Request to consolidate 0857

83-C 0686 Rx drug advertising to add 3rd party communications GFI JUNE 2024.docx

Prescription Drug Advertisements and Product Communications

Request to consolidate 0857

OMB: 0910-0686

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UNITED STATES FOOD & DRUG ADMINISTRATION


Prescription Drug Advertising & Product Communications – 21 CFR 202


OMB Control No. 0910-0686

Request for Non-Substantive/Non-Material Change:


This information collection supports implementation of statutory and regulatory requirements that govern prescription drug advertisements. Currently, the information collection accounts for regulatory requirements as well as recommendations found in pertinent agency guidance. For efficiency of operations, we are requesting to move burden currently discussed and accounted for in OMB control no. 0910-0857 into this collection. We have modified the title of the collection to better characterize the scope of activity and are specifically requesting to include burden attendant to the guidance document “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities Questions and Answers,” (June 2018) as itemized below:


Table 1.--Estimated Annual Third-Party Disclosure Burden

Information Collection Activity

No. of Respondents

No. of Responses per Respondent

Total Annual Responses

Average Burden per Response

Total Hours

Recommended information to be included when firms choose to disseminate HCEI materials to payors about approved prescription drugs

430

10

4,500

20

90,000

Recommended information to be included when firms choose to disseminate HCEI materials to payors about approved or cleared devices

236

10

2,360

20

47,200

Recommended information to be included when firms choose to disseminate information about unapproved products or unapproved uses of approved or cleared products

717

2

1,434

0.5

717

Follow-up information to payors regarding previously communicated about unapproved products or unapproved uses of approved or cleared products

359

2

718

2

1,436

TOTAL



9,012


139,353


Rather than include an individual line item, however, we have modified the entry “IC recommended in FDA guidance” by uploading the guidance document and adjusting our estimated burden upward by 9,012 responses and 139,555 hours. There have been no changes to referenced guidance document.


Submitted: June 2024


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