National Health and Nutrition Examination Survey (NHANES) Stored Biologic Specimens: Guidelines for Proposals to Use Samples and Proposed Cost Schedule, 35872-35875 [E9-17267]
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environmental assessment by August
20, 2009.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Blondell Anderson, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1304.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 9A4778) has been filed by
Ajinomoto Co., Inc., c/o Ajinomoto
Corporate Services LLC, 1120
Connecticut Ave. NW., suite 1010,
Washington, DC 20036. The petition
proposes to amend the food additive
regulations in part 172 Food Additives
Permitted For Direct Addition to Food
for Human Consumption (21 CFR part
172) to provide for the safe use of N-[N[3-(3-hydroxy-4-methoxyphenyl)
propyl-a-aspartyl]-L-phenylalanine 1methyl ester, monohydrate (CAS Reg.
No. 714229–20–6) for use as a nonnutritive sweetener in tabletop
applications and powdered beverage
mixes.
The potential environmental impact
of this petition is being reviewed. To
encourage public participation
consistent with regulations issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see DATES and ADDRESSES) for public
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Interested persons may submit to the
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Submit a single copy of electronic
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that an environmental impact statement
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regulation in the Federal Register in
accordance with 21 CFR 25.51(b).
Dated: July 10, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E9–17250 Filed 7–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Health and Nutrition
Examination Survey (NHANES) Stored
Biologic Specimens: Guidelines for
Proposals to Use Samples and
Proposed Cost Schedule
ACTION: Notice and request for
comments.
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 health
and nutritional status of the United
States civilian non-institutionalized
population. To add to the large amount
of information collected for the purpose
of describing the health of the
population in the most recent survey,
serum, urine and limited plasma
samples were collected and stored for
future research projects. Specimens are
currently available from NHANES III
(conducted from 1988–1994) and from
NHANES 1999–2008. In 1999, NHANES
became a continuous survey with data
release every two years. Specimens are
available from two year survey cycles
after the demographic file has been
released to the public. Participants in
the survey that began in 1999 signed a
separate consent document agreeing to
specimen storage allowing their biologic
specimens to be used for approved
research projects.
Specimens are stored in two
Specimen Banks. Surplus samples that
were initially used for laboratory assays
included in the surveys, have since been
stored at ¥70 °C and have been through
at least two freeze-thaw cycles. They are
stored at a commercial repository under
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contract to NCHS. In addition, on
average, six vials of sera were also
stored in vapor-phase liquid nitrogen at
the CDC and ATSTR Specimen
Packaging, Inventory and Repository
(CASPIR) Repository in Lawrenceville,
GA. These specimens have not
undergone a freeze-thaw cycle. The
CASPIR Repository is considered a longterm repository for the NHANES
specimens. NCHS is making both of
these collections available for research
proposals. The research proposals that
can use the surplused specimens will
receive higher priority. Proposals that
request the specimens in CASPIR need
to justify the use of the unthawed
specimens.
The purpose of this notice is to
request comments on this program and
the proposed cost schedule. After
consideration of comments submitted,
CDC will finalize and publish the cost
schedule and accept proposals for use of
the NHANES stored biologic samples.
Please go to https://www.cdc.gov/nchs/
nhanes/proposal_guidelines.htm for
final proposal guidelines.
All interested researchers are
encouraged to submit proposals. No
funding is provided as part of this
solicitation. Samples will not be
provided to those projects requiring
funding until the project has received
funds. Approved projects that do not
obtain funding will be canceled. A more
complete description of this program
follows.
DATES:
• Comment Receipt Date: August 20,
2009.
• Invitation to Submit Proposals: Can
be submitted on an ongoing basis
• Scientific Review Date: Within two
months of proposal submission.
• Institutional Review Date: Within
one month of final proposal acceptance.
• Anticipated distribution of samples:
one month after IRB approval.
ADDRESSES: To send comments and to
request information, contact: Dr.
Geraldine McQuillan, 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: gmm2@cdc.gov.
Internet: https://www.cdc.gov/nchs/
about/major/nhanes/serum1b.htm.
Authority: Sections 301,306 and 308 of the
Public Health Service Act (42 U.S.C. 241,
242k and 242M).
SUPPLEMENTARY INFORMATION:
The goals of NHANES are: (1) To
estimate the number and percent of
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persons in the U.S. population and
designated subgroups with selected
diseases and risk factors; (2) to monitor
trends in the prevalence, awareness,
treatment and control of selected
diseases; (3) to monitor trends in risk
behaviors and environmental exposures;
(4) to analyze risk factors for selected
diseases; (5) to study the relationship
between diet, nutrition and health; (6) to
explore emerging public health issues
and new technologies; and, (7) to
establish and maintain a national
probability sample of baseline
information on health and nutrition
status.
Specimens are available from the
third National Health and Nutrition
Examination Survey (NHANES III) and
the continuous NHANES that started in
1999. Approximately 30,000 individuals
were examined in NHANES III which
began in the fall of 1988, and ended in
the fall of 1994. This survey can be
analyzed in two phases. Phase 1 was
conducted from October 1988 to
October 1991 and Phase 2 began
October 1991 and ended October 1994.
Though participants consented to
storing samples of their blood for future
testing only research projects that
include results that are judged not to
have clinical significance for
participants will be accepted. Clinical
significance is defined by the following
criteria:
• The findings are valid and done by
a CLIA-certified laboratory, and
• The findings may have significant
implications for the subjects’ health
concerns, and
• A course of action to ameliorate, or
treat the concerns is readily available.
There are approximately 368,473 serum
samples available for research proposals
using NHANES III samples. An aliquot
of the samples will be reserved in
perpetuity. See: https://www.cdc.gov/
nchs/about/major/nhanes/nh3data.htm
for more information on NHANES III.
Beginning in 1999, NHANES became
a continuous, annual survey with
examination of approximately 5,000
individuals a year and data release
every two years. Proposed research
projects and samples requested must
come from this two-year design (i.e.
request must be for 1999–2000 samples
or 2001–2002, etc.). Samples from a
single year of the survey will not be
provided for research projects, but
multiple two-year cycles may be
requested. There are approximately
329,420 serum samples, 55,411 urine
samples and 79,604 plasma samples
available for research proposals. An
aliquot of the samples will be reserved
in perpetuity. For details of the
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sampling design see the Analytic
Guidelines at: https://www.cdc.gov/nchs/
about/major/nhanes/nhanes2003–2004/
analytical_guidelines.htm.
Starting in 1999 to 2008 survey
participants were informed in the
consent document for future laboratory
analysis that they would not receive the
results from these studies. Therefore,
only research projects that propose
laboratory results that do not have
clinical significance (see definition of
clinical relevance above) to an
individual will be accepted by NCHS.
Clinical significance of a laboratory test
will be judged by the NHANES Medical
Officer, but the researcher should
address this in the research proposal.
See https://www.cdc.gov/nchs/about/
major/nhanes/nhanes2007–2008/
current_nhanes_07_08.htm for a copy of
the current consent document.
All proposals for use of NHANES
samples will be evaluated by a technical
panel for scientific merit and by the
NHANES Ethics Review Board (ERB) for
any potential human subjects concerns.
The NHANES ERB will review the
proposal even if the investigator has
received approval by their institutional
review panel.
To determine if this limited resource
should be used in the proposed projects,
a Technical Panel will evaluate the
public health significance and scientific
merit of the proposed research.
Scientific merit will be judged as to 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. See ‘Criteria for
Technical Evaluation of Proposals’
below. The proposal should outline how
the results from the laboratory analysis
will be used. Because NHANES is a
complex, multistage probability sample
of the national population, the
appropriateness of the NHANES sample
to address the goals of the proposal will
be an important aspect of scientific
merit. The survey oversamples the two
largest race/ethnic minority groups,
non-Hispanic blacks and Mexican
Americans along with other subgroups
of the population. Sampling weights are
therefore used to make national
estimates of frequencies. The use of
weights, sampling frame and methods of
assessment of variables included in the
data are likely to affect the proposed
research. The Technical Panel will
review the analysis plan and evaluate
whether the proposal is an appropriate
use of the NHANES population. The
Technical Panel will also assure that the
proposed project does not go beyond
either the general purpose for collecting
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the samples in the survey, or of the
specific stated goals of the proposal.
Investigators are encouraged to review
the NHANES data, survey documents,
manuals and questionnaires at: https://
www.cdc.gov/nchs/about/major/
nhanes/nhanes99–02.htm or for
NHANES III: https://www.cdc.gov/nchs/
about/major/nhanes/nh3data.htm.
Procedures for Proposals: All
investigators (including CDC
investigators) must submit a proposal
for use of NHANES specimens.
Proposals are limited to a maximum
of 10 single-spaced typed pages,
excluding figures and tables, using 10
cpi type density. The cover of the
proposal should include the name,
address, and phone number and E-mail
address of the principal investigator (PI)
and the name of the institution where
the laboratory analysis will be done. All
proposals should be E-mailed to
gmm2@cdc.gov. Proposals must include
a cover page with the title of the
proposal and the name, address, phone
number and E-mail address of all
investigators. Proposals from CDC
investigators must also include
investigators’ scientific ethic
verification number.
The following criteria will be used for
technical evaluation of proposals:
Proposals should include the
following information:
(1) Specific Aims: List the broad
objectives; describe concisely and
realistically what the research is
intended to accomplish, and state the
specific hypotheses to be tested.
NHANES is designed to provide
prevalence estimates of diseases or
conditions that are expected to affect
between 5–10 percent of the population.
Research proposals that expect much
lower prevalence estimates need to
provide more detail on why specimens
from NHANES are needed for the
project and provide details on how
these data will be analyzed.
(2) Background and Public Health
Significance: Describe the public health
significance, scientific merit and
practical utility of the assay. Briefly
describe in 1–2 pages the background of
the proposal, identifying gaps in
knowledge that the project is intended
to fill. State concisely the importance of
the research in terms of the broad, longterm objectives and public health
relevance including a discussion of how
the results will affect public health
policy or further scientific knowledge.
The proposal should justify the need for
specimens that are representative of the
U.S. population. The proposer should
convey how the results will be used and
the relationship of the results to the data
already collected in NHANES. The
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proposer should include an analysis
plan. The analyses ought to be
consistent with the NHANES mission
and the health status variables.
(3) Research Design and Methods:
Describe the research design and the
procedures to be used. A detailed
description of laboratory methods
including validity and reliability must
be included with references. The
volume of specimen and number of
samples requested must be specified.
Adequate methods for handling and
storage of samples must also be
addressed. The laboratory must
demonstrate expertise in the proposed
laboratory test including the capability
for handling the workload requested in
the proposal. The proposal should also
include a justification for determination
of sample size or a power calculation. If
the researcher is requesting a subsample of specimens, a detailed
description and justification, must be
given. The researcher must describe
how this sub-sample will be re-weighted
to provide national estimates. The
program will evaluate the study design
and analysis plan in the proposal to
determine whether the project is
consistent with the design of the
NHANES survey. Sub-samples are less
useful to the research community when
the data are released in the public
domain, so such requests will receive a
lower priority for the specimens.
Restricting a research proposal to
demographic categories that are design
variables for the survey is encouraged if
laboratory testing must be restricted.
(4) Clinical Significance or results:
Since the consent document for
specimen storage and continuing
studies states that individual results
will not be provided, the clinical
significance of the proposed laboratory
test should be addressed. The proposal
should include a discussion of the
potential clinical significance of the
results and whether there is definitive
evidence that results of the test would
provide grounds for medical
intervention even if many years have
passed since the examination of the
participant and collection of the sample.
Any test with results that should be
reported to a participant should be
considered for inclusion in the
concurrent survey, and is not
appropriate for testing on the stored
samples.
(5) Qualification: Provide a brief
description of the Principal
Investigator’s expertise in the proposed
area should be provided, including
publications in this area within the last
three years. A representative sample of
earlier publications may be listed as
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long as this section does not exceed two
pages.
(6) Period of performance: Specify the
project period. Substantial progress
must be made in the first year, and the
project should be completed in two
years. If additional time is needed for
the research project a detailed
justification with a timeline should be
included. The investigator should
address his/her ability to comply with
this timeline or request and justify
additional time for the project. Return of
the specimens will be requested if
progress is not made in the project at the
end of the second year. Refund of
payment for the specimens will not be
returned in this situation. At the end of
the project period, any unused samples
must be returned to the NHANES
Specimen Bank or discarded. The NCHS
Project Officer must be consulted about
the disposition of the samples.
(7) Funding: Include the source and
status of the funding to perform the
requested laboratory analysis should be
included. Investigators will be
responsible for the cost of processing
and shipping the samples. The cost per
specimen is $6.50. The basis for the cost
structure is in the last section of this
document. Reimbursement for the
samples will be collected before the
samples are released.
Submission of Proposals: Proposals
can be submitted in MS Word format by
e-mail to: Dr. Geraldine McQuillan,
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: gmm2@cdc.gov.
Approved Proposals: Approved
projects will be provided specimens on
receipt of a signed Materials Transfer
Agreement (MTA) and a check (written
to The Centers for Disease Control and
Prevention) for the cost of the
specimens. All laboratory results
obtained from the samples will be sent
back to NCHS to be linked to the
sequence number that is the linking
identifier on the public use files. All
files will undergo disclosure review at
NCHS. Within 90 days of the return of
the data to NCHS these data may be
released to the public.
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
samples as stated in this document and
as agreed upon by the investigators and
CDC.
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Progress Reports: Brief progress
reports will be submitted annually. This
will be the basis for the NHANES ERB
continuation reports that are required
annually.
Disposition of Results and Samples:
No samples provided can be used for
any purpose other than those
specifically requested in the proposal
and approved by the Technical Panel
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 to the
NHANES Specimen Bank or disposed of
upon completion of the approved
project. These results, once returned to
NCHS, will be part of the public
domain. The proposer will have 90 days
for quality control review of the data
before public release.
Proposed Cost Schedule for Providing
NHANES Specimens: A nominal
processing fee of $8.50 is proposed for
each sample received from the NHANES
Specimen Bank. The costs include both
the collection, storage and processing of
the specimens along with the review of
proposals and the preparation of the
data files. These costs were based on an
assumption that NCHS will receive and
process eight proposals in a year, each
requesting 5,000 samples as shown in
the table below.
The materials listed are for the
recurring laboratory costs to dispense
and prepare the samples during
collection and for shipping; the
computer software needed for the
preparation of the data files and for the
release of the data along with
documentation on the NHANES Web
page. Labor costs are based on a
proposal administrator and computer
programmers at NCHS to prepare the
data files. The storage and pulling fees
include the costs for the NHANES
repository.
Total costs
Cost per
vial
Labor .............................................
Collection Storage ........................
Pulling specimens .........................
Shipping ........................................
Subtotal .........................................
CDC/FMO support (9%) ...............
$1.15
4.10
1.04
0.32
6.61
0.59
Subtotal .................................
NCHS support (18%) ....................
7.20
1.30
Total .......................................
8.50
Comments are solicited on the
proposed cost schedule. Comments are
due by: August 20, 2009.
Send Comments and Requests for
Information to: Dr. Geraldine
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McQuillan, 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, email: gmm2@cdc.gov.
Tanja Popovic,
Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–17267 Filed 7–20–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0309]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on
Bracketing and Matrixing Designs for
Stability Testing of New Veterinary
Drug Substances and Medicinal
Products (VICH GL45); Availability
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry (#198) entitled ‘‘Draft Guidance
for Industry on Bracketing and
Matrixing Designs For Stability Testing
of New Veterinary Drug Substances and
Medicinal Products,’’ VICH GL45. This
draft guidance has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This draft guidance is an annex
to a VICH guidance entitled ‘‘Stability
Testing of New Veterinary Drug
Substances and Medicinal Products
(Revision),’’ VICH GL3(R), that
published in the Federal Register of
November 23, 2007 (72 FR 65751). This
draft VICH guidance document is
intended to provide guidance on the
application of reduced designs (i.e.,
bracketing and matrixing) for stability
studies conducted in accordance with
the principles outlined in VICH GL3(R).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance submit
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written or electronic comments on the
draft guidance by August 20, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Dennis Bensley, Center for Veterinary
Medicine (HFV–140), Food and Drug
Administration, 7500 Standish Place,
Rockville, MD 20855, 240–276–8268, email: dennis.bensley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry (#198)
entitled ‘‘Draft Guidance for Industry on
Bracketing and Matrixing Designs for
Stability Testing of New Veterinary
Drug Substances and Medicinal
Products,’’ VICH GL45. In recent years,
many important initiatives have been
undertaken by regulatory authorities
and industry associations to promote
the international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Approval of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
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States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from: The European Commission,
European Medicines Evaluation Agency,
European Federation of Animal Health,
Committee on Veterinary Medicinal
Products, the U.S. FDA, the U.S.
Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary
Pharmaceutical Association, the
Japanese Association of Veterinary
Biologics, and the Japanese Ministry of
Agriculture, Forestry, and Fisheries.
Four observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, and one representative from the
industry of Canada. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Draft Guidance on Bracketing and
Matrixing Designs for Stability Testing
The VICH Steering Committee held a
meeting on February 11, 2008, and
agreed that the draft guidance document
entitled ‘‘Draft Guidance for Industry on
Bracketing and Matrixing Designs for
Stability Testing of New Veterinary
Drug Substances and Medicinal
Products,’’ VICH GL45 should be made
available for public comment. This draft
VICH guidance document provides
guidance on bracketing and matrixing
study designs. Specific principles are
defined in this guidance for situations
in which bracketing or matrixing can be
applied. This document is intended to
address recommendations on the
application of bracketing and matrixing
to stability studies conducted in
accordance with principles outlined in
the VICH GL3(R), ‘‘Stability Testing of
New Veterinary Drug Substances and
Medicinal Products (Revision).’’ FDA
and the VICH Expert Quality Working
Group will consider comments about
the draft guidance document.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
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21JYN1
Agencies
[Federal Register Volume 74, Number 138 (Tuesday, July 21, 2009)]
[Notices]
[Pages 35872-35875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17267]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Health and Nutrition Examination Survey (NHANES) Stored
Biologic Specimens: Guidelines for Proposals to Use Samples and
Proposed Cost Schedule
ACTION: Notice and request for comments.
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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 health and nutritional status of
the United States civilian non-institutionalized population. To add to
the large amount of information collected for the purpose of describing
the health of the population in the most recent survey, serum, urine
and limited plasma samples were collected and stored for future
research projects. Specimens are currently available from NHANES III
(conducted from 1988-1994) and from NHANES 1999-2008. In 1999, NHANES
became a continuous survey with data release every two years. Specimens
are available from two year survey cycles after the demographic file
has been released to the public. Participants in the survey that began
in 1999 signed a separate consent document agreeing to specimen storage
allowing their biologic specimens to be used for approved research
projects.
Specimens are stored in two Specimen Banks. Surplus samples that
were initially used for laboratory assays included in the surveys, have
since been stored at -70 [deg]C and have been through at least two
freeze-thaw cycles. They are stored at a commercial repository under
contract to NCHS. In addition, on average, six vials of sera were also
stored in vapor-phase liquid nitrogen at the CDC and ATSTR Specimen
Packaging, Inventory and Repository (CASPIR) Repository in
Lawrenceville, GA. These specimens have not undergone a freeze-thaw
cycle. The CASPIR Repository is considered a long-term repository for
the NHANES specimens. NCHS is making both of these collections
available for research proposals. The research proposals that can use
the surplused specimens will receive higher priority. Proposals that
request the specimens in CASPIR need to justify the use of the unthawed
specimens.
The purpose of this notice is to request comments on this program
and the proposed cost schedule. After consideration of comments
submitted, CDC will finalize and publish the cost schedule and accept
proposals for use of the NHANES stored biologic samples. Please go to
https://www.cdc.gov/nchs/nhanes/proposal_guidelines.htm for final
proposal guidelines.
All interested researchers are encouraged to submit proposals. No
funding is provided as part of this solicitation. Samples will not be
provided to those projects requiring funding until the project has
received funds. Approved projects that do not obtain funding will be
canceled. A more complete description of this program follows.
DATES:
Comment Receipt Date: August 20, 2009.
Invitation to Submit Proposals: Can be submitted on an
ongoing basis
Scientific Review Date: Within two months of proposal
submission.
Institutional Review Date: Within one month of final
proposal acceptance.
Anticipated distribution of samples: one month after IRB
approval.
ADDRESSES: To send comments and to request information, contact: Dr.
Geraldine McQuillan, 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: gmm2@cdc.gov.
Internet: https://www.cdc.gov/nchs/about/major/nhanes/serum1b.htm.
Authority: Sections 301,306 and 308 of the Public Health
Service Act (42 U.S.C. 241, 242k and 242M).
SUPPLEMENTARY INFORMATION:
The goals of NHANES are: (1) To estimate the number and percent of
[[Page 35873]]
persons in the U.S. population and designated subgroups with selected
diseases and risk factors; (2) to monitor trends in the prevalence,
awareness, treatment and control of selected diseases; (3) to monitor
trends in risk behaviors and environmental exposures; (4) to analyze
risk factors for selected diseases; (5) to study the relationship
between diet, nutrition and health; (6) to explore emerging public
health issues and new technologies; and, (7) to establish and maintain
a national probability sample of baseline information on health and
nutrition status.
Specimens are available from the third National Health and
Nutrition Examination Survey (NHANES III) and the continuous NHANES
that started in 1999. Approximately 30,000 individuals were examined in
NHANES III which began in the fall of 1988, and ended in the fall of
1994. This survey can be analyzed in two phases. Phase 1 was conducted
from October 1988 to October 1991 and Phase 2 began October 1991 and
ended October 1994. Though participants consented to storing samples of
their blood for future testing only research projects that include
results that are judged not to have clinical significance for
participants will be accepted. Clinical significance is defined by the
following criteria:
The findings are valid and done by a CLIA-certified
laboratory, and
The findings may have significant implications for the
subjects' health concerns, and
A course of action to ameliorate, or treat the concerns is
readily available.
There are approximately 368,473 serum samples available for research
proposals using NHANES III samples. An aliquot of the samples will be
reserved in perpetuity. See: https://www.cdc.gov/nchs/about/major/nhanes/nh3data.htm for more information on NHANES III.
Beginning in 1999, NHANES became a continuous, annual survey with
examination of approximately 5,000 individuals a year and data release
every two years. Proposed research projects and samples requested must
come from this two-year design (i.e. request must be for 1999-2000
samples or 2001-2002, etc.). Samples from a single year of the survey
will not be provided for research projects, but multiple two-year
cycles may be requested. There are approximately 329,420 serum samples,
55,411 urine samples and 79,604 plasma samples available for research
proposals. An aliquot of the samples will be reserved in perpetuity.
For details of the sampling design see the Analytic Guidelines at:
https://www.cdc.gov/nchs/about/major/nhanes/nhanes2003-2004/analytical_guidelines.htm.
Starting in 1999 to 2008 survey participants were informed in the
consent document for future laboratory analysis that they would not
receive the results from these studies. Therefore, only research
projects that propose laboratory results that do not have clinical
significance (see definition of clinical relevance above) to an
individual will be accepted by NCHS. Clinical significance of a
laboratory test will be judged by the NHANES Medical Officer, but the
researcher should address this in the research proposal. See https://www.cdc.gov/nchs/about/major/nhanes/nhanes2007-2008/current_nhanes_07_08.htm for a copy of the current consent document.
All proposals for use of NHANES samples will be evaluated by a
technical panel for scientific merit and by the NHANES Ethics Review
Board (ERB) for any potential human subjects concerns. The NHANES ERB
will review the proposal even if the investigator has received approval
by their institutional review panel.
To determine if this limited resource should be used in the
proposed projects, a Technical Panel will evaluate the public health
significance and scientific merit of the proposed research. Scientific
merit will be judged as to 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. See `Criteria for Technical Evaluation of Proposals'
below. The proposal should outline how the results from the laboratory
analysis will be used. Because NHANES is a complex, multistage
probability sample of the national population, the appropriateness of
the NHANES sample to address the goals of the proposal will be an
important aspect of scientific merit. The survey oversamples the two
largest race/ethnic minority groups, non-Hispanic blacks and Mexican
Americans along with other subgroups of the population. Sampling
weights are therefore used to make national estimates of frequencies.
The use of weights, sampling frame and methods of assessment of
variables included in the data are likely to affect the proposed
research. The Technical Panel will review the analysis plan and
evaluate whether the proposal is an appropriate use of the NHANES
population. The Technical Panel will also assure that the proposed
project does not go beyond either the general purpose for collecting
the samples in the survey, or of the specific stated goals of the
proposal.
Investigators are encouraged to review the NHANES data, survey
documents, manuals and questionnaires at: https://www.cdc.gov/nchs/about/major/nhanes/nhanes99-02.htm or for NHANES III: https://www.cdc.gov/nchs/about/major/nhanes/nh3data.htm.
Procedures for Proposals: All investigators (including CDC
investigators) must submit a proposal for use of NHANES specimens.
Proposals are limited to a maximum of 10 single-spaced typed pages,
excluding figures and tables, using 10 cpi type density. The cover of
the proposal should include the name, address, and phone number and E-
mail address of the principal investigator (PI) and the name of the
institution where the laboratory analysis will be done. All proposals
should be E-mailed to gmm2@cdc.gov. Proposals must include a cover page
with the title of the proposal and the name, address, phone number and
E-mail address of all investigators. Proposals from CDC investigators
must also include investigators' scientific ethic verification number.
The following criteria will be used for technical evaluation of
proposals:
Proposals should include the following information:
(1) Specific Aims: List the broad objectives; describe concisely
and realistically what the research is intended to accomplish, and
state the specific hypotheses to be tested. NHANES is designed to
provide prevalence estimates of diseases or conditions that are
expected to affect between 5-10 percent of the population. Research
proposals that expect much lower prevalence estimates need to provide
more detail on why specimens from NHANES are needed for the project and
provide details on how these data will be analyzed.
(2) Background and Public Health Significance: Describe the public
health significance, scientific merit and practical utility of the
assay. Briefly describe in 1-2 pages the background of the proposal,
identifying gaps in knowledge that the project is intended to fill.
State concisely the importance of the research in terms of the broad,
long-term objectives and public health relevance including a discussion
of how the results will affect public health policy or further
scientific knowledge. The proposal should justify the need for
specimens that are representative of the U.S. population. The proposer
should convey how the results will be used and the relationship of the
results to the data already collected in NHANES. The
[[Page 35874]]
proposer should include an analysis plan. The analyses ought to be
consistent with the NHANES mission and the health status variables.
(3) Research Design and Methods: Describe the research design and
the procedures to be used. A detailed description of laboratory methods
including validity and reliability must be included with references.
The volume of specimen and number of samples requested must be
specified. Adequate methods for handling and storage of samples must
also be addressed. The laboratory must demonstrate expertise in the
proposed laboratory test including the capability for handling the
workload requested in the proposal. The proposal should also include a
justification for determination of sample size or a power calculation.
If the researcher is requesting a sub-sample of specimens, a detailed
description and justification, must be given. The researcher must
describe how this sub-sample will be re-weighted to provide national
estimates. The program will evaluate the study design and analysis plan
in the proposal to determine whether the project is consistent with the
design of the NHANES survey. Sub-samples are less useful to the
research community when the data are released in the public domain, so
such requests will receive a lower priority for the specimens.
Restricting a research proposal to demographic categories that are
design variables for the survey is encouraged if laboratory testing
must be restricted.
(4) Clinical Significance or results: Since the consent document
for specimen storage and continuing studies states that individual
results will not be provided, the clinical significance of the proposed
laboratory test should be addressed. The proposal should include a
discussion of the potential clinical significance of the results and
whether there is definitive evidence that results of the test would
provide grounds for medical intervention even if many years have passed
since the examination of the participant and collection of the sample.
Any test with results that should be reported to a participant should
be considered for inclusion in the concurrent survey, and is not
appropriate for testing on the stored samples.
(5) Qualification: Provide a brief description of the Principal
Investigator's expertise in the proposed area should be provided,
including publications in this area within the last three years. A
representative sample of earlier publications may be listed as long as
this section does not exceed two pages.
(6) Period of performance: Specify the project period. Substantial
progress must be made in the first year, and the project should be
completed in two years. If additional time is needed for the research
project a detailed justification with a timeline should be included.
The investigator should address his/her ability to comply with this
timeline or request and justify additional time for the project. Return
of the specimens will be requested if progress is not made in the
project at the end of the second year. Refund of payment for the
specimens will not be returned in this situation. At the end of the
project period, any unused samples must be returned to the NHANES
Specimen Bank or discarded. The NCHS Project Officer must be consulted
about the disposition of the samples.
(7) Funding: Include the source and status of the funding to
perform the requested laboratory analysis should be included.
Investigators will be responsible for the cost of processing and
shipping the samples. The cost per specimen is $6.50. The basis for the
cost structure is in the last section of this document. Reimbursement
for the samples will be collected before the samples are released.
Submission of Proposals: Proposals can be submitted in MS Word
format by e-mail to: Dr. Geraldine McQuillan, 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: gmm2@cdc.gov.
Approved Proposals: Approved projects will be provided specimens on
receipt of a signed Materials Transfer Agreement (MTA) and a check
(written to The Centers for Disease Control and Prevention) for the
cost of the specimens. All laboratory results obtained from the samples
will be sent back to NCHS to be linked to the sequence number that is
the linking identifier on the public use files. All files will undergo
disclosure review at NCHS. Within 90 days of the return of the data to
NCHS these data may be released to the public.
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 samples as stated
in this document and as agreed upon by the investigators and CDC.
Progress Reports: Brief progress reports will be submitted
annually. This will be the basis for the NHANES ERB continuation
reports that are required annually.
Disposition of Results and Samples: No samples provided can be used
for any purpose other than those specifically requested in the proposal
and approved by the Technical Panel 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 to
the NHANES Specimen Bank or disposed of upon completion of the approved
project. These results, once returned to NCHS, will be part of the
public domain. The proposer will have 90 days for quality control
review of the data before public release.
Proposed Cost Schedule for Providing NHANES Specimens: A nominal
processing fee of $8.50 is proposed for each sample received from the
NHANES Specimen Bank. The costs include both the collection, storage
and processing of the specimens along with the review of proposals and
the preparation of the data files. These costs were based on an
assumption that NCHS will receive and process eight proposals in a
year, each requesting 5,000 samples as shown in the table below.
The materials listed are for the recurring laboratory costs to
dispense and prepare the samples during collection and for shipping;
the computer software needed for the preparation of the data files and
for the release of the data along with documentation on the NHANES Web
page. Labor costs are based on a proposal administrator and computer
programmers at NCHS to prepare the data files. The storage and pulling
fees include the costs for the NHANES repository.
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Cost per
Total costs vial
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Labor........................................................ $1.15
Collection Storage........................................... 4.10
Pulling specimens............................................ 1.04
Shipping..................................................... 0.32
Subtotal..................................................... 6.61
CDC/FMO support (9%)......................................... 0.59
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Subtotal................................................. 7.20
NCHS support (18%)........................................... 1.30
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Total.................................................... 8.50
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Comments are solicited on the proposed cost schedule. Comments are
due by: August 20, 2009.
Send Comments and Requests for Information to: Dr. Geraldine
[[Page 35875]]
McQuillan, 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: gmm2@cdc.gov.
Tanja Popovic,
Chief Science Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-17267 Filed 7-20-09; 8:45 am]
BILLING CODE 4163-18-P