Specific Requirements on the Content and Format of Labeling for Human Prescription Drugs; Addition of Geriatric Use Subsection

ICR 200407-0910-011

OMB: 0910-0370

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0370 200407-0910-011
Historical Active 200104-0910-003
HHS/FDA
Specific Requirements on the Content and Format of Labeling for Human Prescription Drugs; Addition of Geriatric Use Subsection
Extension without change of a currently approved collection   No
Regular
Approved without change 09/21/2004
Retrieve Notice of Action (NOA) 07/19/2004
  Inventory as of this Action Requested Previously Approved
09/30/2007 09/30/2007 09/30/2004
557 0 588
1,762 0 1,920
0 0 0

Section 201.57(f)(10) requires that a specific geriatric indication, if any, that is supported by adequate and well-controlled studies in the geriatric population must be described under the "Indications and Usage" section of the labeling, and appropriate geriatric dosage must be stated under the "Dosage and Administration" section of the labeling.

None
None


No

  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 557 588 0 0 -31 0
Annual Time Burden (Hours) 1,762 1,920 0 0 -158 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
07/19/2004


© 2024 OMB.report | Privacy Policy