Secure Supply Chain Pilot Program (SSCPP)

ICR 201206-0910-014

OMB: 0910-0729

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2013-02-01
Supporting Statement A
2012-06-26
ICR Details
0910-0729 201206-0910-014
Historical Active
HHS/FDA
Secure Supply Chain Pilot Program (SSCPP)
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 02/04/2013
Retrieve Notice of Action (NOA) 06/28/2012
  Inventory as of this Action Requested Previously Approved
02/29/2016 36 Months From Approved
26,506 0 0
27,756 0 0
0 0 0

The Secure Supply Chain Pilot Program (SSCPP) is intended to assist FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and that may pose such risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and APIs imported into the United States that meet the criteria for selection under the program.

US Code: 21 USC 381(d) Name of Law: 801(d)(1) - Federal Food, Drug, and Cosmetic Act (the act)
   US Code: 21 USC 384 Name of Law: Federal Food, Drug, and Cosmetic Act (the act)
  
None

Not associated with rulemaking

  74 FR 2605 01/15/2009
77 FR 37055 06/20/2012
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 26,506 0 0 26,506 0 0
Annual Time Burden (Hours) 27,756 0 0 27,756 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new collection.

$600,000
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@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.
06/28/2012


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