Number or Email Address.
Contact Person for More Information:
Marquita Black, Office of Science and Public
Health Practice Executive Assistant, Centers
for Disease Control and Prevention, 1600
Clifton Road NE., Mailstop D–44, Atlanta,
Georgia 30333, telephone (404) 639–7325;
facsimile (404) 639–7977; email:
OPHPR.BSC.Questions@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: July 27, 2012.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2012–18852 Filed 8–1–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2012–N–0001]
Statistical Process Controls for Blood
Establishments; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Statistical Process Controls for
Blood Establishments.’’ The purpose of
this public workshop is to discuss the
implementation of statistical process
controls to validate and monitor
manufacturing processes in blood
establishments. The public workshop
has been planned in partnership with
the AABB, America’s Blood Centers,
and the Department of Health and
Human Services (HHS) Office of the
Assistant Secretary for Health. The
public workshop will include
presentations and discussions led by
experts from government and industry.
Dates and Times: The public
workshop will be held on October 19,
2012, from 8:30 a.m. to 5 p.m.
PO 00000
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Location: The public workshop will
be held at the FDA White Oak Campus,
The Great Room, Bldg. 31, 10903 New
Hampshire Ave. Silver Spring, MD,
20993. Please visit the following Web
site for location, parking, security, and
travel information: https://www.fda.gov/
AboutFDA/WorkingatFDA/
BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. The public workshop
will also be available to be viewed
online via webcast.
Streaming Webcast of the Public
Workshop: For those unable to attend in
person, FDA will webcast the public
workshop. To join the web-cast of the
public workshop, please go to: https://
collaboration.fda.gov/stat101912/.
If you have never attended a Connect
Pro meeting before: Test your
connection: https://collaboration.fda.
gov/common/help/en/support/meeting_
test.htm. Get a quick overview: https://
www.adobe.com/go/connectpro_
overview.
Contact Person: Jennifer Scharpf,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6128, FAX: 301–827–2843,
email:
CBEROBRRWorkshops@fda.hhs.gov.
Registration: Mail, fax, or email your
registration information (including
name, title, firm name, address,
telephone and fax numbers, and email
address) to Jennifer Scharpf (see Contact
Person) by September 27, 2012. Please
indicate if you will attend the workshop
in person or if you will participate in
the webcast. There is no registration fee
for the public workshop. Early
registration is recommended because
seating is limited. Those who wish to
present at the workshop must attend in
person. Registration on the day of the
public workshop will be provided on a
space-available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
Jennifer Scharpf (see Contact Person) at
least 7 days in advance.
Requests for Oral Presentations:
Interested persons are invited to make
presentations relevant to the public
workshop topic. Attendees who wish to
make presentations at the public
workshop should notify the Contact
Person and submit a brief statement of
the general nature of the presentation
before September 27, 2012.
Presentations will be scheduled on the
afternoon of October 19, 2012. Time
allotted for each presentation may be
limited depending on the number of
individuals requesting to speak.
E:\FR\FM\02AUN1.SGM
02AUN1
46097
Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices
Statistical
process control is the application of
statistical methods to the monitoring, or
quality control, of a manufacturing
process. The implementation of
acceptable statistical process controls
ensures that a process performs
predictably to manufacture a product
that meets specific standards. FDA
monitors manufacturing procedures,
validation summaries, and quality
control data prior to licensure and
during periodic inspection of facilities.
Millions of units of Whole Blood and
blood components, including those
collected by apheresis, are
manufactured in the United States
annually. Blood establishments
manufacture these products in
accordance with specific standards
established by FDA regulations and
guidance, as well as in accordance with
specifications established by device
manufacturers and industry standards.
To ensure that product standards are
met, blood establishments validate
manufacturing processes at
implementation and then monitor these
processes on a regular basis, using
quality control methods.
Manufacturing biologic products,
including Whole Blood and blood
components, comes with specific
challenges due to biologic variability
and the potential risk to recipients if
products are not manufactured
appropriately. Recognizing these issues,
FDA has developed statistical plans that
are capable of identifying when the
manufacturing process varies or has a
high frequency of nonconformance.
The goal of the workshop is to
educate participants on statistical
process control theory and options for
the implementation of scientifically
sound sampling plans in blood
establishments. The public workshop
will include presentations and
discussions on the following topics:
(1) The evolution of statistical process
control for Whole Blood and blood
components; (2) statistical methods
used for biologic product quality
control; (3) FDA considerations for
SUPPLEMENTARY INFORMATION:
sampling plans for blood
establishments; and (4) industry
perspectives and case studies on
implementing statistical process
controls.
Transcripts: Please be advised that a
transcript of the public workshop will
be posted as soon as possible on the
Internet at: https://www.fda.gov/Biologics
BloodVaccines/NewsEvents/Workshops
MeetingsConferences/Transcripts
Minutes/default.htm. Transcripts of the
public workshop may also be requested
in writing from the Division of Freedom
of Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Rockville, MD 20857.
Dated: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18854 Filed 8–1–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(Section 3506(c)(2)(A) of Title 44,
United States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Number of
respondents
Instrument
Responses
per
respondent
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Telehealth Resource Center
Performance Measurement Tool (OMB
No. 0915–xxxx)–[New]
To ensure the best use of public funds
and to meet the Government
Performance Review Act (GPRA)
requirements, HRSA’s Office for the
Advancement of Telehealth (OAT), in
collaboration with the Telehealth
Resource Centers (TRCs), created a set of
performance measures that grantees can
use to evaluate the technical assistance
services provided by the TRCs. Grantee
goals are to customize the provision of
telehealth technical assistance across
the country. The TRCs provide technical
assistance to health care organizations,
health care networks and health care
providers in the implementation of costeffective telehealth programs to serve
rural and medically underserved areas
and populations. The TRC Performance
Indicator Data Collection Tool contains
the data elements that would need to be
collected by the TRCs in order to report
on the performance metrics. This tool
can be easily translated into the webbased data collection system,
Performance Improvement and
Measurement System (PIMS). Reporting
via PIMS allows the TRCs and OAT to
track project performance. The tool
assists in the production of annual
reports, available to Congress, that
demonstrate the value added from the
TRC Grant Program.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
mstockstill on DSK4VPTVN1PROD with NOTICES
Telehealth Resource Center Performance Data Collection
Tool ...................................................................................
14
72
1,008
0.07
70.56
Total ..............................................................................
14
........................
1,008
........................
70.56
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18:15 Aug 01, 2012
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]]>Agencies
[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Notices]
[Pages 46096-46097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18854]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2012-N-0001]
Statistical Process Controls for Blood Establishments; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Statistical Process Controls for Blood
Establishments.'' The purpose of this public workshop is to discuss the
implementation of statistical process controls to validate and monitor
manufacturing processes in blood establishments. The public workshop
has been planned in partnership with the AABB, America's Blood Centers,
and the Department of Health and Human Services (HHS) Office of the
Assistant Secretary for Health. The public workshop will include
presentations and discussions led by experts from government and
industry.
Dates and Times: The public workshop will be held on October 19,
2012, from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at the FDA White Oak
Campus, The Great Room, Bldg. 31, 10903 New Hampshire Ave. Silver
Spring, MD, 20993. Please visit the following Web site for location,
parking, security, and travel information: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The public workshop will also be available to be viewed
online via webcast.
Streaming Webcast of the Public Workshop: For those unable to
attend in person, FDA will webcast the public workshop. To join the
web-cast of the public workshop, please go to: https://collaboration.fda.gov/stat101912/.
If you have never attended a Connect Pro meeting before: Test your
connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a quick overview: https://www.adobe.com/go/connectpro_overview.
Contact Person: Jennifer Scharpf, Center for Biologics Evaluation
and Research (HFM-302), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6128, FAX: 301-827-
2843, email: CBEROBRRWorkshops@fda.hhs.gov.
Registration: Mail, fax, or email your registration information
(including name, title, firm name, address, telephone and fax numbers,
and email address) to Jennifer Scharpf (see Contact Person) by
September 27, 2012. Please indicate if you will attend the workshop in
person or if you will participate in the webcast. There is no
registration fee for the public workshop. Early registration is
recommended because seating is limited. Those who wish to present at
the workshop must attend in person. Registration on the day of the
public workshop will be provided on a space-available basis beginning
at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Jennifer Scharpf (see Contact Person) at least 7 days in
advance.
Requests for Oral Presentations: Interested persons are invited to
make presentations relevant to the public workshop topic. Attendees who
wish to make presentations at the public workshop should notify the
Contact Person and submit a brief statement of the general nature of
the presentation before September 27, 2012. Presentations will be
scheduled on the afternoon of October 19, 2012. Time allotted for each
presentation may be limited depending on the number of individuals
requesting to speak.
[[Page 46097]]
SUPPLEMENTARY INFORMATION: Statistical process control is the
application of statistical methods to the monitoring, or quality
control, of a manufacturing process. The implementation of acceptable
statistical process controls ensures that a process performs
predictably to manufacture a product that meets specific standards. FDA
monitors manufacturing procedures, validation summaries, and quality
control data prior to licensure and during periodic inspection of
facilities.
Millions of units of Whole Blood and blood components, including
those collected by apheresis, are manufactured in the United States
annually. Blood establishments manufacture these products in accordance
with specific standards established by FDA regulations and guidance, as
well as in accordance with specifications established by device
manufacturers and industry standards. To ensure that product standards
are met, blood establishments validate manufacturing processes at
implementation and then monitor these processes on a regular basis,
using quality control methods.
Manufacturing biologic products, including Whole Blood and blood
components, comes with specific challenges due to biologic variability
and the potential risk to recipients if products are not manufactured
appropriately. Recognizing these issues, FDA has developed statistical
plans that are capable of identifying when the manufacturing process
varies or has a high frequency of nonconformance.
The goal of the workshop is to educate participants on statistical
process control theory and options for the implementation of
scientifically sound sampling plans in blood establishments. The public
workshop will include presentations and discussions on the following
topics: (1) The evolution of statistical process control for Whole
Blood and blood components; (2) statistical methods used for biologic
product quality control; (3) FDA considerations for sampling plans for
blood establishments; and (4) industry perspectives and case studies on
implementing statistical process controls.
Transcripts: Please be advised that a transcript of the public
workshop will be posted as soon as possible on the Internet at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Dated: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18854 Filed 8-1-12; 8:45 am]
BILLING CODE 4160-01-P
