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

ICR 199803-0910-007

OMB: 0910-0370

Federal Form Document

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Document
Name
Status
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ICR Details
0910-0370 199803-0910-007
Historical Active
HHS/FDA
Specific Requirements on Content and Format of Labeling for Human Prescription Drugs, Addition of "Geriatric Use" Subsection in the Labeling
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 05/26/1998
Retrieve Notice of Action (NOA) 03/27/1998
  Inventory as of this Action Requested Previously Approved
07/31/2001 07/31/2001
290 0 0
34,800 0 0
0 0 0

FDA is amending its regulations governing the content and format of labeling for human prescription drug products, including biological products, to include information pertinent to the appropriate use of drugs in the elderly (persons aged 65 and over) and to facilitate access to this information by establishing a geriatric subsection in the labeling as provided in #201.57(f)(10). FDA believes that improving access to informaton that is important to the elderly will facilitate the safe and effective use of prescription drugs in older populations.

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 290 0 0 290 0 0
Annual Time Burden (Hours) 34,800 0 0 34,800 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
03/27/1998


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