Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K

ICR 202011-0910-001

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 202011-0910-001
Active 201710-0910-008
HHS/FDA CDER
Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K
Revision of a currently approved collection   No
Regular
Approved without change 12/30/2020
Retrieve Notice of Action (NOA) 11/27/2020
  Inventory as of this Action Requested Previously Approved
12/31/2023 36 Months From Approved 12/31/2020
116 0 109
429 0 425
0 0 0

This information collection helps to support implementation of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Drug Quality and Security Act (DQSA) regarding the registration of human drug compounding outsourcing facilities. The information collection also implements provisions applicable to registered outsourcing facilities and the assessment and remission of user fees under section 744K of the FD&C Act.

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

  85 FR 51442 08/20/2020
85 FR 73483 11/18/2020
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 116 109 0 0 7 0
Annual Time Burden (Hours) 429 425 0 0 4 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects changes and adjustments. We have consolidated activity pertaining to the assessment of fees established under 0910-0777 into this collection established for registration of the outsourcing facilities that incur those fees. We have also adjusted the number of respondents to the collection consistent with submissions received since last review of the information collection.

$208,103
No
    No
    No
No
No
No
No
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.
11/27/2020


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