IMPROVE Study Phase 2

ICR 201701-0910-014

OMB: 0910-0695

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2016-07-26
Justification for No Material/Nonsubstantive Change
2016-01-06
Supplementary Document
2011-09-27
Supporting Statement B
2014-10-15
Supporting Statement A
2014-10-15
IC Document Collections
IC ID
Document
Title
Status
228664 New
228656 New
228550 New
228338 New
227844 New
227721 New
227062 New
226226 New
225302 New
224206 Modified
223175 Unchanged
221657 Unchanged
221063 Unchanged
220613 Unchanged
220363 Unchanged
218520 Unchanged
218426 Unchanged
216972 Unchanged
214412 Unchanged
213287
Unchanged
ICR Details
0910-0695 201701-0910-014
Historical Active 201607-0910-010
HHS/FDA CDER
IMPROVE Study Phase 2
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 01/23/2017
Retrieve Notice of Action (NOA) 01/19/2017
Prior terms remain in effect. This generic clearance for FDA/CDER is approved for 3 years under the following conditions: (1) For individual "tests," FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, justification for any proposed incentive, etc.); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days.
  Inventory as of this Action Requested Previously Approved
12/31/2017 12/31/2017 12/31/2017
20,500 0 20,500
9,500 0 9,500
0 0 0

Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews. FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.

US Code: 21 USC 355 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 19096 04/07/2014
79 FR 58786 09/30/2014
Yes

20
IC Title Form No. Form Name
Clinical Trial Data in Professional Prescription Drug Promotion
Rapid Message Testing with Consumer Panel-Caregiver Tipsheet
The Influence of Brand and Prinicple Display for Safe Consumer Use of OTC Drugs - Advancing the Science
Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)
Studies to Enhance FDA Communications Addressing Opioids and Other Potentially Addictive Pain Medications
CONFER: Comprehension of Over-the-Counter Naloxone for Emergency Response (Task 2 - Adolescents)
Pretests for a Study on Quantitative Information in Direct-to-Consumer Television Advertisements
IMPROVE Study Phase 2
Pretest for a Study on Quantitative Information in Direct-to-Consumer Television Advertisements
Animation in DTC Promotion
Rapid Message Testing with Consumer Panel; Clinical Trials Brochure
Interviews/Surveys
Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-To-Consumer Prescription Drug Ads (Cognitive Interviews)
Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews)
Studies to Enhance FDA Communications Addressing Medical Countermeasures Prescription Drug Products
CONFER Study; Comprehension of Over-the-Counter Naloxone for Emergency Response
Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines
Studies to Enhance FDA Communications Addressing Opioids and Other Potentially Addictive Pain Medications
Educating Groups Influencing Generic Drug Use
Rapid Message Testing with Consumer Panel - Public Service Announcement Video about Generic Drugs

  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 20,500 20,500 0 0 0 0
Annual Time Burden (Hours) 9,500 9,500 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-I) to add 9,500 burden hours and 20,500 annual responses. This generic clearance was originally thought to include projects originating in only the Center for Drug Evaluation and Research but because various programs within FDA deal with drug products we experienced more use of this generic approval then anticipated and, therefore, require an increase in hours until the expiration date in 2017.

$2,209,708
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.
01/19/2017


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