Substudy Summer Yaffe Series July 2020

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: Sumner J Yaffe Webinar Series Feedback

PURPOSE:

NICHD conducts periodic webinars as part of the Sumner J Yaffe Memorial Webinar Series. The webinars focus on special topics relevant to pediatric clinical pharmacology and developmental pharmacology including research into the use of biomarkers as surrogates for endpoints and obstetric-fetal pharmacology. These webinars are a vehicle for presentation of the latest research in a specific field related to pediatric clinical pharmacology. NICHD would like to collect feedback from participants for the upcoming July 30, 2020 lecture titled “Clinical Lactation Studies and the Role of Pharmacokinetic Modeling and Simulation in Predicting Drug Exposure in Breastfed Infants.”

Feedback will be collected through the Cvent event management system. Participant feedback is used to determine if the speakers are effective in meeting the goals of their presentation, 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 the speakers upon request but not the public.

DESCRIPTION OF RESPONDENTS:

The feedback questionnaire will be sent to all registrants of the webinar in the Sumner J Yaffe Memorial Webinar Series. There are approximately 160 registrants per webinar. Participants are researchers, public health officials, T32 trainees, and others with an interest in pediatric clinical pharmacology.

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
Sumner J Yaffe Webinar Series Feedback Request	Individuals or Households	160	1	3/60	8 hours
Total		.	160		8

Category of Respondents	Total Burden Hours	Wage Rate*	Total Burden Cost
Individuals or Households	8	$84.28	$674.24
Totals			$674.24

* Citing median hourly wage for 29-1221 Pediatricians, General, May 2019, https://www.bls.gov/oes/current/oes291221.htm

FEDERAL COST: The estimated annual cost to the Federal government is $1,506.02

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Officer	GS-15, Step 4	$144,945	1.0	N/A	$1,449.45
Contractor Cost (T&M Contract)		$56.57 per hour	1 hour		$56.57
Travel
Other Cost
Total					$1,506.02

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 Sumner J Yaffe 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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