QUALITY OF LIFE FOR INDIVIDUALS AT THE END-OF-LIFE

Release Date:  August 2, 2000

PA NUMBER:  PA-00-127

National Institute of Nursing Research
National Cancer Institute
National Center for Complementary and Alternative Medicine
National Institute of Allergy and Infectious Diseases
National Institute of Dental and Craniofacial Research
National Institute of Mental Health
National Institute on Aging

This program announcement replaces PA-98-019, which was published in the NIH
Guide, Vol. 26, No. 40, December 19, 1997.

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

The National Institute of Nursing Research (NINR) and 6 other ICs seek 
research grant applications that will generate scientific knowledge  to 
improve the quality of life for individuals who are facing end-of-life issues 
and for their families.  Research applications may include basic, clinical or 
care delivery studies focused on management of physical and psychological 
symptoms, patient-provider and patient-family communication, ethics and 
clinical decision-making, caregiver support, or the context of care delivery 
for those facing life-limiting illnesses. In a broad sense the purpose of this 
program announcement is to enhance the quality of life remaining for 
individuals who are nearing the end of their lives.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS led national 
activity for setting priority areas.  This Program Announcement (PA), Quality 
of Life for Individuals at the End-of-Life, is related to one or more of the 
priority areas.   Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) Research Project 
Grant (R01) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this PA may 
not exceed 5 years.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Background

The life expectancy of the American people has reached an all time high, but 
along with the increased life expectancy is an increase in the number of 
people living with, and dying from, chronic debilitating diseases such as 
heart disease, cancer, stroke and chronic obstructive pulmonary disease 
(National Center for Health Statistics, 1999).  While the elderly with chronic 
illnesses comprise a group one might associate with end-of-life issues, there 
are other groups for whom these concerns are important.  Examples extend 
across the life span including neonates in intensive care units, children with 
AIDS, teens with cancer, and young adults with degenerative diseases.  Coupled 
with this spectrum of individuals is the increased availability of 
technologies and treatments that can be used to prolong life and, in some 
cases, death.  Defining when these technologies and treatments shift from life 
saving interventions to burdensome and futile procedures that negatively 
impact quality of life has proved elusive.  When these technologies and 
treatments become futile, the individuals’ families and significant others may 
be involved in a difficult period of decision-making about how much aggressive 
treatment to try and when to stop.  Conversely there is widespread fear that 
the only alternative to aggressive treatment is abandonment and suffering.

For many Americans, end-of-life care is fragmented, painful, and emotionally 
distressing, with unnecessary transitions between health care institutions, 
community-based organizations and home care settings.  There are opportunities 
for health care providers to learn more about how to deliver optimal end-of-
life care.  Results of two separate surveys found on average only 2% of the 
content of nursing (Oncology Nursing Forum, 1999) and medical (JAMA, 2000) 
text books was relevant to end-of-life care.  

There are many national initiatives underway to improve care of the dying.  
Significant efforts are being made to better train health professionals and to 
encourage public awareness of the issues. Yet important gaps in knowledge 
limit our ability to help individuals who are dying achieve the highest 
possible quality of life.  “From the cellular to the social level, much 
remains to be learned about how people die and how reliably excellent and 
compassionate care can be achieved” (IOM, 1997).  Research is needed to better 
define what is meant by end-of-life, to identify aspects of an optimal death 
experience within the cultural and ethnic context of the individual so better 
palliative care can be provided, to facilitate communication and ethical 
decision-making among those involved in end-of-life decisions, and to support 
the development of a well integrated health care system that includes the 
family and the multidisciplinary team.

A research workshop convened by the National Institutes of Health in 
September, 1997, focused on “Symptoms in Terminal Illness”.  The report from 
that workshop is available at http://www.ninr.nih.gov/end-of-life.htm.  
Subsequently, a Program Announcement “Management of Symptoms at the End-of-
Life” and a Request For Applications “Research on the Care at End-of-Life” 
were published.  This program announcement builds on those two initiatives.

More needs to be understood about the physical, emotional, social, cultural 
and spiritual experiences of people who are dying and about the environmental 
context which influences the quality of the life remaining.  Issues related to 
research methods are important to consider with inquiry into dying. There are 
pressing needs to better define key concepts, identify and test appropriate 
measures, develop strategies to minimize subject burden, and devise methods 
for complex data analysis.  Advances in understanding how to help individuals 
who are dying to attain the highest quality of life possible can be advanced 
with innovative, science-based research.

Objectives:

Topics of interest include, but are not limited to:

Clinical management to promote the quality of life of individuals across the 
life span who are at the end-of-life
o  pathogenesis of symptoms that result from common end-of-life conditions 
such as AIDS, emphysema, heart disease, stroke and cancer
o  more effective techniques to prevent and manage symptoms including better 
targeted drugs and delivery techniques and alternative and complementary 
approaches
o  prevention and reduction of secondary side effects of medications used to 
treat common end-of-life conditions such as antiretrovirals, steroids, and 
chemotherapy
o  better understanding of the cultural and ethnic context surrounding the 
death event to enhance clinical management and sensitivity to patient and 
family choices
o  multidisciplinary interventions to enhance the psychological, social or 
spiritual well-being of persons facing life-limiting illness such as children 
with AIDS or cancer
o  the explicit role that mental disorders, symptoms, and related disabilities 
play in the quality of life at the end-of-life, specifically, studies on 
modifiable risk and protective processes including developing and testing new 
interventions

Communication
o  interventions relating to patterns and processes of communication between 
patients and caregivers which facilitate open discussion, discernment of 
patient and family wishes and concerns, and respect for cultural and ethnic 
diversity
o  strategies to foster high quality care at the end-of-life

Ethics and clinical decision making
o  processes that assist providers, patients and families to assess the 
situation-specific value of healthcare interventions so they can make informed 
decisions about treatments that affect quality of life
o  ethical issues for dying persons who are vulnerable such as children and 
people who are cognitively impaired
o  strategies to better incorporate patients’ culture, values and preferences 
into decisions such as advance care planning

Caregiver support
o  strategies used by clinicians to maintain the integrity of the family 
through the dying process
o  interventions which provide social support for those caring for dying 
persons
o  efficacy of interventions to support grieving survivors

Care delivery
o  identification of the clinical contextual factors that foster an optimal 
death experience in persons across the life span
o  international studies of the approaches to using life-sustaining devices 
such as ventilators and the impact of such devices on quality of life 
remaining
o  investigations that include evaluation of the economic aspects of providing 
culturally-sensitive care at the end-of-life
o  organizational and economic determinants of hospice use, including 
transitions from acute and nursing home settings and length of stay in 
hospices

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, 
No. 11, March 18, 1994 and is available on the web at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not94-100.html
 
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

NOTE FOR APPLICATIONS FOCUSED ON AGING RESEARCH

Applications received in response to this program announcement are expected to 
focus on scientific issues related to aging and to aging-related aspects of 
disease.  In describing the plan to recruit human subjects, investigators may 
cite a focus on aging or on aging-related aspects of disease as the 
justification for why children will be excluded.  In this regard, applicants 
may use Justification 1, the research topic to be studied is irrelevant to 
children, from the policy announcement.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations. Unless otherwise specified in an NIH solicitation, 
internet addresses (URLs) should not be used to provide information necessary 
to the review because reviewers are under no obligation to view the Internet 
sites. Reviewers are cautioned that their anonymity may be compromised when 
they directly access an Internet site.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit.  Application kits are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, email: GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application, 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC will accept 
the application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
Institute or Center who agreed to accept assignment of the application.  

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year. (Applications that request 
more than $250,000 direct costs in any year must follow the traditional PHS 
398 application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative  (F&A) costs] for the initial budget 
period Items 8a and 8b should be completed indicating the Direct and Total 
Costs for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398. It is not required and will not be accepted with the 
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398. It is not required and 
will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.) At the top of the page, enter the total direct costs requested for 
each year.  This is not a Form page.

o Under Personnel, List key project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language  
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000. List the individuals/organizations with whom consortium or contractual 
arrangements have been made, the percent effort of key personnel, and the role 
on the project. Indicate whether the collaborating institution is foreign or 
domestic. The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the Letter of 
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team. A biographical sketch is required for all 
key personnel, following the instructions below. No more than three pages may 
be used for each person. A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate the type 
of agreement and the date. All appropriate exclusions must be applied  in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and five signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, generally 
the top half of applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the National Advisory 
Council for Nursing Research.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) 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?

(2) 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?

(3) Innovation:  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

Additional scientific/technical merit criteria specific to the objectives of 
the PA and the mechanism used must be included if they are to be used in the 
review.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Ann Knebel
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5966
FAX:  (301) 480-8260
Email:  aknebel@nih.gov

Dr. Claudette Varricchio
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN 300
Bethesda, MD  20892
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email: varriccc@mail.nih.gov

Dr. Mary Ann Richardson
National Center for Complementary and Alternative Medicine
31 Center Drive, Building 31, Room 5B58
Bethesda, MD  20892-2182
Telephone: (301) 402-1272
FAX: (301) 402-4741
Email: marich@od.nih.gov

Dr. Frederick Batzold
Division of AIDS
National Institute of Allergy, Immunology, and Infectious Diseases
Rockledge Drive 6700B, Room 5154
Bethesda MD, 20892
Telephone: (301) 496-8214
FAX: (301) 402-1505
Email: fbatzold@niaid.nih.gov

Dr. Patricia Bryant
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-24E
Bethesda, MD  20892-6500
Telephone:  (301) 594-2095
FAX:  (301) 480-8318
Email:  BryantP@DE45.nidr.nih.gov

Dr. Peter Muehrer
National Institute of Mental Health
6001 Executive Blvd., Room 6189, MSC 9615
Bethesda, MD  20892-9615
Telephone: (301) 443-4708
FAX: (301) 443-4415
Email: pmuehrer@mail.nih.gov

Dr. Sidney M. Stahl
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, #533
7201 Wisconsin Ave.
Bethesda, MD  20892-9205
Telephone:  (301) 402-4156
FAX:  (301) 402-0051
Email: Sidney_Stahl@nih.gov

AHRQ Statement:
The Agency for Healthcare Research and Quality (AHRQ) supports the development 
of knowledge that improves health care services provided for patients at the 
end of life.  AHRQ is interested in supporting research on the most 
appropriate sites of health care for patients at the end of life (e.g., home, 
nursing home, hospice, acute care), and on the quality, costs and access to 
the services provided in these settings.  Methods of improving the process of 
decision-making by family, providers and patients themselves, and of relieving 
the financial and social burden on family caregivers, are also of interest.  
For inquiries regarding AHRQ programmatic issues, contact: Dr. David Lanier, 
Center for Primary Care Research, AHRQ, (301) 594-1489.  Email: 
dlanier@ahrq.gov

Direct inquiries regarding fiscal matters to:

Mr. Robert Tarwater
Office of Grants and Contracts Management
National Institute of Nursing Research
Building 45, Room Number 3AN12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-2807
FAX:  (301) 480-8260
Email:  Robert_tarwater@nih.gov

Mr. William T. Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd. Room 243
Bethesda, MD 20892
Telephone: (301) 496-7800
FAX:(301) 496-8601
Email: William_Wells@nih.gov

Ms. Suzanne White
Grants Management Branch
National Center for Complementary and Alternative Medicine
6201 Rockledge Drive, MSC 7926
Bethesda, MD  20817-7926
Telephone: (301) 435-0171
FAX: (301) 480-3310
Email: whitesa@nhlbi.nih.gov

Ms. Jane Unsworth
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2128
6700-B Rockledge Drive - MSC 7614
Bethesda, MD 20892-7614
Telephone:  (301) 402-6824
FAX: (301) 402-0369
Email: junsworth@niaid.nih.gov

Mr. Martin Rubinstein
Office of Grants Management
National Institute of Dental and Craniofacial Research
Natcher Bldg, Rm 4AN-44A
Bethesda, MD 20892-6402
Phone: (301) 594-4800
FAX: (301) 594-8301
Email: Martin.Rubinstein@nih.gov

Ms. Diana S. Trunnell
Division of Extramural Activities 
National Institute of Mental Health
Parklawn Bldg, Room 7C-08
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: diana_trunnell@nih.gov

Mr. David Reiter
Grants Management Office
National Institute on Aging
Gateway Building, #2N212
7201 Wisconsin Ave.
Bethesda, MD  20892
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  David_Reiter@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.361 (NINR); 93.399 (NCI); 93.213 (NCCAM); 93.855 and 93.856 (NIAID); 93.121 
(NIDCR); 93.242 (NIMH); 93.866 (NIA); and 93.854 (NINDS).  Awards are made 
under authorization of sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, and portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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