45644 Federal Register / Vol. 74, No. 170 / Thursday, September 3, 2009 / Notices 

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. 

Authority: Sections 301, 306 and 308 of 

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

2421 and 242m). 

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 

approximately 7,157 participants 

enrolled in Phase II of NHANES III 

(1991–1994). In addition, DNA purified 

from whole blood is also available from 

approximately 7,900 participants 

enrolled in the NHANES 1999–2002 and 

4,621 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 beginning in 

January and July of each year. 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. 

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]) and Thursday, October 

18, 2007 [72 FR59094]. 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. 

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 or 

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 previous 

announcements for use of NHANES III 

DNA samples (Thursday, August 8, 


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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, 7,157 

samples; NHANES 1999–2002, 

approximately 7,900 samples; NHANES 

2007–2008 4,621 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 the publication of 

frequencies for all genetic variations 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/

nh3data_genetic.htm#Available_

Genetic_Data_Sets. 

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 7,157 NHANES III samples 

distributed in a total of 75 plates with 

an additional five plates of quality 

control samples. There are 

approximately 7,900 NHANES 1999– 

2002 purified DNA samples. These will 

be distributed into 83 plates with 

approximately five plates of quality 

control samples. There are 4,421 

purified DNA samples available from 

NHANES 2007–2008. These will be 

distributed into 51 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 480 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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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 ................................................... 63,024 NA 42,596.36 NA 

Total Cost per Category B Proposal: for Data handling 6,302 (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. Both proposal categories 

need a full research proposal for review. 

The cover page of 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 DNA analysis will 

be done, 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. The 

technical panel will evaluate the whole 

proposal but will focus on proposal 

elements 1, 3, and 4. 

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. 

Proposals should include the 

following information: 

(1) Specific Aims: List the broad 

objectives; describe concisely and 

realistically what the research is 

intended to accomplish, and state the 

specific hypotheses to be tested. 

(2) Background and Public Health 

Significance: Describe the public health 

significance, scientific merit, and 

practical utility of the proposed 

research. Scientific merit will be judged 

on the basis of the scientific, technical, 

or medical significance of the research; 

the appropriateness and adequacy of the 

experimental approach; and the 

methodology proposed to reach the 

research goals. Convey how the results 

will be used and the relationship of the 

results to the data already collected in 

NHANES 1999–2002. Analyses should 

be consistent with the NHANES mission 

to assess the health of the nation. 

Because NHANES is a complex, 

multistage probability sample of the 

national population, the 

appropriateness of using the NHANES 

sample to address the goals of the 

proposal will be an important aspect of 

determining scientific merit. The Panel 

will ensure that the proposed project 

does not go beyond either the general 

purpose for collecting the samples in 

the survey, i.e., to determine allele 

frequencies in subgroups of the 

population, or, the specific stated goals 

of the proposal. 

(3) Research Design and Methods: 

Include power calculations and a list of 

variables requested. 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. 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. 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. 

(4) 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. 

(5) Clinical Relevance of Research 

Findings: The samples for research 

based on specific hypothesis 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 


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Federal Register / Vol. 74, No. 170 / Thursday, September 3, 2009 / Notices 45647 

results should not be reported to the 

subjects. 

(6) Qualifications: Provide a brief 

description of the requestor’s expertise 

in the proposed area, including 

publications in this area within the last 

three years. 

(7) 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. 

(8) 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. Currently the cost per DNA 

specimen is $7.98 for NHANES 1999– 

2002 and 2007–2008 proposals that use 

the full set of samples. Costs for partial 

sets are $40.78 per specimen. 

Reimbursement for the samples will be 

collected before the samples are 

released. NHANES III samples which 

are DNA crude lysates, not purified 

DNA, are $5.95 per sample for the 7,157 

total set of samples. If a subsample of 

NHANES III is requested and approved 

the cost schedule published in (Friday, 

January 13, 2006 [71 FR 22248]) will be 

utilized ($35.45 per sample). 

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/nh3data_genetic.htm#

Available_Genetic_Data_Sets. 

Proposals for secondary data analyses 

linking NHANES public use data with 

genetic variation data are accepted in 

May and October of each year. 

Proposals to obtain DNA for testing 

will be reviewed first by a Genetics 

Technical Panel and then by a 

Secondary Review Panel. 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 part 46. The ERB review 

will be conducted, even though 

investigators’ proposals may have 

received review by their home 

institution. The Director of NCHS will 

verify that projects have received 

appropriate reviews. 

Requirements for the Inclusion of 

Women and Racial and Ethnic 

Minorities in Research: In NHANES III 

and NHANES 1999–2002, race/ethnicity 

was derived by combining responses to 

questions on race and Hispanic origin. 

These categories are defined as nonHispanic white, non-Hispanic black, or 

Mexican American. Individuals who did 

not self-select 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 

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). 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 

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 in May and 

October of each year (http:// 


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www.cdc.gov/nchs/nhanes/ 

nh3data_genetic.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: August 27, 2009. 

Tanja Popovic, 

Chief Science Officer, Centers for Disease 

Contro and Prevention. 

[FR Doc. E9–21287 Filed 9–2–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form N–400, Revision of an 

Existing Information Collection; 

Comment Request 

ACTION: 60-Day Notice of Information 

Collection Under Review; Form N–400, 

Application for Naturalization; OMB 

Control No. 1615–0052. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services has submitted the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

sixty days until November 2, 2009. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), USCIS, Chief, Regulatory 

Products Division, Clearance Officer, 

111 Massachusetts Avenue, Suite 3008, 

Washington, DC 20529–2210. 

Comments may also be submitted to 

DHS via facsimile to 202–272–8352 or 

via e-mail at rfs.regs@dhs.gov. When 

submitting comments by e-mail, please 

make sure to add OMB Control No. 

1615–0052 in the subject box. 

Written comments and suggestions 

from the public and affected agencies 

concerning the collection of information 

should address one or more of the 

following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Revision of an existing information 

collection. 

(2) Title of the Form/Collection: 

Application for Naturalization. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form N–400; 

U.S. Citizenship and Immigration 

Services. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

households. USCIS uses the information 

on this form to determine an applicant’s 

eligibility for naturalization. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 700,000 responses at 6 hours 

and 8 minutes (6.13 hours) per 

response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 4,291,000 annual burden 

hours. 

If you need a copy of the information 

collection instrument, please visit: 

http://www.regulations.gov/search/ 

Regs/home.html#home. 

We may also be contacted at: USCIS, 

Regulatory Products Division, 111 

Massachusetts Avenue, NW., Suite 

3008, Washington, DC 20529–2210, 

telephone number 202–272–8377. 

Dated: August 27, 2009. 

Stephen Tarragon, 

Deputy Chief, Regulatory Products Division, 

U.S. Citizenship and Immigration Services, 

Department of Homeland Security. 

[FR Doc. E9–21260 Filed 9–2–09; 8:45 am] 

BILLING CODE 9111–97–P 

DEPARTMENT OF HOMELAND 

SECURITY 

United States Coast Guard 

[Docket No. USCG–2009–0761] 

Cook Inlet Regional Citizen’s Advisory 

Committee; Charter Renewal 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of Recertification. 

SUMMARY: The Coast Guard has 

recertified the Cook Inlet Regional 

Citizen’s Advisory Council for the 

period covering September 1, 2009, 

through August 31, 2010. Under the Oil 

Terminal and Oil Tanker Environmental 

Oversight Act of 1990, the Coast Guard 

may certify on an annual basis an 

alternative voluntary advisory group in 

lieu of a regional citizens’ advisory 

council for Cook Inlet, Alaska. This 

advisory group monitors the activities of 

terminal facilities and crude oil tankers 

under the Cook Inlet Program 

established by the statute. 

DATES: The Cook Inlet Regional Citizen’s 

Advisory Council is certified through 

August 31, 2010. 

ADDRESSES: You may request a copy of 

the recertification letter by writing to 

Commander, Seventeenth Coast Guard 

District (dpi), P.O. Box 25517, Juneau, 

AK 99802–5517; or by calling 907–463– 

2821. 

FOR FURTHER INFORMATION CONTACT: 

Lieutenant-Commander Ken Phillips, 

Seventeenth Coast Guard District (dpi), 

telephone 907–463–2821. 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

On September 1, 2008, the Coast 

Guard recertified the Cook Inlet 

Regional Citizen’s Advisory Council 

through August 31, 2009 (73 FR 57127). 

Under the Oil Terminal and Oil Tanker 

Environmental Oversight Act of 1990 

(33 U.S.C. 2732), the Coast Guard may 

certify, on an annual basis, an 

alternative voluntary advisory group in 

lieu of a regional citizens’ advisory 

council for Cook Inlet, Alaska. This 

advisory group monitors the activities of 

terminal facilities and crude oil tankers 

under the Cook Inlet Program 

established by Congress, 33 U.S.C. 2732 

(b). 

On September 16, 2002, the Coast 

Guard published a notice of policy on 

revised recertification procedures for 

alternative voluntary advisory groups in 

lieu of councils at Cook Inlet, Alaska (67 

FR 58440). This revised policy indicated 

that Cook Inlet Regional Citizen’s 

Advisory Council recertification in 2009 

need only submit a streamlined 


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