TITLE OF INFORMATION COLLECTION: TP53 Mutated Head and Neck Cancer Clinical Trials Planning Meeting (NCI)
PURPOSE: General Objectives of the Clinical Trials Planning Meeting (CTPM) Identify promising synthetic lethal interaction partners and therapeutic combinations for randomized phase II trials in TP53 mutant HPV-negative HNSCC that are suitable to be conducted in a cooperative group setting; Design two-three Phase II/III clinical trials for Stage III/IV HPV-negative HNSCC that employs genomic selection or stratification; Design a randomized phase II trial employing novel combination in recurrent/metastatic HNSCC; Advance infrastructure for a generalizable approach to mutation calling. The clinical trials developed will be conducted within the NCTN with the goal of improving survival in these patients. Additionally, the plan is to develop consensus on synthetic lethal therapies, patient selection, mutation calling algorithms, and correlative science, to rapidly advance recent breakthroughs to the clinic for this common and treatment-resistant form of head and neck cancer.
DESCRIPTION OF RESPONDENTS:
Steering committee members and their colleagues; 45 members and 15 NCI staff (5 FTEs) will be invited
TYPE OF COLLECTION: (Check all that apply)
[ ] Abstract [ ] Application
[ X ] Registration Form [ ] Other: ______________
CERTIFICATION:
I certify the following to be true:
The collection is voluntary.
The collection is low-burden for respondents and low-cost for the Federal Government.
The collection is non-controversial and does not raise issues of concern to other federal agencies.
Name: Annette Mitchell
To assist review, please provide answers to the following question:
Personally Identifiable Information:
Is personally identifiable information (PII) collected? [ X ] Yes [ ] No
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 |
55 |
1 |
5/60 |
5 |
Totals |
|
55 |
|
5 |
Category of Respondent |
Total Burden Hours |
Hourly Wage Rate* |
Total Burden Cost |
Individuals |
5 |
$46.95 |
$ 234.75 |
Total |
|
|
$ 234.75 |
*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/2019/May/oes_nat.htm#00-0000.
FEDERAL COST: The estimated annual cost to the Federal government is $8,598.06.
Staff |
Grade/Step |
Salary** |
% of Effort |
Fringe (if applicable) |
Total Cost to Gov’t |
Federal Oversight |
|
|
|
|
|
Program Director |
14/6 |
$141,534 |
5% |
|
$7,076.70 |
Contractor Cost |
|
|
|
|
$1,521.36 |
Travel |
|
|
|
|
|
Other Cost |
|
|
|
|
|
Total |
|
|
|
|
$8,598.06 |
**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?
There is a list of steering committee members and government members that we use to invite to the 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
[ ] Survey Form
[ ] Chart Abstraction
[ ] Other, Explain
Will interviewers,facilitators, or research coordinators be used? [ X ] Yes [] No
Please make sure that all instruments, instructions, and scripts are submitted with the request.
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Title | Generic Clearance Submission Template |
Subject | Generic Clearance Submission Template |
Author | Morales, Sussana (NIH/NCI) [E] |
File Modified | 0000-00-00 |
File Created | 2022-02-14 |