National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples, 58206-58209 [2017-26591]

Download as PDF 58206 Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices 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 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of stored 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 healthrelated 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: Serumplasmaurine@ cdc.gov SUMMARY: Authority: Sections 301,306 and 308 of the Public Health Service Act (42 U.S.C. 241,242k and 242M). 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: SUPPLEMENTARY INFORMATION: (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 °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 °C or below in vapor-phase liquid nitrogen. These samples have not undergone a freezethaw 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 daltland on DSKBBV9HB2PROD with NOTICES Sample Type Pristine 1 NHANES Cycle Surplus 2 Sera III (1988–1994) ..................................................................................................... 1999–2000 ........................................................................................................... 2001–2002 ........................................................................................................... 2003–2004 ........................................................................................................... VerDate Sep<11>2014 17:54 Dec 08, 2017 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Plasma Urine Sera Plasma Urine X X X X .............. X X X .............. X X X X X X X .............. X X .............. .............. X X .............. E:\FR\FM\11DEN1.SGM 11DEN1 58207 Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices TABLE A—OVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III (1988–1994) AND NHANES 1999–2014— Continued Sample Type Pristine 1 NHANES Cycle Surplus 2 Sera 2005–2006 2007–2008 2009–2010 2011–2012 2013–2014 2015–2016 ........................................................................................................... ........................................................................................................... ........................................................................................................... ........................................................................................................... ........................................................................................................... ........................................................................................................... 1 Samples 2 Samples daltland on DSKBBV9HB2PROD with NOTICES Urine Sera Plasma Urine X X X X X X X X X .............. .............. .............. X X X X X X X X X X X X .............. .............. .............. .............. .............. .............. .............. .............. .............. .............. .............. .............. immediately frozen for storage, did not undergo laboratory testing. 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 VerDate Sep<11>2014 Plasma 17:54 Dec 08, 2017 Jkt 244001 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 Serumplasmaurine@cdc.gov. 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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, longterm objectives and public health relevance including a discussion of how the results will affect public health policy or further scientific knowledge. The proposal should justify the need for samples that are representative of the U.S. population. The 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 E:\FR\FM\11DEN1.SGM 11DEN1 daltland on DSKBBV9HB2PROD with NOTICES 58208 Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices the researcher is requesting a subsample 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. VerDate Sep<11>2014 17:54 Dec 08, 2017 Jkt 244001 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. 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 ....... Processing the samples (Receiving, handling and shipping) .................................. Administrative, management of the proposal process .... Inventory management ......... Preparation of data files ....... $2.85 Subtotal ......................... CDC Support (5%) ............... 11.50 0.58 Subtotal ......................... NCHS Support (7.50%) ........ 12.08 0.91 Total ....................... 13.00 * 2.15 1.50 1.50 3.50 Disposition of Results and Samples No samples provided can be used for any purpose other than those PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 • Total is rounded up from $12.99 E:\FR\FM\11DEN1.SGM 11DEN1 Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10142] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by January 10, 2018. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806 OR Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and any related forms for the daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:54 Dec 08, 2017 Jkt 244001 proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at Web site address at https:// www.cms.gov/Regulations-andGuidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP); Use: We require that Medicare Advantage organizations and Prescription Drug Plans complete the BPT as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to us for review and approval. The purpose of the BPT is to collect the actuarial pricing information for each plan. The BPT calculates the plan’s bid, enrollee premiums, and payment rates. We publish beneficiary premium information using a variety of formats (www.medicare.gov, the Medicare & You handbook, Summary of Benefits marketing information) for the purpose of beneficiary education and PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 58209 enrollment. Form Number: CMS–10142 (OMB control number: 0938–0944); Frequency: Yearly; Affected Public: Private sector (Business or other forprofits and Not-for-profit institutions); Number of Respondents: 555; Total Annual Responses: 4,995; Total Annual Hours: 149,850. (For policy questions regarding this collection contact Rachel Shevland at 410–786–3026.) Dated: December 6, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017–26604 Filed 12–8–17; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10529] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by January 10, 2018. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier SUMMARY: E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Pages 58206-58209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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