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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Food Contact Substances Notification

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Food and Drug Administration, HHS.




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


Fax written comments on the collection of information by November 23, 2005.


OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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

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

Food Contact Substances Notification System—21 CFR 170.101 and 170.106—(OMB Control Number 0910-0495)—Extension

Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(h)) establishes a premarket notification process for food contact substances. Section 409(h)(6) of the act defines a “food contact substance” as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” Section 409(h)(3) of the act requires that the notification process be used for authorizing the marketing of food contact substances Start Printed Page 61453except where FDA determines that the submission and premarket review of a food additive petition (FAP) under section 409(b) of the act is necessary to provide adequate assurance of safety or where FDA and the manufacturer or supplier agree that an FAP should be submitted. Section 409(h)(1) of the act requires that a notification include information on the identity and the intended use of the food contact substance and the basis for the manufacturer's or supplier's determination that the food contact substance is safe under the intended conditions of use.

Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101 and 170.106) require that a food contact notification (FCN) include FDA Form 3480 entitled ``Notification for New Use of a Food Contact Substance” and that a notification for a food contact substance formulation include FDA Form 3479 entitled “Notification for a Food Contact Substance Formulation.” These forms will serve to summarize pertinent information in the notification. FDA believes that these forms will facilitate both preparation and review of notifications because the forms will serve to organize information necessary to support the safety of the use of the food contact substance. The burden of filling out the appropriate form has been included in the burden estimate for the notification.

Description of Respondents: Manufacturers of food contact substances.

In the Federal Register of June 7, 2005 (70 FR 33180), FDA published a 60-day notice requesting public comment on the information collection provisions. 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 RespondentsFormAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
170.1062 (Category A)5FDA 347915210
170.1013,7 (Category B)5FDA 34801525125
170.1014,7 (Category C)5FDA 34802101201,200
170.1015,7 (Category D)33FDA 34802661509,900
170.1016,7 (Category E)30FDA 34801301504,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of FDA form 3479 (“Notification for a Food Contact Substance Formulation”) only.
3 Duplicate notifications for uses of food contact substances.
4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
5 Notifications for uses that are the subject of moderately complex food additive petitions.
6 Notifications for uses that are the subject of very complex food additive petitions.
7 These notifications require the submission of FDA Form 3480.

These estimates are based on FDA's experience with the food contact substances notification system.

  • Based on input from industry sources, FDA estimates that the agency will receive approximately five notifications annually for food contact substance formulations.
  • FDA also has included five expected duplicate submissions in the second row of table 1 of this document. FDA expects that the burden for preparing these notifications primarily will consist of the manufacturer or supplier filling out FDA Form 3480, verifying that a previous notification is effective, and preparing necessary documentation.
  • Based on the submissions received, FDA identified three other tiers of FCNs that represent escalating levels of burden required to collect information (the third, fourth and fifth rows of table 1 of this document).
  • FDA estimated the median number of hours necessary for collecting information for each type of notification within each of the three tiers based on input from industry sources.
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Dated: October 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 05-21155 Filed 10-21-05; 8:45 am]