2008 Potential Extramural
Projects (PEPs)
Research Specific Questions
Non-Research Specific Questions |2008-R-02|2008-R-04|2008-R-06|2008-R-07|2008-R-08|2008-R-09|2008-R-13|
|2008-R-14|2008-R-15|2008-R-21|2008-R-22|2008-R-24|2008-R-28|
2008-R-02 Question: I wanted
to clarify what type of study design would be appropriate in response to PEP 2008-R-02,
“Improving postpartum follow up in women with a gestational diabetes-affected
pregnancy.” Given the limited funding, if an intervention were implemented would
it be appropriate to compare post intervention levels of testing to pre-intervention
levels of testing rather than prospectively obtaining information from clinics/women
who do and do not receive an intervention. Chart review would be required to determine
pre-intervention levels of postpartum testing.
Answer: Question
submitted to CDC on February 29, 2008. Response pending.
Question:
I wanted to clarify the objective of the PEP 2008-R-02, "Improving postpartum
follow up in women with a gestational diabetes-affected pregnancy." Under "awardee
activities" in the announcement it lists "to implement and evaluate an intervention..."
I am wondering if you are specifically looking for intervention studies, or whether
studies that focus on planning a future intervention would still be applicable.
The listed objectives in the announcement seem to be focused on planning an intervention
(e.g. "identify strategies," "identify factors"). Answer: The
proposed project should plan, implement, and evaluate an intervention. However,
we understand that the amount of the award might be a limiting factor, and are
willing to consider a pilot study. If the prospective applicant is describing
a pilot study, then that would be acceptable.
Question: Are
any costs associated with the clinical care of these patients (e.g., the cost
of their GTTs) permissible in the project budget? Answer: Question submitted
to CDC on February 29, 2008. Response pending.
Top 2008-R-04Question:
We will be collecting data at various points from both intervention and control
groups. If OMB is required, this will certainly play a role in our study timeline.
Is OMB clearance required for this study? Answer: If the data
is being collected from 10 or more persons, then OMB clearance would be needed.
Since we do not know exactly what type of data will be collected for this study,
we are not sure if clearance is needed. Question: The call stated
the application should focus on women with a recent history of gestational diabetes.
Could you offer more explanations about "recent"? Newly diagnosed? Or diagnosis
in the past 1-2 years etc.? Answer: Women who are 1-2 years out
from their diagnosis would be included in the definition of "recent." Question:Does
the agency expect the applicant to propose a study with statistical power to detect
significant differences? Answer: We realize that funds are limited,
and that some applicants may prefer to submit a pilot study. This is acceptable.
Question: Are any costs associated with the clinical care
of these patients (e.g., the cost of their GTTs) permissible in the project budget? Answer:
If the applicant would like to use some of the project funds to cover the cost
of GTTs, this is permitted.
Question: Page 3 of the
PEP identifies 5 CDC activities. We are pleased that an opportunity to collaborate
with CDC is part of this project, but request some additional details regarding
CDC's level of engagement and contribution to this project, as they will impact
the scope and budget of our proposal. We have questions for items 1, 2, and 4
on this list:
(A) The first CDC activity is "Provide technical assistance
in designing, developing,and evaluating methodologies and data collection tools
to be used in the project." Does CDC have pre-existing preferences about the methodolgy
that should be included in proposals? Does CDC already have a data collection
tool in mind? Answer: No, the CDC does not have preferences about
the methodology or data collection tools, other that what was presented in the
PEP previously.
(B) The second CDC activity is: "Assist in identifying
resources that can be used for planning and executing the project." What type
of resources are anticipated? Should these be part of the proposal?
Answer:
This could include consultation with experts at CDC or elsewhere if needed, identification
of existing study tools, or similar resources. It isn't necessary to include this
in the proposal, but if the applicant knows of specific resources available at
CDC that they would like to use (such as consultation with a specific individual
or group), they can include them if they wish
(C) The fourth CDC activity
is "Assist in data analysis and interpretation of findings." Will CDC staff actively
participate in data analysis?
Answer: CDC staff would
participate in decisions about what specific analyses should be done, but do not
necessarily expect to have direct access to identified data. Top 2008-R-05Questions:
The guidance notes: "Provide a description of how the revised tool will be
validated using external experts in instrument development, testing, and validation."
Does the expert have to be "external" to the school or can the school
involve other faculty/staff that are experts in instrument development, testing
and validation? If not, please clarify the criteria of an external expert.
Answer:
Question submitted to CDC on March 6, 2008. Response pending.
Top
2008-R-06Question: 2008-R-06 -
Ntl Center on Birth Defects and Developmental Disabilities Will NCBDDD only consider
projects that are multi-state or will they consider proposals that include population-based
data, representing diverse populations, from one state? Answer: If
the state has a large, diverse population the proposal will be accepted for review.
Top 2008-R-07Question:
Language in the PEP suggests that an activity that the CDC would like performed
in this project is an analysis of "an existing cohort study conducted by CDC and
Peking University Health Sciences Center." Since the details of this activity
is very vague it would be difficult for anyone not already familiar with this
Peking University cohort study to write a successful application building it into
the work plan. My questions are the following. 1) Does the CDC already have a
partnership with a US university in the conduct of this Chinese cohort study?
2) Is there more information that can be provided about this cohort and was the
CDC planning on providing it to potential applicants prior to submission of the
LOIs? Answer: The following resources will assist applicant's
in preparing their proposals: Berry RJ, Li Z, Erickson JD, et al. Preventing
neural tube defects with folic acid in the People's Republic of China. N Eng J
Med 1999; 341:1485-1490. Berry RJ, Li Z. Folic acid alone prevents neural
tube defects: evidence from the China study. [Letter] Epidemiology 2002;13:114
-116. Question: Our question is whether our subject matter is fundable
under the objective of CDC for 2008-R-07. We wish to study women at a reproductive
age from a cohort of 2147 white and black females followed from childhood. This
will provide evidence of health risk associated with what is considered the "cardiometabolic
syndrome". We have a unique population followed over 34 years from childhood that
could give insight to very common health risks in the childbearing age, such as
hypertension, obesity, insulin resistance, that affect preeclapsia, birth weight,
and CV-renal-diabetic disease in women. The childhood developmental data and black-white
contrasts are very important to diseases in young women. Is this of sufficient
interest to CDC for us to compete for a grant to do this study? Are we eligible?
Thank you for your interest. Answer: This cohort might be adequate
for addressing the first objective, but it might not be adequate for addressing
the 2nd and 3rd objectives. Without looking at a more detailed proposal and the
power calculations based on their data, it is hard to tell. Additionally, the
cohort being followed may not be representative of the general population and
adequate for yielding generalizable knowledge on cardiometabolic risk factors. Top 2008-R-08Question:
We would like to apply for using cancer registries to track measures of care in
colorectal and breast cancer. We have a question related to whether our proposal
would be responsive and competitive in the PEP. We have already done much of what
was asked for in the PEP. Our plan for our study would be to add clinical data
to the registry and use this clinical data to test the validity of conclusions
reached by analyzing administrative data. Are you interested in projects that
use medical record as well as administrative data? Your input would help a great
deal with our planning for this proposal. Answer: The intent
of the PEP is to supplement data that is missing from the registry data. Proposals
that test the validity of data found in the registry are acceptable. Question:
Should the proposal focus on data sources that are applicable on a national or
regional basis?
Answer: It should be from state-based to national.
Question: The title suggests this is a feasibility study however
the "Awardee Activities" seems to indicate specific plans rather than an assessment
of feasibility as the expected outcomes. Please clarify.
Answer:
Yes. It is a feasibility study. However, we expect a protocol to be developed
that can be used by others.
Question: In the first paragraph
under "Awardee Activities", proposals are directed to include "quality measures
for risk factor reduction" while the rest of the proposal specifically focuses
on measures of care for diagnosis and treatment. Please clarify the scope of quality
measures that should be included in the proposal.
Answer: The
diagnostic and treatment measures are required. We are interested in how other
quality measures might be obtained from administrative data.
Top 2008-R-09Question:
Please clarify scope of work: Is the intent to develop a plan during the first
year--to be implemented in year 2--or if by end of year 1 grantees should have
implemented the partnership--increased referrals/linkages across partners--and
have some data to show success. Answer: The intent of this PEP
is to develop a plan during the first year, to be implemented in year 2. Top 2008-R-13Question:
For this PEP application, the goal is to obtain national level estimates that
will be representative of US women aged 40 and older (via telephone interviews).
The instructions ask for a sample that is representative of the US population
in terms of age, race/ethnicity, income, region of residence and insurance coverage.
Is it acceptable to use a listed sample as opposed to random digit dialing (RDD)?
While RDD could achieve a better representative (in terms of capturing non-listed
numbers) it would be time consuming and financially prohibitive. Answer:
The applicant should list the pros and cons of the listed sample method and also
other potential sampling methods in their proposal. If the listed sample method
is the best way to collect representative and useful data using the provided funds,
a justification should be provided in the proposal. Question:
For this PEP application, the instructions ask for development of strategies for
enrolling participants, and plan for "non-compliant" participants. Are we to assume
that "non-compliant" participants are those who are not willing to complete a
telephone survey? Answer: Yes, non-compliant participants
are individuals who are not willing to complete the survey. Top 2008-R-14Question:
Does CDC anticipate that the project will also fund the actual conference, or
just the background research and planning for the conference? The budget of $150K
is hardly sufficient to actually put on such an international conference. Answer:
This PEP will fund background research and planning only, not conducting the
conference. Top 2008-R-15Question:
Under Awardee Activities it lists a variety of activities that seem like they
would be elements of a protocol the awardees would actually implement if funded.
Correct? As it is worded it can be construed as saying that the awardees would
plan such a study, but not implement it. Perhaps it is better to think of the
Awardee Activities section as a Application Elements section. Please confirm that
part of the deliverables from the Awardee involves the actual recruitment of a
small retrospective AIAN cohort and conducting the research outlined in the RFA
not just preparing a proposal for it. Answer: The grantee will
develop, plan and conduct the research activities. Question:
The RFA states " Outcomes should include, . . . description of appropriate methods
to use for follow-up of AIAN men with elevated PSA tests." Our question is: by
"follow-up: do you mean clinical follow-up (i.e. recommendations on how to get
patients back in to clinics to be taken care of) or recommendations to retain
and track patients enrolled in future research (like a prospective cohort study)?
Answer: We want follow up to include if a patient with elevated
PSA was referred to a urologist, if he kept that appt, if a biopsy was done, if
he was determined to have prostate cancer, what treatments he was offered, and
did he get treated. We are interested if the system worked for him or if he was
lost before being treated. Question: My question relates to
the survey cohort. Will it be acceptable to select a cohort who has undergone
biopsy (with and without diagnosis of prostate cancer)? I'm concerned about the
ethical--and malpractice--issues related to contacting men with an elevated PSA
who have not undergone a biopsy (especially if they have not been referred to
urology). Answer: The intent of this PEP is to determine: 1) if
men have been referred to a urologist and 2) if referred, what was the follow-up
(biopsy received or not?) - in order to identify gaps in service (where men might
fall through the cracks). The referral process could be one of these places. If
the cohort is of biopsied men, the ability to assess the earlier steps in the
process is lost. Top 2008-R-21Question:
In this PEP, the awardee is to provide serum specimens for the detection of HSV-2
antibodies either from existing repositories or prospectively. Does the CDC have
a preference as to which type of specimens are used? Answer: CDC
does not necessarily prefer one type of specimens over the other. The applicant
should use the approach that is best in meeting the study objectives after taking
all important factors, such as potential biases, representativeness of the samples,
and feasibility and cost etc, into consideration. Question: I
am interested in applying for this grant but the study population I have identified
is 25 years or older (this was the entry criteria of the study with the pre-collected
sera). All the other sex, race/ethnicity an geographic criteria are met. My question
is whether it is worthwhile to apply given this drawback? Answer:
Because the distribution by age was listed under Special Requirements, limiting
the study population to those 25 years of age and older may affect the overall
score of the application. However, CDC would still consider this application,
and if the application is otherwise strong.
Questions: Since
one of CDC's stated activities are to "purchase and ship the test kits needed
to the testing laboratories after the algorithm(s) for screening and additional
testing are finalized in discussion with the awardee," may investigators exclude
the costs of the test kits (HSV-1,HSV-2, and HIV) from project budgets? Should
shipping costs also be excluded?
Answer: The proposals do not
need to include test kit cost nor costs for shipping the kits.
Question:
The grant request states "In collaboration with CDC, (the awardee will)…develop
the algorithm(s) to be evaluated for HSV-2 serodiagnosis using serologic test
kits that re either currently available in the US or have ....". This statement
suggests that although a plan for testing the specimens may be suggested in the
proposal, the actual plan of testing will be decided after the awarding of the
grant in conjunction with the CDC. This would impact both the statistical analysis
and the budget. Is this a correct interpretation? Answer: It
is true that the plan would impact the statistical analysis and the budget. We
still want the applicant to propose a plan. If modifications are made, we can
accommodate changes in budget later the project period.
Top
2008-R-22Question:
The guidance requires the project to conduct a study group with a period of 18
months It will be difficult to complete the project within 2 years given the enrollment
period. Will CDC entertain a scope of work for a 3-year period? If not, will CDC
consider a planned no cost extension period?
Answer: Question
submitted to CDC on March 6, 2008. Response pending. Top 2008-R-24Question:
Regarding the "associated long-term care healthcare facilities," would a subacute
rehabilitation facility (with average length of stay of several weeks) be acceptable
in place of or in addition to a long-term care facility? Answer:
Yes, inclusion of a subacute rehabilitation facility would be acceptable in
place of or in addition to a long-term care facility.
Question:
After doing some budget preparation, we are concerned that the amount of funding
offered per year will not be enough to support the project. We are both really
interested in doing this, but want to make sure that we are able to do it in the
proper way. After looking at our own institutional statistics, we have come up
with one potential solution to this problem. It appears that a single year of
surveillance would provide a substantial number of cases and that a second year
of surveillance may not be necessary. We wondered if it would be possible to have
the two-year funding total compressed into a shorter time period (either 12 or
18 months).
Answer: In the application it states that surveillance
for the organisms would be for one year- FY 2009. Hence the answer to this question
(in my opinion) is: "Though funding cannot be compressed into a 12-18 month period,
the intent was that surveillance for the KPC producing organisms would only occur
for 1 year of project- FY 2009".
Top 2008-R-28Question:
Are you expecting that a retrospective chart review would be conducted to identify
subjects who had postpartum hemorrhage and matched controls, and then these subjects
would be contacted to request a blood sample? Or is there another scenario where
patients could be enrolled prospectively, blood samples obtained, and then only
analyzed if postpartum hemorrhage occurred? (This doesn’t seem to fit the standard
definition of a retrospective study.) Answer: The original intention
was to recruit and enroll women still in the hospital for PPH and obtain a blood
sample as well as administer a questionnaire. There would also be a retrospective
chart review to gather data regarding medical history. However, depending on the
facility, there could be a retrospective chart review to identify patients. If
the facility or institution can provide a convincing argument that they would
be able to easily contact these patients and obtain a blood sample and questionnaire
data, that would be acceptable. Question: In the RFP, it states
that the CDC staff will be involved in the project and that analysis of venous
blood samples will occur by them. In the list of awardee activities it states
that a plan for blood sample management needs to be proposed. It would be important
to know what kinds of analysis will be performed on the blood samples in order
to build a plan for handling the samples. For instance, will tubes need to be
centrifuged so that testing can be done on the plasma, or will whole blood be
desired and if so how should the blood sample be anticoagulated? Will they need
to be refrigerated or frozen? Answer: Laboratory analyses will
include testing for coagulation, factor, and, hopefully, platelet abnormalities.
The study site will perform tests for ferritin, CBC, liver function, and TSH levels.
The samples will need to be centrifuged on site and processing should be completed
within 2 hours of blood draw. Sites should store samples at -70° C and ship to
CDC on dry ice. In terms of testing for platelet function, those tests will have
to be done on site and within 2 hours of blood draw. CDC would work with sites
to help them obtain an aggrogometer, if needed. CDC will conduct all coagulation
and factor studies. CDC will also provide tubes, aliquots, and pipettes. Question:
Likewise, the awardee activities include data analysis, a description of how study
findings will be analyzed and disseminated yet the CDC responsibilities that are
listed involve data management and analysis and manuscript development. Is the
grant looking for hypotheses to be proposed, or do they already have them formulated?
My sense from the RFP is that they are already developed Answer:
We are open to the applicants’ proposed hypotheses. Question:
Is the analysis, guidelines, and manuscript expected to all fall within the two
year timeline? We have the capability of capturing 500 patients retrospectively
who have had postpartum hemorrhage but prior experience with retrospective patient
contacts is that it is a very time consuming activity with approximately a 15-30%
success rate, unless sophisticated techniques for finding patients are put into
place. Manuscript preparation and guideline development by itself can be a prolonged
process making the two year period ambitious. Answer: We expect
data collection to take 2 years and anticipate that another funding mechanism
will become available to either continue data collection or start analysis/manuscript
preparation. Question: Under awardee activities, item 2 states
that awardee activities include enrolling and retaining targeted participants.
Does this mean that this is a pilot study intended for further prospective evaluation?
Answer: Further prospective evaluation was not necessarily intended,
but it is dependent on the proposal. Question: Lastly, the total
project costs state that $500,000 includes direct and indirect costs, excluding
the additional academic partner administrative costs. Does this exclusion mean
that secretarial costs are not covered? What does this mean? Also, the size of
the necessary funding really changes considerably dependent upon what activities
are expected of the awardee versus what the CDC plans to conduct. Answer:
The total funding available for this project is $500,000. This costs includes
both direct and indirect costs that are directly related to the project. The exclusion
only refers to the association's administrative costs. If further clarity is needed
concerning this question, please contact the association in which you are a member
of. Top | 
