Color Additive Certification

ICR 202304-0910-007

OMB: 0910-0216

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2023-10-20
IC Document Collections
IC ID
Document
Title
Status
5817
Modified
182949
Modified
ICR Details
0910-0216 202304-0910-007
Received in OIRA 202009-0910-002
HHS/FDA CFSAN
Color Additive Certification
Extension without change of a currently approved collection   No
Regular 10/23/2023
  Requested Previously Approved
36 Months From Approved 10/31/2023
15,008 15,048
3,527 3,536
0 0

The information collection implements section 721(a) of the Federal Food Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a) providing that a color additive shall be deemed unsafe unless it meets the requirement of a listing regulation including any requirement for batch certification. FDA lists color additives that have been shown to be safe for their intended uses in Title 21 of the Code of Federal regulations.( CFR). FDA requires batch certification for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification. The requirements for color additive certification are described in 21 CFR part 80.

US Code: 21 USC 301 et. seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  88 FR 54329 08/10/2023
88 FR 71872 10/18/2023
No

2
IC Title Form No. Form Name
Recordkeeping; Record of distribution
Reporting; Request for certification

  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 15,008 15,048 0 0 -40 0
Annual Time Burden (Hours) 3,527 3,536 0 0 -9 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Based on a review of the information collection since our last request for OMB approval, we have slightly decreased our burden estimate based on our experience with this program. Although the number of respondents increased, the number of responses per respondent decreased.

$10,900,000
No
    No
    No
No
No
No
No
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov

  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.
10/23/2023


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