Notice2021-17265
National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals To Use Serum, Plasma, and Urine Samples
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 12, 2021
Effective
August 12, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of stored serum, plasma, and urine samples obtained from participants in the National Health and Nutrition Examination Survey (NHANES) and the proposal parameters and fee schedule for 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).
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 153 (Thursday, August 12, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Pages 44367-44370]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17265]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
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 serum, plasma, and urine samples obtained from
participants in the National Health and Nutrition Examination Survey
(NHANES) and the proposal parameters and fee schedule for 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 August 12,
2021. The fee structure for these samples is effective August 12, 2021.
FOR FURTHER INFORMATION CONTACT: Bryan Stierman, National Center for
Health Statistics, Centers for Disease Control and Prevention, 3311
Toledo Road, Hyattsville, MD 20782. Telephone: (301) 458-4798. Email:
<a href="/cdn-cgi/l/email-protection#8cdfe9fef9e1fce0edffe1edf9fee5e2e9ccefe8efa2ebe3"><span class="__cf_email__" data-cfemail="df8cbaadaab2afb3beacb2beaaadb6b1ba9fbcbbbcf1b8b0">[email protected]</span></a>v.
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.
For NHANES cycles prior to the 2021-22 cycle, the survey
oversamples the two largest race/ethnicity groups, non-Hispanic black
and Mexican American (and all Hispanic since 2007-08). In 2011-2020,
NHANES also oversampled the Asian race/ethnicity group.
Sample Availability
Samples are available from NHANES III, a periodic survey that was
conducted from 1988-1994 (see: <a href="https://wwwn.cdc.gov/nchs/nhanes/nhanes3/default.aspx">https://wwwn.cdc.gov/nchs/nhanes/nhanes3/default.aspx</a> for more information on NHANES III), and the
continuous NHANES, with data release in two-year cycles starting in
1999-2000 through the 2019-March 2020 (Coronavirus Disease 2019 (COVID-
19) pre-pandemic) (Table A) collection. NCHS is making both collections
available for study proposals.
Approximately 30,000 individuals were examined in NHANES III, which
began in the fall of 1988, and ended in the fall of 1994. Investigators
can analyze samples 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.
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). Projects must use two-
year cycles or multiple two-year cycles for their studies (i.e., 1999-
2000, 2001-2002 etc.).
Serum, plasma, and urine samples are stored in two biorepositories.
Samples that were initially used for laboratory assays included in the
surveys, that were stored at -70[deg]C and that have been through at
least two freeze-thaw cycles, are considered surplus samples. They are
stored at a commercial biorepository under contract to NCHS. In
addition, another set of 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 Biorepository (CBR)
is the long-term repository for the pristine NHANES serum, plasma, and
urine samples. NCHS is making both pristine and surplus collections
available for study proposals. Please see the NHANES Biospecimen
Program series report for details about collection and storage of
serum, plasma, and urine samples <a href="http://www.cdc.gov/nchs/data/series/sr_02/sr02_170.pdf">http://www.cdc.gov/nchs/data/series/sr_02/sr02_170.pdf</a>.
Table A--Overview of Biospecimens by Survey Year, NHANES III (1988-1994) and NHANES 1999-March 2020
[Pre-pandemic]
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 ...............
2001-2002......................................... X X X X X ...............
2003-2004......................................... X X X X ............... ...............
2005-2006......................................... X X X X ............... ...............
2007-2008......................................... X X X X X ...............
[[Page 44368]]
2009-2010......................................... X X X X ............... ...............
2011-2012......................................... X ............... X X ............... ...............
2013-2014......................................... X ............... X X ............... ...............
2015-2016......................................... X ............... X X ............... ...............
2017-2018......................................... X ............... X X ............... ...............
2019--March pre-pandemic 2020..................... X ............... X X ............... ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Samples immediately frozen for storage, did not undergo laboratory testing.
\2\ Samples are surplus specimens after laboratories had completed testing.
Parameters for Sample Use
1. Investigators should justify why they need a national
probability sample for their study.
2. 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: <a href="https://wwwn.cdc.gov/nchs/nhanes/analyticguidelines.aspx">https://wwwn.cdc.gov/nchs/nhanes/analyticguidelines.aspx</a>.
3. Investigators that request pristine (never thawed) samples
should justify the use of the pristine samples.
4. Only proposals with test results that are determined not to have
clinical significance for participants will be accepted. 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. Though the consent form for NHANES III had
less detail, this parameter is also applicable to the use of NHANES III
samples. Therefore, only proposals with laboratory test results that do
not have clinical significance to the survey participant will be
accepted. The potential for clinical significance of a laboratory test
should be addressed by investigators in the proposal; the determination
of clinical significance will be made by the Technical Panel. A
laboratory test result is considered clinically significant to the
survey participant if the following criteria are met:
<bullet> The laboratory test is performed by a Clinical Laboratory
Improvement Amendments (CLIA)- certified laboratory deeming the
findings valid,
<bullet> the findings have significant implications for the
participant's health concerns, and
<bullet> a course of action is readily available to treat the
associated health concern
Proposal Evaluation
All proposals for use of NHANES samples will be evaluated by a
Technical Panel, the NCHS Confidentiality Officer, the NCHS Human
Subjects Contact and the NCHS Ethics Review Board (ERB). The current
Technical Panel consists of NHANES staff: Two physicians, one
statistician and a laboratory expert. Other experts from inside or
outside the Federal Government are added as needed. The Technical Panel
reviews proposals for scientific merit to determine: The need to use a
nationally representative sample, public health significance, and
laboratory assay validity, and potential for clinical significance to
the participant. The NCHS Confidentiality Officer reviews for
disclosure risk; the NCHS Human Subjects Officer for potential human
subjects concerns; and the NCHS ERB for conforming to the informed
consent. The NCHS ERB will review the proposal even if the investigator
has received approval by their respective institutional review panel.
The proposal, if approved, will become an amendment to the current
NHANES ERB Protocol (i.e., the NHANES ERB Protocol that is in effect at
the time of the investigator's proposal approval and held at NCHS).
The Technical Panel will evaluate the proposal for the scientific,
technical, and clinical significance to the participant, the
appropriateness and adequacy of the study design, and the methodology
proposed to reach the study goals. See ``Procedures for 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.
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 study. For this reason, investigators submitting proposals 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 study. The Technical Panel review will
seek to 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 NHANES proposal.
Investigators are encouraged to review the NHANES data, survey
documents, manuals and questionnaires at: NHANES Questionnaires,
Datasets, and Related Documentation (<a href="http://cdc.gov">cdc.gov</a>) or for NHANES III:
<a href="https://wwwn.cdc.gov/nchs/nhanes/nhanes3/datafiles.aspx">https://wwwn.cdc.gov/nchs/nhanes/nhanes3/datafiles.aspx</a>
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. The cover of the
proposal (which is not included in the 10-page limit) should include
the title of the proposal, the name, address, phone number and Email
address of the principal investigator (PI), and the name of the
institution where the laboratory analysis will be done. The name,
address, phone number and Email address of all additional investigators
should also be included on the cover. All proposals should be Emailed
to
[[Page 44369]]
<a href="/cdn-cgi/l/email-protection#6a390f181f071a060b19070b1f1803040f2a090e09440d05"><span class="__cf_email__" data-cfemail="ebb88e999e869b878a98868a9e9982858eab888f88c58c84">[email protected]</span></a>v. Proposals from CDC investigators must also
include the investigator's Collaborative Institutional Training
Initiative (CITI) expiration date.
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 study 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. 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 study 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 investigator 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) Study Design and Methods: Describe the study 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 the investigator is requesting a sub-sample of samples, a detailed
description and justification must be given.
The Technical Panel 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. The
resulting data will be released in the public domain or in rare
occasions to the NCHS Research Data Center by NCHS (if there is a
disclosure concern, e.g. one year of NHANES cycle). Released data from
sub-samples may be less useful to the scientific community, so such
requests will receive a lower priority for obtaining 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 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
and will not be approved; laboratory testing that is clinically
significant should be considered for inclusion in a future NHANES
survey cycle see NHANES New Content and Proposal Guidelines (<a href="http://cdc.gov">cdc.gov</a>).
(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 if 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. The NCHS
Project Officer must be consulted about the disposition of the samples.
At the end of the project period, any unused samples must be returned
to the NHANES Specimen Repository or discarded appropriately.
(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 $15.00. The basis for the cost structure is in the
last section of this document. Payment 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:
<a href="/cdn-cgi/l/email-protection#80d3e5f2f5edf0ece1f3ede1f5f2e9eee5c0e3e4e3aee7ef"><span class="__cf_email__" data-cfemail="3d6e584f48504d515c4e505c484f5453587d5e595e135a52">[email protected]</span></a>v.
Project Timeframes
<bullet> Submitting Proposals: Can be submitted on an ongoing
basis.
<bullet> Scientific Review Date (NHANES Technical Panel): Within
one month of proposal submission.
<bullet> Scientific Review Date (NCHS Human Subjects,
Confidentiality and ERB): Within two months of Technical Panel proposal
acceptance.
<bullet> Anticipated distribution of samples: One month after ERB
approval and after all Interagency Agreements or Material Transfer
Agreements are signed, and fees are paid.
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 NHANES variables requested by
the investigator and that are needed to perform a quality control
review of the data. The results data files will undergo disclosure
review by the NCHS Disclosure Review Board or NCHS Confidentiality
Officer or designee before the linked data are sent to the investigator
for quality control review. Once approved by disclosure review and
after the investigator has signed the Data Sharing Agreement or a
Designated Agent Agreement (respectively ``Agreement''), the linked
data file will be sent to the investigator for use pursuant to the
terms of the relevant agreement. The quality control review must take
place within 60 days and the return of the data to NCHS within the next
30 days so these data may be released to the public.
Agency Agreement
A formal signed agreement in the form of an MTA or an IAA with
investigators who have projects approved will be completed before the
release of the samples to the investigator. This agreement will contain
the conditions for use of the samples as stated in this Federal
Register Notice and as agreed upon by the investigators and CDC.
[[Page 44370]]
Continuations
A brief progress report will be submitted annually to NHANES. This
report should describe work completed and timeline to project
completion. If five years have elapsed since the initial approval of
the protocol by the NCHS ERB a more detailed plan and timeline to
complete the study will be required by NHANES. If at any time during
the project a new investigator(s) are added or the Principal
Investigator has changed, the NHANES Serum/plasma/urine Project Officer
must be notified.
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 NHANES
Technical Panel and the NCHS ERB. No samples can be shared with others,
including other investigators, unless specified in the proposal and so
approved by the NHANES Technical Panel and the NCHS ERB. 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. The results, once returned to NCHS, will be part
of the public domain. The investigator will have 60 days for quality
control review of the data before public release by NHANES.
Cost Schedule for Providing NHANES Samples
There is a nominal processing fee of $15.00 for each sample
received from an 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 additional cost will be $5.50
per sample to handle the processing of the data and management of the
subsequent proposal process. A new proposal must be submitted and go
through the approval process before any additional use of the samples.
The costs include the collection, processing, storage, and retrieval 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 costs for the NHANES repository include long term storage
(including inventory management and materials and equipment) and
accessioning of samples and pulling samples from the freezer for
shipment to the investigator. Labor costs are based on a proposal
administrator to manage the proposal process and computer programmers
at NCHS who prepare the data files for the release of the data along
with documentation on the NHANES web page.
Elements of the Fee for NHANES Biologic Samples
------------------------------------------------------------------------
Cost per
Cost factors vial
------------------------------------------------------------------------
Material and Equipment....................................... $3.42
Processing the samples (Receiving, handling, and shipping)... 2.58
Inventory management......................................... 1.80
Administrative, management of the proposal process........... 1.65
Preparation of data files.................................... 3.85
----------
Subtotal................................................... 13.30
------------------------------------------------------------------------
CDC Support (5%)............................................. 0.67
----------
Subtotal................................................... 13.97
NCHS Support (7.50%)......................................... 1.05
----------
Total...................................................... * 15.00
------------------------------------------------------------------------
* Total is rounded down from $15.02.
Authority: Sections 301,306 and 308 of the Public Health Service
Act (42 U.S.C. 241,242k and 242m).
Dated: August 9, 2021.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-17265 Filed 8-11-21; 8:45 am]
BILLING CODE 4163-18-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 12, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.