National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals To Use Serum, Plasma, and Urine Samples, 44367-44370 [2021-17265]
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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
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[FR Doc. 2021–17169 Filed 8–11–21; 8:45 am]
BILLING CODE P
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
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 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).
SUMMARY:
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:
Serumplasmaurine@cdc.gov.
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.
DATES:
Sample Availability
Samples are available from NHANES
III, a periodic survey that was
conducted from 1988–1994 (see: https://
wwwn.cdc.gov/nchs/nhanes/nhanes3/
default.aspx for more information on
NHANES III), and the continuous
NHANES, with data release in two-year
44367
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°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°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
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-MARCH 2020
[Pre-pandemic]
Sample type
Pristine 1
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NHANES cycle
III (1988–1994) .........................................
1999–2000 ...............................................
2001–2002 ...............................................
2003–2004 ...............................................
2005–2006 ...............................................
2007–2008 ...............................................
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Surplus 2
Sera
Plasma
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
X
........................
X
X
........................
........................
X
........................
........................
........................
........................
........................
........................
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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
TABLE A—OVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III (1988–1994) AND NHANES 1999-MARCH
2020—Continued
[Pre-pandemic]
Sample type
Pristine 1
NHANES cycle
2009–2010 ...............................................
2011–2012 ...............................................
2013–2014 ...............................................
2015–2016 ...............................................
2017–2018 ...............................................
2019—March pre-pandemic 2020 ...........
1 Samples
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2 Samples
Surplus 2
Sera
Plasma
Urine
Sera
Plasma
Urine
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.
are surplus specimens after laboratories had completed testing.
Parameters for Sample Use
Proposal Evaluation
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: https://wwwn.cdc.gov/
nchs/nhanes/analyticguidelines.aspx.
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:
• The laboratory test is performed by
a Clinical Laboratory Improvement
Amendments (CLIA)- certified
laboratory deeming the findings valid,
• the findings have significant
implications for the participant’s health
concerns, and
• a course of action is readily
available to treat the associated health
concern
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.
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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 (cdc.gov) 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. 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
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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
Serumplasmaurine@cdc.gov. 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, 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 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 subsample of samples, a detailed
description and justification must be
given.
The Technical Panel will evaluate the
Investigator’s submitted proposal study
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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
(cdc.gov).
(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
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44369
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:
Serumplasmaurine@cdc.gov.
Project Timeframes
• Submitting Proposals: Can be
submitted on an ongoing basis.
• Scientific Review Date (NHANES
Technical Panel): Within one month of
proposal submission.
• Scientific Review Date (NCHS
Human Subjects, Confidentiality and
ERB): Within two months of Technical
Panel proposal acceptance.
• 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.
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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
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.
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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
vial
Cost factors
Material and Equipment ..........................
Processing the samples (Receiving, handling, and shipping) .............................
Inventory management ...........................
Administrative, management of the proposal process. .....................................
Preparation of data files ..........................
$3.42
Subtotal ................................................
13.30
CDC Support (5%) ..................................
0.67
Subtotal ................................................
NCHS Support (7.50%) ...........................
13.97
1.05
Total .....................................................
* 15.00
2.58
1.80
1.65
3.85
* 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; ORR–6 Performance Report
(OMB #0970–0036)
Office of Refugee Resettlement,
Administration for Children and
Families, Health and Human Services
(HHS).
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR) is
SUMMARY:
requesting a revision of the ORR–6
Performance Report (OMB #0970–0036,
expiration 2/28/2022). Proposed
revisions include new data collection
primarily for the new Refugee Health
Promotion (RHP) set-aside program, and
reformatting and revisions of
instructions and forms for clarity.
Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
DATES:
Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street,
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: ACF/ORR requests
information from the ORR–6
Performance Report to determine
effectiveness of state Cash and Medical
Assistance (CMA) and Refugee Support
Services programs. ORR uses state-bystate CMA utilization rates, derived
from the ORR–6 Performance Report, to
formulate program initiatives, priorities,
standards, budget requests, and
assistance policies. Federal regulations
require state Refugee Resettlement,
Replacement Designee agencies, and
local governments submit statistical or
programmatic information that the ORR
Director determines to be required to
fulfill their responsibility under the
Immigration and Nationality Act (INA).
The existing ORR–6 was revised to
include data collection for the new RHP
set-aside program, add new data
elements to better understand the
meaning of existing data collection, and
update the instructions and reformat
some of the forms to provide clearer
definitions and better distinguish the
participation and performance results of
different support services programs.
Respondents: State governments and
Replacement Designees.
ANNUAL BURDEN ESTIMATES
Instrument
Total number of
respondents
Total number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
ORR–6 Performance Report ...........................................
69
6
19
7,866
2,622
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]]>Agencies
[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Pages 44367-44370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17265]
=======================================================================
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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 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:
[email protected]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: https://wwwn.cdc.gov/nchs/nhanes/nhanes3/default.aspx 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 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-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: https://wwwn.cdc.gov/nchs/nhanes/analyticguidelines.aspx.
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:
The laboratory test is performed by a Clinical Laboratory
Improvement Amendments (CLIA)- certified laboratory deeming the
findings valid,
the findings have significant implications for the
participant's health concerns, and
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 (cdc.gov) 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. 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]]
[email protected]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 (cdc.gov).
(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:
[email protected]v.
Project Timeframes
Submitting Proposals: Can be submitted on an ongoing
basis.
Scientific Review Date (NHANES Technical Panel): Within
one month of proposal submission.
Scientific Review Date (NCHS Human Subjects,
Confidentiality and ERB): Within two months of Technical Panel proposal
acceptance.
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
