OLAW Guidance on PHS Policy on Humane Care and Use of Laboratory Animals Provided in Frequently Asked Questions
Notice Number: NOT-OD-06-101
Key Dates
Release Date: September 11, 2006
Issued by
Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research (
http://grants.nih.gov/grants/olaw/olaw.htm )
This Notice announces the availability of a series of Frequently Asked Questions
(FAQs) at
http://grants.nih.gov/grants/olaw/faqs.htm about the PHS Policy on Humane
Care and Use of Laboratory Animals (PHS Policy) (
http://grants.nih.gov/grants/olaw/references/phspol.htm ).
Background
Between 1990 and 2003 OLAW (and its predecessor the Division of Animal
Welfare, Office for Protection from Research Risks) published a number of
articles in journals and magazines such as ILAR News, Lab Animal, and
Contemporary Topics, that provided guidance or commentary for the Institutional
Animal Care and Use Committee (IACUC) community concerning issues associated
with the PHS Policy. In the early 1990s, OPRR also issued a number of “Dear
Colleague” letters addressing various PHS Policy requirements and related
issues.
Frequently Asked Questions Posted
Nearly 60 FAQs are now posted that address a significant number of the
topics previously addressed in the publications noted above. The information in
the FAQs is updated and supersedes previously published guidance or commentary.
However, in many instances the previously published material provides additional
information or elaboration, and is therefore available through hyperlinks
provided on the FAQ site.
In addition, the FAQs provide guidance on topics not previously addressed,
including the Freedom of Information Act, post approval monitoring, HVAC
malfunctions/failures, and rodent cage density.
Institutions are encouraged to review the FAQs and make use of this new
resource. As necessary, OLAW will update the site with new FAQs.
Inquiries
For questions or further
information, contact:
Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health
Rockledge 1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982
phone: 301-496-7163
fax: 301-402-2803
e-mail:
olaw@od.nih.gov
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Department of Health |
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National Institutes of Health (NIH) |
NIH and AHRQ Publish Edits to the Ruth L. Kirschstein Individual Fellowship Application (PHS 416-1) Instructions
Notice Number: NOT-OD-07-002
Key Dates
Release Date: October 5, 2006
Effective Date: October 5, 2006 (Immediately)
Issued by
National
Institutes of Health (NIH), (http://www.nih.gov)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov/)
The instructions in the PHS416-1 have been revised to clarify the following issues. The revised instructions and Form Pages are required to be used immediately in all application submissions regardless of submission date. Revised instructions and Form pages have been posted on the NIH Forms Page at: http://grants1.nih.gov/grants/funding/416/phs416.htm
Face
Page, Item 4b ERA Commons User Name
This item is now a required field for NIH applications. The NIH announced in
NIH Guide Notice
NOT-OD-06-066 that all notifications for assignment mailers would be
discontinued. In a previous Notice (NOT-OD-05-075)
NIH announced the elimination of mailing Peer Review Outcomes and Summary
Statements. Since these procedural changes affected individual fellowship
applications as well, applicant/fellows must now be registered in the eRA
Commons in order to access assignment mailer information, summary statements as
well as other useful information and documents. Applicant/Fellows should work
with the administrative officials at the sponsoring institution to be
registered.
There has been some reluctance in research organizations to create eRA Commons accounts with the PI role for Fellows. Designating the PI role in the eRA Commons for an individual does not bestow on them any special status. It is merely the name of the role within the electronic system that provides the administrative authority needed to see pertinent information regarding an application (e.g., summary statements, scores, electronic submission status, etc.). See Guide Notice OD-07-003 for additional information on registering individual fellows in the eRA Commons.
Form
Page 5, Item 27, Doctoral Dissertation and Other Research Experience
The instructions have been clarified for this section.
Unless otherwise instructed in a specific
Funding Opportunity Announcement, applicants for early
(pre-dissertation) Predoctoral and Senior Fellowships should omit their doctoral
dissertation, but should include any other research experience, if applicable.
Advanced graduate students (ONLY) must also include a narrative of their
doctoral dissertation (may be preliminary) and any other research experience
under item 27. The information is required of advanced graduate students who
have successfully completed their comprehensive examinations or the equivalent
by the time of award and will be performing dissertation research.
Checklist, Section I.D. Tuition and Fees
The instructions have been modified to reflect the new policy concerning
reimbursement of tuition, fees and health insurance (See
NOT-OD-06-093).
Publications in Appendix Material
As announced in NIH Guide Notice
NOT-OD-06-053, when publications are publicly available in on-line journals,
applicants should provide links to the on-line journals in lieu of providing a
paper copy of the publication. This policy change applied to all applications,
including individual fellowships. The instructions have been revised to reflect
this policy change.
Other minor editorial corrections have been made throughout the instructions.
Inquiry
Questions concerning these changes 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
Telephone: (301) 435-0938
FAX: (301) 435-3059
Email:
GrantsPolicy@od.nih.gov
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National Institutes of Health (NIH) |
NIH Announces Requirement for Detailed (Non-Modular) Budget Submissions for All Competing Grant Applications from Foreign (Non-U.S.) Institutions
Notice Number: NOT-OD-06-096
Key Dates
Release Date: August 23, 2006
Issued by
National
Institutes of Health (NIH), (http://www.nih.gov/)
The purpose of this Notice is to inform the research community that all competing grant applications (new, competing continuation/renewal applications, amended/resubmission, and competing supplement/revision) from foreign (non-U.S.) institutions must include only detailed (non-modular) budgets. In recent years the number of grantees in foreign sites has expanded significantly. Providing a budget from our foreign applicants will allow the NIH staff to assist this applicant community with applicable regulatory and policy requirements for grant funding expenditure.
This policy is effective with applications prepared for submission dates on or after October 1, 2006 and affects all application formats (SF424 (R&R) and PHS 398). This Notice replaces instructions in all active Funding Opportunity Announcements; individual announcements will not be updated.
Applications from foreign
(non-U.S.) institutions submitted via Grants.gov using the
SF 424 (R&R):
Follow the Research & Related Budget Component Instructions. Complete and submit
the RESEARCH & RELATED BUDGET forms. Do not complete or submit the PHS 398
Modular Budget component.
Applications from foreign (non-U.S.) institutions submitted using the
PHS 398: Follow the
NON-MODULAR FORMAT instructions and submit Form Page 4 and Form Page 5. Do not
complete or submit the Modular Budget Format Page.
This change does not impact applications from domestic (U.S.) institutions. Domestic institutions submitting applications for grant mechanisms that use the modular budget (R01, R03, R15, R21, and R34) that request $250,000 in direct costs or less for all years must continue to use the modular format even if the application includes a subaward with a foreign (non-U.S.) institution.
Inquiry
Inquiries on this NIH
Guide Notice may 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
Telephone: (301) 435-0938
FAX: (301) 435-3059
Email:
GrantsPolicy@od.nih.gov
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NIH Policy on Late Submission of Grant Applications
Notice Number: NOT-OD-06-086
Key Dates
Release Date: August 11, 2006
Issued by
National Institutes of Health (NIH),
(http://www.nih.gov/)
Purpose
This notice provides an update and further clarification of the policy published on January 27, 2005 (Notice OD-05-030). The new dates for AREA applications are included as is information about the New Investigator Pilot. Further details about the process of accepting late submissions are provided.
NIH expects that grant applications will be submitted on time. Standing dates are listed at: http://grants.nih.gov/grants/funding/submissionschedule.htm.
- For applications that are required to use paper format these are submission or postmark dates; applications are on time if they are sent on these dates.
- For applications that are required to use electronic submission this requires successful submission to Grants.gov by 5 p.m. local time on the date indicated.
- For both paper and electronic submissions, when these dates fall on a weekend or holiday, they are extended to the next business day. However, Requests for Applications (RFAs) and Program Announcements with Special Referral Considerations (PARs) with special receipt dates always must be received (by Grants.gov for electronic applications and the Center for Scientific Review for paper applications) on the dates designated in the announcement to be on time. This is clearly noted in the website above and in the text of each RFA/PAR.
The long standing NIH policy on late applications is stated in the application instructions. Late applications are generally not accepted. Permission for a late submission is not granted in advance. In rare cases, late applications will be accepted but only when accompanied by a cover letter that details compelling reasons for the delay. While the reasons are sometimes personal in nature, an objective evaluation of their merit requires that some details be provided. It is not sufficient, for example, to state simply that there has been an unforeseen circumstance that delayed submission. Specific information about the timing and nature of the cause of the delay is necessary so that a decision can be made. Only the explanatory letter is needed; no other documentation is expected.
NIH will consider accepting late applications based on the acceptability of the explanation and the processing time required for two different kinds of submission dates:
- Regular Standing Submission Dates: January 10, February 1, February 25, March 1, May 10, June 1, June 25, July 1, September 10, October 1, October 25, November 1. Applications must be received at the NIH within two weeks of the standing submission date.
- Expedited Standing Submission Dates: April 1, April 5, April 15, May 1, August 1, August 5, August 15, September 1, December 1, December 5, December 15, and January 2. Applications must be received at the NIH within one week of the standing submission date.
The windows of time for consideration of late applications have been carefully chosen so that the late applications can be processed with the cohort of on-time applications. In all cases, when the regular standing submission date or expedited submission date falls on a weekend or federal holiday and is extended to the next business day, the window of consideration for late applications will be calculated from that business day. Note that the late window always ends in a receipt (not submission) date for both paper and electronic applications.
NIH will not consider accepting late applications for the Special Receipt Dates for RFAs and PARs. This includes the special receipt dates (March 20, July 20, and November 20) for resubmission/amended applications that are part of the New Investigator Pilot (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-060.html).
NIH will consider all late applications received within the window of time specified above but will not automatically accept all of them. The reasons for the delay will be carefully considered by the Division of Receipt and Referral at the Center for Scientific Review and a decision made. In unusual cases the reasons provided will be considered by senior staff of CSR; Institutes/Centers will be consulted for applications that are their review responsibility. Applications submitted within the window with reasons that are not found to be acceptable will be returned without review. NIH does not expect to accept any applications received beyond the window of consideration.
In the past, late applications have been accepted for reasons such as: death of an immediate family member of the Principal Investigator, sudden acute severe illness of the Principal Investigator or immediate family member, or large scale natural disasters. Recent service by the Principal Investigator only (this does not include other participants in the application) on an NIH extramural review group that could reasonably be expected to require a time commitment that could have been used to prepare an application is also an allowable reason. Note this applies only to NIH extramural review activities, not those of other Federal agencies or private organizations. Examples of reasons that have not led to the acceptance of a late application are: heavy teaching or administrative responsibilities, relocation of laboratory, health problems, personal events, or review service for participants other than the principal investigator, attendance at scientific meetings, or having a very busy schedule.
It is important to emphasize that these various examples are just that, examples. No NIH staff member whether in the Center for Scientific Review or any of the other Institutes/Centers has the authority to give permission in advance for a late application. Contacting the Division of Receipt and Referral or any other component of the NIH will not lead to either permission to submit late or an evaluation of the acceptability of the reasons for a delay.
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Notice of New NIH Policy for Funding of Tuition, Fees, and Health Insurance on Ruth L. Kirschstein National Research Service Awards
Notice Number: NOT-OD-06-090
Key Dates
Release Date: August 4, 2006
Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
The NIH announces a change in policy for funding of tuition, fees, and health insurance costs associated with Ruth L. Kirschstein National Research Service Awards (NRSA). The new policy applies to new and competing-continuation (renewal) NRSA institutional research training grants (T32, T34, and T35) beginning in fiscal year (FY) FY 2007, and competing individual fellowships (F30, F31, F32, and F33) awarded beginning in FY 2007. It also applies to institutional research training grants that received competing awards in FY 2006. For this cohort, the FY2007 non-competing awards will be issued recalculating budget categories to reflect this new policy.
Background
The NRSA program has been
used by the NIH as the primary means of supporting graduate and postdoctoral
research training since enactment of the NRSA legislation in 1974. This program
uses a combination of institutional training grants and individual fellowships
to ensure a continuing cadre of well-trained scientists prepared to conduct and
lead health-related research. Currently, the NIH reimburses 100% of the
requested tuition, fees, and health insurance costs up to $3,000 and 60% of the
costs above $3,000, per trainee (NIH
Grants Policy Statement, 12/2003). Due to the rising costs for tuition,
fees, and health insurance, NIH temporarily limited support for these costs for
FY 2006 competing applications for NRSA institutional training grant support (NOT-OD-05-059).
In November 2005, the NIH held a
Town Hall Meeting to hear comments and insights concerning NRSA fiscal
policies. Several potential modifications to the NIH's current tuition, fees,
and health insurance formula were discussed at the meeting. The NIH considered
the feedback from the meeting participants and other stakeholders, evaluated and
modeled several options, and solicited additional comments from the stakeholders
(NOT-OD-06-064).
NIH received two differing perspectives from the communitypart of the community
places highest priority on maintaining the current total number of Kirschstein
NRSA supported trainees and fellows; another part of the community places
highest priority on limiting the additional costs of training that must be born
by the awardee institutions. In developing this policy, NIH has sought to
balance the need to maintain the preparation of future investigators with a
desire to moderate the impact on the extramural research training community.
The NIH realizes the potential impact of the new policy, acknowledges the
difficulty in deciding among the various options, and has strived to reach an
equitable balance amongst them in the following policy, which will be
implemented as a pilot to provide a basis for an analysis to reconcile these
perspectives.
New Policy
Institutional Training Grants
Effective with new and competing renewal institutional NRSA awards made in FY
2007 and for non-competing awards in FY 2007 for programs that received
competing awards in FY 2006, the NIH will provide funds for tuition, fees,
health insurance, and training related expenses, as detailed below.
- Tuition and fees: For institutional training grants (T32, T34, and T35), an amount per predoctoral trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D, D.D.S.-Ph.D.), the amount provided per trainee will be up to $21,000 per year. For institutional training grants (T32 and T35), an amount per postdoctoral trainee equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports postdoctoral individuals in formal degree-granting training, the amount provided per trainee enrolled in a degree-granting program will be up to $16,000 per year.
- Training related expenses: For institutional training grants (T32, T34, and T35), the training related expenses category will be modified to include health insurance as an allowable expense. An additional $2,000 per predoctoral trainee, per year, and an additional $4,000 per postdoctoral trainee, per year, will be provided in this category. This category will continue to be referred to as training related expenses but will now include health insurance as an allowable cost.
- Individual Fellowships
Effective with competing individual NRSA awards made in FY 2007, the NIH will provide funds for tuition, fees, health insurance, and institutional allowance, as detailed below.
- Predoctoral Institutional Allowance: For individual predoctoral fellowships (F30 and F31), the institutional allowance category will be modified to include health insurance as an allowable expense. An additional $1,450 per predoctoral fellow per year will be provided in this category.
- Postdoctoral Institutional Allowance: For individual postdoctoral fellowships (F32 and F33), the current institutional allowance category already includes health insurance as an allowable cost. The NIH proposes to adjust the funding provided under this category so that it is comparable to that provided via the new health insurance and training related expenses category of postdoctoral institutional training grants. Specifically, an additional $850 per postdoctoral fellow, per year, will be provided in this category which will be referred to as health insurance and institutional allowance.
The following table summarizes differences between the old policy and the new policy.
|
Institutional Training Grants |
||||
|
Award |
Predoctoral |
Postdoctoral |
||
|
OLD |
NEW |
OLD |
NEW |
|
|
Stipend |
$20,772 |
$20,772 |
$35,568-$51,036 |
$35,568-$51,036 |
|
Tuition/Fees |
$3,000 + 60% above
$3,000 |
60% up to $16,000 |
$3,000 + 60% above
$3,000 |
60% up to $4,500 |
|
Training Related Expenses |
$2,200 |
$4,200 |
$3,850 |
$7,850 |
|
Trainee Travel (per trainee) |
$400-$1,000 |
|||
|
F&A |
8% (excludes tuition/fees/health insurance, equipment) |
|||
|
Individual Fellowships |
||||
|
Award |
Predoctoral |
Postdoctoral |
||
|
OLD |
NEW |
OLD |
NEW |
|
|
Stipend |
$20,772 |
$20,772 |
$35,568-$51,036 |
$35,568-$51,036 |
|
Tuition/Fees |
$3,000 + 60% above
$3,000 |
60% up to $16,000 |
$3,000 + 60% above
$3,000 |
60% up to $4,500 |
|
Institutional Allowance |
$2,750
|
$4,200 |
$7,000 |
$7,850 |
- *Higher figures are applicable to Public and Private Non-Profit Institutions. Lower figures are applicable to Federal and For- Profit Institutions.
The new policy is a pilot that will be evaluated after data have been collected for two full years.
The NIH recognizes the potential impact of the new policy on sponsoring institutions, but notes that institutions have considerable flexibility in their use of the awarded funds as described in the NIH Grants Policy Statement. See: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm.
This Notice modifies policy for NRSA institutional awards for this cohort of new and competing grants referenced above as follows:
Beginning with awards issued with FY2007 dollars, funds may be rebudgeted as follows:
- Trainee-related expenses (now includes Health Insurance as an allowable expense). Rebudgeting of funds awarded in a lump sum for trainee-related expenses is allowable without NIH awarding office prior approval.
- Trainee costs (now excludes Health Insurance). For rebudgeting purposes, trainee costs include funds awarded in the stipends and tuition/fees budget categories. These costs may not be used for other purposes except under unusual circumstances and then only with the prior approval of the NIH awarding office. Unless otherwise restricted, rebudgeting into or within the stipends, tuition, and fees categories is allowable without prior approval of the NIH awarding office.
- Trainee travel. For rebudgeting purposes, trainee travel is not considered a trainee cost and, therefore, may be rebudgeted into any other budget category without prior approval of the NIH awarding office.
For those institutional
training grants not immediately affected by this policy change, existing
budgeting and rebudgeting policies will continue to apply until such time as the
program is awarded under the new guidelines.
For those individual fellowships not affected by this policy change, existing
budgeting and rebudgeting policies will continue to apply until the end of the
fellowship project period.
Opportunity to Rebudget Formally
- As part of the two year pilot, institutions that choose to rebudget between stipends and tuition/fees for institutional (T32, T34, and T35) programs will notify NIH as part of the budget justification in each annual progress report. Currently in the annual progress report grantees are instructed to indicate whether all stipends awarded for the current budget period will be used. This instruction will be modified to request specific information from grantees that choose to rebudget awarded positions into the tuition and fees category, including the number of trainee positions (predoc and postdoc) and the estimated dollar figure that was rebudgeted during the budget period being reported. Similar information will be requested about plans for rebudgeting during the coming budget period. The recommended levels will remain as committed in the initial competing award; however, adjustments in support may occur as a result of other budgetary and administrative issues during the course of the project.
Evaluation Plans
The use of the rebudgeting option along with other aspects of this policy will
be evaluated following the pilot period; e.g., progress reports submitted in
FY2008 & FY2009. During early FY2010, data collected on the use of the
rebudgeting option will be evaluated to determine if the data: 1) are adequate
for analysis; and 2) support a reassessment or implementation of a final policy
for a longer term.
- The final policy, expected to be issued by July 2010 (FY2010), will be applied to competing awards made in FY2011.
Inquiries
Inquiries concerning this
Notice may be directed to:
Office of Extramural Programs
National Institutes of Health
Email:
NIHTrain@mail.nih.gov
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Item of Interest July 13, 2006
There are exceptions to every rule
Yesterday, we provided an update on our Version 2 forms implementation. As weve all figured out by now, updating forms in this brave new electronic world is messy business. We did our best to introduce the Version 2 forms to existing Funding Opportunity Announcements (FOAs) at a time that would be the least disruptive to applications in progress for standard submission dates. There just isnt any time, however, that misses ALL submission dates. So we have identified about a dozen FOAs that are exceptions to the general update rules.
Here is the general rule so you can have this all in one place:
|
Release/Posted Date of FOA |
Expiration Date |
Grant Mechanism |
Use New Forms |
|
Before June 15, 2006 |
On/Before Dec. 31, 2006 |
All mechanisms |
N/A - will be allowed to close gracefully with no form change. |
|
Before June 15, 2006 |
After Dec. 31, 2006 |
R03, R15, R21, R21/R33, R33, R34, R36 and XO1 |
After July 18, 2006 |
|
Before June 15, 2006 |
After Dec. 31, 2006 |
SBIR/STTR (R43, R44, R41, R42), R13/U13 |
After Sept. 15, 2006 |
|
On/After June 15, 2006 |
Any |
All mechanisms |
Immediately initial posting will include new form package. |
The following group of eleven FOAs will be held for reposting of the Version 2 forms until 9/15/2006, since the next submission dates for these FOAs are too close to the update dates in the general rule.
|
Announcement |
Issuing |
Release |
Opening Date |
Expiration |
Activity |
Title |
|
Number |
Organization |
Date |
|
Date |
Code(s) |
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NIDCD |
3/2/2006 |
5/2/2006 |
2/23/2007 |
R21 |
NIDCD Translational Research Grants (R21) |
|
|
AHRQ |
1/13/2006 |
3/10/2006 |
4/11/2008 |
R36 |
AHRQ Grants for Health Services Research Dissertation (R36) |
|
|
NIMH |
3/3/2006 |
3/3/2006 |
1/3/2008 |
R36 |
Mental Health Dissertation Research Grant To Increase Diversity (R36) |
|
|
NCI |
3/29/2006 |
5/2/2006 |
4/10/2008 |
R21 |
Quick-Trials for Imaging and Image-Guided Interventions: Exploratory Grants (R21) |
|
|
NCI |
3/29/2006 |
5/2/2006 |
11/22/2008 |
R03 |
Small Grants Program for Cancer Epidemiology (R03) |
|
|
NCI |
4/4/2006 |
5/2/2006 |
12/21/2007 |
R03 |
Cancer Prevention Research Small Grant Program (R03) |
|
|
FIC |
5/17/2006 |
5/17/2006 |
8/24/2007 |
R21 |
Brain Disorders in the Developing World: Research Across the Lifespan (R21) |
|
|
AHRQ |
6/7/2006 |
6/24/2006 |
11/25/2008 |
R03 |
AHRQ Small Research Grant Program (R03) |
|
|
NCI |
6/9/2006 |
6/9/2006 |
12/10/2007 |
R21 |
Quick-Trials for Novel Cancer Therapies: Exploratory Grants (R21) |
|
|
NCI |
6/12/2006 |
6/12/2006 |
12/23/2008 |
R03 |
Small Grants for Behavioral Research in Cancer Control (R03) |
|
|
NINDS |
6/14/2006 |
7/18/2006 |
4/21/2009 |
R34 |
NINDS Clinical Trial Planning Grant (R34) |
In addition, the following AHRQ R13/U13 FOA was moved from the 9/15 round to the 7/18 round, since it uses standard research submission dates:
|
Announcement |
Issuing |
Release |
Opening Date |
Expiration |
Activity |
Title |
|
Number |
Organization |
Date |
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Date |
Code(s) |
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