National Health and Nutrition Examination Survey (NHANES) DNA Specimens: Guidelines for Proposals To Use Samples and Cost Schedule, 5441-5445 [2019-02908]
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ESTIMATED ANNUALIZED BURDEN HOURS
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respondents
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1
1
20
15
1,220
915
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2,135
BILLING CODE 4163–18–P
SUPPLEMENTARY INFORMATION:
Centers for Disease Control and
Prevention
Background
[Docket No. CDC–2019–0003]
National Health and Nutrition
Examination Survey (NHANES) DNA
Specimens: Guidelines for Proposals
To Use Samples 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, with
their permission, during NHANES III
(1991–1994), NHANES 1999–2000,
NHANES 2001–02, NHANES 2007–08,
NHANES 2009–10, and NHANES 2011–
12 (Office of Management and Budget
Control Numbers # 0920–0237/0920–
0950). DNA samples 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.
FOR FURTHER INFORMATION CONTACT:
NHANES Genetic Project Officer, Jody
McLean M.P.H., Division of Health and
SUMMARY:
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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).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Total burden
(in hours)
61
61
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Average
burden per
response
(in hours)
Work Plan .........................................
Annual Report ..................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
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Number of
responses per
respondent
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respondents
Form name
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 samples has been previously
announced in 2002 (67 FR 51585), 2006
(71 FR 22248), 2007 (72 FR 59094), 2009
(74 FR 45644), 2010 (75 FR 32191) and
2016 (81 FR 69822). NHANES III Phase
II DNA samples (1991–1994) are from
participants ages 12 or older (see
NHANES III DNA Samples section for a
description). For details about available
NHANES III non-genetic data see
https://wwwn.cdc.gov/nchs/nhanes/
nhanes3/default.aspx.
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
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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 ages 20 years and older in
survey years 1999–2002 and 2007–12.
DNA samples are available as
collections from NHANES 1999–2002
(NHANES 1999–2000 and 2001–02
samples available as one collection),
and NHANES two-year cycles 2007–08,
2009–10, and 2011–12(see NHANES
1999–2002, 2007–08, 2009–10, and
2011–12 DNA samples section for a
description). The availability of the
NHANES 1999–2002 DNA samples has
been previously announced (2007 [72
FR 59094], 2009 [74 FR 45644], 2010 [75
FR 32191], and 2016 [81 FR 69822]).
The availability of the NHANES 2007–
08 DNA samples has been previously
announced (2009 [74 FR 45644], 2010
[75 FR 32191], and 2016 [81 FR 69822]).
The availability of the NHANES 2009–
10 DNA samples has been previously
announced (2016 [81 FR 69822]). The
data release cycle for the NHANES
corresponding to the period in which
samples were collected for DNA is
described in the following web links:
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.
aspx?BeginYear=1999
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.aspx?Be
ginYear=2001
https://wwwn.cdc.gov/nchs/nhanes/
continuousnhanes/default.aspx?
BeginYear=2007
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.aspx?
BeginYear=2009
https://wwwn.cdc.gov/nchs/nhanes/
ContinuousNhanes/Default.aspx?
BeginYear=2011
Identifiable health information
collected in the NHANES is kept
confidential. 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
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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, 2009–
10, and 2011–12 a separate consent form
was signed by eligible participants who
agreed to the storing of blood samples
for future genetic research. DNA
samples will be available for testing
only from participants who consented to
future research. Resulting data from
DNA samples 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 DNA samples (2002 (67
FR 51585), 2006 (71 FR 22248), 2007 (72 FR
59094), 2009 (74 FR 45644), 2010 (75 FR
32191), and 2016 (81 FR 69822)).
Proposals testing a complete
NHANES DNA collection of samples:
NHANES III, 7,159 samples; NHANES
1999–2002, 7,839 samples; NHANES
2007–08, 4,612 samples; NHANES
2009–10, 4,893 samples; NHANES
2011–12, 4,147 samples.
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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
must specify which DNA collection they
are requesting and the tests to be
conducted on DNA samples excluding
tests that produce incidental findings.
The investigator is required to include
in the research proposal 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
NHANES DNA samples 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
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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 website 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 samples 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 samples
already obtained from previous
solicitations:
Investigators who have obtained
NHANES DNA samples from previous
solicitations and have sufficient DNA
left may request to do additional tests
on the remaining DNA. These proposals
must be submitted and approved before
the initial proposal expiration date. The
investigator is required to specify the
test to be conducted on the samples
excluding tests that produce incidental
findings. The investigator must 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 samples (NHANES III,
NHANES 1999–2002, NHANES 2007–
08, NHANES 2009–10, and NHANES
2011–12) 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 Samples
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%
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of the total) will be sent at no charge,
on separate plates as blind replicates.
DNA samples are available from 7,159
NHANES III participants. Samples will
be distributed in a total of 82 plates
including four plates of quality control
samples. NHANES III DNA samples are
in limited supply and, thus, are not
available as a partial set. Due to the
method of extraction, NHANES III DNA
samples are not appropriate for all
projects and/or assays.
NHANES 1999–2002, 2007–08, 2009–10,
2011–12 DNA Samples
The laboratory will distribute aliquots
of purified, high molecular DNA in
normalized concentrations of 50.0 ng/
mL. Some samples may fall below this
threshold. A sample of 40 microliters of
each samples will be supplied. The
amount of DNA in each sample may
vary but will be on average
approximately two micrograms.
There are purified DNA samples from
7,839 NHANES 1999–2002 participants.
These samples will be distributed into
90 plates including four plates of quality
control samples.
There are purified DNA samples
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 samples
available from 4,893 NHANES 2009–10
participants. These will be distributed
into 58 plates including approximately
three additional plates of quality control
samples.
There are purified DNA samples
available from 4,147 NHANES 2011–12
participants. These will be distributed
into 49 plates including 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. 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.
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Procedures for Proposals
The investigator should follow these
instructions for preparation of
proposals. Proposals 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
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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 April
22, 2019.
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 in the
research project should be included.
CDC investigators need to include their
Collaborative Institutional Training
Initiative (CITI) training expiration date.
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.
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 Research 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.
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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 not
be maintained by NCHS.
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 CITI training expiration
date.
(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
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
DNA samples. 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.
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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.
(B) Data analysis: Note: All resulting
data are restricted access data and must
be analyzed in the NCHS Research Data
Center (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 samples 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 and
describe how potential incidental test
results will be handled. As of its
publication in February 2017, the most
recent report, ‘‘Recommendations for
reporting of secondary findings in
Clinical Exome and Genome
Sequencing, 2016 update (ACMG SF
v2.0): A policy statement of the
American College of Medical Genetics
and Genomics’’, lists 59 genes where
specific variants on these genes are
pathogenic for 27 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
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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).
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Public Availability of Data
Data resulting from use of DNA
samples 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, informing that test
results are available for secondary data
analyses after submission and
acceptance of proposals, will occur once
the quality assurance review timeframe
has ended. For a list of currently
available variant data see: https://
www.nhgeneticvariant.com/.
Proposals for secondary data analyses
linking NCHS restricted data, NCHS
public use data, or non-NCHS data to
data resulting from DNA sample 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 this notice and will
include all proposals submitted as of
that date.
Electronic submission of proposals is
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,
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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 samples with
CDC/NCHS prior to the release of the
NHANES DNA samples. Investigators
must agree to: (a) Use the samples only
for the approved tests; (b) use the test
results only for purposes as stated in the
approved proposal; (c) not link the
results of the proposed research to any
other data; and (d) not use the DNA
samples for commercial purposes, as set
forth in a legally binding Materials
Transfer Agreement (if non-government
researchers) or Interagency Agreement
(if 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 CIPSEAprotected NHANES DNA samples.
Approved Proposals: Post-Testing
Procedures
After DNA samples are received and
testing is complete, the investigator
must send the resulting data back for
DHANES/NCHS quality control(QC)
assessment. While DHANES/NCHS QC
assessment is under way, the
investigator can submit a NCHS RDC
proposal (https://www.cdc.gov/rdc) to
conduct additional quality assurance
review. Once the investigator’s quality
assurance review is complete and the
results returned to DHANES/NCHS, the
test results will be made available to the
public. Data are made public through
the NCHS RDC and at this point 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
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by the investigator, a list of variants
generated from NHANES samples
testing will be made available to the
public for potential requests for
proposals 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 website and/or available via
email.
Progress Reports
The investigator must submit a
progress report 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, but only with the
written approval of the NHANES
Genetic Project Officer). Test results
from all studies using NHANES DNA
samples 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.
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1999–2002,
2007–08,
2009–10,
2011–12
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 ............................................................................................................................
2011–2012 ............................................................................................................................
III ...........................................................................................................................................
Cost per additional proposal: **
1999–2002 ............................................................................................................................
2007–2008 ............................................................................................................................
2009–2010 ............................................................................................................................
2011–2012 ............................................................................................................................
III ...........................................................................................................................................
1999–2002,
2007–08,
2009–10,
2011–12
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
118,369
69,641
73,884
62,605
........................
*
........................
........................
........................
........................
........................
........................
........................
54,050
........................
5,918
3,633
3,694
3,131
........................
***
........................
........................
........................
........................
........................
........................
........................
2,702
........................
* Cost calculated upon request.
** Additional research using DNA samples 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.
Dated: February 14, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2019–02908 Filed 2–20–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
amozie on DSK3GDR082PROD with NOTICES1
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Chief Operating Officer, CDC,
pursuant to Public Law 92–463. The
grant applications and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
Control Special Emphasis Panel (SEP)—
RFA–CE–19–005, Research Grants for
Preventing Violence and Violence
Related Injury.
Date: May 14–15, 2019.
Time: 8:30 a.m.–5:30 p.m., EDT.
Place: Atlanta Marriott Buckhead and
Conference Center, 3405 Lenox Road
NE, Atlanta, GA 30326.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Mikel Walters, Ph.D., Scientific Review
Official, NCIPC, CDC, 4770 Buford
Highway NE, Mailstop F–63, Atlanta,
Georgia 30341, Telephone (404) 639–
0913, MWalters@cdc.gov.
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Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–02949 Filed 2–20–19; 8:45 am]
BILLING CODE 4163–18–P
PO 00000
Frm 00042
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—IP19–001,
Surveillance for Respiratory Syncytial
Virus (RSV) and Other Viral
Respiratory Infections Among Native
Americans/Alaskan Natives; IP19–002,
Increasing Influenza and Tdap
Vaccination of Pregnant Women in
Obstetric/Gynecologic Practices in
Large Health Systems Through Quality
Improvement Interventions and IP19–
003, Understanding and Improving
Immunization Services Among Adult
Hospital Inpatient and Observation/
Clinical Decision Unit Settings;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—IP19–
001, Surveillance for Respiratory
Syncytial Virus (RSV) and Other Viral
Respiratory Infections Among Native
Americans/Alaskan Natives; IP19–002,
Increasing Influenza and Tdap
Vaccination of Pregnant Women in
Obstetric/Gynecologic Practices in Large
Health Systems through Quality
Improvement Interventions and IP19–
003, Understanding and Improving
Immunization Services Among Adult
Hospital Inpatient and Observation/
Clinical Decision Unit Settings; March
19–20, 2019; 10:00 a.m.–5:00 p.m.,
E:\FR\FM\21FEN1.SGM
21FEN1
]]>Agencies
[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5441-5445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02908]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2019-0003]
National Health and Nutrition Examination Survey (NHANES) DNA
Specimens: Guidelines for Proposals To Use Samples 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, with their permission, during
NHANES III (1991-1994), NHANES 1999-2000, NHANES 2001-02, NHANES 2007-
08, NHANES 2009-10, and NHANES 2011-12 (Office of Management and Budget
Control Numbers # 0920-0237/0920-0950). DNA samples 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.
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 samples has been previously
announced in 2002 (67 FR 51585), 2006 (71 FR 22248), 2007 (72 FR
59094), 2009 (74 FR 45644), 2010 (75 FR 32191) and 2016 (81 FR 69822).
NHANES III Phase II DNA samples (1991-1994) are from participants ages
12 or older (see NHANES III DNA Samples section for a description). For
details about available NHANES III non-genetic data see https://wwwn.cdc.gov/nchs/nhanes/nhanes3/default.aspx.
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 ages 20 years and older in survey years
1999-2002 and 2007-12. DNA samples are available as collections from
NHANES 1999-2002 (NHANES 1999-2000 and 2001-02 samples available as one
collection), and NHANES two-year cycles 2007-08, 2009-10, and 2011-
12(see NHANES 1999-2002, 2007-08, 2009-10, and 2011-12 DNA samples
section for a description). The availability of the NHANES 1999-2002
DNA samples has been previously announced (2007 [72 FR 59094], 2009 [74
FR 45644], 2010 [75 FR 32191], and 2016 [81 FR 69822]). The
availability of the NHANES 2007-08 DNA samples has been previously
announced (2009 [74 FR 45644], 2010 [75 FR 32191], and 2016 [81 FR
69822]). The availability of the NHANES 2009-10 DNA samples has been
previously announced (2016 [81 FR 69822]). The data release cycle for
the NHANES corresponding to the period in which samples were collected
for DNA is described in the following web links:
https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/Default.aspx?BeginYear=1999
https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/Default.aspx?BeginYear=2001
https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/default.aspx?BeginYear=2007
https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/Default.aspx?BeginYear=2009
https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/Default.aspx?BeginYear=2011
Identifiable health information collected in the NHANES is kept
confidential. 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
[[Page 5442]]
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, 2009-10, and
2011-12 a separate consent form was signed by eligible participants who
agreed to the storing of blood samples for future genetic research. DNA
samples will be available for testing only from participants who
consented to future research. Resulting data from DNA samples 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 DNA samples (2002 (67 FR
51585), 2006 (71 FR 22248), 2007 (72 FR 59094), 2009 (74 FR 45644),
2010 (75 FR 32191), and 2016 (81 FR 69822)).
Proposals testing a complete NHANES DNA collection of samples:
NHANES III, 7,159 samples; NHANES 1999-2002, 7,839 samples; NHANES
2007-08, 4,612 samples; NHANES 2009-10, 4,893 samples; NHANES 2011-12,
4,147 samples.
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 must specify which DNA collection they are requesting and
the tests to be conducted on DNA samples excluding tests that produce
incidental findings. The investigator is required to include in the
research proposal 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 NHANES DNA samples 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 website
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 samples 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 samples already obtained from previous
solicitations:
Investigators who have obtained NHANES DNA samples from previous
solicitations and have sufficient DNA left may request to do additional
tests on the remaining DNA. These proposals must be submitted and
approved before the initial proposal expiration date. The investigator
is required to specify the test to be conducted on the samples
excluding tests that produce incidental findings. The investigator must
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 samples (NHANES III, NHANES 1999-2002, NHANES 2007-08,
NHANES 2009-10, and NHANES 2011-12) 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 Samples
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 samples are
available from 7,159 NHANES III participants. Samples will be
distributed in a total of 82 plates including four plates of quality
control samples. NHANES III DNA samples are in limited supply and,
thus, are not available as a partial set. Due to the method of
extraction, NHANES III DNA samples are not appropriate for all projects
and/or assays.
NHANES 1999-2002, 2007-08, 2009-10, 2011-12 DNA Samples
The laboratory will distribute aliquots of purified, high molecular
DNA in normalized concentrations of 50.0 ng/[mu]L. Some samples may
fall below this threshold. A sample of 40 microliters of each samples
will be supplied. The amount of DNA in each sample may vary but will be
on average approximately two micrograms.
There are purified DNA samples from 7,839 NHANES 1999-2002
participants. These samples will be distributed into 90 plates
including four plates of quality control samples.
There are purified DNA samples 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 samples available from 4,893 NHANES 2009-10
participants. These will be distributed into 58 plates including
approximately three additional plates of quality control samples.
There are purified DNA samples available from 4,147 NHANES 2011-12
participants. These will be distributed into 49 plates including
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. 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.
[[Page 5443]]
Procedures for Proposals
The investigator should follow these instructions for preparation
of proposals. Proposals 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
April 22, 2019.
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 in the
research project should be included. CDC investigators need to include
their Collaborative Institutional Training Initiative (CITI) training
expiration date. 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.
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 Research 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.
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 not be maintained by
NCHS.
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 CITI training expiration date.
(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
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 DNA samples. 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.
(B) Data analysis: Note: All resulting data are restricted access
data and must be analyzed in the NCHS Research Data Center (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 samples 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 and describe how potential
incidental test results will be handled. As of its publication in
February 2017, the most recent report, ``Recommendations for reporting
of secondary findings in Clinical Exome and Genome Sequencing, 2016
update (ACMG SF v2.0): A policy statement of the American College of
Medical Genetics and Genomics'', lists 59 genes where specific variants
on these genes are pathogenic for 27 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
[[Page 5444]]
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 samples 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, informing that test
results are available for secondary data analyses after submission and
acceptance of proposals, will occur once the quality assurance review
timeframe has ended. For a list of currently available variant data
see: https://www.nhgeneticvariant.com/.
Proposals for secondary data analyses linking NCHS restricted data,
NCHS public use data, or non-NCHS data to data resulting from DNA
sample 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 this notice and
will include all proposals submitted as of that date.
Electronic submission of proposals is 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 samples with CDC/NCHS prior to the
release of the NHANES DNA samples. Investigators must agree to: (a) Use
the samples only for the approved tests; (b) use the test results only
for purposes as stated in the approved proposal; (c) not link the
results of the proposed research to any other data; and (d) not use the
DNA samples for commercial purposes, as set forth in a legally binding
Materials Transfer Agreement (if non-government researchers) or
Interagency Agreement (if 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 samples.
Approved Proposals: Post-Testing Procedures
After DNA samples are received and testing is complete, the
investigator must send the resulting data back for DHANES/NCHS quality
control(QC) assessment. While DHANES/NCHS QC assessment is under way,
the investigator can submit a NCHS RDC proposal (https://www.cdc.gov/rdc) to conduct additional quality assurance review. Once the
investigator's quality assurance review is complete and the results
returned to DHANES/NCHS, the test results will be made available to the
public. Data are made public through the NCHS RDC and at this point 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
samples testing will be made available to the public for potential
requests for proposals 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
website and/or available via email.
Progress Reports
The investigator must submit a progress report 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, but
only with the written approval of the NHANES Genetic Project Officer).
Test results from all studies using NHANES DNA samples 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.
[[Page 5445]]
----------------------------------------------------------------------------------------------------------------
1999-2002, 1999-2002,
2007-08, 2009- 2007-08, 2009- NHANES III
Total costs 10, 2011-12 10, 2011-12 complete set
complete set partial 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................................................... 118,369 * ..............
2007-2008................................................... 69,641 .............. ..............
2009-2010................................................... 73,884 .............. ..............
2011-2012................................................... 62,605 .............. 54,050
III......................................................... .............. .............. ..............
Cost per additional proposal: **
1999-2002................................................... 5,918 *** ..............
2007-2008................................................... 3,633 .............. ..............
2009-2010................................................... 3,694 .............. ..............
2011-2012................................................... 3,131 .............. 2,702
III......................................................... .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
* Cost calculated upon request.
** Additional research using DNA samples 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.
Dated: February 14, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-02908 Filed 2-20-19; 8:45 am]
BILLING CODE 4163-18-P
