Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substances Notification System, 50628-50630 [E8-19843]
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50628
Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Notices
Terry Nicolosi,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E8–19849 Filed 8–26–08; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (DHHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold a meeting.
The meeting is open to the public.
DATES: The meeting will be held on
September 16, 2008, from 9 a.m. to 5:30
p.m., and on September 17, 2008, from
9 a.m. to 3 p.m.
ADDRESSES: Department of Health and
Human Services, Hubert H. Humphrey
Building, Room 800, 200 Independence
Avenue, SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms.
Andrea Krull, National Vaccine Program
Office, Department of Health and
Human Services, Room 443–H, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201; (202) 690–5566,
nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. Section 300aa–1),
the Secretary of Health and Human
Services was mandated to establish the
National Vaccine Program to achieve
optimal prevention of human infectious
diseases through immunization and to
achieve optimal prevention against
adverse reactions to vaccines. The
National Vaccine Advisory Committee
was established to provide advice and
make recommendations to the Director
of the National Vaccine Program on
matters related to the Program’s
responsibilities. The Assistant Secretary
for Health serves as Director of the
National Vaccine Program.
Topics to be discussed at the meeting
include vaccine financing, vaccine
stockpile, seasonal influenza and related
issues, vaccine safety, vaccine
development, and the National Vaccine
Plan. Updates will be given by each of
the working groups. An agenda will be
posted on the NVAC Web site: https://
www.hhs.gov/nvpo/nvac prior to
September 1, 2008.
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Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person. Members of
the public will have the opportunity to
provide comments at the meeting.
Public comment will be limited to five
minutes per speaker. Any members of
the public who wish to have printed
material distributed to NVAC members
should submit materials to the
Executive Secretary, NVAC, through the
contact person listed above prior to
close of business September 11, 2008.
Pre-registration is required for both
public attendance and comment. Any
individual who wishes to attend the
meeting and/or participate in the public
comment session should e-mail
nvpo@hhs.gov or call 202–690–5566.
Dated: August 21, 2008.
Bruce Gellin,
Director, National Vaccine Program Office.
[FR Doc. E8–19848 Filed 8–26–08; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
President’s Committee for People with
Intellectual Disabilities; Notice of
Meeting
President’s Committee for
People with Intellectual Disabilities
(PCPID).
ACTION: Notice of quarterly meeting.
AGENCY:
September 9, 2008, from 8:30
a.m. to 5 p.m. EST; and September 10,
2008, from 9 a.m. to 5 p.m. The meeting
will be open to the public.
ADDRESSES: The meeting will be held in
Room 800 of the Hubert H. Humphrey
Building, 200 Independence Ave., SW.,
Washington, DC 20201. Individuals who
would like to participate via conference
call may do so by dialing 888–603–
6970, passcode: PCPID. Individuals who
will need accommodations for a
disability in order to attend the meeting
(e.g., sign language interpreting services,
assistive listening devices, materials in
alternative formats such as large print or
Braille) should notify MJ Karimi via
e-mail at
Madjid.KarimieAsl@ACF.hhs.gov, or via
telephone at 202–619–0634, no later
than August 29, 2008. PCPID will
attempt to meet requests made after that
date, but cannot guarantee availability.
All meeting sites are barrier free.
DATES:
PO 00000
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Agenda: PCPID will meet to continue
work on the 2009 Annual Report to the
President.
Additional Information: For further
information, please contact Sally D.
Atwater, Executive Director, President’s
Committee for People with Intellectual
Disabilities, the Aerospace Center,
Second Floor West, 370 L’Enfant
Promenade, SW., Washington, DC
20447. Telephone: 202–619–0634. Fax:
202–205–9591. E-mail:
satwater@acf.hhs.gov.
PCPID
acts in an advisory capacity to the
President and the Secretary of Health
and Human Services on a broad range
of topics relating to programs, services
and supports for persons with
intellectual disabilities. PCPID, by
Executive Order, is responsible for
evaluating the adequacy of current
practices in programs, services and
supports for persons with intellectual
disabilities, and for reviewing legislative
proposals that impact the quality of life
experienced by citizens with
intellectual disabilities and their
families.
SUPPLEMENTARY INFORMATION:
Dated: August 19, 2008.
Sally D. Atwater,
Executive Director, President’s Committee for
People with Intellectual Disabilities.
[FR Doc. E8–19898 Filed 8–26–08; 8:45 am]
BILLING CODE 4184–01–P
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.
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
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Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Notices
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 https://
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 BURDEN1
21 CFR Section
Form No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
FDA 3479
5
1
5
2
10
170.1013,7 (Category B)
FDA 3480
5
1
5
25
125
170.1014,7 (Category C)
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170.1062 (Category A)
FDA 3480
5
2
10
120
1,200
170.1015,7 (Category D)
FDA 3480
33
2
66
150
9,900
170.1016,7 (Category E)
FDA 3480
30
1
30
150
4,500
2
2
2
10,995
21,990
171.1 Indirect Food Additive
Petitions
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Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
No. of
Respondents
Form No.
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Guidance
Use of Recycled Plastics in
Food Packaging: Chemistry
Considerations
10
1
10
25
Total
250
37,975
1 There
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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
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18:52 Aug 26, 2008
Jkt 214001
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 § 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
https://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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Subcommittee I—
Career Development, September 30,
2008, 8 a.m. to October 1, 2008, 5 p.m.,
Crowne Plaza National Airport, 1480
Crystal Drive, Arlington, VA, 22202
which was published in the Federal
Register on August 8, 2008, 73 FR
46308.
This meeting is amended to change
the meeting date to September 30, 2008.
The meeting is closed to the public.
Dated: August 20, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–19805 Filed 8–26–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
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]]>Agencies
[Federal Register Volume 73, Number 167 (Wednesday, August 27, 2008)]
[Notices]
[Pages 50628-50630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19843]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Form No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 ............................. 2 2 2 10,995 21,990
Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 50630]]
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.
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 https://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
