Record Retention Requirements for the Soy Protein/CHD Health Claim

ICR 202106-0910-008

OMB: 0910-0428

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-06-24
IC Document Collections
ICR Details
0910-0428 202106-0910-008
Received in OIRA 201805-0910-008
HHS/FDA CFSAN
Record Retention Requirements for the Soy Protein/CHD Health Claim
Extension without change of a currently approved collection   No
Regular 06/25/2021
  Requested Previously Approved
36 Months From Approved 07/31/2021
25 25
25 25
0 0

Section 101.82(c)(2)(ii)(B) of FDA's regulations (21 CFR 101.82(c)(2)(ii)(B)) authorizes use of a health claim about consumption of soy protein and heart disease risk on labels of foods that contain qualifying amounts of soy protein. The regulation requires that manufacturers of food products that bear the health claim and that contain non-soy sources of protein identify and retain records that permit the calculation of the ratio of soy protein to total protein, and provide such records upon written request to appropriate regulatory officials.

US Code: 21 USC 343 Name of Law: FFDCA
  
None

Not associated with rulemaking

  85 FR 66999 10/21/2020
86 FR 21748 04/23/2021
No

1
IC Title Form No. Form Name
Record Retention Requirements for the Soy Protein/CHD Health Claim

  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 25 25 0 0 0 0
Annual Time Burden (Hours) 25 25 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$2,484
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/25/2021


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