National Health and Nutrition Examination Survey (NHANES) Stored Biologic Specimens: Guidelines for Proposals To Use Samples and Proposed Cost Schedule, 51487-51489 [E8-20335]
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to oversee the project; see Exhibit 3. The
annualized cost for this two year project
is $422,000.
EXHIBIT 3—PROJECT COST
COMPONENTS
Cost components
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Experimental design ...................
Development of simulated Webbased reports ..........................
Pilot testing .................................
Usability testing of Web-based
reports .....................................
Data collection via Knowledge
Networks .................................
Data analysis ..............................
Preparation of reports and journal papers ...............................
AHRQ project management
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Health and Nutrition
Examination Survey (NHANES) Stored
Cost
Biologic Specimens: Guidelines for
estimate
Proposals To Use Samples and
$168,900 Proposed Cost Schedule
Centers for Disease Control and
Prevention, Department of Health and
Human Services.
ACTION: Notice and request for
56,300
comments.
157,900
56,000
AGENCY:
126,000
56,300
SUMMARY: The National Health and
Nutrition Examination Survey
112,600 (NHANES) is a program of periodic
110,000 surveys conducted by the National
Center for Health Statistics (NCHS) of
Total .....................................
844,000 the Centers for Disease Control and
Prevention (CDC). Examination surveys
conducted since 1960 by NCHS, have
Request for Comments
provided national estimates of health
In accordance with the above-cited
and nutritional status of the United
Paperwork Reduction Act legislation,
States civilian non-institutionalized
comments on AHRQ’s information
population. To add to the large amount
collection are requested with regard to
of information collected for the purpose
any of the following: (a) Whether the
of describing the health of the
proposed collection of information is
population in the most recent survey,
necessary for the proper performance of serum, urine and limited plasma
samples were collected and stored for
AHRQ health care research and health
future research projects. Specimens are
care information dissemination
currently available from NHANES III
functions, including whether the
(conducted from 1988–1994) and from
information will have practical utility;
NHANES 1999+. In 1999, NHANES
(b) the accuracy of AHRQ’s estimate of
became a continuous survey with data
burden (including hours and costs) of
release every two years. Specimens are
the proposed collection(s) of
available from two year survey cycles
information; (c) ways to enhance the
after the demographic file has been
quality, utility, and clarity of the
released to the public. Participants in
information to be collected; and (d)
the survey that began in 1999 signed a
ways to minimize the burden of the
separate consent document agreeing to
collection of information upon the
specimen storage allowing their biologic
respondents, including the use of
specimens to be used for approved
automated collection techniques or
research projects.
other forms of information technology.
Specimens are stored in two
Comments submitted in response to
Specimen Banks. Surplus samples that
this notice will be summarized and
were initially used for laboratory assays
included in the surveys, have since been
included in the Agency’s subsequent
stored at ¥70° C and have been through
request for OMB approval of the
at least two freeze-thaw cycles. They are
proposed information collection. All
stored at a commercial repository under
comments will become a matter of
contract to NCHS. In addition, on
public record.
average, six vials of sera were also
Dated: August 26, 2008.
stored in vapor-phase liquid nitrogen at
Carolyn M. Clancy,
the CDC and ATSTR Specimen
Director.
Packaging, Inventory and Repository
(CASPIR) Repository in Lawrenceville,
[FR Doc. E8–20315 Filed 9–2–08; 8:45 am]
GA. These specimens have not
BILLING CODE 4160–90–M
undergone a freeze-thaw cycle. The
CASPIR Repository is considered a longterm repository for the NHANES
specimens. NCHS is making both of
these collections available for research
proposals. The research proposals that
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51487
can use the surplused specimens will
receive higher priority. Proposals that
request the specimens in CASPIR need
to justify the use of the unthawed
specimens.
The purpose of this notice is to
request comments on this program and
the proposed cost schedule. After
consideration of comments submitted,
CDC will finalize and publish the cost
schedule and accept proposals for use of
the NHANES stored biologic samples.
Please go to https://www.cdc.gov/nchs/
about/major/nhanes/serum1b.htm for
final proposal guidelines.
All interested researchers are
encouraged to submit proposals. No
funding is provided as part of this
solicitation. Samples will not be
provided to those projects requiring
funding until the project has received
funds. Approved projects that do not
obtain funding will be canceled. A more
complete description of this program
follows.
DATES:
• Comment Receipt Date: October 3,
2008.
• Invitation to Submit Proposals: Can
be submitted on an ongoing basis.
• Scientific Review Date: Within two
months of proposal submission.
• Institutional Review Date: Within
one month of final proposal acceptance.
• Anticipated distribution of samples:
One month after IRB approval.
ADDRESSES: To send comments and to
request information, contact: Dr.
Geraldine McQuillan, Division of Health
and Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road, Room
4204, Hyattsville, MD 20782, Phone:
301–458–4371, Fax: 301–458–4028, Email gmm2@cdc.gov. Internet: https://
www.cdc.gov/nchs/about/major/
nhanes/serum1b.htm.
Authority: Sections 301, 306 and 308 of the
Public Health Service Act (42 U.S.C. 241,
242k and 242M).
The goals
of NHANES are: (1) To estimate the
number and percent of persons in the
U.S. population and designated
subgroups with selected diseases and
risk factors; (2) to monitor trends in the
prevalence, awareness, treatment and
control of selected diseases; (3) to
monitor trends in risk behaviors and
environmental exposures; (4) to analyze
risk factors for selected diseases; (5) to
study the relationship between diet,
nutrition and health; (6) to explore
emerging public health issues and new
technologies; and, (7) to establish and
maintain a national probability sample
SUPPLEMENTARY INFORMATION:
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of baseline information on health and
nutrition status.
Specimens are available from the
third National Health and Nutrition
Examination Survey (NHANES III) and
the continuous NHANES that started in
1999. Approximately 30,000 individuals
were examined in NHANES III which
began in the fall of 1988, and ended in
the fall of 1994. This survey can be
analyzed in two phases. Phase 1 was
conducted from October 1988 to
October 1991 and Phase 2 began
October 1991 and ended October 1994.
Though participants consented to
storing samples of their blood for future
testing only research projects that
include results that are judged not to
have clinical significance for
participants will be accepted. See:
https://www.cdc.gov/nchs/about/major/
nhanes/nh3data.htm for more
information on NHANES III.
Beginning in 1999, NHANES became
a continuous, annual survey with
examination of approximately 5,000
individuals a year and data release
every two years. Proposed research
projects and samples requested must
come from this two-year design (i.e.
request must be for 1999–2000 samples
or 2001–2002, etc.). Samples from a
single year of the survey will not be
provided for research projects, but
multiple two-year cycles may be
requested. For details of the sampling
design see the Analytic Guidelines at:
https://www.cdc.gov/nchs/about/major/
nhanes/nhanes2003-2004/
analytical_guidelines.htm.
Starting in 1999 to 2008 survey
participants were informed in the
consent document for future laboratory
analysis that they would not receive the
results from these studies. Therefore,
only research projects that propose
laboratory results that do not have
clinical relevance to an individual will
be accepted by NCHS. Clinical
significance of a laboratory test will be
judged by the NHANES Medical Officer,
but the researcher should address this in
the research proposal. See https://
www.cdc.gov/nchs/about/major/
nhanes/nhanes2007-2008/
current_nhanes_07_08.htm for a copy of
the current consent document.
All proposals for use of NHANES
samples will be evaluated by a technical
panel for scientific merit and by the
NHANES Ethics Review Board (ERB) for
any potential human subjects concerns.
The NHANES ERB will review the
proposal even if the investigator has
received approval by their institutional
review panel.
To determine if this limited resource
should be used in the proposed projects,
a Technical Panel will evaluate the
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public health significance and scientific
merit of the proposed research.
Scientific merit will be judged as to the
scientific, technical or medical
significance of the research, the
appropriateness and adequacy of the
experimental approach, and the
methodology proposed to reach the
research goals. See ‘Criteria for
Technical Evaluation of Proposals’
below. The proposal should outline how
the results from the laboratory analysis
will be used. Because NHANES is a
complex, multistage probability sample
of the national population, the
appropriateness of the NHANES sample
to address the goals of the proposal will
be an important aspect of scientific
merit. The survey oversamples the two
largest race/ethnic minority groups,
non-Hispanic blacks and Mexican
Americans along with other subgroups
of the population. Sampling weights are
therefore used to make national
estimates of frequencies. The use of
weights, sampling frame and methods of
assessment of variables included in the
data are likely to affect the proposed
research. The Technical Panel will
review the analysis plan and evaluate
whether the proposal is an appropriate
use of the NHANES population. The
Technical Panel will also assure that the
proposed project does not go beyond
either the general purpose for collecting
the samples in the survey, or of the
specific stated goals of the proposal.
Investigators are encouraged to review
the NHANES data, survey documents,
manuals and questionnaires at: https://
www.cdc.gov/nchs/about/major/
nhanes/nhanes99-02.htm or for
NHANES III: https://www.cdc.gov/nchs/
about/major/nhanes/nh3data.htm.
Procedures for Proposals
All investigators (including CDC
investigators) must submit a proposal
for use of NHANES specimens.
Proposals are limited to a maximum
of 10 single-spaced typed pages,
excluding figures and tables, using 10
cpi type density. The cover of the
proposal should include the name,
address, and phone number and E-mail
address of the principal investigator (PI)
and the name of the institution where
the laboratory analysis will be done. All
proposals should be E-mailed to
gmm2@cdc.gov. Proposals must include
a cover page with the title of the
proposal and the name, address, phone
number and E-mail address of all
investigators. Proposals from CDC
investigators must also include
investigators scientific ethic verification
number.
The following criteria will be used for
technical evaluation of proposals:
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Proposals should include the
following information:
(1) Specific Aims: List the broad
objectives; describe concisely and
realistically what the research is
intended to accomplish, and state the
specific hypotheses to be tested.
NHANES is designed to provide
prevalence estimates of diseases or
conditions that are expected to affect
between 5–10 percent of the population.
Research proposals that expect much
lower prevalence estimates need to
provide more detail on why specimens
from NHANES are needed for the
project and provide details on how
these data will be analyzed.
(2) Background and Public Health
Significance: Describe the public health
significance, scientific merit and
practical utility of the assay. Briefly
describe in 1–2 pages the background of
the proposal, identifying gaps in
knowledge that the project is intended
to fill. State concisely the importance of
the research in terms of the broad, longterm objectives and public health
relevance including a discussion of how
the results will affect public health
policy or further scientific knowledge.
The proposal should justify the need for
specimens that are representative of the
U.S. population. The proposer should
convey how the results will be used and
the relationship of the results to the data
already collected in NHANES. The
proposer should include an analysis
plan. The analyses ought to be
consistent with the NHANES mission
and the health status variables.
(3) Research Design and Methods:
Describe the research design and the
procedures to be used. A detailed
description of laboratory methods
including validity and reliability must
be included with references. The
volume of specimen and number of
samples requested must be specified.
Adequate methods for handling and
storage of samples must also be
addressed. The laboratory must
demonstrate expertise in the proposed
laboratory test including the capability
for handling the workload requested in
the proposal. The proposal should also
include a justification for determination
of sample size or a power calculation. If
the researcher is requesting a subsample of specimens, a detailed
description and justification, must be
given. The researcher must describe
how this sub-sample will be re-weighted
to provide national estimates. The
program will evaluate the study design
and analysis plan in the proposal to
determine whether the project is
consistent with the design of the
NHANES survey. Sub-samples are less
useful to the research community when
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the data are released in the public
domain, so such requests will receive a
lower priority for the specimens.
Restricting a research proposal to
demographic categories that are design
variables for the survey is encouraged if
laboratory testing must be restricted.
(4) Clinical Significance or results:
Since the consent document for
specimen storage and continuing
studies states that individual results
will not be provided, the clinical
significance of the proposed laboratory
test should be addressed.
The proposal should include a
discussion of the potential clinical
significance of the results and whether
there is definitive evidence that results
of the test would provide grounds for
medical intervention even if many years
have passed since the examination of
the participant and collection of the
sample. Any test with results that
should be reported to a participant
should be considered for inclusion in
the concurrent survey, and is not
appropriate for testing on the stored
samples.
(5) Qualification: Provide a brief
description of the Principal
Investigator’s expertise in the proposed
area should be provided, including
publications in this area within the last
three years. A representative sample of
earlier publications may be listed as
long as this section does not exceed two
pages.
(6) Period of performance: Specify the
project period. Substantial progress
must be made in the first year, and the
project should be completed in two
years. If additional time is needed for
the research project a detailed
justification with a timeline should be
included. The investigator should
address his/her ability to comply with
this timeline or request and justify
additional time for the project. Return of
the specimens will be requested if
progress is not made in the project at the
end of the second year. Refund of
payment for the specimens will not be
returned in this situation. At the end of
the project period, any unused samples
must be returned to the NHANES
Specimen Bank or discarded. The NCHS
Project Officer must be consulted about
the disposition of the samples.
(7) Funding: Include the source and
status of the funding to perform the
requested laboratory analysis should be
included. Investigators will be
responsible for the cost of processing
and shipping the samples. The cost per
specimen is $6.50. The basis for the cost
structure is in the last section of this
document. Reimbursement for the
samples will be collected before the
samples are released.
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Submission of Proposals
Proposals can be submitted in MS
Word format by E-mail to: Dr. Geraldine
McQuillan, Division of Health and
Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road, Room
4204, Hyattsville, MD 20782, Phone:
301–458–4371 Fax: 301–458–4028, Email gmm2@cdc.gov.
Approved Proposals
Approved projects will be provided
specimens on receipt of a signed
Materials Transfer Agreement (MTA)
and a check (written to The Centers for
Disease Control and Prevention) for the
cost of the specimens. All laboratory
results obtained from the samples will
be sent back to NCHS to be linked to the
sequence number that is the linking
identifier on the public use files. All
files will undergo disclosure review at
NCHS. Within 90 days of the return of
the data to NCHS these data may be
released to the public.
Agency Agreement
A formal signed agreement in the
form of a Materials Transfer Agreement
(MTA) with individuals who have
projects approved will be completed
before the release of the samples. This
agreement will contain the conditions
for use of the samples as stated in this
document and as agreed upon by the
investigators and CDC.
Progress Reports
Brief progress report will be
submitted annually. This will be the
basis for the NHANES ERB continuation
reports that are required annually.
Disposition of Results and Samples
No samples provided can be used for
any purpose other than those
specifically requested in the proposal
and approved by the Technical Panel
and the NHANES ERB. No sample can
be shared with others, including other
investigators, unless specified in the
proposal and so approved. Any unused
samples must be returned to the
NHANES Specimen Bank or disposed of
upon completion of the approved
project. These results, once returned to
NCHS, will be part of the public
domain. The proposer will have 90 days
for quality control review of the data
before public release.
Proposed Cost Schedule for Providing
NHANES Specimens:
A nominal processing fee of $6.50 is
proposed for each sample received from
the NHANES Specimen Bank. The costs
include both the collection, storage and
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51489
processing of the specimens along with
the review of proposals and the
preparation of the data files. These costs
were based on an assumption that
NCHS will receive and process eight
proposals in a year, each requesting
5,000 samples as shown in the table
below.
The materials listed are for the
recurring laboratory costs to dispense
and prepare the samples during
collection and for shipping; the
computer software needed for the
preparation of the data files and for the
release of the data along with
documentation on the NHANES Web
page. Labor costs are based on a
proposal administrator and computer
programmers at NCHS to prepare the
data files. The storage and pulling fees
include the costs for the NHANES
repository.
Total costs
Cost
Labor .............................................
Collection Storage ........................
Pulling specimens .........................
Shipping ........................................
Subtotal .........................................
CDC/FMO support (10%) .............
Subtotal .........................................
NCHS support (18%) ....................
$0.70
2.96
1.04
0.31
5.01
0.50
5.51
0.99
Total .......................................
6.50
Comments are solicited on the
proposed cost schedule. Comments are
due by: October 3, 2008.
Send Comments and Requests for
Information to: Dr. Geraldine
McQuillan, Division of Health and
Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road, Room
4204, Hyattsville, MD 20782, Phone:
301–458–4371; Fax: 301–458–4028,
e-mail gmm2@cdc.gov.
Dated: August 26, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E8–20335 Filed 9–2–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notification of the Establishment of the
National Commission on Children and
Disasters
Administration for Children
and Families, Department of Health and
Human Services.
AGENCY:
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]]>Agencies
[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Notices]
[Pages 51487-51489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20335]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Health and Nutrition Examination Survey (NHANES) Stored
Biologic Specimens: Guidelines for Proposals To Use Samples and
Proposed Cost Schedule
AGENCY: Centers for Disease Control and Prevention, Department of
Health and Human Services.
ACTION: Notice and request for comments.
-----------------------------------------------------------------------
SUMMARY: The National Health and Nutrition Examination Survey (NHANES)
is a program of periodic surveys conducted by the National Center for
Health Statistics (NCHS) of the Centers for Disease Control and
Prevention (CDC). Examination surveys conducted since 1960 by NCHS,
have provided national estimates of health and nutritional status of
the United States civilian non-institutionalized population. To add to
the large amount of information collected for the purpose of describing
the health of the population in the most recent survey, serum, urine
and limited plasma samples were collected and stored for future
research projects. Specimens are currently available from NHANES III
(conducted from 1988-1994) and from NHANES 1999+. In 1999, NHANES
became a continuous survey with data release every two years. Specimens
are available from two year survey cycles after the demographic file
has been released to the public. Participants in the survey that began
in 1999 signed a separate consent document agreeing to specimen storage
allowing their biologic specimens to be used for approved research
projects.
Specimens are stored in two Specimen Banks. Surplus samples that
were initially used for laboratory assays included in the surveys, have
since been stored at -70[deg] C and have been through at least two
freeze-thaw cycles. They are stored at a commercial repository under
contract to NCHS. In addition, on average, six vials of sera were also
stored in vapor-phase liquid nitrogen at the CDC and ATSTR Specimen
Packaging, Inventory and Repository (CASPIR) Repository in
Lawrenceville, GA. These specimens have not undergone a freeze-thaw
cycle. The CASPIR Repository is considered a long-term repository for
the NHANES specimens. NCHS is making both of these collections
available for research proposals. The research proposals that can use
the surplused specimens will receive higher priority. Proposals that
request the specimens in CASPIR need to justify the use of the unthawed
specimens.
The purpose of this notice is to request comments on this program
and the proposed cost schedule. After consideration of comments
submitted, CDC will finalize and publish the cost schedule and accept
proposals for use of the NHANES stored biologic samples. Please go to
https://www.cdc.gov/nchs/about/major/nhanes/serum1b.htm for final
proposal guidelines.
All interested researchers are encouraged to submit proposals. No
funding is provided as part of this solicitation. Samples will not be
provided to those projects requiring funding until the project has
received funds. Approved projects that do not obtain funding will be
canceled. A more complete description of this program follows.
DATES:
Comment Receipt Date: October 3, 2008.
Invitation to Submit Proposals: Can be submitted on an
ongoing basis.
Scientific Review Date: Within two months of proposal
submission.
Institutional Review Date: Within one month of final
proposal acceptance.
Anticipated distribution of samples: One month after IRB
approval.
ADDRESSES: To send comments and to request information, contact: Dr.
Geraldine McQuillan, Division of Health and Nutrition Examination
Surveys, National Center for Health Statistics, Centers for Disease
Control and Prevention, 3311 Toledo Road, Room 4204, Hyattsville, MD
20782, Phone: 301-458-4371, Fax: 301-458-4028, E-mail gmm2@cdc.gov.
Internet: https://www.cdc.gov/nchs/about/major/nhanes/serum1b.htm.
Authority: Sections 301, 306 and 308 of the Public Health
Service Act (42 U.S.C. 241, 242k and 242M).
SUPPLEMENTARY INFORMATION: The goals of NHANES are: (1) To estimate the
number and percent of persons in the U.S. population and designated
subgroups with selected diseases and risk factors; (2) to monitor
trends in the prevalence, awareness, treatment and control of selected
diseases; (3) to monitor trends in risk behaviors and environmental
exposures; (4) to analyze risk factors for selected diseases; (5) to
study the relationship between diet, nutrition and health; (6) to
explore emerging public health issues and new technologies; and, (7) to
establish and maintain a national probability sample
[[Page 51488]]
of baseline information on health and nutrition status.
Specimens are available from the third National Health and
Nutrition Examination Survey (NHANES III) and the continuous NHANES
that started in 1999. Approximately 30,000 individuals were examined in
NHANES III which began in the fall of 1988, and ended in the fall of
1994. This survey can be analyzed in two phases. Phase 1 was conducted
from October 1988 to October 1991 and Phase 2 began October 1991 and
ended October 1994. Though participants consented to storing samples of
their blood for future testing only research projects that include
results that are judged not to have clinical significance for
participants will be accepted. See: https://www.cdc.gov/nchs/about/
major/nhanes/nh3data.htm for more information on NHANES III.
Beginning in 1999, NHANES became a continuous, annual survey with
examination of approximately 5,000 individuals a year and data release
every two years. Proposed research projects and samples requested must
come from this two-year design (i.e. request must be for 1999-2000
samples or 2001-2002, etc.). Samples from a single year of the survey
will not be provided for research projects, but multiple two-year
cycles may be requested. For details of the sampling design see the
Analytic Guidelines at: https://www.cdc.gov/nchs/about/major/nhanes/
nhanes2003-2004/analytical_guidelines.htm.
Starting in 1999 to 2008 survey participants were informed in the
consent document for future laboratory analysis that they would not
receive the results from these studies. Therefore, only research
projects that propose laboratory results that do not have clinical
relevance to an individual will be accepted by NCHS. Clinical
significance of a laboratory test will be judged by the NHANES Medical
Officer, but the researcher should address this in the research
proposal. See https://www.cdc.gov/nchs/about/major/nhanes/nhanes2007-
2008/current_nhanes_07_08.htm for a copy of the current consent
document.
All proposals for use of NHANES samples will be evaluated by a
technical panel for scientific merit and by the NHANES Ethics Review
Board (ERB) for any potential human subjects concerns. The NHANES ERB
will review the proposal even if the investigator has received approval
by their institutional review panel.
To determine if this limited resource should be used in the
proposed projects, a Technical Panel will evaluate the public health
significance and scientific merit of the proposed research. Scientific
merit will be judged as to the scientific, technical or medical
significance of the research, the appropriateness and adequacy of the
experimental approach, and the methodology proposed to reach the
research goals. See `Criteria for Technical Evaluation of Proposals'
below. The proposal should outline how the results from the laboratory
analysis will be used. Because NHANES is a complex, multistage
probability sample of the national population, the appropriateness of
the NHANES sample to address the goals of the proposal will be an
important aspect of scientific merit. The survey oversamples the two
largest race/ethnic minority groups, non-Hispanic blacks and Mexican
Americans along with other subgroups of the population. Sampling
weights are therefore used to make national estimates of frequencies.
The use of weights, sampling frame and methods of assessment of
variables included in the data are likely to affect the proposed
research. The Technical Panel will review the analysis plan and
evaluate whether the proposal is an appropriate use of the NHANES
population. The Technical Panel will also assure that the proposed
project does not go beyond either the general purpose for collecting
the samples in the survey, or of the specific stated goals of the
proposal.
Investigators are encouraged to review the NHANES data, survey
documents, manuals and questionnaires at: https://www.cdc.gov/nchs/
about/major/nhanes/nhanes99-02.htm or for NHANES III: https://
www.cdc.gov/nchs/about/major/nhanes/nh3data.htm.
Procedures for Proposals
All investigators (including CDC investigators) must submit a
proposal for use of NHANES specimens.
Proposals are limited to a maximum of 10 single-spaced typed pages,
excluding figures and tables, using 10 cpi type density. The cover of
the proposal should include the name, address, and phone number and E-
mail address of the principal investigator (PI) and the name of the
institution where the laboratory analysis will be done. All proposals
should be E-mailed to gmm2@cdc.gov. Proposals must include a cover page
with the title of the proposal and the name, address, phone number and
E-mail address of all investigators. Proposals from CDC investigators
must also include investigators scientific ethic verification number.
The following criteria will be used for technical evaluation of
proposals:
Proposals should include the following information:
(1) Specific Aims: List the broad objectives; describe concisely
and realistically what the research is intended to accomplish, and
state the specific hypotheses to be tested. NHANES is designed to
provide prevalence estimates of diseases or conditions that are
expected to affect between 5-10 percent of the population. Research
proposals that expect much lower prevalence estimates need to provide
more detail on why specimens from NHANES are needed for the project and
provide details on how these data will be analyzed.
(2) Background and Public Health Significance: Describe the public
health significance, scientific merit and practical utility of the
assay. Briefly describe in 1-2 pages the background of the proposal,
identifying gaps in knowledge that the project is intended to fill.
State concisely the importance of the research in terms of the broad,
long-term objectives and public health relevance including a discussion
of how the results will affect public health policy or further
scientific knowledge. The proposal should justify the need for
specimens that are representative of the U.S. population. The proposer
should convey how the results will be used and the relationship of the
results to the data already collected in NHANES. The proposer should
include an analysis plan. The analyses ought to be consistent with the
NHANES mission and the health status variables.
(3) Research Design and Methods: Describe the research design and
the procedures to be used. A detailed description of laboratory methods
including validity and reliability must be included with references.
The volume of specimen and number of samples requested must be
specified. Adequate methods for handling and storage of samples must
also be addressed. The laboratory must demonstrate expertise in the
proposed laboratory test including the capability for handling the
workload requested in the proposal. The proposal should also include a
justification for determination of sample size or a power calculation.
If the researcher is requesting a sub-sample of specimens, a detailed
description and justification, must be given. The researcher must
describe how this sub-sample will be re-weighted to provide national
estimates. The program will evaluate the study design and analysis plan
in the proposal to determine whether the project is consistent with the
design of the NHANES survey. Sub-samples are less useful to the
research community when
[[Page 51489]]
the data are released in the public domain, so such requests will
receive a lower priority for the specimens. Restricting a research
proposal to demographic categories that are design variables for the
survey is encouraged if laboratory testing must be restricted.
(4) Clinical Significance or results: Since the consent document
for specimen storage and continuing studies states that individual
results will not be provided, the clinical significance of the proposed
laboratory test should be addressed.
The proposal should include a discussion of the potential clinical
significance of the results and whether there is definitive evidence
that results of the test would provide grounds for medical intervention
even if many years have passed since the examination of the participant
and collection of the sample. Any test with results that should be
reported to a participant should be considered for inclusion in the
concurrent survey, and is not appropriate for testing on the stored
samples.
(5) Qualification: Provide a brief description of the Principal
Investigator's expertise in the proposed area should be provided,
including publications in this area within the last three years. A
representative sample of earlier publications may be listed as long as
this section does not exceed two pages.
(6) Period of performance: Specify the project period. Substantial
progress must be made in the first year, and the project should be
completed in two years. If additional time is needed for the research
project a detailed justification with a timeline should be included.
The investigator should address his/her ability to comply with this
timeline or request and justify additional time for the project. Return
of the specimens will be requested if progress is not made in the
project at the end of the second year. Refund of payment for the
specimens will not be returned in this situation. At the end of the
project period, any unused samples must be returned to the NHANES
Specimen Bank or discarded. The NCHS Project Officer must be consulted
about the disposition of the samples.
(7) Funding: Include the source and status of the funding to
perform the requested laboratory analysis should be included.
Investigators will be responsible for the cost of processing and
shipping the samples. The cost per specimen is $6.50. The basis for the
cost structure is in the last section of this document. Reimbursement
for the samples will be collected before the samples are released.
Submission of Proposals
Proposals can be submitted in MS Word format by E-mail to: Dr.
Geraldine McQuillan, Division of Health and Nutrition Examination
Surveys, National Center for Health Statistics, Centers for Disease
Control and Prevention, 3311 Toledo Road, Room 4204, Hyattsville, MD
20782, Phone: 301-458-4371 Fax: 301-458-4028, E-mail gmm2@cdc.gov.
Approved Proposals
Approved projects will be provided specimens on receipt of a signed
Materials Transfer Agreement (MTA) and a check (written to The Centers
for Disease Control and Prevention) for the cost of the specimens. All
laboratory results obtained from the samples will be sent back to NCHS
to be linked to the sequence number that is the linking identifier on
the public use files. All files will undergo disclosure review at NCHS.
Within 90 days of the return of the data to NCHS these data may be
released to the public.
Agency Agreement
A formal signed agreement in the form of a Materials Transfer
Agreement (MTA) with individuals who have projects approved will be
completed before the release of the samples. This agreement will
contain the conditions for use of the samples as stated in this
document and as agreed upon by the investigators and CDC.
Progress Reports
Brief progress report will be submitted annually. This will be the
basis for the NHANES ERB continuation reports that are required
annually.
Disposition of Results and Samples
No samples provided can be used for any purpose other than those
specifically requested in the proposal and approved by the Technical
Panel and the NHANES ERB. No sample can be shared with others,
including other investigators, unless specified in the proposal and so
approved. Any unused samples must be returned to the NHANES Specimen
Bank or disposed of upon completion of the approved project. These
results, once returned to NCHS, will be part of the public domain. The
proposer will have 90 days for quality control review of the data
before public release.
Proposed Cost Schedule for Providing NHANES Specimens:
A nominal processing fee of $6.50 is proposed for each sample
received from the NHANES Specimen Bank. The costs include both the
collection, storage and processing of the specimens along with the
review of proposals and the preparation of the data files. These costs
were based on an assumption that NCHS will receive and process eight
proposals in a year, each requesting 5,000 samples as shown in the
table below.
The materials listed are for the recurring laboratory costs to
dispense and prepare the samples during collection and for shipping;
the computer software needed for the preparation of the data files and
for the release of the data along with documentation on the NHANES Web
page. Labor costs are based on a proposal administrator and computer
programmers at NCHS to prepare the data files. The storage and pulling
fees include the costs for the NHANES repository.
------------------------------------------------------------------------
Total costs Cost
------------------------------------------------------------------------
Labor........................................................ $0.70
Collection Storage........................................... 2.96
Pulling specimens............................................ 1.04
Shipping..................................................... 0.31
Subtotal..................................................... 5.01
CDC/FMO support (10%)........................................ 0.50
Subtotal..................................................... 5.51
NCHS support (18%)........................................... 0.99
----------
Total.................................................... 6.50
------------------------------------------------------------------------
Comments are solicited on the proposed cost schedule. Comments are
due by: October 3, 2008.
Send Comments and Requests for Information to: Dr. Geraldine
McQuillan, Division of Health and Nutrition Examination Surveys,
National Center for Health Statistics, Centers for Disease Control and
Prevention, 3311 Toledo Road, Room 4204, Hyattsville, MD 20782, Phone:
301-458-4371; Fax: 301-458-4028, e-mail gmm2@cdc.gov.
Dated: August 26, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E8-20335 Filed 9-2-08; 8:45 am]
BILLING CODE 4163-18-P
