Reporting and Recordkeeping Requirements for Reportable Food

Forms and Documents

Document	Type	Status	Availability
SS-0910-0643 #3.doc	Supporting Statement A	Uploaded 2010-05-05	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
192857	Recordkeeping-FDAAA, Section417(g)-Maintenance of Reportable Food Records-- ( Voluntary Reports.)	Other-Guidance with instructions	New
192856	Recordkeeping-FDAAA, Section 417(g)- Maintenance of Reportable Food Records( Mandatory)	Other-Guidance with Instructions	New
192855	Third Party Disclosure-FDAAA,Section417 (d)(7)( C )(ii) Immediate Notification of The Subsequent Recipient of The Article of Food	Other-Guidance with Instructions	New
192854	Third Party Disclosure-FDAAA, Section 417(d)(7)( C )(i)- Immediate Notification	Other-Guidance - Questions & Answers	New
189627	Third Party Disclosure- FDAAA- Section 417(d)(6)(B)(ii) Immediate Notification of Subsequent Recipient of The Article of Food	Other-guidance document	Modified
189626	Third Party disclosure-FDAAA -Section417(d)(6)(B)(i) Immediate Notification of Previous Source of The Article of Food	Other-guidance document	Modified

ICR Details

OMB Control No: 0910-0643	ICR Reference No: 201005-0910-003
Status: Historical Inactive	Previous ICR Reference No: 200906-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Reporting and Recordkeeping Requirements for Reportable Food
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 11/08/2010
	Date Received in OIRA: 05/10/2010
Terms of Clearance: In accordance with 5 CFR 1320, OMB is withdrawing this ICR at the request of the agency.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2010	36 Months From Approved	11/30/2010
Responses	6,000	0	6,000
Time Burden (Hours)	3,180	0	3,180
Cost Burden (Dollars)	0	0	0

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Abstract: Section 1005 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), among other things. Section 417 of the act defines "reportable food" as an "article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." (Section 417(a)(2) of the act). Section 417 of the act requires FDA to establish an electronic portal (the Reportable Food electronic portal) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. FDA made the decision that the most efficient and cost effective means to implement the requirements of section 417 of the act relating to the Registry was to utilize the business enterprise system currently under development within the agency: the MedWatchPlus Portal. In addition, Section 1005(f) of FDAAA required FDA to issue guidance to industry about submitting reports through the electronic portal of instances of reportable food and providing notifications to other persons in the supply chain of such article of food. FDA is issuing guidance containing questions and answers relating to the requirements under section 417 of the act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

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Authorizing Statute(s): US Code: 21 USC 350f Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 350f Name of Law: FFDCA

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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:
	74 FR 53746	10/20/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 8960	02/26/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Third Party disclosure-FDAAA -Section417(d)(6)(B)(i) Immediate Notification of Previous Source of The Article of Food
Third Party Disclosure- FDAAA- Section 417(d)(6)(B)(ii) Immediate Notification of Subsequent Recipient of The Article of Food
Third Party Disclosure-FDAAA, Section 417(d)(7)( C )(i)- Immediate Notification
Third Party Disclosure-FDAAA,Section417 (d)(7)( C )(ii) Immediate Notification of The Subsequent Recipient of The Article of Food
Recordkeeping-FDAAA, Section 417(g)- Maintenance of Reportable Food Records( Mandatory)
Recordkeeping-FDAAA, Section417(g)-Maintenance of Reportable Food Records-- ( Voluntary Reports.)

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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: Program change for recordkeeping requirements(increase) of 150 hours due to requirement for maintainence of recordss for voluntary reports.

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Annual Cost to Federal Government: $350

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

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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: 05/10/2010

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