Text Analysis of Proprietary Drug Name Interpretations

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Text Analysis PDN Interpretations SS Part B final 10-14-22.docx	Supporting Statement B	Uploaded 2022-10-21	Repair queued
Text Analysis PDN Interpretations SS Part A final 10-14-22.docx	Supporting Statement A	Uploaded 2022-10-21	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
256443	Pretest and Main Study	Other-Screener	New

ICR Details

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.

table that charts list comparision

	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

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Pretest and Main Study

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ICR Summary of Burden

table that charts list 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.

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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

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Common Form ICR:  No

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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

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