GFI: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the Federal Food, Drug, and Cosmetic Act

ICR 201710-0910-008

OMB: 0910-0776

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0776 201710-0910-008
Historical Active 201409-0910-002
HHS/FDA CDER
GFI: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Regular
Approved without change 12/13/2017
Retrieve Notice of Action (NOA) 10/19/2017
  Inventory as of this Action Requested Previously Approved
12/31/2020 36 Months From Approved 12/31/2017
109 0 104
425 0 425
0 0 0

This information collection supports agency guidance. The guidance describes fees associated with registration as an outsourcing facility, including the types and amounts of fees that outsourcing facilities must pay, the adjustments to fees required by law, how outsourcing facilities may submit payment to FDA, the consequences of outsourcing facilities' failure to pay fees, and how an outsourcing facility may qualify as a small business to obtain a reduction in fees. Respondents to the collection are individuals or entities engaged in these activities.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 27493 06/15/2017
82 FR 48090 10/16/2017
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 109 104 0 0 5 0
Annual Time Burden (Hours) 425 425 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The ICR reflects adjustments within the individual ICs. This is explained more fully in Q15 of the supporting statement.

$208,103
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
10/19/2017


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