Fast-track template

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB#: 0925-0642 Expiration Date: 3/31/2023)

TITLE OF INFORMATION COLLECTION: Drug Development Topics of Interest to NCI Developmental Therapeutics Program (NCI)

PURPOSE:

The program staff at the NCI’s Developmental Therapeutics Program (DTP) is planning to organize a series of educational workshops. The goal of the workshops is to help DTP grantees gain an enhanced knowledge of late stage preclinical product development, in order to be better positioned in obtaining resources necessary to develop their candidate agents for clinical evaluation.

This survey is designed to gauge the topics of interest to DTP grantees. It entails a series of topics that generally need to be addressed for the development of cancer drugs. The survey outcome will help us identify potential knowledge gaps and topics of special interest to the grantees and design an effective workshop tailored to the needs of the grantees.

DESCRIPTION OF RESPONDENTS: The respondents are grantees who have active grants managed by Program Directors in DTP and opt to respond.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ x ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software) [ ] Small Discussion Group

[ ] Focus Group [ ] 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.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name: Weiwei Chen, Program Director, PTGB/DTP/DCTD/NCI

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

Personally Identifiable Information:

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

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

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] 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	400	1	5/60	33
Totals		400		33

Category of Respondent	Total Burden Hours	Wage Rate*	Total Burden Cost
Individuals	33	$46.95	$1,549.35
Total			$1,549.35

*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: $1,124.20

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director 1	14/3	$129,404	0.004%		$517.62
Program Director 2	14/7	$145,578	0.002%		$291.16
Program Director 3	14/10	$157,709	0.002%		$315.42
Contractor Cost					$0
Travel					$0
Other Cost					$0
Total					$1,124.20

**The salary in the table above is cited from: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/20Tables/html/DCB.aspx

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

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?

Potential respondents are NCI grantees who are conducting preclinical studies to discover and develop chemical entities or biological agents for cancer therapy. Identified potential respondents who have grants in the DTP portfolio will be selected for this survey. The list of potential respondents will be identified using the Query, View, Report (QVR) system.

Administration of the Instrument

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

[ ] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[x] Survey Form

[ ] Chart Abstraction

[ ] Other, Explain

2. 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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