Regulatory Systems Strengthening, 38053-38055 [2013-15101]
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Federal Register / Vol. 78, No. 122 / Tuesday, June 25, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–P–0895]
Determination That OPANA ER
(Oxymorphone Hydrochloride) Drug
Products Covered by New Drug
Application 21–610 Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that OPANA ER (oxymorphone
hydrochloride (HCl)) Extended-Release
Tablet products approved under new
drug application (NDA) 21–610 were
not withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to these drug
products, and it will allow FDA to
continue to approve ANDAs for
oxymorphone HCl extended-release
tablets if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:28 Jun 24, 2013
Jkt 229001
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 U.S.C.
355(j)(7)(C); 21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made before
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Endo submitted a citizen petition
dated August 10, 2012 (Docket No.
FDA–2012–P–0895), under 21 CFR
10.30, requesting that the Agency: (1)
Determine that OPANA ER
(oxymorphone hydrochloride)
Extended-Release Tablets approved
under NDA 21–610 were discontinued
for reasons of safety, (2) refuse to
approve any pending ANDA for a
generic version of OPANA ER approved
under NDA 21–610, and (3) suspend
and withdraw the approval of any
ANDA referencing OPANA ER approved
under NDA 21–610 as the reference
listed drug (Petition at 1).
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that the original OPANA ER
was not withdrawn for reasons of safety
or effectiveness. We describe the basis
for this determination in our letter
response to Endo’s citizen petition
(available on https://www.regulations.gov
under Docket No. FDA–2012–P–0895).
Accordingly, the Agency will
continue to list OPANA ER
(oxymorphone HCl) Extended-Release
Tablets approved under NDA 21–610 in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
includes drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of ANDAs that refer to these
drug products. Additional ANDAs that
refer to OPANA ER (oxymorphone HCl)
Extended-Release Tablets may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
38053
Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–15099 Filed 6–24–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0010]
Regulatory Systems Strengthening
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 the Office of International
Programs. The goal of the Cooperative
Agreement is to strengthen global
regulatory capacity through activities
that may include: Development of global
norms and standards for product
regulation; generation and analysis of
evidence of regulatory systems
performance; and provision of technical
support to national regulatory systems
strengthening efforts.
DATES: Important dates are as follows:
1. The application due date is August
9, 2013.
2. The anticipated start date is
September 10, 2013.
3. The opening date is July 10, 2013.
4. The expiration date is August 10,
2013.
ADDRESSES: Submit electronic
applications to: https://www.grants.gov.
For more information, see section III of
the SUPPLEMENTARY INFORMATION section
of this notice.
FOR FURTHER INFORMATION CONTACT:
Charles Preston, Office of Science Policy
Analysis/Office of International
Programs, HFG–1, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Silver Spring, MD 20993,
301–796–0654, charles.preston@fda.
hhs.gov; or Daniel Lukash, Office of
Acquisitions and Grants Services, Food
and Drug Administration, 5630 Fishers
Lane, Rm. 2028, Rockville, MD 20857,
301–827–6771, Daniel.Lukash@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/InternationalPrograms/
CapacityBuilding/default.htm.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Funding Opportunity Description
RFA–FD–13–024
93.103
E:\FR\FM\25JNN1.SGM
25JNN1
mstockstill on DSK4VPTVN1PROD with NOTICES
38054
Federal Register / Vol. 78, No. 122 / Tuesday, June 25, 2013 / Notices
A. Background
The World Health Organization
(WHO) has responsibility for helping to
ensure access to essential medical
products of assured safety, quality, and
efficacy within its 193 Member States. It
does so in three primary areas: (1)
Setting global norms and standards; (2)
articulating evidence-based policy
options, including those relating to
regulatory systems performance; and (3)
providing technical support to national
regulatory authorities and governments.
These activities help to strengthen
national regulatory systems. In this era
of globalization, products can be
imported from anywhere in the world
within increasingly complex supply
chains. As national and global health
programs work to scale up access to
medicines and health products, strong
national regulatory systems are more
important than ever before.
What are the necessary constituents of
an effective medical products regulatory
system? This is an important question,
and one which the U.S. Institute of
Medicine recently addressed,
identifying some core elements of a
successful regulatory system. These
include sound government; good
manufacturing, clinical, and laboratory
practices; staff development and
professionalization; monitoring and
evaluation of product quality using
laboratories; inspection and surveillance
of products throughout the supply
chain; risk assessment, analysis, and
management; and emergency response.
WHO helps to strengthen medical
products regulatory systems through
activities that include disseminating
global quality norms and standards;
facilitating the exchange of regulatory
information; assessing regulatory
authorities; providing training;
distributing scientific materials and
information on aspects of regulation
from regional and global perspectives;
expanding the global monitoring and
surveillance system for falsified and
substandard products; supporting
national pharmacovigilance programs;
and building capacity as a component of
WHO’s prequalification programs.
Another important area of work on
regulatory systems strengthening is
through a new Member State
Mechanism (MSMech) on Substandard,
Spurious, Falsified, Falsely-labeled, and
Counterfeit (SSFFC) medical products,
which was established as part of a
resolution at the 65th World Health
Assembly in May 2012. The MSMech is
designed to address SSFFC issues and
advance medical product safety and
quality through the strengthening of
national regulatory capacities. The first
VerDate Mar<15>2010
17:28 Jun 24, 2013
Jkt 229001
meeting of the MSMech occurred in
Buenos Aires, Argentina, in November
2012, and the representatives agreed to
form a global steering committee with
representation from the WHO regions to
support implementation of the
workplan; the creation and management
of selected work groups to address
specific work areas; and the
development of data-driven approaches
to SSFFC issues. Participants also
stressed the need for initiatives to
educate consumers on the threats of
SSFFC, for methodologies and
instruments to obtain more accurate
information about the nature and
magnitude of the SSFFC problem, and
for guidelines on how to better respond
to the detection of SSFFC medical
products.
FDA has been actively engaged with
WHO on a number of these fronts. FDA
experts participate in WHO drug and
vaccine safety advisory committees,
which develop important international
norms and standards for the regulation
of medical products. In addition, FDA
has implemented a number of
Cooperative Agreements with WHO on
medical product safety and quality in
recent years. In 2010, the Office of
International Programs (OIP)/FDA set
up a Cooperative Agreement with WHO
to develop a global monitoring platform
for SSFFC medical products. A steering
group of experts from relevant FDA
Centers provides guidance, direction,
and advice regarding this cooperative
effort. The overarching priority is the
exchange of information about and
expertise on matters relating to SSFFC
so that data can be collected and
contribute to the formulation of policies
and programs that combat the problem.
The system allows participating
countries to report SSFFC information
using a simple, electronic rapid alert
form. Once the information has been
submitted, WHO can take the
appropriate first-response measures to
circulate such information to
governments, WHO regional offices, and
other stakeholders as necessary.
Analyses, threat assessments, thematic
reporting, and bulletins based on the
reported data may also be completed
and shared.
B. Research Objectives
The Cooperative Agreement
announced in this FOA represents the
further expansion of well-established
collaborations between WHO and OIP/
FDA in support of data-driven and
science-based public health strategies
and approaches. These collaborations
align well with FDA domestic and
global goals, as outlined in its 2011
Pathway Report to Global Product
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Safety and Quality, including
addressing medical product safety and
quality problems. Relevant strategies
include: (1) Developing global norms
and standards; (2) generating and
analyzing evidence on regulatory
systems performance; and (3) providing
technical support to national regulatory
systems strengthening efforts. This
Cooperative Agreement is expected to
support the following types of
collaboration:
• Developing global norms and
standards
• Enabling the sharing of scientific
findings and data through expert
meetings and technical
consultations;
• Assisting Member States in the
implementation and subsequent
evaluation of internationally
recognized standards and
guidelines, e.g. WHO guidelines
and standards and those emerging
from standards development venues
such as the International
Conference on Harmonisation of
Technical Requirements for
Registration of Pharmaceuticals for
Human Use (ICH);
• Utilizing WHO’s convening power
to engage with relevant
stakeholders on science-based
norms and standards;
• Generating and analyzing evidence of
regulatory systems performance
• Contributing to the knowledge base
of the current state of medical
product regulation globally,
including challenges, risks, and
emerging trends;
• Enabling and/or further
strengthening the development of
data/information systems as sources
of inputs for evidence-based
regulatory decisions and actions
and enhanced knowledge
management systems, coalitions,
and networks;
• Providing technical support to
national regulatory systems
strengthening efforts
• Enabling the strengthening of
regulatory systems at the national
and international levels in such
critical domains as good
manufacturing, clinical, and
laboratory practices; developing
curricula that supports regulatory
professionalization; monitoring and
evaluating product quality;
laboratory capacity; inspection and
surveillance of products throughout
the supply chain;
pharmacovigilance systems
building and analyses; risk
assessment, analysis, and
E:\FR\FM\25JNN1.SGM
25JNN1
Federal Register / Vol. 78, No. 122 / Tuesday, June 25, 2013 / Notices
Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
management; and making the
business case for investments in
regulatory systems.
[FR Doc. 2013–15101 Filed 6–24–13; 8:45 am]
C. Eligibility Information
BILLING CODE 4160–01–P
This is a Single Source Cooperative
Agreement.
II. Award Information/Funds Available
A. Award Amount
An award of up to $1,500,000 for this
cooperative agreement will be available
the first year (fiscal year (FY) 2013)
based on available appropriations.
Funding for subsequent years for this 5year award will be contingent on the
availability of appropriations and
successful performance in the award not
to exceed $1,500,000 per year.
mstockstill on DSK4VPTVN1PROD with NOTICES
B. Length of Support
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0012]
Building Research Capacity in Global
Tobacco Product Regulation Program
(U18)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
17:18 Jun 24, 2013
SUMMARY:
Jkt 229001
PO 00000
Frm 00050
Fmt 4703
the SUPPLEMENTARY INFORMATION section
of this notice.
FOR FURTHER INFORMATION CONTACT:
Caitlin Addorisio, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–796–0371; or
Lisa Ko, Office of Acquisition and
Grants Services, Food and Drug
Administration, 5630 Fishers Lane,
Rockville, MD 20857, 301–827–5095.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.grants.gov. Search by Funding
Opportunity Number: RFA–FD–13–032.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Notice.
The Food and Drug
The initial period of performance is 1 Administration (FDA) is announcing the
availability of grant funds for the
year. Contingent upon successful
support of the Center for Tobacco
performance, additional awards may be
Product’s (CTP’s) Building Research
available in FYs 2014, 2015, 2016, and
Capacity in Global Tobacco Product
2017.
Regulation Program. FDA intends to
III. Electronic Application,
accept and consider a single source
Registration, and Submission
application for award to the World
Health Organization (WHO) to identify,
Only electronic applications will be
support, develop, conduct, and
accepted. To submit an electronic
coordinate research efforts relating to
application in response to this FOA,
tobacco control laws and rules in
applicants should first review the full
foreign countries that will directly
announcement located at https://
inform and support FDA’s exercise of its
www.fda.gov/InternationalPrograms/
CapacityBuilding/default.htm. (FDA has authority to regulate the manufacture,
distribution, marketing, and sale of
verified the Web site addresses
tobacco products in the United States.
throughout this document, but FDA is
The Building Research Capacity in
not responsible for any subsequent
Global Tobacco Product Regulation
changes to the Web sites after this
Program seeks to advance and expand
document publishes in the Federal
research in support of tobacco product
Register.) For all electronically
regulation, in order to reduce the
submitted applications, the following
morbidity and mortality associated with
steps are required.
tobacco use both within the United
• Step 1: Obtain a Dun and Bradstreet
States and internationally. The program
(DUNS) Number
will advance FDA’s and CTP’s mission
by utilizing WHO Member States’
• Step 2: Register With System for
expertise and extensive international
Award Management (SAM)
contacts in global tobacco control, as
• Step 3: Obtain Username & Password
well as WHO’s own programmatic
• Step 4: Obtain Authorized
expertise, to inform and support
Organization Representative (AOR)
adequate manufacture, distribution, and
Authorization
market regulations of tobacco products
• Step 5: Track AOR Status
for the protection of public health in the
• Step 6: Register With Electronic
United States.
Research Administration (eRA)
DATES: Important dates are as follows:
Commons
1. The application due date is July 31,
2013.
Steps 1 through 5, in detail, can be
2. The anticipated start date is
found at https://www07.grants.gov/
applicants/organization_registration.jsp. September 2013.
3. The opening date is July 1, 2013.
Step 6, in detail, can be found at
4. The expiration date is August 1,
https://commons.era.nih.gov/commons/
2013.
registration/registrationInstructions.jsp.
After you have followed these steps,
ADDRESSES: Submit electronic
submit electronic applications to:
applications to: https://www.grants.gov.
https://www.grants.gov.
For more information, see section III of
VerDate Mar<15>2010
38055
Sfmt 4703
RFA–FD–13–032.
93.103.
A. Background
1. Authority
The Building Research Capacity in
Global Tobacco Product Regulation
Program is authorized by 42 U.S.C. 241
of the Public Health Service Act and the
Family Smoking Prevention and
Tobacco Control Act (Pub. L. 111–31).
2. Program Background
Tobacco use is the foremost
preventable cause of premature death in
America. It causes over 443,000 deaths
in the United States each year, and
another 8.6 million smokers have at
least one serious illness due to smoking.
A compelling body of evidence
illustrates that tobacco products are
inherently dangerous and cause cancer,
heart disease, and other serious adverse
health effects.
On June 22, 2009, President Obama
signed the Tobacco Control Act, giving
FDA regulatory authority to regulate the
manufacturing, labeling, sale,
distribution, advertising, and promotion
of tobacco products.
Some key FDA activities authorized
or required by the Tobacco Control Act
include:
• Mandating larger, more varied, and
more prominent warning labels on
cigarette and smokeless tobacco
products (Title II of the Tobacco Control
Act).
• Restricting tobacco product sales,
advertising, and promotion (section
906(d) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C
387f(d)); section 102 of the Tobacco
Control Act)).
• Establishing product standards to
regulate the contents, design,
components, emissions, and other
characteristics of tobacco products
E:\FR\FM\25JNN1.SGM
25JNN1
]]>Agencies
[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38053-38055]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15101]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0010]
Regulatory Systems Strengthening
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 the Office of
International Programs. The goal of the Cooperative Agreement is to
strengthen global regulatory capacity through activities that may
include: Development of global norms and standards for product
regulation; generation and analysis of evidence of regulatory systems
performance; and provision of technical support to national regulatory
systems strengthening efforts.
DATES: Important dates are as follows:
1. The application due date is August 9, 2013.
2. The anticipated start date is September 10, 2013.
3. The opening date is July 10, 2013.
4. The expiration date is August 10, 2013.
ADDRESSES: Submit electronic applications to: https://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.
FOR FURTHER INFORMATION CONTACT: Charles Preston, Office of Science
Policy Analysis/Office of International Programs, HFG-1, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Silver Spring, MD
20993, 301-796-0654, charles.preston@fda.hhs.gov; or Daniel Lukash,
Office of Acquisitions and Grants Services, Food and Drug
Administration, 5630 Fishers Lane, Rm. 2028, Rockville, MD 20857, 301-
827-6771, Daniel.Lukash@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/InternationalPrograms/CapacityBuilding/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-13-024
93.103
[[Page 38054]]
A. Background
The World Health Organization (WHO) has responsibility for helping
to ensure access to essential medical products of assured safety,
quality, and efficacy within its 193 Member States. It does so in three
primary areas: (1) Setting global norms and standards; (2) articulating
evidence-based policy options, including those relating to regulatory
systems performance; and (3) providing technical support to national
regulatory authorities and governments. These activities help to
strengthen national regulatory systems. In this era of globalization,
products can be imported from anywhere in the world within increasingly
complex supply chains. As national and global health programs work to
scale up access to medicines and health products, strong national
regulatory systems are more important than ever before.
What are the necessary constituents of an effective medical
products regulatory system? This is an important question, and one
which the U.S. Institute of Medicine recently addressed, identifying
some core elements of a successful regulatory system. These include
sound government; good manufacturing, clinical, and laboratory
practices; staff development and professionalization; monitoring and
evaluation of product quality using laboratories; inspection and
surveillance of products throughout the supply chain; risk assessment,
analysis, and management; and emergency response. WHO helps to
strengthen medical products regulatory systems through activities that
include disseminating global quality norms and standards; facilitating
the exchange of regulatory information; assessing regulatory
authorities; providing training; distributing scientific materials and
information on aspects of regulation from regional and global
perspectives; expanding the global monitoring and surveillance system
for falsified and substandard products; supporting national
pharmacovigilance programs; and building capacity as a component of
WHO's prequalification programs.
Another important area of work on regulatory systems strengthening
is through a new Member State Mechanism (MSMech) on Substandard,
Spurious, Falsified, Falsely-labeled, and Counterfeit (SSFFC) medical
products, which was established as part of a resolution at the 65th
World Health Assembly in May 2012. The MSMech is designed to address
SSFFC issues and advance medical product safety and quality through the
strengthening of national regulatory capacities. The first meeting of
the MSMech occurred in Buenos Aires, Argentina, in November 2012, and
the representatives agreed to form a global steering committee with
representation from the WHO regions to support implementation of the
workplan; the creation and management of selected work groups to
address specific work areas; and the development of data-driven
approaches to SSFFC issues. Participants also stressed the need for
initiatives to educate consumers on the threats of SSFFC, for
methodologies and instruments to obtain more accurate information about
the nature and magnitude of the SSFFC problem, and for guidelines on
how to better respond to the detection of SSFFC medical products.
FDA has been actively engaged with WHO on a number of these fronts.
FDA experts participate in WHO drug and vaccine safety advisory
committees, which develop important international norms and standards
for the regulation of medical products. In addition, FDA has
implemented a number of Cooperative Agreements with WHO on medical
product safety and quality in recent years. In 2010, the Office of
International Programs (OIP)/FDA set up a Cooperative Agreement with
WHO to develop a global monitoring platform for SSFFC medical products.
A steering group of experts from relevant FDA Centers provides
guidance, direction, and advice regarding this cooperative effort. The
overarching priority is the exchange of information about and expertise
on matters relating to SSFFC so that data can be collected and
contribute to the formulation of policies and programs that combat the
problem. The system allows participating countries to report SSFFC
information using a simple, electronic rapid alert form. Once the
information has been submitted, WHO can take the appropriate first-
response measures to circulate such information to governments, WHO
regional offices, and other stakeholders as necessary. Analyses, threat
assessments, thematic reporting, and bulletins based on the reported
data may also be completed and shared.
B. Research Objectives
The Cooperative Agreement announced in this FOA represents the
further expansion of well-established collaborations between WHO and
OIP/FDA in support of data-driven and science-based public health
strategies and approaches. These collaborations align well with FDA
domestic and global goals, as outlined in its 2011 Pathway Report to
Global Product Safety and Quality, including addressing medical product
safety and quality problems. Relevant strategies include: (1)
Developing global norms and standards; (2) generating and analyzing
evidence on regulatory systems performance; and (3) providing technical
support to national regulatory systems strengthening efforts. This
Cooperative Agreement is expected to support the following types of
collaboration:
Developing global norms and standards
Enabling the sharing of scientific findings and data
through expert meetings and technical consultations;
Assisting Member States in the implementation and
subsequent evaluation of internationally recognized standards and
guidelines, e.g. WHO guidelines and standards and those emerging from
standards development venues such as the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH);
Utilizing WHO's convening power to engage with relevant
stakeholders on science-based norms and standards;
Generating and analyzing evidence of regulatory systems
performance
Contributing to the knowledge base of the current state of
medical product regulation globally, including challenges, risks, and
emerging trends;
Enabling and/or further strengthening the development of
data/information systems as sources of inputs for evidence-based
regulatory decisions and actions and enhanced knowledge management
systems, coalitions, and networks;
Providing technical support to national regulatory systems
strengthening efforts
Enabling the strengthening of regulatory systems at the
national and international levels in such critical domains as good
manufacturing, clinical, and laboratory practices; developing curricula
that supports regulatory professionalization; monitoring and evaluating
product quality; laboratory capacity; inspection and surveillance of
products throughout the supply chain; pharmacovigilance systems
building and analyses; risk assessment, analysis, and
[[Page 38055]]
management; and making the business case for investments in regulatory
systems.
C. Eligibility Information
This is a Single Source Cooperative Agreement.
II. Award Information/Funds Available
A. Award Amount
An award of up to $1,500,000 for this cooperative agreement will be
available the first year (fiscal year (FY) 2013) based on available
appropriations. Funding for subsequent years for this 5-year award will
be contingent on the availability of appropriations and successful
performance in the award not to exceed $1,500,000 per year.
B. Length of Support
The initial period of performance is 1 year. Contingent upon
successful performance, additional awards may be available in FYs 2014,
2015, 2016, and 2017.
III. Electronic Application, Registration, and Submission
Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at https://www.fda.gov/InternationalPrograms/CapacityBuilding/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.) For all electronically
submitted applications, the following steps are required.
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management (SAM)
Step 3: Obtain Username & Password
Step 4: Obtain Authorized Organization Representative (AOR)
Authorization
Step 5: Track AOR Status
Step 6: Register With Electronic Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: https://www.grants.gov.
Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15101 Filed 6-24-13; 8:45 am]
BILLING CODE 4160-01-P
