Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule

ICR 200806-0910-002

OMB: 0910-0624

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-06-02
ICR Details
0910-0624 200806-0910-002
Historical Inactive
HHS/FDA
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 06/25/2008
Retrieve Notice of Action (NOA) 06/05/2008
The information collection requirements contained in this proposed rule are not approved at this time. FDA will resubmit this request at the time of the final rule, after fully considering public comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

The proposed rule would amend FDA regulations concerning the format and content of the "Pregnancy," "Labor and Delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drugs. The proposal would require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary.

US Code: 21 USC 314 Name of Law: FD&C act
  
US Code: 21 USC 314.50 Name of Law: Code of Federal Regulations

0910-AF11 Proposed rulemaking 73 FR 104 05/29/2008

No

No
No
This proposal would require that labeling include a summary of the risks of using a drug during pregnancy and latation and a discussion of the data supporting that summary.

$500,000
No
No
Uncollected
Uncollected
Uncollected
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.
06/05/2008


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