81 FR 69822 - National Health and Nutrition Examination Survey (NHANES) DNA Specimens: Guidelines for Proposals To Use Specimens and Cost Schedule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 195 (October 7, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 195 (October 7, 2016)
| Page Range | 69822-69826 | |
| FR Document | 2016-24349 |
[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)] [Notices] [Pages 69822-69826] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24349] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Health and Nutrition Examination Survey (NHANES) DNA Specimens: Guidelines for Proposals To Use Specimens and Cost Schedule AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces reopening of the National Center for Health Statistics' (NCHS) National Health and Nutrition Examination Survey (NHANES) DNA Specimen Repository for research proposals. Blood samples for DNA purification were collected from study participants during NHANES III, NHANES 1999- 2000, NHANES 2001-02, NHANES 2007-08, and NHANES 2009-10 (Office of Management and Budget Control Numbers 0920-0237/0920-0950). Samples from these DNA Specimens are being made available to the research community for genetic testing. The information gained from research using these samples can be combined with the extensive amount of information available in NHANES which describes the prevalence/trends of disease, nutrition, risk behaviors, and environmental exposures in the US population. A more complete description of this program follows. [[Page 69823]] FOR FURTHER INFORMATION CONTACT: NHANES Genetic Project Officer: Jody McLean M.P.H., Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, MD 20782, Phone: 301-458- 4683, Fax: 301-458-4029, EMail: NHANESgenetics@cdc.gov. Authority: Sections 301, 306 and 308 of the Public Health Service Act (42 U.S.C. 241, 2421 and 242m). SUPPLEMENTARY INFORMATION: Background NHANES is a program of periodic surveys conducted by NCHS. Examination surveys conducted since 1960 by NCHS have provided national estimates of the health and nutritional status of the U.S. civilian non-institutionalized population. The goals of NHANES are (1) to estimate the number and percentage of people in the U.S. population and designated subgroups with selected diseases and risk factors for those diseases; (2) to monitor trends in the prevalence, awareness, treatment and control of selected diseases; (3) to monitor trends in risk behaviors and environmental exposures; (4) to analyze risk factors for selected diseases; (5) to study the relation among diet, nutrition and health; (6) to explore emerging public health issues and new technologies; and (7) to establish and maintain a national probability sample of baseline information on health and nutritional status. The availability of the NHANES III DNA specimens has been previously announced in 2002 (67 FR 51585), 2006 (71 FR 22248), 2007 (72 FR 59094), 2009 (74 FR 45644), and 2010 (75 FR 32191). NHANES III Phase II DNA specimens (1991-1994) are from participants ages 12 or older (see NHANES III DNA Specimens section for a description). For details about available NHANES III non-genetic data see http://www.cdc.gov/nchs/nhanes/nh3data.htm. Beginning in 1999, NHANES became a continuous, annual survey rather than a periodic survey. For a variety of reasons, including disclosure and reliability issues, the survey data are released as public use data files every two years. In addition to the analysis of data from any two year cycle, it is possible to combine two cycles to increase sample size and analytic options. Blood samples for DNA purification were collected from participants aged 20 years and older in survey years 1999-2002 and 2007-12. DNA specimens are available as collections from NHANES 1999-2002 (NHANES 1999-2000 and 2001-02 specimens available as one collection), and NHANES two-year cycles 2007-08 and 2009-10(see NHANES 1999-2002, 2007-08, and 2009-10 DNA specimens section for a description). Availability of DNA specimens from NHANES 2011-12 is forthcoming and will be announced in a future FRN. The availability of the NHANES 1999-2002 and NHANES 2007-08 DNA specimens has been previously announced (Thursday, September 3, 2009 [74 FR 45644], and Monday, June 7, 2010 [75 FR 32191]). The data release cycle for the NHANES corresponding to the period in which specimens were collected for DNA is described in the following web links: http://wwwn.cdc.gov/nchs/nhanes/search/nhanes99_00.aspx, http://wwwn.cdc.gov/nchs/nhanes/search/nhanes01_02.aspx, http://wwwn.cdc.gov/nchs/nhanes/search/nhanes07_08.aspx, and http://wwwn.cdc.gov/Nchs/Nhanes/Search/nhanes09_10.aspx. Identifiable health information collected in the NHANES is kept in strictest confidence. During the informed consent process, survey participants are assured that data collected will be used only for stated purposes and will not be disclosed or released to others without the consent of the individual in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m). During NHANES III, participants 12 years and older (parent or guardian signed the consent form if the participant was under age 18 years) signed a consent form to store a sample of their blood for future research. In NHANES 1999- 2002, 2007-08 and 2009-10 a separate consent form was signed by eligible participants who agreed to the storing of specimens for future genetic research. DNA specimens will be available for testing only from participants who consented to future genetic research. Resulting data from DNA specimen testing will be linked to the NCHS variables (public use and restricted) and available for analyses through an NCHS Research Data Center (RDC). Access to these data at an NCHS RDC is only through an approved proposal process mechanism to assure confidentiality. Research Proposal Note: The following proposal types differ from those used in previous announcements for use of NHANES III DNA specimens (Thursday, August 8, 2002 [67 FR 51585], Friday, January 13, 2006 [71 FR 22248], and Monday, June 10, 2010 [75 FR 32191]). Proposals testing a complete NHANES DNA collection of specimens (NHANES III, 7,159 samples; NHANES 1999-2002, 7,839 specimens; NHANES 2007-08, 4,612 specimens; NHANES 2009-10, 4,893 specimens): Note: If the investigator would like to propose a subsample of the complete set please contact the NHANES Genetic Project Officer to discuss feasibility. Proposals should investigate specific research hypotheses. The investigator will specify which DNA collection they are requesting and the tests to be conducted on DNA specimens excluding tests that produce incidental findings. The investigator will also include in the research protocol an analytic plan that includes a list of proposed NCHS variables (public use and restricted) that would be used for the data analyses. The investigator will conduct the tests of the approved variants or approved assays on samples of NHANES DNA specimens that are labeled with a lab identification number that is not directly linkable to the public use file and therefore, anonymous to the investigator. Investigators are required to provide the data obtained from DNA testing to Division of Health and Nutrition Examination Survey (DHANES)/NCHS for quality control assessment. Analysis and linkage of the resulting data are conducted in the NCHS RDC via a separate proposal. After the DHANES/NCHS has completed the initial quality control assessment, investigators will be given up to six months to conduct a comprehensive quality assurance review. The timeframe allowed for this review will depend on the number and characteristics of the tests submitted. At the completion of this review, the availability of the resulting data will be announced to the public on the NHANES Web site Genetic Variant Search: http://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: http://www.cdc.gov/nchs/nhanes/biospecimens/dnaspecimens.htm#Genetic. DNA specimen collections will be provided in 96 well plates to investigators and distributed as samples from a complete collection or from a subsample of a collection. Proposals testing DNA specimens already obtained from previous solicitations: Investigators that have obtained samples from NHANES DNA specimens from previous solicitations and have sufficient DNA left may request to do additional tests on the [[Page 69824]] remaining DNA. These proposals must be submitted and approved before the DNA specimens were scheduled to be destroyed or returned. The investigator will specify the test to be conducted on the samples excluding tests that produce incidental findings. The investigator will also include in the research protocol an analytic plan that includes a list of proposed NCHS variables (public use and restricted) that would be used for the data analyses. DNA Samples These DNA specimens (NHANES III, NHANES 1999-2002, NHANES 2007-08 and NHANES 2009-10) were processed by the Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH), Division of Laboratory Sciences (DLS). NHANES III DNA Specimens The laboratory will distribute aliquots (samples) of crude DNA lysates extracted from cell lines. DNA concentrations vary and are estimated to range from 7.5-65.0 ng/[mu]L with an average of approximately four micrograms in 100 [mu]L. Samples will be provided in 96 well plates that are bar-coded and labeled with a readable identifier. Quality control samples (5% of the total) will be sent at no charge, on separate plates as blind replicates. DNA specimens are available from 7,159 NHANES III participants. Samples will be distributed in a total of 78 plates with an additional four plates of quality control samples. NHANES III DNA specimens are in limited supply thus are not available as a partial set. Due to the method of extraction, NHANES III DNA specimens are not appropriate for all projects and/or assays. NHANES 1999-2002, 2007-08, 2009-10 DNA Specimens The laboratory will distribute aliquots of purified, high molecular DNA in normalized concentrations of 50.0 ng/[mu]L. Some specimens may fall below this threshold. A sample of 40 microliters of each specimen will be supplied. The amount of DNA in each sample may vary but will be on average approximately two micrograms. There are purified DNA specimens from 7,839 NHANES 1999-2002 participants. Samples from these specimens will be distributed into 90 plates including four plates of quality control samples. There are purified DNA specimens available from 4,612 NHANES 2007- 08 participants. These will be distributed into approximately 54 plates including three plates of quality control samples. There are purified DNA specimens available from 4,893 NHANES 2009- 10 participants. Samples from the specimens will be distributed into 54 plates with approximately three additional plates of quality control samples. Each 96 well plate will be bar-coded and labeled with a readable identifier. Quality control samples (5% of a collection) will be sent at no charge, on separate plates as blind replicates. Proposed Cost Schedule for Providing NHANES DNA Samples Costs are determined by NCHS and include costs incurred from the contracting DNA Repository and DHANES administrative costs. The fee covers the costs of materials, equipment, labor, proposal review, administration and space for storage. For more details see Table 1 below. In prior years, the DNA Repository was maintained by CDC. The DNA Repository is now maintained by a private contractor. The costs of contracting, along with annual inflation increases, are reflected in the proposed cost schedule. Procedures for Proposals The investigator should follow these instructions for preparation of proposals. Protocols must be written using the outline below. Proposal TimelineSubmission of Proposals: Can be submitted on an ongoing basis. Scientific Review: Within two months of proposal submission. Institutional Review Date: Within six weeks of final proposal acceptance. Notification of approval: Approximately 30 days after Institutional Review. Anticipated distribution of samples: Approximately 60 days after all approvals are obtained. Note: Timeframe may vary depending on the nature of the proposal and the results of each level of review. Unforeseen circumstances could result in a change to this schedule. DNA Specimen Program will begin accepting research proposals on December 6, 2016. In addition to the cover page, the research proposal should contain the title of the research project, the name, address phone number and Email address of the lead investigator along with the name of the institution where the testing will be conducted. Office of Human Research Protections assurance numbers for the institutions engaged in the research project should be included. CDC investigators need to include their Scientific Ethics Verification Number. Email submission of the proposal is required. The proposals should be a maximum of 20 single-spaced typed pages, excluding figures and tables. Please use appendices sparingly. If a proposal is approved, the title, specific aims, name, and phone number of the author will be maintained by NCHS and released if requested by the public. Unapproved proposals will be returned to the investigator and will not be maintained by NCHS. Applications will have a Scientific Review by the Genetic Project Officer and the Technical Panel. The Technical Panel is comprised of two members: A Genetic Research Scientist and a Genetic Epidemiologist. The members review each proposal for scientific and technical merit. After the proposal is approved by the Genetic Technical Panel and the Genetic Project Officer it will be submitted for Institutional review. All proposals will undergo Institutional Review by the NCHS Human Subjects Contact and the NCHS Ethics Review Board (ERB) for any potential human subjects concerns to ensure appropriate human subjects protections are provided in compliance with 45 CFR 46, and by the NCHS Confidentiality Officer for disclosure risk. The ERB will review the proposal even if the investigator has received approval by their institutional review panel. Proposals should include the following information: (1) Cover sheet: Include the name of the institution where the test will be conducted and Office of Human Research Protections assurance numbers for the institutions engaged in the research project. CDC investigators need to include their Scientific Ethics Verification Number. (2) Abstract: Please limit the abstract to 300 words. (3) Specific Aims: List the broad objectives; describe concisely and realistically what the research is intended to accomplish, and state the specific hypotheses to be tested. (4) Background and Public Health Significance: (A) Describe the public health significance of the proposed research. (B) Discuss how the results will be used. Analyses should be consistent with the NHANES mission to assess the health of the nation. The Scientific Review will ensure that the proposed project does not go beyond either the general purpose for collecting the blood samples for DNA in the survey or the specific stated goals of the proposal. (5) Design, Method, and Data analysis: The appropriateness and [[Page 69825]] adequacy of the methodology proposed to reach the research aims, and the appropriateness of using the NHANES (a complex, multistage probability sample of the national population) to address the goals of the proposal will be assessed. (A) Research Design and Methods: Describe the analytic and statistical methods to be employed. Include power calculations. For all proposal categories, include a detailed description of the laboratory methods. The characteristics of the laboratory assay, such as reliability, validity, should be included with appropriate references. The potential difficulties and limitations of the proposed procedures should also be discussed. Address adequate methods planned for handling and storage of samples of DNA specimens. Proposals must specify specific variants or the standard assay(s) that will be used to test the proposed research hypotheses and include a statement of why the specific standard assay(s) is/are necessary to test the proposed hypotheses. The standard assay is a commercially available assay for a curated set of variants. (1) Proposals will be provided with quality control samples at no additional cost. Approved projects must run these quality control samples and submit these results along with the results from the NHANES DNA samples, unless the Genetic Project Officer has approved an alternative quality control review plan. (2) Proposals using residual samples should have residual quality control samples and investigators will be required to use these residual quality control samples. The proposal should address additional quality control procedures the laboratory will use to assure the validity of the test results and address adequate methods planned for handling and storage of sample specimens. (B) Data analysis: Note: All resulting data must be analyzed in the NCHS RDC Output: Please describe the data output that you would like to retain and take out of the RDC after analyses. (6) Additional information for NHANES: (A) Clinical Relevance of Research Findings: The consent document for DNA specimen storage and future studies states that individual results will not be provided to participants therefore no tests that would need to be reported back to the participant can be proposed. DHANES/NCHS will use the most recent American College of Medical Genetics and Genomics (ACMG) recommendations for reporting incidental findings to review the proposed tests and the potential incidental findings. Investigators must justify that the proposed tests do not produce sets of variants on specific genes listed by the most recent ACMG as reportable incidental findings as well as how potential incidental test results will be handled. As of publication the most recent report, published July 2013, ``ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing'', lists 56 genes where specific variants on these genes are pathogenic for 24 conditions. (B)Data Transfer: Specify the secure method to transfer resultant data to NCHS. Investigators must use a device that meets federal information processing standards (FIPS 140-2 and FIPS 197). (C) Period of Performance: Specify the project period. The period may be up to three years. At the end of the project period, any unused samples must be returned to the NHANES DNA Specimen Repository or destroyed by the investigator. Extensions to the period of performance may be requested. (D) Funding: Include the source and status of the funding to perform the requested laboratory analysis. Investigators will be responsible for the cost of processing and shipping the samples (See table). (7) References. (8) Resumes/CV: Please include a 2-page CV for each member of the research team in this document (not as attachments). Public Availability of Data Data resulting from use of DNA specimens will be made available to the public for secondary data analyses via the NCHS RDC. After DHANES/ NCHS quality control assessment is completed, investigators will be given up to six months to conduct comprehensive quality assurance review in the NCHS RDC. The quality assurance review timeframe will be negotiated between the investigator and the NHANES Genetic Project Officer and will depend on the type, number, and characteristics of the tests submitted. The results of the quality assurance review will be provided to DHANES/NCHS and appropriate aspects will become part of the data set documentation. The public announcement, that test results are available for submission of proposals for secondary data analyses, will occur once the quality assurance review timeframe has ended. For a list of currently available variant data see: http://www.cdc.gov/nchs/nhanes/biospecimens/dnaspecimens.htm#Genetic. Proposals for secondary data analyses linking NCHS restricted data, NCHS public use data, or non-NCHS data to data resulting from DNA specimen testing will be reviewed by the NCHS RDC. See http://www.cdc.gov/rdc for proposal guidelines. Submission of Proposals Proposals can be submitted immediately. The review process will begin approximately 60 days from the publication of the notice and will include all proposals submitted as of that date. Electronic submission of proposals are required. Please submit proposals to the NHANES Genetic Project Officer: Jody McLean M.P.H., Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, MD 20782, Phone: 301-458-4683, EMail: NHANESgenetics@cdc.gov. Agency Agreement Investigators must secure funding and sign terms and conditions agreements for the use of the DNA specimens with CDC/NCHS prior to the release of the NHANES DNA samples. Investigators must agree to use the specimens only for the approved tests and use the test results only for purposes as stated in the approved proposal, not link the results of the proposed research to any other data, and not use the DNA specimens for commercial purposes via a legally binding Materials Transfer Agreement for non-government researchers or Interagency Agreement for government researchers. In addition, all investigators will be required to sign a Designated Agent Agreement (DAA) with CDC/NCHS in accordance with NCHS' confidentiality legislation, the Confidential Information Protection and Statistical Efficiency Act (CIPSEA; Title V of the E- Government Act of 2002 (Pub. L. 107-347)). The DAA is the mechanism by which CDC/NCHS may authorize designation of agents to exclusively perform activities needed to produce approved data on CIPSEA protected NHANES DNA specimens. Approved Proposals After DNA samples are received and testing is complete, the resulting data will be sent back to DHANES/NCHS for quality control (QC) assessment. While DHANES/NCHS QC assessment is under way the investigator can submit a NCHS RDC proposal to conduct comprehensive quality assurance review. Once the investigator's quality assurance review is complete and the [[Page 69826]] results returned to DHANES/NCHS, the test results will be made available to the public and the investigator can submit an NCHS RDC proposal to request linkage to NCHS restricted data, NCHS public use data, or Non-NCHS data to conduct their analysis. After the comprehensive quality assessment process has been completed by the investigator, a list of variants generated from NHANES specimen testing will be made available to the public for potential solicitation via NCHS RDC proposals. The list of variants will be available in the NHANES Genetic Variant Search (http://www.nhgeneticvariant.com/). In addition, DHANES/NCHS quality control assessment procedures will be posted on the NHANES Genetic Repository Web site and/or available via email. Progress Reports A progress report will be submitted in the annual CDC/NCHS/ERB continuation report. An ERB continuation form will be sent to the investigator each year for project update. If an approved proposal is unable to obtain funding the proposal will be closed. Termination of ERB Protocol At the end of laboratory testing the ERB Protocol will be closed. Disposition of Results and Samples The provided DNA samples cannot be used for any purpose other than the specifically requested purpose outlined in the proposal and approved through the Scientific and Institutional Review. No DNA samples can be shared with others, including other investigators, unless specified in the proposal and so approved. Samples must be returned upon completion of the approved project or destroyed only with the written approval of the NHANES Genetic Project Officer. Test results from all studies using NHANES DNA specimens will be made available to the public for secondary data analyses. After the DHANES/ NCHS quality control assessment is completed, investigators will be given up to six months to conduct a more comprehensive quality assurance review. The final quality assurance review timeframe will be negotiated between the researcher and the NHANES Genetic Project Officer and characteristics of the tests submitted. Proposals for secondary data analyses will be reviewed by the NCHS RDC on a rolling basis; see: http://www.cdc.gov/rdc for proposal guidelines. All data analyses will be conducted via access modes available at NCHS RDC. Dated: October 4, 2016. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. Table 1--Cost Schedule for NHANES DNA Specimens ---------------------------------------------------------------------------------------------------------------- 1999-2002, 1999-2002, 2007-08, 2009- 2007-08, 2009- NHANES III Total costs 10 Complete 10 Partial complete set set set ---------------------------------------------------------------------------------------------------------------- Materials and Equipment--contractor: Plates, reagents, assays, $1.51 $4.53 $0.75 aliquoting and packaging samples; use of equipment............. Labor--contractor: Processing, handling, and shipping; NCHS: 4.98 24.90 2.49 Data quality control........................................... Proposal review and Administrative expenses--contractor: 3.02 6.04 1.51 Inventory management and reporting; NCHS: Management of proposal process non-NCHS: Technical panel fees................ Space--contractor: Freezer use and maintenance.................. 5.59 5.59 2.79 Cost per sample................................................. 15.10 41.06 7.55 Cost per new proposal: 1999-2002................................................... 119,260 NA 2007-2008................................................... 72,661 2009-2010................................................... 73,884 III......................................................... .............. .............. 54,050 Cost per additional proposal: * 1999-2002................................................... 5,963 ** 2007-2008................................................... 3,633 2009-2010................................................... 3,694 III......................................................... .............. .............. 2,702 ---------------------------------------------------------------------------------------------------------------- * Additional research using DNA specimens already obtained from previous solicitations. ** This charge will be 5 percent of the original cost. Note: Applicable CDC overhead and NCHS management and oversight charges will be added to these rates for proposals coming from Federal agencies. [FR Doc. 2016-24349 Filed 10-6-16; 8:45 am] BILLING CODE 4163-18-P
![69822 Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
preparation and submission of notices recommend whether the NSA boundary- should bring their driver’s license or a
of intent to withdraw is (276 setting process should be replaced, government-issued photo identification
withdrawing members × 1.5 hours per changed, or maintained as is. Interested card. Seating will be capped at 275
application) = 414 hours. parties are invited to attend and provide people on a first-come, first-served
comments. basis.
IV. Requests for Automatic Transfer of Procedures for Providing Comments:
DATES: The meeting will be held on
Membership Written comments will be accepted
Thursday, October 27, 2016, beginning
FHFA estimates that the average at 10:00 a.m. Eastern Standard Time, until November 4, 2016, for
number of Bank members submitting a ending no later than 3:00 p.m. Eastern consideration. Please email comments
request for automatic transfer to another Standard Time. to travelpolicy@gsa.gov with
Bank will be 1 and that the average time ADDRESSES: The meeting will be held in
attachments being no more than three
to prepare and submit a request will be the GSA Auditorium, located at the GSA pages. Any registrant who wishes to
1.5 hours. Accordingly, the estimate for Central Office, 1800 F Street NW., comment orally at the meeting will be
the annual hour burden associated with Washington, DC, 20405. limited to 10 minutes. All comments
preparation and submission of requests from the public, including attachments
FOR FURTHER INFORMATION CONTACT: Mr.
for automatic transfer is (1 transferring and other supporting materials received,
Cy Greenidge, Office of Government-
member × 1.5 hours per request) = 1.5 are subject to public disclosure.
wide Policy, Office of Asset and
hours. Dated: October 3, 2016.
Transportation Management, at 202–
C. Comment Request 219–2349, or by email at travelpolicy@ Troy Cribb,
gsa.gov. Associate Administrator, Office of
FHFA requests written comments on Government-wide Policy.
the following: (1) Whether the collection SUPPLEMENTARY INFORMATION: Pursuant
to 5 U.S.C. 5702, the Administrator of [FR Doc. 2016–24263 Filed 10–6–16; 8:45 am]
of information is necessary for the
proper performance of FHFA functions, General Services (GSA) sets the BILLING CODE 6820–14–P
including whether the information has maximum lodging allowance and M&IE
practical utility; (2) The accuracy of reimbursement rates for CONUS
FHFA’s estimates of the burdens of the locations. Each year, GSA sets a DEPARTMENT OF HEALTH AND
collection of information; (3) Ways to standard maximum lodging allowance HUMAN SERVICES
enhance the quality, utility, and clarity and M&IE reimbursement rates to cover
the majority of CONUS. GSA also sets Centers for Disease Control and
of the information collected; and (4) Prevention
Ways to minimize the burden of the individual rates for each established
collection of information on survey NSA. The current methodology for
National Health and Nutrition
respondents, including through the use setting rates was established by an
Examination Survey (NHANES) DNA
of automated collection techniques or independent Federal Advisory
Specimens: Guidelines for Proposals
other forms of information technology. Committee in 2006. Another Federal
To Use Specimens and Cost Schedule
Advisory Committee, chartered in 2013,
Dated: September 30, 2016. validated the existing methodology. The AGENCY: Centers for Disease Control and
Kevin Winkler, latter Committee had a full briefing and Prevention (CDC), Department of Health
Chief Information Officer, Federal Housing discussed the overall per diem and Human Services (HHS).
Finance Agency. methodology, but did not specifically ACTION: Notice.
[FR Doc. 2016–24345 Filed 10–6–16; 8:45 am] evaluate setting NSA boundaries.
BILLING CODE 8070–01–P Under the current methodology, NSA SUMMARY: The Centers for Disease
boundaries are set as a single county Control and Prevention (CDC), located
unless an exception is made. As of within the Department of Health and
GENERAL SERVICES FY2017, 68 of the 346 CONUS NSAs, or Human Services (HHS) announces
ADMINISTRATION approximately 20 percent, have an reopening of the National Center for
exception for one of three reasons: (1) Health Statistics’ (NCHS) National
[Notice-MA–2016–07; Docket No. 2016– Health and Nutrition Examination
Historically the boundary was set that
0002; Sequence No. 7] Survey (NHANES) DNA Specimen
way, (2) an agency requested that a one-
county boundary be adjusted to meet Repository for research proposals. Blood
Interagency Per Diem Working Group
official needs, or (3) the survey samples for DNA purification were
Meeting Concerning Boundaries To
methodology required inclusion of collected from study participants during
Set Continental United States Lodging
multiple counties to have sufficient data NHANES III, NHANES 1999–2000,
and Meals and Incidental Per Diem
to establish a rate. NHANES 2001–02, NHANES 2007–08,
Reimbursement Rates
Authority: 5 U.S.C. 5707. and NHANES 2009–10 (Office of
AGENCY: Office of Government-wide Meeting Access: The meeting is open Management and Budget Control
Policy (OGP), General Services to the public. Those wishing to attend Numbers 0920–0237/0920–0950).
Administration (GSA). must do so in person. Teleconferencing Samples from these DNA Specimens are
ACTION: Notice of meeting. will not be available. being made available to the research
Registration: Interested parties must community for genetic testing. The
SUMMARY: The Interagency Per Diem register by October 21, 2016 via email at information gained from research using
Working Group (IPDWG) is meeting to travelpolicy@gsa.gov. Please provide these samples can be combined with the
mstockstill on DSK3G9T082PROD with NOTICES
discuss studying the process of setting your full name to expedite entrance into extensive amount of information
continental United States (CONUS) the building. To gain entry into the available in NHANES which describes
Non-Standard Area (NSA) boundaries Federal building where the meeting is the prevalence/trends of disease,
for lodging maximum reimbursement being held, public attendees who are nutrition, risk behaviors, and
rates and meals and incidental expense Federal employees should bring their environmental exposures in the US
(M&IE) per diem reimbursement rates. Federal employee identification cards, population. A more complete
The purpose of the study would be to and members of the general public description of this program follows.
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FOR FURTHER INFORMATION CONTACT: DNA specimens are available as Proposals testing a complete NHANES
NHANES Genetic Project Officer: Jody collections from NHANES 1999–2002 DNA collection of specimens (NHANES
McLean M.P.H., Division of Health and (NHANES 1999–2000 and 2001–02 III, 7,159 samples; NHANES 1999–2002,
Nutrition Examination Surveys, specimens available as one collection), 7,839 specimens; NHANES 2007–08,
National Center for Health Statistics, and NHANES two-year cycles 2007–08 4,612 specimens; NHANES 2009–10,
Centers for Disease Control and and 2009–10(see NHANES 1999–2002, 4,893 specimens):
Prevention, 3311 Toledo Road, 2007–08, and 2009–10 DNA specimens Note: If the investigator would like to
Hyattsville, MD 20782, Phone: 301– section for a description). Availability of propose a subsample of the complete set
458–4683, Fax: 301–458–4029, EMail: DNA specimens from NHANES 2011–12 please contact the NHANES Genetic
NHANESgenetics@cdc.gov. is forthcoming and will be announced Project Officer to discuss feasibility.
in a future FRN. The availability of the Proposals should investigate specific
Authority: Sections 301, 306 and 308 of the
NHANES 1999–2002 and NHANES research hypotheses. The investigator
Public Health Service Act (42 U.S.C. 241,
2421 and 242m). 2007–08 DNA specimens has been will specify which DNA collection they
previously announced (Thursday, are requesting and the tests to be
SUPPLEMENTARY INFORMATION:
September 3, 2009 [74 FR 45644], and conducted on DNA specimens
Background Monday, June 7, 2010 [75 FR 32191]). excluding tests that produce incidental
The data release cycle for the NHANES findings. The investigator will also
NHANES is a program of periodic
corresponding to the period in which include in the research protocol an
surveys conducted by NCHS.
specimens were collected for DNA is analytic plan that includes a list of
Examination surveys conducted since
described in the following web links: proposed NCHS variables (public use
1960 by NCHS have provided national
http://wwwn.cdc.gov/nchs/nhanes/ and restricted) that would be used for
estimates of the health and nutritional the data analyses. The investigator will
status of the U.S. civilian non- search/nhanes99_00.aspx, http://
wwwn.cdc.gov/nchs/nhanes/search/ conduct the tests of the approved
institutionalized population. The goals variants or approved assays on samples
of NHANES are (1) to estimate the nhanes01_02.aspx, http://
wwwn.cdc.gov/nchs/nhanes/search/ of NHANES DNA specimens that are
number and percentage of people in the labeled with a lab identification number
nhanes07_08.aspx, and http://
U.S. population and designated that is not directly linkable to the public
wwwn.cdc.gov/Nchs/Nhanes/Search/
subgroups with selected diseases and use file and therefore, anonymous to the
nhanes09_10.aspx.
risk factors for those diseases; (2) to Identifiable health information investigator. Investigators are required
monitor trends in the prevalence, collected in the NHANES is kept in to provide the data obtained from DNA
awareness, treatment and control of strictest confidence. During the testing to Division of Health and
selected diseases; (3) to monitor trends informed consent process, survey Nutrition Examination Survey
in risk behaviors and environmental participants are assured that data (DHANES)/NCHS for quality control
exposures; (4) to analyze risk factors for collected will be used only for stated assessment. Analysis and linkage of the
selected diseases; (5) to study the purposes and will not be disclosed or resulting data are conducted in the
relation among diet, nutrition and released to others without the consent of NCHS RDC via a separate proposal.
health; (6) to explore emerging public the individual in accordance with After the DHANES/NCHS has
health issues and new technologies; and section 308(d) of the Public Health completed the initial quality control
(7) to establish and maintain a national Service Act (42 U.S.C. 242m). During assessment, investigators will be given
probability sample of baseline NHANES III, participants 12 years and up to six months to conduct a
information on health and nutritional older (parent or guardian signed the comprehensive quality assurance
status. consent form if the participant was review. The timeframe allowed for this
The availability of the NHANES III under age 18 years) signed a consent review will depend on the number and
DNA specimens has been previously form to store a sample of their blood for characteristics of the tests submitted. At
announced in 2002 (67 FR 51585), 2006 future research. In NHANES 1999–2002, the completion of this review, the
(71 FR 22248), 2007 (72 FR 59094), 2009 2007–08 and 2009–10 a separate availability of the resulting data will be
(74 FR 45644), and 2010 (75 FR 32191). consent form was signed by eligible announced to the public on the
NHANES III Phase II DNA specimens participants who agreed to the storing of NHANES Web site Genetic Variant
(1991–1994) are from participants ages specimens for future genetic research. Search: http://
12 or older (see NHANES III DNA DNA specimens will be available for www.nhgeneticvariant.com/. The
Specimens section for a description). testing only from participants who resulting data can be linked to other
For details about available NHANES III consented to future genetic research. NCHS variables (public use and
non-genetic data see http:// Resulting data from DNA specimen restricted) for secondary data analysis.
www.cdc.gov/nchs/nhanes/ testing will be linked to the NCHS For further information on available
nh3data.htm. variables (public use and restricted) and variant data visit: http://www.cdc.gov/
Beginning in 1999, NHANES became available for analyses through an NCHS nchs/nhanes/biospecimens/
a continuous, annual survey rather than Research Data Center (RDC). Access to dnaspecimens.htm#Genetic.
a periodic survey. For a variety of these data at an NCHS RDC is only DNA specimen collections will be
reasons, including disclosure and through an approved proposal process provided in 96 well plates to
reliability issues, the survey data are mechanism to assure confidentiality. investigators and distributed as samples
released as public use data files every from a complete collection or from a
two years. In addition to the analysis of Research Proposal subsample of a collection.
mstockstill on DSK3G9T082PROD with NOTICES
data from any two year cycle, it is Note: The following proposal types Proposals testing DNA specimens
possible to combine two cycles to differ from those used in previous already obtained from previous
increase sample size and analytic announcements for use of NHANES III solicitations: Investigators that have
options. Blood samples for DNA DNA specimens (Thursday, August 8, obtained samples from NHANES DNA
purification were collected from 2002 [67 FR 51585], Friday, January 13, specimens from previous solicitations
participants aged 20 years and older in 2006 [71 FR 22248], and Monday, June and have sufficient DNA left may
survey years 1999–2002 and 2007–12. 10, 2010 [75 FR 32191]). request to do additional tests on the
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![69826 Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
results returned to DHANES/NCHS, the continuation report. An ERB specimens will be made available to the
test results will be made available to the continuation form will be sent to the public for secondary data analyses.
public and the investigator can submit investigator each year for project After the DHANES/NCHS quality
an NCHS RDC proposal to request update. If an approved proposal is control assessment is completed,
linkage to NCHS restricted data, NCHS unable to obtain funding the proposal investigators will be given up to six
public use data, or Non-NCHS data to will be closed. months to conduct a more
conduct their analysis. comprehensive quality assurance
After the comprehensive quality Termination of ERB Protocol
review. The final quality assurance
assessment process has been completed At the end of laboratory testing the
ERB Protocol will be closed. review timeframe will be negotiated
by the investigator, a list of variants
between the researcher and the
generated from NHANES specimen Disposition of Results and Samples
testing will be made available to the NHANES Genetic Project Officer and
public for potential solicitation via The provided DNA samples cannot be characteristics of the tests submitted.
NCHS RDC proposals. The list of used for any purpose other than the Proposals for secondary data analyses
variants will be available in the specifically requested purpose outlined will be reviewed by the NCHS RDC on
NHANES Genetic Variant Search in the proposal and approved through a rolling basis; see: http://www.cdc.gov/
(http://www.nhgeneticvariant.com/). In the Scientific and Institutional Review. rdc for proposal guidelines. All data
addition, DHANES/NCHS quality No DNA samples can be shared with analyses will be conducted via access
control assessment procedures will be others, including other investigators, modes available at NCHS RDC.
posted on the NHANES Genetic unless specified in the proposal and so
Dated: October 4, 2016.
Repository Web site and/or available via approved. Samples must be returned
upon completion of the approved Sandra Cashman,
email.
project or destroyed only with the Executive Secretary, Centers for Disease
Progress Reports written approval of the NHANES Control and Prevention.
A progress report will be submitted in Genetic Project Officer. Test results from
the annual CDC/NCHS/ERB all studies using NHANES DNA
TABLE 1—COST SCHEDULE FOR NHANES DNA SPECIMENS
1999–2002, 1999–2002,
2007–08, 2007–08, NHANES III
Total costs 2009–10 2009–10 complete set
Complete set Partial set
Materials and Equipment—contractor: Plates, reagents, assays, aliquoting and packaging
samples; use of equipment ...................................................................................................... $1.51 $4.53 $0.75
Labor—contractor: Processing, handling, and shipping; NCHS: Data quality control ................ 4.98 24.90 2.49
Proposal review and Administrative expenses—contractor: Inventory management and re-
porting; NCHS: Management of proposal process non-NCHS: Technical panel fees ............ 3.02 6.04 1.51
Space—contractor: Freezer use and maintenance ..................................................................... 5.59 5.59 2.79
Cost per sample .......................................................................................................................... 15.10 41.06 7.55
Cost per new proposal:
1999–2002 ............................................................................................................................ 119,260 NA
2007–2008 ............................................................................................................................ 72,661
2009–2010 ............................................................................................................................ 73,884
III ........................................................................................................................................... ........................ ........................ 54,050
Cost per additional proposal: *
1999–2002 ............................................................................................................................ 5,963 **
2007–2008 ............................................................................................................................ 3,633
2009–2010 ............................................................................................................................ 3,694
III ........................................................................................................................................... ........................ ........................ 2,702
* Additional research using DNA specimens already obtained from previous solicitations.
** This charge will be 5 percent of the original cost.
Note: Applicable CDC overhead and NCHS management and oversight charges will be added to these rates for proposals coming from Fed-
eral agencies.
[FR Doc. 2016–24349 Filed 10–6–16; 8:45 am] DEPARTMENT OF HEALTH AND Advisory Committee to the Director
BILLING CODE 4163–18–P HUMAN SERVICES (ACD), Centers for Disease Control and
Prevention—Health Disparities
Centers for Disease Control and Subcommittee (HDS) Meeting on
Prevention October 19, 2016 as follows:
Time and Date: 8:00 a.m.–4:00 p.m.,
Advisory Committee to the Director EDT, October 19, 2016.
Place: CDC, Building 19, Room 151,
mstockstill on DSK3G9T082PROD with NOTICES
(ACD), Centers for Disease Control and
Prevention (CDC) 1600 Clifton Road NE., Atlanta, Georgia
30329.
Amendment: A notice of this meeting Status: Open to the public, limited
was published in the Federal Register only by the space available. The meeting
on August 30, 2016, Volume 81, room accommodates approximately 50
Number 168, Page 59626. The original people. The public is welcome to
notice is amended to include the participate during the public comment
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Document Created: 2018-02-13 16:31:51
Document Modified: 2018-02-13 16:31:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Within six weeks of final proposal acceptance. | |
| 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: [email protected] | |
| FR Citation | 81 FR 69822 |
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