Export Notification and Recordkeeping Requirements

Forms and Documents

Document Name	Status
0482 Export Notifications and Records SSA 2019 Ext.pdf Supporting Statement A	2019-06-03

IC Document Collections

IC ID	Document Title	Status
6183	CBER, CDER, CDRH Notification Requirements	Modified
213495	CTP (currently regulated tobacco products) Recordkeeping Requirements	Modified
213494	Office of International Programs Recordkeeping Requirements	Modified
213327	CBER, CDER, CDRH Recordkeeping Requirements	Modified
213326	Non-Tobacco - 1.101(d) -- (CDRH)	Removed
184868	Non-Tobacco - 1.101(d) -- CDER	Removed

ICR Details

OMB Control No: 0910-0482	ICR Reference No: 201811-0910-004
Status: Active	Previous ICR Reference No: 201601-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Export Notification and Recordkeeping Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/01/2019
	Date Received in OIRA: 06/05/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	06/30/2019
Responses	3,635	0	12,239
Time Burden (Hours)	69,330	0	198,873
Cost Burden (Dollars)	363,500	0	0

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Abstract: The information collection supports FDA regulations at 21 CFR 1.101 and pertains to the notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262).

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301, et. seq. Name of Law: FFDCA
  

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:
	84 FR 4473	02/15/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 23055	05/21/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Non-Tobacco - 1.101(d) -- (CDRH)
CBER, CDER, CDRH Recordkeeping Requirements
CBER, CDER, CDRH Notification Requirements
Office of International Programs Recordkeeping Requirements
CTP (currently regulated tobacco products) Recordkeeping Requirements
Non-Tobacco - 1.101(d) -- CDER

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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	3,635	12,239	0	0	-8,604	0
Annual Time Burden (Hours)	69,330	198,873	0	0	-129,543	0
Annual Cost Burden (Dollars)	363,500	0	0	0	363,500	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: The information collection reflects adjustments in our estimated burden. Cumulatively these adjustments result in an overall reduction to the information collection by 8,604 annual responses and 129,543 burden hours.

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Annual Cost to Federal Government: $168,882

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.     No

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? Uncollected

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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: 06/05/2019

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