Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 32191 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Health and Nutrition 

Examination Survey (NHANES) DNA 

Samples: Guidelines for Proposals To 

Use Samples and Cost Schedule 

AGENCY: Centers for Disease Control and 

Prevention, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The National Health and 

Nutrition Examination Survey 

(NHANES) is a program of periodic 

surveys conducted by the National 

Center for Health Statistics (NCHS) of 

the Centers for Disease Control and 

Prevention (CDC). 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. To add to the extensive 

amount of information collected for the 

purpose of describing the health of the 

population, DNA specimens were 

collected during three NHANES 

surveys. DNA is available in the form of 

crude lysates of cell lines derived from 

7,159 participants enrolled in Phase II of 

NHANES III (1991–1994). In addition, 

DNA purified from whole blood is also 

available from 7,839 participants 

enrolled in the NHANES 1999–2002 and 

4,615 participants enrolled in NHANES 

2007–2008. All specimens (NHANES III, 

NHANES 1999–2002 and NHANES 

2007–2008) were sent to the Division of 

Laboratory Sciences (DLS) at the 

National Center for Environmental 

Health (NCEH) for processing. DNA 

samples from these specimens are being 

made available to the research 

community for genetic analyses. 

No funding is provided as part of this 

solicitation. NCHS will review 

proposals twice a year, in January and 

July. Proposals will be reviewed by a 

technical panel and by an internal 

Secondary Review Committee of senior 

CDC scientists. The Secondary Review 

Committee will perform a programmatic 

review based on the results of the 

technical review panel and consider the 

scientific and technical results from the 

first level of review, important 

programmatic considerations such as 

program priorities, program relevance, 

and other criteria germane to this 

announcement and to CDC. Projects 

approved by both reviews will be 

submitted to the NCHS Ethics Review 

Board for final approval. 

Approved projects that do not obtain 

funding on their own will be canceled. 

A more complete description of this 

program follows. 

DATES:

• Submission of Proposals: On 

January 1 and July 1 of each year. 

• Scientific Review: 30 days after 

proposal submission date. 

• Secondary Review: Approximately 

30 days after Scientific review is 

complete. 

• Ethics Review Board: 

Approximately 30 days after Secondary 

review is complete. 

• Notification of approval: 

Approximately 30 days after ERB 

approval. 

• Anticipated distribution of samples: 

Approximately 60 days after all 

approvals are obtained. 

Note: Timeframe may vary depending on 

the nature of the proposal and the results of 

each level of review. Unforeseen 

circumstances could result in a change to this 

schedule. 

ADDRESSES: To send comments and for 

information, contact: Geraldine 

McQuillan, PhD, Division of Health and 

Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, Room 

4204, Hyattsville, MD 20782, Phone: 

301–458–4371, Fax: 301–458–4028, 

E-Mail: NHANESgenetics@cdc.gov. 

Authority: Sections 301, 306 and 308 of 

the Public Health Service Act (42 U.S.C. 241, 

2421 and 242m). 

SUPPLEMENTARY INFORMATION: 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; 

(7) to establish and maintain a national 

probability sample of baseline 

information on health and nutritional 

status. 

The availability of the NHANES III 

DNA samples has been previously 

announced (Thursday, August 8, 2002 

[67 FR 51585], Friday, January 13, 2006 

[71 FR 22248]), Thursday, October 18, 

2007 [72 FR 59094] and Thursday, 

September 3, 2009 [(74 FR 45644)]. 

NHANES III DNA samples are in the 

form of crude cell lysates available from 

the cell lines derived from samples 

obtained from Phase II (1991–1994) 

participants. DNA concentrations are 

unknown and vary between samples 

(see NHANES III DNA Samples section 

for a description). 

Beginning in 1999, NHANES became 

a continuous, annual survey rather than 

a periodic survey. For a variety of 

reasons, including disclosure and 

reliability issues, the survey data are 

released on public use data files every 

two years. In addition to the analysis of 

data from any two year cycle, it is 

possible to combine two cycles to 

increase sample size and analytic 

options. Blood samples for DNA 

purification were collected from 

participants age 20 or more years in 

survey years 1999–2002 and 2007–2008. 

Purified DNA samples are available 

from these survey years in a single set 

from each survey cycle. DNA samples 

can be obtained and analyzed with 

survey data from the NHANES 1999– 

2000 or 2001–2002 or all four years 

combined (NHANES 1999–2002) and 

NHANES 2007–2008. The data release 

cycle for the NHANES during the period 

in which DNA specimens were 

collected is described as NHANES 

1999–2000, NHANES 2001–2002 and 

NHANES 2007–2008. 

See: http://www.cdc.gov/nchs/ 

nhanes/nhanes99_00.htm, http:// 

www.cdc.gov/nchs/nhanes/nhanes01- 

02.htm, http://www.cdc.gov/nchs/ 

nhanes/nhanes2007-2008/ 

nhanes07_08.htm for additional details. 

Identifiable health information 

collected in the NHANES is kept in 

strictest confidence. During the 

informed consent process, survey 

participants are assured that data 

collected will be used only for stated 

purposes and will not be disclosed or 

released to others without the consent of 

the individual in accordance with 

section 308(d) of the Public Health 

Service Act (42 U.S.C. 242m). In 

NHANES 1999–2002 and 2007–2008, a 

separate consent form was signed by 

eligible participants who agreed to the 

storing of specimens for future genetic 

research. Only participants that 

consented specifically to future genetic 

research in 1999–2002 and 2007–2008 

will be available for analyses. Genetic 

variation results will be linked to the 

requested information from the 

NHANES public use data file by the 

Division of Health and Nutrition 

Examination Surveys (DHANES) staff. 

All analyses must be done through an 

NCHS Research Data Center (RDC) 

approved mechanism to assure 

confidentiality. 

Research Proposals Categories 

Note that the following proposal 

categories differ from those used in 

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32192 Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 

previous announcements for use of 

NHANES III DNA samples (Thursday, 

August 8, 2002 [67 FR 51585] and 

Friday, January 13, 2006 [71 FR 22248]. 

Category (A): Studies involving the 

typing of the complete set of NHANES 

DNA samples (NHANES III, 7,159 

samples; NHANES 1999–2002, 7,839 

samples; NHANES 2007–2008, 4,615 

samples) for proposals that investigate 

specific research hypotheses that relate 

tests of selected genes and demographic 

or demographic and phenotypic data 

available from NHANES. This category 

is open for proposals for use of 

NHANES III, NHANES 1999–2002 and 

NHANES 2007–2008 samples. A total of 

ten full sets of samples for each survey 

will be available for any review cycle. 

The investigator will specify which 

DNA bank, NHANES III, NHANES 

1999–2002 or 2007–2008, they are 

requesting as well as the genetic 

analyses to be conducted on the 

samples. The investigator will also 

include in the research protocol an 

analytic plan that includes a list of 

NHANES demographic and clinical 

variables that would be used for the data 

analyses. The researcher will conduct 

the genetic analyses of the approved 

variations on the samples that are 

labeled with a unique identification 

number that is not directly linkable to 

the public use file and therefore, 

anonymous to the researcher. To 

analyze these data with the NHANES 

public use data, the researcher will 

provide the genetic variation results 

with the identification numbers to the 

Division of Health and Nutrition 

Examination Surveys. The identification 

numbers will be matched to the 

requested variables from public use files 

data by DHANES staff for analyses that 

must be conducted through the NCHS 

RDC or its equivalent. Proposals are 

limited to the testing of 1,000 genetic 

variations or less. NCHS cannot 

guarantee that frequencies for all genetic 

variations can be published due to 

confidentiality concerns. 

After the NCHS has completed the 

initial quality control assessment, 

researchers will be given up to six 

months to conduct a more 

comprehensive quality assurance 

review. The timeframe allowed for this 

review will depend on the number and 

characteristics of the genetic tests 

submitted. At the completion of this 

review, an announcement will be made 

to the public announcing the 

availability of the genetic variation 

results and the opportunity to link these 

results to other NHANES data for 

secondary data analysis. The list of 

currently available SNPs is available at: 

http://www.cdc.gov/nchs/nhanes/ 

genetics/genetic_types.htm. 

All samples will be distributed in 

complete sets of samples of 96 well 

plates. NHANES III DNA is in the form 

of crude cell lysates. There will be a 

total of 7,159 NHANES III samples 

distributed in a total of 75 plates with 

an additional four plates of quality 

control samples. There are 7,839 

NHANES 1999–2002 purified DNA 

samples. These will be distributed into 

82 plates with approximately five plates 

of quality control samples. There are 

4,615 purified DNA samples available 

from NHANES 2007–2008. These will 

be distributed into 49 plates with 

approximately three plates of quality 

control samples. 

Note: If the investigator would like to 

propose a subsample of the full set please 

contact the Program to discuss feasibility. 

Category (B): Additional research 

using samples already obtained from 

previous solicitations: Researchers that 

have obtained NHANES DNA samples 

from previous solicitations and have 

sufficient DNA left may request to do 

additional tests on the remaining DNA. 

Proposals under this Category must be 

submitted and approved before the DNA 

samples were scheduled to be destroyed 

or returned. The investigator will 

specify the genetic analyses to be 

conducted on the samples. The 

investigator will also include in the 

research protocol an analytic plan that 

includes a list of demographic and 

clinical variables that would be used for 

the data analyses. 

Category (C) Proposals involving 

whole-genome genotyping of DNA 

samples: All proposals for wholegenome genotyping of more than 1,000 

genetic variations must provide funding 

for the testing to the NHANES program 

so that the testing can be done under an 

NHANES contract. If funding is 

available, CDC intends to provide whole 

genome-genotyping data from NHANES 

III and NHANES 1999–2002 samples. 

These data will be available for 

secondary data analysis. 

NHANES III DNA Samples 

The laboratory will distribute aliquots 

of crude cell lysates. DNA 

concentrations vary and are estimated to 

range from 7.5–65 ng/μL with an 

average of approximately four 

micrograms in 100 μL. Each 96 well 

plate will be bar-coded and labeled with 

a readable identifier. Quality control 

samples (approximately 384 samples) 

will be sent at no charge, either inserted 

with the NHANES samples or in 

separate plates, as blind replicates and/ 

or blanks. Description of these samples 

and cost has been previously published 

see: (Friday, January 13, 2006 [71 FR 

22248]). 

NHANES 1999–2002 and 2007–2008 

DNA Samples 

The laboratory will distribute aliquots 

of purified DNA of normalized 

concentrations of 50 ng/μL whenever 

possible. Some samples may fall below 

this threshold. Forty microliters of each 

specimen will be supplied. The amount 

of DNA in each aliquot may vary but 

will be on average approximately two 

micrograms. Each 96 well plate will be 

bar-coded and labeled with a readable 

identifier. Quality control samples 

(NHANES 1999–2002, approximately 

480 samples; NHANES 2007–2008, 

approximately 288 samples) will be sent 

at no charge, either inserted with the 

NHANES samples or in separate plates, 

as blind replicates and/or blanks. 

Proposed Cost Schedule for Providing 

NHANES DNA Samples 

Costs are determined both for NCEH 

and NCHS and include the physical 

materials needed to process the samples 

at the NCEH laboratory, as well as the 

materials to process the requests for 

samples at NCHS. These costs include 

salaries of the staff needed to conduct 

these activities at each Center. The fee 

is estimated to cover the costs of 

processing, handling, and preparing the 

samples. Technical panel travel and 

expenses are based on the panel meeting 

twice a year. The space estimate is 

based on acquiring storage and sample 

aliquoting space in the laboratory. The 

cost per samples for NHANES III 

samples is the same as published in 

2006 (Friday, January 13, 2006 [71 FR 

22248]) and the cost for NHANES 1999– 

2002 and NHANES 2007–2008 are the 

same as published in 2007 (Thursday, 

October 18, 2007 [72 FR 5904]). 

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Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 32193 

Total costs 

Cost per sample 

full set, 

99–02 & 07–08 

Cost per sample 

partial set, 

99–02 & 07–08 

(special request) 

Cost per sample 

full set, 

NHANES III 

Cost per sample 

partial set, 

NHANES III 

(special request) 

Materials .................................................................................. $0.89 $2.19 $0.85 $1.90 

Labor ........................................................................................ 4.60 25.30 3.30 22.00 

Application review and other administrative expenses ........... 0.54 3.09 0.35 2.69 

Space ....................................................................................... 0.17 1.12 0.13 0.97 

Subtotal ............................................................................. 6.20 31.70 4.63 27.56 

NCHS overhead (18 percent) .................................................. 1.12 5.71 0.83 4.97 

Subtotal ............................................................................. 7.32 37.41 5.46 32.52 

CDC/FMO overhead (0.9 percent) .......................................... 0.66 3.37 0.49 2.93 

Total sample cost per sample .......................................... 7.98 40.78 5.95 35.45 

Total cost per proposal ..................................................... 99–02: $63,555 

07–08: $36,828 

NA 42,596.36 NA 

Total cost per Category B proposal: for data handling .... 99–02: $6,255 

07–08: $3,683 

1 4,260 1

1 10 percent of original cost of samples. 

Procedures for Proposals 

The investigator should follow these 

instructions for preparation of 

proposals. Once testing is complete the 

IRB protocol is closed and the project is 

transferred to the Research Data Center 

(RDC). The content of the IRB protocol 

becomes the RDC project description 

and the project is covered by the 

umbrella RDC IRB Protocol. Protocols 

must be written using the outline below. 

All proposal categories need a full 

research proposal for review. In 

addition to the cover page, the research 

proposal should contain the title of the 

research project, the name, address 

phone number and E-mail address of the 

lead investigator along with the name of 

the institution where the genotyping 

will be conducted, and the category of 

proposal (A, B or C) submitted. Office of 

Human Research Protections assurance 

numbers for the institutions engaged in 

the research project should be included. 

CDC investigators need to include their 

Scientific Ethics Verification Number. 

E-mail submission of the proposal is 

encouraged. 

The proposals should be a maximum 

of 20 single-spaced typed pages, 

excluding figures and tables, using ten 

cpi type density. Please use appendices 

sparingly. If a proposal is approved, the 

title, specific aims, name, and phone 

number of the author will be maintained 

by NCHS and released if requested by 

the public. Unapproved proposals will 

be returned to the investigator and will 

not be maintained by NCHS. 

Since the number of sets of DNA is 

limited, proposals will be reviewed by 

the technical panel and then will be 

reviewed by a secondary review panel 

composed of CDC officials. The 

technical panel will determine if the 

proposal is technically sound and if so, 

the technical panel will rank the 

proposal on a scale of 0–100. Proposals 

that are rejected will not be scored. 

Applications will also be reviewed by 

an internal Secondary Review 

Committee which will perform a 

programmatic review based on the 

results of the peer review for technical 

merit. The Secondary Review 

Committee considers the scientific and 

technical merit results from the first 

level of review, important programmatic 

considerations such as program 

priorities, program relevance, and other 

criteria germane to this announcement 

and to CDC. The Secondary Review 

Panel will be comprised of senior CDC 

scientists. Approved proposal will then 

be reviewed by the CDC/NCHS Ethics 

Review Board (ERB) to ensure 

appropriate human subjects protections 

are provided, in compliance with 45 

CFR 46. 

Category A, B and C Proposals should 

include the following information: 

(1) Cover sheet: See Example in 

Sample Proposal on http:// 

www.cdc.gov/rdc/B3Prosal/PP320.htm 

Also include, the name of the institution 

where the genotyping will be 

conducted, which category, and Office 

of Human Research Protections 

assurance numbers for the institutions 

engaged in the research project should 

be included. Plus, CDC investigators 

need to include their Scientific Ethics 

Verification Number. 

(2) Abstract: Please limit the abstract 

to 300 words. 

(3) Specific Aims: List the broad 

objectives; describe concisely and 

realistically what the research is 

intended to accomplish, and state the 

specific hypotheses to be tested. 

(4) Background and Public Health 

Significance: (A) Describe the public 

health significance of the proposed 

research. (B) Discuss how the results 

will be used. Analyses should be 

consistent with the NHANES mission to 

assess the health of the nation. The 

Panel will ensure that the proposed 

project does not go beyond either the 

general purpose for collecting the 

samples in the survey or the specific 

stated goals of the proposal. 

(5) Design, Method, and Output: (A) 

Research Design and Methods: Describe 

the analytic and statistical methods to 

be employed. Include power 

calculations. For all proposal categories, 

include a detailed description of the 

laboratory methods. The characteristics 

of the laboratory assay, such as 

reliability, validity, should be included 

with appropriate references. The 

potential difficulties and limitations of 

the proposed procedures should also be 

discussed. Address adequate methods 

planned for handling and storage of 

samples. (1) Category A proposals will 

be provided with approximately 480 

quality control samples at no additional 

cost. Approved projects must run these 

quality control samples and submit the 

results from the NHANES DNA samples. 

(2) Category B proposals will be 

required to use residual quality control 

samples. The proposal should contain a 

discussion of additional quality control 

procedures the laboratory will use to 

assure the validity of the test results. 

Address adequate methods planned for 

handling and storage of samples. (B). 

Output: Please describe any output that 

you would like to take out of the RDC: 

Please be detailed as this section helps 

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32194 Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 

the Review Committee assess disclosure 

risk. Include detailed examples of table 

shells, models, and/or graphs. How will 

you present the results of this project? 

(C). Data Dictionary: Includes (1) NCHS 

Restricted Data Dictionary (2) NCHS 

Public Use Data Dictionary (3) NonNCHS Data Dictionary see: http:// 

www.cdc.gov/rdc/B3Prosal/PP323.htm. 

The appropriateness and adequacy of 

the methodology proposed to reach the 

research aims as well as 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. 

(6) Additional information for 

NHANES: (A) Discussion Regarding the 

Race/Ethnicity Variables: If the research 

is limited to specific race or ethnic 

groups (only applicable for a subsample 

request) or if information about the race 

or ethnicity of the subjects is requested, 

indicate the reason for analyzing race/ 

ethnicity and how the results will be 

interpreted. Discuss the potential for 

group harm. (B) Clinical Relevance of 

Research Findings: The samples under 

this Plan are available for genetic 

research, not genetic testing. Therefore, 

it is the intent of the program to approve 

only those proposals that would yield 

meaningful research, but not clinically 

relevant information for the 

participants. Researchers should justify 

that the test results should not be 

reported to the subjects. (C) Period of 

Performance: Specify the project period. 

The period may be up to three years. At 

the end of the project period, any 

unused samples must be returned to the 

NHANES DNA Specimen Bank in 

accordance with instructions from the 

Division of Environmental Laboratory 

Science. Extensions to the period of 

performance may be requested. (D) 

Funding: Include the source and status 

of the funding to perform the requested 

laboratory analysis. Investigators will be 

responsible for the cost of processing 

and shipping the samples (See table). 

Also, in general information for RDC. 

(7) References 

(8) Re ́sume ́s/CV: Please include a 2- 

page CV for each member of the 

research team in this document (not as 

attachments). 

Public Availability of Data 

Genetic test results from all studies 

using NHANES DNA samples will be 

made available to the public for 

secondary data analyses. After the 

NCHS quality control review is 

completed, researchers will be given up 

to six months to conduct a more 

comprehensive quality assurance 

review. The final quality control review 

timeframe will be negotiated between 

the researcher and the NCHS Project 

Officer and will depend on the number 

and characteristics of the genetic tests 

submitted. This time for final review is 

provided before the announcement is 

made to the public that the test results 

are available for submission of 

proposals for secondary data analyses. 

The list of currently available genotypes 

will be outlined on: http://www.cdc.gov/ 

nchs/nhanes/genetics/ 

genetic_types.htm. Proposals for 

secondary data analyses linking 

NHANES public use data with genetic 

variation data will be reviewed by the 

Research Data Center on a rolling basis 

see: http://www.cdc.gov/rdc/B3Prosal/ 

PP320.htm for proposal guidelines. 

Requirements for the Inclusion of 

Women and Racial and Ethnic 

Minorities in Research 

In NHANES III, NHANES 1999–2002, 

and NHANES 2007–2008 race/ethnicity 

was derived by combining responses to 

questions on race and Hispanic origin. 

For NHANES III, These categories are 

defined as non-Hispanic white, nonHispanic black, or Mexican American. 

For NHANES 1999–2002, and NHANES 

2007–2008, these categories are defined 

as non-Hispanic white, non-Hispanic 

black, Mexican American or Other 

Hispanics. Individuals who did not selfselect into these categories were 

classified as ‘‘other’’. If proposal requests 

a subsample and excludes one or more 

race/ethnic groups or a gender, this 

exclusion must be justified. 

CDC is also sensitive to the 

stigmatization of racial/ethnic specific 

populations through inappropriate 

reporting and interpretation of findings. 

For all proposals that request 

information on race/ethnicity for the 

samples selected, the investigator 

should discuss the reason for analyzing 

race/ethnicity, how the results will be 

interpreted, and the potential for group 

harm. 

Submission of Proposals 

Proposals can be submitted 

immediately. The review process will 

begin approximately 60 days from the 

publication of the notice and will 

include all proposals submitted as of 

that date. 

Electronic submission of proposals is 

encouraged. Please submit proposals to: 

Geraldine McQuillan, PhD, Division of 

Health and Nutrition Examination 

Surveys, National Center for Health 

Statistics, Centers for Disease Control 

and Prevention, 3311 Toledo Road, 

Room 4204, Hyattsville, MD 20782, 

Phone: 301–458–4840, Fax: 301–458– 

4028 E-Mail: NHANESgenetics@cdc.gov. 

Approved Proposals 

The genetic results will be sent back 

to NCHS so they can be linked to the 

requested NHANES III, NHANES 1999– 

2002 or NHANES 2007–2008 public use 

data. Analysis will be done in the 

Research Data Center. 

Agency Agreement 

A formal signed agreement in the 

form of a Materials Transfer Agreement 

(MTA) with individuals who have 

projects approved and funding has been 

secured will be completed before the 

release of the samples. This agreement 

will contain the conditions for use of 

the DNA as stated in this document and 

as agreed upon by the investigators and 

CDC. A key component of this 

agreement is that no attempt will be 

made to link the results of the proposed 

research to any other data, including, 

but not limited to, the NHANES public 

use data sets outside the Research Data 

Center. Also, the investigator agrees that 

the samples cannot be used for 

commercial purposes. A list of genes 

generated from the testing of the 

NHANES samples will be made 

available to the public for potential 

solicitation of proposals for secondary 

data analysis after the quality control 

process has been completed 

(approximately six months after NCHS 

receives the genetic variation results). 

These secondary data analysis proposals 

must also be reviewed by the ERB. 

Progress Reports 

A progress report will be submitted 

annually. CDC/NCHS/ERB continuation 

reports are also required annually if 

testing is not completed within a year. 

An ERB continuation form will be sent 

to the researcher each year for project 

update. 

Termination of ERB Protocol 

At the end of laboratory testing the 

Ethics Review Board Protocol will be 

closed. All data analysis will be 

conducted through the NCHS Research 

Data Center (RDC). For secondary data 

analysis project an analytic plan must 

be submitted to the RDC to set up the 

analytic data set. See: http:// 

www.cdc.gov/nchs/r&d/rdc.htm for 

guidelines. 

Disposition of Results and Samples 

No DNA samples provided can be 

used for any purpose other than those 

specifically requested in the proposal 

and approved by the Genetics Technical 

Panel, the Secondary Review Committee 

and the NHANES ERB. No sample can 

be shared with others, including other 

investigators, unless specified in the 

proposal and so approved. Any unused 

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Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 32195 

samples must be returned upon 

completion of the approved project. 

These results, once returned to NCHS 

and quality controlled, will be part of 

the public domain. Genetic test results 

from all studies using NHANES DNA 

samples will be made available to the 

public for secondary data analyses. 

After the NCHS quality control review 

is completed, researchers will be given 

up to six months to conduct a more 

comprehensive quality assurance 

review. The final quality control review 

timeframe will be negotiated between 

the researcher and the NCHS Project 

Officer and will depend on the number 

and characteristics of the genetic tests 

submitted. Data analyses will be 

conducted at the NCHS’ Research Data 

Center or similar environment provided 

by NCHS. Proposals for secondary data 

analyses are accepted on a rolling basis 

(http://www.cdc.gov/nchs/nhanes/ 

genetics/genetic_types.htm). 

Send Requests for Information 

Geraldine McQuillan, PhD, Division 

of Health and Nutrition Examination 

Surveys, National Center for Health 

Statistics, Centers for Disease Control 

and Prevention, 3311 Toledo Road, 

Room 4204, Hyattsville, MD 20782, 

Phone: 301–458–4371, Fax: 301–458– 

4028, E-Mail: 

NHANESgenetics@cdc.gov. 

Dated: May 24, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–13517 Filed 6–4–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Procedures and Costs for Use of the 

Research Data Center 

AGENCY: National Center for Health 

Statistics, Centers for Disease Control 

and Prevention (CDC), Department of 

Health and Human Services (HHS). 

ACTION: Notice and request for 

comments. 

Authority: Section 306 of the Public Health 

Service Act, as amended (42 U.S.C. 242k) and 

Public Law 103–333. 

SUMMARY: This notice provides 

information about the Research Data 

Center (RDC) operated by the National 

Center for Health Statistics (NCHS) 

within the Centers for Disease Control 

and Prevention (CDC). The Research 

Data Center was established in 1998 to 

provide a mechanism whereby 

researchers can access detailed data files 

in a secure environment, without 

jeopardizing the confidentiality of 

respondents. Historically, the data files 

accessed in the RDC have consisted of 

NCHS survey data and vital statistics. 

RDC has recently begun accepting data 

files that were not produced from NCHS 

survey data. In order to assure that all 

data files are processed in a consistent 

manner, the original guidelines for 

accessing files in the RDC are being 

reviewed and revised as necessary. As 

part of the revision process, potential 

users are being given the opportunity to 

provide input on how the procedures of 

the RDC can best serve their research 

needs. This notice describes how to 

submit proposals requesting use of the 

data, mechanisms to access the RDC, 

requirements, use of outside data sets, 

costs for using the RDC, and other 

pertinent topics. We are seeking 

comments on these procedures and will 

post the final procedures on the NCHS 

Web site. 

ADDRESSES: Send comments concerning 

this notice to Peter Meyer, National 

Center for Health Statistics, 3311 Toledo 

Road, Room 4113, Hyattsville, MD 

20782, or e-mail to pmeyer1@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Peter Meyer, telephone 301–458–4375. 

SUPPLEMENTARY INFORMATION: 

Operational Procedures for Use of the 

Research Data Center; National Center 

for Health Statistics; Centers for Disease 

Control and Prevention 

Table of Contents 

Background 

Methods of Access to Data 

Submission of Research Proposals Using 

NCHS Data 

Proposal Review 

Researcher Supplied Data 

General Procedures for Onsite Access 

General Procedures for Remote Access 

Confidentiality and Human Subjects 

Protection 

Disclosure Review Process 

Costs for Using the RDC 

National Center for Health Statistics 

Research Data Center Procedures 

Background 

The National Center for Health 

Statistics (NCHS) releases and hosts a 

range of statistical data products on the 

health and well-being of the nation and 

its health care system. Statistical 

tabulations (tables) present data in 

predetermined categories such as age, 

race, sex or geographic region that are 

important to describe health status and 

trends. In addition, statistical microdata 

containing health and related variables 

are published so that outside analysts 

may conduct original research and 

special studies to address issues of 

public health science and policy. 

Section 308 (d) of the Public Health 

Service Act and the NCHS Staff Manual 

on Confidentiality do not permit the 

release of data that are either identified 

or identifiable to persons outside of 

NCHS. In order to preserve privacy and 

confidentiality, details that might 

identify or facilitate the identification of 

persons and entities participating in 

NCHS surveys and data systems either 

owned or hosted by NCHS are not 

released in published data products. 

Examples of data elements that might be 

abridged or suppressed to prevent 

reidentification are geographic 

identifiers, genetic data, details of 

sample design, and variables such as age 

or income that might exist in other 

databases. 

Despite the wide dissemination of 

NCHS data through publications, Web 

releases, etc., the inability to release 

files with these sensitive variables limits 

the utility of NCHS data for research, 

policy, and programmatic purposes and 

sets a boundary on one of the 

Department of Health and Human 

Service’s goals: to increase our capacity 

to provide state and local area estimates. 

In pursuit of this goal and in response 

to the public research community’s 

interest in restricted data, NCHS 

established the NCHS Research Data 

Centers (RDCs), a place where Guest 

Researchers can access detailed data 

files in a secure environment, without 

jeopardizing the confidentiality of 

respondents. Access for Guest 

Researchers is regulated by the 

Confidential Information Protection and 

Statistical Efficiency Act (CIPSEA) and 

other Federal statutes. The RDCs 

provide restricted access to NCHS data 

and non-NCHS data. Guest Researchers 

function under the supervision of NCHS 

employees and are subject to the same 

provisions of law with regard to 

confidentiality as NCHS employees. 

Instructions for developing a research 

proposal can be found in Appendix II. 

Special requirements for use of nonNCHS data can be found in Appendix 

III, Project-Specific Requirements. 

Methods to Access Data 

Restricted NCHS data or data hosted 

by NCHS can be made accessible 

through the RDC. To gain access to these 

data, Guest Researchers must submit a 

proposal for review and approval. Once 

the proposal is approved, Guest 

Researchers meeting certain criteria are 

allowed access, under strict supervision, 

to restricted statistical microdata file(s). 

There are four modes of access: (1) 

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