82_FR_58442 82 FR 58206 - National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples

82 FR 58206 - National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 236 (December 11, 2017)

Page Range58206-58209
FR Document2017-26591

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of stored sera, plasma, and urine samples obtained from participants in the National Health and Nutrition Examination Survey (NHANES) for use and the fee schedule for such use. The National Health and Nutrition Examination Survey (NHANES) is one of a series of health- related surveys conducted by CDC's National Center for Health Statistics (NCHS).

Federal Register, Volume 82 Issue 236 (Monday, December 11, 2017)
[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Pages 58206-58209]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26591]



[[Page 58206]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2017-0117]


National Health and Nutrition Examination Survey (NHANES) Stored 
Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals 
to Use Serum, Plasma, and Urine Samples

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) announces the 
availability of stored sera, plasma, and urine samples obtained from 
participants in the National Health and Nutrition Examination Survey 
(NHANES) for use and the fee schedule for such use. The National Health 
and Nutrition Examination Survey (NHANES) is one of a series of health-
related surveys conducted by CDC's National Center for Health 
Statistics (NCHS).

DATES: The stored NHANES biologic samples are available December 11, 
2017. The fee structure for these samples is effective December 11, 
2017.

FOR FURTHER INFORMATION CONTACT: Dr. Geraldine McQuillan, National 
Center for Health Statistics, Centers for Disease Control and 
Prevention, 3311 Toledo Road, Hyattsville, MD 20782. Telephone: 301-
458-4371; Fax: 301-458-4029; Email: [email protected]v

    Authority: Sections 301,306 and 308 of the Public Health Service 
Act (42 U.S.C. 241,242k and 242M).

SUPPLEMENTARY INFORMATION: NHANES is a program of periodic surveys 
conducted by NCHS. Examination surveys conducted since 1960 by NCHS 
have provided national estimates of the health and nutritional status 
of the U.S. civilian non-institutionalized population. The goals of 
NHANES are: (1) To estimate the number and percent of persons in the 
U.S. population and designated subgroups with selected diseases and 
risk factors; (2) to monitor trends in the prevalence, awareness, 
treatment and control of selected diseases; (3) to monitor trends in 
risk behaviors and environmental exposures; (4) to analyze risk factors 
for selected diseases; (5) to study the relationship between diet, 
nutrition and health; (6) to explore emerging public health issues and 
new technologies; and (7) to establish and maintain a national 
probability sample of baseline information on health and nutrition 
status.
    Samples are available from NHANES III and the continuous NHANES 
that started in 1999. Approximately 30,000 individuals were examined in 
NHANES III, which began in the fall of 1988, and ended in the fall of 
1994. Researchers can analyze data from this survey in two phases. 
Phase 1 was conducted from October 1988 to October 1991 and Phase 2 
began October 1991 and ended October 1994. Though participants 
consented to storing samples of their blood and urine for future 
testing, only research proposals with test results that are judged not 
to have clinical significance for participants will be accepted. See: 
http://www.cdc.gov/nchs/nhanes/nhanes3.htm, for more information on 
NHANES III.
    Beginning in 1999, NHANES became a continuous, annual survey with 
examination of approximately 5,000 individuals a year and data release 
every two years. Samples from a single year of the survey will only be 
provided in emergency situations (outbreaks). Research projects must 
use two-year cycles or multiple two year cycles for their research 
(i.e. 1999-2000, 2001-2002 etc.) In order to assure the representative 
nature of NHANES at least a \1/3\ sample of a two year cycle must be 
requested for an individual proposal. For details of the sampling 
design, see the Analytic Guidelines at: https://wwwn.cdc.gov/nchs/nhanes/analyticguidelines.aspx.
    Starting in 1999, the consent form informed participants that they 
would not receive results from any future laboratory analysis that may 
be conducted on their samples. Therefore, only research proposals with 
laboratory test results that do not have clinical significance to the 
survey participant will be accepted. Clinical significance of a 
laboratory test will be judged by the technical panel reviewing 
proposals, and the researcher should address this in the research 
proposal. A laboratory analyte is considered clinically significant to 
the survey participant if the following criteria are met: The findings 
have significant implications for the participant's health, a course of 
action is readily available to treat the associated health concern, and 
laboratory tests are performed by a Clinical Laboratory Improvement 
Amendments (CLIA)-certified laboratory and therefore deemed valid.
    Serum, plasma, and urine samples are currently available from 
NHANES III (conducted from 1988-1994) and from NHANES 1999-2016 (Table 
A).
    Serum, plasma, and urine samples are stored in two biorepositories. 
Surplus samples that were initially used for laboratory assays included 
in the surveys, were stored at -70 [deg]C and have been through at 
least two freeze-thaw cycles. They are stored at a commercial 
biorepository under contract to NCHS. In addition, serum, plasma, and 
urine samples were also stored immediately after collection at -80 
[deg]C or below in vapor-phase liquid nitrogen. These samples have not 
undergone a freeze-thaw cycle and are considered pristine samples. The 
CDC and Agency for Toxic Substances and Disease Registry (ATSDR) Sample 
Packaging and Handling Repository (CASPIR) is the long-term repository 
for the pristine NHANES serum, plasma, and urine samples. NCHS is 
making both of these collections available for research proposals. 
Proposals that request pristine samples stored at CASPIR should justify 
the use of the unthawed samples. Please see the NHANES Biospecimen 
Program series report for details about collection and storage of 
serum, plasma, and urine samples http://www.cdc.gov/nchs/data/series/sr_02/sr02_170.pdf.

          Table A--Overview of Biospecimens by Survey Year, NHANES III (1988-1994) and NHANES 1999-2014
----------------------------------------------------------------------------------------------------------------
                                                                           Sample Type
                                               -----------------------------------------------------------------
                 NHANES Cycle                             Pristine \1\                     Surplus \2\
                                               -----------------------------------------------------------------
                                                   Sera      Plasma     Urine       Sera      Plasma     Urine
----------------------------------------------------------------------------------------------------------------
III (1988-1994)...............................         X   .........  .........         X   .........  .........
1999-2000.....................................         X          X          X          X          X          X
2001-2002.....................................         X          X          X          X          X          X
2003-2004.....................................         X          X          X          X   .........  .........

[[Page 58207]]

 
2005-2006.....................................         X          X          X          X   .........  .........
2007-2008.....................................         X          X          X          X   .........  .........
2009-2010.....................................         X          X          X          X   .........  .........
2011-2012.....................................         X   .........         X          X   .........  .........
2013-2014.....................................         X   .........         X          X   .........  .........
2015-2016.....................................         X   .........         X          X   .........  .........
----------------------------------------------------------------------------------------------------------------
\1\ Samples immediately frozen for storage, did not undergo laboratory testing.
\2\ Samples were surplus after laboratories had completed testing.

Proposal Evaluation

    All proposals for use of NHANES samples will be evaluated by a 
Technical Panel for scientific merit, public health significance, and 
lack of clinical significance to the participant; by the NCHS 
Confidentiality Officer for disclosure risk; and by the NCHS Human 
Subjects Officer and the ERB for any potential human subjects concerns. 
The NCHS Ethics Review Board (ERB) will review the proposal even if the 
investigator has received approval by their institutional review panel.
    The Technical Panel consists of NHANES staff: Two physicians, one 
statistician and two laboratory experts, other experts from inside or 
outside the Federal Government are added as needed. The Technical Panel 
will evaluate the proposal for the scientific, technical and medical 
significance of the research, the appropriateness and adequacy of the 
research design, and the methodology proposed to reach the research 
goals. See `Criteria for Technical Evaluation of Proposals' below. The 
proposal should outline how the results from the laboratory analysis 
will be used. Because NHANES is a complex, multistage probability 
sample of the U.S. population, the appropriateness of the NHANES sample 
to address the goals of the proposal will be an important aspect of 
scientific merit.
    The survey oversamples the two largest race/ethnic minority groups, 
non-Hispanic blacks and Mexican Americans (and all Hispanics since 
2007-08), and, since 2011-2012, Asians. Sampling weights are therefore 
used to make national estimates of frequencies. The use of weights, 
sampling frame and methods of assessment of variables included in the 
data are likely to affect the proposed research. For this reason 
proposers are required to request at least a \1/3\ sample of a NHANES 
cycle to maintain the representative nature of the survey.
    The Technical Panel will also review the data analysis plan and 
evaluate whether the proposal is an appropriate use of the NHANES 
samples. The investigators should justify why they need a national 
probability sample for their research. The Technical Panel will assure 
that the proposed project does not go beyond either the general purpose 
for collecting the samples in the survey, or of the specific stated 
goals of the proposal.
    Investigators are encouraged to review the NHANES data, survey 
documents, manuals and questionnaires at: http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm or for NHANES III: https://wwwn.cdc.gov/nchs/nhanes/nhanes3/datafiles.aspx

Procedures for Proposals

    All investigators (including CDC investigators) must submit a 
proposal for use of NHANES serum, plasma, or urine samples. Proposals 
are limited to a maximum of 10 single-spaced typed pages, excluding 
figures and tables, using at least a size 10 font 10cpi. The cover of 
the proposal should include the name, address, and phone number and 
Email address of the principal investigator (PI) and the name of the 
institution where the laboratory analysis will be done. All proposals 
should be Emailed to [email protected]v. Proposals must include a 
cover page with the title of the proposal and the name, address, phone 
number and Email address of all investigators. Proposals from CDC 
investigators must also include investigators scientific ethics 
verification number.
    The following criteria will be used for technical evaluation of 
proposals:
    Proposals should include the following information:
    (1) Specific Aims: List the broad objectives; describe concisely 
and realistically what the research is intended to accomplish, and 
state the specific hypotheses to be tested. NHANES is designed to 
provide prevalence estimates of diseases or conditions that are 
expected to affect at least 5-10 percent of the population. Research 
proposals that expect much lower prevalence estimates need to provide 
more detail on why samples from NHANES are needed for the project and 
provide details on how these data will be analyzed.
    (2) Background and Public Health Significance: Describe the public 
health significance, scientific merit, and practical utility of the 
assay. Briefly describe in 1-2 pages the background of the proposal, 
identifying gaps in knowledge that the project is intended to fill. 
State concisely the importance of the research in terms of the broad, 
long-term objectives and public health relevance including a discussion 
of how the results will affect public health policy or further 
scientific knowledge. The proposal should justify the need for samples 
that are representative of the U.S. population. The proposer should 
convey how the results will be used and the relationship of the results 
to the data already collected in NHANES. The analyses should be 
consistent with the NHANES mission and the health status variables.
    (3) Research Design and Methods: Describe the research design, 
analytic plan, and the procedures to be used. A detailed description of 
laboratory methods including validity and reliability must be included 
with references. The volume of sample and number of samples requested 
must be specified. Adequate methods for handling and storage of samples 
must also be addressed. The laboratory must demonstrate expertise in 
the proposed laboratory test including the capability for handling the 
workload requested in the proposal. The proposal should also include a 
justification for determination of sample size or a power calculation. 
If

[[Page 58208]]

the researcher is requesting a sub-sample of samples, a detailed 
description and justification, must be given. The researcher must 
describe how this sub-sample will be re-weighted to provide national 
estimates.
    The program will evaluate the Investigator's submitted proposal 
study design and analysis plan to determine whether the project is 
consistent with the design of the NHANES survey. In general, resulting 
data will be released in the public domain. Released data from sub-
samples may be less useful to the research community, so such requests 
will receive a lower priority for the samples.
    (4) Clinical Significance of Results: Address the clinical 
significance to the survey participant of the proposed laboratory test. 
Since the consent document for sample storage and future studies states 
that individual results will not be provided to the participant, the 
investigator must address whether there is definitive evidence that the 
proposed test results have health implications to the participants and 
whether knowledge of results would provide grounds for medical 
intervention (even if many years have passed since the participant was 
in the survey and the sample collected). Any test with results that are 
clinically significant, and would require reporting to the participant, 
is not appropriate for testing on the stored serum, plasma, or urine 
samples; laboratory testing that is clinically significant should be 
considered for inclusion in a concurrent NHANES survey.
    (5) Qualification: Provide a brief description of the Principal 
Investigator's expertise in the proposed area, including publications 
in this area within the last three years. A representative sample of 
earlier publications may be listed as long as this section does not 
exceed two pages.
    (6) Period of Performance: Specify the project time period. 
Substantial progress must be made in the first year that samples have 
been obtained, and the project should be completed within a reasonable 
time period. Please discuss the approximate time the investigator 
expects this project will take to complete the project. At the end of 
the project period, any unused samples must be returned to the NHANES 
Specimen Repository or discarded. The NCHS Project Officer must be 
consulted about the disposition of the samples.
    (7) Funding: The source and status of the funding to perform the 
requested laboratory analysis should be included. Investigators will be 
responsible for the cost of processing and shipping the samples. The 
cost per sample is $13.00. The basis for the cost structure is in the 
last section of this document. Reimbursement for the samples will be 
collected before the samples are released.

Submission of Proposals

    Proposals can be submitted in MS Word format by Email to: Dr. 
Geraldine McQuillan (see FOR FURTHER INFORMATION CONTACT).

Project Timeframes

 Submitting Proposals: Can be submitted on an ongoing basis
 Scientific Review Date: Within two months of proposal 
submission
 Institutional Review Date: Within one month of final proposal 
acceptance
 Anticipated distribution of samples: One month after ERB 
approval

Approved Proposals

    Approved projects will be provided samples after receipt of a 
signed Materials Transfer Agreement (MTA) and a check (written to The 
Centers for Disease Control and Prevention) for the cost of the samples 
or for Federal Government proposals a signed Interagency Agreement 
(IAA). All laboratory results obtained from the samples must be sent 
back to NCHS to be linked to the variables requested by the 
investigator that are needed to perform a quality control review of the 
data under a signed Data Sharing Agreement or a Designated Agent 
Agreement. This review must take place within 60 days of the return of 
the data to NCHS so these data may be released to the public. All files 
will also undergo disclosure review at NCHS before release.

Agency Agreement

    A formal signed agreement in the form of a MTA or an IAA with 
investigators who have projects approved will be completed before the 
release of the samples. This agreement will contain the conditions for 
use of the samples as stated in this document and as agreed upon by the 
investigators and CDC.

Continuations

    A brief progress report will be submitted annually. This will be 
the basis for the NCHS ERB continuation reports that are required 
annually. After 5 years of annual continuations, if there is need for 
continued use of samples to complete the protocol study, a new protocol 
is required.

Disposition of Results and Samples

    No samples provided can be used for any purpose other than those 
specifically requested in the proposal and approved by the Technical 
Panel and the NCHS ERB. No samples can be shared with others, including 
other investigators, unless specified in the proposal and so approved. 
Any unused samples must be returned to the NHANES Serum, Plasma and 
Urine Repository or disposed of, after NHANES approval, upon completion 
of the approved project. These results, once returned to NCHS, will be 
part of the public domain. The proposer will have 60 days for quality 
control review of the data before public release.

Cost Schedule for Providing NHANES Samples

    There is a nominal processing fee of $13.00 for each sample 
received from the NHANES Serum, Plasma and Urine Repository. If the 
investigator requests to use the samples for another project after the 
completion of the initial project, the cost will be $5.00 per sample to 
handle the processing of the data and management of the proposal 
process. The costs include the collection, storage, and processing of 
the samples along with the review of proposals and the preparation of 
the data files. The costs listed are for the recurring laboratory 
materials to dispense and prepare the samples during collection and for 
shipping; the computer software needed for the preparation of the data 
files and for the release of the data along with documentation on the 
NHANES Web page. See: https://www.cdc.gov/nchs/nhanes/about_nhanes.htm. 
Labor costs are based on a proposal administrator and computer 
programmers at NCHS to prepare the data files. The storage and pulling 
the samples from the freezer fees include the costs for the NHANES 
repository.

                Fee Schedule for NHANES Biologic Samples
------------------------------------------------------------------------
                      Cost factors                         Cost per vial
------------------------------------------------------------------------
Material and Equipment..................................           $2.85
Processing the samples (Receiving, handling and                     2.15
 shipping)..............................................
Administrative, management of the proposal process......            1.50
Inventory management....................................            1.50
Preparation of data files...............................            3.50
                                                         ---------------
    Subtotal............................................           11.50
CDC Support (5%)........................................            0.58
                                                         ---------------
    Subtotal............................................           12.08
NCHS Support (7.50%)....................................            0.91
                                                         ---------------
        Total...........................................         13.00 *
------------------------------------------------------------------------
 Total is rounded up from $12.99



[[Page 58209]]

    Dated: December 5, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2017-26591 Filed 12-8-17; 8:45 am]
 BILLING CODE 4163-18-P



                                               58206                               Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices

                                               DEPARTMENT OF HEALTH AND                                                 (1) To estimate the number and percent                             laboratory analysis that may be
                                               HUMAN SERVICES                                                           of persons in the U.S. population and                              conducted on their samples. Therefore,
                                                                                                                        designated subgroups with selected                                 only research proposals with laboratory
                                               Centers for Disease Control and                                          diseases and risk factors; (2) to monitor                          test results that do not have clinical
                                               Prevention                                                               trends in the prevalence, awareness,                               significance to the survey participant
                                               [Docket No. CDC–2017–0117]                                               treatment and control of selected                                  will be accepted. Clinical significance of
                                                                                                                        diseases; (3) to monitor trends in risk                            a laboratory test will be judged by the
                                               National Health and Nutrition                                            behaviors and environmental exposures;                             technical panel reviewing proposals,
                                               Examination Survey (NHANES) Stored                                       (4) to analyze risk factors for selected                           and the researcher should address this
                                               Biologic Samples; Proposed Cost                                          diseases; (5) to study the relationship                            in the research proposal. A laboratory
                                               Schedule and Guidelines for Proposals                                    between diet, nutrition and health; (6) to                         analyte is considered clinically
                                               to Use Serum, Plasma, and Urine                                          explore emerging public health issues                              significant to the survey participant if
                                               Samples                                                                  and new technologies; and (7) to                                   the following criteria are met: The
                                                                                                                        establish and maintain a national                                  findings have significant implications
                                               AGENCY: Centers for Disease Control and                                  probability sample of baseline
                                               Prevention (CDC), Department of Health                                                                                                      for the participant’s health, a course of
                                                                                                                        information on health and nutrition                                action is readily available to treat the
                                               and Human Services (HHS).                                                status.                                                            associated health concern, and
                                               ACTION: Notice.                                                             Samples are available from NHANES                               laboratory tests are performed by a
                                               SUMMARY:   The Centers for Disease                                       III and the continuous NHANES that                                 Clinical Laboratory Improvement
                                               Control and Prevention (CDC) in the                                      started in 1999. Approximately 30,000                              Amendments (CLIA)-certified laboratory
                                               Department of Health and Human                                           individuals were examined in NHANES                                and therefore deemed valid.
                                               Services (HHS) announces the                                             III, which began in the fall of 1988, and
                                                                                                                                                                                              Serum, plasma, and urine samples are
                                               availability of stored sera, plasma, and                                 ended in the fall of 1994. Researchers
                                                                                                                        can analyze data from this survey in two                           currently available from NHANES III
                                               urine samples obtained from                                                                                                                 (conducted from 1988–1994) and from
                                               participants in the National Health and                                  phases. Phase 1 was conducted from
                                                                                                                        October 1988 to October 1991 and Phase                             NHANES 1999–2016 (Table A).
                                               Nutrition Examination Survey
                                               (NHANES) for use and the fee schedule                                    2 began October 1991 and ended                                        Serum, plasma, and urine samples are
                                               for such use. The National Health and                                    October 1994. Though participants                                  stored in two biorepositories. Surplus
                                               Nutrition Examination Survey                                             consented to storing samples of their                              samples that were initially used for
                                               (NHANES) is one of a series of health-                                   blood and urine for future testing, only                           laboratory assays included in the
                                               related surveys conducted by CDC’s                                       research proposals with test results that                          surveys, were stored at ¥70 °C and have
                                               National Center for Health Statistics                                    are judged not to have clinical                                    been through at least two freeze-thaw
                                               (NCHS).                                                                  significance for participants will be                              cycles. They are stored at a commercial
                                                                                                                        accepted. See: http://www.cdc.gov/                                 biorepository under contract to NCHS.
                                               DATES: The stored NHANES biologic                                        nchs/nhanes/nhanes3.htm, for more                                  In addition, serum, plasma, and urine
                                               samples are available December 11,                                       information on NHANES III.                                         samples were also stored immediately
                                               2017. The fee structure for these                                           Beginning in 1999, NHANES became                                after collection at ¥80 °C or below in
                                               samples is effective December 11, 2017.                                  a continuous, annual survey with                                   vapor-phase liquid nitrogen. These
                                               FOR FURTHER INFORMATION CONTACT: Dr.                                     examination of approximately 5,000                                 samples have not undergone a freeze-
                                               Geraldine McQuillan, National Center                                     individuals a year and data release                                thaw cycle and are considered pristine
                                               for Health Statistics, Centers for Disease                               every two years. Samples from a single                             samples. The CDC and Agency for Toxic
                                               Control and Prevention, 3311 Toledo                                      year of the survey will only be provided                           Substances and Disease Registry
                                               Road, Hyattsville, MD 20782.                                             in emergency situations (outbreaks).                               (ATSDR) Sample Packaging and
                                               Telephone: 301–458–4371; Fax: 301–                                       Research projects must use two-year                                Handling Repository (CASPIR) is the
                                               458–4029; Email: Serumplasmaurine@                                       cycles or multiple two year cycles for                             long-term repository for the pristine
                                               cdc.gov                                                                  their research (i.e. 1999–2000, 2001–                              NHANES serum, plasma, and urine
                                                 Authority: Sections 301,306 and 308 of the                             2002 etc.) In order to assure the                                  samples. NCHS is making both of these
                                               Public Health Service Act (42 U.S.C.                                     representative nature of NHANES at                                 collections available for research
                                               241,242k and 242M).                                                      least a 1⁄3 sample of a two year cycle                             proposals. Proposals that request
                                               SUPPLEMENTARY INFORMATION:     NHANES                                    must be requested for an individual                                pristine samples stored at CASPIR
                                               is a program of periodic surveys                                         proposal. For details of the sampling                              should justify the use of the unthawed
                                               conducted by NCHS. Examination                                           design, see the Analytic Guidelines at:                            samples. Please see the NHANES
                                               surveys conducted since 1960 by NCHS                                     https://wwwn.cdc.gov/nchs/nhanes/                                  Biospecimen Program series report for
                                               have provided national estimates of the                                  analyticguidelines.aspx.                                           details about collection and storage of
                                               health and nutritional status of the U.S.                                   Starting in 1999, the consent form                              serum, plasma, and urine samples
                                               civilian non-institutionalized                                           informed participants that they would                              http://www.cdc.gov/nchs/data/series/sr_
                                               population. The goals of NHANES are:                                     not receive results from any future                                02/sr02_170.pdf.

                                                      TABLE A—OVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III (1988–1994) AND NHANES 1999–2014
                                                                                                                                                                                                      Sample Type
daltland on DSKBBV9HB2PROD with NOTICES




                                                                                             NHANES Cycle                                                                        Pristine 1                               Surplus 2

                                                                                                                                                                         Sera    Plasma             Urine          Sera    Plasma            Urine

                                               III (1988–1994) .....................................................................................................      X      ..............   ..............    X     ..............   ..............
                                               1999–2000 ...........................................................................................................      X            X                X           X           X                X
                                               2001–2002 ...........................................................................................................      X            X                X           X           X                X
                                               2003–2004 ...........................................................................................................      X            X                X           X     ..............   ..............



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                                                                                 Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices                                                                               58207

                                                   TABLE A—OVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III (1988–1994) AND NHANES 1999–2014—
                                                                                              Continued
                                                                                                                                                                                                       Sample Type

                                                                                            NHANES Cycle                                                                              Pristine 1                        Surplus 2

                                                                                                                                                                              Sera    Plasma           Urine     Sera    Plasma            Urine

                                               2005–2006      ...........................................................................................................      X            X           X         X     ..............   ..............
                                               2007–2008      ...........................................................................................................      X            X           X         X     ..............   ..............
                                               2009–2010      ...........................................................................................................      X            X           X         X     ..............   ..............
                                               2011–2012      ...........................................................................................................      X      ..............    X         X     ..............   ..............
                                               2013–2014      ...........................................................................................................      X      ..............    X         X     ..............   ..............
                                               2015–2016      ...........................................................................................................      X      ..............    X         X     ..............   ..............
                                                  1 Samples     immediately frozen for storage, did not undergo laboratory testing.
                                                  2 Samples     were surplus after laboratories had completed testing.


                                               Proposal Evaluation                                                       maintain the representative nature of                                  intended to accomplish, and state the
                                                                                                                         the survey.                                                            specific hypotheses to be tested.
                                                  All proposals for use of NHANES                                          The Technical Panel will also review                                 NHANES is designed to provide
                                               samples will be evaluated by a                                            the data analysis plan and evaluate                                    prevalence estimates of diseases or
                                               Technical Panel for scientific merit,                                     whether the proposal is an appropriate                                 conditions that are expected to affect at
                                               public health significance, and lack of                                   use of the NHANES samples. The                                         least 5–10 percent of the population.
                                               clinical significance to the participant;                                 investigators should justify why they                                  Research proposals that expect much
                                               by the NCHS Confidentiality Officer for                                   need a national probability sample for                                 lower prevalence estimates need to
                                               disclosure risk; and by the NCHS                                          their research. The Technical Panel will                               provide more detail on why samples
                                               Human Subjects Officer and the ERB for                                    assure that the proposed project does                                  from NHANES are needed for the
                                               any potential human subjects concerns.                                    not go beyond either the general                                       project and provide details on how
                                               The NCHS Ethics Review Board (ERB)                                        purpose for collecting the samples in                                  these data will be analyzed.
                                               will review the proposal even if the                                      the survey, or of the specific stated goals                               (2) Background and Public Health
                                               investigator has received approval by                                     of the proposal.                                                       Significance: Describe the public health
                                               their institutional review panel.                                           Investigators are encouraged to review                               significance, scientific merit, and
                                                  The Technical Panel consists of                                        the NHANES data, survey documents,                                     practical utility of the assay. Briefly
                                               NHANES staff: Two physicians, one                                         manuals and questionnaires at: http://                                 describe in 1–2 pages the background of
                                               statistician and two laboratory experts,                                  www.cdc.gov/nchs/nhanes/nhanes_                                        the proposal, identifying gaps in
                                               other experts from inside or outside the                                  questionnaires.htm or for NHANES III:                                  knowledge that the project is intended
                                                                                                                         https://wwwn.cdc.gov/nchs/nhanes/                                      to fill. State concisely the importance of
                                               Federal Government are added as
                                                                                                                         nhanes3/datafiles.aspx                                                 the research in terms of the broad, long-
                                               needed. The Technical Panel will
                                                                                                                                                                                                term objectives and public health
                                               evaluate the proposal for the scientific,                                 Procedures for Proposals                                               relevance including a discussion of how
                                               technical and medical significance of
                                                                                                                           All investigators (including CDC                                     the results will affect public health
                                               the research, the appropriateness and
                                                                                                                         investigators) must submit a proposal                                  policy or further scientific knowledge.
                                               adequacy of the research design, and the
                                                                                                                         for use of NHANES serum, plasma, or                                    The proposal should justify the need for
                                               methodology proposed to reach the
                                                                                                                         urine samples. Proposals are limited to                                samples that are representative of the
                                               research goals. See ‘Criteria for
                                                                                                                         a maximum of 10 single-spaced typed                                    U.S. population. The proposer should
                                               Technical Evaluation of Proposals’
                                                                                                                         pages, excluding figures and tables,                                   convey how the results will be used and
                                               below. The proposal should outline how
                                                                                                                         using at least a size 10 font 10cpi. The                               the relationship of the results to the data
                                               the results from the laboratory analysis                                                                                                         already collected in NHANES. The
                                                                                                                         cover of the proposal should include the
                                               will be used. Because NHANES is a                                                                                                                analyses should be consistent with the
                                                                                                                         name, address, and phone number and
                                               complex, multistage probability sample                                                                                                           NHANES mission and the health status
                                                                                                                         Email address of the principal
                                               of the U.S. population, the                                                                                                                      variables.
                                                                                                                         investigator (PI) and the name of the
                                               appropriateness of the NHANES sample                                      institution where the laboratory analysis                                 (3) Research Design and Methods:
                                               to address the goals of the proposal will                                 will be done. All proposals should be                                  Describe the research design, analytic
                                               be an important aspect of scientific                                      Emailed to Serumplasmaurine@cdc.gov.                                   plan, and the procedures to be used. A
                                               merit.                                                                    Proposals must include a cover page                                    detailed description of laboratory
                                                  The survey oversamples the two                                         with the title of the proposal and the                                 methods including validity and
                                               largest race/ethnic minority groups,                                      name, address, phone number and                                        reliability must be included with
                                               non-Hispanic blacks and Mexican                                           Email address of all investigators.                                    references. The volume of sample and
                                               Americans (and all Hispanics since                                        Proposals from CDC investigators must                                  number of samples requested must be
                                               2007–08), and, since 2011–2012, Asians.                                   also include investigators scientific                                  specified. Adequate methods for
                                               Sampling weights are therefore used to                                    ethics verification number.                                            handling and storage of samples must
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                                               make national estimates of frequencies.                                     The following criteria will be used for                              also be addressed. The laboratory must
                                               The use of weights, sampling frame and                                    technical evaluation of proposals:                                     demonstrate expertise in the proposed
                                               methods of assessment of variables                                          Proposals should include the                                         laboratory test including the capability
                                               included in the data are likely to affect                                 following information:                                                 for handling the workload requested in
                                               the proposed research. For this reason                                      (1) Specific Aims: List the broad                                    the proposal. The proposal should also
                                               proposers are required to request at least                                objectives; describe concisely and                                     include a justification for determination
                                               a 1⁄3 sample of a NHANES cycle to                                         realistically what the research is                                     of sample size or a power calculation. If


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                                               58208                      Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices

                                               the researcher is requesting a sub-                     The basis for the cost structure is in the            specifically requested in the proposal
                                               sample of samples, a detailed                           last section of this document.                        and approved by the Technical Panel
                                               description and justification, must be                  Reimbursement for the samples will be                 and the NCHS ERB. No samples can be
                                               given. The researcher must describe                     collected before the samples are                      shared with others, including other
                                               how this sub-sample will be re-weighted                 released.                                             investigators, unless specified in the
                                               to provide national estimates.                                                                                proposal and so approved. Any unused
                                                  The program will evaluate the                        Submission of Proposals
                                                                                                                                                             samples must be returned to the
                                               Investigator’s submitted proposal study                   Proposals can be submitted in MS                    NHANES Serum, Plasma and Urine
                                               design and analysis plan to determine                   Word format by Email to: Dr. Geraldine                Repository or disposed of, after
                                               whether the project is consistent with                  McQuillan (see FOR FURTHER                            NHANES approval, upon completion of
                                               the design of the NHANES survey. In                     INFORMATION CONTACT).                                 the approved project. These results,
                                               general, resulting data will be released                                                                      once returned to NCHS, will be part of
                                               in the public domain. Released data                     Project Timeframes
                                                                                                                                                             the public domain. The proposer will
                                               from sub-samples may be less useful to                  • Submitting Proposals: Can be                        have 60 days for quality control review
                                               the research community, so such                           submitted on an ongoing basis                       of the data before public release.
                                               requests will receive a lower priority for              • Scientific Review Date: Within two
                                               the samples.                                              months of proposal submission                       Cost Schedule for Providing NHANES
                                                  (4) Clinical Significance of Results:                • Institutional Review Date: Within one               Samples
                                               Address the clinical significance to the                  month of final proposal acceptance                     There is a nominal processing fee of
                                               survey participant of the proposed                      • Anticipated distribution of samples:                $13.00 for each sample received from
                                               laboratory test. Since the consent                        One month after ERB approval                        the NHANES Serum, Plasma and Urine
                                               document for sample storage and future                                                                        Repository. If the investigator requests
                                                                                                       Approved Proposals
                                               studies states that individual results                                                                        to use the samples for another project
                                               will not be provided to the participant,                  Approved projects will be provided                  after the completion of the initial
                                               the investigator must address whether                   samples after receipt of a signed                     project, the cost will be $5.00 per
                                               there is definitive evidence that the                   Materials Transfer Agreement (MTA)                    sample to handle the processing of the
                                               proposed test results have health                       and a check (written to The Centers for               data and management of the proposal
                                               implications to the participants and                    Disease Control and Prevention) for the               process. The costs include the
                                               whether knowledge of results would                      cost of the samples or for Federal                    collection, storage, and processing of the
                                               provide grounds for medical                             Government proposals a signed                         samples along with the review of
                                               intervention (even if many years have                   Interagency Agreement (IAA). All                      proposals and the preparation of the
                                               passed since the participant was in the                 laboratory results obtained from the                  data files. The costs listed are for the
                                               survey and the sample collected). Any                   samples must be sent back to NCHS to                  recurring laboratory materials to
                                               test with results that are clinically                   be linked to the variables requested by               dispense and prepare the samples
                                               significant, and would require reporting                the investigator that are needed to                   during collection and for shipping; the
                                               to the participant, is not appropriate for              perform a quality control review of the               computer software needed for the
                                               testing on the stored serum, plasma, or                 data under a signed Data Sharing                      preparation of the data files and for the
                                               urine samples; laboratory testing that is               Agreement or a Designated Agent                       release of the data along with
                                               clinically significant should be                        Agreement. This review must take place                documentation on the NHANES Web
                                               considered for inclusion in a concurrent                within 60 days of the return of the data              page. See: https://www.cdc.gov/nchs/
                                               NHANES survey.                                          to NCHS so these data may be released                 nhanes/about_nhanes.htm. Labor costs
                                                  (5) Qualification: Provide a brief                   to the public. All files will also undergo            are based on a proposal administrator
                                               description of the Principal                            disclosure review at NCHS before                      and computer programmers at NCHS to
                                               Investigator’s expertise in the proposed                release.                                              prepare the data files. The storage and
                                               area, including publications in this area                                                                     pulling the samples from the freezer fees
                                               within the last three years. A                          Agency Agreement
                                                                                                                                                             include the costs for the NHANES
                                               representative sample of earlier                          A formal signed agreement in the                    repository.
                                               publications may be listed as long as                   form of a MTA or an IAA with
                                               this section does not exceed two pages.                 investigators who have projects                              FEE SCHEDULE FOR NHANES
                                                  (6) Period of Performance: Specify the               approved will be completed before the
                                               project time period. Substantial progress                                                                                 BIOLOGIC SAMPLES
                                                                                                       release of the samples. This agreement
                                               must be made in the first year that                     will contain the conditions for use of                            Cost factors                     Cost per vial
                                               samples have been obtained, and the                     the samples as stated in this document
                                               project should be completed within a                    and as agreed upon by the investigators               Material and Equipment .......                       $2.85
                                               reasonable time period. Please discuss                  and CDC.                                              Processing the samples (Re-
                                               the approximate time the investigator                                                                           ceiving, handling and ship-
                                               expects this project will take to                       Continuations                                           ping) ..................................            2.15
                                               complete the project. At the end of the                    A brief progress report will be                    Administrative, management
                                               project period, any unused samples                      submitted annually. This will be the                    of the proposal process ....                        1.50
                                                                                                                                                             Inventory management .........                        1.50
                                               must be returned to the NHANES                          basis for the NCHS ERB continuation                   Preparation of data files .......                     3.50
                                               Specimen Repository or discarded. The                   reports that are required annually. After
                                               NCHS Project Officer must be consulted                  5 years of annual continuations, if there                Subtotal .........................                11.50
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                                               about the disposition of the samples.                   is need for continued use of samples to               CDC Support (5%) ...............                      0.58
                                                  (7) Funding: The source and status of                complete the protocol study, a new
                                               the funding to perform the requested                    protocol is required.                                    Subtotal .........................                12.08
                                               laboratory analysis should be included.                                                                       NCHS Support (7.50%) ........                         0.91
                                               Investigators will be responsible for the               Disposition of Results and Samples
                                                                                                                                                                         Total .......................           13.00 *
                                               cost of processing and shipping the                       No samples provided can be used for
                                               samples. The cost per sample is $13.00.                 any purpose other than those                             • Total is rounded up from $12.99



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                                                                          Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices                                                  58209

                                                 Dated: December 5, 2017.                              proposed collection(s) summarized in                  enrollment. Form Number: CMS–10142
                                               Sandra Cashman,                                         this notice, you may make your request                (OMB control number: 0938–0944);
                                               Executive Secretary, Centers for Disease                using one of following:                               Frequency: Yearly; Affected Public:
                                               Control and Prevention.                                   1. Access CMS’ Web site address at                  Private sector (Business or other for-
                                               [FR Doc. 2017–26591 Filed 12–8–17; 8:45 am]             Web site address at https://                          profits and Not-for-profit institutions);
                                               BILLING CODE 4163–18–P                                  www.cms.gov/Regulations-and-                          Number of Respondents: 555; Total
                                                                                                       Guidance/Legislation/                                 Annual Responses: 4,995; Total Annual
                                                                                                       PaperworkReductionActof1995/PRA-                      Hours: 149,850. (For policy questions
                                               DEPARTMENT OF HEALTH AND                                Listing.html.                                         regarding this collection contact Rachel
                                               HUMAN SERVICES                                            2. Email your request, including your               Shevland at 410–786–3026.)
                                                                                                       address, phone number, OMB number,                       Dated: December 6, 2017.
                                               Centers for Medicare & Medicaid                         and CMS document identifier, to
                                               Services                                                                                                      William N. Parham, III,
                                                                                                       Paperwork@cms.hhs.gov.
                                                                                                         3. Call the Reports Clearance Office at             Director, Paperwork Reduction Staff, Office
                                               [Document Identifier: CMS–10142]                                                                              of Strategic Operations and Regulatory
                                                                                                       (410) 786–1326.                                       Affairs.
                                               Agency Information Collection                           FOR FURTHER INFORMATION CONTACT:                      [FR Doc. 2017–26604 Filed 12–8–17; 8:45 am]
                                               Activities: Submission for OMB                          William Parham at (410) 786–4669.                     BILLING CODE 4120–01–P
                                               Review; Comment Request                                 SUPPLEMENTARY INFORMATION: Under the
                                               AGENCY: Centers for Medicare &                          Paperwork Reduction Act of 1995 (PRA)
                                               Medicaid Services, Department of                        (44 U.S.C. 3501–3520), federal agencies               DEPARTMENT OF HEALTH AND
                                               Health and Human Services.                              must obtain approval from the Office of               HUMAN SERVICES
                                               ACTION: Notice.                                         Management and Budget (OMB) for each
                                                                                                       collection of information they conduct                Centers for Medicare & Medicaid
                                               SUMMARY:    The Centers for Medicare &                  or sponsor. The term ‘‘collection of                  Services
                                               Medicaid Services (CMS) is announcing                   information’’ is defined in 44 U.S.C.                 [Document Identifier: CMS–10529]
                                               an opportunity for the public to                        3502(3) and 5 CFR 1320.3(c) and
                                               comment on CMS’ intention to collect                    includes agency requests or                           Agency Information Collection
                                               information from the public. Under the                  requirements that members of the public               Activities: Submission for OMB
                                               Paperwork Reduction Act of 1995                         submit reports, keep records, or provide              Review; Comment Request
                                               (PRA), federal agencies are required to                 information to a third party. Section
                                               publish notice in the Federal Register                  3506(c)(2)(A) of the PRA (44 U.S.C.                   AGENCY: Centers for Medicare &
                                               concerning each proposed collection of                  3506(c)(2)(A)) requires federal agencies              Medicaid Services, HHS.
                                               information, including each proposed                    to publish a 30-day notice in the                     ACTION: Notice.
                                               extension or reinstatement of an existing               Federal Register concerning each
                                               collection of information, and to allow                                                                       SUMMARY:    The Centers for Medicare &
                                                                                                       proposed collection of information,
                                               a second opportunity for public                                                                               Medicaid Services (CMS) is announcing
                                                                                                       including each proposed extension or
                                               comment on the notice. Interested                                                                             an opportunity for the public to
                                                                                                       reinstatement of an existing collection
                                               persons are invited to send comments                                                                          comment on CMS’ intention to collect
                                                                                                       of information, before submitting the
                                               regarding the burden estimate or any                                                                          information from the public. Under the
                                                                                                       collection to OMB for approval. To
                                               other aspect of this collection of                                                                            Paperwork Reduction Act of 1995
                                                                                                       comply with this requirement, CMS is
                                               information, including the necessity and                                                                      (PRA), federal agencies are required to
                                                                                                       publishing this notice that summarizes
                                               utility of the proposed information                                                                           publish notice in the Federal Register
                                                                                                       the following proposed collection(s) of
                                               collection for the proper performance of                                                                      concerning each proposed collection of
                                                                                                       information for public comment:
                                               the agency’s functions, the accuracy of                                                                       information, including each proposed
                                                                                                         1. Type of Information Collection
                                               the estimated burden, ways to enhance                                                                         extension or reinstatement of an existing
                                                                                                       Request: Revision of a currently
                                               the quality, utility, and clarity of the                                                                      collection of information, and to allow
                                                                                                       approved collection; Title of
                                               information to be collected; and the use                                                                      a second opportunity for public
                                                                                                       Information Collection: Bid Pricing Tool
                                               of automated collection techniques or                                                                         comment on the notice. Interested
                                                                                                       (BPT) for Medicare Advantage (MA)
                                               other forms of information technology to                                                                      persons are invited to send comments
                                                                                                       Plans and Prescription Drug Plans
                                               minimize the information collection                                                                           regarding the burden estimate or any
                                                                                                       (PDP); Use: We require that Medicare
                                               burden.                                                                                                       other aspect of this collection of
                                                                                                       Advantage organizations and
                                                                                                                                                             information, including the necessity and
                                               DATES: Comments on the collection(s) of                 Prescription Drug Plans complete the
                                                                                                                                                             utility of the proposed information
                                               information must be received by the                     BPT as part of the annual bidding
                                                                                                                                                             collection for the proper performance of
                                               OMB desk officer by January 10, 2018.                   process. During this process,
                                                                                                                                                             the agency’s functions, the accuracy of
                                               ADDRESSES: When commenting on the                       organizations prepare their proposed
                                                                                                                                                             the estimated burden, ways to enhance
                                               proposed information collections,                       actuarial bid pricing for the upcoming
                                                                                                                                                             the quality, utility, and clarity of the
                                               please reference the document identifier                contract year and submit them to us for
                                                                                                                                                             information to be collected; and the use
                                               or OMB control number. To be assured                    review and approval. The purpose of the
                                                                                                                                                             of automated collection techniques or
                                               consideration, comments and                             BPT is to collect the actuarial pricing
                                                                                                                                                             other forms of information technology to
                                               recommendations must be received by                     information for each plan. The BPT
                                                                                                                                                             minimize the information collection
                                               the OMB desk officer via one of the                     calculates the plan’s bid, enrollee
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                                                                                                                                                             burden.
                                               following transmissions: OMB, Office of                 premiums, and payment rates. We
                                               Information and Regulatory Affairs,                     publish beneficiary premium                           DATES: Comments on the collection(s) of
                                               Attention: CMS Desk Officer, Fax                        information using a variety of formats                information must be received by the
                                               Number: (202) 395–5806 OR Email:                        (www.medicare.gov, the Medicare & You                 OMB desk officer by January 10, 2018.
                                               OIRA_submission@omb.eop.gov.                            handbook, Summary of Benefits                         ADDRESSES: When commenting on the
                                                  To obtain copies of a supporting                     marketing information) for the purpose                proposed information collections,
                                               statement and any related forms for the                 of beneficiary education and                          please reference the document identifier


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Document Created: 2017-12-09 01:49:58
Document Modified: 2017-12-09 01:49:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe stored NHANES biologic samples are available December 11, 2017. The fee structure for these samples is effective December 11, 2017.
ContactDr. Geraldine McQuillan, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, MD 20782. Telephone: 301- 458-4371; Fax: 301-458-4029; Email: [email protected]
FR Citation82 FR 58206 

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