Electronic Format for Submissions; Promotional Labeling and Advertising Materials for Human Prescription Drugs

ICR 201905-0910-003

OMB: 0910-0870

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0870 201905-0910-003
Active
HHS/FDA CDER
Electronic Format for Submissions; Promotional Labeling and Advertising Materials for Human Prescription Drugs
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 05/16/2019
Retrieve Notice of Action (NOA) 05/09/2019
  Inventory as of this Action Requested Previously Approved
05/31/2022 36 Months From Approved
1,552 0 0
55,278 0 0
4,698,630 0 0

This information collection supports implementation of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371k(a)). Section 745A(a) provides for the issuance of final guidance, after public notice and opportunity for comment, specifying the electronic format for submissions to the Food and Drug Administration (FDA, us or we) for drugs and biologics.

PL: Pub.L. 116 - 8 745A(a) Name of Law: Federal Food, Drug, and Cosmetic Act; Electronic Format for Submissions; Drugs & Biologics
  
PL: Pub.L. 116 - 8 745A(a) Name of Law: Federal Food, Drug, and Cosmetic Act; Electronic Format for Submissions; Drugs & Biologics

Not associated with rulemaking
Other Documents for OIRA Review

  80 FR 22529 04/22/2015
84 FR 13302 04/04/2019
Yes

1
IC Title Form No. Form Name
eSubmission: Promotional Labeling and Advertising Materials for Human Prescription 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 1,552 0 1,552 0 0 0
Annual Time Burden (Hours) 55,278 0 55,278 0 0 0
Annual Cost Burden (Dollars) 4,698,630 0 4,698,630 0 0 0
No
No
This is a new information collection.

$0
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.
05/09/2019


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