Fast track template for CTG

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB#: 0925-0648 Exp., date: 06/2024)

TITLE OF INFORMATION COLLECTION: ClinicalTrials.gov Modernization Satisfaction (NLM)

PURPOSE:

The NIH ClinicalTrials.gov is offering an optional survey requesting feedback on satisfaction of the new modernized web products for virtual meeting on April 25, 2023.

• Modernized ClinicalTrials.gov beta website

• Modernized PRS (Protocol Registration and Results System) Beta

The goals are to assess the level of satisfaction and access of with the new website, including the submission database. We want to learn if the new sites are meeting customer expectations.

DESCRIPTION OF RESPONDENTS:

The plan is to obtain feedback from a general audience already registered to attend a public webinar to learn about the modernization of ClinicalTrials.gov. The audience may be scientists who frequently use the product or may be a first-time user accessing the ClinicalTrials.gov website. The audience is most likely an hourly wage worker or scientist who submits to the database and have access to a computer, internet, or social media.

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: ______________________

FREQUENCY OF REPORTING: (Check one)

[ ] Once [ ] Quarterly

[ ] Monthly [X] On Occasion

[ ] Annually [ ] 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:_Anna M. Fine, PharmD, MS__________________________________

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 [X] 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

Category of Respondent	No. of Respondents	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Individuals or Households from the General Public	500	1	3/60	25
Totals		500		25

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals or Households from the General Public	25 hr	$28.01	$700.25
Totals			$700.25

* BLS May 2021 National Occupational Employment and Wage Estimates, United States

https://www.bls.gov/oes/current/oes_nat.htm#00-0000

FEDERAL COST: The estimated annual cost to the Federal government is _$1,239__

Staff	Grade/Step	Salary*	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Technical Information Specialist	GS 13/2	$115,749	0.5%		$579
Contractor Cost
Meeting Coordinator		$88,000	0.75%		$660
Travel
Other Cost
Total					$1,239

*the Salary in table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2018/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

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?

We plan to send the survey to an email subscriber list of participants that registered to attend a virtual webinar. People who are interested in attending the virtual webinar meeting and register online in advance, will receive a confirmation email with a link to the survey. Based on previously hosted meetings and public webinars, we average 350-500 participants at our events. The sample audience for the survey are those who register for the meeting held on April 25, 2023 and will then optionally click on the link to the survey and respond to the survey questions (assuming 100% response rate).

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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