National Health and Nutrition Examination Survey III (NHANES) DNA Specimens: Guidelines for Proposals To Use Samples and Cost Schedule, 2248-2253 [E5-8104]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 9 (Friday, January 13, 2006)]
[Notices]
[Pages 2248-2253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


National Health and Nutrition Examination Survey III (NHANES) DNA 
Specimens: Guidelines for Proposals To Use Samples and Cost Schedule

AGENCY: Centers for Disease Control and Prevention (CDC), Health and 
Human Services (HHS).

ACTION: Notice.

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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 large 
amount of information collected for the purpose of describing the 
health of the population, blood lymphocytes were collected in NHANES 
III in anticipation of advances in genetic research.
    The lymphocytes have been stored and maintained at the Division of 
Laboratory Sciences (DLS) at the National Center for Environmental 
Health (NCEH), CDC. The collection of lymphocytes was begun in the 
second phase of the survey (1991-1994) because of the significant 
advances in the rapidly evolving field of molecular biology that were 
occurring during the planning phase of this survey. CDC is making DNA 
samples from these specimens available to the research community for 
genetic analyses. Specimens are available from approximately 7,159 
participants in the second phase of NHANES III. No cell lines will be 
made available.
    This program has been previously announced (Tuesday, June 1, 1999 
[64 FR 29321]; Thursday, August 8, 2002 [67 FR 51585]). The purpose of 
this notice is to announce a fourth category for proposals for use of 
these specimens, add an additional secondary review of approved 
applications and provide a new proposal schedule. For final proposal 
guidelines and requests or letters of intent, please contact Ms. 
Oraegbu or go to https://www.cdc.gov/nchs/about/major/nhanes/
dnafnlgm2.htm.
    All interested researchers are encouraged to submit letters of 
intent. No funding is provided as part of this solicitation. Proposals 
will be reviewed by a technical panel and approved applications will 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 primary purpose of the Secondary Review Committee 
is to factor in 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. The secondary review panel will be comprised 
of senior CDC scientists, who will advise the Director, NCHS, on the 
approved applications. 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: 
     Letter of Intent Receipt: February 13, 2006.
     Submission of Proposals: March 14, 2006.
     Scientific Review: April 13, 2006.
     Secondary Review: May 15, 2006.
     Ethics Review Board: July 12, 2006.
     Notification of approval: August 1, 2006.
     Anticipated distribution of samples: December 11, 2006.

[[Page 2249]]


ADDRESSES: To send comments and for information, contact:

Ms. Kika Oraegbu, Division of Health and Nutrition Examination Surveys, 
National Center for Health Statistics, Centers for Disease Control and 
Prevention, 3311 Toledo Road, Room 4207, Hyattsville, MD 20782, Phone: 
301-458-4367, Fax: 301-458-4028, E-mail: KDO1@cdc.gov. Internet: http:/
/www.cdc.gov/nchs/about/major/nhanes/dnafnlgm2.htm.

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 Third National Health and Nutrition Examination Survey (NHANES 
III) began in the Fall of 1988 and ended in the Fall of 1994. Survey 
data were collected and can be analyzed from two phases: Phase I was 
conducted from October, 1988, to October, 1991, and Phase II was 
conducted from October, 1991, to October, 1994. Both phases are 
nationally representative samples. For details of the sampling design 
see the Plan and Operation of NHANES III (1). This information can be 
obtained by contacting the Data Dissemination Branch, NCHS, at 301-458-
4636 or from the Internet at https://www.cdc.gov/nchs/about/major/
nhanes/nh3data.htm.
    Blood specimens were collected from participants as a part of 
NHANES III. Lymphocytes were isolated from the blood collected from 
participants aged 12 years and older and stored frozen in liquid 
nitrogen or as cell cultures immortalized with Epstein-Barr virus and 
frozen at the Molecular Biology Branch of DLS, NCEH, CDC, Atlanta, GA. 
DNA in the form of crude cell lysates is available from the cell lines 
derived from samples obtained from Phase II (1991-1994) participants. 
DNA concentrations are unknown and vary between samples.
    Health information collected in the NHANES III 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 or the establishment in accordance with section 308(d) 
of the Public Health Service Act (42 U.S.C. 242m). Although the consent 
form was signed by participants in the survey, and participants 
consented to storing specimens of their blood for future research, 
specific mention of genetic research was not included. Nevertheless, 
given the scientific importance of this resource, the CDC/NCHS Ethics 
Review Board (ERB) approved making anonymized samples of DNA available 
to the genetic research community.
    The anonymization requirements proved to be restrictive and 
difficult to implement, therefore, in August, 2001, the CDC/NCHS ERB 
approved a revised plan for using these specimens based on the 
guidelines in the August, 1999, National Bioethics Advisory Commission 
(NBAC) report on the use of stored biological materials for research. 
This revised plan includes a process that gives researchers the ability 
to obtain more information associated with specimens for protocols that 
are determined by the ERB to have minimal risk for harm to the 
participant. For those protocols that cannot be conducted under 
unlinked (or anonymous) conditions, but have been determined to involve 
minimal risk, the revised plan allows for linking the genetic 
laboratory results to the NHANES data through the NCHS Research Data 
Center. This process would ensure that confidentiality of the subjects' 
identity is maintained and would reduce the possibility that linking 
genetic information to the NHANES III data files might identify an 
individual or cause group harm.

Potential Research Proposals

    Category (A): Special studies using the NCHS Research Data Center: 
Complete set of samples in 96-well plates (a total of 7,159 samples 
distributed into 75 plates with additional five plates of quality 
control samples). Studies which request DNA samples linked to 
previously collected NHANES III public use data without the restriction 
of anonymization. Data analyses must be done within the NHANES Research 
Data Center.
    Category (B): Age-race-sex studies using anonymized samples: A 
limited number of subsets may be distributed in 50[mu]L cryovials. 
Subsets based on the selection criteria proposed by investigators. 
Studies of allele frequencies which require only basic demographic 
information (age, race/ethnicity, and sex) to be linked to the samples.
    Category (C): Special anonymized studies: A limited number of 
subsets may be distributed in 50[mu]L cryovials. Subsets based on the 
selection criteria proposed by investigators. Studies in which 
additional co-variates from the NHANES III public use database are 
required, but the re-coding maintains anonymization (minimum of five 
individuals in each statistical cell) of the samples.
    Category (D): Additional research using specimens already obtained 
from previous solicitations: Researchers that have obtained NHANES III 
DNA samples from previous solicitations and have sufficient DNA left 
that they can now do additional genotyping, may request doing these 
additional tests on the remaining DNA. Proposals under this Category 
must be submitted and approved before the DNA would have had to be 
destroyed or returned. The proposals will be reviewed by the NHANES 
Genetic Technical Panel, the CDC Secondary Review panel and the ERB and 
if accepted, the researcher can begin the additional analysis with only 
the administrative cost for data handling.
    These research designs A-C do not differ from the previous Plan for 
distributing NHANES III DNA samples to researchers.
    Category (A): Special studies using the NCHS Research Data Center--
Distribution of the complete set of 96 well plates (a total of 7,159 
samples distributed into 75 plates with five additional plates with 
quality control samples). The investigator will specify the genetic 
analyses to be conducted on the samples. The investigator will also 
include in the research protocol application a list of demographic and 
clinical variables that would be used for the data analyses. Data 
analyses that combine the genetic analyses with NHANES III public use 
data must be conducted through the NCHS Research Data Center (RDC) or 
its equivalent in the Division of Health and Nutrition Examination 
Surveys. The researcher will conduct the genetic laboratory analyses 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 perform the data analyses, the 
researcher will provide the results of the genetic laboratory tests 
with the identification numbers to the Division of Health and Nutrition 
Examination Surveys (DHANES). The identification numbers will be 
matched to the NHANES III public use file data

[[Page 2250]]

by DHANES staff. The resulting data file will be used for these 
analyses. Data analyses will be conducted at NCHS under the direction 
of the researcher. Individual data sets will not be generated but the 
researcher can obtain the output from these analyses.
    Category (B) Age-race-gender Studies: A limited number of subsets 
may be distributed in 50[mu]L cryovials. Subsets based on the selection 
criteria proposed by investigators. To facilitate the research proposal 
preparation of allele frequency, NCHS will make the following data 
available with the DNA sample: age in ten year age groups, race-
ethnicity (white, black, Mexican-American), gender, mean sample weights 
for each demographic group and the average design effect. Thus, 
investigators wishing to submit proposals under this research design 
type do not need to provide an analysis of NHANES III data to support 
the unlinked (anonymization) scheme proposed. These data have 
sufficient sample sizes in each category (the smallest age, race/
ethnicity, gender statistical cell contains 62 persons) to preserve 
anonymity. To further preserve anonymity, only 80 percent of the 
subjects in each statistical cell will be used. NCHS will provide a 
data file with the demographic variables and the sample weights linked 
to a randomly assigned unique identification number that is linked to 
the DNA specimen. No record connecting the new number with the original 
identification number will be kept after the samples have been sent. 
These samples cannot be traced to any files maintained by NCHS.
    Proposals submitted for this category of review are limited to 
those requesting samples from within this ages, gender, race/ethnicity 
cells for identifying the frequency of the alleles in the population. 
These proposals must address all criteria except for the verification 
that anonymization can be achieved.
    Category (C): Special Anonymized Studies (Requests for Additional 
Variables)--A limited number of subsets may be distributed in 50[mu]L 
aliquots in cryovials. Subsets are based on the selection criteria 
proposed by the investigator(s). The investigator will include a list 
of demographic and clinical variables and specify recoding schemes, if 
appropriate, that the principal investigator would like to have linked 
to the samples to meet the objectives of the study. The combined 
information on all variables provided to the investigator by CDC must 
not constitute a unique set of values that could link the samples with 
participant data on the NHANES III public use data set. Investigators 
should obtain the NHANES III Public Use Data and should verify that 
anonymity can be achieved before submitting the proposal with the 
requested set of variables.
    A cross tabulation of all requested variables must be provided and 
must demonstrate that there are at least five individuals in each 
statistical cell of that cross tabulation. Recoding is required for 
continuous variables and may be required for integral variables to 
ensure anonymity. Because the samples are primarily available from 
phase II subjects, these analyses should be run using phase II subjects 
only (SDPPHASE=2). (Household codes are confidential data. Therefore, 
if only one individual per household is to be included in the protocol, 
the investigator can estimate the sample size per statistical cell by 
halving the cross tabulation results. For instance, if only one 
individual per household is requested, the minimum statistical cell 
size of the cross tabulation should be ten subjects.) From each 
statistical cell, either two observations or 20 percent of the subjects 
of the cell, whichever is larger, will be deleted from the pool of 
samples sent to the investigator. In all this proposal design, the 
investigators will receive samples that are coded with a random 
identifier that is unique to that proposal and not linkable to any 
other data or data file once the crosswalk is deleted. NCHS will 
provide a data file with the requested recoded variables and a randomly 
assigned unique identification number that is linked to the DNA 
specimen. No record connecting the new number with the original 
identification number will be kept after the samples have been sent. 
These samples cannot be traced to any files maintained by NCHS.
    Category (D): Additional research using specimens already obtained 
from previous solicitations: Researchers that have obtained NHANES III 
DNA samples from previous solicitations and have sufficient DNA left 
that they can now do additional genotyping, may request doing these 
additional tests on the remaining DNA. The guidelines for the proposals 
are the same as Category A proposals and will be reviewed by the NHANES 
Genetic Technical Panel, the CDC Secondary Review Panel and the ERB. If 
the additional research proposal is accepted, the researcher can begin 
the additional analysis with only the administrative cost for data 
handling (ten percent of the cost of a full set of samples). Proposals 
under this Category must be submitted and approved before the DNA would 
have had to be destroyed or returned.

DNA Samples

    For proposals falling into category A, the laboratory will 
distribute 100 [mu]l aliquots of crude cell lysate. The amount of DNA 
in each aliquot will be approximately 180-1,500 nanograms (ng). 
Aliquots will be dispensed into 96-well plates for distribution to 
investigators. Each plate will be bar-coded and labeled with a readable 
identifier. Quality control samples (approximately 480 samples) will be 
sent, either inserted with the NHANES samples or in separate plates, as 
blind duplicate and/or blanks. Approximately ten sample sets of 
specimens from 7,159 participants will be available for proposals. An 
investigator must purchase the samples in full sets. For proposals 
falling into category B or C, specimens will be distributed in 50 [mu]L 
aliquots in cryovials rather than 96-well plates. The amount of DNA in 
each aliquot will be approximately 90 to 750 nanograms. Only a limited 
number of smaller specialized sets for category B or C are available. 
There are only two complete sets of cryovials, so the number of 
projects that can be filled with these samples depends on the types of 
projects proposed.

Proposed Cost Schedule for Providing Nhanes III DNA Specimens

    A nominal processing fee of $6.39 is charged for each sample 
received from the NHANES III DNA Specimen Bank if the full sets of 
specimens (category A) are requested. If more limited sets of cryovials 
are requested, a cost of $38.00/vial is assessed to cover the manual 
selection of these samples. For proposals submitted under category D, 
where the researcher already is in possession of the NHANES DNA and 
administrative cost of ten percent of the processing fee will be 
charged to cover the data base processing and handling at NCHS. 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 in accordance with the detailed 
requirements of the investigators.
    The materials listed are for the recurring laboratory costs to 
dispense and prepare the samples for shipping. Labor costs are based on 
the need for genetic analysts, a proposal administrator, and computer 
programmers for NCHS and NCEH to

[[Page 2251]]

maintain the data bases and verify anonymity. Technical panel travel 
and expenses are based on the panel meeting once a year. The space 
estimate is based on acquiring storage and sample aliquoting space in 
the laboratory.

------------------------------------------------------------------------
                                          Per sample for
                                           7,159 samples  Per sample for
               Total costs                  in 96-well      individual
                                              plates         cryovials
------------------------------------------------------------------------
Materials...............................           $0.85           $1.90
Labor...................................            3.30           22.00
Application review and other                        0.35            2.69
 administrative expenses................
Space...................................            0.13            0.97
                                         -----------------
    Subtotal............................            4.63           27.56
NCHS overhead (15 percent)..............            0.69            4.12
                                         -----------------
    Subtotal............................            5.32           31.68
CDC/FMO overhead (20 percent)...........            1.06            6.32
                                         -----------------
    Total cost per sample...............            6.39           38.00
    Total cost per proposal.............          45,746              NA
    Total cost per Category D proposal:            4,662             \1\
     for Data handling..................
------------------------------------------------------------------------
\1\ 10 Percent of original cost of specimens.

    Shipping costs are not included in the processing fee. These costs 
must also be paid by the investigator.

Procedures for Letter of Intent

    NCHS will post information about letters of intent on the NHANES 
Web site www.cdc.gov/nchs/about/major/nhanes/nhanes.htm, by January 13, 
2006. The letter of intent is required to enable CDC to plan the review 
more efficiently, evaluate the number of requests, and to assess the 
capacity of the DNA Bank to fulfill requests. All letters of intent 
will be reviewed by the Division of Health and Nutrition Examination 
Surveys staff for potential major problems related to the feasibility 
of the project. If a problem is identified, the Division staff will 
inform the investigator so it can be addressed in the proposal.
    All potential investigators must submit letters of intent. The 
letter should be no more than two pages and include (1) A descriptive 
title of the overall proposed research; (2) the name, address and 
telephone number of the Principal Investigator (PI); (3) a list of key 
investigators and their institution(s); (4) one paragraph on the 
background for the proposal and a paragraph briefly addressing each 
criterion for technical evaluation of letters of intent and proposals; 
(5) the genetic assessments proposed; (6) a list of proposed variables; 
and (7) an estimate of the number of samples that would be requested. 
The background paragraph should state concisely the importance of the 
research in terms of the broad, long-term objectives and public health 
relevance and consistency of NCHS' mission to monitor the nation's 
health.
    Letters of intent should be submitted by February 13, 2006. E-mail 
submission is encouraged.
    Ms. Kika Oraegbu, Division of Health and Nutrition Examination 
Surveys, National Center for Health Statistics, Centers for Disease 
Control and Prevention, 3311 Toledo Road, Room 4207, Hyattsville, MD 
20782, Phone: 301-458-4367, FAX: 301-458-4028, E-mail: KDO1@cdc.gov.

Procedures for Proposals

    The investigator should follow these instructions for preparation 
of proposals. All 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, C, D) submitted. Office for Human Research Protections 
(OHRP) assurance number for the institutions included 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 for this round of 
proposals, 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, 5, 6, and 7.
    Approved applications will 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 primary purpose of 
the Secondary Review Committee is to factor in 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, 
who will advise the Director, NCHS, on the approved applications.
    The proposal title page should include the title of the research 
proposal; a list of the investigators and institutions; OHRP assurance 
number for the institutions included in the research project; address, 
phone number and E-mail address of lead investigator. CDC investigators 
need to include their Scientific Ethics Verification Number. The 
proposal should contain, and will be evaluated according to, the 
following elements:
    (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. Category D proposals where 
the

[[Page 2252]]

researcher already has the set of DNA samples and Category A proposals 
which request using the full set of specimens will receive priority 
consideration. Category B and C proposals will be evaluated together 
since they will be competing for the limited set of cryovials.
    (2) Background and Public Health Significance: Describe the public 
health significance, scientific merit, and practical utility of the 
assay. 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 relation of the results to the data already collected in NHANES 
III. 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: Describe the sampling scheme and 
number of samples requested if submitting a category C proposal. 
Include power calculations for the sub-sample and a list of variables 
requested; provide a cross-tabulation of requested variables for 
category C proposals. For all proposal categories, include a detailed 
description of the laboratory methods. The use of standard genotyping 
reactions vs. multiplex reactions should be discussed with reference to 
any anticipated problems and proposed solutions with the use of the 
cell lysate provided. 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. Approximately 480 quality control 
samples will be provided at no additional cost but the approved 
projects must run these samples and submit the results with the NHANES 
DNA samples. The proposal should contain a discussion of additional 
quality control procedures the laboratory used to assure the validity 
of the test results. Address adequate methods for handling and storage 
of samples. NCHS will verify the anonymity for category B and C 
proposals.
    (4) Discussion regarding the race/ethnicity variables: If the 
sample request is limited to specific race or ethnic groups 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 specimens 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 address 
whether or not findings from the proposed research merit disclosure.
    (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) Anonymity: Final approval is based upon NCHS confirmation that 
anonymity can be maintained by the categorization of variables for 
category C proposals (proposals requiring anonymity).
    (8) 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 
unless a new Category (D) proposal has been approved. Extensions to the 
period of performance may be requested.
    (9) 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 $6.39 for proposals that use the 
full set of samples (7,159) and $38.00 per sample for subsets. 
Reimbursement for the samples will be collected before the samples are 
released.
    Proposals approved by a Genetics Technical Panel and the Secondary 
Review Panel will also be reviewed by the CDC/NCHS ERB for human 
subject concerns. The ERB review will be conducted, even though 
investigator's proposals may have received review by their home 
institution. The Panel will also review an NCHS evaluation of whether 
anonymity can be assured for the proposed project for proposals in 
categories B and C. The samples that are sent to the investigator will 
be selected randomly from the domains by NCHS staff. 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, race/ethnicity was defined by self-report as non-
Hispanic white, non-Hispanic black, or Mexican American. Individuals 
who did not self-select into these categories were classified as 
``other''. If the proposal 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 indicate 
the reason for analyzing race/ethnicity and how the results will be 
interpreted.

Submission of Proposals

    Proposals should be submitted by March 14, 2006. All investigators 
who submitted letters of intent may submit proposals.
    Electronic submission of proposals is encouraged. Please submit 
proposals to: Ms. Kika Oraegbu, Division of Health and Nutrition 
Examination Surveys, National Center for Health Statistics, Centers for 
Disease Control and Prevention, 3311 Toledo Rd., Room 4207, 
Hyattsville, MD 20782, Phone: (301) 458-4367, Fax: (301) 458-4028, E-
mail: KDO1@cdc.gov.

Approved Proposals

    NCHS will provide a data file with the requested recoded variables 
(for category B and C proposals) and a randomly assigned unique 
identification number that is linked to the DNA specimen. No record 
connecting the new number with the original identification number will 
be kept after the samples have been sent. These samples cannot be 
traced to any files maintained by NCHS. For proposals in category A and 
D, the genetic results will be sent back to NCHS so they can be linked 
to the NHANES III public use data in the Research Data Center for 
analysis.

Agency Agreement

    A formal signed agreement in the form of a Materials Transfer 
Agreement (MTA) with individuals who have projects approved will be 
completed

[[Page 2253]]

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 
III public use data set. Also, the investigator agrees that the samples 
cannot be used for commercial purposes. A list of genes generated from 
the testing of the NHANES III samples will be made available to the 
public for potential solicitation of proposal for secondary data 
analysis, six months after the data is sent to the RDC. These secondary 
data analysis proposals must also be reviewed by the NHANES Genetics 
Technical Panel and the ERB.

Progress Reports

    A progress report will be submitted annually. CDC/NCHS ERB 
continuation reports are also required annually.

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 destroyed upon completion of the approved 
project, unless a request is submitted and approved under Category D. 
Researchers requesting DNA samples for age-race-gender studies and 
special studies will be required to provide NCHS with the results of 
all DNA tests performed for each anonymized sample. These results, once 
returned to NCHS, will be part of the public domain. Therefore, ample 
time will be given to the investigator to publish results prior to 
reporting the results to NCHS.

Send Requests for Information

    Ms. Kika Oraegbu, Division of Health and Nutrition Examination 
Surveys, National Center for Health Statistics, Centers for Disease 
Control and Prevention, 3311 Toledo Road, Room 4207, Hyattsville, MD 
20782, Phone: 301-458-4367, Fax: 301-458-4028, E-mail: KDO1@cdc.gov.

References

    1. Plan and Operation of the Third National Health and Nutrition 
Examination Survey, 1988-94. National Center for Health Statistics. 
Vital Health Stat (32) 1994.
    2. Clayton EW, Steinberg KK, Khoury MJ, et al. Informed consent for 
genetic research on stored tissue samples. JAMA 1995;274:1786-1792.

    Dated: December 21, 2005.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control 
and Prevention.
 [FR Doc. E5-8104 Filed 1-12-06; 8:45 am]
BILLING CODE 4163-18-P