Color Additive Certification Requests and Recordkeeping

ICR 201708-0910-013

OMB: 0910-0216

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Removed
Supporting Statement A
2017-09-29
IC Document Collections
ICR Details
0910-0216 201708-0910-013
Historical Active 201407-0910-008
HHS/FDA CFSAN
Color Additive Certification Requests and Recordkeeping
Extension without change of a currently approved collection   No
Regular
Approved without change 10/30/2017
Retrieve Notice of Action (NOA) 09/29/2017
  Inventory as of this Action Requested Previously Approved
10/31/2020 36 Months From Approved 10/31/2017
15,048 0 20,895
3,536 0 3,273
0 0 0

FDA has regulatory oversight for color additives used in foods, drugs, cosmetics and medical devices. Section 721(a) of the Federal Food Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a) provides that a color additive shall be deemed unsafe unless it meets the requirement of a listing regulation including any requirement for batch certification and is used in accordance with the regulation. 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

  82 FR 27259 06/14/2017
82 FR 44420 09/22/2017
No

2
IC Title Form No. Form Name
Record of distribution
Sample to accompany request (21 CFR 80.22) 3000 Color Certification Online
Request for certification

  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 15,048 20,895 0 0 -5,847 0
Annual Time Burden (Hours) 3,536 3,273 0 0 263 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects agency adjustments. Specifically, we have increased our total estimate for the collection by 263 hours (from 3,273 to 3,536). Because we have received an increase in the number of certification requests over the past 3 fiscal years (FY), we increased the number of respondents submitting requests from 35 to 38. At the same time, we reduced our estimate by 1 (from 199 to 198) in the average number of annual responses per respondent. We attribute these fluctuations to respondent submissions and our experience with the information collection.

$0
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.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.
09/29/2017


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