Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 41129 

1See ‘‘Guidelines for Returning Individual Results 

from Genome Research Using Population-Based 

Banked Specimens’’ (https://nap.national

academies.org/catalog/18829/issues-in-returningindividual-results-from-genome-research-usingpopulation-based-banked-specimens-with-a-focuson-the-national-health-and-nutrition-examinationsurvey), convened by the National Academies of 

Science Committee on National Statistics in 2014 at 

the request of NCHS’s Board of Scientific 

Counselors. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Health and Nutrition 

Examination Survey (NHANES) Stored 

DNA Specimens; Proposed Cost 

Schedule and Guidelines for Proposal 

To Use DNA Specimens 

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 the 

availability of stored DNA specimens 

obtained from participants in the 

National Health and Nutrition 

Examination Survey (NHANES) and the 

proposal parameters and fee schedule 

for use. NHANES is one of a series of 

health-related surveys conducted by 

CDC’s National Center for Health 

Statistics (NCHS). 

DATES: The stored NHANES DNA 

specimens are available July 11, 2022. 

The fee structure for these specimens is 

effective July 11, 2022. 

FOR FURTHER INFORMATION CONTACT: Jody 

McLean, Division of Health and 

Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, 

Hyattsville, MD 20782, Telephone: (301) 

458–4683; Email: NHANESgenetics@

cdc.gov. 

Authority: Sections 301,306 and 308 

of the Public Health Service Act (42 

U.S.C. 241, 242k, and 242m). 

SUPPLEMENTARY INFORMATION: 

Background: NHANES is a program of 

periodic surveys conducted by NCHS. 

NHANES has provided national 

estimates of the health and nutritional 

status of the U.S. civilian noninstitutionalized population since the 

1960s. 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. 

DNA Specimens, Availability, and 

Resulting Data 

The availability of the NHANES III 

Phase 2 DNA specimens was first 

announced in 2002. NHANES III Phase 

2 DNA specimens (1991–1994) are from 

participants ages 12 or older (see: 

https://wwwn.cdc.gov/nchs/nhanes/ 

nhanes3/default.aspx for more 

information on NHANES III). 

NHANES III Phase 2 DNA specimens 

are crude DNA lysates extracted from 

cell lines; therefore, DNA 

concentrations vary and are estimated to 

range from 7.5–65.0 ng/mL with an 

average of approximately four 

micrograms in 100 mL. DNA specimens 

are available from 7,159 NHANES III 

Phase 2 participants. Forty microliters 

of each DNA specimen will be 

distributed in 82 plates, including four 

plates of quality control specimens. 

NHANES III DNA specimens are in 

limited supply and thus are not 

available as a partial set (which is a 

request for less than the total number of 

participants available). Due to the 

extraction method, NHANES III DNA 

specimens are not appropriate for all 

projects and assays. For background 

information on all DNA specimens, see 

the NHANES Biospecimen Program 

report at https://www.cdc.gov/nchs/ 

data/series/sr_02/sr02_170.pdf. 

In 1999, NHANES became a 

continuous survey, with data released 

every two years (see https://

wwwn.cdc.gov/nchs/nhanes/continuous

nhanes/default.aspx for more 

information on continuous NHANES). 

The availability of DNA specimens from 

the continuous NHANES was first 

announced in 2007. 

Continuous NHANES DNA specimens 

are available as collections from 

NHANES 1999–2002 (NHANES 1999– 

2000 and 2001–2002 specimens are 

available as one collection) and 

NHANES two-year cycles 2007–08, 

2009–10, and 2011–12. In continuous 

NHANES, DNA was purified from 

whole blood; aliquots of DNA were 

normalized to concentrations of 

approximately 50 ng/ml, and 40 ml of 

each DNA specimen will be distributed. 

There are purified DNA specimens from 

7,830 NHANES 1999–2002 participants. 

These specimens will be distributed 

into 90 plates, including four plates of 

quality control specimens. There are 

purified DNA specimens available from 

4,612 NHANES 2007–2008 participants. 

These will be distributed into 

approximately 54 plates, including three 

plates of quality control specimens. 

There are purified DNA specimens 

available from 4,893 NHANES 2009– 

2010 participants. These will be 

distributed into 58 plates, including 

three additional plates of quality control 

specimens. There are purified DNA 

specimens available from 4,147 

NHANES 2011–12 participants. These 

will be distributed into 49 plates, 

including three additional plates of 

quality control specimens. 

DNA specimens will be available for 

testing only from participants who 

consented to future research. 

The resulting data from DNA 

specimen testing will be linkable to 

variables (public use and restricted) and 

available for analyses through the NCHS 

Research Data Center (RDC; https://

www.cdc.gov/rdc/index.htm) for 

approved proposals unless otherwise 

determined by the NHANES Project 

Officer. Access to these data at the 

NCHS RDC is only through an approved 

proposal process mechanism to assure 

confidentiality (see ‘‘APPROVED 

PROPOSALS: Post-Testing Procedures’’ 

section). 

Parameters for DNA Specimen Use and 

Resulting Data 

1. Investigators must justify why they 

need a specimen from a national 

probability sample of the U.S. 

population for their study. 

2. Investigators must specify which 

NHANES cycles they are requesting 

DNA specimens from and the specific 

laboratory tests to be conducted on 

those specified DNA specimens. 

3. Only those proposals for which the 

laboratory testing will result in findings 

determined not to have clinical 

significance for participants will be 

approved. The consent document for 

DNA storage and future research use of 

DNA specimens states that individual 

results will not be provided to 

participants. Therefore, no proposals 

involving tests with clinical significance 

will be approved. DHANES/NCHS will 

use the most recent American College of 

Medical Genetics and Genomics 

(ACMG) recommendations for reporting 

secondary findings 1 to assess the 

proposed tests and their potential for 

yielding clinically significant findings. 

Investigators must verify that the 

proposed tests do not produce variants 

(e.g., single-nucleotide polymorphisms, 


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translocation and inversions, copy 

number variations) on specific genes 

listed by the most recent ACMG 

recommendations as reportable 

secondary findings and describe how 

potential secondary findings results will 

be handled. 

4. Upon receipt of the specimen and 

after conducting the approved testing, 

investigators must provide a copy of the 

resulting data obtained from DNA 

testing to the Division of Health and 

Nutrition Examination Survey 

(DHANES)/NCHS for quality control 

assessment. 

5. After DHANES/NCHS has 

completed the initial quality control 

assessment of submitted data, 

investigators will be given up to six 

months to conduct a comprehensive 

quality assurance review. At this 

review’s completion, the resulting data’s 

availability will be publicly announced 

on the NHANES website Genetic 

Variant Search: http://www.nhgenetic

variant.com/. The resulting data can be 

linked to other NCHS variables (public 

use and restricted) for secondary data 

analysis. Analysis and linkage of the 

resulting data are conducted in the 

NCHS RDC via a separate proposal 

unless otherwise determined by the 

NHANES Project Officer (see 

‘‘APPROVED PROPOSALS: Post-Testing 

Procedures’’ section). 

Proposals Testing DNA Specimens 

Already Obtained From Previous 

Solicitations 

Investigators who have obtained 

NHANES DNA specimens from 

previous solicitations and have 

sufficient DNA left may request to do 

additional tests on the remaining DNA. 

These proposals must be submitted and 

approved as further provided herein. 

The investigator must pay an additional 

cost (see ‘‘COST SCHEDULE’’ section) 

per each additional proposal). 

Proposal Evaluation 

All proposals for the use of NHANES 

DNA specimens will be evaluated by the 

NHANES Project Officer, a Technical 

Panel, the NCHS Confidentiality Officer, 

the NCHS Human Subjects Contact, and 

the NCHS Ethics Review Board (ERB). 

Applications will have a Scientific 

Review by the NHANES Project Officer 

and the Technical Panel. The Technical 

Panel comprises two members with 

subject matter expertise: one from CDC 

staff and one external to CDC, i.e., from 

other federal agencies, academia, or 

industry. Only technical panel members 

with no conflict of interest and no 

previous knowledge of the research 

project will be asked to review the 

proposal. The members review each 

proposal for scientific and technical 

merit and ensure that the proposed 

project does not go beyond the general 

purpose of collecting the blood 

specimens for DNA in NHANES (see 

‘‘PROCEDURES FOR PROPOSALS’’ 

section). 

After the proposal is approved by the 

NHANES Project Officer and the 

Technical Panel, it will be submitted for 

Institutional Review. All proposals will 

undergo Institutional Review by the 

NCHS Human Subjects Contact and the 

NCHS 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 NCHS ERB will 

review the proposal even if the 

investigators have received approval 

from their institutional review panel. 

The proposal, if approved, will become 

an amendment to the current NHANES 

ERB Protocol (i.e., the NHANES ERB 

Protocol that is in effect at the time of 

the investigator’s proposal approval). 

If a proposal is approved, the author’s 

title, specific aims, name, and phone 

number will be maintained by NCHS 

and released if requested by the public. 

NCHS will not maintain unapproved 

proposals. 

Procedures for Proposals 

All investigators (including CDC 

investigators) must submit a proposal 

for the use of NHANES DNA specimens 

and follow the instructions as set forth 

herein, including following the outline 

set out below. Proposals should be a 

maximum of 20 1.5-spaced typed pages, 

excluding figures and tables, using at 

least size 10 font. The cover of the 

proposal (which is not included in the 

20-page limit) should include the title of 

the proposal, the name, address, phone 

number, and email address of the 

principal investigator (PI), and the name 

of the institution where the laboratory 

analysis will be done. The name, 

address, phone number, and email 

address of all additional investigators 

should also be included on the cover. 

Office of Human Research Protections 

assurance numbers for the institutions 

in the proposed project should be 

included. CDC investigators must 

include the expiration date of their 

Collaborative Institutional Training 

Initiative (CITI) training. All proposals 

should be submitted via email to 

NHANESgenetics@cdc.gov. Note: If the 

investigator would like to propose a 

subsample of the complete set, please 

contact the NHANES Project Officer to 

discuss feasibility. 

The following criteria will be used for 

technical evaluation of proposals: 

(1) Abstract: Please limit the abstract 

to 300 words. 

(2) Specific Aims: List the broad 

objectives; describe concisely and 

realistically what the proposed project 

is intended to accomplish and state the 

specific hypotheses to be tested. 

(3) Background and Public Health 

Significance: 

(A) Describe the public health 

significance of the proposed study. 

(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 the general 

purpose of collecting the blood 

specimens for DNA in the survey or the 

specific stated goals of the proposal. 

(4) Design, Method, and Analytic 

Plan: The appropriateness and adequacy 

of the methodology proposed to reach 

the specific 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) Study Design and Methods: 

Include a detailed description of the 

laboratory methods. The characteristics 

of the laboratory assay, such as 

reliability, and validity, should be 

included with appropriate references. 

The laboratory must demonstrate 

expertise in the proposed test, including 

the capability to handle the workload 

requested in the proposal. The potential 

difficulties and limitations of the 

proposed procedures should also be 

discussed. Address methods to ensure 

adequate handling and storage of DNA 

specimens. Proposals must specify 

variants or the commercial assay(s) 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. Note: A standard assay is a 

commercially available assay for a 

curated set of variants or biological 

markers. Investigators who submit 

successful proposals will be provided 

with quality control specimens at no 

additional cost. Approved projects must 

run these quality control specimens and 

submit these results along with the 

results from the NHANES DNA 

specimens unless the NHANES Project 

Officer has approved an alternative 

quality control review plan. The 

proposal should address any additional 

quality control procedures the 

laboratory will use to assure the validity 

of the test results and address methods 

to ensure adequate handling and storage 

of specimens. 


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(B) Analytic Plan: Describe the data 

analysis and statistical methods to be 

employed. Include power calculations. 

Resulting data from DNA specimens are 

restricted access data and must be 

analyzed in the NCHS RDC. The 

proposal should state that the data 

analysis will be conducted in the RDC 

unless DHANES/NCHS determines 

otherwise. 

(5) Additional information for 

NHANES: 

(A) Clinical Significance of Results: 

The consent document for DNA 

specimen storage and future studies 

states that individual results will not be 

provided to participants; therefore, no 

tests that 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 

secondary findings to review the 

proposed tests and the potential 

secondary findings. Investigators must 

verify that the proposed tests do not 

produce variants on specific genes listed 

by the most recent ACMG 

recommendations as reportable 

secondary findings and describe how 

potential secondary test results will be 

handled. The 2021 statement, ‘‘ACMG 

SF v3.0 list for reporting of secondary 

findings in clinical exome and genome 

sequencing: a policy statement of the 

American College of Medical Genetics 

and Genomics (ACMG),’’ lists 73 genes 

where specific variants on these genes 

are pathogenic for 34 conditions. 

(B) Data Transfer: Specify the secure 

method to transfer the resulting 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 

proposed project period. Substantial 

progress must be made in the first year 

that specimens have been obtained, and 

the project should be completed within 

a reasonable period of time. Please 

discuss the approximate time the 

investigator expects this project will 

take to complete. The NHANES Project 

Officer must be consulted about the 

disposition of the specimens. At the end 

of the project period, any unused 

specimens must be returned to the 

NHANES DNA Specimen Repository or 

destroyed by the investigator. 

(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 

specimens (see COST SCHEDULE FOR 

PROVIDING NHANES DNA 

SPECIMENS and Cost Schedule for 

NHANES DNA Specimens for details). 

(6) Resumes/CV: Please include a twopage CV for each member of the study 

team in the proposal (not as 

attachments; CVs do not count towards 

page maximum). 

Submission of Proposals 

Proposals must be submitted in MS 

Word format by email to 

NHANESgenetics@cdc.gov. 

Proposal Timeframes 

• Submission of Proposals: Can be 

submitted on an ongoing basis 

• Scientific Review: Completed 

approximately two months after 

proposal submission 

• Institutional Review: Completed 

approximately six weeks after 

completion of scientific review 

• Notification of Approval: 

Approximately 30 days after 

completion of Institutional Review 

• Anticipated Distribution of 

Specimens: Approximately 60 days 

after the following is completed: 

notification of proposal approval, 

agreements signed (as described 

below), and payments received (as 

described below) 

Note: Timeframes 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. 

Approved Proposals 

Investigators must transfer payment to 

DHANES/NCHS and sign terms and 

conditions agreements for the use of the 

DNA specimens with CDC/NCHS before 

releasing the NHANES DNA specimens. 

Investigator(s) must agree to: (a) use the 

specimens only for the approved tests; 

(b) use the test results only for purposes 

as stated in the approved proposal; (c) 

not link the results of the proposed 

project to any other data; (d) not use the 

DNA specimens for commercial 

purposes, as set forth in a legally 

binding Materials Transfer Agreement 

(MTA; if non-government investigators) 

or Interagency Agreement (IAA; if 

government investigators); and (e) sign 

and abide by a Designated Agent 

Agreement (DAA) with CDC/NCHS in 

accordance with NCHS’ confidentiality 

legislation. 

Agency Agreements 

A formal signed agreement, embodied 

in the form of an MTA or an IAA, and 

a DAA with investigators who have 

projects approved, must be completed 

before the release of the specimens to 

the investigator. For the MTA or IAA, 

this agreement will contain the 

conditions for use of the specimens as 

stated in this Federal Register notice 

and as agreed upon by the investigators 

and CDC. The DAA is the mechanism by 

which CDC/NCHS may authorize the 

designation of agents to exclusively 

perform activities needed to produce 

approved data using the Confidential 

Information Protection and Statistical 

Efficiency Act (CIPSEA; Title V of the EGovernment Act of 2002 [Pub. L. 107– 

347])-protected NHANES DNA 

specimens. The DAA must be signed by 

the investigator taking custody of DNA 

specimens and producing resulting data. 

Continuations 

A brief progress report must be 

submitted annually to NHANES. This 

report should describe the work 

completed and the timeline to project 

completion. When five years have 

elapsed since the initial approval of the 

proposal by the NCHS ERB, the 

investigator must provide an updated 

project timeline to complete the study 

for approval by NHANES. If a new 

investigator(s) is added at any time 

during the project, or the Principal 

Investigator has changed, the NHANES 

Project Officer must be notified. 

Approved Proposals: Post-Testing 

Procedures 

After DNA specimens are received 

and testing is complete, the 

investigators must send the resulting 

data back for DHANES/NCHS quality 

control assessment. While DHANES/ 

NCHS quality control assessment is 

underway, the investigator can submit 

an NCHS RDC proposal (http://

www.cdc.gov/rdc) to conduct an 

additional quality assurance review. 

The vast majority of resulting data from 

DNA specimens is restricted; therefore, 

the data are available only in the NCHS 

RDC. Once the investigators’ quality 

assurance review is complete and the 

results are returned to DHANES/NCHS, 

investigators will be given up to six 

months to conduct a comprehensive 

quality assurance review in the NCHS 

RDC. The quality assurance review 

timeframe will be negotiated between 

the investigators and the NHANES 

Project Officer and will depend on the 

type, number, and characteristics of the 

tests submitted. The results of the 

quality assurance review will be 

provided to DHANES/NCHS, and 

appropriate aspects will become part of 

the data set documentation. The public 

announcement, informing that test 

results are available for secondary data 

analyses after submission and 

acceptance of proposals, will occur once 

the quality assurance review timeframe 

has ended. For a list of currently 


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41132 Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 

available variant data, see: http://

www.nhgeneticvariant.com/. 

A minority of resulting data from 

DNA specimens are not restricted. In 

these cases, the resulting data will 

undergo disclosure review by the NCHS 

Confidentiality Officer and NCHS 

Disclosure Review Board or designee 

before the linked data are sent to the 

investigators for quality control review. 

Once approved by disclosure review 

and after the investigators have signed 

the Data Sharing Agreement, the linked 

data file will be sent to the investigators 

for use pursuant to the terms of the 

relevant agreement. The quality control 

review must take place within 60 days 

or a negotiated length of time, and the 

return of the data to NCHS within the 

next 30 days so these data may be 

released to the public. 

Disposition of Specimens 

The provided DNA specimens 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 specimens can be shared with 

others, including other investigators, 

unless specified in the proposal and so 

approved. Specimens must be returned 

upon completion of the approved 

project or destroyed. Both options 

require written approval from the 

NHANES Project Officer. 

Cost Schedule for Providing NHANES 

DNA Specimens 

There is a nominal processing fee of 

$17.17 for each DNA specimen received 

from an NHANES DNA Repository. The 

costs include collecting, processing, 

storing, and retrieving the DNA 

specimens, reviewing proposals, and 

preparing the data files. The costs listed 

are for the recurring laboratory materials 

to dispense and prepare the DNA 

specimens during collection and 

shipping. The NHANES DNA Specimen 

repository costs include long-term 

storage (including inventory 

management and materials and 

equipment) and accessioning of 

specimens and specimen retrieval for 

shipment to the investigator. Labor costs 

are based on a proposal administrator to 

manage the proposal process and 

computer programmers at NCHS who 

prepare the data files for the release of 

the data along with documentation on 

the NHANES web page. If the 

investigators request to use the DNA 

specimens for another proposed project 

after the completion of the initial 

project, the additional cost will be 5 

percent of the specimen set cost to 

handle the processing of the data and 

management of the subsequent proposal 

process. A new proposal must be 

submitted and go through the approval 

process before any additional use of the 

DNA specimens. 

COST SCHEDULE FOR NHANES DNA SPECIMENS

Total costs 

1999–2002, 

2007–2008, 

2009–2010, 

2011–2012 

complete sets 

1999–2002, 

2007–2008, 

2009–2010, 

2011–2012 

partial set 

NHANES III 

complete set 

Materials and equipment—contractor: plates, reagents, assays, aliquoting and packaging 

specimens; use of equipment ........................................................................................... $1.72 $5.15 $0.85 

Labor—contractor: processing, handling, and shipping; NCHS: data quality control .......... 5.66 28.31 2.83 

Proposal review and administrative expenses—contractor: inventory management and 

reporting; NCHS: management of proposal process non-NCHS: technical panel fees ... 3.43 6.87 1.72 

Space—contractor: freezer use and maintenance ............................................................... 6.36 6.36 3.17 

Cost per specimen ............................................................................................................... 17.17 46.69 8.58 

Cost per new proposal: 

1999–2002 ............................................................................................................................ 134,430.92 * 

2007–2008 ............................................................................................................................ 79,181.82 * 

2009–2010 ............................................................................................................................ 84,006.11 * 

2011–2012 ............................................................................................................................ 71,181.89 * 

III ........................................................................................................................................... ........................ ........................ 61,454.85 

Cost per additional proposal: ** 

1999–2002 ............................................................................................................................ 6,721.94 *** 

2007–2008 ............................................................................................................................ 4,130.72 *** 

2009–2010 ............................................................................................................................ 4,200.08 *** 

2011–2012 ............................................................................................................................ 3,559.95 *** 

III ........................................................................................................................................... ........................ ........................ 3,072.17 

* Cost calculated upon request. 

** 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. 

Angela K. Oliver, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2022–14702 Filed 7–8–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Solicitation of Nominations for 

Appointment to the Board of Scientific 

Counselors, National Center for Injury 

Prevention and Control (BSC, NCIPC) 

ACTION: Notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) is seeking 

nominations for membership on the 

BSC, NCIPC. The BSC, NCIPC consists 

of 18 experts in fields associated with 

surveillance; basic epidemiologic 

research; intervention research; and 

implementation, dissemination, and 

evaluation of promising and evidencebased strategies for the prevention of 

injury, violence, and drug abuse. 

Nominations are being sought for 


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