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:
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:
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
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:
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
Number of Information Collection (IC) in this ICR:
15
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)
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
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:
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
Agency Contact:
Ila Mizrachi 301 796-7726 ila.mizrachi@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:
11/13/2019
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