Infant Formula Recall Regulations

Forms and Documents

Document Name	Status
0188 ss 10-19-2017 FINAL.docx Supporting Statement A	2017-11-09

IC Document Collections

IC ID	Document Title	Status
5796	Reporting: Requirements for Written Recall Strategy Furnished to Appropriate FDA District Office By Recalling Firm	Unchanged
199075	Third- Party Disclosure- Additional Notification Requirements When Implementation of Recall Strategy is Determined Deficient	Unchanged
199074	Third- Party Disclosure- Notification and Posting Requirements of Recall by Recalling Firm	Unchanged
185740	Reporting: Requirements For Additional Effectiveness Checks when Recall Implementation Is Determined Deficient	Unchanged
185739	Reporting: Recommendation Requirements for Terminating a Recall by Recalling Firm	Unchanged
185738	Reporting: Notification , Written Reports & Status Update Requirements for Recalling Firms or Establishments	Unchanged

ICR Details

OMB Control No: 0910-0188	ICR Reference No: 201710-0910-010
Status: Historical Active	Previous ICR Reference No: 201410-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Infant Formula Recall Regulations
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: 12/14/2017
	Date Received in OIRA: 11/09/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2020	36 Months From Approved	12/31/2017
Responses	10	0	10
Time Burden (Hours)	12,854	0	12,854
Cost Burden (Dollars)	0	0	0

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Abstract: This collection request supports agency regulations requiring information from manufacturers of infant formula that allows FDA to conduct effective recalls of infant formula should it become necessary.

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Authorizing Statute(s): US Code: 21 USC 350a(e) 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:
	82 FR 27509	06/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 52055	11/09/2017
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Reporting: Requirements For Additional Effectiveness Checks when Recall Implementation Is Determined Deficient
Third- Party Disclosure- Notification and Posting Requirements of Recall by Recalling Firm
Reporting: Recommendation Requirements for Terminating a Recall by Recalling Firm
Reporting: Notification , Written Reports & Status Update Requirements for Recalling Firms or Establishments
Reporting: Requirements for Written Recall Strategy Furnished to Appropriate FDA District Office By Recalling Firm
Third- Party Disclosure- Additional Notification Requirements When Implementation of Recall Strategy is Determined Deficient

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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	10	10	0	0	0	0
Annual Time Burden (Hours)	12,854	12,854	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:

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Annual Cost to Federal Government: $312,824

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: 11/09/2017

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