sub-study Variation to biology

Request for Approval under the “Generic Clearance for NIH Citizen Science and Crowdsourcing Projects” (OMB#: 0925-0766, Expiration Date: 04/30/2023)

TITLE OF INFORMATION COLLECTION: Variation to Biology: Optimizing Functional Analysis of Cancer Risk Variants (NCI)

PURPOSE: NCI is planning a meeting to identify and discuss how best to address scientific challenges and opportunities for understanding the path from genetic variation to the cancer phenotype.

This questionnaire will solicit challenges (i.e., topics) for discussion at the meeting and let respondents volunteer to lead the discussion on a particular challenge at the meeting.

The results will be used to select discussion topics and identify potential discussants for the forthcoming “Variation to Biology: Optimizing Functional Analysis of Cancer Risk Variants” meeting in 2023.

DESCRIPTION OF RESPONDENTS: The respondents are 500 biomedical researchers, including those investigating the genetic epidemiology of cancer, molecular biology laboratory studies, and bioinformatics.

TYPE OF COLLECTION: (Check one)

[ ] Data Catalogue [ ] Repository of Tools and Best Practices

[ ] Recommendations of scientific reviewers [ ] Resources

[ ] Call for Nominations

[ X ] Other: Crowdsourcing

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is a low burden for respondents and a 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 Audrey Wellons, M.P.H.

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 subject to the Privacy Act of 1974? [ ] 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: _________

The explanation for incentive: (include the 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	500	1	10/60	83
Totals		500		83

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	83	$49.44	$ 4,103.52
Total			$ 4,103.52

*Source of the mean Hourly Wage Rate is the average provided by the Bureau of Labor Statistics, for Occupation title “Medical Scientists” 19-1040, at $49.44, https://www.bls.gov/oes/current/oes_nat.htm#19-1040.

FEDERAL COST: The estimated annual cost to the Federal government is $ 977.54

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Communications Specialist	13/3	$113,944	.004		$455.78
Program Officer	14/2	$130,441	.004		$521.76
Contractor Cost					$0
Travel					$0
Other Cost (Venue, AV)					$0
Total					$977.54

**The salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/DCB.pdf.

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

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 describe how you plan to identify your potential group of respondents and how you will select them.

The survey will be sent to

• members of the Impact of Genomic Variation on Function (IGVF) Consortium

• biomedical researchers who have applied for grants from NCI/DCCPS/EGRP

• individuals subscribed to receive updates about NCI/DCCPS/EGRP SeqSPACE (Sequencing Strategies for Population and Cancer Epidemiology Studies) webinars

• FTE staff members in NIH/NCI/DCEG

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 ensure that all instruments, instructions, and scripts are submitted with the request.

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