Color Additive Certification Requests and Recordkeeping

Forms and Documents

Document Name	Status
Form 3000 Sample to accompany request (21 CFR 80.22) Form and Instruction	Removed
0216 ss 9-29-2017.docx Supporting Statement A	2017-09-29

IC Document Collections

IC ID	Document Title	Status
5817	Request for certification	Modified
182949	Record of distribution	Modified
182948	Sample to accompany request (21 CFR 80.22) Form and Instruction	Removed

ICR Details

OMB Control No: 0910-0216	ICR Reference No: 201708-0910-013
Status: Historical Active	Previous ICR Reference No: 201407-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Color Additive Certification Requests and Recordkeeping
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: 10/30/2017
	Date Received in OIRA: 09/29/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	36 Months From Approved	10/31/2017
Responses	15,048	0	20,895
Time Burden (Hours)	3,536	0	3,273
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 301 et. seq. 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 27259	06/14/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 44420	09/22/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 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

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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	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

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: 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.

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Annual Cost to Federal Government: $0

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: 09/29/2017

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