Data To Support Social and Behavioral Research as Used by the Food and Drug Administration

ICR 202311-0910-005

OMB: 0910-0847

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2023-11-03
Supporting Statement B
2022-12-22
Supplementary Document
2022-12-13
Supporting Statement A
2022-12-22
ICR Details
0910-0847 202311-0910-005
Received in OIRA 202211-0910-003
HHS/FDA CDER
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
No material or nonsubstantive change to a currently approved collection   No
Regular 11/03/2023
  Requested Previously Approved
02/28/2026 02/28/2026
109,470 109,470
27,368 27,368
0 0

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.

US Code: 21 USC 393 Name of Law: Food and Drug Administration; General Responsibilities
  
None

Not associated with rulemaking

  87 FR 48665 08/10/2022
87 FR 68173 11/14/2022
Yes

  Total Request 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 109,470 109,470 0 0 0 0
Annual Time Burden (Hours) 27,368 27,368 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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.

$2,329,109
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/03/2023


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