sub-study for CRCI registration

Request for Approval under the Generic Clearance for the “Conference, Meeting, Workshop, and Poster Session Registration Generic Clearance (OD)”

(OMB#: 0925-0740, Expiration Date: 07/31/2022)

TITLE OF INFORMATION COLLECTION:

Cancer-Related Cognitive Impairment (CRCI) Clinical Trials Planning Meeting (CTPM)

PURPOSE:

The objectives of this meeting are: Identification of biomarkers (e.g. biospecimen, neuroimaging) for CRCI potentially ready for validation studies in large cohorts to predict short and long-term CRCI and those that should be considered for interventions in randomized controlled trials (RCTs); Determination of CRCI phenotypes (e.g., disease, treatment, baseline cognitive function, socio-demographic factors) that can be independently studied in randomized clinical trials and by prospective observational evaluation; Discussion on best practices for assessment and measurement of self-reported and objectively assessed cognitive function outcomes within large-scale trials; Discussion of interventions with the highest level of evidence to move forward to Phase II/III RCTs.

DESCRIPTION OF RESPONDENTS:

Steering Committee Members and NCI Staff

TYPE OF COLLECTION: (Check one)

[ ] Abstract [ ] Application

[ X ] Registration Form [ ] Other: __ ______

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

Name: Annette Mitchell

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [X ] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ X ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants?

[ ] Yes [X ] No

Amount: _________

Explanation for incentive: (include number of visits, etc)

ESTIMATED BURDEN HOURS and COSTS

Category of Respondent	No. of Respondents	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Individuals	56	1	2/60	2
Totals		56		2

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	2	$46.95	$93.90
Total			$93.90

*Source of the mean Hourly Wage Rate is provided by the Bureau of Labor Statistics, Occupation title “Medical Scientists” 19-1040, https://www.bls.gov/oes/2019/May/oes_nat.htm#00-0000.

FEDERAL COST: The estimated annual cost to the Federal government is $8,668.86.

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director	14/6	$142,950	5%		$7,147.50
Contractor Cost					$1,521.36
Travel
Other Cost
Total					$8,668.86

**The salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/DCB.aspx

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions: N/A

The selection of your targeted respondents

Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [x] Yes [ ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

Steering committee members are the invited guests

Administration of the Instrument

How will you collect the information? (Check all that apply)

[X ] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Survey Form

[ ] Chart Abstraction

[ ] Other, Explain

Will interviewers, facilitators, or research coordinators be used? [ ] Yes [X ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

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