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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
TABLE AOVERVIEW OF BIOSPECIMENS BY SURVEY YEAR, NHANES III 19881994 AND NHANES 1999-MARCH
2020Continued Pre-pandemic Sample type Pristine 1

NHANES cycle
20092010
20112012
20132014
20152016
20172018
2019March pre-pandemic 2020
1 Samples
lotter on DSK11XQN23PROD with NOTICES1

2 Samples
Surplus 2

Sera
Plasma
Urine
Sera
Plasma
Urine
X X
X X
X X

X

X
X X
X X
X

X
X X
X X
X

immediately frozen for storage, did not undergo laboratory testing.
are surplus specimens after laboratories had completed testing.

Parameters for Sample Use
Proposal Evaluation
1. Investigators should justify why they need a national probability sample for their study.
2. To assure the representative nature of NHANES, at least a 13 sample of a two-year cycle must be requested for an individual proposal. For details of the sampling design, see the Analytic Guidelines at: https wwwn.cdc.gov/
nchs/nhanes/analyticguidelines.aspx.
3. Investigators that request pristine never thawed samples should justify the use of the pristine samples.
4. Only proposals with test results that are determined not to have clinical significance for participants will be accepted. Starting in 1999, the consent form informed participants that they would not receive results from any future laboratory analysis that may be conducted on their samples. Though the consent form for NHANES III had less detail, this parameter is also applicable to the use of NHANES III samples.
Therefore, only proposals with laboratory test results that do not have clinical significance to the survey participant will be accepted. The potential for clinical significance of a laboratory test should be addressed by investigators in the proposal; the determination of clinical significance will be made by the Technical Panel. A
laboratory test result is considered clinically significant to the survey participant if the following criteria are met:
The laboratory test is performed by a Clinical Laboratory Improvement Amendments CLIAcertified laboratory deeming the findings valid, the findings have significant implications for the participants health concerns, and a course of action is readily available to treat the associated health concern
All proposals for use of NHANES
samples will be evaluated by a Technical Panel, the NCHS
Confidentiality Officer, the NCHS
Human Subjects Contact and the NCHS
Ethics Review Board ERB. The current Technical Panel consists of NHANES
staff: Two physicians, one statistician and a laboratory expert. Other experts from inside or outside the Federal Government are added as needed. The Technical Panel reviews proposals for scientific merit to determine: The need to use a nationally representative sample, public health significance, and laboratory assay validity, and potential for clinical significance to the participant. The NCHS Confidentiality Officer reviews for disclosure risk; the NCHS Human Subjects Officer for potential human subjects concerns; and the NCHS ERB for conforming to the informed consent. The NCHS ERB will review the proposal even if the investigator has received approval by their respective institutional review panel. The proposal, if approved, will become an amendment to the current NHANES ERB Protocol i.e., the NHANES ERB Protocol that is in effect at the time of the investigators proposal approval and held at NCHS.
The Technical Panel will evaluate the proposal for the scientific, technical, and clinical significance to the participant, the appropriateness and adequacy of the study design, and the methodology proposed to reach the study goals. See Procedures for 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 U.S. population, the appropriateness of the NHANES sample to address the goals of the proposal will be an important aspect of scientific merit.

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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 study. For this reason, investigators submitting proposals are required to request at least a 13 sample of a NHANES cycle to maintain the representative nature of the survey.
The Technical Panel will also review the data analysis plan and evaluate whether the proposal is an appropriate use of the NHANES samples. The investigators should justify why they need a national probability sample for their study. The Technical Panel review will seek to 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 NHANES proposal.
Investigators are encouraged to review the NHANES data, survey documents, manuals and questionnaires at:
NHANES Questionnaires, Datasets, and Related Documentation cdc.gov or for NHANES III: https wwwn.cdc.gov/
nchs/nhanes/nhanes3/datafiles.aspx Procedures for Proposals All investigators including CDC
investigators must submit a proposal for use of NHANES serum, plasma, or urine samples. Proposals are limited to a maximum of 10 single-spaced typed pages, excluding figures and tables, using at least a size 10 font. The cover of the proposal which is not included in the 10-page limit should include the title of the proposal, the name, address, phone number and Email address of the principal investigator PI, and the name of the institution where the laboratory analysis will be done. The name, address, phone number and Email address of all additional investigators should also be included on the cover.
All proposals should be Emailed to
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