[Federal Register: August 27, 2008 (Volume 73, Number 167)]
[Notices]
[Page 50628-50630]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au08-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0454]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Contact Substances Notification System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated
[[Page 50629]]
with the Food Contact Substances Notification System.
DATES: Submit written or electronic comments on the collection of
information by October 27, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Food Contact Substances Notification System--21 CFR 170.101, 170.106,
and 171.1 (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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Form No. Respondents per Response Responses Response Total Hours
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170.106\2\ (Category A) FDA 3479 5 1 5 2 10
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170.101\3,7\ (Category B) FDA 3480 5 1 5 25 125
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170.101\4,7\ (Category C) FDA 3480 5 2 10 120 1,200
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170.101\5,7\ (Category D) FDA 3480 33 2 66 150 9,900
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170.101\6,7\ (Category E) FDA 3480 30 1 30 150 4,500
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171.1 Indirect Food Additive ............................. 2 2 2 10,995 21,990
Petitions
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[[Page 50630]]
Guidance
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Use of Recycled Plastics in Food ............................. 10 1 10 25 250
Packaging: Chemistry
Considerations
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Total 37,975
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\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.
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 ten 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: August 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19843 Filed 8-26-08; 8:45 am]
BILLING CODE 4160-01-S