View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
0910-0847
ICR Reference No:
202211-0910-003
Status:
Historical Active
Previous ICR Reference No:
202205-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/02/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/28/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2026
36 Months From Approved
02/28/2023
Responses
109,470
0
73,584
Time Burden (Hours)
27,368
0
18,396
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection is intended to support research conducted by the Food and Drug Administration (FDA or we). Understanding patients, consumers, and health care professionals' perceptions and behaviors plays an important role in improving FDA's regulatory decisionmaking processes and communications impacting various stakeholders. To better understand patients, consumers, and health care professionals' perceptions and behaviors regarding various issues and patient reported outcomes associated with the safety and administration of drug products overseen by the agency, FDA is requesting approval of this generic information collection request for the purpose of conducting studies in these areas.
Authorizing Statute(s):
US Code:
21 USC 393
Name of Law: Food and Drug Administration; General Responsibilities
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
87 FR 48665
08/10/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 68173
11/14/2022
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
A Positive Deviance Approach for Representing Women, Older Adults and Patients Identifying as Racial and Ethnic Minorities in Oncology Research
Multimorbidity and Medications: The Unheard Perspective of Older Adults
Social Media Usability: Consumer Interviews
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
109,470
73,584
0
0
35,886
0
Annual Time Burden (Hours)
27,368
18,396
0
0
8,972
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Based on a review of the information collection since our last request for OMB approval, our burden estimate for this information collection reflects an overall increase of 35,886 responses with a corresponding increase of 8,972 hours. We attribute this adjustment to an increase in funding and need to obtain additional information in specific areas, particularly substance abuse (for example, opioids and stimulants) and COVID-19. In addition, we attribute the increase in the number of respondents (from 7,298 to 109,470) and decrease in the number of responses per respondent from 15 to 1 to an inadvertent administrative error reflected in the 60-day notice. These changes, however, do not impact the estimated total annual responses or burden hours.
Annual Cost to Federal Government:
$2,329,109
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
12/28/2022
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