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Notice

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Color Additive Certification Requests and Recordkeeping

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments on the collection of information by July 30, 2001.

ADDRESSES:

Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.

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FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA Start Printed Page 34686has submitted the following proposed collection of information to OMB for review and clearance.

Color Additive Certification Requests and Recordkeeping—21 CFR Part 80—(OMB Control No. 0910-0216)—Extension

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 the color additive and its use are in conformity with a regulation that describes the conditions under which the color additive may be safely used, or unless the color additive and its use conform to the terms of an exemption for investigational use. If a regulation prescribing safe conditions of use has been issued, the color additive must be from a batch certified by FDA to conform to the requirements of that regulation and other applicable regulations, unless the color additive has been exempted from the certification requirement.

Section 721(c) of the act instructs the Secretary of Health and Human Services (the Secretary) (through FDA) to issue regulations providing for batch certification of color additives for which the Secretary finds such requirement to be necessary in the interest of protecting the public health. FDA's implementing regulations in part 80 (21 CFR part 80) specify the information that must accompany a request for certification of a batch of color additive and require certain records to be kept pending and after certification. 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 exempt from certification.

Under § 80.21, a request for certification must include: Name of color additive, batch number and weight in pounds, name and address of manufacturer, storage conditions, statement of use(s), fee, and signature of requester. The request for certification must also include a sample of the batch of color additive that is the subject of the request. Under § 80.22, the sample must be labeled to show: Name of color additive, batch number and quantity, and name and address of the person requesting certification. A copy of the label or labeling to be used for the batch must accompany the sample. 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.

The request for certification of a batch of color additive is reviewed by FDA's Office of Cosmetics and Colors to verify that all of the required information has been included. Because the information required in the request for certification is unique to the specific batch of color additive involved, it must be generated for each batch. The information submitted with the request helps FDA to ensure that only safe color additives will be used in foods, drugs, cosmetics, and medical devices sold in the United States. The batch number assigned by the manufacturer is a means of temporary identification until a certification lot number has been issued by FDA. After certification, the manufacturer's batch number helps ensure that the proper batch of color is indeed being used under the certification lot number issued by FDA. In the case of a batch that has been refused certification for noncompliance with the regulations, the manufacturer's batch number aids in tracing the ultimate disposal of that batch of color additive. The batch weight serves to account for the disposal of the entire batch. For example, it might be used in determining whether uncertified color has been sold under the lot number assigned to the batch by FDA or, in the event of a recall after certification, to determine whether all unused color has been recalled. In addition, the batch weight is the basis for assessing the certification fee. The name and address of the manufacturer of the color additive being submitted for certification allows FDA to contact the person responsible for its manufacture should a question arise concerning compliance with the regulations. Information on storage conditions pending certification is used to evaluate the possibility that the batch could have been inadvertently or intentionally altered in a manner that would make the sample submitted for certification analysis no longer representative of the batch. It is also used when an FDA investigator is sent to the site; the veracity of the storage statements is checked during normal plant inspections. Information on the uses is needed to ensure that all of the proposed uses are within the limits of the listing regulation for which the person seeking certification proposes that the color be certified. The statement of the fee on the certification request is for accounting purposes so that the person seeking certification can be promptly notified if any discrepancies appear. The information requested on the label of the sample submitted with the certification request is used to identify the sample. The regulations require an accompanying copy of the label or labeling to be used for the batch so that FDA can verify that the batch will be labeled appropriately when it enters commerce.

In the Federal Register of April 13, 2001 (66 FR 19174), the agency requested comments on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionNo. of ­RespondentsAnnual Frequency per ­ResponseTotal Annual ResponsesHours per ­ResponseTotal ­Hours
80.21411064,34620.2869
80.22411064,34620.05217
Total1,086
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Due to a clerical error, the total annual records that appeared in tables 1 and 2 in the Federal Register notice of April 13, 2001 (66 FR 19175), was incorrect. Tables 1 and 2 of this document contains the correct total.
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Table 2.—Estimated Annual Recordkeeping Burden1

21 CFR SectionNo. of ­RecordkeepersAnnual Frequency per ­RecordkeepingTotal Annual ­RecordsHours per ­RecordkeeperTotal Hours
80.39411064,34620.251,086
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Due to a clerical error, the total annual records that appeared in tables 1 and 2 in the Federal Register notice of April 13, 2001 (66 FR 19175), was incorrect. Tables 1 and 2 of this document contains the correct total.

The estimated total annual burden for this information collection is 2,172 hours. Over the period fiscal year (FY) 1998 to 2000, FDA processed an average of 4,346 requests for certification of batches of color additives. Approximately 41 different respondents submitted requests for certification each year over the period FY 1998 to 2000. FDA obtained the estimates for the length of time necessary to prepare certification requests and accompanying samples and to comply with recordkeeping requirements from industry program area personnel.

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Dated: June 22, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 01-16325 Filed 6-28-01; 8:45 am]

BILLING CODE 4160-01-S