Collaboration in Regulatory Science and Capacity To Advance Global Access to Safe Vaccines and Biologicals, 32364-32366 [2011-13885]
Download as PDF
32364
Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
retail pharmacy, a statement identifying
each prior sale, purchase, or trade of the
drug.
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
21 CFR section
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Total hours
203.11 ..................................................................................
203.30(a)(1) and (b) .............................................................
203.30(a)(3), (a)(4), and (c) .................................................
203.31(a)(1) and (b) .............................................................
203.31(a)(3), (a)(4), and (c) .................................................
203.37(a) ..............................................................................
203.37(b) ..............................................................................
203.37(c) ..............................................................................
203.37(d) ..............................................................................
203.39(g) ..............................................................................
1
61,961
61,961
232,355
232,355
50
50
1
50
1
1
12
12
135
135
4
40
1
1
1
1
743,532
743,532
31,367,925
31,367,925
200
2,000
1
50
1
30/60
4/60
4/60
2/60
2/60
15/60
15/60
1
5/60
1
.50
44,612
44,612
1,254,717
941,038
50
500
1
4
1
Total ..............................................................................
........................
........................
........................
........................
2,285,535.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours) 2
Total hours
203.23(a) and (b) .................................................................
203.23(c) ..............................................................................
203.30(a)(2) and 203.31(a)(2) .............................................
203.31(d)(1) and (d)(2) ........................................................
203.31(d)(4) .........................................................................
203.31(e) ..............................................................................
203.34 ..................................................................................
203.37(a) ..............................................................................
203.37(b) ..............................................................................
203.39(d) ..............................................................................
203.39(e) ..............................................................................
203.39(f) ...............................................................................
203.39(g) ..............................................................................
203.50(a) ..............................................................................
203.50(b) ..............................................................................
203.50(d) ..............................................................................
31,676
31,676
2,208
2,208
442
2,208
90
50
50
65
3,221
3,221
3,221
125
125
691
5
5
100
1
1
1
1
4
40
1
1
1
1
100
100
1
158,380
158,380
220,800
2,208
442
2,208
90
200
2,000
65
3,221
3,221
3,221
12,500
12,500
691
15/60
5/60
30/60
40
24
1
40
6
6
1
30/60
8
8
10/60
30/60
2
39,595
12,670
110,400
88,320
10,608
2,208
3,600
1,200
1,200
65
1,610
25,768
25,768
2,125
6,250
1,382
Total ..............................................................................
........................
........................
........................
........................
332,769
1 There
are capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
Dated: May 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13442 Filed 6–3–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0375]
BILLING CODE 4160–01–P
jlentini on DSK4TPTVN1PROD with NOTICES
Collaboration in Regulatory Science
and Capacity To Advance Global
Access to Safe Vaccines and
Biologicals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces its
intention to accept and consider a single
SUMMARY:
VerDate Mar<15>2010
16:06 Jun 03, 2011
Jkt 223001
PO 00000
Frm 00010
Fmt 4703
Sfmt 4703
source application for award of a
cooperative agreement to the World
Health Organization (WHO) in support
of collaboration in regulatory science
and capacity of National Regulatory
Authorities (NRAs) to advance global
access to safe and effective vaccines and
other biologicals that meet international
standards. The goal of FDA’s Center for
Biologics Evaluation and Research
(FDA/CBER) is to enhance technical
collaboration and cooperation between
FDA, WHO, and its Member States.
DATES: Important dates are as follows:
1. The application due date is July 8,
2011.
2. The anticipated start date is August
15, 2011.
E:\FR\FM\06JNN1.SGM
06JNN1
Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
3. The expiration date is July 9, 2011.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
Gopa Raychaudhuri, Center for
Biologics and Evaluation and
Research, Liaison to the World Health
Organization, Food and Drug
Administration, 1401 Rockville Pike
(HFM–30), suite 200N, Rockville, MD
20852, 301–827–6352,
gopa.raychaudhuri@fda.hhs.gov;
Leslie Haynes, Foreign Regulatory
Capacity Building Coordinator,
International Affairs, Food and Drug
Administration, 1401 Rockville Pike
(HFM–30), suite 200N, Rockville, MD
20852, 301–827–3114,
leslie.haynes@fda.hhs.gov; or
Vieda Hubbard, Grants Management
Specialist, Office of Acquisitions and
Grants Services, Food and Drug
Administration, 5630 Fishers Lane
(HFA 500), rm. 2141, Rockville, MD
20857, 301–827–7177,
vieda.hubbard@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.grants.gov and/or https://
www.fda.gov/BiologicsBloodVaccines/
ScienceResearch/ucm251665.htm.
SUPPLEMENTARY INFORMATION:
jlentini on DSK4TPTVN1PROD with NOTICES
I. Funding Opportunity Description
RFA–FD–11–011.
93.103.
A. Background
The U.S. Department of Health and
Human Services (HHS) has invested
significantly in developing sustainable
global influenza vaccines production
capacity. These financial and
intellectual investments in vaccine
development and manufacture should
not be made in a regulatory vacuum.
Adequate regulatory oversight is
essential in assuring the safety, efficacy
and quality of vaccines.
WHO is the directing and
coordinating authority for health within
the United Nations (U.N.) system. It is
responsible for providing leadership on
global health matters, shaping the health
research agenda, setting norms and
standards, articulating evidence-based
policy options, providing technical
support to countries, and monitoring
and assessing health trends. It is the
only organization with the mandate,
technical expertise, and broad reach to
meet the stated objectives.
WHO plays a key role in establishing
the WHO International Biological
Reference Preparations and in
developing WHO guidelines and
recommendations on the production
VerDate Mar<15>2010
16:06 Jun 03, 2011
Jkt 223001
and control of influenza and other
vaccines, biological products and
technologies. These norms and
standards are based on wide scientific
consultation and on international
consensus and are intended to ensure
the consistent quality and safety of
biological medicines and related in vitro
diagnostic tests worldwide.
Advancement of these efforts requires
close collaboration with the
international scientific and professional
communities, regional and national
regulatory authorities, manufacturers,
and expert laboratories worldwide.
FDA/CBER has worked with WHO in
the global community to improve
human public health worldwide for
many years. A core principle of FDA/
CBER’s international engagements to
protect global public health is the fact
that efforts to address infectious disease
threats anywhere in the world translates
to protection of the U.S. population
which benefits U.S. public health
overall. Indeed, in 2011, improving
global public health through
international collaboration, including
promoting research and information
sharing, is one of FDA/CBER’s six
primary strategic goals. FDA generally,
and more specifically FDA/CBER, has
long-standing productive collaborations
with WHO in the area of vaccines and
other biologics.
FDA/CBER is a Pan American Health
Organization (PAHO)/WHO
Collaborating Center for Biological
Standardization. In this capacity, FDA/
CBER contributes significantly through
participation as expert consultants, as
members of advisory and other expert
committees, in laboratory collaborations
for establishing physical standards, and
other activities. An important additional
area of work is FDA/CBER’s engagement
with the WHO Vaccine Prequalification
Program. The WHO provides advice to
the United Nations Children’s Fund
(UNICEF) and other United Nations
(U.N.) Agencies on the acceptability of
vaccines considered for purchase by
such Agencies for vaccination programs
which they administer globally. In 2009,
FDA/CBER was assessed by WHO and
recognized as a functional national
regulatory authority (NRA). FDA
entered into a confidentiality
arrangement with WHO/QSS to enable
FDA/CBER to serve as a reference NRA
for the Vaccine Prequalification
Program, and FDA/CBER is currently a
reference NRA for eight U.S. licensed
vaccines including five influenza
vaccines.
The establishment of strong regulatory
systems is very important for FDA’s
ability to fulfill its mission to better
monitor and ensure the safety of the
PO 00000
Frm 00011
Fmt 4703
Sfmt 4703
32365
supply chain for food, feed, medical
products, and cosmetics that enter the
United States from other parts of the
world. Strengthening regulatory
capacity in the developing world is
equally important for improving the
health and quality of life of individuals
and communities in those countries.
Strong regulatory systems reinforce and
secure public and private investments
in development and manufacture of new
drugs and vaccines, as well as
agriculture and food production—all of
which are vulnerable in the absence of
functional regulatory frameworks.
FDA, with other U.S. Government
Agencies at HHS, WHO, and other
regulatory counterparts, are working to
strategize on approaches to enhance the
regulatory capabilities of NRAs in
developing countries so that they can
meet the needs for providing oversight
of vaccines manufactured in their
countries, specifically influenza
vaccines. Sustainable vaccine
production capacity cannot be achieved
in the absence of robust and functional
national regulatory systems. Thus,
investments for improving
manufacturing facilities must be
accompanied in parallel with
strengthening regulatory oversight for
the manufactured products.
Additionally, NRAs are encouraged to
build relationships with the
policymakers to gain support so that
advancements in regulatory capabilities
in these countries can be sustained. The
aim is to bolster resources for regulatory
oversight, thus maximizing the returns
on total investments with the
production and availability of high
quality, effective influenza vaccines that
can be deployed worldwide quickly and
equitably in future pandemics. In doing
so, it is anticipated that strengthening
regulatory capacity will benefit the
broader arena of access to, and supply
of, vaccines globally.
B. Research Objectives
The project has the following goals:
• Contribute to the knowledge base of
the current state of regulatory oversight
of influenza and other vaccines and
biologicals by supporting analysis,
synthesis, and application of
assessments of associated regulatory
frameworks and processes in select
countries/regions. For example, this
could include but is not limited to,
analyses and synthesis of existing data
from assessments of vaccine regulatory
capabilities of different NRAs, and new
applications of assessment frameworks
to specific areas, such as
pharmacovigilance (e.g., following
vaccination with seasonal or pandemic
influenza vaccines). Expected outputs
E:\FR\FM\06JNN1.SGM
06JNN1
32366
Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
could include analyses, reports and
data-driven strategy papers, among
others.
• Enable the timely and effective
sharing of scientific findings and data,
e.g., on safety and effectiveness of
adjuvanted influenza and other vaccines
and other emerging technologies in
support of developing WHO guidance
where appropriate, the utility of new
technologies for assessment of product
safety, among other areas.
• Support the sharing and application
of knowledge, data, and information
through active participation in regional
and global networks, such as the African
Vaccine Regulatory Forum (AVAREF)
and the Developing Countries’ Vaccine
Regulators Network (DCVRN).
C. Eligibility Information
The following organizations/
institutions are eligible to apply: The
World Health Organization.
II. Award Information/Funds Available
FDA/CBER anticipates providing in
Fiscal Year (FY) 2011 up to $800,000
(total costs including indirect costs for
one award subject to availability of
funds) in support of this project. With
the possibility of four additional years
of support up to $2,000,000 of funding
contingent upon successful performance
and the availability of funding.
B. Length of Support
The support will be 1 year with the
possibility of an additional 4 years of
noncompetitive support. Continuation
beyond the first year will be based on
satisfactory performance during the
preceding year, receipt of a
noncompeting continuation application
and available Federal FY
appropriations.
jlentini on DSK4TPTVN1PROD with NOTICES
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/
BiologicsBloodVaccines/
ScienceResearch/ucm251665.htm and/
or https://www.grants.gov. (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://grants.nih.gov/grants/funding/
phs398/phs398.html. For all paper
application submissions, the following
steps are required:
16:06 Jun 03, 2011
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13885 Filed 6–3–11; 8:45 am]
A. Award Amount
VerDate Mar<15>2010
• 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: Vieda
Hubbard, Grants Management, 5630
Fishers Lane (HFA–500), rm. 1079,
Rockville, MD 20857 and Leslie Haynes,
Center for Biologics Evaluation and
Research, Office of the Director, 1401
Rockville Pike (HFM–30), suite 200N,
Rockville, Maryland 20852–1448.
Jkt 223001
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2007–P–0347 formerly
2007P–0431/CP1 and FDA–2010–P–0505]
Determination That ORLAAM
(Levomethadyl Acetate Hydrochloride)
Oral Solution, 10 Milligrams/Milliliter,
Was 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 ORLAAM (levomethadyl acetate
hydrochloride (HCl)) oral solution, 10
milligrams (mg)/milliliter (mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for levomethadyl
acetate HCl oral solution, 10 mg/mL, if
all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Sandra Park, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6221, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
SUMMARY:
PO 00000
Frm 00012
Fmt 4703
Sfmt 4703
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
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 only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
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,
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 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
ORLAAM (levomethadyl acetate HCl)
oral solution, 10 mg/mL, is the subject
of NDA 20–315, held by Roxane
Laboratories, Inc. (Roxane), and
approved on July 9, 1993. ORLAAM is
indicated for the management of opiate
dependence, reserved for use in
treatment of opiate-addicted patients
who fail to show an acceptable response
to other adequate treatments for opiate
addiction, either because of insufficient
effectiveness or the inability to achieve
effective dose due to intolerable adverse
effects from those drugs.
In a letter dated April 10, 2003,
Roxane notified FDA that ORLAAM
(levomethadyl acetate HCl) oral
solution, 10 mg/mL, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In the Federal Register of
November 7, 2007 (72 FR 62858), FDA
E:\FR\FM\06JNN1.SGM
06JNN1
Agencies
[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Pages 32364-32366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13885]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0375]
Collaboration in Regulatory Science and Capacity To Advance
Global Access to Safe Vaccines and Biologicals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces its intention
to accept and consider a single source application for award of a
cooperative agreement to the World Health Organization (WHO) in support
of collaboration in regulatory science and capacity of National
Regulatory Authorities (NRAs) to advance global access to safe and
effective vaccines and other biologicals that meet international
standards. The goal of FDA's Center for Biologics Evaluation and
Research (FDA/CBER) is to enhance technical collaboration and
cooperation between FDA, WHO, and its Member States.
DATES: Important dates are as follows:
1. The application due date is July 8, 2011.
2. The anticipated start date is August 15, 2011.
[[Page 32365]]
3. The expiration date is July 9, 2011.
FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
Gopa Raychaudhuri, Center for Biologics and Evaluation and Research,
Liaison to the World Health Organization, Food and Drug Administration,
1401 Rockville Pike (HFM-30), suite 200N, Rockville, MD 20852, 301-827-
6352, gopa.raychaudhuri@fda.hhs.gov;
Leslie Haynes, Foreign Regulatory Capacity Building Coordinator,
International Affairs, Food and Drug Administration, 1401 Rockville
Pike (HFM-30), suite 200N, Rockville, MD 20852, 301-827-3114,
leslie.haynes@fda.hhs.gov; or
Vieda Hubbard, Grants Management Specialist, Office of Acquisitions and
Grants Services, Food and Drug Administration, 5630 Fishers Lane (HFA
500), rm. 2141, Rockville, MD 20857, 301-827-7177,
vieda.hubbard@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.grants.gov and/or https://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm251665.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-11-011.
93.103.
A. Background
The U.S. Department of Health and Human Services (HHS) has invested
significantly in developing sustainable global influenza vaccines
production capacity. These financial and intellectual investments in
vaccine development and manufacture should not be made in a regulatory
vacuum. Adequate regulatory oversight is essential in assuring the
safety, efficacy and quality of vaccines.
WHO is the directing and coordinating authority for health within
the United Nations (U.N.) system. It is responsible for providing
leadership on global health matters, shaping the health research
agenda, setting norms and standards, articulating evidence-based policy
options, providing technical support to countries, and monitoring and
assessing health trends. It is the only organization with the mandate,
technical expertise, and broad reach to meet the stated objectives.
WHO plays a key role in establishing the WHO International
Biological Reference Preparations and in developing WHO guidelines and
recommendations on the production and control of influenza and other
vaccines, biological products and technologies. These norms and
standards are based on wide scientific consultation and on
international consensus and are intended to ensure the consistent
quality and safety of biological medicines and related in vitro
diagnostic tests worldwide. Advancement of these efforts requires close
collaboration with the international scientific and professional
communities, regional and national regulatory authorities,
manufacturers, and expert laboratories worldwide.
FDA/CBER has worked with WHO in the global community to improve
human public health worldwide for many years. A core principle of FDA/
CBER's international engagements to protect global public health is the
fact that efforts to address infectious disease threats anywhere in the
world translates to protection of the U.S. population which benefits
U.S. public health overall. Indeed, in 2011, improving global public
health through international collaboration, including promoting
research and information sharing, is one of FDA/CBER's six primary
strategic goals. FDA generally, and more specifically FDA/CBER, has
long-standing productive collaborations with WHO in the area of
vaccines and other biologics.
FDA/CBER is a Pan American Health Organization (PAHO)/WHO
Collaborating Center for Biological Standardization. In this capacity,
FDA/CBER contributes significantly through participation as expert
consultants, as members of advisory and other expert committees, in
laboratory collaborations for establishing physical standards, and
other activities. An important additional area of work is FDA/CBER's
engagement with the WHO Vaccine Prequalification Program. The WHO
provides advice to the United Nations Children's Fund (UNICEF) and
other United Nations (U.N.) Agencies on the acceptability of vaccines
considered for purchase by such Agencies for vaccination programs which
they administer globally. In 2009, FDA/CBER was assessed by WHO and
recognized as a functional national regulatory authority (NRA). FDA
entered into a confidentiality arrangement with WHO/QSS to enable FDA/
CBER to serve as a reference NRA for the Vaccine Prequalification
Program, and FDA/CBER is currently a reference NRA for eight U.S.
licensed vaccines including five influenza vaccines.
The establishment of strong regulatory systems is very important
for FDA's ability to fulfill its mission to better monitor and ensure
the safety of the supply chain for food, feed, medical products, and
cosmetics that enter the United States from other parts of the world.
Strengthening regulatory capacity in the developing world is equally
important for improving the health and quality of life of individuals
and communities in those countries. Strong regulatory systems reinforce
and secure public and private investments in development and
manufacture of new drugs and vaccines, as well as agriculture and food
production--all of which are vulnerable in the absence of functional
regulatory frameworks.
FDA, with other U.S. Government Agencies at HHS, WHO, and other
regulatory counterparts, are working to strategize on approaches to
enhance the regulatory capabilities of NRAs in developing countries so
that they can meet the needs for providing oversight of vaccines
manufactured in their countries, specifically influenza vaccines.
Sustainable vaccine production capacity cannot be achieved in the
absence of robust and functional national regulatory systems. Thus,
investments for improving manufacturing facilities must be accompanied
in parallel with strengthening regulatory oversight for the
manufactured products. Additionally, NRAs are encouraged to build
relationships with the policymakers to gain support so that
advancements in regulatory capabilities in these countries can be
sustained. The aim is to bolster resources for regulatory oversight,
thus maximizing the returns on total investments with the production
and availability of high quality, effective influenza vaccines that can
be deployed worldwide quickly and equitably in future pandemics. In
doing so, it is anticipated that strengthening regulatory capacity will
benefit the broader arena of access to, and supply of, vaccines
globally.
B. Research Objectives
The project has the following goals:
Contribute to the knowledge base of the current state of
regulatory oversight of influenza and other vaccines and biologicals by
supporting analysis, synthesis, and application of assessments of
associated regulatory frameworks and processes in select countries/
regions. For example, this could include but is not limited to,
analyses and synthesis of existing data from assessments of vaccine
regulatory capabilities of different NRAs, and new applications of
assessment frameworks to specific areas, such as pharmacovigilance
(e.g., following vaccination with seasonal or pandemic influenza
vaccines). Expected outputs
[[Page 32366]]
could include analyses, reports and data-driven strategy papers, among
others.
Enable the timely and effective sharing of scientific
findings and data, e.g., on safety and effectiveness of adjuvanted
influenza and other vaccines and other emerging technologies in support
of developing WHO guidance where appropriate, the utility of new
technologies for assessment of product safety, among other areas.
Support the sharing and application of knowledge, data,
and information through active participation in regional and global
networks, such as the African Vaccine Regulatory Forum (AVAREF) and the
Developing Countries' Vaccine Regulators Network (DCVRN).
C. Eligibility Information
The following organizations/institutions are eligible to apply: The
World Health Organization.
II. Award Information/Funds Available
A. Award Amount
FDA/CBER anticipates providing in Fiscal Year (FY) 2011 up to
$800,000 (total costs including indirect costs for one award subject to
availability of funds) in support of this project. With the possibility
of four additional years of support up to $2,000,000 of funding
contingent upon successful performance and the availability of funding.
B. Length of Support
The support will be 1 year with the possibility of an additional 4
years of noncompetitive support. Continuation beyond the first year
will be based on satisfactory performance during the preceding year,
receipt of a noncompeting continuation application and available
Federal FY appropriations.
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/BiologicsBloodVaccines/ScienceResearch/ucm251665.htm and/or
https://www.grants.gov. (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://grants.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: Vieda Hubbard, Grants Management, 5630
Fishers Lane (HFA-500), rm. 1079, Rockville, MD 20857 and Leslie
Haynes, Center for Biologics Evaluation and Research, Office of the
Director, 1401 Rockville Pike (HFM-30), suite 200N, Rockville, Maryland
20852-1448.
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13885 Filed 6-3-11; 8:45 am]
BILLING CODE 4160-01-P