Data to Support Drug Product Communications

ICR 201712-0910-001

OMB: 0910-0695

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-12-28
Supporting Statement B
2017-12-28
IC Document Collections
IC ID
Document
Title
Status
244796 New
243753 New
242291 New
241785 New
241315 New
241197 New
239426 New
239246 New
238971 New
238464 New
238395 New
238253 New
238199 New
238184 New
237679 New
236850 New
236797 New
236673 New
236618 New
236514 New
236377 New
236111 New
235559 New
234886 New
233476 New
232370 New
231559 New
231318 New
231073 New
231048 New
230946 New
230838 New
230243 New
230242 New
230240 New
ICR Details
0910-0695 201712-0910-001
Active 201711-0910-001
HHS/FDA CDER
Data to Support Drug Product Communications
Extension without change of a currently approved collection   No
Regular
Approved without change 02/14/2018
Retrieve Notice of Action (NOA) 12/28/2017
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
02/28/2021 36 Months From Approved 02/28/2018
43,875 0 35,603
9,620 0 9,625
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 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  82 FR 27840 06/19/2017
82 FR 58621 12/13/2017
Yes

35
IC Title Form No. Form Name
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020
Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings
Rapid Message Testing with Consumer Panel - Warnings on Opioid Packaging
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups with Patients
Rapid Message Testing with Consumer Panel - Medication Guide Template for Buprenorphine Products (CDER)
Rapid Message Testing with Healthcare Professionals - Search and Rescue Website (CDER)
Rapid Message Testing with Consumer Panel - Storyboards About Safe Disposal of Opioids and Other Medicines
Rapid Message Testing with Consumer Panel - Drug Safety Communications About Misuse and Abuse of Over-the-Counter Medications (CDER)
Rapid Message Testing with Consumer Panel - Vaccines and Seniors Brochure
Rapid Message Testing With Consumer Panel - Medical Countermeasure Messages
Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adolescents)
Biosimilars Prescribing Survey
Rapid Message Testing with Consumer Panel - Public Service Announcements About Safe Disposal of Opioids
Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs
Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations
Physician Interviews on FDA-Approved Labeling
Identifying Messages to Promote Value and Education of Generic Prescribing
Educating Groups Influencing Generic Drug Use
Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups and INterviews with Healthcare Professionals
Biosimilars Prescribing Survey
Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adult All Comers)
Healthcare Professional Ihterviews: Risk Processing for Newly Promoted Prescription Drugs
Rapid Message Testing with Consumer Panel - BeSafeRx Campaign Messages
Rapid Message Testing with Consumer Panel - Testosterone Medication Guide
Rapid Message Testing with Consumer Panel - Transmucosal Immediate Release Fentanyl Patient Presriber Agreement Form
Promotional Implications of Proprietary Prescription Drug Names
Rapid Message Testing with Consumer Panel - Safe Drug Disposal Notecard
Endorsement in Direct-to-Consumer Promotion: Cognitive Interviews
Rapid Message Testing with Consumer Panel - Retest of Warnings on Opioid Packaging
Rapid Message Testing with Consumer Panel -Messages About Cannabidiol (CBD)
Healthcare Professional Interviews: Data Disclosures in Communications About Prescription Drugs
Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs (CDER)
Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings
Rapid Message Testing With Consumer Panel - Asthma Fact Sheet
Rapid Message Testing with Consumer Panel - FDA's Purple Book Website (CDER)

  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 43,875 35,603 0 8,272 0 0
Annual Time Burden (Hours) 9,620 9,625 0 -5 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
There are no program changes to the information collection. However, we have made adjustments to the burden hours and annual responses in keeping with the approval of a recent change request and previous burden approval. Thus the information collection reflects an increase to 43,875 in annual responses and a decrease to 9,620 total hours.

$2,209,708
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
12/28/2017


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