Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

ICR 201810-0910-004

OMB: 0910-0572

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-12-05
IC Document Collections
IC ID
Document
Title
Status
6295
Modified
ICR Details
0910-0572 201810-0910-004
Active 201506-0910-012
HHS/FDA CDER
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Extension without change of a currently approved collection   No
Regular
Approved without change 01/28/2019
Retrieve Notice of Action (NOA) 12/06/2018
  Inventory as of this Action Requested Previously Approved
01/31/2022 36 Months From Approved 12/31/2018
541 0 197
1,258,907 0 659,753
0 0 0

The information collection supports agency regulations governing the content and format of labeling for human prescription drug and biological products. Respondents to the collection are sponsors of new drug and biological product applications.

None
None

Not associated with rulemaking

  83 FR 34596 07/20/2018
83 FR 58776 11/21/2018
Yes

1
IC Title Form No. Form Name
Labeling Requirements

  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 541 197 0 0 344 0
Annual Time Burden (Hours) 1,258,907 659,753 0 0 599,154 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
12/06/2018


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