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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Template for Data to Support Social and Behavioral Research.doc	Supplementary Document	Uploaded 2019-12-12	Available
Summary of Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics.docx	Supplementary Document	Uploaded 2019-11-12	Available
Summary of Prescription Medication Information.doc	Supplementary Document	Uploaded 2019-11-01	Available
Summary of Opioid ADF Formulations.docx	Supplementary Document	Uploaded 2019-11-01	Available
Summary of Physician Knowledge of Drug Quality.docx	Supplementary Document	Uploaded 2019-11-01	Available
Summary of Improving Health Communications with Older Womens Health.doc	Supplementary Document	Uploaded 2019-11-01	Available
Summary of Framing of Risks.doc	Supplementary Document	Uploaded 2019-10-31	Available
Summary of Consumer Knowledge of Drug Quality.docx	Supplementary Document	Uploaded 2019-10-31	Available
Summary of Comparative Effectiveness of Disease Education Messaging.docx	Supplementary Document	Uploaded 2019-10-31	Available
0847 Supporting Statement Part B 2019.docx	Supporting Statement B	Uploaded 2019-10-31	Available
0847 Supporting Statement Part A 2019.docx	Supporting Statement A	Uploaded 2019-10-31	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
251449	Assessment of a Pharmacist-Led Transition of Care Service Utilizing an Admissions Enhanced, Patient Risk Evaluation Approach: the ICARE Program	Other-Survey Instrument: Consent Form	New
251395	Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Experiences with REMS Programs (CDER)	Other-Patient Guide	New
250770	Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER)	Other-Recruitment Message - Physicians	New
250492	Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Experiences with REMS Programs (CDER)	Other-Invitation	New
250366	Training Decay for Medical Products: Insulin Pump Usability Study (CDER)	Other-Initial Training Script	New
249972	Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs (CDER)	Other-Interview Guide	New
248684	Multistate Pharmacist Survey for Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics (Maryland)	Other-Survey	New
248266	NMURx Express Survey to Evaluate Stimulant Abuse in the United States: Trajectories from Medical Use to Non-Medical Use (CDER)	Other-Questionnaire	New
248160	Multistate Pharmacist Survey for Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics (CDER)	Other-Questionnaire	New
246919	Improving the Quality and Representativeness of the Treatment Center Program Data: Survey to Quantify the Magnitude of Misclassification of Opioid Product Identification (CDER)	Other-Survey Instrument	New
246077	Accuracy of Opioid Product Ascertainment (CDER)	Other-Survey Instrument	New
244834	Perioperative Medication Safety Self-Assessment for Hospitals and Ambulatory Surgical Centers and Targeted Risk-Reduction Tool Development (CDER)	Other-Survey Instrument	New
243036	An Exploratory Assessment of Substances Used as Adjuncts or Alternatives to Prescription Opioids	Other-Screener	New
238930	Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products (CDER)	Other-Consent Form	New
238929	Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER)	Other-Moderator Script	New

ICR Details

OMB Control No: 0910-0847	ICR Reference No: 201910-0910-010
Status: Historical Active	Previous ICR Reference No: 201709-0910-002
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/12/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/13/2019
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved	11/30/2020
Responses	73,584	0	36,792
Time Burden (Hours)	18,396	0	9,198
Cost Burden (Dollars)	0	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:
	84 FR 28557	06/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 57442	10/25/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 15

table that charts list of burden

IC Title	Form No.	Form Name
Accuracy of Opioid Product Ascertainment (CDER)
An Exploratory Assessment of Substances Used as Adjuncts or Alternatives to Prescription Opioids
Assessment of a Pharmacist-Led Transition of Care Service Utilizing an Admissions Enhanced, Patient Risk Evaluation Approach: the ICARE Program
Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER)
Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products (CDER)
Improving the Quality and Representativeness of the Treatment Center Program Data: Survey to Quantify the Magnitude of Misclassification of Opioid Product Identification (CDER)
Multistate Pharmacist Survey for Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics (CDER)
Multistate Pharmacist Survey for Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics (Maryland)
NMURx Express Survey to Evaluate Stimulant Abuse in the United States: Trajectories from Medical Use to Non-Medical Use (CDER)
Perioperative Medication Safety Self-Assessment for Hospitals and Ambulatory Surgical Centers and Targeted Risk-Reduction Tool Development (CDER)
Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Experiences with REMS Programs (CDER)
Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Physician Experiences with REMS Programs (CDER)
Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs (CDER)
Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on Experiences with REMS Programs (CDER)
Training Decay for Medical Products: Insulin Pump Usability Study (CDER)

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ICR Summary of Burden

table that charts list 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	73,584	36,792	0	0	36,792	0
Annual Time Burden (Hours)	18,396	9,198	0	0	9,198	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:

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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.     No

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? Uncollected

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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: 11/13/2019

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