Importation of Prescription Drugs

Forms and Documents

Document Name	Status
0888 SSA_ImportationofPrescriptionDrugs 2023.docx Supporting Statement A	2023-10-20

IC Document Collections

IC ID	Document Title	Status
242229	3rd Party DISCLOSURE: Manuracturer	Removed
242228	Recordkeeping; SIPs Sponsor, Importer, Manufacturer	Modified
242227	REPORTING: SIP sponsor; importer; manufacturer	Removed

ICR Details

OMB Control No: 0910-0888	ICR Reference No: 202302-0910-012
Status: Received in OIRA	Previous ICR Reference No: 202010-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Importation of Prescription Drugs
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/20/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2023
Responses	100	100
Time Burden (Hours)	6,040	6,040
Cost Burden (Dollars)	0	0

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Abstract: This ICR collects information from Section 804 Importation Programs (SIPs), which would be authorized by FDA and overseen by States or certain other governmental entities (SIP Sponsors) that seek to import certain prescription drugs from Canada.

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Authorizing Statute(s): US Code: 21 USC 384 Name of Law: FFDCA; Importation of Prescription Drugs
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 37549	06/08/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 70995	10/13/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
3rd Party DISCLOSURE: Manuracturer
REPORTING: SIP sponsor; importer; manufacturer
Recordkeeping; SIPs Sponsor, Importer, Manufacturer

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ICR Summary of Burden

	Total Request	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	100	100	0	0	0	0
Annual Time Burden (Hours)	6,040	6,040	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: We have retained figures from the previous information collection approval. We assume burden pertaining to these information collection activities will be distributed among respondents for an average of 100 responses and 6,040 hours annually.

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Annual Cost to Federal Government: $163,094

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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Common Form ICR:  No

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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: 10/20/2023

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