Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substances Notification System, 73936-73938 [E8-28694]
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73936
Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. E-mail address:
OPREinfocollection@acfjov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 28, 2008.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. E8–28656 Filed 12–3–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB No.: 0970–0209.
Description: The purpose of the
Intergovernmental Referral Guide (IRG)
project is to provide States, Foreign
Nations and Tribes with an effective and
efficient way of viewing and updating
their profiles with child support
enforcement policies and procedures,
and their address and location code
information by consolidating data
available through numerous discrete
sources into a centralized, automated
repository.
Respondents: State IV–D Child
Support Programs, Foreign Nation Child
Support Programs and Tribes.
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Interstate Referral Guide (IRG).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
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IRG State User Guide (Foreign Nations ) .......................................................
IRG Tribal User Guide .....................................................................................
IRG State User Guide (States and Territories) ...............................................
Estimated Total Annual Burden
Hours: 533.80.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
VerDate Aug<31>2005
17:35 Dec 03, 2008
Jkt 217001
23
44
54
Dated: December 1, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–28728 Filed 12–3–08; 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; 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.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
2
18
18
Average
burden hours
per response
0.10
0.30
0.30
Total burden
hours
4.60
237.60
291.60
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.
ADDRESSES:
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
E:\FR\FM\04DEN1.SGM
04DEN1
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Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices
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 BURDEN1
21 CFR Section
170.106
2
170.101
3,7
170.101
(Category A)
Annual
Frequency per
Response
No. of
Respondents
Form No.
Total Annual
Responses
Hours per
Response
Total Hours
FDA 3479
5
1
5
2
10
(Category B)
FDA 3480
5
1
5
25
125
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 Packaging: Chemistry Considerations’’
10
1
10
25
250
Total
37,975
1There
mstockstill on PROD1PC66 with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2Notifications 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.
3Duplicate notifications for uses of food contact substances.
4Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
5Notifications for uses that are the subject of moderately complex food additive petitions.
6Notifications for uses that are the subject of very complex food additive petitions.
7These 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
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17:35 Dec 03, 2008
Jkt 217001
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,
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\04DEN1.SGM
04DEN1
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Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices
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 § 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
[Docket No. FDA–2008–N–0607]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reclassification
Petitions for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
17:35 Dec 03, 2008
Jkt 217001
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
reclassification petitions for medical
devices.
DATES: Submit written or electronic
comments on the collection of
information by February 2, 2009.
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:
Denver Presley, Jr.,Office Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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.
Reclassification Petitions for Medical
Devices—21 CFR Section 860.123 (OMB
Control Number 0910–0138)—Extension
FDA has responsibility under sections
513(e) and (f), 514(b), 515(b), and 520(l)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(e) and (f), 360d(b),
360e(b), and 360j(l)) and part 860 (21
CFR part 860), subpart C, to collect data
and information contained in
reclassification petitions. The
reclassification provisions of the act
allow any person to petition for
reclassification of a device from any one
of the three classes, i.e., I, II, and III, to
another class. The reclassification
content regulation (§ 860.123) requires
the submission of sufficient, valid
scientific evidence demonstrating that
the proposed reclassification will
provide a reasonable assurance of safety
and effectiveness of the device type for
its indications for use. Thus, the
reclassification provisions of the act
serve primarily as a vehicle for
manufacturers to seek reclassification
from a higher to a lower class, thereby
reducing the regulatory requirements
applicable to a particular device type or
to seek reclassification from a lower to
a higher class, thereby increasing the
regulatory requirements. The
reclassification petitions requesting
classification from class III to class II or
class I, if approved, provides an
alternative route to the market in lieu of
premarket approval for class III devices
or from class I or II to one or the other
class, which may increase requirements.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\04DEN1.SGM
04DEN1
Agencies
[Federal Register Volume 73, Number 234 (Thursday, December 4, 2008)]
[Notices]
[Pages 73936-73938]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28694]
-----------------------------------------------------------------------
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