2021 Spring ETCTN (Experimental Therapeutics Clinical Trial Network) Portfolio Presentation/IDSC (Investigational Drug Steering

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: 2021 Spring ETCTN (Experimental Therapeutics Clinical Trial Network) Portfolio Presentation/IDSC (Investigational Drug Steering Committee) Meeting

PURPOSE:

The ETCTN portion of the meeting will be for CTEP’s UM1 investigators to present their early phase clinical trial portfolios. The meeting will enable both NCI staff and ETCTN investigators to be apprised of ongoing and planned clinical trials within the ETCTN program. This face-to-face meeting will promote improved scientific collaboration across the network and enhance accrual to CTEP-sponsored trials. This top to bottom review of the CTEP ETCTN will facilitate alignment of ETCTN activities with CTEP’s program goals. The IDSC (Investigational Drug Steering Committee) portion of the meeting will consist of an afternoon session where IDSC members provide input into CTEP’s clinical development plan for investigational agents for CTEPs portfolio. The agent being considered at this meeting is Lutetium-177 Dotatate.

DESCRIPTION OF RESPONDENTS:

Medical Oncologists, Biostatistians, Pharmacologists, Biologists, Advocates

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: __No incentive/reimbursement is being given $0_______

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	76	1	2/60	3
Totals		76		3

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	3	$ 46.95	$140.85
Total			$ 140.85

*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 $1,757.10.

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director	14/6	$142,950	5%		$714.75
Contractor Cost					$1042.35
Travel					$0
Other Cost					$0
Total					$1,757.10

****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? [ ] 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?

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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