sub study for Relating Target Engagement to Clinical Benefit: Biomarkers

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

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

TITLE OF INFORMATION COLLECTION: Relating Target Engagement to Clinical Benefit: Biomarkers (NCCIH)

PURPOSE:

NIH, in collaboration with the Foundation for the NIH and the Renée Fleming Foundation, are sponsoring an expert panel discussion—the third in a series of three meetings intended to develop evidence-based music therapies for brain disorders of aging.

DESCRIPTION OF RESPONDENTS:

Advocates, basic/mechanistic researchers, clinical researchers, health care providers, journalists, members of the public, music/art therapy providers, NIH employees, policymakers, professional musician/artists, other

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:

Emmeline Edwards, Ph.D., director, NCCIH Division of Extramural Research

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? [X] 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 (Registration)	250	1	10/60	42
Totals		250		42

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	42	$45.80	$1923.60
Total

*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/2018/May/oes_nat.htm#00-0000.

FEDERAL COST: The estimated annual cost to the Federal government is $2,374.91

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Division Director	Top 5 Science Executive Title 42	$270,000	1%		$2,700
Contractor Cost
Travel
Other Cost
Total					$2,700

**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:

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?

NCCIH will reach out to list of grantees, applicants, potential researchers, health care professionals, advocacy groups, and media. We will promote this meeting through the NCCIH Update and Resources for Researchers newsletters as well as on the NCCIH website and social media. The webinar will be listed on the NIH and NCCIH websites; the agenda will be available on both the NCCIH website and Eventbrite registration site.

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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