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Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices Serumplasmaurine@cdc.gov. Proposals from CDC investigators must also include the investigators Collaborative Institutional Training Initiative CITI
expiration date.
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 study 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 at least 510
percent of the population. Proposals that expect much lower prevalence estimates need to provide more detail on why samples 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 12 pages the background of the proposal, identifying gaps in knowledge that the project is intended to fill. State concisely the importance of the study 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 samples that are representative of the U.S. population. The investigator should convey how the results will be used and the relationship of the results to the data already collected in NHANES. The analyses should be consistent with the NHANES mission and the health status variables.
3 Study Design and Methods:
Describe the study design, analytic plan, and the procedures to be used. A
detailed description of laboratory methods including validity and reliability must be included with references. The volume of sample 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 investigator is requesting a subsample of samples, a detailed description and justification must be given.
The Technical Panel will evaluate the Investigators submitted proposal study
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design and analysis plan to determine whether the project is consistent with the design of the NHANES survey. The resulting data will be released in the public domain or in rare occasions to the NCHS Research Data Center by NCHS if there is a disclosure concern, e.g. one year of NHANES cycle.
Released data from sub-samples may be less useful to the scientific community, so such requests will receive a lower priority for obtaining the samples.
4 Clinical Significance of Results:
Address the clinical significance to the survey participant of the proposed laboratory test. Since the consent document for sample storage and future studies states that individual results will not be provided to the participant, the investigator must address whether there is evidence that the proposed test results have health implications to the participants and whether knowledge of results would provide grounds for medical intervention even if many years have passed since the participant was in the survey and the sample collected. Any test with results that are clinically significant, and would require reporting to the participant, is not appropriate for testing on the stored serum, plasma, or urine samples and will not be approved; laboratory testing that is clinically significant should be considered for inclusion in a future NHANES survey cycle see NHANES
New Content and Proposal Guidelines cdc.gov.
5 Qualification: Provide a brief description of the Principal Investigators expertise in the proposed area, including publications in this area within the last three years. A
representative sample of earlier publications may be listed if this section does not exceed two pages.
6 Period of Performance: Specify the project time period. Substantial progress must be made in the first year that samples have been obtained, and the project should be completed within a reasonable time period. Please discuss the approximate time the investigator expects this project will take to complete the project. The NCHS Project Officer must be consulted about the disposition of the samples. At the end of the project period, any unused samples must be returned to the NHANES Specimen Repository or discarded appropriately.
7 Funding: 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 sample is $15.00.
The basis for the cost structure is in the last section of this document. Payment
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for the samples will be collected before the samples are released.
Submission of Proposals Proposals can be submitted in MS
Word format by Email to:
Serumplasmaurine@cdc.gov.
Project Timeframes Submitting Proposals: Can be submitted on an ongoing basis.
Scientific Review Date NHANES
Technical Panel: Within one month of proposal submission.
Scientific Review Date NCHS
Human Subjects, Confidentiality and ERB: Within two months of Technical Panel proposal acceptance.
Anticipated distribution of samples:
One month after ERB approval and after all Interagency Agreements or Material Transfer Agreements are signed, and fees are paid.
Approved Proposals Approved projects will be provided samples after 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 samples, or for Federal Government proposals, a signed Interagency Agreement IAA. All laboratory results obtained from the samples must be sent back to NCHS to be linked to the NHANES variables requested by the investigator and that are needed to perform a quality control review of the data. The results data files will undergo disclosure review by the NCHS Disclosure Review Board or NCHS Confidentiality Officer or designee before the linked data are sent to the investigator for quality control review. Once approved by disclosure review and after the investigator has signed the Data Sharing Agreement or a Designated Agent Agreement respectively Agreement, the linked data file will be sent to the investigator for use pursuant to the terms of the relevant agreement. The quality control review must take place within 60 days and the return of the data to NCHS
within the next 30 days so these data may be released to the public.
Agency Agreement A formal signed agreement in the form of an MTA or an IAA with investigators who have projects approved will be completed before the release of the samples to the investigator. This agreement will contain the conditions for use of the samples as stated in this Federal Register Notice and as agreed upon by the investigators and CDC.

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