Secure Supply Chain Pilot Program (SSCPP)

Forms and Documents

Document Name	Status
Evaluation Plan for Secure Supply Chain Pilot 01-18-2013 tjc.doc Supplementary Document	2013-02-01
Supporting Statement A - SSCPP.doc Supporting Statement A	2012-06-26

IC Document Collections

IC ID	Document Title	Status
202933	Secure Supply Chain Pilot Program Records - Recordkeeping Other-SSC - Pilot Application	New
202932	Information Submitted In Response To Termination Of Participation Other-SSC - Pilot Application	New
202931	Modified Secure Supply Chain Application Form Other-SSC - Pilot Application	New
202930	Secure Supply Chain Application Form Other-Secure Supply Chain (SSC) Pilot Application	New

ICR Details

OMB Control No: 0910-0729	ICR Reference No: 201206-0910-014
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Secure Supply Chain Pilot Program (SSCPP)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/04/2013
	Date Received in OIRA: 06/28/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved
Responses	26,506	0	0
Time Burden (Hours)	27,756	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): 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)
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 2605	01/15/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 37055	06/20/2012
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Information Submitted In Response To Termination Of Participation
Secure Supply Chain Pilot Program Records - Recordkeeping
Secure Supply Chain Application Form
Modified Secure Supply Chain Application Form

---

ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection.

---

Annual Cost to Federal Government: $600,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 06/28/2012

---