[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Notices]
[Page 51487-51489]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se08-78]
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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.
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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
http://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: http://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: http://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: http://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 http://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: http://www.cdc.gov/nchs/
about/major/nhanes/nhanes99-02.htm or for NHANES III: http://
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.
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Total costs Cost
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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
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Total.................................................... 6.50
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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