[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73936-73938]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de08-41]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0454]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Contact
Substances Notification System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Fax written comments on the collection of information by January
5, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0495.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: 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--(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
[[Page 73937]]
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 except when: (1) 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 (2) 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: (1) Information on the identity and the
intended use of the food contact substance and (2) 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) specify the information that a notification must contain
and require that: (1) A food contact notification (FCN) include FDA
Form 3480 entitled ``Notification for New Use of a Food Contact
Substance'' and (2) 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.
Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the
information that a petitioner must submit in order to: (1) Establish
that the proposed use of an indirect food additive is safe and (2)
secure the publication of an indirect food additive regulation in parts
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178
describe the conditions under which the additive may be safely used.
In addition, FDA's guidance document entitled ``Use of Recycled
Plastics in Food Packaging: Chemistry Considerations'' provides
assistance to manufacturers of food packaging in evaluating processes
for producing packaging from post-consumer recycled plastic. The
recommendations in the guidance address the process by which
manufacturers certify to FDA that their plastic products are safe for
food contact.
Description of Respondents: Manufacturers of food contact
substances.
In the Federal Register of August 27, 2008 (73 FR 50628), 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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Form No. No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106 \2\ (Category A) FDA 3479 5 1 5 2 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \3,7\ (Category B) FDA 3480 5 1 5 25 125
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \4,7\ (Category C) FDA 3480 5 2 10 120 1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \5,7\ (Category D) FDA 3480 33 2 66 150 9,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101 \6,7\ (Category E) FDA 3480 30 1 30 150 4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1 Indirect Food Additive Petitions ................. 2 2 2 10,995 21,990
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance, ``Use of Recycled Plastics in Food ................. 10 1 10 25 250
Packaging: Chemistry Considerations''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 37,975
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 approximately five respondents will submit one
notification annually for food contact substance formulations (Form FDA
3479), for a total of five responses. FDA estimates the reporting
burden to be 2.0 hours per response, for a total burden of 10 hours.
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. Thus, FDA estimates that five respondents will submit
one such submission annually, for a total of five responses. FDA
estimates the reporting burden to be 25.0 hours per response, for a
total burden of 125 hours.
[[Page 73938]]
Based on the submissions received, FDA identified three other tiers
of FCNs that represent escalating levels of burden required to collect
information (denoted as Categories C, D, and E in 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. FDA estimates that five respondents will submit two
Category C submissions annually, for a total of 10 responses. FDA
estimates the reporting burden to be 120 hours per response, for a
total burden of 1,200 hours. FDA estimates that 33 respondents will
submit 2 Category D submissions annually, for a total of 66 responses.
FDA estimates the reporting burden to be 150 hours per response, for a
total burden of 9,900 hours. FDA estimates that 30 respondents will
submit 1 Category E submission annually, for a total of 30 responses.
FDA estimates the reporting burden to be 150 hours per response,
for a total burden of 4,500 hours.
FDA estimates that two respondents will submit one indirect food
additive petition under Sec. 171.1, for a total of two responses. FDA
estimates the reporting burden to be 10,995 hours per response, for a
total burden of 21,990 hours.
FDA estimates that 10 respondents will utilize the recommendations
in the guidance document entitled ``Use of Recycled Plastics in Food
Packaging: Chemistry Considerations,'' to develop the additional
information for one such submission annually, for a total of 10
responses. FDA estimates the reporting burden to be 25 hours per
response, for a total burden of 250 hours.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28694 Filed 12-3-08; 8:45 am]
BILLING CODE 4160-01-S