Importation of Prescription Drugs

Forms and Documents

Document Name	Status
0888 Importation of Rx drugs SSA 2020 Final Rule.docx Supporting Statement A	2020-10-01
Importation of Prescription Drugs FRIA Sept 2020.pdf Supplementary Document	2020-10-01

IC Document Collections

IC ID	Document Title	Status
242229	3rd Party DISCLOSURE: Manuracturer	Unchanged
242228	RECORDKEEPING: SIP sponsor; importer, manufactuer	Unchanged
242227	REPORTING: SIP sponsor; importer; manufacturer	Modified

ICR Details

OMB Control No: 0910-0888	ICR Reference No: 202010-0910-005
Status: Active	Previous ICR Reference No: 202006-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Importation of Prescription Drugs
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: 10/09/2020
	Date Received in OIRA: 10/01/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved
Responses	100	0	0
Time Burden (Hours)	6,040	0	0
Cost Burden (Dollars)	0	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:
0910-AI45	Final or interim final rulemaking	85 FR 62094	10/01/2020

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
REPORTING: SIP sponsor; importer; manufacturer
RECORDKEEPING: SIP sponsor; importer, manufactuer
3rd Party DISCLOSURE: Manuracturer

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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	100	0	0	0	100	0
Annual Time Burden (Hours)	6,040	0	0	-360	6,400	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:

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Annual Cost to Federal Government: $0

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: 10/01/2020

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