[Federal Register Volume 67, Number 153 (Thursday, August 8, 2002)]
[Notices]
[Pages 51585-51589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20038]


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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 Proposed Cost 
Schedule

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 
such analyses. Specimens are available from approximately 7,300 
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)). The purpose of this notice is to announce a third 
category for proposals for use of these specimens and a new cost 
schedule. For final proposal guidelines and request for letters of 
intent, please contact Ms. Oraegbu or go to http://www.cdc.gov/nchs/
about/major/nhanes/dnafnlgm2.htm.
    All interested researchers are encouraged to submit letters of 
intent. Approximately twenty proposals for a full set of specimens 
(~7,300 samples) and a limited number of proposals (less than five, 
depending on the number of specimens requested) for smaller sets of 
samples can be awarded in this solicitation. No funding is provided as 
part of this solicitation. Proposals will be reviewed by a technical 
panel. 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: September 9, 2002
     Submission of Proposals: October 7, 2002
     Application Receipt: November 18, 2002
     Scientific Review: January, 2003
     Institutional Review: February, 2003
     Notification of approval: March 2003
     Anticipated distribution of samples: July-August 2003

ADDRESSES: To send comments and for information, contact:
    Ms. Kika Oraegbu, Division of Health Examination Statistics, 
National Center for Health Statistics, Centers for Disease Control and 
Prevention, 6525 Belcrest Road, Room 1000, Hyattsville, MD 20782, 
Phone: 301-458-4367, FAX: 301-458-4028, E-Mail: [email protected], 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 nutrition 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 http://www.cdc.gov/nchs/about/major/nhanes/nh3data.htm.

[[Page 51586]]

    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 is available from cell lines of Phase II (1991-1994) participants.
    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 
Institutional Review Board (IRB) 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 IRB 
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 IRB 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 deep-well format (96 specimens/per plate) 
~7,300 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 NCHS Research Data 
Center.
    Category (B): Age-race-sex studies using anonymized samples: A 
limited number of subsets may be distributed in 50uL 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 50uL 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 5 
individuals in each statistical cell) of the samples.
    These latter two research designs 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 samples in deep-well format (96 
specimens/per plate) ~7,300 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 data must be 
conducted in the NCHS Research Data Center (RDC). The researcher will 
conduct the genetic laboratory analyses on the samples that are labeled 
with a unique random ID and are, therefore, anonymous to the 
researcher. To perform the data analyses, the researcher will then 
provide the results of the genetic laboratory tests with the random 
identification numbers to the Division of Health Examination Statistics 
(DHES). The random identification numbers are also anonymous to all 
staff, except the one person who has the crosswalk file. These results 
will be matched to the NHANES III data by that person. The resulting 
data file will be provided to the RDC. These analyses will be subject 
to all the confidentiality restrictions of the RDC (http://www.cdc.gov/nchs/r&d/rdc.htm). Because all the data analyses will be completed in 
the NCHS RDC, which charges for computer time and for RDC support time, 
it is recommended that the investigator develop the project proposal in 
conjunction with the NHANES Staff and Research Data Center staff. The 
investigator should perform preliminary analyses using NHANES public 
use data to determine whether the proposed research is feasible. 
Approval of these protocols by the RDC is required after approval by 
the Genetics Technical Panel. The RDC uses the following criteria for 
approval: risk of disclosure, consistency with the mission of NCHS, 
availability of RDC resources, and the feasibility of the project.
    Although researchers sign confidentiality agreements to use the 
RDC, strict confidentiality protocols require that researchers with 
approved projects must complete their work using the facilities located 
within the Research Data Centers (currently only the Hyattsville, MD, 
facility is in operation). Two access methods are available for 
researchers to accomplish their tasks: onsite and remote. The costs and 
restrictions are different for each method. Onsite researchers have the 
ability to use the full capabilities of the SAS system with the only 
additional requirement being a disclosure review. Individual cells are 
suppressed if the minimum requirements for disclosure are not met. 
Additional restrictions limit the analysis capabilities of the remote 
access system. Under these situations, the printed output is scanned 
and screened prior to transmittal to the investigator. Strict minimal 
disclosure limits are adhered to and data items are suppressed if the 
minimums are not met. For remote access, all statistical cells with 
fewer than five observations are suppressed. Under the RDC option 
(protocol category A), the researcher may obtain aggregate statistics 
from statistical calculations which effectively use smaller statistical 
cell sizes for intermediate steps, such as performing regression 
analyses on detailed data, as long as the intermediate steps are never 
made available separately.
    Category (B) Age-race-gender Studies: A limited number of subsets 
may be distributed in 50uL 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 10-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

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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.
    Proposals submitted for this category of review are limited to 
those requesting samples from within these age, 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 50uL 
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 2 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 three proposal designs, the investigators will 
receive samples that are coded with a random identifier that is unique 
to that proposal.

DNA Samples

    For proposals falling into category A, the laboratory will dilute 
the stock specimens that are currently in deep-well plates 1:2 and 
distribute 50 ul aliquots of diluted lysate. The amount of DNA in each 
aliquot will be approximately 180-1,500 nanograms (ng). Aliquots will 
be dispensed into deep-well plates for distribution to investigators. 
Each well will be bar-coded and labeled with a readable identifier. 
Approximately 20-22 sample sets of specimens from 7,300 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 L aliquots in cryovials 
rather than deep-well plates. The amount of DNA in each aliquot will be 
75 to 650 nanograms. Only a limited number of smaller specialized sets 
for category B or C are available. There are only 3 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 Specimen Bank

    A nominal processing fee of $5.00 is charged for each sample 
received from the NHANES III DNA Specimen Bank if the full set of 
specimens (category A) are requested. If the more limited set of 
cryovials is requested, a cost of $38.00/vial is assessed to cover the 
manual selection of these 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 
in accordance with the detailed requirements of the investigators. 
These costs were based on an assumption that NCEH and NCHS will receive 
and process 20 proposals in a year, each requesting 7,300 samples as 
shown in the table below or 5 subsets of 1000 samples in cryovials.
    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 microbiologists, a proposal administrator, and computer 
programmers for NCHS and NCEH to maintain the data bases and verify 
anonymity. 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.

------------------------------------------------------------------------
                                    Per sample for      Per sample for
           Total costs             7,300 samples in       individual
                                    96 well plates         cryovials
------------------------------------------------------------------------
Materials.......................  $ 0.25............  $ 1.90
Labor...........................  2.90..............  22.00
Application review and other      0.35..............  2.69
 administrative expenses.
Space...........................  0.13..............  0.97
Subtotal........................  3.63..............  27.56
NCHS overhead (15%).............  0.54..............  4.12
Subtotal........................  4.17..............  31.68
CDC/FMO overhead (20%)..........  0.83..............  6.32
Total cost per sample...........  5.00..............  38.00
Total cost per proposal.........  36,500............  NA
------------------------------------------------------------------------

    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 September 
9, 2002. 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. Only

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20-22 full sets of samples (7,300 specimens) are available for this 
round of proposals. A limited set of individual cryovials will be 
available for less than the full set of samples. All letters of intent 
will be reviewed by Division of Health Examination Statistics 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's mission to monitor the nations's 
health.
    Letters of intent should be submitted by September 9, 2002.
    Ms. Kika Oraegbu, National Center for Health Statistics, Centers 
for Disease Control and Prevention, 6525 Belcrest Road, Room 1000, 
Hyattsville, MD 20782, Phone: 301-458-4367, FAX: 301-458-4028, E-Mail: 
[email protected].

Procedures for Proposals

    The investigator should follow these instructions for preparation 
of proposals: Prepare proposals with a maximum of five single-spaced 
typed pages, excluding figures and tables, using ten cpi type density. 
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. The cover of the 
proposal should include the name, address, phone number, and E-mail 
address, if available, of the PI, and the name of the institution where 
the DNA analysis will be done, and the category of proposal (A, B, C) 
that would be submitted. The cover page should be signed by the 
responsible institution representative. Proposals will be ranked by the 
technical panel on a scale of 1-10 with 10 being the highest rank for 
each category.
    As there are only 20-22 full sets of samples (7,300 specimens) and 
only a limited set of individual cryovials for proposals requiring less 
than the full set of samples available for this round of proposals, 
proposals will be ranked by the technical panel on a scale of 1-10 with 
10 being the highest rank for each category.
    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 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 subsample 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. If a non-standard laboratory 
method is to be used, discuss its advantages over using existing 
methods. The characteristics of the laboratory assay, such as 
reliability, validity, and ``state-of-the-art,'' should be included 
with appropriate references. The potential difficulties and limitations 
of the proposed procedures should also be discussed. 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. 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 $5.00 for proposals that use the 
full set of samples (~7,300) and $38.00 for subsets. Reimbursement for 
the samples will be collected before the samples are released.
    Proposals will be evaluated by a Genetics Technical Panel and, if 
approved, by the CDC/NCHS IRB for human subject concerns. The IRB 
review will be conducted, even though investigators' 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

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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 October 7, 2002. All investigators 
who submitted letters of intent may submit proposals.
    Electronic submission of proposals is encouraged. Please submit 
proposals to: Ms. Kika Oraegbu, National Center for Health Statistics, 
6525 Belcrest Rd., Rm 1000, Hyattsville MD 20782, Phone: (301) 458-
4367, FAX: (301) 458-4028, E-Mail: [email protected], Attention: NHANES III 
Genetic Testing Program.

Approved Proposals

    NCHS/NCEH 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, 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 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.

Progress Reports

    A progress report will be submitted annually. CDC/NCHS IRB 
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 and the NHANES IRB. 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. 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 Request for Information: Ms. Kika Oraegbu, National Center for 
Health Statistics, Centers for Disease Control and Prevention, 6525 
Belcrest Road, Room 1000, Hyattsville, MD 20782, Phone: 301-458-4367, 
FAX: 301-458-4028, E-Mail: [email protected].

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: August 2, 2002.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 02-20038 Filed 8-7-02; 8:45 am]
BILLING CODE 4163-18-P