View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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 ICR - OIRA Conclusion
OMB Control No:
0910-0910
ICR Reference No:
202210-0910-007
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Text Analysis of Proprietary Drug Name Interpretations
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/25/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/25/2022
Terms of Clearance:
Any changes resulting from the pre-test(s) should be reflected in a revision or non-substantive change (depending on the nature of the changes) to this ICR.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2025
36 Months From Approved
Responses
1,100
0
0
Time Burden (Hours)
374
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
As part of the prescription drug regulatory review process, sponsors propose proprietary names for their products. These names undergo a proprietary name review (PNR) that involves the Office of Drug Safety, the relevant medical office, and OPDP. OPDP reviews names to assess for alignment with the FD&C Act, which provides, among other things, that labeling can misbrand a product if false or misleading representations are made (see 21 U.S.C. 321(n) and 352(a)). OPDP reviews, among other things, whether names (1) overstate the efficacy or safety of the drug, (2) suggest drug indications that are not accurate, (3) suggest superiority without substantiation, or (4) are of a fanciful nature that misleadingly implies unique effectiveness or composition. It would be helpful in OPDP’s review of promotional implications of proprietary names for data on consumer and prescriber interpretations of proposed proprietary names to be more readily available for consideration. The proposed research will utilize text analysis (e.g., topic modeling and sentiment analysis) to ascertain how consumer and primary care physician populations interpret prescription drug names, which will assist OPDP’s consideration of promotional implications. The sample will include 300 general population consumers and 300 primary care physicians.
Authorizing Statute(s):
US Code:
42 USC 300u(a)(4)
Name of Law: PHS Act
US Code:
21 USC 393(d)(2)(C)
Name of Law: FFDCA
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:
86 FR 60254
11/01/2021
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 62426
10/14/2022
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Pretest and Main Study
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
1,100
0
0
1,100
0
0
Annual Time Burden (Hours)
374
0
0
374
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection.
Annual Cost to Federal Government:
$858,663
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?
No
Agency Contact:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
10/25/2022
An official website of the United States government
The .gov means it's official.
The site is secure.
