National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples, 58206-58209 [2017-26591]
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Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2017–0117]
National Health and Nutrition
Examination Survey (NHANES) Stored
Biologic Samples; Proposed Cost
Schedule and Guidelines for Proposals
to Use Serum, Plasma, and Urine
Samples
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the
availability of stored sera, plasma, and
urine samples obtained from
participants in the National Health and
Nutrition Examination Survey
(NHANES) for use and the fee schedule
for such use. The National Health and
Nutrition Examination Survey
(NHANES) is one of a series of healthrelated surveys conducted by CDC’s
National Center for Health Statistics
(NCHS).
DATES: The stored NHANES biologic
samples are available December 11,
2017. The fee structure for these
samples is effective December 11, 2017.
FOR FURTHER INFORMATION CONTACT: Dr.
Geraldine McQuillan, National Center
for Health Statistics, Centers for Disease
Control and Prevention, 3311 Toledo
Road, Hyattsville, MD 20782.
Telephone: 301–458–4371; Fax: 301–
458–4029; Email: Serumplasmaurine@
cdc.gov
SUMMARY:
Authority: Sections 301,306 and 308 of the
Public Health Service Act (42 U.S.C.
241,242k and 242M).
NHANES
is a program of periodic surveys
conducted by NCHS. Examination
surveys conducted since 1960 by NCHS
have provided national estimates of the
health and nutritional status of the U.S.
civilian non-institutionalized
population. The goals of NHANES are:
SUPPLEMENTARY INFORMATION:
(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 of baseline
information on health and nutrition
status.
Samples are available from 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. Researchers
can analyze data from this survey 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 and urine for future testing, only
research proposals with test results that
are judged not to have clinical
significance for participants will be
accepted. See: https://www.cdc.gov/
nchs/nhanes/nhanes3.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. Samples from a single
year of the survey will only be provided
in emergency situations (outbreaks).
Research projects must use two-year
cycles or multiple two year cycles for
their research (i.e. 1999–2000, 2001–
2002 etc.) In order to assure the
representative nature of NHANES at
least a 1⁄3 sample of a two year cycle
must be requested for an individual
proposal. For details of the sampling
design, see the Analytic Guidelines at:
https://wwwn.cdc.gov/nchs/nhanes/
analyticguidelines.aspx.
Starting in 1999, the consent form
informed participants that they would
not receive results from any future
laboratory analysis that may be
conducted on their samples. Therefore,
only research proposals with laboratory
test results that do not have clinical
significance to the survey participant
will be accepted. Clinical significance of
a laboratory test will be judged by the
technical panel reviewing proposals,
and the researcher should address this
in the research proposal. A laboratory
analyte is considered clinically
significant to the survey participant if
the following criteria are met: The
findings have significant implications
for the participant’s health, a course of
action is readily available to treat the
associated health concern, and
laboratory tests are performed by a
Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory
and therefore deemed valid.
Serum, plasma, and urine samples are
currently available from NHANES III
(conducted from 1988–1994) and from
NHANES 1999–2016 (Table A).
Serum, plasma, and urine samples are
stored in two biorepositories. Surplus
samples that were initially used for
laboratory assays included in the
surveys, were stored at ¥70 °C and have
been through at least two freeze-thaw
cycles. They are stored at a commercial
biorepository under contract to NCHS.
In addition, serum, plasma, and urine
samples were also stored immediately
after collection at ¥80 °C or below in
vapor-phase liquid nitrogen. These
samples have not undergone a freezethaw cycle and are considered pristine
samples. The CDC and Agency for Toxic
Substances and Disease Registry
(ATSDR) Sample Packaging and
Handling Repository (CASPIR) is the
long-term repository for the pristine
NHANES serum, plasma, and urine
samples. NCHS is making both of these
collections available for research
proposals. Proposals that request
pristine samples stored at CASPIR
should justify the use of the unthawed
samples. Please see the NHANES
Biospecimen Program series report for
details about collection and storage of
serum, plasma, and urine samples
https://www.cdc.gov/nchs/data/series/sr_
02/sr02_170.pdf.
TABLE A—OVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III (1988–1994) AND NHANES 1999–2014
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Sample Type
Pristine 1
NHANES Cycle
Surplus 2
Sera
III (1988–1994) .....................................................................................................
1999–2000 ...........................................................................................................
2001–2002 ...........................................................................................................
2003–2004 ...........................................................................................................
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Plasma
Urine
Sera
Plasma
Urine
X
X
X
X
..............
X
X
X
..............
X
X
X
X
X
X
X
..............
X
X
..............
..............
X
X
..............
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TABLE A—OVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III (1988–1994) AND NHANES 1999–2014—
Continued
Sample Type
Pristine 1
NHANES Cycle
Surplus 2
Sera
2005–2006
2007–2008
2009–2010
2011–2012
2013–2014
2015–2016
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
...........................................................................................................
1 Samples
2 Samples
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Urine
Sera
Plasma
Urine
X
X
X
X
X
X
X
X
X
..............
..............
..............
X
X
X
X
X
X
X
X
X
X
X
X
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
immediately frozen for storage, did not undergo laboratory testing.
were surplus after laboratories had completed testing.
Proposal Evaluation
All proposals for use of NHANES
samples will be evaluated by a
Technical Panel for scientific merit,
public health significance, and lack of
clinical significance to the participant;
by the NCHS Confidentiality Officer for
disclosure risk; and by the NCHS
Human Subjects Officer and the ERB for
any potential human subjects concerns.
The NCHS Ethics Review Board (ERB)
will review the proposal even if the
investigator has received approval by
their institutional review panel.
The Technical Panel consists of
NHANES staff: Two physicians, one
statistician and two laboratory experts,
other experts from inside or outside the
Federal Government are added as
needed. The Technical Panel will
evaluate the proposal for the scientific,
technical and medical significance of
the research, the appropriateness and
adequacy of the research design, 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 U.S. 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 (and all Hispanics since
2007–08), and, since 2011–2012, Asians.
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. For this reason
proposers are required to request at least
a 1⁄3 sample of a NHANES cycle to
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maintain the representative nature of
the survey.
The Technical Panel will also review
the data analysis plan and evaluate
whether the proposal is an appropriate
use of the NHANES samples. The
investigators should justify why they
need a national probability sample for
their research. The Technical Panel will
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/nhanes/nhanes_
questionnaires.htm or for NHANES III:
https://wwwn.cdc.gov/nchs/nhanes/
nhanes3/datafiles.aspx
Procedures for Proposals
All investigators (including CDC
investigators) must submit a proposal
for use of NHANES serum, plasma, or
urine samples. Proposals are limited to
a maximum of 10 single-spaced typed
pages, excluding figures and tables,
using at least a size 10 font 10cpi. The
cover of the proposal should include the
name, address, and phone number and
Email address of the principal
investigator (PI) and the name of the
institution where the laboratory analysis
will be done. All proposals should be
Emailed to Serumplasmaurine@cdc.gov.
Proposals must include a cover page
with the title of the proposal and the
name, address, phone number and
Email address of all investigators.
Proposals from CDC investigators must
also include investigators scientific
ethics 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
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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 at
least 5–10 percent of the population.
Research proposals that expect much
lower prevalence estimates need to
provide more detail on why samples
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
samples 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
analyses should be consistent with the
NHANES mission and the health status
variables.
(3) Research Design and Methods:
Describe the research design, analytic
plan, and the procedures to be used. A
detailed description of laboratory
methods including validity and
reliability must be included with
references. The volume of sample 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
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the researcher is requesting a subsample of samples, 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
Investigator’s submitted proposal study
design and analysis plan to determine
whether the project is consistent with
the design of the NHANES survey. In
general, resulting data will be released
in the public domain. Released data
from sub-samples may be less useful to
the research community, so such
requests will receive a lower priority for
the samples.
(4) Clinical Significance of Results:
Address the clinical significance to the
survey participant of the proposed
laboratory test. Since the consent
document for sample storage and future
studies states that individual results
will not be provided to the participant,
the investigator must address whether
there is definitive evidence that the
proposed test results have health
implications to the participants and
whether knowledge of results would
provide grounds for medical
intervention (even if many years have
passed since the participant was in the
survey and the sample collected). Any
test with results that are clinically
significant, and would require reporting
to the participant, is not appropriate for
testing on the stored serum, plasma, or
urine samples; laboratory testing that is
clinically significant should be
considered for inclusion in a concurrent
NHANES survey.
(5) Qualification: Provide a brief
description of the Principal
Investigator’s expertise in the proposed
area, 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 time period. Substantial progress
must be made in the first year that
samples have been obtained, and the
project should be completed within a
reasonable time period. Please discuss
the approximate time the investigator
expects this project will take to
complete the project. At the end of the
project period, any unused samples
must be returned to the NHANES
Specimen Repository or discarded. The
NCHS Project Officer must be consulted
about the disposition of the samples.
(7) Funding: 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 sample is $13.00.
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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 Email to: Dr. Geraldine
McQuillan (see FOR FURTHER
INFORMATION CONTACT).
Project Timeframes
• Submitting 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 ERB approval
Approved Proposals
Approved projects will be provided
samples after 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 samples or for Federal
Government proposals a signed
Interagency Agreement (IAA). All
laboratory results obtained from the
samples must be sent back to NCHS to
be linked to the variables requested by
the investigator that are needed to
perform a quality control review of the
data under a signed Data Sharing
Agreement or a Designated Agent
Agreement. This review must take place
within 60 days of the return of the data
to NCHS so these data may be released
to the public. All files will also undergo
disclosure review at NCHS before
release.
Agency Agreement
A formal signed agreement in the
form of a MTA or an IAA with
investigators 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.
Continuations
A brief progress report will be
submitted annually. This will be the
basis for the NCHS ERB continuation
reports that are required annually. After
5 years of annual continuations, if there
is need for continued use of samples to
complete the protocol study, a new
protocol is required.
specifically requested in the proposal
and approved by the Technical Panel
and the NCHS ERB. No samples 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 Serum, Plasma and Urine
Repository or disposed of, after
NHANES approval, upon completion of
the approved project. These results,
once returned to NCHS, will be part of
the public domain. The proposer will
have 60 days for quality control review
of the data before public release.
Cost Schedule for Providing NHANES
Samples
There is a nominal processing fee of
$13.00 for each sample received from
the NHANES Serum, Plasma and Urine
Repository. If the investigator requests
to use the samples for another project
after the completion of the initial
project, the cost will be $5.00 per
sample to handle the processing of the
data and management of the proposal
process. The costs include the
collection, storage, and processing of the
samples along with the review of
proposals and the preparation of the
data files. The costs listed are for the
recurring laboratory materials 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. See: https://www.cdc.gov/nchs/
nhanes/about_nhanes.htm. Labor costs
are based on a proposal administrator
and computer programmers at NCHS to
prepare the data files. The storage and
pulling the samples from the freezer fees
include the costs for the NHANES
repository.
FEE SCHEDULE FOR NHANES
BIOLOGIC SAMPLES
Cost factors
Cost per vial
Material and Equipment .......
Processing the samples (Receiving, handling and shipping) ..................................
Administrative, management
of the proposal process ....
Inventory management .........
Preparation of data files .......
$2.85
Subtotal .........................
CDC Support (5%) ...............
11.50
0.58
Subtotal .........................
NCHS Support (7.50%) ........
12.08
0.91
Total .......................
13.00 *
2.15
1.50
1.50
3.50
Disposition of Results and Samples
No samples provided can be used for
any purpose other than those
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• Total is rounded up from $12.99
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Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices
Dated: December 5, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2017–26591 Filed 12–8–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10142]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by January 10, 2018.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
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SUMMARY:
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proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Bid Pricing Tool
(BPT) for Medicare Advantage (MA)
Plans and Prescription Drug Plans
(PDP); Use: We require that Medicare
Advantage organizations and
Prescription Drug Plans complete the
BPT as part of the annual bidding
process. During this process,
organizations prepare their proposed
actuarial bid pricing for the upcoming
contract year and submit them to us for
review and approval. The purpose of the
BPT is to collect the actuarial pricing
information for each plan. The BPT
calculates the plan’s bid, enrollee
premiums, and payment rates. We
publish beneficiary premium
information using a variety of formats
(www.medicare.gov, the Medicare & You
handbook, Summary of Benefits
marketing information) for the purpose
of beneficiary education and
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58209
enrollment. Form Number: CMS–10142
(OMB control number: 0938–0944);
Frequency: Yearly; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 555; Total
Annual Responses: 4,995; Total Annual
Hours: 149,850. (For policy questions
regarding this collection contact Rachel
Shevland at 410–786–3026.)
Dated: December 6, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–26604 Filed 12–8–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10529]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by January 10, 2018.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
SUMMARY:
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]]>Agencies
[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Pages 58206-58209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26591]
[[Page 58206]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2017-0117]
National Health and Nutrition Examination Survey (NHANES) Stored
Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals
to Use Serum, Plasma, and Urine Samples
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) announces the
availability of stored sera, plasma, and urine samples obtained from
participants in the National Health and Nutrition Examination Survey
(NHANES) for use and the fee schedule for such use. The National Health
and Nutrition Examination Survey (NHANES) is one of a series of health-
related surveys conducted by CDC's National Center for Health
Statistics (NCHS).
DATES: The stored NHANES biologic samples are available December 11,
2017. The fee structure for these samples is effective December 11,
2017.
FOR FURTHER INFORMATION CONTACT: Dr. Geraldine McQuillan, National
Center for Health Statistics, Centers for Disease Control and
Prevention, 3311 Toledo Road, Hyattsville, MD 20782. Telephone: 301-
458-4371; Fax: 301-458-4029; Email: [email protected]v
Authority: Sections 301,306 and 308 of the Public Health Service
Act (42 U.S.C. 241,242k and 242M).
SUPPLEMENTARY INFORMATION: NHANES is a program of periodic surveys
conducted by NCHS. Examination surveys conducted since 1960 by NCHS
have provided national estimates of the health and nutritional status
of the U.S. civilian non-institutionalized population. 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 of baseline information on health and nutrition
status.
Samples are available from 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. Researchers can analyze data from this survey 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 and urine for future
testing, only research proposals with test results that are judged not
to have clinical significance for participants will be accepted. See:
https://www.cdc.gov/nchs/nhanes/nhanes3.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. Samples from a single year of the survey will only be
provided in emergency situations (outbreaks). Research projects must
use two-year cycles or multiple two year cycles for their research
(i.e. 1999-2000, 2001-2002 etc.) In order to assure the representative
nature of NHANES at least a \1/3\ sample of a two year cycle must be
requested for an individual proposal. For details of the sampling
design, see the Analytic Guidelines at: https://wwwn.cdc.gov/nchs/nhanes/analyticguidelines.aspx.
Starting in 1999, the consent form informed participants that they
would not receive results from any future laboratory analysis that may
be conducted on their samples. Therefore, only research proposals with
laboratory test results that do not have clinical significance to the
survey participant will be accepted. Clinical significance of a
laboratory test will be judged by the technical panel reviewing
proposals, and the researcher should address this in the research
proposal. A laboratory analyte is considered clinically significant to
the survey participant if the following criteria are met: The findings
have significant implications for the participant's health, a course of
action is readily available to treat the associated health concern, and
laboratory tests are performed by a Clinical Laboratory Improvement
Amendments (CLIA)-certified laboratory and therefore deemed valid.
Serum, plasma, and urine samples are currently available from
NHANES III (conducted from 1988-1994) and from NHANES 1999-2016 (Table
A).
Serum, plasma, and urine samples are stored in two biorepositories.
Surplus samples that were initially used for laboratory assays included
in the surveys, were stored at -70 [deg]C and have been through at
least two freeze-thaw cycles. They are stored at a commercial
biorepository under contract to NCHS. In addition, serum, plasma, and
urine samples were also stored immediately after collection at -80
[deg]C or below in vapor-phase liquid nitrogen. These samples have not
undergone a freeze-thaw cycle and are considered pristine samples. The
CDC and Agency for Toxic Substances and Disease Registry (ATSDR) Sample
Packaging and Handling Repository (CASPIR) is the long-term repository
for the pristine NHANES serum, plasma, and urine samples. NCHS is
making both of these collections available for research proposals.
Proposals that request pristine samples stored at CASPIR should justify
the use of the unthawed samples. Please see the NHANES Biospecimen
Program series report for details about collection and storage of
serum, plasma, and urine samples https://www.cdc.gov/nchs/data/series/sr_02/sr02_170.pdf.
Table A--Overview of Biospecimens by Survey Year, NHANES III (1988-1994) and NHANES 1999-2014
----------------------------------------------------------------------------------------------------------------
Sample Type
-----------------------------------------------------------------
NHANES Cycle Pristine \1\ Surplus \2\
-----------------------------------------------------------------
Sera Plasma Urine Sera Plasma Urine
----------------------------------------------------------------------------------------------------------------
III (1988-1994)............................... X ......... ......... X ......... .........
1999-2000..................................... X X X X X X
2001-2002..................................... X X X X X X
2003-2004..................................... X X X X ......... .........
[[Page 58207]]
2005-2006..................................... X X X X ......... .........
2007-2008..................................... X X X X ......... .........
2009-2010..................................... X X X X ......... .........
2011-2012..................................... X ......... X X ......... .........
2013-2014..................................... X ......... X X ......... .........
2015-2016..................................... X ......... X X ......... .........
----------------------------------------------------------------------------------------------------------------
\1\ Samples immediately frozen for storage, did not undergo laboratory testing.
\2\ Samples were surplus after laboratories had completed testing.
Proposal Evaluation
All proposals for use of NHANES samples will be evaluated by a
Technical Panel for scientific merit, public health significance, and
lack of clinical significance to the participant; by the NCHS
Confidentiality Officer for disclosure risk; and by the NCHS Human
Subjects Officer and the ERB for any potential human subjects concerns.
The NCHS Ethics Review Board (ERB) will review the proposal even if the
investigator has received approval by their institutional review panel.
The Technical Panel consists of NHANES staff: Two physicians, one
statistician and two laboratory experts, other experts from inside or
outside the Federal Government are added as needed. The Technical Panel
will evaluate the proposal for the scientific, technical and medical
significance of the research, the appropriateness and adequacy of the
research design, 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 U.S. 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 (and all Hispanics since
2007-08), and, since 2011-2012, Asians. 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. For this reason
proposers are required to request at least a \1/3\ sample of a NHANES
cycle to maintain the representative nature of the survey.
The Technical Panel will also review the data analysis plan and
evaluate whether the proposal is an appropriate use of the NHANES
samples. The investigators should justify why they need a national
probability sample for their research. The Technical Panel will 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/nhanes/nhanes_questionnaires.htm or for NHANES III: https://wwwn.cdc.gov/nchs/nhanes/nhanes3/datafiles.aspx
Procedures for Proposals
All investigators (including CDC investigators) must submit a
proposal for use of NHANES serum, plasma, or urine samples. Proposals
are limited to a maximum of 10 single-spaced typed pages, excluding
figures and tables, using at least a size 10 font 10cpi. The cover of
the proposal should include the name, address, and phone number and
Email address of the principal investigator (PI) and the name of the
institution where the laboratory analysis will be done. All proposals
should be Emailed to [email protected]v. Proposals must include a
cover page with the title of the proposal and the name, address, phone
number and Email address of all investigators. Proposals from CDC
investigators must also include investigators scientific ethics
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 at least 5-10 percent of the population. Research
proposals that expect much lower prevalence estimates need to provide
more detail on why samples 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 samples
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 analyses should be
consistent with the NHANES mission and the health status variables.
(3) Research Design and Methods: Describe the research design,
analytic plan, and the procedures to be used. A detailed description of
laboratory methods including validity and reliability must be included
with references. The volume of sample 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
[[Page 58208]]
the researcher is requesting a sub-sample of samples, 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 Investigator's submitted proposal
study design and analysis plan to determine whether the project is
consistent with the design of the NHANES survey. In general, resulting
data will be released in the public domain. Released data from sub-
samples may be less useful to the research community, so such requests
will receive a lower priority for the samples.
(4) Clinical Significance of Results: Address the clinical
significance to the survey participant of the proposed laboratory test.
Since the consent document for sample storage and future studies states
that individual results will not be provided to the participant, the
investigator must address whether there is definitive evidence that the
proposed test results have health implications to the participants and
whether knowledge of results would provide grounds for medical
intervention (even if many years have passed since the participant was
in the survey and the sample collected). Any test with results that are
clinically significant, and would require reporting to the participant,
is not appropriate for testing on the stored serum, plasma, or urine
samples; laboratory testing that is clinically significant should be
considered for inclusion in a concurrent NHANES survey.
(5) Qualification: Provide a brief description of the Principal
Investigator's expertise in the proposed area, 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 time period.
Substantial progress must be made in the first year that samples have
been obtained, and the project should be completed within a reasonable
time period. Please discuss the approximate time the investigator
expects this project will take to complete the project. At the end of
the project period, any unused samples must be returned to the NHANES
Specimen Repository or discarded. The NCHS Project Officer must be
consulted about the disposition of the samples.
(7) Funding: 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 sample is $13.00. 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 Email to: Dr.
Geraldine McQuillan (see FOR FURTHER INFORMATION CONTACT).
Project Timeframes
Submitting 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 ERB
approval
Approved Proposals
Approved projects will be provided samples after 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 samples
or for Federal Government proposals a signed Interagency Agreement
(IAA). All laboratory results obtained from the samples must be sent
back to NCHS to be linked to the variables requested by the
investigator that are needed to perform a quality control review of the
data under a signed Data Sharing Agreement or a Designated Agent
Agreement. This review must take place within 60 days of the return of
the data to NCHS so these data may be released to the public. All files
will also undergo disclosure review at NCHS before release.
Agency Agreement
A formal signed agreement in the form of a MTA or an IAA with
investigators 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.
Continuations
A brief progress report will be submitted annually. This will be
the basis for the NCHS ERB continuation reports that are required
annually. After 5 years of annual continuations, if there is need for
continued use of samples to complete the protocol study, a new protocol
is required.
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 NCHS ERB. No samples 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 Serum, Plasma and
Urine Repository or disposed of, after NHANES approval, upon completion
of the approved project. These results, once returned to NCHS, will be
part of the public domain. The proposer will have 60 days for quality
control review of the data before public release.
Cost Schedule for Providing NHANES Samples
There is a nominal processing fee of $13.00 for each sample
received from the NHANES Serum, Plasma and Urine Repository. If the
investigator requests to use the samples for another project after the
completion of the initial project, the cost will be $5.00 per sample to
handle the processing of the data and management of the proposal
process. The costs include the collection, storage, and processing of
the samples along with the review of proposals and the preparation of
the data files. The costs listed are for the recurring laboratory
materials 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. See: https://www.cdc.gov/nchs/nhanes/about_nhanes.htm.
Labor costs are based on a proposal administrator and computer
programmers at NCHS to prepare the data files. The storage and pulling
the samples from the freezer fees include the costs for the NHANES
repository.
Fee Schedule for NHANES Biologic Samples
------------------------------------------------------------------------
Cost factors Cost per vial
------------------------------------------------------------------------
Material and Equipment.................................. $2.85
Processing the samples (Receiving, handling and 2.15
shipping)..............................................
Administrative, management of the proposal process...... 1.50
Inventory management.................................... 1.50
Preparation of data files............................... 3.50
---------------
Subtotal............................................ 11.50
CDC Support (5%)........................................ 0.58
---------------
Subtotal............................................ 12.08
NCHS Support (7.50%).................................... 0.91
---------------
Total........................................... 13.00 *
------------------------------------------------------------------------
Total is rounded up from $12.99
[[Page 58209]]
Dated: December 5, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2017-26591 Filed 12-8-17; 8:45 am]
BILLING CODE 4163-18-P
