[Federal Register Volume 68, Number 26 (Friday, February 7, 2003)]
[Notices]
[Pages 6460-6467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3035]


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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: 
[email protected].
    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: [email protected].

    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