OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

ICR 200702-0910-001 · OMB 0910-0530 · Historical Active

Forms and Documents
Document
Name
Status
Supplementary Document
2007-01-11
Supplementary Document
2007-01-12
Supporting Statement A
2007-01-11
IC Document Collections
IC ID
Document
Title
Status
6248 Modified
178673 New
178672 New
178671 New
178670 New
178669 New
178668 New
178667 New
178666 New
ICR Details
0910-0530 200702-0910-001
Historical Active 200311-0910-005
HHS/FDA
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Extension without change of a currently approved collection   No
Regular
Approved without change 05/15/2007
Retrieve Notice of Action (NOA) 02/08/2007
  Inventory as of this Action Requested Previously Approved
05/31/2010 36 Months From Approved 05/31/2007
14,714 0 9,200
3,680 0 52,344
0 0 0
The information collection requires the electronic submission of the content of labeling (i.e., the content of the package insert or professional labeling, including all text, tables and figures) in NDA's, certain BLA's, ANDA's, supplements, and annual reports electronically in a form that FDA can process, review, and archive. The form that FDA can accept for processing, reviewing, and archiving under the final rule is portable dcoument format (PDF).
US Code: 21 USC 321 Name of Law: FFDCA
  
None
Not associated with rulemaking
  71 FR 15752 03/29/2006
71 FR 74924 12/12/2006
Yes
  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 14,714 9,200 0 5,514 0 0
Annual Time Burden (Hours) 3,680 52,344 0 -48,664 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The changes in burden from the final rule are the result of more recent data submissions, and the elimination of one-time costs in the Paperwork Reduction Act section of the final rule.
$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
  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.
01/12/2007