Cancer Centers Administrators Forum

1
Cancer Centers Administrators Forum

• October 20, 2009
• Leo F. Buscher Jr.
• Director, NCI Office of Grants Administration

2
Welcome to Washington D.C.
UAB Comprehensive Cancer Center Arizona Cancer
Center City of Hope National Medical
Center Salk Institute Cancer Center Moores
Cancer Center UC San Diego The Burnham
Institute Jonsson Comprehensive Cancer Center
UCLA USC/Norris Comp. Cancer Center Chao Family
Comprehensive Cancer Center UC Irvine Stanford
Cancer Center UCSF Helen Diller Family
Comprehensive Cancer Center UC Davis Cancer
Center University of Colorado Cancer
Center Yale Cancer Center Lombardi
Comprehensive Cancer Center Georgetown
U Winship Cancer Institute Emory U H. Lee
Moffitt Cancer Center Res. Inst. U of South
Florida Cancer Research Center of
Hawaii University of Chicago Cancer Research
Center Holden Comp. Cancer Center U of
Iowa Robert H. Lurie Comprehensive Cancer Center
Northwestern The Jackson Laboratory Cancer
Center Indiana University Melvin and Bren Simon
Cancer Center Purdue U Center for Cancer
Research Sidney Kimmel Comprehensive Cancer
Center Johns Hopkins U Greenebaum Cancer
Center U of Maryland David H. Koch Institute
for Integrative Cancer Research at
MIT Dana-Farber/Harvard Cancer Center University
of Michigan Comprehensive Cancer Center Masonic
Cancer Center U of Minnesota The Barbara Ann
Karmanos Cancer Institute Wayne State U Mayo
Clinic Cancer Center University of Nebraska
Medical Center/Eppley Cancer Center Siteman
Cancer Center Norris Cotton Cancer Center
Dartmouth-Hitchcock Med. Center The Cancer
Institute of New Jersey U of New Mexico Cancer
Center Research Treatment Center Albert
Einstein Cancer Research Center Roswell Park
Cancer Institute Cold Spring Harbor
Laboratory Memorial Sloan-Kettering Cancer
Center NYU Cancer Institute Hebert Irving
Comprehensive Cancer Center Columbia
University Duke Comprehensive Cancer Center UNC
Lineberger Comprehensive Cancer Center Wake
Forest Comprehensive Cancer Center Comprehensive
Cancer Center The Ohio State University Case
Comprehensive Cancer Center OHSU Knight Cancer
Center Oregon University The Wistar
Institute Abramson Cancer Center University of
Pennsylvania Fox Chase Cancer Center Kimmel
Cancer Center Thomas Jefferson
University University of Pittsburgh Cancer
Institute Hollings Cancer Center University of
South Carolina St. Jude Childrens Research
Hospital Cancer Therapy Research Center U of
Texas, San Antonio Vanderbilt-Ingram Cancer
Center Huntsman Cancer Institute University of
Utah M.D. Anderson Cancer Center U of
Texas Fred Hutchinson/University of Washington
Cancer Consortium Dan L. Duncan Cancer Center
Baylor Massey Cancer Center Virginia
Commonwealth University UVA Cancer Center UW
Paul P. Carbone Comprehensive Cancer Center
2
3
Cancer Centers Program

• The NCI Cancer Centers Program was created by
  Congress in the National Cancer Act of 1971.
• 65 NCI-designated Cancer Centers.
• New NCI-designated Cancer Centers in Spring 2009
• Winship Cancer Institute at Emory University
• Hollings Cancer Center Medical University of
  South Carolina
• 40 Comprehensive Cancer Centers.
• Budget in FY 2009
• 286 million (CORE grants only)

Georgetown University Healy Hall
3
4
New NIH DirectorFrancis S. Collins
NIH Building 1
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NIHs New Director

• On 8/17/09, Dr. Francis S. Collins became NIHs
  new director.
• During his first day on the job, Dr. Collins
  addressed NIH staff, outlining five key themes
  for the agency five themes tied together by the
  value they gain from extramural research.

NIH Building 1
6
Dr. Collins Five Key Themes

• Apply high-throughput technologies to understand
  fundamental biology and uncover causes of
  specific disease states.
• Translation develop diagnostics, preventive
  strategies, and therapeutics.
• Put science to work for healthcare reform.
• A greater focus on global health.
• Reinvigorate and empower the biomedical research
  community.

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Agenda

• NCI Cancer Centers Program
• NIH New Director Themes
• Budget News
• ARRA ARRA Reporting Requirements
• Policy Updates
• Funding Policy - New/Early Stage Investigators
• SBIR/STTR FA Rate Negotiation
• Registration of Clinical Trials
• Protecting Sensitive Data
• Policy Reminders
• Revised NCI Cap on Renewal Applications
• Salary Cap
• Other Support
• Human Stem Cell Research
• Public Access
• Financial Conflict of Interest
• Change of Scope
• OLAW OHRP Updates
• Electronic Submissions Update

8
Budget News
9
NIH Funding Trends

• Since 2003, NIH's RD increase in funding has
  slowed considerably

10
Final NIH Appropriations FY 2009

• NIH received a total of 30.4 billion in new
  budget authority.
• Increase of 3.2 from FY 2008
• Supported 9,800 new and competing RPGs
• Average competing award increased by 3.
• Noncompeting awards were supported at the most
  recently committed levels.
• NIH supported a 1 increase in all NRSA stipend
  levels.

More at http//grants.nih.gov/grants/guide/notic
e-files/NOT-OD-09-066.html
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What Stays at NIH and what goes Elsewhere
83 Outside NIH gt 325,000 Scientists gt 3,000
Organizations Worldwide
17 Inside NIH Intramural Research (10) Staff
Buildings (5) Other (2)
12
NIH Extramural Funding
13
Breakdown of 30.4 Billion Appropriated to NIH
for FY 2009
16.1 B
14
FY 2009 Budget for NCI 4.97 Billion
2.1 B
15
NCI FY 2009 Grants Estimated Actuals
Grant Mechanism Dollars ( in millions) RPGs
2,063 Centers Total 562 CORE Grants (P30,
P20) 286 SPOREs 131 Centers
(Other) 145 Other Research 417 Cancer
Education 32 Careers
79 Groups 234 Other 72 NRSA
70 Total 3,112
16
NCI FY 2009 Operating Budget Paylines

• NCI RPG Paylines
• R01 16th percentile
• R01 22nd percentile
• Large R01 16th percentile
• R03 210 priority score
• R21 16th percentile
• R33 155 priority score
• P01 Selected via exception on a case-by-case
  basis in priority order.

17
FY 2010 NIH Budget
Rock Creek Park
18
Breakdown of 30.9 Billion FY 2010 Presidents
Budget for NIH
16.4 B
19
ARRA
New Jobs
Summer Students
Research
Diversity Programs
Technology
Clinical Trials
SBIR STTR
Genome
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American Recovery andReinvestment Act (ARRA)

• 10 billion appropriated directly to NIH
• Stimulate and accelerate biomedical research with
  existing mechanisms.
• Expand science with new programs.
• ARRA website http//grants.nih.gov/recovery/

21
NIH Allocation of ARRA Funds(dollars in billions)
22
ARRA Funds Allocated to NIH

• 7.4 billion NIH Institutes and Centers
• 1.26 billion to NCI
• 1 billion extramural construction
• 500 million NIH construction
• 300 million shared instrumentation
• 400 million comparative effectiveness research
  (400M HHS 300M AHRQ)
• 800 million NIH Office of the Director

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NIHs Working Plan for Allocating ARRA Funds

• Support the best scientific opportunities.
• Projects with the broadest impact.
• Work that can be accomplished in two years.

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New ARRA NIH-Wide Programs

• Challenge Grants
• Grand Opportunities (GO Grants)
• Small Business Opportunities (BRDG-SPAN and
  Small Business Catalyst awards)
• Recruit new faculty to conduct research
• Provide summer jobs for high school / college
  students and teachers to work in science labs
• Administrative Supplements and Competitive
  Revisions to existing grants

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NCI and ARRA
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ARRA Funding A Once in a Lifetime Opportunity

• Careful and thoughtful planning by the NCI
• Strategic foresight minimizing the out-year
  (cliff) effect
• Maximizing our ability to generate Congressional
  enthusiasm about investments in cancer research

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ARRA at NCI (FY 2009 FY 2010)
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NCI FY 2009 Operating BudgetARRA Paylines

• 16th-18th percentile pay R01s for 4 years, R21s
  for 2 years.
• 18th-25th percentile pay R01s and R21s for 2
  years with selected R01s for 4 years.
• 22nd-25th percentile pay R01s for 5 years.
• Additional 2 P01s per point 16th-25th
  percentile.
• Estimated total ARRA RPG cost to raise payline
  159 million.
• 369 RPGs have been funded due to the extended
  payline under ARRA.

29
Supplements

• ARRA Supplements awarded as of 9/30/09
• Est. of Awards Est. Total Awarded
• Administrative 847 272,737,000
• Competing 68 45,188,000
• Total 915 317,925,000
• Supplement Success Rates
• Equipment (admin.) 16.6
• General Support (admin.) 15.0
• Payline for competitive supplements set at 23
  (based on priority score)

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NIH Funded Cancer Grants
CER comparative effectiveness research
31
Challenge Grants

• Challenge Grants support published research topic
  areas using two-year ARRA funds.
• NIH received approximately 20,000 Challenge Grant
  applications.
• The number of applications submitted to the
  Challenge Grant funding opportunity nearly
  matches the total number of applications NIH
  receives in a regular Council round.

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Challenge Grants (cont.)

• NIH opted to fund 18 cancer Challenge Grants
  (17.7M) of the 37 NCI sent forward.
• NCI selected an additional 41 high priority
  grants (38M).
• Comparative effectiveness research NIH funded 15
  NCI grants for 13.2M.
• NCIs overall success rate was 20 of grants
  reviewed.

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Grand Opportunities (GO) Grants

• GO Grants use two-year ARRA funds to support
  biomedical and biobehavioral research endeavors
  to enable growth and investment in biomedical
  research.
• NIH matched NCIs funding of 18 cancer GO Grants
  (24M).
• NCI funded 33 additional GO Grants (64M).
• AIDS 21 awards, 21M.
• Functional biology 5 awards, 24M.
• Translational 5 awards, 16M.
• Viruses and cancer 2 awards, 3M.
• Comparative effectiveness research NIH fully
  funded 12 NCI grants for 48M.
• Overall success rate 17 of grants reviewed.

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ACTNOW

• Accelerating Clinical Trials of Novel Oncologic
  Pathways
• 37 early phase clinical trials of new treatment
  regimens.
• Awards contingent on IRB approval and opening to
  patient enrollment within 90 days completion in
  2 years.

35
ARRA Funding for Cancer Research by Organ Site
As of July 2009
36
NCI ARRA-Supported Items in FY 09

• 31 NIH Blue Sheets contained NCI ARRA-supported
  items in FY 2009.
• 1,613 items were approved for 846 million in FY
  2009.
• 1,564 grants for 522 million.
• 49 contracts for 318 million.

37
ARRA Expenditures on Cancer Research Grants in FY
09 628 Million
522 M
106 M
38
Total Cancer Grant Obligations in FY 09 3,740
Million
3,112 M
628 M
39
New Grant Actions in September 2009
40
NCI Grant Awards by Quarter in FY 09
41
RD Contracts

• Examples of programs and projects funded under
  contracts (current estimate of ARRA funds 494M)
• Cohort studies
• Phase I/II therapeutic imaging clinical trials
• DCTD expansion of Chemical Biology Consortium
  overall therapeutics program
• caBIG - Cancer Cloud
• DCTD clinical assay development molecular
  characterization centers
• TCGA/TARGET

42
Contract Example CBC

• Goal accelerate new therapies
• Government-academic collaborations
• Subcontracting
• Identified qualified pool of academic contractors
• Solicitation went to 30 bidders
• 11 awards made
• 8 academic labs
• 3 commercial labs

43
ARRA Reporting Requirements
44
ARRA Requirements

• ARRA fund recipients are required to submit
  reports within 10 days of the end of each federal
  quarter.
• Reports must be submitted to www.federalreporting.
  gov and possibly to the awarding agency.
• First reports were due 10/10/09.
• Separate Accounts in Payment Management System
  (PMS)
• ARRA funding will be accessed through a totally
  unique account from non-ARRA funding for each
  funded award.
• Separate Financial Reporting
• Separate SF 272 and Financial Status Reports will
  be required to be submitted covering this
  additional funding.
• These will be in addition to any required
  financial reports for the parent grant.

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ARRA Requirements (cont.)

• Separate closeout documents
• Separate Final Progress Reports, Final Financial
  Status Reports, and Final Invention Statements
  will also be required to closeout the Recovery
  Act funding at the time the ARRA funding ends.
• These closeout reports for the ARRA funding are
  required even when the parent grant continues.
• ARRA funds are not available for rebudgeting or
  carryover into the parent grant.
• Any ARRA funding remaining at the end of the
  funding period for this award must be reported as
  an unobligated balance.

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ARRA Requirements (cont.)

• No co-mingling of ARRA T-3 and parent grant
  dollars allowed (assuming parent grant funded
  with regular appropriation dollars).
• Separate institution accounts and PMS drawdowns
  required.
• No rebudgeting between parent and ARRA T-3.
• No carryover of ARRA T-3 balances into the
  parent.
• If an ARRA award includes a commitment for an
  ARRA-funded future year in FY2010, grantees will
  be able to carryover from the FY2009 budget
  period into FY2010.
• No carryover allowed between ARRA funding budget
  periods and budget periods funded by non-ARRA
  fund.

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Unique Business ProcessesModified Carryover
Authorities

• 04 Yr funds CANNOT be carried forward into -05
  -04 year financially closed.
• 05 Yr funds CAN be carried forward into -06.
• 06 Yr funds CANNOT be carried forward into -07.
• 04 Yr funds CANNOT be carried forward into -07

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NIH ARRA Reporting Requirements Website

• Prime recipients of ARRA-funded grants and
  cooperative agreements are subject to the
  quarterly reporting provisions of Section 1512 of
  the Act, as are any subrecipients delegated
  reporting responsibility by a prime recipient.
• NIH has developed NIH-specific resources to help
  ARRA grant recipients fulfill their reporting
  requirements.
• These resources include an extensive list of FAQs
  that will be regularly updated, applicable Guide
  Notices, and links to OMB guidance and Webinars.
• These resources can be found at
  http//grants.nih.gov/recovery/recipient_reporting
  .html

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Policy Updates
50
Revised New and Early Stage Investigator Policies

• For R01 applications in FY2009, NIH expects to
  support New Investigators at success rates
  equivalent to that of established investigators
  submitting new applications.
• Majority of New Investigators are expected to be
  Early Stage Investigators.
• Applications will be clustered during initial
  peer review to the extent possible.
• NIH encourages New Investigators and ESIs to
  apply for R01 grants when seeking first-time
  funding from NIH.
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-09-013.html

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New Threshold for Negotiating FA Rates on
SBIR/STTR Grants

• SBIR/STTR applicants proposing FA rates of 40
  of direct costs or less will not be required to
  provide further justification at the time of
  award, and FA costs will be awarded at the
  requested rate.
• NIH retains authority to require well-documented
  proposals for FA rates on an ad-hoc basis.
• If applicant has a currently effective rate, such
  rates should continue to be used in NIH
  applications.
• Policy applies to all competing SBIR/STTR
  applications submitted for FY2009 funding and
  beyond. Non-competing awards funded in 2009 or
  earlier will continue to be funded at the
  committed level if between 25-40.
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-09-038.html

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Mandatory Registration of Clinical Trials

• Mandatory Registration
• All applicable clinical trials of drugs and
  biologics and devices are to be registered in the
  ClinicalTrials.gov database by the responsible
  party
• NIH will verify registration before funds are
  released.
• Civil penalties to be levied for noncompliance if
  trials are not properly registered.
• Results Reporting
• P. L. 110-85 mandates the establishment of a
  clinical trials results database. Effective
  September 27, 2008, the NIH launched an expanded
  ClinicalTrials.gov database that can accept
  basic results information.
• See NIH Guide Notice 4/1/09 http//grants.nih.go
  v/grants/guide/notice-files/NOT-OD-09-077.html

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Renewed Focus on Protecting Sensitive Data in
Research

• Federal Information Security Management Act
  (FISMA) requires that all information systems
  which contain Federal data, electronic or hard
  copy, must be protected from unauthorized access.
  Public Law 107-347
• Access to data should be limited through password
  protection and other appropriate means.
• Personally identifiable, sensitive and
  confidential information should not be housed on
  portable electronic devices, but if they must be
  used the data should be encrypted.
• FISMA applies to grantees but only when they
  collect, store, process, transmit, or use
  information on behalf of HHS.
• All grantees have responsibility to protect
  personally identifiable, sensitive and
  confidential data.

54
Policy Reminders
55
Revised NCI Cap on Renewal Applications
Reminder

• For all Type 2 R01, U01, and P01 renewal
  applications, the direct cost budget request for
  the first year cannot generally exceed an
  increase of 10 over the direct cost budget
  awarded for the last year of the prior project
  period (i.e., the last Type 5 award).
• Effective for renewal applications that have
  receipt/submission dates on and after October 1,
  2008.

56
Reminder
Salary Cap

• Restricts the amount of direct salary under a
  grant or contract to Executive Level I of the
  Federal Executive Pay Scale.
• Salary Cap Summary (Historical Information)
  http//grants.nih.gov/grants/policy/salcap_summary
  .htm
• See NIH Guide Notice 3/19/09 http//grants.nih.g
  ov/grants/guide/notice-files/NOT-OD-09-069.html

?
196,700
191,300
186,600
57
Reminder
Other Support

• NIH requires complete and up-to-date other
  support information before an award can be made
• Complete means all sources of research support
  (including outside the applicant organization)
• Grantees must report changes in other support as
  part of the annual progress report.
• Far too many applications are submitted without
  reporting complete other support.

58
Human Stem Cell Research
59
Final NIH Guidelines on Human Stem Cell Research

• Effective July 7, 2009 (see Guide Notice
  NOT-OD-09-116).
• Guidelines establish a new NIH Registry of Human
  Embryonic Stem Cells (hESCs) eligible for use in
  NIH funding, and centralize processes and
  procedures for NIH review of hESCs for inclusion
  on Registry.
• Guide Notice NOT-OD-09-123 provides information
  about
• new applications proposing to use hESCs,
• ongoing NIH research using previously approved
  hESC lines, and
• the status of applications previously submitted
  (including ARRA applications).
• More at http//stemcells.nih.gov

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Final NIH Guidelines on Human Stem Cell Research
(cont.)

• Guidelines prescribe the assurances and
  supporting documentation that must accompany
  requests for NIH funding for research using hESCs
  and describe research that is not eligible for
  NIH funding.
• Ongoing NIH-supported research involving
  previously approved hESC lines may continue.
• No new uses of hESC may be initiated in ongoing
  funded studies unless reviewed and approved by
  the NIH.
• Inquiries should be directed to
• Division of Grants Policy
• Office of Policy for Extramural Research
  Administration
• National Institutes of Health
• 6705 Rockledge Drive, Suite 350
• Bethesda, MD 20892
• Email GrantsPolicy_at_od.nih.gov

61
Awards for hESC Research

• Until hESCs are included on the new NIH Registry,
  all awards for hESCs will include special terms
• New awards will include a restriction that no
  hESC research may be conducted until hESCs are
  listed on the Registry and the grantee identifies
  the line to be used.
• Ongoing awards (including Type 5s) will include
  an informational term that no new use of hESCs
  may be initiated unless the grantee notifies NIH
  of the specific line from the Registry to be used.

62
NIH hESC Registry

• NIH is developing a new web-based form to be used
  by the research community to submit hESCs to the
  Registry.
• The form is separate from the grant application.
• The Registry will list hESCs that are pending
  review by NIH, those approved for use in NIH
  funded research, and those reviewed and not
  approved for use in NIH funded research.
• The Registry will be posted at
  http//grants.nih.gov/stem_cells/registry/current.
  htm.

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Human Subject Research Considerations in Relation
to hESCs

• HHS-supported research that involves neither
  interactions nor interventions with living
  individuals or obtaining identifiable private
  information is not considered human subjects
  research according to regulations at 45 CFR 46.
• See OHRP guidance at http//www.hhs.gov/ohrp/human
  subjects/guidance/stemcell.pdf.
• Therefore, in vitro research or research in
  animals using previously derived and established
  human cell lines, from which the identity of the
  donor cannot be readily ascertained by the
  investigator, is not considered human subjects
  research and does not require IRB review and
  approval.

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Public Access
65
Reminder
Public Access Policy Now Permanent

• All investigators funded by NIH must submit to
  PubMed Central an electronic version of their
  final, peer-reviewed manuscripts upon acceptance
  for publication.
• Compliance mandated by Public Law 110-161.
• Applicable to
• Peer-reviewed articles,
• Accepted for publication on or after 4/7/08, and
• Arising from direct grant or contract funds
  active in FY 2008, and beyond.
• Full-text articles to be made publicly available
  on NLMs PubMed Central no later than 12 months
  after date of publication.
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-09-071.html

66
NIH Public Access Policy Compliance

• Compliance with the NIH Public Access Policy is
  an institutional responsibility. Failure to
  provide evidence of compliance in an application,
  proposal or report is a violation of the terms
  and conditions of the NIH award.
• NIH may suspend awards found to be out of
  compliance, pending corrective action, or may
  terminate the award for cause (per 45 CFR 74.61,
  74.62, and 92.43).
• Direct NIH Public Access Policy questions to
• Office of Extramural Research
• National Institutes of Health
• 1 Center Drive, Room 144
• Bethesda, MD 20892-0152
• Email PublicAccess_at_nih.gov
• Website http//publicaccess.nih.gov
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-09-136.html

67
Financial Conflict of Interest
Federal Treasury Building
68
IOM Calls for More Regulations to Reduce Conflict
of Interest

• On 4/28/09, the Institute of Medicine (IOM)
  issued a reports calling for major voluntary and
  regulatory actions to reduce conflicts of
  interest in medical research, education, and
  practice.
• The report, entitled Conflict of Interest in
  Medical Research, Education, and Practice,
  recommends
• the "format for disclosure and categories of
  relationships" be standardized across
  institutions and
• Congress should require pharmaceutical,
  biotechnology, and device firms to report through
  a public Web site the payments they make to
  doctors, researchers, academic health centers,
  professional societies, patient advocacy groups,
  and others involved in medicine.

69
Advanced Notice of Proposed Rulemaking (ANPRM)

• ANPRM addresses various topics including
• Expanding the scope of regulation and disclosure
  of interests
• Definition of Significant Financial Interest
• Identification and management of conflicting
  interests by institutions
• Assuring institutional compliance
• Requiring institutions to provide additional
  information
• Broadening the regulations to address
  institutional conflict of interest
• Comment period closed 7/7/09.

70
Financial Conflict of Interest (FCOI)

• Everyone must take responsibility to ensure
  compliance with the FCOI regulation that has been
  in effect since 1995 by ensuring NIH-funded
  research is conducted objectively and in the
  absence of inappropriate influences.
• NIH continues to enhance and promote compliance
  with the FCOI Regulation (42 CFR Part 50, Subpart
  F)
• NIH system-wide review of FCOI policies,
  procedures, and guidance.
• eRA Commons FCOI module/reporting tool for
  grantees.
• Updated FAQs and a Web-based tutorial.
• Web Postings / Resources at grants.nih.gov/grants
  /policy/coi/index.htm

71
eRA Commons FCOI Module/Reporting Tool

• Enables grantees to report identified FCOIs to
  NIH through the eRA Commons.
• System allows institutions to
• Initiate and send a new FCOI report
  electronically through the eRA Commons
• Search previously created records
• Edit a previously submitted record
• Respond to a request for additional information
• Rescind a previously submitted record
• View history of actions
• Effective July 1, 2009, system will be mandatory
  for all NIH grants and cooperative agreements.
• To prepare, institutional Signing Officials must
  assign FCOI roles to users in eRA Commons.
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-09-072.html

72
Updated Expanded FAQs on FCOI

• For all NIH-supported Institutions
• Categorized for ease of reference
• General Questions
• Institution-Specific Questions
• Investigator-Specific Questions
• Web Postings and Resources at http//grants.nih.g
  ov/grants/guide/notice-files/NOT-OD-08-063.html
  and http//grants.nih.gov/grants/policy/coifaq.htm

73
FCOI Web-Based Tutorial

• Reviews requirements of and responsibilities for
  compliance with Federal FCOI regulations
• Designed for use by
• Institutional officials responsible for managing
  NIH-funded grants, cooperative agreements and/or
  contracts
• Individuals who are responsible for the design,
  conduct or reporting of NIH-supported research.
• Includes quizzes to test understanding and a
  Certificate of Completion
• See NIH Guide Notice 8/15/08 http//grants.nih.g
  ov/grants/guide/notice-files/NOT-OD-08-106.html

74
FCOI Subrecipients

• If the grantee institution performs NIH-funded
  research through subgrantees, contractors, or
  collaborators, the grantee institution must
  take reasonable steps to ensure compliance by
  requiring either
• Subrecipient Investigators to comply with the
  grantee institutions policy OR
• Subrecipient institutions to provide assurances
  to the grantee institution that will enable it to
  comply.
• Subrecipients should report identified FCOIs to
  grantee institution. Grantee institution reports
  to NIH.

75
Change of Scope
Old Post Office
76
New Business Process Concerning Change of Scope

• Effective 5/5/09, there is a new business process
  for submitting revised Project Summary/Abstracts,
  Specific Aims, and/or Public Health Relevance
  statements when changing the scope of proposed
  research projects.
• Grant applicants should discuss potential changes
  in scope with NIH Program Officials and revise
  the Project Summary/Abstract, Specific Aims,
  and/or Public Health Relevance sections of their
  application as appropriate.
• Once all issues are resolved, applicants should
  e-mail a document with final versions of the
  revised sections to the IC-designated e-mail
  address (normally either a Program Official,
  Grants Management Official, or centralized e-mail
  box) as a single Microsoft Word or Adobe PDF
  (Portable Document Format) file.
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-09-088.html

77
OLAW and OHRP Updates
78
OLAW Compliance Assistance

• What Investigators Need to Know About the Care
  and Use of Laboratory Animals
• Brochure explains the requirements for using
  animals in PHS-supported research.
• Contact OLAW to request multiple copies.
• FAQs on PHS Policy on Humane Care and Use of
  Vertebrate Animals available on the OLAW
  website.
• IACUC 101 is a series of workshops on the roles
  and responsibilities of IACUCs, including federal
  policies and regulations regarding animal
  welfare.
• A list of IACUC workshops can be found at
  http//grants.nih.gov/grants/olaw/iacuc101s.htm

More at http//olaw.nih.gov
79
Consortium Agreements Subawards and Animals

• Prime grantee is accountable to NIH and must
  confirm Assurance and IACUC approval (dated
  within 3 years).
• Animal welfare requirements apply to all
  consortium participants and sub-projects.
• Inter-Institutional Assurance is needed
• Prime grantee has no animal program animal work
  is being conducted at an Assured performance
  site.
• Foreign Assurance is needed
• Direct support to a foreign institution.
• Domestic prime grantee with a foreign performance
  site using animals (Domestic grantees IACUC
  approves animal activities performed at foreign
  site).
• GPS Page 224 at http//grants.nih.gov/grants/pol
  icy/nihgps_2003/index.htm

80
Updated Guidance from OHRP

• Revised Guidance on Research Involving Coded
  Private Information or Biological Specimens
• Provides guidance on when coded private
  information or specimens is or is not research
  involving human subjects.
• Reaffirms OHRP policy that, under certain limited
  conditions, this research is not human subjects
  research.
• Clarifies distinction between
• Research involving coded private information or
  specimens that does not involve human subjects,
  and
• Human subjects research that is exempt from the
  requirements of HHS regulations.
• More at http//www.hhs.gov/ohrp/humansubjects/gu
  idance/cdebiol.htm

81
Registration Requirements for Institutional
Review Boards

• Published in Federal Register on January 15, 2009
  and effective July 14, 2009.
• OHRP has added a new subpart E to the HHS
  protection of human subjects regulations, which
  requires IRBs to register with HHS.
• Registration information includes contact
  information, approximate numbers of all active
  protocols and active protocols involving research
  conducted or supported by HHS, and staffing for
  the IRB.
• Initial registration was due by September 14,
  2009.
• Registration does not mean OHRP has determined
  the IRB is in compliance with Protection of Human
  Subjects regulations at 45 CFR Part 46.
• More at http//edocket.access.gpo.gov/2009/E9-58
  8.htm

82
Adobe Application Forms and Electronic Submission
Washington D.C. Temple
83
Adobe Not very different

• The new Adobe forms look very similar to PureEdge
  forms -- Changes are cosmetic and navigational
  (see comparison at http//era.nih.gov/ElectronicR
  eceipt/files/PureEdge_v_Adobe.pdf
• Overall electronic submission process remains the
  same
• Find opportunity
• Download application package
• Develop research plan and other PDF attachments
• Complete forms
• Submit application
• Check assembled application in eRA Commons

Works on both Macs and PCs
84
but follow these important tips to ensure
success

• Adobe Reader 8.1.3 or 9.0 required to open forms
  (8.1.6 and 9.1.2 are recommended)
• Stay tuned to Grants.govs Download Software
  page for changes (http//www.grants.gov/help/down
  load_software.jsp)
• A pop-up usually warns if you have a wrong
  version
• If using an Adobe Acrobat product to create PDFs,
  check Grants.govs Web site for help on settings
• To ensure the application reader opens in the
  correct version of Adobe

85
Electronic Submission Update

• Adobe-based grant application forms are now
  available for all Funding Opportunity
  Announcements (FOAs) requiring electronic
  submission.
• Individual Fellowship Awards (Fs) transitioned to
  electronic submission for the August 8 submission
  date.
• Next set of transitions
• New PHS 398 and SF 424 (RR) Application forms
  expected in late 2009.
• Transition of Training (T) and complex mechanisms.

86
Sample Changes to Application Forms

• RR Senior/Key Person Profile
• Added Degree Type and Year (note this will allow
  NIH to remove Degree fields from PHS 398 Cover Pg
  Supplement)
• RR Project/Performance Site Location(s)
• Moved Congressional District data from RR Cover
  Component
• Added DUNS Number field
• RR Other Project Information
• Re-ordered and revised Human Subjects fields
• Revised fields on Environmental Impact
• Added field for impact on Historical Places
• PHS 398 Checklist
• Added Disclosure Permission Statement
• PHS 398 Research Plan
• Alignment with enhanced peer review criteria and
  shortening of the application.

• More at http//grants.nih.gov/grants/forms.htm

87
Future Transitions to Electronic Submission with
Adobe Forms
Transition Complete!

• Fellowship (F) August 8, 2009
• K12, K30 Training (T) January 25, 2010
• Complex TBD

More at http//era.nih.gov/ElectronicReceipt/str
ategy_timeline.htm
88
Available Resources

• Resources for the Adobe transition
• can be found on
• NIH Electronic Submission of Grant Applications
  Web site http//era.nih.gov/ElectronicReceipt/
• Grants.gov Web site (Applicant Resources)
  http//grants.gov/applicants/resources.jsp

89
X-Train
Amtraks Acela Express
90
X-Train Open to All Institutions

• X-Train is a new system to improve the
  administration of NIH Training Grants.
• Allows PIs and staff to electronically submit
  appointment forms and termination notices.
• Allows institutional staff to track status and
  timing of appointment actions.
• Available for all NIH NRSA Research Training
  Grants (i.e., T32, T34, T35, T90, TL1 and TU2).
• Accommodates separate appointments for ARRA
  supplements to training grants.
• Accessible through eRA Commons.
• NIH continues to develop X-Train for use in other
  training programs in the future.
• See NIH Guide Notice 7/10/09 http//grants.nih.g
  ov/grants/guide/notice-files/NOT-OD-09-121.html

91
Fellowships
Iwo Jima Memorial
92
Electronic Submission of Fellowships

• Effective with the 8/8/09 submission date, all
  grant applications for the Individual National
  Research Service Award (NRSA) Fellowships
  (F-series) will require electronic submission
  through Grants.gov to eRA Commons.
• Paper applications will not be accepted for
  submissions on or after the August 8 transition.
  
• For a complete listing of Fellowship FOAs, see
  the F-Kiosk http//grants1.nih.gov/training/F_fi
  les_nrsa.htm.

93
Electronic Submission of Fellowships (cont.)

• Reference Letters Electronic submission of
  reference letters is separate from the electronic
  submission of applications.
• Reference letters are submitted directly through
  the eRA Commons and do not use Grants.gov.
• Fellowship applicants must follow the Reference
  Letter Instructions in the SF424 (RR) Individual
  Fellowship Application Guide for specific
  directions (Part 1, Section 5.4).
• Resubmissions Resubmission applications must
  include an Introduction addressing the previous
  peer review critique (Summary Statement).
• See new NIH policy on resubmission (amended)
  applications (NOT-OD-09-003, NOT-OD-09-016).
• NIH Guide Notice 5/15/09
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-09-100.html

94
Closeout
Library of Congress
95
Reminder
Closeout Final Reports

• Grantees are strongly encouraged to submit
  closeout documents electronically through the eRA
  Commons!

• Documents are due within 90 days of project
  period end date.
• Final Financial Status Report (now required
  electronically)
• Final Inventions Statement Certification
• Final Progress Report

WWII Memorial
More at http//grants.nih.gov/grants/guide/notic
e-files/NOT-OD-08-061.html
96
NIH Centralized Processing Center

• NIH encourages electronic submission of closeout
  documents through the eRA Commons.
• Centralized office accepts receipt of all
  non-financial, paper-based closeout documents
• Final Progress Report
• Final Invention Statement and Certification
• Mail to the Central NIH unit at
• NIH Centralized Processing Center
• 6705 Rockledge Drive, Room 2207, MSC 7987
• Bethesda, MD 20892-7987 (for regular or US Postal
  Service Express mail)
• Bethesda, MD 20817 (for other courier/express
  mail delivery only)

97
Helpful NIH Technical Assistance Resources
98
Quick and Easy SearchNew Tools to Search NIH
Funding

• The new reports, data and analyses website was
  significantly upgraded in January 2009 with
  addition of RCDC data (Research, Condition and
  Disease Categorization process).
• Replaces the current Award Information and Data
  web page and will provide
• Quick access to Frequently Requested Reports
• FAQs on how success rates are computed and
  questions on the NIH budget
• Search tools for locating data and reports
  quickly and easily
• Links to funding estimates for certain research
  areas, conditions, and diseases.
• Foundation for broader NIH-wide Research
  Portfolio Online Reporting Tool (RePORT).
• RePORT website http//report.nih.gov

99
New Tools to Search NIH Funding (cont.)

• This is the first time a complete list of all
  NIH-funded projects related to each category will
  be available.
• RCDC combines data from NIH ICs explaining
  research spending and priorities to Congress and
  the public in 215 disease, condition, and
  research areas.
• Reports actual and estimated spending figures for
  FY 2005-2010 not set-asides or allocations.

• More at http//report.nih.gov/RCDC/

100
Web Page on NIH Extramural Response to Natural
Disasters

• Part of NIHs commitment to the health of the
  biomedical community in the impacted areas, and
  concern for the health and safety of people and
  animals in the programs we oversee.
• Includes
• Links to Recent Guide Notices and event-specific
  web page
• Links to other Federal web sites for disasters
• NIH Emergency Contact Information
• Examples of extramural assistance provided to
  previous natural disasters and emergencies
• Frequently Asked Questions
• Available at http//grants.nih.gov/grants/natura
  l_disasters.htm

101
Web Page on NIH Extramural Response to Natural
Disasters (cont.)

• In the wake of natural disasters, NIH may
• Allow a delay in grant application submissions
  equal to the time of institution closure or
  evacuation order.
• Permit the limited expenditure of award funds, in
  accordance with grantee policy, to continue
  paying salaries and fringe benefits to
  researchers under unexpected or extraordinary
  circumstances.
• Assist with animal welfare issues.
• Waive certain prior approval requirements.
• Provide extensions of time for financial and
  other reporting.
• Publish opportunities for funded extensions
  and/or one-time administrative supplements to
  current awards targeted at institutions in
  particularly impacted areas.

102
Frequently Asked Questions
Statue of Andrew Jackson, Lafayette Square
103
1 How do I change a Single PD/PI Application
to Multiple PD/PI?

• This can only be done through a competing
  application e.g. renewal, resubmission, or
  competing revision.
• For renewals resubmissions The PD/PI of the
  previous grant should be listed as the Contact
  PD/PI on the Multiple PD/PI grant. If another
  PD/PI is listed as a contact PD/PI, the
  application must also show as a Change of PD/PI.
• For competing revisions The Contact PD/PI must
  be the individual previously noted as the PD/PI.
• The renewal, resubmission, or revision
  application must now include the Multiple PD/PI
  leadership plan
• You cannot change this through an administrative
  supplement request.
• Multiple PI QAs http//grants.nih.gov/grants/mu
  lti_pi/faq.htm

104
2 Does NIH Still Receive Late Applications and
Closeout Reports?
Definitely, Yes.

• NCI was criticized in a recent Inspector General
  audit for 40 of applications coming in late in
  addition to late closeout reports.
• It is necessary for grantee submit applications
  and closeout reports on time.

105
3 Do Late and Incomplete Applications have an
Impact on ICs?
Definitely, Yes.

• NCI Considerable IC resources are diverted
  chasing late applications and missing items on
  incomplete applications.
• NCI grants management specialists are spending a
  large amount of time emailing and/or calling
  grantee business officials to resolve these
  issues.
• Often grant management specialists do not receive
  replies to their inquiries even with follow-up
  communication.

WWII Memorial
106
4 Does NIH Still Accept Unsolicited Grant
Applications
Yes. Use Parent Announcements (available on
Grants.gov and NIH web pages) for unsolicited
or investigator-initiated applications.

• Other funding opportunity announcements include
• Program Announcements
• Statement of new or ongoing NIH interest in a
  certain research area.
• Requests for Applications (RFAs)
• Statement soliciting applications in a
  well-defined scientific area to accomplish
  specific program objectives.
• All Available at http//grants.nih.gov/grants/gu
  ide/index.html

107
5 Are Fellowship Candidates Required to
Register in eRA Commons?
Yes. Applicant organizations should register any
individual fellows submitting applications to NIH
and AHRQ.

• PI Role in the Commons does not provide special
  status only a record in the system that
  provides administrative authority to see
  pertinent application documents (e.g. summary
  statements, scores, submission status, etc.).
• Individual Fellows registered by any organization
  other than the sponsoring organization should not
  have more than one eRA Commons account.
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-07-003.html

108
6 Are Consortium FA Costs Included as Part of
an Applicants Direct Costs?
No. Applicants are to exclude the facilities and
administrative (FA) costs requested by
consortium participants when determining if the
budget exceeds a direct cost limit.

• This policy applies to
• 250K direct cost calculation for modular
  budgets.
• 500K direct cost calculation for NIH data
  sharing policy and requirement to contact IC
  staff for unsolicited applications requesting
  over 500K.
• This policy does not apply to
• Small Business Innovation Research (SBIR) grants.
• Small Business Technology Transfer (STTR) grants.
• More at http//grants.nih.gov/grants/guide/notic
  e-files/NOT-OD-05-004.html

109
7 Does NIH have a Cap on Consultant Fees?
No. There is no cap on consultant fees and the
NIH salary cap does not apply.

• HOWEVER,
• Grantees must have written policies for paying
  consultants that
• Are consistently applied regardless of fund
  source.
• Include conditions for paying consultant fees.
• Consultants must be properly classified.
• Consultants are defined as individuals who
  provide professional services or advice for a
  fee, but normally are not employees of the
  organization. This also includes firms that
  provide advice or services.

110
8 How Different does a New Application have
to be?
New applications are expected to be
substantially different in content and scope

• More significant differences than normally
  encountered in resubmission applications.
• Rewording the Title and Specific Aims is not
  sufficient.
• Incorporating minor changes in response to
  reviewer comments is not sufficient
• Research Plan changes should produce a
  significant change in direction and approach.
  All research plan sections should have
  substantial changes, particularly the Specific
  Aims and Research Design and Methods sections.

111
9 As a PI, what happens if I change
institutions mid-grant?
Prior, written approval is required for
transferring legal and administrative authority
for a grant to a different organization.

• Transfer approval is not automatic and requires
  approval from both NIH and the original grantee
  organization.
• Contact your GMO before moving to initiate the
  transfer process.
• Grants to individuals may not be transferred but
  individual fellowships may transfer to a new
  sponsoring institution.

112
10 Do ARRA Reporting Requirements Apply to all
ARRA-Funded Grant and Cooperative Agreement
Recipients?
Yes. All ARRA-funded, NIH extramural grant or
cooperative agreement recipients must report
information in accordance with Section 1512 of
the Recovery Act on a quarterly basis using the
www.FederalReporting.gov Web site.

• Prime recipients are responsible for fulfilling
  the reporting requirements for both prime and
  sub-recipients however, prime recipients may
  delegate the reporting responsibilities to
  sub-recipients.
• The prime recipient is the grantee institution.
• For details, see http//grants.nih.gov/recovery/f
  aqs_recovery.htmlVIa1
• OMB Guidance http//www.recovery.gov/sites/defau
  lt/files/OMBFinalCoverMemo.pdf

113
11 Do ARRA Reporting Requirements Apply to all
ARRA-Funded Supplements even when the Parent
Grant is Non-ARRA?
Yes. All ARRA-funded recipients must submit
reports within 10 days of the end of each federal
quarter.

• Reports must be submitted to www.FederalReporting.
  gov and possibly to the awarding agency.
• Separate Financial Reporting
• Separate SF 272 and Financial Status Reports will
  be required to be submitted covering this
  additional funding.
• These are in addition to required financial
  reports for parent grant.
• Separate closeout documents
• Separate Final Progress Reports, Final Financial
  Status Reports, and Final Invention Statements
  will also be required to close out the Recovery
  Act funding at the time ARRA funding ends.
• These closeout reports for the ARRA funding are
  required even when the parent grant continues.

114
12 Can ARRA Funds be Extended to Summer
Students Beyond the Summer Months?
No. Use of ARRA funds to support summer students
in non-summer months is inconsistent with the
goals of ARRA.

• The program was intended to provide research
  experiences and jobs for students solely during
  their summer break from school.
• In fact, OPERA provided specific wording for use
  in these awards that stated "...solely for the
  purpose of providing summer research experiences
  to applicable individuals and may not be used for
  any other purpose.
• However, it is possible for grantees to use any
  unexpended funds in the summer of 2010 or the
  summer of 2011, under certain circumstances.
• For details, see http//grants.nih.gov/recovery/f
  aqs_recovery.htmlIIIb10

115

• OGA Staff Makes it Happen

116
Cancer Survivors

• .
• Death rates for the four most common cancers
  (prostate, breast, lung and colorectal) as well
  for all cancers combined, continue to decline.
• The rate of cancer incidence has declined since
  the early 1990s.
• And

There are approximately 12 million cancer
survivors in the U.S.
117
Working Together
Clinicians
Scientists
Researchers
Administrators
Patients
Volunteers
American Public
Wecan Continue to Make a Difference.
118
Thank You
119
Questions?

• .Take your best shot

120
Useful Resources
National Cathedral
121
Summary of Helpful NIH Web Pages

• NIH searchable database of RFAs, PAs, and Guide
  Notices http//grants1.nih.gov/grants/guide/index.
  html
• NIH Grants Policy Statement (Rev. 12/03)
  http//grants1.nih.gov/grants/policy/nihgps_2003/i
  ndex.htm
• NIH Extramural Nexus Monthly newsletter for the
  extramural community http//grants.nih.gov/grants
  /nexus.htm
• Electronic Submission of Grant Applications
  Homepage http//era.nih.gov/ElectronicReceipt/ind
  ex.htm
• CRISP database - Search to analyze an
  Institutes portfolio of funded projects,
  research areas, and more. http//crisp.cit.nih.gov
  /crisp/crisp_querty.generate_screen
• Grant Application Basics http//grants.nih.gov/gra
  nts/grant_basics.htm

122
NIH OER Listserv Addresses and Instructions

• Office of Biotechnology Activities (OBA)
• https//list.nih.gov/archives/oba_news.html
• Office of Human Research Protections (OHRP)
• http//www.hhs.gov/ohrp/news/distributionlist.html
  
• Office of Laboratory Animal Welfare (OLAW)
• http//grants2.nih.gov/grants/olaw/references/list
  .htm
• eSubmission
• http//era.nih.gov/ElectronicReceipt/listserv.htm
• Separate listservs available for scientists and
  administrators
• NIH Guide for Grants and Contracts
• http//grants.nih.gov/grants/guide/listserv.htm
• The official publication for NIH medical and
  behavioral research Grant Policies, Guidelines
  and Funding Opportunities

123
Grants Information Who to Contact!

• Institutional Resources - Utilize the expertise
  of your organizations Office of Sponsored
  Programs
• Application Specific Questions
• Administrative - Contact the Grants Management
  Specialist at the awarding Institute/Center
• Scientific/Programmatic - Contact the designated
  Program Official/Director at awarding
  Institute/Center
• Review Questions - Contact the assigned
  Scientific Review Officer

124
Grants Information Who to Contact!

• Grants Administration individuals at all NIH ICs
• http//grants.nih.gov/grants/staff_list_grants_adm
  in.htm
• NIH Chief Grants Management Officers
• http//grants.nih.gov/grants/stafflist_gmos.htm
• Grants Policy Interpretation Consultation
• E-Mail GrantsPolicy_at_mail.nih.gov
• Phone [phone]
• Compliance Issues
• E-Mail GrantsCompliance_at_mail.nih.gov
• Phone [phone]

125
Grants Information Who to Contact!

• General Application Questions (Including
  e-Submission guidelines, resources referrals,
  application review award process, etc.)
• E-Mail GrantsInfo_at_nih.gov
• Phone [phone]
• Customer Support for Grants.gov (navigating
  forms, aspects of submitting through the system,
  resources available, etc.)
• E-Mail support_at_grants.gov
• Webpage http//grants.gov/
• Phone [phone]
• eRA Commons Help Desk (Including Commons
  registration help, application verification,
  Commons functionality questions, etc.)
• E-Mail commons_at_od.nih.gov
• Webpage https//commons.era.nih.gov/commons/inde
  x.jsp
• Phone [phone] (Toll Free 866-504-9552)