Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

ICR 201409-0910-001

OMB: 0910-0777

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-09-04
ICR Details
0910-0777 201409-0910-001
Historical Active
HHS/FDA CDER
Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 10/17/2014
Retrieve Notice of Action (NOA) 09/08/2014
  Inventory as of this Action Requested Previously Approved
10/31/2017 36 Months From Approved
51 0 0
226 0 0
0 0 0

The guidance implements new provisions added to the Federal Food, Drug, and Cosmetic Act in the Drug Quality and Security Act in which Congress created a new statutory category of "outsourcing facilities" that compound human drugs. New section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) allows compounders to register with FDA as outsourcing facilities, and the draft guidance discusses the process for the registration of outsourcing facilities.

US Code: 21 USC 353(b) Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 355 Name of Law: FD&C Act
   US Code: 21 USC 352(f)(1) Name of Law: FD&C Act
  
None

Not associated with rulemaking

  78 FR 72899 12/04/2013
79 FR 51176 08/27/2014
Yes

  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 51 0 0 51 0 0
Annual Time Burden (Hours) 226 0 0 226 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
This is a new data collection.

$285,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
09/08/2014


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