OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201709-0910-002 · OMB 0910-0847 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
PASE Generic SS Part B 2017.pdf Supporting Statement B Uploaded 2017-09-01 Available
PASE Generic SS Part A 2017 Final.pdf Supporting Statement A Uploaded 2017-09-01 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
238396 Methodologic Advances in Evaluating Abuse Deterrent Opioid Analgesics: Physician and Pharmacist Surveys Other-Email Invitation New
237251 Stated Preference Survey of Willingness to Pay for Prescription Medication Information Other-survey New
234959 Health Care Providers' Understanding of Opioid Analgesic Abuse-Deterrent Formulations Other-Survey Instrument New
232312 Study on Physician Knowledge of Drug Quality Other-Survey New
231932 Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products Other-Moderator guide New
231636 Pilot Study Regarding Framing of Risks in Direct-to-Consumer Prescription Drug TV Ads Other-Survey New
230779 Study on Consumer Knowledge of Drug Quality Other-Survey New
229930 Study of Comparative Effectiveness of Disease Education Messaging Other-Survey Instrument New
ICR Details
0910-0847 201709-0910-002
Historical Active
HHS/FDA CDER
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 11/14/2017
Retrieve Notice of Action (NOA) 09/01/2017
  Inventory as of this Action Requested Previously Approved
11/30/2020 36 Months From Approved
36,792 0 0
9,198 0 0
0 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
  81 FR 64166 09/19/2016
82 FR 27492 06/15/2017
No
  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 36,792 0 0 36,792 0 0
Annual Time Burden (Hours) 9,198 0 0 9,198 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request.
$2,329,109
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]
  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.
09/01/2017