[Federal Register: February 7, 2003 (Volume 68, Number 26)]
[Notices]
[Page 6460-6467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07fe03-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 03023]
Grants for Acute Care, Rehabilitation, and Disability Prevention
Research; Notice of Availability of Funds
A. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under section 301(a) [42 U.S.C. 241(a)]
of the Public Health Service Act, and section 391(a) [42 U.S.C.
280b(a)] of the Public Service Health Act, as amended. The catalog of
Federal Domestic Assistance number is 93.136.
B. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2003 funds for grants for Acute Care,
Rehabilitation and Disability Prevention Research. This program
addresses the ``Healthy People 2010'' focus areas of Injury and
Violence Prevention.
The purposes of the program are to:
1. Solicit research applications that address the priorities
reflected under the heading, ``Program Requirements.''
2. Build the scientific base for the prevention and control of
injuries, disabilities and deaths.
3. Encourage professionals from a wide spectrum of disciplines of
engineering, epidemiology, medicine, biostatistics, public health, law
and criminal justice, behavioral and social sciences to perform
research in order to prevent and control injuries more effectively.
4. Encourage investigators to propose research that involves
intervention development and testing as well as research on methods; to
encourage individuals, organizations, or communities to adopt and
maintain effective intervention strategies.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for Injury
Prevention and Control (NCIPC): Develop new or improved approaches for
preventing and controlling death and disability due to injuries.
C. Eligible Applicants
Applications may be submitted by public and private nonprofit and
for profit organizations and by governments and their agencies; that
is, universities, colleges, technical schools, research institutions,
hospitals, other public and private nonprofit and for profit
organizations, community-based organizations, faith-based
organizations, state and local governments or their bona fide agents,
including the District of Columbia, the Commonwealth of Puerto Rico,
the Virgin Islands, the Commonwealth of the Northern Mariana Islands,
American Samoa, Guam, the Federated States of Micronesia, the Republic
of the Marshall Islands, and the Republic of Palau, federally
recognized Indian tribal governments, Indian tribes, or Indian tribal
organizations, and small, minority, and/or women-owned businesses.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501c(4) of the Internal Revenue
Code that engages in lobbying activities is not eligible to receive
Federal funds constituting an award, grant or loan.
Applications that are incomplete or non-responsive to the below
requirements will be returned to the applicant without further
consideration.
[[Page 6461]]
The following are applicant requirements:
1. A principal investigator who has conducted research, published
the findings in peer-reviewed journals, and has specific authority and
responsibility to carry out the proposed project.
2. Demonstrated experience on the applicant's project team in
conducting, evaluating, and publishing injury control research in peer-
reviewed journals.
3. Effective and well defined working relationships within the
performing organization and with outside entities which will ensure
implementation of the proposed activities.
4. The ability to carry out injury control research projects as
defined under Attachment 2 (1.a-c). The attachment is posted with this
program announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm
.
5. The overall match between the applicant's proposed theme and
research objectives and the program priorities as described under the
heading, ``Program Requirements.''
D. Funding
Availability of Funds
Approximately $1,800,000 is available in FY 2003 to fund
approximately 6-9 awards. It is expected that the awards will begin on
or about September 1, 2003, and will be made for a 12-month budget
period within a project period of up to three years. The maximum
funding level for each project will not exceed $300,000 per year
(including both direct and indirect costs) or $900,000 for a three year
project period.
Applications that exceed the funding caps noted above will be
excluded from the competition and returned to the applicant. The
availability of Federal funding may vary and is subject to change.
Consideration will also be given to current grantees who submit a
competitive supplement requesting one year of funding to enhance or
expand existing projects, or to conduct one-year pilot studies. These
awards will not exceed $150,000, including both direct and indirect
costs. Supplemental awards will be made for the budget period to
coincide with the actual budget period of the grant and are based on
the availability of funds.
Continuation awards within the approved project period will be made
based on satisfactory progress demonstrated by investigators at work-
in-progress monitoring workshops (travel expenses for this annual one
day meeting should be included in the applicant's proposed budget), the
achievement of work plan milestones reflected in the continuation
application, and the availability of funds.
Funding Priority
The specific program priorities for these funding opportunities are
outlined with examples in this announcement under the section,
``Programmatic Requirements.''
Use of Funds
Grant funds will not be made available to support the provision of
direct care. Eligible applicants may enter into contracts, including
consortia agreements, as necessary to meet the requirements of the
program and strengthen the overall application.
Recipient Financial Participation
Matching funds are not required for this program.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for accomplishing one of the
following activities:
Research Activity 1: Develop and evaluate protocols that provide
onsite interventions in acute care settings or linkages to off-site
services for patients at risk of injury or psycho social problems
following injury.
Research Activity 2: Develop and apply methods that can be used to
calculate population-based estimates of the incidence, costs, and long-
term consequences of spinal cord injury (SCI) and non-hospitalized
traumatic brain injury (TBI).
Research Activity 3: Identify methods and strategies to ensure that
people with TBI and SCI receive needed services.
For more information on all 3 Research Activities, see Attachment 3
of this announcement as posted on the CDC Web site.
F. Content
Letter of Intent (LOI)
A LOI is optional for this program. The narrative should be no more
than two double-spaced pages, printed on one side, with one inch
margins, and unreduced 12-point font. The letter should identify the
announcement number, the name of the principal investigator, and
briefly describe the scope and intent of the proposed research work.
The letter of intent does not influence review or funding decisions,
but the number of letters received will enable CDC to plan the review
more effectively and efficiently.
Applications
The Program Announcement title and number must appear in the
application. Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan. The narrative should be no more than 25 pages, printed on one
side, with one-inch margins, and unreduced 12-point font.
Applications should follow the PHS-398 (Rev. 5/2001) application
and Errata Sheet (see Attachment 4 of this announcement as it is posted
on the CDC Web site). The narrative should include the following
information:
1. The project's focus that justifies the research needs and
describes the scientific basis for the research, the expected outcome,
and the relevance of the findings to reduce injury morbidity,
mortality, disability, and economic losses. This focus should be based
on recommendations in ``Healthy People 2010'' and the ``CDC Injury
Research Agenda,'' and should seek creative approaches that will
contribute to a national program for injury control.
2. Specific, measurable, and time-framed objectives.
3. A detailed plan describing the methods by which the objectives
will be achieved, including their sequence. A comprehensive evaluation
plan is an essential component of the application.
4. A description of the principal investigator's role and
responsibilities.
5. A description of all the project staff, regardless of their
funding source. It should include their titles, qualifications,
experience, percentage of time each will devote to the project, as well
as that portion of their salary to be paid by the grant.
6. A description of those activities related to, but not supported
by, the grant.
7. A description of the involvement of other entities that will
relate to the proposed project, if applicable. It should include
commitments of support and a clear statement of their roles.
8. A detailed first year's budget for the grant, including future
annual projections, if relevant.
9. An explanation of how the research findings will contribute to
the national effort to reduce the morbidity, mortality and disability
caused by injuries within three to five years from project start-up.
An applicant organization has the option of having specific salary
and fringe benefit amounts for individuals omitted from the copies of
the
[[Page 6462]]
application which are made available to outside reviewing groups. To
exercise this option: on the original and two copies of the
application, the applicant must use asterisks to indicate those
individuals for whom salaries and fringe benefits are not shown;
however, the subtotals must still be shown. In addition, the applicant
must submit an additional copy of page 4 of Form PHS-398, completed in
full, with the asterisks replaced by the salaries and fringe benefits.
This budget page will be reserved for internal staff use only.
F. Submission and Deadline
Letter of Intent (LOI) Submission
On or before March 7, 2003, submit the LOI to the Grants Management
Specialist identified in the ``Where to Obtain Additional Information''
section of this announcement.
Application Forms
Submit the signed original and two copies of the PHS 398 (OMB
Number 0925-0001)(adhere to the instructions on the Errata Instruction
Sheet for PHS 398). Forms are available at the following Internet
address: http://www.cdc.gov/od/pgo/forminfo.htm. If you do not have
access to the Internet, or if you have difficulty accessing the forms
on-line, you may contact the CDC Procurement and Grants Office
Technical Information Management Section (PGO-TIM) at: 770-488-2700.
Application forms can be mailed to you.
Submission Date, Time, and Address
The application must be received by 4 p.m. Eastern Time April 8,
2003. Submit the application to: Technical Information Management--
PA03023, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341-4146. Applications may not be submitted
electronically.
CDC Acknowledgment of Application Receipt
A postcard will be mailed by PGO-TIM, notifying you that CDC has
received your application.
Deadline
Letters of intent and applications shall be considered as meeting
the deadline if they are received before 4 p.m. Eastern Time on the
deadline date. Applicants sending applications by the United States
Postal Service or commercial delivery services must ensure that the
carrier will be able to guarantee delivery of the application by the
closing date and time. If an application is received after closing due
to (1) carrier error, when the carrier accepted the package with a
guarantee for delivery by the closing date and time, or (2) significant
weather delays or natural disasters, CDC will upon receipt of proper
documentation, consider the application as having been received by the
deadline.
Applications which do not meet the above criteria will not be
eligible for competition and will be discarded. Applicants will be
notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Application
Upon receipt, applications will be reviewed by CDC staff for
completeness and responsiveness as outlined under the ``Eligible
Applicants'' Section (Items 1-5). Incomplete applications and
applications that are not responsive will be returned to the applicant
without further consideration. It is especially important that the
applicant's abstract reflects the project's focus, because the abstract
will be used to help determine the responsiveness of the application.
Applications which are complete and responsive may be subjected to
a preliminary evaluation (streamline review) by a peer review
committee, the Injury Research Grant Review Committee (IRGRC), to
determine if the application is of sufficient technical and scientific
merit to warrant further review by the IRGRC. CDC will withdraw from
further consideration applications judged to be noncompetitive and
promptly notify the principal investigator/program director and the
official signing for the applicant organization. Those applications
judged to be competitive will be further evaluated by a dual review
process.
Competing supplemental grant awards may be made, when funds are
available, to support research work or activities not previously
approved by the IRGRC. Applications should be clearly labeled to denote
their status as requesting supplemental funding support. These
applications will be reviewed by the IRGRC and the secondary review
group.
All awards will be determined by the Director of the NCIPC based on
priority scores assigned to applications by the primary review
committee IRGRC, recommendations by the secondary review committee of
the Science and Program Review Subcommittee of the Advisory Committee
for Injury Prevention and Control(ACIPC), consultation with NCIPC
senior staff, and the availability of funds.
1. The primary review will be a peer review conducted by the IRGRC.
All applications will be reviewed for scientific merit using current
National Institutes of Health (NIH) criteria (a scoring system of 100-
500 points) to evaluate the methods and scientific quality of the
application. All categories are of equal importance, however, the
application does not need to be strong in all categories to be judged
likely to have a major scientific impact. Factors to be considered will
include:
a. Significance--Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge
be advanced? What will be the effect of these studies on the concepts
or methods that drive this field?
b. Approach--Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? Does the project include plans
to measure progress toward achieving the stated objectives? Is there an
appropriate work plan included?
c. Innovation--Does the project employ novel concepts, approaches
or methods? Are the aims original and innovative? Does the project
challenge or advance existing paradigms, or develop new methodologies
or technologies?
d. Investigator--Is the principal investigator appropriately
trained and well-suited to carry out this work? Is the proposed work
appropriate to the experience level of the principal investigator and
other significant investigator participants? Is there a prior history
of conducting injury-related research?
e. Environment--Does the scientific environment in which the work
will be done contribute to the probability of success? Does the
proposed research take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support? Is there an appropriate degree of
commitment and cooperation of other interested parties as evidenced by
letters detailing the nature and extent of the involvement?
f. Ethical Issues--What provisions have been made for the
protection of human subjects and the safety of the research
environments? How does the applicant plan to handle issues of
confidentiality and compliance with mandated reporting requirements,
e.g., suspected child abuse? Does the application adequately address
the requirements of 45 CFR 46 for the protection of human subjects? Not
scored; however an application can be
[[Page 6463]]
disapproved if the research risks are sufficiently serious and
protection against risks is so inadequate as to make the entire
application unacceptable. The degree to which the applicant has met the
CDC Policy requirements regarding the inclusion of women, ethnic, and
racial groups in the proposed research (See Attachment 1, AR-2, of this
announcement, as posted on the CDC Web site). This includes:
(1) The proposed plan for the inclusion of both sexes and racial
and ethnic minority populations for appropriate representation.
(2) The proposed justification when representation is limited or
absent.
(3) A statement as to whether the design of the study is adequate
to measure differences when warranted.
(4) A statement as to whether the plans for recruitment and
outreach for study participants include the process of establishing
partnerships with community(ies) and recognition of mutual benefits.
g. Study Samples--Are the samples sufficiently rigorously defined
to permit complete independent replication at another site? Have the
referral sources been described, including the definitions and
criteria? What plans have been made to include women and minorities and
their subgroups as appropriate for the scientific goals of the
research? How will the applicant deal with recruitment and retention of
subjects?
h. Dissemination--What plans have been articulated for
disseminating findings?
i. Measures of Effectiveness--The Peer Review Panel shall assure
that measures set forth in the application are in accordance with CDC's
performance plans. How adequately has the applicant addressed these
measures?
The IRGRC will also examine the appropriateness of the proposed
project budget and duration in relation to the proposed research and
the availability of data required for the project.
2. The secondary review will be conducted by the Science and
Program Review Subcommittee (SPRS) of the ACIPC. The ACIPC Federal
agency experts will be invited to attend the secondary review and will
receive modified briefing books (i.e., abstracts, strengths and
weaknesses from summary statements, and project officer's briefing
materials). ACIPC Federal agency experts will be encouraged to
participate in deliberations when applications address overlapping
areas of research interest, so that unwarranted duplication in
federally-funded research can be avoided and special subject area
expertise can be shared. The NCIPC Division Associate Directors for
Science (ADS) or their designees will attend the secondary review in a
similar capacity as the ACIPC Federal agency experts to assure that
research priorities of the announcement are understood and to provide
background regarding current research activities. Only SPRS members
will vote on funding recommendations, and their recommendations will be
carried to the entire ACIPC for voting by the ACIPC members in closed
session. If any further review is needed by the ACIPC, regarding the
recommendations of the SPRS, the factors considered will be the same as
those considered by the SPRS.
The committee's responsibility is to develop funding
recommendations for the NCIPC Director based on the results of the
primary review, the relevance and balance of proposed research relative
to the NCIPC programs and priorities, and to assure that unwarranted
duplication of federally-funded research does not occur. The secondary
review committee has the latitude to recommend to the NCIPC Director,
to reach over better ranked proposals in order to assure maximal impact
and balance of proposed research. The factors to be considered will
include:
a. The results of the primary review including the application's
priority score as the primary factor in the selection process.
b. The relevance and balance of proposed research relative to the
NCIPC programs and priorities.
c. The significance of the proposed activities in relation to the
priorities and objectives stated in ``Healthy People 2010,'' the
Institute of Medicine report, ``Reducing the Burden of Injury,'' and
the ``CDC Injury Research Agenda.'' (See Attachment 2, Resource
Materials, of this announcement, as posted on the CDC web site.)
d. Budgetary considerations.
3. Continued Funding.
Continuation awards made after FY 2003, but within the project
period, will be made on the basis of the availability of funds and the
following criteria:
a. The accomplishments reflected in the progress report of the
continuation application indicate that the applicant is meeting
previously stated objectives or milestones contained in the project's
annual work plan and satisfactory progress is being demonstrated
through presentations at work-in-progress monitoring workshops.
b. The objectives for the new budget period are realistic,
specific, and measurable.
c. The methods described will clearly lead to achievement of these
objectives.
d. The evaluation plan will allow management to monitor whether the
methods are effective.
e. The budget request is clearly explained, adequately justified,
reasonable and consistent with the intended use of grant funds.
I. Other Requirements
Technical Reporting Requirements
Provide CDC with an original plus two copies of:
1. Annual progress report. The progress report will include a data
requirement that demonstrates measures of effectiveness.
2. A financial status report, no more than 90 days after the end of
the budget period.
3. Final financial report and performance report, no more than 90
days after the end of the project period.
4. At the completion of the project, the grant recipient will
submit a brief summary 2,500 to 4,000 words written in non-scientific
[laymen's] terms. The narrative should highlight the findings and their
implications for injury prevention programs, policies, environmental
changes, etc. The grant recipient will also include a description of
the dissemination plan for research findings. This plan will include
publications in peer-reviewed journals and ways in which research
findings will be made available to stakeholders outside of academia
(e.g., state injury prevention program staff, community groups, public
health injury prevention practitioners, and others). CDC will place the
summary report and each grant recipient's final report with the
National Technical Information Service (NTIS) to further the agency's
efforts to make the information more available and accessible to the
public.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
Additional Requirements
The following additional requirements are applicable to this
program. For a complete description of each see Attachment 1 of the
program announcement, as posted on the CDC web site.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-3 Animal Subjects Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirement
[[Page 6464]]
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-13 Prohibition on Use of CDC Funds for Certain Gun Control
Activities
AR-21 Small, Minority, and Women-Owned Business
AR-22 Research Integrity
Executive Order 12372 does not apply to this program.
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC Web site, Internet address:
http://www.cdc.gov. Click on ``Funding,'' then ``Grants and Cooperative
Agreements.''
For general questions about this announcement, contact: Technical
Information Management, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
For business management and budget assistance, contact: Cheryl
Maddux, Grants Management Specialist, Procurement and Grants Office,
Centers for Disease Control and Prevention, 2920 Brandywine Road, Room
3000, Atlanta, GA 30341-4146, Telephone: 770-488-2759, E-mail address:
afx0@cdc.gov.
For program technical assistance, contact:Tom Voglesonger, Program
Manager, Office of the Director, National Center for Injury Prevention
and Control, Centers for Disease Control and Prevention (CDC), 4770
Buford Highway, NE, Mailstop K-02, Atlanta, GA 30341-3724, Telephone:
(770) 488-4823, E-mail address: TVoglesonger@cdc.gov.
Dated: February 1, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
BILLING CODE 4163-18-P
Attachment 1
Additional Requirements
AR-1
Human Subjects Requirements
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human
Services (DHHS) Regulations (Title 45 Code of Federal Regulations
Part 46) regarding the protection of human research subjects. All
awardees of CDC grants and cooperative agreements and their
performance sites engaged in human subjects research must file an
assurance of compliance with the Regulations and have continuing
reviews of the research protocol by appropriate institutional review
boards.
In order to obtain a Federal wide Assurance (FWA) of Protection
for Human Subjects, the applicant must complete an on-line
application at the Office for Human Research Protections (OHRP)
website or write to the OHRP for an application. OHRP will verify
that the Signatory Official and the Human Subjects Protections
Administrator have completed the OHRP Assurance Training/Education
Module before approving the FWA. Existing Multiple Project
Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single
Project Assurances (SPAs) remain in full effect until they expire or
until December 31, 2003, whichever comes first.
To obtain a FWA contact the OHRP at: http://ohrp.osophs.dhhs.gov/irbasur.htm
OR If your organization is not
Internet-active, please obtain an application by writing to: Office
for Human Research Protections (OHRP), Department of Health and
Human Services, 6100 Executive Boulevard, Suite 3B01, MSC 7501,
Rockville, Maryland 20892-7507.
Note: For Express or Hand Delivered Mail, Use Zip Code 20852
Note: In addition to other applicable committees, Indian Health
Service (IHS) institutional review committees must also review the
project if any component of IHS will be involved with or will
support the research. If any American Indian community is involved,
its tribal government must also approve the applicable portion of
that project.
AR-2
Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
It is the policy of the Centers for Disease Control and
Prevention (CDC) and the Agency for Toxic Substances and Disease
Registry (ATSDR) to ensure that individuals of both sexes and the
various racial and ethnic groups will be included in CDC/ATSDR-
supported research projects involving human subjects, whenever
feasible and appropriate. Racial and ethnic groups are those defined
in OMB Directive No. 15 and include American Indian or Alaska
Native, Asian, Black or African American, Hispanic or Latino, Native
Hawaiian or Other Pacific Islander. Applicants shall ensure that
women, racial and ethnic minority populations are appropriately
represented in applications for research involving human subjects.
Where clear and compelling rationale exist that inclusion is
inappropriate or not feasible, this situation must be explained as
part of the application. This policy does not apply to research
studies when the investigator cannot control the race, ethnicity,
and/or sex of subjects. Further guidance to this policy is contained
in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and
dated Friday, September 15, 1995.
AR-3
Animal Subjects Requirements
If the proposed project involves research on animal subjects,
compliance with the ``PHS Policy on Humane Care and Use of
Laboratory Animals by Awardee Institutions'' is required. An
applicant (as well as each subcontractor or cooperating institution
that has immediate responsibility for animal subjects) proposing to
use vertebrate animals in CDC-supported activities must file (or
have on file) the Animal Welfare Assurance with the Office of
Laboratory Animal Welfare (OLAW) at the National Institutes of
Health. The applicant must provide in the application the assurance
of compliance number and evidence of review and approval (including
the date of the most recent approval) by the Institutional Care and
Use Committee (IACUC). Web page: http://grants.nih.gov/grants/olaw
AR-9
Paperwork Reduction Act
Under the Paperwork Reduction Act, projects that involve the
collection of information from 10 or more individuals and funded by
a grant or a cooperative agreement will be subject to review and
approval by the Office of Management and Budget (OMB).
AR-10
Smoke-Free Workplace Requirements
CDC strongly encourages all recipients to provide a smoke-free
workplace and to promote abstinence from all tobacco products.
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities that receive Federal funds in which education,
library, day care, health care, or early childhood development
services are provided to children.
AR-11
Healthy People 2010
CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2010,'' a national
activity to reduce morbidity and mortality and improve the quality
of life. For the conference copy of ``Healthy People 2010,'' visit
the internet site: <http://www.health.gov/healthypeople.
AR-12
Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS
funds for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352, recipients (and their subtier
contractors) are prohibited from using appropriated Federal Funds
(other than profits from a Federal contract) for lobbying congress
or any Federal agency in connection with the award of a particular
contract, grant, cooperative agreement, or loan. This includes
grants/cooperative agreements that, in whole or in part, involve
conferences for which Federal funds cannot be used directly or
indirectly to encourage participants to lobby or to instruct
participants on how to lobby.
In addition no part of CDC appropriated funds shall be used,
other than for normal and recognized executive-legislative
relationships, for publicity or propaganda purposes, for the
preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to
support or defeat legislation pending before the Congress or
[[Page 6465]]
any State or local legislature, except in presentation to the
Congress or any State or local legislature itself. No part of the
appropriated funds shall be used to pay the salary or expenses of
any grant or contract recipient, or agent acting for such recipient,
related to any activity designed to influence legislation or
appropriations pending before the Congress or any State or local
legislature.
Any activity designed to influence action in regard to a
particular piece of pending legislation would be considered
``lobbying.'' That is lobbying for or against pending legislation,
as well as indirect or ``grass roots'' lobbying efforts by award
recipients that are directed at inducing members of the public to
contact their elected representatives at the Federal or State levels
to urge support of, or opposition to, pending legislative proposals
is prohibited. As a matter of policy, CDC extends the prohibitions
to lobbying with respect to local legislation and local legislative
bodies.
The provisions are not intended to prohibit all interaction with
the legislative branch, or to prohibit educational efforts
pertaining to public health. Clearly there are circumstances when it
is advisable and permissible to provide information to the
legislative branch in order to foster implementation or prevention
strategies to promote public health. However, it would not be
permissible to influence, directly or indirectly, a specific piece
of pending legislation.
It remains permissible to use CDC funds to engage in activity to
enhance prevention; collect and analyze data; publish and
disseminate results of research and surveillance data; implement
prevention strategies; conduct community outreach services; provide
leadership and training, and foster safe and healthful environments.
Recipients of CDC grants and cooperative agreements need to be
careful to prevent CDC funds from being used to influence or promote
pending legislation. With respect to conferences, public events,
publications, and ``grassroots'' activities that relate to specific
legislation, recipients of CDC funds should give close attention to
isolating and separating the appropriate use of CDC funds from non-
CDC funds. CDC also cautions recipients of CDC funds to be careful
not to give the appearance that CDC funds are being used to carry
out activiites in a manner that is prohibited under Federal law.
AR-13
Prohibition on Use of CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act specifies that;
``None of the funds made available for injury prevention and control
at the Centers for Disease Control and Prevention may be used to
advocate or promote gun control.'' Anti-Lobbying Act requirements
prohibit lobbying Congress with appropriated Federal monies.
Specifically, this Act prohibits the use of Federal funds for direct
or indirect communications intended or designed to influence a
member of Congress with regard to specific Federal legislation. This
prohibition includes the funding and assistance of public grassroots
campaigns intended or designed to influence members of Congress with
regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, CDC
interprets the language in the CDC's Appropriations Act to mean that
CDC's funds may not be spent on political action or other activities
designed to affect the passage of specific Federal, State, or local
legislation intended to restrict or control the purchase or use of
firearms.
AR-21
Small, Minority, and Women-Owned Business
It is a national policy to place a fair share of purchases with
small, minority and women-owned business firms. The Department of
Health and Human Services is strongly committed to the objective of
this policy and encourages all recipients of its grants and
cooperative agreements to take affirmative steps to ensure such
fairness. In particular, recipients should:
1. Place small, minority, women-owned business firms on bidders
mailing lists.
2. Solicit these firms whenever they are potential sources of
supplies, equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs,
and set delivery schedules that will encourage participation by
these firms.
4. Use the assistance of the Minority Business Development
Agency of the Department of Commerce, the Office of Small and
Disadvantaged Business Utilization, DHHS, and similar state and
local offices.
AR-22
Research Integrity
The signature of the institution official on the face page of
the application submitted under this Program Announcement is
certifying compliance with the Department of Health and Human
Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled
``Responsibility of PHS Awardee and Applicant Institutions for
Dealing with and Reporting Possible Misconduct in science.''
The regulation places several requirements on institutions
receiving or applying for funds under the PHS Act that are monitored
by the DHHS Office of Research Integrity's (ORI) Assurance Program.
For examples: Section 50.103(a) of the regulation states: ``Each
institution that applies for or receives assistance under the Act
for any project or program which involves the conduct of biomedical
or behavioral research must have an assurance satisfactory to the
Secretary (DHHS) that the applicant: (1) Has established an
administrative process, that meets the requirements of this subpart,
for reviewing, investigating, and reporting allegations of
misconduct in science in connection with PHS-sponsored biomedical
and behavioral research conducted at the applicant institution or
sponsored by the applicant; and (2) Will comply with its own
administrative process and the requirements of this Subpart.''
Section 50.103(b) of the regulation states that: ``an applicant
or recipient institution shall make an annual submission to the
[ORI] as follows: (1) The institution's assurance shall be submitted
to the [ORI], on a form prescribed by the Secretary, * * * and
updated annually thereafter * * * (2) An institution shall submit,
along with its annual assurance, such aggregate information on
allegations, inquiries, and investigations as the Secretary may
prescribe.''
An additional policy is added in the year 2000 that ``requires
research institutions to provide training in the responsible conduct
of research to all staff engaged in research or research training
with PHS funds.
Attachment 2
Definitions
1. Individual injury research projects (R49's) are defined as
research designed to:
a. Elucidate the chain of causation--the etiology and
mechanisms--of injuries and subsequent disabilities.
b. Yield results directly applicable to identifying
interventions to prevent injury occurrence or minimize disability
c. Evaluate the effect of known interventions on injury
morbidity, mortality, disability, and costs.
2. Injury is defined as physical damage to an individual that
occurs over a short period of time as a result of acute exposure to
one of the forms of physical energy in the environment, or to
chemical agents, or the acute lack of oxygen. Excluded from this
definition of injury are cumulative trauma disorders,
musculoskeletal disorders of the back not caused by acute trauma,
and effects of repeated exposure to chemical or physical agents. The
three phases of injury control are defined as prevention, acute
care, and rehabilitation. The major categories of injury are
intentional, unintentional, and occupational. Intentional injuries
result from interpersonal or self-inflicted violence, and include
homicide, assaults, suicide and suicide attempts, child abuse and
neglect (includes child sexual abuse), intimate partner violence,
elder abuse, and sexual assault. Unintentional injuries include
those that result from motor vehicle collisions, falls, fires,
poisonings, drownings, recreational, and sports-related activities.
Occupational injuries occur at the worksite and include
unintentional trauma (for example, work-related motor-vehicle
injuries, drownings, and electrocutions), and intentional injuries
in the workplace.
Resource Materials
1. National Center for Injury prevention and Control. CDC Injury
research Agenda. Atlanta (GA): Centers for Disease Control and
Prevention; 2002. Internet Address: http://www.cdc.gov/ncipc/pub-res/research_agenda/index.htm
.
2. Reducing the Burden of Injury: Advancing Prevention and
Treatment. Institute of Medicine, National Academy Press, 1999. 2101
Constitution Avenue, NW. Washington, DC 20418. Cost: $27.96
Telephone 202-334-3313 Internet Address: http://www.nap.edu/catalog/6321.html
.
[[Page 6466]]
Attachment 3
Research Activities
1. Develop and evaluate protocols that provide onsite
interventions in acute care settings or linkages to off-site
services for patients at risk of injury or psycho social problems
following injury.
Clinical preventive services for patients treated in emergency
departments (ED), hospital trauma units, and other acute care
settings can help reduce the risk of injury and mitigate the effects
of injuries that do occur. Such services might include instruction
in the proper use of safety restraints and screening and
interventions for alcohol problems, intimate partner violence, or
child abuse. For injured patients, ED visits and inpatient hospital
admissions for trauma care may provide crucial opportunities for
early identification of and intervention for post-traumatic stress
disorder and other psycho social problems that can follow or be
exacerbated by injury.
Decision makers are often reluctant to fund preventive clinical
services because they believe the investment needed to implement a
single service in one clinical setting is too high. Research should
demonstrate the effectiveness and value of such services and examine
ways to implement multiple services simultaneously to amortize
operational costs. Medical staff from the clinical setting should be
actively involved in carrying out this research.
2. Develop and apply methods that can be used to calculate
population-based estimates of the incidence, prevalence, costs, and
long-term consequences of SCI and non-hospitalized TBI.
Development and validation of methods is needed to assess and
describe both the spectrum of outcomes following ``mild'' TBI and
the magnitude of those outcomes. Such methods are lacking for some
subgroups of people with TBI, particularly those with ``mild'' TBI.
Research should focus on increasing uniformity of case
identification methods to improve the comparability of national-
level data for people with TBI. Considering available resources and
the language in the TBI Act Re-Authorization for 2000, case
identification for people with ``mild'' TBI, including those who do
not receive medical care, should receive highest priority.
The NCIPC conducts population-based surveillance to develop
nationally representative estimates of the incidence, prevalence,
nature, and causes of injuries that result in long-term disability.
This activity includes conducting population-based follow-up studies
to identify and track the long-term outcomes of disabling injuries.
Research should investigate the unique outcomes and special needs of
specific subgroups of TBI and SCI populations, such as those
violently injured. Better information about outcomes could improve
estimates of the true burden of disability for individuals with
``mild'' TBI by helping to document long-term problems resulting
from these injuries. These improved estimates should also include
screening persons for previous history of TBI, including ``mild''
TBI. Research should also identify the service needs of people with
TBI and SCI, providing useful information for injured persons,
service providers, and policy makers.
The direct medical costs and indirect costs associated with
disabling injuries are not well documented; however, this
information is important to guide decisions about resource
allocation and other policies. For TBI, the study most often cited
was published 10 years ago. Research should provide comprehensive,
up-to-date information about the direct and indirect costs of TBI
and SCI. In addition, research should estimate the costs associated
with secondary conditions, e.g., pressure sores, depression, and
alcohol abuse.
3. Identify methods and strategies to ensure that people with
TBI and SCI receive needed services.
People disabled by an injury often do not receive the help they
need. A CDC-funded follow-up study of TBI in Colorado found that one
year after injury, about one third of people with a disability said
they had not received any services since their discharge from the
hospital. According to a 1998 General Accounting Office report,
people who have cognitive or behavior problems, but not physical
problems, resulting from TBI are among those most likely to have
unmet service needs. Without treatment, people with behavior
problems are the most likely to become homeless, be committed to
mental institutions, or be sentenced to prison. A recent study
showed that people with TBI who received the services they needed
reported a better quality of life. Research should increase
understanding of the gaps between needed and available services for
people with TBI and SCI and should identify strategies to close
those gaps. Development and validation of methods are needed to
better identify persons with the mildest forms of central nervous
system injury (including ``mild'' TBI) and to explore the
possibility of using these identification methods to link these
injured persons with services.
People with ``mild'' TBI may not even be diagnosed with a TBI,
making it even more difficult for them to get assistance. Research
should explore the possibility of adapting case identification
methods to help link people with TBI and SCI to services. To that
end, the Injury Center has already funded two small, pilot projects
to investigate the feasibility of using state-based TBI surveillance
to identify people hospitalized with TBI who may need help finding
out about services. Studies should investigate specific methods for
linking people to information and services, such as evaluating the
usefulness of toll-free telephone numbers that serve as single
points of entry to the service delivery system. Studies should also
describe the spectrum of rehabilitation services and trends in
service provision, and they should evaluate access to medical,
rehabilitation, and social services to prevent disabling outcomes
and secondary conditions.
Attachment 4
Errata Sheet
Special Instructions for PHS-398, Rev. 11/2002
Announcement PA Title
Section I--Preparing Your Application
B. General Instructions (Page 3)
Use English only and avoid jargon and unusual abbreviations.
Type the application.
Format Specifications
The Content section of the Program Announcement refers to ``the
narrative.'' The narrative should consist of items listed in the
program announcement. Use only standard size fonts in black print
that can be photocopied and easily read, do not use photo reduction
or compressed print. Draw all graphs, diagrams tables, and charts in
black ink. Do not include photographs, oversized documents, or
materials that cannot be photocopied in the body of the application.
The ONLY item that should be used to keep the application
together is a rubber band. Please do not use spiral binders, 3-ring
notebooks, envelopes, binder clips, etc.
Do not submit an incomplete application. An application will be
considered incomplete and returned if it is illegible, if it fails
to follow the instructions, or if the material presented is
insufficient to permit an adequate review. Unless specifically
required by these instructions (e.g., human subjects certification,
vertebrate animals verification, changes in other support), do not
send supplementary or corrective material pertinent to the
application after the receipt date without its being specifically
solicited or agreed to by prior discussion with the Grants
Management Specialist.
Page Limitations and Content Requirements (Page 4)
Disregard Page Limit under Research Plan, Sections a-d and
adhere to the prescribed guidance in the Program Announcement.
C. Specific Instructions
Budget Instructions (Page 11)
CDC does not use the modular budget format. Disregard
instructions regarding the dollar limitations. PHS 398 Form Page 4
and Form Page 5 are required to be submitted by all applicants
regardless of the dollar amount requested.
Human Subject Research (Section 8.e., Pages 18-19)
Ensure that the application addresses the issue of Women and
Minority Inclusion in Research Involving Human Subjects. The
application could be determined as non-responsive if this issue is
not covered within the research plan.
Section II--Submitting Your Application
Send the Application to the following address: Technical
Information Management-PA, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, Georgia 30341-4146. Please do
not send the application to the National Institutes of Health.
[[Page 6467]]
Disregard all instructions under Section A. INSTRUCTIONS (Page
31)
Disregard Sections B-D (Pages 34-35). Please refer to the
Program Announcement, ``Evaluation Criteria'' section, for the
applicable CDC review process.
Disregard Section M, First Paragraph (Pages 53-54); Section N
(Pages 54-55) and Section O (Pages 55-56); and all pages following
Page 56.
[FR Doc. 03-3035 Filed 2-6-03; 8:45 am]
BILLING CODE 4163-18-M