Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24), 36277-36279 [2012-14741]
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Federal Register / Vol. 77, No. 117 / Monday, June 18, 2012 / Notices
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[FR Doc. 2012–14656 Filed 6–15–12; 8:45 am]
BILLING CODE 4184–09–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0011]
mstockstill on DSK4VPTVN1PROD with NOTICES
Academic Development of a Training
Program for Good Laboratory
Practices in High Containment
Environments (U24)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of a Funding Opportunity
SUMMARY:
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17:02 Jun 15, 2012
Jkt 226001
Number of
responses per
respondent
Average
burden hours
per response
32
2
31.2
5,125
32
1
160
Announcement (FOA) entitled
‘‘Academic Development of a Training
Program for Good Laboratory Practices
in High Containment Environments
(U24).’’ In this FOA, FDA announces its
intention to accept and consider a single
source application for an award to the
University of Texas Medical Branch
(UTMB) Galveston National Laboratory
(GNL) for the development and
implementation of a certified, academic
training course for instruction in Good
Laboratory Practices (GLP) in a
Biosafety Level (BSL) 4 High
Containment Environment. FDA seeks
to support an effort to design a robust,
collaborative, and educational program
using problem-based learning
techniques designed to bring researchers
and regulators together to educate each
other on the challenges related to these
issues and to identify solutions that are
acceptable from both scientific and
regulatory perspectives.
DATES: Important dates are as follows:
1. The application due date is July 16,
2012.
2. The anticipated start date is
September 15, 2012.
3. The opening date is June 18, 2012.
4. The expiration date is July 17,
2012.
ADDRESSES: Submit the paper
application to: Gladys Melendez Bohler,
Office of Acquisitions and Grants
Services (HFA–500), 5630 Fishers Lane,
rm. 1078, Rockville, MD 20857, 301–
827–7175, email:
gladys.bohler@fda.hhs.gov. For more
information, see section III of the
SUPPLEMENTARY INFORMATION section of
this notice.
FOR FURTHER INFORMATION CONTACT:
CAPT. Estella Jones, Office of the Chief
Scientist, Food and Drug
Administration, Bldg. 32, rm. 4130,
Silver Spring, MD 20993, 301–796–
0742, Email: estella.jones@fda.hhs.gov.;
or
Lisa Hensley, Office of Counterterrorism
and Emerging Threats, Food and Drug
Administration, Bldg. 32, rm. 4128,
Silver Spring, MD 20993, 301–796–
8518, Email:
lisa.hensley@fda.hhs.gov.; or
Gladys Melendez Bohler, Office of
Acquisitions and Grants Services
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
0.25
0.25
Total burden
hours
1,997
1,281
1,280
(HFA–500), 5630 Fishers Lane, rm.
1078, Rockville, MD 20857, 301–827–
7175, Email:
gladys.bohler@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.fda.gov/EmergencyPreparedness/
MedicalCountermeasures/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Request for Application: RFA–FD–12–
024
Catalog of Federal Domestic Assistance:
93.103
A. Background
FDA’s Office of Counterterrorism and
Emerging Threats (OCET) is a leader and
active participant in the public health
community and with the military
defense community, helping to advance
the development, evaluation, and
approval of medical countermeasures to
be used against threats involving
chemical, biological, radiological, or
nuclear (CBRN) agents. In 2010, FDA
launched its Medical Countermeasures
initiative (MCMi) in response to a report
by the Secretary of the Department of
Health and Human Services to assess
the our nation’s emergency readiness
and in answer to a charge by President
Obama to improve our nation’s capacity
to respond faster and more effectively to
CBRN and emerging infectious disease
threats—such as pandemic influenza.
OCET was tasked with leading the
implementation of the MCMi. OCET’s
activities are informed by the
knowledge that protecting the civilian
public and the warfighter against CBRN
agents is a national security priority. A
significant area of engagement for OCET
is its support of innovative science to
advance CBRN countermeasure
development with the goal of improving
access to safe and effective medical
countermeasures, should the need arise.
These efforts are central to
strengthening national preparedness
and security.
The ‘‘Animal Rule’’ (21 CFR 314.600
for drugs; 21 CFR 601.9 for biological
products) permits animal models to be
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36278
Federal Register / Vol. 77, No. 117 / Monday, June 18, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
used to test the effectiveness of a
product when testing in humans is
neither possible nor feasible. Under the
‘‘Animal Rule,’’ pivotal efficacy studies
must be conducted in accordance with
Good Laboratory Practice (GLP)
regulations (21 CFR part 58). Biological
threats, such as Ebola virus, Marburg
virus, Variola virus, or Lassa fever virus,
for which medical countermeasures are
needed, require testing in high and
maximum biosecurity level (BSL–4)
laboratories. These laboratory
environments pose daunting challenges
to a researcher’s ability to meet the
requirements of GLP regulations. There
has been tremendous progress in the
development of candidate interventions
over the last decade. However, to date
there is not a single facility that is
capable of performing pivotal studies
under GLP at BSL–4. To break the
current choke point in the development
process for interventions against agents
requiring maximum containment, it will
be critical for laboratories with BSL–4
capacity to receive the training and
develop the capability necessary to
routinely perform pivotal studies in
accordance with GLP.
OCET seeks to support an effort to
design a robust, collaborative, and
educational program using problembased learning techniques designed to
bring researchers and regulators together
to educate each other on the challenges
related to these issues and to identify
solutions that are acceptable from both
scientific and regulatory perspectives.
1. GLP Natural History Studies in BSL–
4 Laboratories
Natural history studies are performed
to establish the dose of the disease
agent, the route of exposure, and to
study the pathogenicity of the disease
agent in the animal model. Results of
these studies help determine which
animal model best describes the disease
in humans. Acceptance of results of
these studies for regulatory decisionmaking is contingent upon these studies
being conducted in accordance with
GLP. Examples of challenges in meeting
GLP requirements include appropriate
data recording, record keeping,
inspections, and equipment validation.
Training on the development of
strategies to meet GLP requirements in
high and maximum biocontainment
laboratories can be realized when
everyone has a common understanding
of the challenges and requirements. In
such a case, the scientific validity and
regulatory acceptance of a study can be
ensured early on, reducing the need for
repeat studies, thereby reducing the
numbers of animals needed to address
the scientific and regulatory objectives.
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17:02 Jun 15, 2012
Jkt 226001
Once the natural history of the disease
in the animal model has been
established, it can be used to test the
efficacy of antibiotics, vaccine, or other
therapies as described in the ‘‘Animal
Rule.’’
2. GLP Animal Efficacy Studies in BSL–
4 Laboratories
Animal efficacy studies are performed
in accordance with the ‘‘Animal Rule’’
to test the effectiveness of a medical
countermeasure against a specific threat
agent in an animal model that best
models the disease in humans. Results
from these studies also help determine
the dose of the medical countermeasure
that will be effective in humans.
Acceptance of efficacy study results for
regulatory decision-making is also
contingent upon meeting GLP
requirements. To date, three
countermeasure products have been
FDA approved using ‘‘Animal Rule’’type studies in support of efficacy.
B. Research Objectives
1. The Role of the University of Texas
Medical Branch, Galveston National
Laboratory
The University of Texas Medical
Branch, Galveston National Laboratory
(UTMB–GNL) is globally renowned for
educational excellence in the sciences,
medicine and research, as well as for its
Laboratory Biosafety Training Program
(LBTP). The LBTP courses are designed
to provide training for laboratorians
working at BSL–2 through BSL–4 levels.
UTMB’s Institutional Office of
Regulated Nonclinical Studies (ORNcS)
provides oversight for regulated studies
and regulatory operations. In addition to
the LBTP courses, the ORNcS offers an
extensive, high-quality GLP training
program to support faculty and staff at
UTMB that are conducting nonclinical
studies to support product licensure,
including nonclinical studies conducted
in BSL–3 and BSL–4 laboratories.
ORNcS and OCET concur that an
educational gap exists regarding the
performance challenges of conducting
GLP compliant studies in (A)BSL3/4
environments. Both have identified the
need for an educational opportunity
designed to better link GLP regulatory
requirements with BSL–4 laboratory
work to increase the efficiency of FDA
data review and subsequently facilitate
approval of medical countermeasures.
2. Project Description
This project represents a collaborative
effort between OCET, the UTMB–GNL,
and UTMB ORNcS to support scientific
and regulatory collaboration and
enhance regulatory science to advance
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
the development of safe and effective
antibiotics, vaccines, and other medical
countermeasures for use by civilian and
military personnel in response to CBRN
threat agents. The goal is to develop
training strategies for scientists to foster
a thorough understanding of the
challenges and establish collaborative
classroom environments to find
solutions for overcoming hurdles. A
common understanding of the
challenges and requirements can lead to
scientific validity and early regulatory
acceptance of a study, reducing the need
for repeat studies, thereby reducing the
numbers of animals needed to address
the scientific and regulatory objectives.
Empowered with knowledge of how to
successfully meet GLP requirements in
high and maximum biocontainment,
scientists working in this environment
and FDA staff who will be evaluating
applications will be better able to link
GLP regulatory requirements with
BSL–4 laboratory work, thus increasing
the quality of the data and the efficiency
of data review, subsequently facilitating
approval of medical countermeasures.
This project will also lead to improved
technical cooperation between FDA and
the regulated institutions conducting
GLP research in maximum
biocontainment. The project has the
following goals:
a. Mutual understanding. Progress in
the development of animal models for
efficacy testing of medical
countermeasures has been very slow as
developers struggle to design and
conduct studies that meet scientific
objectives and regulatory requirements
for approval. Progress is further slowed
as developers are sometimes at a loss
with regard to how to satisfy GLP
requirements when conducting studies
in maximum biocontainment
conditions. Currently, FDA’s Basic
Bioresearch Monitoring training
program used to train field inspectors
who inspect laboratories for GLP
compliance lacks specific guidance for
inspection of BSL–3 or BSL–4
laboratories that conduct GLP studies.
OCET and ORNcS believe one way to
foster progress on this issue is by
gathering researchers and regulators
together in a nonthreatening educational
environment to identify the challenges
and needs, then work together to find
solutions.
b. Develop collaborations. The
training opportunity will bring together
the community of researchers involved
in conducting research in high and
maximum biocontainment laboratories,
who are also interested in conducting
‘‘animal rule’’ studies and animal
qualification studies to support medical
countermeasure development and
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Federal Register / Vol. 77, No. 117 / Monday, June 18, 2012 / Notices
approval. In some cases, similar
research is being conducted in different
laboratories for the same medical
countermeasure need. Participants will
be encouraged to share experiences and
join in collaborations to prevent
duplication of research and avoid
repetition of failed efforts and otherwise
join in support of each other to attain
shared goals and facilitate
countermeasure development and
approval.
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3. Continuing Education—Areas of
Focus
a. GLP in high and maximum
containment.—This portion of the
training will be a joint UTMB/FDA
effort, with UTMB providing the course
foundation and FDA offering the field
inspector perspective. Lecture examples
would include a GLP Refresher, Good
Documentation practices, Internal GLP
Audits, Equipment Validation and
Calibration, and Effective SOPs.
Lectures could be followed with
practical exercises pointing out specific
challenges in meeting GLP requirements
that have been encountered in BSL–3
and BSL–4 studies conducted at UTMB.
b. The ‘‘Animal Rule.’’—FDA will
provide an overview of the regulations
for approval of new drugs and biologics
based on evidence of effectiveness from
studies in animals, including the status
of FDA’s draft document entitled,
‘‘Guidance for Industry: Animal
Models—Essential Elements to Address
Efficacy Under the Animal Rule’’ dated
January 2009 (Draft Guidance) and the
animal model qualification process.
c. Animal welfare.—This portion of
the training will review animal welfare
laws, policies guidelines and
requirements, including lectures and
discussions on the role of the
veterinarian, determination of humane
endpoints, and use of supportive care
measures in BSL–4 studies.
d. Telemetry.—Use of telemetry for
remote monitoring of routine clinical
parameters, such as body temperature,
heart rate, respiration rate, and blood
pressure is a helpful and sometimes an
essential tool for conducting studies in
BSL–4 laboratories. An entire half-day
will be devoted to teaching what is
available and how to implement
telemetry techniques into BSL–4
studies.
4. Dissemination of Successful
Enhancements to the Regulatory Science
and Regulation of Animal Rule Studies
for Medical Countermeasure
Development
UTMB and OCET will collaborate to
incorporate any new FDA guidances
and educational tools into the training
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17:02 Jun 15, 2012
Jkt 226001
program as new measures are developed
(e.g., drug development tool guidance,
updates to GLPs).
C. Eligibility Information
As work in regulatory science for
medical countermeasure development
progresses, OCET and UTMB anticipate
additional collaboration through
seminars and training programs,
particularly in the areas of GLP in
maximum and high biocontainment
laboratories, training FDA field
inspectors how to effectively conduct
GLP inspections in a high or maximum
biocontainment laboratories, and
training laboratorians and regulators in
how to work in high or maximum
biocontainment laboratories. With the
financial and scientific support from
FDA, UTMB is uniquely qualified to
undertake these activities, given its
mandate as an educational and
scientific institution, its high visibility
as a pioneer in implementing GLP in
maximum and high biocontainment
laboratories, and its access to worldwide
scientific and regulatory expertise.
UTMB has demonstrated a GLP
reporting structure and large animal in
vivo GLP BSL–4 expertise. In addition,
the FDA/UTMB training program will
be accessible to researchers at all other
university, government, and private
organizations.
36279
https://grants2.nih.gov/grants/funding/
phs398/phs398.html. For all paper
application submissions, the following
steps are required:
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number.
• Step 2: Register With Central
Contractor Registration.
• Step 3: Register With Electronic
Research Administration (eRA)
Commons.
Steps 1 and 2, in detail, can be found
at https://www07.grants.gov/applicants/
organization_registration.jsp. Step 3, in
detail, can be found at https://
commons.era.nih.gov/commons/
registration/registrationInstructions.jsp.
After you have followed these steps,
submit paper applications to: Gladys
Melendez Bohler, Office of Acquisitions
and Grants Services (HFA–500), 5630
Fishers Lane, Rm. 1078, Rockville, MD
20857.
Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14741 Filed 6–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
II. Award Information/Funds Available
[Docket No. FDA–2012–N–0194]
A. Award Amount
Only one award will be made.
OCET anticipates providing in
FY2012 up to $150,000 (total costs
include direct and indirect costs) for
one award subject to availability of
funds in support of this project. The
possibility of four additional years of
support up to $600,000 of funding is
contingent upon successful performance
and the availability of funds.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biosimilars User
Fee Cover Sheet; Form FDA 3792
B. Length of Support
The timeframe for this project is 5
years from the award date of the initial
application.
III. Paper Application, Registration,
and Submission Information
To submit a paper application in
response to this FOA, applicants should
first review the full announcement
located at (https://www.fda.gov/
EmergencyPreparedness/Medical
Countermeasures/default.htm). (FDA
has verified the Web site addresses
throughout this document, but FDA is
not responsible for any subsequent
changes to the Web sites after this
document publishes in the Federal
Register). Persons interested in applying
for a grant may obtain an application at
PO 00000
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Fmt 4703
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 18,
2012.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Biosimilars User Fee Cover Sheet;
Form FDA 3792’’. Also include the FDA
ADDRESSES:
E:\FR\FM\18JNN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Notices]
[Pages 36277-36279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0011]
Academic Development of a Training Program for Good Laboratory
Practices in High Containment Environments (U24)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of a Funding Opportunity
Announcement (FOA) entitled ``Academic Development of a Training
Program for Good Laboratory Practices in High Containment Environments
(U24).'' In this FOA, FDA announces its intention to accept and
consider a single source application for an award to the University of
Texas Medical Branch (UTMB) Galveston National Laboratory (GNL) for the
development and implementation of a certified, academic training course
for instruction in Good Laboratory Practices (GLP) in a Biosafety Level
(BSL) 4 High Containment Environment. FDA seeks to support an effort to
design a robust, collaborative, and educational program using problem-
based learning techniques designed to bring researchers and regulators
together to educate each other on the challenges related to these
issues and to identify solutions that are acceptable from both
scientific and regulatory perspectives.
DATES: Important dates are as follows:
1. The application due date is July 16, 2012.
2. The anticipated start date is September 15, 2012.
3. The opening date is June 18, 2012.
4. The expiration date is July 17, 2012.
ADDRESSES: Submit the paper application to: Gladys Melendez Bohler,
Office of Acquisitions and Grants Services (HFA-500), 5630 Fishers
Lane, rm. 1078, Rockville, MD 20857, 301-827-7175, email:
gladys.bohler@fda.hhs.gov. For more information, see section III of the
SUPPLEMENTARY INFORMATION section of this notice.
FOR FURTHER INFORMATION CONTACT: CAPT. Estella Jones, Office of the
Chief Scientist, Food and Drug Administration, Bldg. 32, rm. 4130,
Silver Spring, MD 20993, 301-796-0742, Email:
estella.jones@fda.hhs.gov.; or
Lisa Hensley, Office of Counterterrorism and Emerging Threats, Food and
Drug Administration, Bldg. 32, rm. 4128, Silver Spring, MD 20993, 301-
796-8518, Email: lisa.hensley@fda.hhs.gov.; or
Gladys Melendez Bohler, Office of Acquisitions and Grants Services
(HFA-500), 5630 Fishers Lane, rm. 1078, Rockville, MD 20857, 301-827-
7175, Email: gladys.bohler@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at https://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Request for Application: RFA-FD-12-024
Catalog of Federal Domestic Assistance: 93.103
A. Background
FDA's Office of Counterterrorism and Emerging Threats (OCET) is a
leader and active participant in the public health community and with
the military defense community, helping to advance the development,
evaluation, and approval of medical countermeasures to be used against
threats involving chemical, biological, radiological, or nuclear (CBRN)
agents. In 2010, FDA launched its Medical Countermeasures initiative
(MCMi) in response to a report by the Secretary of the Department of
Health and Human Services to assess the our nation's emergency
readiness and in answer to a charge by President Obama to improve our
nation's capacity to respond faster and more effectively to CBRN and
emerging infectious disease threats--such as pandemic influenza. OCET
was tasked with leading the implementation of the MCMi. OCET's
activities are informed by the knowledge that protecting the civilian
public and the warfighter against CBRN agents is a national security
priority. A significant area of engagement for OCET is its support of
innovative science to advance CBRN countermeasure development with the
goal of improving access to safe and effective medical countermeasures,
should the need arise. These efforts are central to strengthening
national preparedness and security.
The ``Animal Rule'' (21 CFR 314.600 for drugs; 21 CFR 601.9 for
biological products) permits animal models to be
[[Page 36278]]
used to test the effectiveness of a product when testing in humans is
neither possible nor feasible. Under the ``Animal Rule,'' pivotal
efficacy studies must be conducted in accordance with Good Laboratory
Practice (GLP) regulations (21 CFR part 58). Biological threats, such
as Ebola virus, Marburg virus, Variola virus, or Lassa fever virus, for
which medical countermeasures are needed, require testing in high and
maximum biosecurity level (BSL-4) laboratories. These laboratory
environments pose daunting challenges to a researcher's ability to meet
the requirements of GLP regulations. There has been tremendous progress
in the development of candidate interventions over the last decade.
However, to date there is not a single facility that is capable of
performing pivotal studies under GLP at BSL-4. To break the current
choke point in the development process for interventions against agents
requiring maximum containment, it will be critical for laboratories
with BSL-4 capacity to receive the training and develop the capability
necessary to routinely perform pivotal studies in accordance with GLP.
OCET seeks to support an effort to design a robust, collaborative,
and educational program using problem-based learning techniques
designed to bring researchers and regulators together to educate each
other on the challenges related to these issues and to identify
solutions that are acceptable from both scientific and regulatory
perspectives.
1. GLP Natural History Studies in BSL-4 Laboratories
Natural history studies are performed to establish the dose of the
disease agent, the route of exposure, and to study the pathogenicity of
the disease agent in the animal model. Results of these studies help
determine which animal model best describes the disease in humans.
Acceptance of results of these studies for regulatory decision-making
is contingent upon these studies being conducted in accordance with
GLP. Examples of challenges in meeting GLP requirements include
appropriate data recording, record keeping, inspections, and equipment
validation. Training on the development of strategies to meet GLP
requirements in high and maximum biocontainment laboratories can be
realized when everyone has a common understanding of the challenges and
requirements. In such a case, the scientific validity and regulatory
acceptance of a study can be ensured early on, reducing the need for
repeat studies, thereby reducing the numbers of animals needed to
address the scientific and regulatory objectives. Once the natural
history of the disease in the animal model has been established, it can
be used to test the efficacy of antibiotics, vaccine, or other
therapies as described in the ``Animal Rule.''
2. GLP Animal Efficacy Studies in BSL-4 Laboratories
Animal efficacy studies are performed in accordance with the
``Animal Rule'' to test the effectiveness of a medical countermeasure
against a specific threat agent in an animal model that best models the
disease in humans. Results from these studies also help determine the
dose of the medical countermeasure that will be effective in humans.
Acceptance of efficacy study results for regulatory decision-making is
also contingent upon meeting GLP requirements. To date, three
countermeasure products have been FDA approved using ``Animal Rule''-
type studies in support of efficacy.
B. Research Objectives
1. The Role of the University of Texas Medical Branch, Galveston
National Laboratory
The University of Texas Medical Branch, Galveston National
Laboratory (UTMB-GNL) is globally renowned for educational excellence
in the sciences, medicine and research, as well as for its Laboratory
Biosafety Training Program (LBTP). The LBTP courses are designed to
provide training for laboratorians working at BSL-2 through BSL-4
levels. UTMB's Institutional Office of Regulated Nonclinical Studies
(ORNcS) provides oversight for regulated studies and regulatory
operations. In addition to the LBTP courses, the ORNcS offers an
extensive, high-quality GLP training program to support faculty and
staff at UTMB that are conducting nonclinical studies to support
product licensure, including nonclinical studies conducted in BSL-3 and
BSL-4 laboratories. ORNcS and OCET concur that an educational gap
exists regarding the performance challenges of conducting GLP compliant
studies in (A)BSL3/4 environments. Both have identified the need for an
educational opportunity designed to better link GLP regulatory
requirements with BSL-4 laboratory work to increase the efficiency of
FDA data review and subsequently facilitate approval of medical
countermeasures.
2. Project Description
This project represents a collaborative effort between OCET, the
UTMB-GNL, and UTMB ORNcS to support scientific and regulatory
collaboration and enhance regulatory science to advance the development
of safe and effective antibiotics, vaccines, and other medical
countermeasures for use by civilian and military personnel in response
to CBRN threat agents. The goal is to develop training strategies for
scientists to foster a thorough understanding of the challenges and
establish collaborative classroom environments to find solutions for
overcoming hurdles. A common understanding of the challenges and
requirements can lead to scientific validity and early regulatory
acceptance of a study, reducing the need for repeat studies, thereby
reducing the numbers of animals needed to address the scientific and
regulatory objectives. Empowered with knowledge of how to successfully
meet GLP requirements in high and maximum biocontainment, scientists
working in this environment and FDA staff who will be evaluating
applications will be better able to link GLP regulatory requirements
with BSL-4 laboratory work, thus increasing the quality of the data and
the efficiency of data review, subsequently facilitating approval of
medical countermeasures. This project will also lead to improved
technical cooperation between FDA and the regulated institutions
conducting GLP research in maximum biocontainment. The project has the
following goals:
a. Mutual understanding. Progress in the development of animal
models for efficacy testing of medical countermeasures has been very
slow as developers struggle to design and conduct studies that meet
scientific objectives and regulatory requirements for approval.
Progress is further slowed as developers are sometimes at a loss with
regard to how to satisfy GLP requirements when conducting studies in
maximum biocontainment conditions. Currently, FDA's Basic Bioresearch
Monitoring training program used to train field inspectors who inspect
laboratories for GLP compliance lacks specific guidance for inspection
of BSL-3 or BSL-4 laboratories that conduct GLP studies. OCET and ORNcS
believe one way to foster progress on this issue is by gathering
researchers and regulators together in a nonthreatening educational
environment to identify the challenges and needs, then work together to
find solutions.
b. Develop collaborations. The training opportunity will bring
together the community of researchers involved in conducting research
in high and maximum biocontainment laboratories, who are also
interested in conducting ``animal rule'' studies and animal
qualification studies to support medical countermeasure development and
[[Page 36279]]
approval. In some cases, similar research is being conducted in
different laboratories for the same medical countermeasure need.
Participants will be encouraged to share experiences and join in
collaborations to prevent duplication of research and avoid repetition
of failed efforts and otherwise join in support of each other to attain
shared goals and facilitate countermeasure development and approval.
3. Continuing Education--Areas of Focus
a. GLP in high and maximum containment.--This portion of the
training will be a joint UTMB/FDA effort, with UTMB providing the
course foundation and FDA offering the field inspector perspective.
Lecture examples would include a GLP Refresher, Good Documentation
practices, Internal GLP Audits, Equipment Validation and Calibration,
and Effective SOPs. Lectures could be followed with practical exercises
pointing out specific challenges in meeting GLP requirements that have
been encountered in BSL-3 and BSL-4 studies conducted at UTMB.
b. The ``Animal Rule.''--FDA will provide an overview of the
regulations for approval of new drugs and biologics based on evidence
of effectiveness from studies in animals, including the status of FDA's
draft document entitled, ``Guidance for Industry: Animal Models--
Essential Elements to Address Efficacy Under the Animal Rule'' dated
January 2009 (Draft Guidance) and the animal model qualification
process.
c. Animal welfare.--This portion of the training will review animal
welfare laws, policies guidelines and requirements, including lectures
and discussions on the role of the veterinarian, determination of
humane endpoints, and use of supportive care measures in BSL-4 studies.
d. Telemetry.--Use of telemetry for remote monitoring of routine
clinical parameters, such as body temperature, heart rate, respiration
rate, and blood pressure is a helpful and sometimes an essential tool
for conducting studies in BSL-4 laboratories. An entire half-day will
be devoted to teaching what is available and how to implement telemetry
techniques into BSL-4 studies.
4. Dissemination of Successful Enhancements to the Regulatory Science
and Regulation of Animal Rule Studies for Medical Countermeasure
Development
UTMB and OCET will collaborate to incorporate any new FDA guidances
and educational tools into the training program as new measures are
developed (e.g., drug development tool guidance, updates to GLPs).
C. Eligibility Information
As work in regulatory science for medical countermeasure
development progresses, OCET and UTMB anticipate additional
collaboration through seminars and training programs, particularly in
the areas of GLP in maximum and high biocontainment laboratories,
training FDA field inspectors how to effectively conduct GLP
inspections in a high or maximum biocontainment laboratories, and
training laboratorians and regulators in how to work in high or maximum
biocontainment laboratories. With the financial and scientific support
from FDA, UTMB is uniquely qualified to undertake these activities,
given its mandate as an educational and scientific institution, its
high visibility as a pioneer in implementing GLP in maximum and high
biocontainment laboratories, and its access to worldwide scientific and
regulatory expertise. UTMB has demonstrated a GLP reporting structure
and large animal in vivo GLP BSL-4 expertise. In addition, the FDA/UTMB
training program will be accessible to researchers at all other
university, government, and private organizations.
II. Award Information/Funds Available
A. Award Amount
Only one award will be made.
OCET anticipates providing in FY2012 up to $150,000 (total costs
include direct and indirect costs) for one award subject to
availability of funds in support of this project. The possibility of
four additional years of support up to $600,000 of funding is
contingent upon successful performance and the availability of funds.
B. Length of Support
The timeframe for this project is 5 years from the award date of
the initial application.
III. Paper Application, Registration, and Submission Information
To submit a paper application in response to this FOA, applicants
should first review the full announcement located at (https://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm).
(FDA has verified the Web site addresses throughout this document, but
FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register). Persons
interested in applying for a grant may obtain an application at https://grants2.nih.gov/grants/funding/phs398/phs398.html. For all paper
application submissions, the following steps are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
Step 2: Register With Central Contractor Registration.
Step 3: Register With Electronic Research Administration
(eRA) Commons.
Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to: Gladys Melendez Bohler, Office of
Acquisitions and Grants Services (HFA-500), 5630 Fishers Lane, Rm.
1078, Rockville, MD 20857.
Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14741 Filed 6-15-12; 8:45 am]
BILLING CODE 4160-01-P
