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

Forms and Documents

Document Name	Status
83-C 0847 accounting correction NOV 2023.docx Justification for No Material/Nonsubstantive Change	2023-11-03
0847 Supporting Statement Part B 2022.docx Supporting Statement B	2022-12-22
0847 OMB Memo Template 12-13-22.docx Supplementary Document	2022-12-13
0847 Supporting Statement Part A 2022.docx Supporting Statement A	2022-12-22

IC Document Collections

IC ID	Document Title	Status
263192	RESTORATION OF INADVERTENT OVERDRAFT Other-CORRECTION MEMO	New
261636	Social Media Usability: Consumer Interviews Other-Interview Recruitment	Unchanged
260732	A Positive Deviance Approach for Representing Women, Older Adults and Patients Identifying as Racial and Ethnic Minorities in Oncology Research Other-Email recruitment flyer	Unchanged
258885	Multimorbidity and Medications: The Unheard Perspective of Older Adults Other-Invitation email (English)	Unchanged

ICR Details

OMB Control No: 0910-0847	ICR Reference No: 202311-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202211-0910-003
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/03/2023

	Requested	Previously Approved
Expiration Date	02/28/2026	02/28/2026
Responses	109,470	109,470
Time Burden (Hours)	27,368	27,368
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: Food and Drug Administration; General Responsibilities
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 4

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
RESTORATION OF INADVERTENT OVERDRAFT
Social Media Usability: Consumer Interviews

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ICR Summary of Burden

	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

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.

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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

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Common Form ICR:  No

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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: 11/03/2023

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