[Federal Register: May 27, 2008 (Volume 73, Number 102)]
[Notices]
[Page 30401-30405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my08-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Department of Health and Human Services Implementation of New
Authorities for the Public Health Emergency Preparedness Cooperative
Agreement
AGENCY: Department of Health and Human Services, Centers for Disease
Control and Prevention, Coordinating Office for Terrorism Preparedness
and Emergency Response, Division of State and Local Readiness.
ACTION: Notification of intent to implement: (1) Maintenance of funding
(MOF); (2) nonfederal matching requirements; (3) evidence-based
benchmarks and objective standards; (4) maximum amount of carryover;
(5) pandemic influenza operations plans criteria; (6) audit
requirements; and (7) withholding and repayment guidelines. Links to
the Interim Progress Report (IPR) for Budget Period 9 (BP9) of the
Public Health Emergency Preparedness (PHEP) program are provided for
informational purposes only.
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SUMMARY: The Department of Health and Human Services (HHS or the
Department), Centers for Disease Control and Prevention (CDC), will
issue an Interim Progress Report (IPR) for the PHEP cooperative
agreement program in the third quarter of Fiscal Year (FY) 2008, as
authorized under section 319C-1 of the Public Health Service (PHS) Act,
as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA)
(Pub. L. 109-417) (42 U.S.C. 247d-3a). The Consolidated Appropriations
Act, 2008, (H.R. 2764) provided funding for these awards. This notice
provides information to facilitate the critical aspects of the program,
including:
Background of the program;
Current requirements for awardees:
[cir] MOF;
Future requirements of awardees:
[cir] Nonfederal matching requirements--reduced or no award
provided;
[cir] Evidence-based benchmarks and objective standards--
substantial failure results in withholding of funds;
[[Page 30402]]
[cir] Maximum amount of carryover--exceeding the limit results in
repayment of funds;
[cir] Pandemic influenza planning documents--failure to submit a
sufficient operations plan results in withholding of funds;
[cir] Audit requirements--failure results in repayment of funds;
Electronic submission;
Important dates;
Reporting;
PHEP IPR for BP9 (http://www.emergency.cdc.gov/);
Withholding and Repayment Guidance (Attachment).
FOR FURTHER INFORMATION CONTACT: Donna Knutson at (404) 639-7530, or e-
mail at [dbk2@cdc.gov].
SUPPLEMENTARY INFORMATION:
Background of the Program
Building on the lessons learned from the attacks of September 11,
2001, and Hurricanes Katrina and Rita in 2005, the PAHPA was enacted in
December 2006 to improve the Nation's public health and medical
preparedness and response capabilities for emergencies, whether
deliberate, accidental, or natural. The PAHPA amended and added new
sections to the PHS Act. Examples of these changes include identifying
the Secretary of Health and Human Services as the lead official for all
Federal public health and medical responses to public health
emergencies and other incidents covered by the National Response
Framework; establishing the position of the Assistant Secretary for
Preparedness and Response (ASPR), who will lead and coordinate HHS
preparedness and response activities, advise the Secretary of Health
and Human Services during an emergency, and lead the coordination of
emergency preparedness and response efforts between HHS and other
Federal agencies; consolidating Federal public health and medical
response programs under the renamed ASPR; requiring the development and
implementation of the National Health Security Strategy; and
reauthorizing the PHEP cooperative agreements administered by CDC and
the Hospital Preparedness Program (HPP) cooperative agreements
administered by ASPR. In addition to reauthorizing these two
cooperative agreement programs, the PAHPA added new requirements that
awardees must meet. The purpose of this notice is to notify PHEP
awardees about critical aspects and requirements of the PHEP
cooperative agreements, as amended by PAHPA. The Secretary of Health
and Human Services is required under section 319C-1(g) of the PHS Act
to develop and require application of measurable benchmarks and
objective standards that measure levels of preparedness with respect to
PHEP activities. The Secretary of Health and Human Services must
withhold funds beginning in FY 2009 from PHEP awardees who fail
substantially to meet the applicable benchmarks or objective standards
for the immediately preceding fiscal year and/or who fail to submit a
sufficient pandemic influenza operations plan. Thus, PHEP awardees will
have funds withheld from their FY 2009 awards (as described in the
attached withholding guidance) if, when expending their FY 2008 PHEP
awards, they fail substantially to meet the benchmarks and objective
standards described in the FY 2008 (BP9) IPR or to submit a sufficient
pandemic influenza operations plan. The Secretary of Health and Human
Services is required to develop and implement a process to notify
entities who have failed substantially to meet the evidence-based
benchmarks and objective standards or who have failed to submit a
sufficient pandemic influenza operations plan. The process must provide
awardees with the opportunity to correct their noncompliance.
Purpose: The purpose of the PHEP cooperative agreement program is
to provide funding to improve and upgrade state and local public health
jurisdictions' preparedness and response to bioterrorism, outbreaks of
infectious diseases, and other public health threats and emergencies,
utilizing the following goals:
1. Integration--integrating public health and public and private
medical capabilities with other first responder systems including
through--
i. The periodic evaluation of Federal, State, local, and tribal
preparedness and response capabilities through drills and exercises;
and
ii. The integration of public and private sector public health and
medical donations and volunteers.
2. Public health--developing and sustaining Federal, State, local,
and tribal essential public health security capabilities, including the
following--
i. Disease situational awareness domestically and abroad, including
detection, identification, and investigation.
ii. Disease containment including capabilities for isolation,
quarantine, social distancing, and decontamination.
iii. Risk communication and public preparedness.
iv. Rapid distribution and administration of medical
countermeasures.
3. Medical--increasing the preparedness, response capabilities, and
surge capacity of hospitals, other healthcare facilities (including
mental health facilities), and trauma care and emergency medical
service systems, with respect to public health emergencies, which shall
include developing plans for the following--
i. Strengthening public health emergency medical management and
treatment capabilities.
ii. Medical evacuation and fatality management.
iii. Rapid distribution and administration of medical
countermeasures.
iv. Effective utilization of any available public and private
mobile medical assets and integration of other Federal assets.
v. Protecting healthcare workers and healthcare first responders
from workplace exposures during a public health emergency.
4. At-risk individuals--
i. Taking into account the public health and medical needs of at-
risk individuals in the event of a public health emergency.
ii. For purposes of these awards, the term ``at-risk individuals''
means children, pregnant women, senior citizens, and other individuals
who have special needs in the event of a public health emergency, as
determined by the Secretary of Health and Human Services (see the IPR
for BP9 for updated definition).
5. Coordination--minimizing duplication of, and ensuring
coordination between, Federal, State, local, and tribal planning,
preparedness, and response activities (including Emergency Management
Assistance Compact). Such planning shall be consistent with the
National Response Framework, or any successor plan, and National
Incident Management Systems and the National Preparedness Goal.
6. Continuity of operations--maintaining vital public health and
medical services to allow for optimal Federal, State, local, and tribal
operations in the event of a public health emergency.
Eligibility: Since the funding opportunity represents the fourth
year of a five-year cooperative agreement, eligibility is limited to
those currently funded through PHEP Program Announcement AA154 and
authorized under 42 U.S.C. 247d-3a. Eligible applicants are the health
departments of States or their bona fide agents, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the
Commonwealth of the Northern Mariana Islands, American
[[Page 30403]]
Samoa, Guam, the Federated States of Micronesia, the Republic of the
Marshall Islands, the Republic of Palau, and the official public health
agencies of New York City, New York; Los Angeles County, California;
and Chicago, Illinois.
Current Requirements of Awardees
Maintenance of Funding (MOF)
MOF is defined as ensuring that the amount contributed by the
entity that receives the award to support public health security does
not fall below the average of the amount provided annually during the
previous two years. This definition includes:
1. Appropriations specifically designed to support public health
emergency preparedness as expended by the entity receiving the award;
and
2. Funds not specifically allocated for public health emergency
preparedness activities but which support public health emergency
preparedness activities, such as personnel assigned to public health
emergency preparedness responsibilities or supplies or equipment
purchased for public health emergency preparedness from general funds
or other lines within the operating budget of the entity receiving the
award.
The definition of expenditures does not include one-time expenses
to support public health preparedness and response, such as purchases
of antiviral drugs. Awardees will be required to document the required
MOF as part of the IPR for BP9. According to Public Law 109-417, any
funds withheld from the PHEP cooperative agreement program or the
Hospital Preparedness Program will be reallocated to the Healthcare
Facilities Partnership program in the same state.
Future Awardee Requirements
Matching Requirements
PHEP cooperative agreement funding must be matched by nonfederal
contributions beginning with the distribution of federal FY 2009 funds
(Budget Period 10). Nonfederal contributions (match) may be provided
directly or through donations from public or private entities and may
be in cash or in-kind, fairly evaluated, including plant, equipment, or
services. Amounts provided by the federal government, or services
assisted or subsidized to any significant extent by the federal
government, may not be included in determining the amount of such
nonfederal contributions. Awardees will be required to provide matching
funds as described:
i. For FY 2009, not less than 5% of such costs ($1 for each $20 of
federal funds provided in the cooperative agreement); and
ii. For any subsequent fiscal year of such cooperative agreement,
not less than 10% of such costs ($1 for each $10 of federal funds
provided in the cooperative agreement).
Please refer to 45 CFR 92.24 for match requirements, including
descriptions of acceptable match resources. Documentation of match must
follow procedures for generally accepted accounting practices and meet
audit requirements. Beginning with federal FY 2009, the Secretary of
Health and Human Services may not make an award to an entity eligible
for PHEP funds unless the eligible entity agrees to make available
nonfederal contributions as described above. CDC will require each
eligible entity to include in its FY 2008 (BP9) mid-year progress
report a plan describing the methods and sources of match that the
eligible entity agrees to pursue in FY 2009.
Evidence-Based Benchmarks and Objective Standards
In accordance with section 319C-1(g)(1), CDC has established the
following evidence-based benchmarks and objective standards.
Substantial failure to meet these benchmarks and standards will result
in withholding of funds for the FY 2009 budget year (BP10). The
following benchmarks and standards also appear in the PHEP IPR for BP9:
1. Demonstrated capability to notify primary, secondary, and
tertiary staff to cover all incident management functional roles during
a complex incident.
To provide an effective and coordinated response to a complex
incident, a public health department must maintain a current roster of
pre-identified staff available to fill core Incident Command System
(ICS) functional roles. During an incident that lasts more than 12
hours, secondary and tertiary staff may be called upon to fill ICS
roles, and thus the health department must maintain a roster of all
staff qualified for those roles. Testing the staff notification system
is critical for an efficient response, especially when the notification
is unannounced and occurs outside of regular business hours.
a. Confirm the accuracy of the primary, secondary, and tertiary
contact information for all eight ICS functional roles at least once
every six months.
b. Test the notification system twice a year, with at least one
test being unannounced and occurring outside of regular hours. The test
can be a drill or an exercise, or it may be demonstrated by a response
to a real incident.
Guidance on the numerator, denominator, and scoring methodology to
determine how results will factor in to a withholding penalty for this
measure will be available by May 15, 2008.
2. Demonstrated capability to receive, stage, store, distribute,
and dispense material during a public health emergency.
Health departments must be able to provide countermeasures to 100%
of their identified population within 48 hours after the decision to do
so. To be able to achieve this standard, health departments must
maintain the capability to plan and execute the receipt, staging,
storage, distribution, and dispensing of material during a public
health emergency.
a. Obtain a score of 69 or higher on the Division of Strategic
National Stockpile (DSNS) State Technical Assistance Review by December
31, 2008.
b. Each planning/local jurisdiction within each Cities Readiness
Initiative (CRI) metropolitan statistical area conducts a minimum of
three DSNS drills by August 10, 2009.
c. To comply with the PAHPA legislation and for purposes of guiding
funding decisions for 2009, the planning/local jurisdiction(s) that
comprises the 25% most populous within a CRI MSA conducts at least one
of the three DSNS drills prior to December 31, 2008 (with the remaining
two drills conducted by August 10, 2009).
These drills may include any three of the following: staff call
down, site activation, facility set-up, pick-list generation,
dispensing, and/or modeling of throughput. Guidance on the numerator,
denominator, and scoring methodology to determine how results will
factor in to a withholding penalty for this measure will be available
by May 15, 2008.
Maximum Amount of Carryover
CDC shall determine the maximum percentage amount of an award that
an awardee may carry over to the succeeding fiscal year. Unjustifiable
unobligated balances will be determined by using the awardee's spend
plan and financial status and progress/performance reports. (See the
Withholding and Repayment Guidance for additional information).
To provide effective program management, an awardee must be able to
develop and execute spend plans, make procurements and let contracts on
schedule, and otherwise assure the
[[Page 30404]]
infrastructure capacity to support the attainment of programmatic
objectives. One outcome of an effective management infrastructure is
the full expenditure of funds awarded in the budget period.
CDC recognizes that there may be justifiable causes (e.g., state
hiring freezes, inefficiencies on the part of the awarding agency) or
unjustifiable causes (e.g., ineffective management infrastructure at
the state level, irregularities in contracting or payment of debt) for
dollars to remain unobligated at the end of the budget period even
after a robust execution of plans. Therefore, the awardee must
immediately communicate with CDC any events occurring between the
scheduled spend plan and progress/performance report date which have
significant impact upon the cooperative agreement.
CDC will make available by May 15, 2008, additional guidance
regarding spend plan and progress/performance reports to determine how
results will factor into a repayment penalty for this measure.
Pandemic Influenza Plans
State pandemic influenza operations plans must meet national
standards. On June 16, 2008, awardees will submit a second version of
their pandemic influenza operations plans based on guidance provided by
HHS on March 13, 2008. Two scores (Comprehensiveness and Operational
Readiness) for each of the seven elements in the ``Health and Medical''
category will be used by CDC to determine the extent to which criteria
have been met, as follows:
Comprehensiveness Score:
No Major Gaps
A Few Major Gaps
Many Major Gaps
Inadequate Preparedness
Operational Readiness Score:
Substantial Evidence of Operational Readiness
Significant Evidence of Operational Readiness
Little Evidence of Operational Readiness
Failure to meet accepted criteria for pandemic influenza operations
planning will result in the withholding of funds for the FY 2009 budget
period. Guidance on the numerator, denominator, and scoring methodology
for this measure will be available by May 15, 2008.
Audit Requirements
Each entity receiving funds shall, not less than once every two
years, audit its expenditures from amounts received from the PHEP
cooperative agreement. Such audits shall be conducted by an entity
independent of the agency administering the PHEP cooperative agreement
in accordance with Office of Management and Budget (OMB) Circular A-
133, Audits of States, Local Governments, and Non-Profit Organizations.
Audit reports must be submitted to CDC. Failure to conduct an audit
or expenditures made not in accordance with PHEP cooperative agreement
guidance and grants management policy may result in a requirement to
repay funds to the Federal treasury or the withholding of future funds.
Electronic Submission
Given the technical capabilities necessary to carry out and
document the activities required under this program, HHS is announcing
the funding opportunity on the grants.gov Web site at http://
www.grants.gov. Detailed instructions for submitting the combined IPR
and application for funding will be available through a download in the
Preparedness Emergency Response System for Oversight, Reporting, and
Management Services (PERFORMS) at https://sdn/cdc/gov.
Important PHEP Dates
Anticipated application due date: June 27, 2008.
Anticipated award date: August 11, 2008.
Reporting
Please refer to the PHEP IPR for actual reporting dates and
requirements.
Withholding and Repayment Guidance
The Withholding and Repayment Guidance is provided in its entirety
for review as an attachment. (See attachment below.)
Dated: May 20, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention,
Department of Health and Human Services.
Attachment
CDC Public Health Emergency Preparedness Cooperative Agreement
Withholding and Repayment Guidance
Procedural Consideration
This standard operating procedure (SOP) describes procedures CDC
will use to implement withholding or repayment actions in connection
with the Public Health Emergency Preparedness (PHEP) cooperative
agreement program.
A. Pandemic and All-Hazards Preparedness Act (PAHPA) requirements
for the PHEP Cooperative Agreement. The PAHPA requires the withholding
of amounts from entities that fail to achieve benchmarks and objective
standards or to submit an acceptable pandemic influenza operations
plan, beginning with Fiscal Year 2009 and in each succeeding fiscal
year:
Benchmarks and Statewide Pandemic Influenza Operations Plan
(1) Enforcement Condition: Awardees substantially fail to meet
evidence-based benchmarks and objective standards and/or fail to
prepare and submit an acceptable pandemic influenza operations plan.
Please note 319C-1(g)(6)(B) Separate Accounting: Each failure
described under A(1) shall be treated as a separate failure for
purposes of calculating amounts withheld under A(2). For example, a
failure to achieve applicable benchmarks as a whole will count as one
failure and a failure to submit a pandemic influenza operations plan
will count as a second failure.
(2) Enforcement Action:
Withhold funds--Fiscal Year 2008 is for the purpose of
evaluation to determine the amount to be withheld from the year
immediately following year of failure. Additionally, each failure is to
be treated as a separate failure for the purposes of the penalties
described below:
Initial failure--withholding in an amount equal to 10% of
funding per failure.
Two consecutive years of failure--withholding in an amount
equal to 15% of funding per failure.
Three consecutive years of failure--withholding in an
amount equal to 20% of funding per failure.
Four consecutive years of failure--withholding in an
amount equal to 25% of funding per failure.
Reallocation of amount withheld--According to Pub. L. 109-
417, any funds withheld from the PHEP or the Hospital Preparedness
Program will be reallocated to the Healthcare Facilities Partnership
program in the same state.
Preference in reallocation--According to Pub. L. 109-417,
any funds withheld from the PHEP or the Hospital Preparedness Program
will be reallocated to the Healthcare Facilities Partnership program in
the same state.
Waive or Reduce: The Secretary of Health and Human Services may
waive or reduce the withholding as described above for a single entity
or for all entities in a fiscal year, if the Secretary determines that
mitigating conditions
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exist that justify the waiver or reduction.
Audit Implementation
(1) Enforcement Condition: Awardees who fail to submit the required
audit or spend amounts in noncompliance.
(2) Enforcement Action: Grants Management Officer disallows costs
and requests payment via standard audit disallowance process or
temporarily withholds funds pending corrective action.
Adjudication: Enforcement will be in accordance with 45 Code of
Federal Regulation (CFR), part 16.
Carryover
(1) Enforcement Condition: For each fiscal year, the percentage
amount of an award unexpended by an awardee exceeds the maximum
percentage permitted by the Secretary.
(2) Enforcement Action: Awardees shall return to the Secretary the
portion of the unexpended amount that exceeds the maximum permitted to
be carried over. According to Public Law 109-417, any funds withheld
from the PHEP or the Hospital Preparedness Program will be reallocated
to the Healthcare Facilities Partnership program in the same state.
Waive or Reduce: The awardee may request a waiver of the maximum
percentage amount or the Secretary may waive or reduce the withholding
as described above for a single entity or for all entities in a fiscal
year, if the Secretary determines that mitigating conditions exist that
justify the waiver or reduction. The Secretary will make a decision
after reviewing the awardee's request for waiver.
The Department of Health and Human Services (HHS) permits grantees
to appeal to the Departmental Appeal Board (DAB) certain post-award
adverse administrative decisions made by HHS officials (see 45 CFR part
16). CDC has established a first-level grant appeal procedure that must
be exhausted before an appeal may be filed with the DAB (see 42 CFR
part 50.404). CDC will assume jurisdiction for any of the above adverse
determinations.
[FR Doc. E8-11718 Filed 5-23-08; 8:45 am]
BILLING CODE 4163-18-P