Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices 44367 

2200 North Pearl Street, Dallas, Texas 

75201–2272: 

1. Woodforest Financial Group 

Employee Stock Ownership Plan (with 

401(k) Provisions) and the related 

Woodforest Financial Group Employee 

Stock Ownership Trust, both of The 

Woodlands, Texas; to acquire up to 32 

percent of Woodforest Financial Group, 

Inc., and thereby indirectly acquire 

Woodforest National Bank, The 

Woodlands, Texas. 

Board of Governors of the Federal Reserve 

System, August 6, 2021. 

Ann Misback, 

Secretary of the Board. 

[FR Doc. 2021–17169 Filed 8–11–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

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 serum, plasma, and 

urine samples obtained from 

participants in the National Health and 

Nutrition Examination Survey 

(NHANES) and the proposal parameters 

and fee schedule for 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 August 12, 2021. 

The fee structure for these samples is 

effective August 12, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Bryan Stierman, National Center for 

Health Statistics, Centers for Disease 

Control and Prevention, 3311 Toledo 

Road, Hyattsville, MD 20782. 

Telephone: (301) 458–4798. Email: 

Serumplasmaurine@cdc.gov. 

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. 

For NHANES cycles prior to the 

2021–22 cycle, the survey oversamples 

the two largest race/ethnicity groups, 

non-Hispanic black and Mexican 

American (and all Hispanic since 2007– 

08). In 2011–2020, NHANES also 

oversampled the Asian race/ethnicity 

group. 

Sample Availability 

Samples are available from NHANES 

III, a periodic survey that was 

conducted from 1988–1994 (see: https:// 

wwwn.cdc.gov/nchs/nhanes/nhanes3/ 

default.aspx for more information on 

NHANES III), and the continuous 

NHANES, with data release in two-year 

cycles starting in 1999–2000 through the 

2019-March 2020 (Coronavirus Disease 

2019 (COVID–19) pre-pandemic) (Table 

A) collection. NCHS is making both 

collections available for study 

proposals. 

Approximately 30,000 individuals 

were examined in NHANES III, which 

began in the fall of 1988, and ended in 

the fall of 1994. Investigators can 

analyze samples 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. 

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). 

Projects must use two-year cycles or 

multiple two-year cycles for their 

studies (i.e., 1999–2000, 2001–2002 

etc.). 

Serum, plasma, and urine samples are 

stored in two biorepositories. Samples 

that were initially used for laboratory 

assays included in the surveys, that 

were stored at ¥70°C and that have 

been through at least two freeze-thaw 

cycles, are considered surplus samples. 

They are stored at a commercial 

biorepository under contract to NCHS. 

In addition, another set of 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 freeze-thaw cycle and are 

considered pristine samples. The CDC 

Biorepository (CBR) is the long-term 

repository for the pristine NHANES 

serum, plasma, and urine samples. 

NCHS is making both pristine and 

surplus collections available for study 

proposals. 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-MARCH 2020 

[Pre-pandemic] 

NHANES cycle 

Sample type 

Pristine 1 Surplus 2

Sera Plasma Urine Sera Plasma Urine 

III (1988–1994) ......................................... X ........................ ........................ X ........................ ........................

1999–2000 ............................................... X X X X X ........................

2001–2002 ............................................... X X X X X ........................

2003–2004 ............................................... X X X X ........................ ........................

2005–2006 ............................................... X X X X ........................ ........................

2007–2008 ............................................... X X X X X ........................


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44368 Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices 

TABLE A—OVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III (1988–1994) AND NHANES 1999-MARCH

2020—Continued 

[Pre-pandemic] 

NHANES cycle 

Sample type 

Pristine 1 Surplus 2

Sera Plasma Urine Sera Plasma Urine 

2009–2010 ............................................... X X X X ........................ ........................

2011–2012 ............................................... X ........................ X X ........................ ........................

2013–2014 ............................................... X ........................ X X ........................ ........................

2015–2016 ............................................... X ........................ X X ........................ ........................

2017–2018 ............................................... X ........................ X X ........................ ........................

2019—March pre-pandemic 2020 ........... X ........................ X X ........................ ........................

1Samples immediately frozen for storage, did not undergo laboratory testing. 

2Samples are surplus specimens after laboratories had completed testing. 

Parameters for Sample Use 

1. Investigators should justify why 

they need a national probability sample 

for their study. 

2. 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. 

3. Investigators that request pristine 

(never thawed) samples should justify 

the use of the pristine samples. 

4. Only proposals with test results 

that are determined not to have clinical 

significance for participants will be 

accepted. 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. Though the 

consent form for NHANES III had less 

detail, this parameter is also applicable 

to the use of NHANES III samples. 

Therefore, only proposals with 

laboratory test results that do not have 

clinical significance to the survey 

participant will be accepted. The 

potential for clinical significance of a 

laboratory test should be addressed by 

investigators in the proposal; the 

determination of clinical significance 

will be made by the Technical Panel. A 

laboratory test result is considered 

clinically significant to the survey 

participant if the following criteria are 

met: 

• The laboratory test is performed by 

a Clinical Laboratory Improvement 

Amendments (CLIA)- certified 

laboratory deeming the findings valid, 

• the findings have significant 

implications for the participant’s health 

concerns, and 

• a course of action is readily 

available to treat the associated health 

concern 

Proposal Evaluation 

All proposals for use of NHANES 

samples will be evaluated by a 

Technical Panel, the NCHS 

Confidentiality Officer, the NCHS 

Human Subjects Contact and the NCHS 

Ethics Review Board (ERB). The current 

Technical Panel consists of NHANES 

staff: Two physicians, one statistician 

and a laboratory expert. Other experts 

from inside or outside the Federal 

Government are added as needed. The 

Technical Panel reviews proposals for 

scientific merit to determine: The need 

to use a nationally representative 

sample, public health significance, and 

laboratory assay validity, and potential 

for clinical significance to the 

participant. The NCHS Confidentiality 

Officer reviews for disclosure risk; the 

NCHS Human Subjects Officer for 

potential human subjects concerns; and 

the NCHS ERB for conforming to the 

informed consent. The NCHS ERB will 

review the proposal even if the 

investigator has received approval by 

their respective 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 and held at NCHS). 

The Technical Panel will evaluate the 

proposal for the scientific, technical, 

and clinical significance to the 

participant, the appropriateness and 

adequacy of the study design, and the 

methodology proposed to reach the 

study goals. See ‘‘Procedures for 

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. 

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 

study. For this reason, investigators 

submitting proposals 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 study. The Technical Panel review 

will seek to 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 NHANES proposal. 

Investigators are encouraged to review 

the NHANES data, survey documents, 

manuals and questionnaires at: 

NHANES Questionnaires, Datasets, and 

Related Documentation (cdc.gov) 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. The cover 

of the proposal (which is not included 

in the 10-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. 

All proposals should be Emailed to 


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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices 44369 

Serumplasmaurine@cdc.gov. Proposals 

from CDC investigators must also 

include the investigator’s Collaborative 

Institutional Training Initiative (CITI) 

expiration date. 

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 study 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. 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 study 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 investigator 

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) Study Design and Methods: 

Describe the study 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 

the investigator is requesting a subsample of samples, a detailed 

description and justification must be 

given. 

The Technical Panel 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. The 

resulting data will be released in the 

public domain or in rare occasions to 

the NCHS Research Data Center by 

NCHS (if there is a disclosure concern, 

e.g. one year of NHANES cycle). 

Released data from sub-samples may be 

less useful to the scientific community, 

so such requests will receive a lower 

priority for obtaining 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 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 and 

will not be approved; laboratory testing 

that is clinically significant should be 

considered for inclusion in a future 

NHANES survey cycle see NHANES 

New Content and Proposal Guidelines 

(cdc.gov). 

(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 if 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. The NCHS Project 

Officer must be consulted about the 

disposition of the samples. At the end 

of the project period, any unused 

samples must be returned to the 

NHANES Specimen Repository or 

discarded appropriately. 

(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 $15.00. 

The basis for the cost structure is in the 

last section of this document. Payment 

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: 

Serumplasmaurine@cdc.gov. 

Project Timeframes 

• Submitting Proposals: Can be 

submitted on an ongoing basis. 

• Scientific Review Date (NHANES 

Technical Panel): Within one month of 

proposal submission. 

• Scientific Review Date (NCHS 

Human Subjects, Confidentiality and 

ERB): Within two months of Technical 

Panel proposal acceptance. 

• Anticipated distribution of samples: 

One month after ERB approval and after 

all Interagency Agreements or Material 

Transfer Agreements are signed, and 

fees are paid. 

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 NHANES variables 

requested by the investigator and that 

are needed to perform a quality control 

review of the data. The results data files 

will undergo disclosure review by the 

NCHS Disclosure Review Board or 

NCHS Confidentiality Officer or 

designee before the linked data are sent 

to the investigator for quality control 

review. Once approved by disclosure 

review and after the investigator has 

signed the Data Sharing Agreement or a 

Designated Agent Agreement 

(respectively ‘‘Agreement’’), the linked 

data file will be sent to the investigator 

for use pursuant to the terms of the 

relevant agreement. The quality control 

review must take place within 60 days 

and the return of the data to NCHS 

within the next 30 days so these data 

may be released to the public. 

Agency Agreement 

A formal signed agreement in the 

form of an MTA or an IAA with 

investigators who have projects 

approved will be completed before the 

release of the samples to the 

investigator. This agreement will 

contain the conditions for use of the 

samples as stated in this Federal 

Register Notice and as agreed upon by 

the investigators and CDC. 


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44370 Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices 

Continuations 

A brief progress report will be 

submitted annually to NHANES. This 

report should describe work completed 

and timeline to project completion. If 

five years have elapsed since the initial 

approval of the protocol by the NCHS 

ERB a more detailed plan and timeline 

to complete the study will be required 

by NHANES. If at any time during the 

project a new investigator(s) are added 

or the Principal Investigator has 

changed, the NHANES Serum/plasma/ 

urine Project Officer must be notified. 

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 NHANES 

Technical Panel and the NCHS ERB. No 

samples can be shared with others, 

including other investigators, unless 

specified in the proposal and so 

approved by the NHANES Technical 

Panel and the NCHS ERB. 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. The results, once 

returned to NCHS, will be part of the 

public domain. The investigator will 

have 60 days for quality control review 

of the data before public release by 

NHANES. 

Cost Schedule for Providing NHANES 

Samples 

There is a nominal processing fee of 

$15.00 for each sample received from an 

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 additional cost will be $5.50 

per sample 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 samples. The costs 

include the collection, processing, 

storage, and retrieval 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 costs for the 

NHANES repository include long term 

storage (including inventory 

management and materials and 

equipment) and accessioning of samples 

and pulling samples from the freezer 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. 

ELEMENTS OF THE FEE FOR NHANES 

BIOLOGIC SAMPLES

Cost factors Cost per 

vial 

Material and Equipment .......................... $3.42 

Processing the samples (Receiving, handling, and shipping) ............................. 2.58 

Inventory management ........................... 1.80 

Administrative, management of the proposal process. ..................................... 1.65 

Preparation of data files .......................... 3.85 

Subtotal ................................................ 13.30 

CDC Support (5%) .................................. 0.67 

Subtotal ................................................ 13.97 

NCHS Support (7.50%) ........................... 1.05 

Total ..................................................... * 15.00 

* Total is rounded down from $15.02. 

Authority: Sections 301,306 and 308 

of the Public Health Service Act (42 

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

Dated: August 9, 2021. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2021–17265 Filed 8–11–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; ORR–6 Performance Report 

(OMB #0970–0036) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, Health and Human Services 

(HHS). 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF), Office of 

Refugee Resettlement (ORR) is 

requesting a revision of the ORR–6 

Performance Report (OMB #0970–0036, 

expiration 2/28/2022). Proposed 

revisions include new data collection 

primarily for the new Refugee Health 

Promotion (RHP) set-aside program, and 

reformatting and revisions of 

instructions and forms for clarity. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by emailing infocollection@

acf.hhs.gov. Alternatively, copies can 

also be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation (OPRE), 330 C Street, 

SW, Washington, DC 20201, Attn: ACF 

Reports Clearance Officer. All requests, 

emailed or written, should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: ACF/ORR requests 

information from the ORR–6 

Performance Report to determine 

effectiveness of state Cash and Medical 

Assistance (CMA) and Refugee Support 

Services programs. ORR uses state-bystate CMA utilization rates, derived 

from the ORR–6 Performance Report, to 

formulate program initiatives, priorities, 

standards, budget requests, and 

assistance policies. Federal regulations 

require state Refugee Resettlement, 

Replacement Designee agencies, and 

local governments submit statistical or 

programmatic information that the ORR 

Director determines to be required to 

fulfill their responsibility under the 

Immigration and Nationality Act (INA). 

The existing ORR–6 was revised to 

include data collection for the new RHP 

set-aside program, add new data 

elements to better understand the 

meaning of existing data collection, and 

update the instructions and reformat 

some of the forms to provide clearer 

definitions and better distinguish the 

participation and performance results of 

different support services programs. 

Respondents: State governments and 

Replacement Designees. 

ANNUAL BURDEN ESTIMATES

Instrument Total number of 

respondents 

Total number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

ORR–6 Performance Report ........................................... 69 6 19 7,866 2,622 


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