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

ICR 201005-0910-007

OMB: 0910-0530

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-05-10
ICR Details
0910-0530 201005-0910-007
Historical Inactive 200702-0910-001
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
Improperly submitted and continue 06/14/2010
Retrieve Notice of Action (NOA) 05/18/2010
In accordance with 5 CFR 1320 OMB notes that this collection has been improperly submitted. The collection has been submitted as an extension but appears to contain a discretionary change in burden. Please correct this error and resubmit this collection to OMB.
  Inventory as of this Action Requested Previously Approved
05/31/2010 36 Months From Approved 06/30/2010
14,714 0 14,714
3,680 0 3,680
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

  74 FR 57491 11/09/2009
75 FR 23779 05/04/2010
Yes

No
Yes
Miscellaneous Actions
The changes in burden are the result of a re-calculation based on the guidance for industry entitled "Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Listing."

$0
No
No
No
Uncollected
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
05/18/2010


© 2024 OMB.report | Privacy Policy