National Health and Nutrition Examination Survey (NHANES) DNA Specimens: Guidelines for Proposals To Use Specimens and Cost Schedule, 69822-69826 [2016-24349]
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Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
preparation and submission of notices
of intent to withdraw is (276
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IV. Requests for Automatic Transfer of
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to prepare and submit a request will be
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the annual hour burden associated with
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Ways to minimize the burden of the
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Dated: September 30, 2016.
Kevin Winkler,
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[FR Doc. 2016–24345 Filed 10–6–16; 8:45 am]
BILLING CODE 8070–01–P
GENERAL SERVICES
ADMINISTRATION
[Notice-MA–2016–07; Docket No. 2016–
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Interagency Per Diem Working Group
Meeting Concerning Boundaries To
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SUMMARY:
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recommend whether the NSA boundarysetting process should be replaced,
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Dated: October 3, 2016.
Troy Cribb,
Associate Administrator, Office of
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[FR Doc. 2016–24263 Filed 10–6–16; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Health and Nutrition
Examination Survey (NHANES) DNA
Specimens: Guidelines for Proposals
To Use Specimens and Cost Schedule
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), located
within the Department of Health and
Human Services (HHS) announces
reopening of the National Center for
Health Statistics’ (NCHS) National
Health and Nutrition Examination
Survey (NHANES) DNA Specimen
Repository for research proposals. Blood
samples for DNA purification were
collected from study participants during
NHANES III, NHANES 1999–2000,
NHANES 2001–02, NHANES 2007–08,
and NHANES 2009–10 (Office of
Management and Budget Control
Numbers 0920–0237/0920–0950).
Samples from these DNA Specimens are
being made available to the research
community for genetic testing. The
information gained from research using
these samples can be combined with the
extensive amount of information
available in NHANES which describes
the prevalence/trends of disease,
nutrition, risk behaviors, and
environmental exposures in the US
population. A more complete
description of this program follows.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
NHANES Genetic Project Officer: Jody
McLean M.P.H., Division of Health and
Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road,
Hyattsville, MD 20782, Phone: 301–
458–4683, Fax: 301–458–4029, EMail:
NHANESgenetics@cdc.gov.
Authority: Sections 301, 306 and 308 of the
Public Health Service Act (42 U.S.C. 241,
2421 and 242m).
SUPPLEMENTARY INFORMATION:
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Background
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 noninstitutionalized population. The goals
of NHANES are (1) to estimate the
number and percentage of people in the
U.S. population and designated
subgroups with selected diseases and
risk factors for those diseases; (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
relation among 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 nutritional
status.
The availability of the NHANES III
DNA specimens has been previously
announced in 2002 (67 FR 51585), 2006
(71 FR 22248), 2007 (72 FR 59094), 2009
(74 FR 45644), and 2010 (75 FR 32191).
NHANES III Phase II DNA specimens
(1991–1994) are from participants ages
12 or older (see NHANES III DNA
Specimens section for a description).
For details about available NHANES III
non-genetic data see https://
www.cdc.gov/nchs/nhanes/
nh3data.htm.
Beginning in 1999, NHANES became
a continuous, annual survey rather than
a periodic survey. For a variety of
reasons, including disclosure and
reliability issues, the survey data are
released as public use data files every
two years. In addition to the analysis of
data from any two year cycle, it is
possible to combine two cycles to
increase sample size and analytic
options. Blood samples for DNA
purification were collected from
participants aged 20 years and older in
survey years 1999–2002 and 2007–12.
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DNA specimens are available as
collections from NHANES 1999–2002
(NHANES 1999–2000 and 2001–02
specimens available as one collection),
and NHANES two-year cycles 2007–08
and 2009–10(see NHANES 1999–2002,
2007–08, and 2009–10 DNA specimens
section for a description). Availability of
DNA specimens from NHANES 2011–12
is forthcoming and will be announced
in a future FRN. The availability of the
NHANES 1999–2002 and NHANES
2007–08 DNA specimens has been
previously announced (Thursday,
September 3, 2009 [74 FR 45644], and
Monday, June 7, 2010 [75 FR 32191]).
The data release cycle for the NHANES
corresponding to the period in which
specimens were collected for DNA is
described in the following web links:
https://wwwn.cdc.gov/nchs/nhanes/
search/nhanes99_00.aspx, https://
wwwn.cdc.gov/nchs/nhanes/search/
nhanes01_02.aspx, https://
wwwn.cdc.gov/nchs/nhanes/search/
nhanes07_08.aspx, and https://
wwwn.cdc.gov/Nchs/Nhanes/Search/
nhanes09_10.aspx.
Identifiable health information
collected in the NHANES is kept in
strictest confidence. During the
informed consent process, survey
participants are assured that data
collected will be used only for stated
purposes and will not be disclosed or
released to others without the consent of
the individual in accordance with
section 308(d) of the Public Health
Service Act (42 U.S.C. 242m). During
NHANES III, participants 12 years and
older (parent or guardian signed the
consent form if the participant was
under age 18 years) signed a consent
form to store a sample of their blood for
future research. In NHANES 1999–2002,
2007–08 and 2009–10 a separate
consent form was signed by eligible
participants who agreed to the storing of
specimens for future genetic research.
DNA specimens will be available for
testing only from participants who
consented to future genetic research.
Resulting data from DNA specimen
testing will be linked to the NCHS
variables (public use and restricted) and
available for analyses through an NCHS
Research Data Center (RDC). Access to
these data at an NCHS RDC is only
through an approved proposal process
mechanism to assure confidentiality.
Research Proposal
Note: The following proposal types
differ from those used in previous
announcements for use of NHANES III
DNA specimens (Thursday, August 8,
2002 [67 FR 51585], Friday, January 13,
2006 [71 FR 22248], and Monday, June
10, 2010 [75 FR 32191]).
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Proposals testing a complete NHANES
DNA collection of specimens (NHANES
III, 7,159 samples; NHANES 1999–2002,
7,839 specimens; NHANES 2007–08,
4,612 specimens; NHANES 2009–10,
4,893 specimens):
Note: If the investigator would like to
propose a subsample of the complete set
please contact the NHANES Genetic
Project Officer to discuss feasibility.
Proposals should investigate specific
research hypotheses. The investigator
will specify which DNA collection they
are requesting and the tests to be
conducted on DNA specimens
excluding tests that produce incidental
findings. The investigator will also
include in the research protocol an
analytic plan that includes a list of
proposed NCHS variables (public use
and restricted) that would be used for
the data analyses. The investigator will
conduct the tests of the approved
variants or approved assays on samples
of NHANES DNA specimens that are
labeled with a lab identification number
that is not directly linkable to the public
use file and therefore, anonymous to the
investigator. Investigators are required
to provide the data obtained from DNA
testing to Division of Health and
Nutrition Examination Survey
(DHANES)/NCHS for quality control
assessment. Analysis and linkage of the
resulting data are conducted in the
NCHS RDC via a separate proposal.
After the DHANES/NCHS has
completed the initial quality control
assessment, investigators will be given
up to six months to conduct a
comprehensive quality assurance
review. The timeframe allowed for this
review will depend on the number and
characteristics of the tests submitted. At
the completion of this review, the
availability of the resulting data will be
announced to the public on the
NHANES Web site Genetic Variant
Search: https://
www.nhgeneticvariant.com/. The
resulting data can be linked to other
NCHS variables (public use and
restricted) for secondary data analysis.
For further information on available
variant data visit: https://www.cdc.gov/
nchs/nhanes/biospecimens/
dnaspecimens.htm#Genetic.
DNA specimen collections will be
provided in 96 well plates to
investigators and distributed as samples
from a complete collection or from a
subsample of a collection.
Proposals testing DNA specimens
already obtained from previous
solicitations: Investigators that have
obtained samples from NHANES DNA
specimens from previous solicitations
and have sufficient DNA left may
request to do additional tests on the
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remaining DNA. These proposals must
be submitted and approved before the
DNA specimens were scheduled to be
destroyed or returned. The investigator
will specify the test to be conducted on
the samples excluding tests that
produce incidental findings. The
investigator will also include in the
research protocol an analytic plan that
includes a list of proposed NCHS
variables (public use and restricted) that
would be used for the data analyses.
There are purified DNA specimens
available from 4,893 NHANES 2009–10
participants. Samples from the
specimens will be distributed into 54
plates with approximately three
additional plates of quality control
samples.
Each 96 well plate will be bar-coded
and labeled with a readable identifier.
Quality control samples (5% of a
collection) will be sent at no charge, on
separate plates as blind replicates.
DNA Samples
Proposed Cost Schedule for Providing
NHANES DNA Samples
Costs are determined by NCHS and
include costs incurred from the
contracting DNA Repository and
DHANES administrative costs. The fee
covers the costs of materials, equipment,
labor, proposal review, administration
and space for storage. For more details
see Table 1 below. In prior years, the
DNA Repository was maintained by
CDC. The DNA Repository is now
maintained by a private contractor. The
costs of contracting, along with annual
inflation increases, are reflected in the
proposed cost schedule.
These DNA specimens (NHANES III,
NHANES 1999–2002, NHANES 2007–08
and NHANES 2009–10) were processed
by the Centers for Disease Control and
Prevention (CDC), National Center for
Environmental Health (NCEH), Division
of Laboratory Sciences (DLS).
NHANES III DNA Specimens
The laboratory will distribute aliquots
(samples) of crude DNA lysates
extracted from cell lines. DNA
concentrations vary and are estimated to
range from 7.5–65.0 ng/mL with an
average of approximately four
micrograms in 100 mL. Samples will be
provided in 96 well plates that are barcoded and labeled with a readable
identifier. Quality control samples (5%
of the total) will be sent at no charge,
on separate plates as blind replicates.
DNA specimens are available from 7,159
NHANES III participants. Samples will
be distributed in a total of 78 plates with
an additional four plates of quality
control samples. NHANES III DNA
specimens are in limited supply thus
are not available as a partial set. Due to
the method of extraction, NHANES III
DNA specimens are not appropriate for
all projects and/or assays.
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NHANES 1999–2002, 2007–08, 2009–10
DNA Specimens
The laboratory will distribute aliquots
of purified, high molecular DNA in
normalized concentrations of 50.0 ng/
mL. Some specimens may fall below this
threshold. A sample of 40 microliters of
each specimen will be supplied. The
amount of DNA in each sample may
vary but will be on average
approximately two micrograms.
There are purified DNA specimens
from 7,839 NHANES 1999–2002
participants. Samples from these
specimens will be distributed into 90
plates including four plates of quality
control samples.
There are purified DNA specimens
available from 4,612 NHANES 2007–08
participants. These will be distributed
into approximately 54 plates including
three plates of quality control samples.
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Procedures for Proposals
The investigator should follow these
instructions for preparation of
proposals. Protocols must be written
using the outline below.
Proposal Timeline
• Submission of Proposals: Can be
submitted on an ongoing basis.
• Scientific Review: Within two
months of proposal submission.
• Institutional Review Date: Within
six weeks of final proposal acceptance.
• Notification of approval:
Approximately 30 days after
Institutional Review.
• Anticipated distribution of samples:
Approximately 60 days after all
approvals are obtained.
Note: Timeframe may vary depending
on the nature of the proposal and the
results of each level of review.
Unforeseen circumstances could result
in a change to this schedule.
DNA Specimen Program will begin
accepting research proposals on
December 6, 2016.
In addition to the cover page, the
research proposal should contain the
title of the research project, the name,
address phone number and Email
address of the lead investigator along
with the name of the institution where
the testing will be conducted. Office of
Human Research Protections assurance
numbers for the institutions engaged in
the research project should be included.
CDC investigators need to include their
Scientific Ethics Verification Number.
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Email submission of the proposal is
required.
The proposals should be a maximum
of 20 single-spaced typed pages,
excluding figures and tables. Please use
appendices sparingly. If a proposal is
approved, the title, specific aims, name,
and phone number of the author will be
maintained by NCHS and released if
requested by the public. Unapproved
proposals will be returned to the
investigator and will not be maintained
by NCHS.
Applications will have a Scientific
Review by the Genetic Project Officer
and the Technical Panel. The Technical
Panel is comprised of two members: A
Genetic Research Scientist and a
Genetic Epidemiologist. The members
review each proposal for scientific and
technical merit.
After the proposal is approved by the
Genetic Technical Panel and the Genetic
Project Officer it will be submitted for
Institutional review. All proposals will
undergo Institutional Review by the
NCHS Human Subjects Contact and the
NCHS Ethics Review Board (ERB) for
any potential human subjects concerns
to ensure appropriate human subjects
protections are provided in compliance
with 45 CFR 46, and by the NCHS
Confidentiality Officer for disclosure
risk. The ERB will review the proposal
even if the investigator has received
approval by their institutional review
panel.
Proposals should include the
following information:
(1) Cover sheet: Include the name of
the institution where the test will be
conducted and Office of Human
Research Protections assurance numbers
for the institutions engaged in the
research project. CDC investigators need
to include their Scientific Ethics
Verification Number.
(2) Abstract: Please limit the abstract
to 300 words.
(3) 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.
(4) Background and Public Health
Significance:
(A) Describe the public health
significance of the proposed research.
(B) Discuss how the results will be
used. Analyses should be consistent
with the NHANES mission to assess the
health of the nation. The Scientific
Review will ensure that the proposed
project does not go beyond either the
general purpose for collecting the blood
samples for DNA in the survey or the
specific stated goals of the proposal.
(5) Design, Method, and Data
analysis: The appropriateness and
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adequacy of the methodology proposed
to reach the research aims, and the
appropriateness of using the NHANES
(a complex, multistage probability
sample of the national population) to
address the goals of the proposal will be
assessed.
(A) Research Design and Methods:
Describe the analytic and statistical
methods to be employed. Include power
calculations. For all proposal categories,
include a detailed description of the
laboratory methods. The characteristics
of the laboratory assay, such as
reliability, validity, should be included
with appropriate references. The
potential difficulties and limitations of
the proposed procedures should also be
discussed. Address adequate methods
planned for handling and storage of
samples of DNA specimens. Proposals
must specify specific variants or the
standard assay(s) that will be used to
test the proposed research hypotheses
and include a statement of why the
specific standard assay(s) is/are
necessary to test the proposed
hypotheses. The standard assay is a
commercially available assay for a
curated set of variants. (1) Proposals
will be provided with quality control
samples at no additional cost. Approved
projects must run these quality control
samples and submit these results along
with the results from the NHANES DNA
samples, unless the Genetic Project
Officer has approved an alternative
quality control review plan. (2)
Proposals using residual samples should
have residual quality control samples
and investigators will be required to use
these residual quality control samples.
The proposal should address additional
quality control procedures the
laboratory will use to assure the validity
of the test results and address adequate
methods planned for handling and
storage of sample specimens.
(B) Data analysis: Note: All resulting
data must be analyzed in the NCHS
RDC Output: Please describe the data
output that you would like to retain and
take out of the RDC after analyses.
(6) Additional information for
NHANES:
(A) Clinical Relevance of Research
Findings: The consent document for
DNA specimen storage and future
studies states that individual results
will not be provided to participants
therefore no tests that would need to be
reported back to the participant can be
proposed. DHANES/NCHS will use the
most recent American College of
Medical Genetics and Genomics
(ACMG) recommendations for reporting
incidental findings to review the
proposed tests and the potential
incidental findings. Investigators must
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justify that the proposed tests do not
produce sets of variants on specific
genes listed by the most recent ACMG
as reportable incidental findings as well
as how potential incidental test results
will be handled. As of publication the
most recent report, published July 2013,
‘‘ACMG Recommendations for
Reporting of Incidental Findings in
Clinical Exome and Genome
Sequencing’’, lists 56 genes where
specific variants on these genes are
pathogenic for 24 conditions.
(B)Data Transfer: Specify the secure
method to transfer resultant data to
NCHS. Investigators must use a device
that meets federal information
processing standards (FIPS 140–2 and
FIPS 197).
(C) Period of Performance: Specify the
project period. The period may be up to
three years. At the end of the project
period, any unused samples must be
returned to the NHANES DNA
Specimen Repository or destroyed by
the investigator. Extensions to the
period of performance may be
requested.
(D) Funding: Include the source and
status of the funding to perform the
requested laboratory analysis.
Investigators will be responsible for the
cost of processing and shipping the
samples (See table).
(7) References.
(8) Resumes/CV: Please include a 2page CV for each member of the
research team in this document (not as
attachments).
Public Availability of Data
Data resulting from use of DNA
specimens will be made available to the
public for secondary data analyses via
the NCHS RDC. After DHANES/NCHS
quality control assessment is completed,
investigators will be given up to six
months to conduct comprehensive
quality assurance review in the NCHS
RDC. The quality assurance review
timeframe will be negotiated between
the investigator and the NHANES
Genetic Project Officer and will depend
on the type, number, and characteristics
of the tests submitted. The results of the
quality assurance review will be
provided to DHANES/NCHS and
appropriate aspects will become part of
the data set documentation. The public
announcement, that test results are
available for submission of proposals for
secondary data analyses, will occur
once the quality assurance review
timeframe has ended. For a list of
currently available variant data see:
https://www.cdc.gov/nchs/nhanes/
biospecimens/
dnaspecimens.htm#Genetic.
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Proposals for secondary data analyses
linking NCHS restricted data, NCHS
public use data, or non-NCHS data to
data resulting from DNA specimen
testing will be reviewed by the NCHS
RDC. See https://www.cdc.gov/rdc for
proposal guidelines.
Submission of Proposals
Proposals can be submitted
immediately. The review process will
begin approximately 60 days from the
publication of the notice and will
include all proposals submitted as of
that date.
Electronic submission of proposals
are required. Please submit proposals to
the NHANES Genetic Project Officer:
Jody McLean M.P.H., Division of Health
and Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road,
Hyattsville, MD 20782, Phone: 301–
458–4683, EMail: NHANESgenetics@
cdc.gov.
Agency Agreement
Investigators must secure funding and
sign terms and conditions agreements
for the use of the DNA specimens with
CDC/NCHS prior to the release of the
NHANES DNA samples. Investigators
must agree to use the specimens only for
the approved tests and use the test
results only for purposes as stated in the
approved proposal, not link the results
of the proposed research to any other
data, and not use the DNA specimens
for commercial purposes via a legally
binding Materials Transfer Agreement
for non-government researchers or
Interagency Agreement for government
researchers. In addition, all investigators
will be required to sign a Designated
Agent Agreement (DAA) with CDC/
NCHS in accordance with NCHS’
confidentiality legislation, the
Confidential Information Protection and
Statistical Efficiency Act (CIPSEA; Title
V of the E-Government Act of 2002
(Pub. L. 107–347)). The DAA is the
mechanism by which CDC/NCHS may
authorize designation of agents to
exclusively perform activities needed to
produce approved data on CIPSEA
protected NHANES DNA specimens.
Approved Proposals
After DNA samples are received and
testing is complete, the resulting data
will be sent back to DHANES/NCHS for
quality control (QC) assessment. While
DHANES/NCHS QC assessment is under
way the investigator can submit a NCHS
RDC proposal to conduct
comprehensive quality assurance
review. Once the investigator’s quality
assurance review is complete and the
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results returned to DHANES/NCHS, the
test results will be made available to the
public and the investigator can submit
an NCHS RDC proposal to request
linkage to NCHS restricted data, NCHS
public use data, or Non-NCHS data to
conduct their analysis.
After the comprehensive quality
assessment process has been completed
by the investigator, a list of variants
generated from NHANES specimen
testing will be made available to the
public for potential solicitation via
NCHS RDC proposals. The list of
variants will be available in the
NHANES Genetic Variant Search
(https://www.nhgeneticvariant.com/). In
addition, DHANES/NCHS quality
control assessment procedures will be
posted on the NHANES Genetic
Repository Web site and/or available via
email.
Progress Reports
A progress report will be submitted in
the annual CDC/NCHS/ERB
continuation report. An ERB
continuation form will be sent to the
investigator each year for project
update. If an approved proposal is
unable to obtain funding the proposal
will be closed.
Termination of ERB Protocol
At the end of laboratory testing the
ERB Protocol will be closed.
Disposition of Results and Samples
The provided DNA samples cannot be
used for any purpose other than the
specifically requested purpose outlined
in the proposal and approved through
the Scientific and Institutional Review.
No DNA samples can be shared with
others, including other investigators,
unless specified in the proposal and so
approved. Samples must be returned
upon completion of the approved
project or destroyed only with the
written approval of the NHANES
Genetic Project Officer. Test results from
all studies using NHANES DNA
specimens will be made available to the
public for secondary data analyses.
After the DHANES/NCHS quality
control assessment is completed,
investigators will be given up to six
months to conduct a more
comprehensive quality assurance
review. The final quality assurance
review timeframe will be negotiated
between the researcher and the
NHANES Genetic Project Officer and
characteristics of the tests submitted.
Proposals for secondary data analyses
will be reviewed by the NCHS RDC on
a rolling basis; see: https://www.cdc.gov/
rdc for proposal guidelines. All data
analyses will be conducted via access
modes available at NCHS RDC.
Dated: October 4, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
TABLE 1—COST SCHEDULE FOR NHANES DNA SPECIMENS
1999–2002,
2007–08,
2009–10
Complete set
Total costs
Materials and Equipment—contractor: Plates, reagents, assays, aliquoting and packaging
samples; use of equipment ......................................................................................................
Labor—contractor: Processing, handling, and shipping; NCHS: Data quality control ................
Proposal review and Administrative expenses—contractor: Inventory management and reporting; NCHS: Management of proposal process non-NCHS: Technical panel fees ............
Space—contractor: Freezer use and maintenance .....................................................................
Cost per sample ..........................................................................................................................
Cost per new proposal:
1999–2002 ............................................................................................................................
2007–2008 ............................................................................................................................
2009–2010 ............................................................................................................................
III ...........................................................................................................................................
Cost per additional proposal: *
1999–2002 ............................................................................................................................
2007–2008 ............................................................................................................................
2009–2010 ............................................................................................................................
III ...........................................................................................................................................
1999–2002,
2007–08,
2009–10
Partial set
NHANES III
complete set
$1.51
4.98
$4.53
24.90
$0.75
2.49
3.02
5.59
15.10
6.04
5.59
41.06
1.51
2.79
7.55
119,260
72,661
73,884
........................
NA
5,963
3,633
3,694
........................
........................
54,050
**
........................
2,702
* Additional research using DNA specimens already obtained from previous solicitations.
** This charge will be 5 percent of the original cost.
Note: Applicable CDC overhead and NCHS management and oversight charges will be added to these rates for proposals coming from Federal agencies.
[FR Doc. 2016–24349 Filed 10–6–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK3G9T082PROD with NOTICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)
Amendment: A notice of this meeting
was published in the Federal Register
on August 30, 2016, Volume 81,
Number 168, Page 59626. The original
notice is amended to include the
VerDate Sep<11>2014
17:36 Oct 06, 2016
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Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention—Health Disparities
Subcommittee (HDS) Meeting on
October 19, 2016 as follows:
Time and Date: 8:00 a.m.–4:00 p.m.,
EDT, October 19, 2016.
Place: CDC, Building 19, Room 151,
1600 Clifton Road NE., Atlanta, Georgia
30329.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 50
people. The public is welcome to
participate during the public comment
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Notices]
[Pages 69822-69826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24349]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Health and Nutrition Examination Survey (NHANES) DNA
Specimens: Guidelines for Proposals To Use Specimens and Cost Schedule
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), located
within the Department of Health and Human Services (HHS) announces
reopening of the National Center for Health Statistics' (NCHS) National
Health and Nutrition Examination Survey (NHANES) DNA Specimen
Repository for research proposals. Blood samples for DNA purification
were collected from study participants during NHANES III, NHANES 1999-
2000, NHANES 2001-02, NHANES 2007-08, and NHANES 2009-10 (Office of
Management and Budget Control Numbers 0920-0237/0920-0950). Samples
from these DNA Specimens are being made available to the research
community for genetic testing. The information gained from research
using these samples can be combined with the extensive amount of
information available in NHANES which describes the prevalence/trends
of disease, nutrition, risk behaviors, and environmental exposures in
the US population. A more complete description of this program follows.
[[Page 69823]]
FOR FURTHER INFORMATION CONTACT: NHANES Genetic Project Officer: Jody
McLean M.P.H., Division of Health and Nutrition Examination Surveys,
National Center for Health Statistics, Centers for Disease Control and
Prevention, 3311 Toledo Road, Hyattsville, MD 20782, Phone: 301-458-
4683, Fax: 301-458-4029, EMail: NHANESgenetics@cdc.gov.
Authority: Sections 301, 306 and 308 of the Public Health
Service Act (42 U.S.C. 241, 2421 and 242m).
SUPPLEMENTARY INFORMATION:
Background
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 percentage of people in the U.S. population and
designated subgroups with selected diseases and risk factors for those
diseases; (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 relation among 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 nutritional status.
The availability of the NHANES III DNA specimens has been
previously announced in 2002 (67 FR 51585), 2006 (71 FR 22248), 2007
(72 FR 59094), 2009 (74 FR 45644), and 2010 (75 FR 32191). NHANES III
Phase II DNA specimens (1991-1994) are from participants ages 12 or
older (see NHANES III DNA Specimens section for a description). For
details about available NHANES III non-genetic data see https://www.cdc.gov/nchs/nhanes/nh3data.htm.
Beginning in 1999, NHANES became a continuous, annual survey rather
than a periodic survey. For a variety of reasons, including disclosure
and reliability issues, the survey data are released as public use data
files every two years. In addition to the analysis of data from any two
year cycle, it is possible to combine two cycles to increase sample
size and analytic options. Blood samples for DNA purification were
collected from participants aged 20 years and older in survey years
1999-2002 and 2007-12. DNA specimens are available as collections from
NHANES 1999-2002 (NHANES 1999-2000 and 2001-02 specimens available as
one collection), and NHANES two-year cycles 2007-08 and 2009-10(see
NHANES 1999-2002, 2007-08, and 2009-10 DNA specimens section for a
description). Availability of DNA specimens from NHANES 2011-12 is
forthcoming and will be announced in a future FRN. The availability of
the NHANES 1999-2002 and NHANES 2007-08 DNA specimens has been
previously announced (Thursday, September 3, 2009 [74 FR 45644], and
Monday, June 7, 2010 [75 FR 32191]). The data release cycle for the
NHANES corresponding to the period in which specimens were collected
for DNA is described in the following web links: https://wwwn.cdc.gov/nchs/nhanes/search/nhanes99_00.aspx, https://wwwn.cdc.gov/nchs/nhanes/search/nhanes01_02.aspx, https://wwwn.cdc.gov/nchs/nhanes/search/nhanes07_08.aspx, and https://wwwn.cdc.gov/Nchs/Nhanes/Search/nhanes09_10.aspx.
Identifiable health information collected in the NHANES is kept in
strictest confidence. During the informed consent process, survey
participants are assured that data collected will be used only for
stated purposes and will not be disclosed or released to others without
the consent of the individual in accordance with section 308(d) of the
Public Health Service Act (42 U.S.C. 242m). During NHANES III,
participants 12 years and older (parent or guardian signed the consent
form if the participant was under age 18 years) signed a consent form
to store a sample of their blood for future research. In NHANES 1999-
2002, 2007-08 and 2009-10 a separate consent form was signed by
eligible participants who agreed to the storing of specimens for future
genetic research. DNA specimens will be available for testing only from
participants who consented to future genetic research. Resulting data
from DNA specimen testing will be linked to the NCHS variables (public
use and restricted) and available for analyses through an NCHS Research
Data Center (RDC). Access to these data at an NCHS RDC is only through
an approved proposal process mechanism to assure confidentiality.
Research Proposal
Note: The following proposal types differ from those used in
previous announcements for use of NHANES III DNA specimens (Thursday,
August 8, 2002 [67 FR 51585], Friday, January 13, 2006 [71 FR 22248],
and Monday, June 10, 2010 [75 FR 32191]).
Proposals testing a complete NHANES DNA collection of specimens
(NHANES III, 7,159 samples; NHANES 1999-2002, 7,839 specimens; NHANES
2007-08, 4,612 specimens; NHANES 2009-10, 4,893 specimens):
Note: If the investigator would like to propose a subsample of the
complete set please contact the NHANES Genetic Project Officer to
discuss feasibility.
Proposals should investigate specific research hypotheses. The
investigator will specify which DNA collection they are requesting and
the tests to be conducted on DNA specimens excluding tests that produce
incidental findings. The investigator will also include in the research
protocol an analytic plan that includes a list of proposed NCHS
variables (public use and restricted) that would be used for the data
analyses. The investigator will conduct the tests of the approved
variants or approved assays on samples of NHANES DNA specimens that are
labeled with a lab identification number that is not directly linkable
to the public use file and therefore, anonymous to the investigator.
Investigators are required to provide the data obtained from DNA
testing to Division of Health and Nutrition Examination Survey
(DHANES)/NCHS for quality control assessment. Analysis and linkage of
the resulting data are conducted in the NCHS RDC via a separate
proposal.
After the DHANES/NCHS has completed the initial quality control
assessment, investigators will be given up to six months to conduct a
comprehensive quality assurance review. The timeframe allowed for this
review will depend on the number and characteristics of the tests
submitted. At the completion of this review, the availability of the
resulting data will be announced to the public on the NHANES Web site
Genetic Variant Search: https://www.nhgeneticvariant.com/. The resulting
data can be linked to other NCHS variables (public use and restricted)
for secondary data analysis. For further information on available
variant data visit: https://www.cdc.gov/nchs/nhanes/biospecimens/dnaspecimens.htm#Genetic.
DNA specimen collections will be provided in 96 well plates to
investigators and distributed as samples from a complete collection or
from a subsample of a collection.
Proposals testing DNA specimens already obtained from previous
solicitations: Investigators that have obtained samples from NHANES DNA
specimens from previous solicitations and have sufficient DNA left may
request to do additional tests on the
[[Page 69824]]
remaining DNA. These proposals must be submitted and approved before
the DNA specimens were scheduled to be destroyed or returned. The
investigator will specify the test to be conducted on the samples
excluding tests that produce incidental findings. The investigator will
also include in the research protocol an analytic plan that includes a
list of proposed NCHS variables (public use and restricted) that would
be used for the data analyses.
DNA Samples
These DNA specimens (NHANES III, NHANES 1999-2002, NHANES 2007-08
and NHANES 2009-10) were processed by the Centers for Disease Control
and Prevention (CDC), National Center for Environmental Health (NCEH),
Division of Laboratory Sciences (DLS).
NHANES III DNA Specimens
The laboratory will distribute aliquots (samples) of crude DNA
lysates extracted from cell lines. DNA concentrations vary and are
estimated to range from 7.5-65.0 ng/[mu]L with an average of
approximately four micrograms in 100 [mu]L. Samples will be provided in
96 well plates that are bar-coded and labeled with a readable
identifier. Quality control samples (5% of the total) will be sent at
no charge, on separate plates as blind replicates. DNA specimens are
available from 7,159 NHANES III participants. Samples will be
distributed in a total of 78 plates with an additional four plates of
quality control samples. NHANES III DNA specimens are in limited supply
thus are not available as a partial set. Due to the method of
extraction, NHANES III DNA specimens are not appropriate for all
projects and/or assays.
NHANES 1999-2002, 2007-08, 2009-10 DNA Specimens
The laboratory will distribute aliquots of purified, high molecular
DNA in normalized concentrations of 50.0 ng/[mu]L. Some specimens may
fall below this threshold. A sample of 40 microliters of each specimen
will be supplied. The amount of DNA in each sample may vary but will be
on average approximately two micrograms.
There are purified DNA specimens from 7,839 NHANES 1999-2002
participants. Samples from these specimens will be distributed into 90
plates including four plates of quality control samples.
There are purified DNA specimens available from 4,612 NHANES 2007-
08 participants. These will be distributed into approximately 54 plates
including three plates of quality control samples.
There are purified DNA specimens available from 4,893 NHANES 2009-
10 participants. Samples from the specimens will be distributed into 54
plates with approximately three additional plates of quality control
samples.
Each 96 well plate will be bar-coded and labeled with a readable
identifier. Quality control samples (5% of a collection) will be sent
at no charge, on separate plates as blind replicates.
Proposed Cost Schedule for Providing NHANES DNA Samples
Costs are determined by NCHS and include costs incurred from the
contracting DNA Repository and DHANES administrative costs. The fee
covers the costs of materials, equipment, labor, proposal review,
administration and space for storage. For more details see Table 1
below. In prior years, the DNA Repository was maintained by CDC. The
DNA Repository is now maintained by a private contractor. The costs of
contracting, along with annual inflation increases, are reflected in
the proposed cost schedule.
Procedures for Proposals
The investigator should follow these instructions for preparation
of proposals. Protocols must be written using the outline below.
Proposal Timeline
Submission of Proposals: Can be submitted on an ongoing
basis.
Scientific Review: Within two months of proposal
submission.
Institutional Review Date: Within six weeks of final
proposal acceptance.
Notification of approval: Approximately 30 days after
Institutional Review.
Anticipated distribution of samples: Approximately 60 days
after all approvals are obtained.
Note: Timeframe may vary depending on the nature of the proposal
and the results of each level of review. Unforeseen circumstances could
result in a change to this schedule.
DNA Specimen Program will begin accepting research proposals on
December 6, 2016.
In addition to the cover page, the research proposal should contain
the title of the research project, the name, address phone number and
Email address of the lead investigator along with the name of the
institution where the testing will be conducted. Office of Human
Research Protections assurance numbers for the institutions engaged in
the research project should be included. CDC investigators need to
include their Scientific Ethics Verification Number. Email submission
of the proposal is required.
The proposals should be a maximum of 20 single-spaced typed pages,
excluding figures and tables. Please use appendices sparingly. If a
proposal is approved, the title, specific aims, name, and phone number
of the author will be maintained by NCHS and released if requested by
the public. Unapproved proposals will be returned to the investigator
and will not be maintained by NCHS.
Applications will have a Scientific Review by the Genetic Project
Officer and the Technical Panel. The Technical Panel is comprised of
two members: A Genetic Research Scientist and a Genetic Epidemiologist.
The members review each proposal for scientific and technical merit.
After the proposal is approved by the Genetic Technical Panel and
the Genetic Project Officer it will be submitted for Institutional
review. All proposals will undergo Institutional Review by the NCHS
Human Subjects Contact and the NCHS Ethics Review Board (ERB) for any
potential human subjects concerns to ensure appropriate human subjects
protections are provided in compliance with 45 CFR 46, and by the NCHS
Confidentiality Officer for disclosure risk. The ERB will review the
proposal even if the investigator has received approval by their
institutional review panel.
Proposals should include the following information:
(1) Cover sheet: Include the name of the institution where the test
will be conducted and Office of Human Research Protections assurance
numbers for the institutions engaged in the research project. CDC
investigators need to include their Scientific Ethics Verification
Number.
(2) Abstract: Please limit the abstract to 300 words.
(3) 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.
(4) Background and Public Health Significance:
(A) Describe the public health significance of the proposed
research.
(B) Discuss how the results will be used. Analyses should be
consistent with the NHANES mission to assess the health of the nation.
The Scientific Review will ensure that the proposed project does not go
beyond either the general purpose for collecting the blood samples for
DNA in the survey or the specific stated goals of the proposal.
(5) Design, Method, and Data analysis: The appropriateness and
[[Page 69825]]
adequacy of the methodology proposed to reach the research aims, and
the appropriateness of using the NHANES (a complex, multistage
probability sample of the national population) to address the goals of
the proposal will be assessed.
(A) Research Design and Methods: Describe the analytic and
statistical methods to be employed. Include power calculations. For all
proposal categories, include a detailed description of the laboratory
methods. The characteristics of the laboratory assay, such as
reliability, validity, should be included with appropriate references.
The potential difficulties and limitations of the proposed procedures
should also be discussed. Address adequate methods planned for handling
and storage of samples of DNA specimens. Proposals must specify
specific variants or the standard assay(s) that will be used to test
the proposed research hypotheses and include a statement of why the
specific standard assay(s) is/are necessary to test the proposed
hypotheses. The standard assay is a commercially available assay for a
curated set of variants. (1) Proposals will be provided with quality
control samples at no additional cost. Approved projects must run these
quality control samples and submit these results along with the results
from the NHANES DNA samples, unless the Genetic Project Officer has
approved an alternative quality control review plan. (2) Proposals
using residual samples should have residual quality control samples and
investigators will be required to use these residual quality control
samples. The proposal should address additional quality control
procedures the laboratory will use to assure the validity of the test
results and address adequate methods planned for handling and storage
of sample specimens.
(B) Data analysis: Note: All resulting data must be analyzed in the
NCHS RDC Output: Please describe the data output that you would like to
retain and take out of the RDC after analyses.
(6) Additional information for NHANES:
(A) Clinical Relevance of Research Findings: The consent document
for DNA specimen storage and future studies states that individual
results will not be provided to participants therefore no tests that
would need to be reported back to the participant can be proposed.
DHANES/NCHS will use the most recent American College of Medical
Genetics and Genomics (ACMG) recommendations for reporting incidental
findings to review the proposed tests and the potential incidental
findings. Investigators must justify that the proposed tests do not
produce sets of variants on specific genes listed by the most recent
ACMG as reportable incidental findings as well as how potential
incidental test results will be handled. As of publication the most
recent report, published July 2013, ``ACMG Recommendations for
Reporting of Incidental Findings in Clinical Exome and Genome
Sequencing'', lists 56 genes where specific variants on these genes are
pathogenic for 24 conditions.
(B)Data Transfer: Specify the secure method to transfer resultant
data to NCHS. Investigators must use a device that meets federal
information processing standards (FIPS 140-2 and FIPS 197).
(C) Period of Performance: Specify the project period. The period
may be up to three years. At the end of the project period, any unused
samples must be returned to the NHANES DNA Specimen Repository or
destroyed by the investigator. Extensions to the period of performance
may be requested.
(D) Funding: Include the source and status of the funding to
perform the requested laboratory analysis. Investigators will be
responsible for the cost of processing and shipping the samples (See
table).
(7) References.
(8) Resumes/CV: Please include a 2-page CV for each member of the
research team in this document (not as attachments).
Public Availability of Data
Data resulting from use of DNA specimens will be made available to
the public for secondary data analyses via the NCHS RDC. After DHANES/
NCHS quality control assessment is completed, investigators will be
given up to six months to conduct comprehensive quality assurance
review in the NCHS RDC. The quality assurance review timeframe will be
negotiated between the investigator and the NHANES Genetic Project
Officer and will depend on the type, number, and characteristics of the
tests submitted. The results of the quality assurance review will be
provided to DHANES/NCHS and appropriate aspects will become part of the
data set documentation. The public announcement, that test results are
available for submission of proposals for secondary data analyses, will
occur once the quality assurance review timeframe has ended. For a list
of currently available variant data see: https://www.cdc.gov/nchs/nhanes/biospecimens/dnaspecimens.htm#Genetic.
Proposals for secondary data analyses linking NCHS restricted data,
NCHS public use data, or non-NCHS data to data resulting from DNA
specimen testing will be reviewed by the NCHS RDC. See https://www.cdc.gov/rdc for proposal guidelines.
Submission of Proposals
Proposals can be submitted immediately. The review process will
begin approximately 60 days from the publication of the notice and will
include all proposals submitted as of that date.
Electronic submission of proposals are required. Please submit
proposals to the NHANES Genetic Project Officer: Jody McLean M.P.H.,
Division of Health and Nutrition Examination Surveys, National Center
for Health Statistics, Centers for Disease Control and Prevention, 3311
Toledo Road, Hyattsville, MD 20782, Phone: 301-458-4683, EMail:
NHANESgenetics@cdc.gov.
Agency Agreement
Investigators must secure funding and sign terms and conditions
agreements for the use of the DNA specimens with CDC/NCHS prior to the
release of the NHANES DNA samples. Investigators must agree to use the
specimens only for the approved tests and use the test results only for
purposes as stated in the approved proposal, not link the results of
the proposed research to any other data, and not use the DNA specimens
for commercial purposes via a legally binding Materials Transfer
Agreement for non-government researchers or Interagency Agreement for
government researchers. In addition, all investigators will be required
to sign a Designated Agent Agreement (DAA) with CDC/NCHS in accordance
with NCHS' confidentiality legislation, the Confidential Information
Protection and Statistical Efficiency Act (CIPSEA; Title V of the E-
Government Act of 2002 (Pub. L. 107-347)). The DAA is the mechanism by
which CDC/NCHS may authorize designation of agents to exclusively
perform activities needed to produce approved data on CIPSEA protected
NHANES DNA specimens.
Approved Proposals
After DNA samples are received and testing is complete, the
resulting data will be sent back to DHANES/NCHS for quality control
(QC) assessment. While DHANES/NCHS QC assessment is under way the
investigator can submit a NCHS RDC proposal to conduct comprehensive
quality assurance review. Once the investigator's quality assurance
review is complete and the
[[Page 69826]]
results returned to DHANES/NCHS, the test results will be made
available to the public and the investigator can submit an NCHS RDC
proposal to request linkage to NCHS restricted data, NCHS public use
data, or Non-NCHS data to conduct their analysis.
After the comprehensive quality assessment process has been
completed by the investigator, a list of variants generated from NHANES
specimen testing will be made available to the public for potential
solicitation via NCHS RDC proposals. The list of variants will be
available in the NHANES Genetic Variant Search (https://www.nhgeneticvariant.com/). In addition, DHANES/NCHS quality control
assessment procedures will be posted on the NHANES Genetic Repository
Web site and/or available via email.
Progress Reports
A progress report will be submitted in the annual CDC/NCHS/ERB
continuation report. An ERB continuation form will be sent to the
investigator each year for project update. If an approved proposal is
unable to obtain funding the proposal will be closed.
Termination of ERB Protocol
At the end of laboratory testing the ERB Protocol will be closed.
Disposition of Results and Samples
The provided DNA samples cannot be used for any purpose other than
the specifically requested purpose outlined in the proposal and
approved through the Scientific and Institutional Review. No DNA
samples can be shared with others, including other investigators,
unless specified in the proposal and so approved. Samples must be
returned upon completion of the approved project or destroyed only with
the written approval of the NHANES Genetic Project Officer. Test
results from all studies using NHANES DNA specimens will be made
available to the public for secondary data analyses. After the DHANES/
NCHS quality control assessment is completed, investigators will be
given up to six months to conduct a more comprehensive quality
assurance review. The final quality assurance review timeframe will be
negotiated between the researcher and the NHANES Genetic Project
Officer and characteristics of the tests submitted. Proposals for
secondary data analyses will be reviewed by the NCHS RDC on a rolling
basis; see: https://www.cdc.gov/rdc for proposal guidelines. All data
analyses will be conducted via access modes available at NCHS RDC.
Dated: October 4, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
Table 1--Cost Schedule for NHANES DNA Specimens
----------------------------------------------------------------------------------------------------------------
1999-2002, 1999-2002,
2007-08, 2009- 2007-08, 2009- NHANES III
Total costs 10 Complete 10 Partial complete set
set set
----------------------------------------------------------------------------------------------------------------
Materials and Equipment--contractor: Plates, reagents, assays, $1.51 $4.53 $0.75
aliquoting and packaging samples; use of equipment.............
Labor--contractor: Processing, handling, and shipping; NCHS: 4.98 24.90 2.49
Data quality control...........................................
Proposal review and Administrative expenses--contractor: 3.02 6.04 1.51
Inventory management and reporting; NCHS: Management of
proposal process non-NCHS: Technical panel fees................
Space--contractor: Freezer use and maintenance.................. 5.59 5.59 2.79
Cost per sample................................................. 15.10 41.06 7.55
Cost per new proposal:
1999-2002................................................... 119,260 NA
2007-2008................................................... 72,661
2009-2010................................................... 73,884
III......................................................... .............. .............. 54,050
Cost per additional proposal: *
1999-2002................................................... 5,963 **
2007-2008................................................... 3,633
2009-2010................................................... 3,694
III......................................................... .............. .............. 2,702
----------------------------------------------------------------------------------------------------------------
* Additional research using DNA specimens already obtained from previous solicitations.
** This charge will be 5 percent of the original cost.
Note: Applicable CDC overhead and NCHS management and oversight charges will be added to these rates for
proposals coming from Federal agencies.
[FR Doc. 2016-24349 Filed 10-6-16; 8:45 am]
BILLING CODE 4163-18-P
