Color Additive Certification Requests and Recordkeeping

Forms and Documents

Document Name	Status
Form 3000 Color Additive Certification (21 CFR 80.21) Form and Instruction	Modified
Form 3000 Sample to accompany request (21 CFR 80.22) Form and Instruction	Modified
0216 SS Part A 2014.doc Supporting Statement A	2014-07-07

IC Document Collections

IC ID	Document Title	Status
5817	Color Additive Certification (21 CFR 80.21) Form and Instruction	Modified
182949	Record of distribution (21 CFR 80.39)	Modified
182948	Sample to accompany request (21 CFR 80.22) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0216	ICR Reference No: 201407-0910-008
Status: Historical Active	Previous ICR Reference No: 201404-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Color Additive Certification Requests and Recordkeeping
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/15/2014
	Date Received in OIRA: 07/08/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	09/30/2014
Responses	20,895	0	17,760
Time Burden (Hours)	3,273	0	2,782
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 379 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:
	79 FR 7199	02/06/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 22688	04/23/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Record of distribution (21 CFR 80.39)
Color Additive Certification (21 CFR 80.21)	3000	Color Certification Online
Sample to accompany request (21 CFR 80.22)	3000	Color Certification Online

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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	20,895	17,760	0	0	3,135	0
Annual Time Burden (Hours)	3,273	2,782	0	0	491	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is an approval request in which both the total annual number of responses/records and the total annual hour burden are being increased. The total annual number of responses/records increased from 17,760 to 20,895 responses/records (an increase of 3,135) and the total annual hour burden has increased from 2,782 to 3,273 hours (an increase of 491). These adjustments are discussed more fully at Q15 of the supporting statement Part A.

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Annual Cost to Federal Government: $0

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: 07/08/2014

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