sub study request NCCIH CBD Workshop

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:

Exploring Analgesic Properties of Minor Cannabinoids & Terpenes

PURPOSE:

The overall goals of this workshop are two-fold—one is to convene principal investigators funded by NCCIH on the topic of the analgesic properties of minor cannabinoids and terpenes from natural products and the underlying mechanisms; and the other is to discuss current research barriers and opportunities on this topic. This workshop is aligned with NCCIH’s mission to support research on the fundamental science, safety, and usefulness of complementary and integrative health approaches. Specifically, minor cannabinoids and terpenes from natural products are part of complementary interventions supported by NCCIH. The workshop is also aligned with NCCIH’s strategic goals of advancing understanding of basic biological mechanisms of action of natural products and improving care for hard-to-manage symptoms, such as pain.

DESCRIPTION OF RESPONDENTS:

Basic and clinical scientists interested in analgesic properties of minor cannabinoids and terpenes; cannabis researchers; applicants for NIH funding on the topic of therapeutic potential of related natural products for pain relief

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:

Inna Belfer, M.D., Ph.D., program director, Basic and Mechanistic Research in Complementary and Integrative Health Branch, 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)	500	1	10/60	83
Totals		500		83

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	83	$45.80	$3,801.40
Total			$3,801.40

*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 $1,455.78.

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director	14/7	$145,578	1%		$1,455.78
Contractor Cost					0
Travel					0
Other Cost					0
Total					$1,455.78

**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?

We will target outreach to the NIH cannabinoid applicants list (previously used for RFA and NOSI outreach). In addition, we will promote this webinar 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 NCCIH website; 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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