Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; final rule

ICR 200403-0910-004

OMB: 0910-0353

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0353 200403-0910-004
Historical Active 200101-0910-001
HHS/FDA
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; final rule
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/11/2004
Retrieve Notice of Action (NOA) 03/11/2004
  Inventory as of this Action Requested Previously Approved
03/31/2004 03/31/2004 03/31/2004
18 0 18
1,178 0 1,178
0 0 0

Requires that all prescription and over-the-counter aqueous-based drug products for oral inhalation be manufactured sterile.

None
None


No

1
IC Title Form No. Form Name
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; final rule

  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 18 18 0 0 0 0
Annual Time Burden (Hours) 1,178 1,178 0 0 0 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.
03/11/2004


© 2024 OMB.report | Privacy Policy