0216 ss 11-15-2007

SUPPORTING STATEMENT

COLOR ADDITIVE CERTIFICATION REQUESTS AND RECORDKEEPING

OMB No. 0910-0216

A. Justification

1. Circumstances Making the Collection of Information Necessary

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 to be unsafe unless it meets the requirements 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 listed in 21 CFR part 74 and 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. In the certification procedure, a representative sample of a new batch of color additive, accompanied by a “request for certification” that provides information about the batch, must be submitted to FDA's Office of Cosmetics and Colors. FDA personnel perform chemical and other analyses of the representative sample and, providing the sample satisfies all certification requirements, issue a certification lot number for the batch. FDA charges a fee for certification based on the batch weight and requires manufacturers to keep records of the batch pending and after certification.

We request the extension of OMB approval for the following collection of information requirements:

21 CFR 80.21 -- Reporting

Under § 80.21, a request for certification must include: Name of color additive, manufacturer's batch number and weight in pounds, name and address of manufacturer, storage conditions, statement of use(s), certification fee, and signature of person requesting certification.

21 CFR 80.22 -- Reporting

Under § 80.22, a request for certification must include a sample of the batch of color additive that is the subject of the request. The sample must be labeled to show: Name of color additive, manufacturer's batch number and quantity, and name and address of person requesting certification.

21 CFR 80.39 -- Recordkeeping

Under § 80.39, the person to whom a certificate is issued must keep complete records showing the disposal of all the color additive covered by the certificate. Such records are to be made available upon request to any accredited representative of FDA until at least 2 years after disposal of all of the color additive.

2. Purpose and Use of the Information Collection

As described above, FDA’s regulations require that a representative sample of each new batch of color additive, accompanied by a “request for certification” that provides information about the batch, be submitted to FDA's Office of Cosmetics and Colors. The purpose for collecting this information is to help FDA assure that only safe color additives will be used in foods, drugs, cosmetics, and medical devices sold in the United States. FDA personnel perform chemical and other analyses of the representative sample and, providing the sample satisfies all certification requirements, issue a certification lot number for the batch.

The manufacturer's batch number is used for temporarily identifying a batch of color additive until FDA issues a certification lot number and for identifying a certified batch during inspections. The manufacturer's batch number also aids in tracing the disposal of a certified batch or a batch that has been refused certification for noncompliance with the color additive regulations. The manufacturer's batch weight is used for assessing the certification fee. The batch weight also is used to account for the disposal of a batch of certified or certification-rejected color additive. The batch weight can be used in a recall to determine whether all unused color additive in the batch has been recalled. The manufacturer's name and address and the name and address of the person requesting certification are used to contact the person responsible should a question arise concerning compliance with the color additive regulations.

Information on storage conditions pending certification is used to evaluate whether a batch of certified color additive is inadvertently or intentionally altered in a manner that would make the sample submitted for certification analysis unrepresentative of the batch. FDA checks storage information during inspections. Information on intended uses for a batch of color additive is used to assure that a batch of certified color additive will be used in accordance with the requirements of its listing regulation. The statement of the fee on a certification request is used for accounting purposes so that a person requesting certification can be notified promptly of any discrepancies.

3. Use of Improved Information Technology and Burden Reduction

On February 13, 2006, FDA introduced a Web-based Color Certification information system. The system was fully operational for FY 2007. This system allows certifiers to request color certification online, follow their submissions through the process, and obtain information on account status. The system sends back the certification results electronically, allowing certifiers to sell their certified color before receiving hard copy certificates. Any delays in the system result only from shipment of color additive samples to FDA's Office of Cosmetics and Colors for analysis. In item 12 below, FDA based its reporting and recordkeeping burden hour estimate on its review of the certification requests received over the past 3 fiscal years. FDA expects that use of the Web-based system will lessen the hour burdens on respondents.

4. Efforts to Identify Duplication and Use of Similar Information

To the best of our knowledge, no other federal government agency is engaged in the collection of this information. No other government agency has either the need or the authority to request the information required in a request for certification of a color additive. There can be no duplicative collection of this information because the required information is unique to the batch of color additive that is the subject of a request for certification.

5. Impact on Small Businesses or Other Small Entities

The reporting and recordkeeping requirements of these regulations are mandated by the act and there is no statutory exception for small businesses. FDA has Small Business Representatives who help small businesses whose products are regulated by FDA.

6. Consequences of Collecting the Information Less Frequently

The information in a request for color additive certification is required by the act and implementing regulations. Without this information, FDA could not assure the safety of batches of color additives. This information is collected once for each new batch of a color additive and therefore cannot be collected less frequently.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

No special circumstances occur when FDA collects this information.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the Federal Register of July 24, 2007 (72 FR 40310). FDA received no comments in response to the notice.

9. Explanation of Any Payment or Gift to Respondents

This information collection does not provide for payments or gifts to respondents.

10. Assurance of Confidentiality Provided to Respondents

Sections 80.21, 80.22, and 80.39 do not specify confidentiality. However, FDA considers the information collected in the requests for color additive certification and summarized on FDA Form 3000 to be privileged commercial information exempt from release under the provisions of the Freedom of Information Act (FOIA) to the maximum extent permitted by that statute and FDA regulations. Confidentiality of the information submitted is protected from disclosure under FOIA under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the agency’s regulations (21 CFR part 20). The information also is safeguarded by Section 301(j) of the act (21 U.S.C. 331(j). Accordingly, all color additive certification files are maintained in a secured area.

11. Justification for Sensitive Questions

This information collection does not involve questions of a sensitive nature.

12. Estimates of Annualized Burden Hours and Costs
FDA estimates the burden of this collection of information as follows:

Table 1. --Estimated Annual Reporting Burden1
21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
80.21	32	174	5,568	0.20	1,114
80.22	32	174	5,568	0.05	278
Total				0.25	1,392
¹ There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2. --Estimated Annual Recordkeeping Burden1
21 CFR Section	No. of Recordkeepers	Annual Frequency of Recordkeeping	Total Annual Records	Hours per Record	Total Hours
80.39	32	174	5,568	0.25	1,392
Total					1,392
¹ There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA bases its estimate on its review of the certification requests received over the past 3 fiscal years. The annual burden estimate for this information collection is 2,784 hours. The estimated reporting burden for this information collection is 1,392 hours and the estimated recordkeeping burden for this information collection is 1,392 hours. From fiscal year (FY) 2004 to FY 2006, FDA processed an average of 5,568 responses (requests for certification of batches of color additives) per year. There were 32 different respondents, corresponding to an average of approximately 174 responses from each respondent per year. Using information from industry personnel, FDA estimates that an average of 0.25 hour per response is required for reporting (preparing certification requests and accompanying sample labels) and an average of 0.25 hour per response is required for recordkeeping.

Hour Cost Burden

The annual hour cost burden to respondents is approximately $89,088 per year. This cost is estimated using an hourly wage of $32 per hour (corresponding to a GS-12, step 1, federal government hourly salary), and 2,784 burden hours times $32 per hour equals $89,088.

13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

There are no capital costs or operating and maintenance costs associated with this information collection.

14. Annualized Cost to Federal Government

Section 721(e) of the Act (21 U.S.C. 379e(e)) provides that fees must be charged for color additive certification “as may be necessary to provide, maintain, and equip an adequate service for such purposes.” Thus, it is required by law that there be no cost to the federal government for color additive certification. As noted above, FDA charges a fee for certification based on the batch weight in accordance with § 80.10 (21 CFR 80.10)

15. Explanation for Program Changes or Adjustments

The change in annual hour burden is an increase of 482 hours over that of the previous approval. The number of batches certified per year over the last few years has remained relatively steady and it is anticipated that this overall trend will continue. The increase in burden is due to an average increase in sales by the color additive manufacturers.

The change in annual hour burden cost is an increase of $24,632 over that of the previous approval. This is due to an average increase in sales by the color additive manufacturers and an increase in the estimated hourly wage rate applied to the burden hours.

16. Plans for Tabulation and Publication and Project Time Schedule

No comprehensive tabulation of the data is planned or anticipated.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

FDA has no reason for not displaying the OMB approval date.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exception is requested.