Fast track sub-study PrinciplesofPedPharm

Request for Approval under the “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NICHD)”

(OMB#: 0925-0643 ExpDate:2/28/2021)

TITLE OF INFORMATION COLLECTION:

Principles of Pediatric Clinical Pharmacology Webinar Feedback.

PURPOSE:

NICHD conducts weekly virtual webinars for its T32 Pediatric Pharmacology Training Program. This course repeats annually. The webinars focus on therapeutic progress and challenges in pediatric medical research and care, particularly in the areas of the safe and effective use of interventions in this population. NICHD would like to collect feedback from participants for each of the webinars in our 28-webinar course, Principles of Pediatric Clinical Pharmacology. Feedback will be collected through the Cvent event management system. The lecture series has been specifically designed to meet the needs of pediatric clinical pharmacology students who lack a formal educational curriculum in this discipline as mandated under the Best Pharmaceuticals for Children Act (BPCA). Participant feedback is used to determine which speakers were effective in meeting the goals of their presentations, to determine what content areas are of most interest to participants for future lectures, and if any logistical/technical issues need to be addressed. Feedback is shared with speakers upon request but not the public.

DESCRIPTION OF RESPONDENTS:

The feedback questionnaire is sent to all registrants for each weekly webinar in the Principles of Pediatric Clinical Pharmacology Lecture Series. Participants are T32 trainees, researchers, public health officials and others with an interest in pediatric clinical pharmacology. The current course has 638 unique participants, who attend as few as one and as many as 28 webinars. During the previous course, participants attended an average of 6 webinars each.

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: George Giacoia, MD, Program Director, Obstetric and Pediatric Pharmacology and Therapeutics Branch, NICHD

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 [X] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [X] No

ESTIMATED BURDEN HOURS and COSTS

Form Name	Category of Respondents	Number of Respondents	Number of Responses per Respondent	Average Burden Per Response (in hours)	Total Annual Burden Hours
Principles of Pediatric Clinical Pharmacology Feedback Request	Individuals or Households	700	10	3/60	350 hours
Total		700	7,000		350

Note: 700 respondents allows for an increase in enrollment in future years. 10 responses per respondent accounts for the fact that respondents will not attend each webinar.

Category of Respondents	Total Burden Hours	Wage Rate*	Total Burden Cost
Individuals or Households	350	$28.64	$10,024
Totals	350		$10,024

* Bureau of Labor Statistics/Occupational Employment and Wages, May 2018: Occupational Code 19-1042, Medical Scientists, national estimates for 25^th percentile (https://www.bls.gov/oes/current/oes191042.htm). This estimate falls within the range allowed for postdoctoral trainees on T32 grants (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-036.html).

FEDERAL COST: The estimated annual cost to the Federal government is $3,033.41

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Officer	GS-14, Step 10	$157,709	1.0	N/A	$1,577
Contractor Cost (T&M Contract)		$56.57 per hour	28 hours		$1,583.96
Travel
Other Cost
Total					$3,033.41

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?

The questionnaire is sent to all registrants of a particular lecture in the 28-lecture webinar series.

Administration of the Instrument

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

[X] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [ ] Yes [X] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

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