sub-study for Drug Development Workshop

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: NCI Drug Development Workshop:

How to Advance A Therapeutic Candidate from Bench to Bedside

PURPOSE: This virtual workshop is organized by the Division of Cancer Treatment and Diagnosis (DCTD) at the National Cancer Institute (NCI). It is planned to introduce the principles of late stage drug development to educate translational scientists who are interested in advancing their agents to the clinic for cancer treatment. The registration page will provide a platform for individuals who are interested in this workshop to register for the workshop. The information collected on the registration page is needed for the purpose of distributing workshop logistic information and materials, as well as for us to understand our audience composition.

DESCRIPTION OF RESPONDENTS: The intended respondents are researchers who are interested in learning how to advance cancer drugs from preclinical development stage to clinical testing and opt to respond. The main body of respondents are anticipated to be academic translational researchers, particularly those who are NCI grantees and their trainees.

TYPE OF COLLECTION: (Check all that apply)

[ ] 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: Weiwei Chen

To assist review, please provide answers to the following question: If you are collecting name and email, then check yes for PII.

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	300	1	5/60	25
Totals		300		25

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	25	$46.95	$1173.75
Total			$1173.75

*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 $833.20.

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director	14/4	$ 134,782	0.5%		$673.91
Program Director	14/10	$159,286	0.1%		$159.29
Contractor Cost					$
Travel					$
Other Cost					$
Total					$833.20

**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

The selection of your targeted respondents

1. 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?

We will focus on the grantees who are conducting preclinical studies to discover and develop small molecule or biological agents for cancer therapy. The potential group of respondents will be identified by searching NIH’s Query, View, Report (QVR) database for grants that are managed under the Developmental Therapeutics Program. The workshop will also be advertised through Division of Cancer Treatment and Diagnosis listservs and NCI internal staff listservs.

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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