National Cancer Institute; Amended Notice of Meeting, 50630 [E8-19805]
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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
sroberts on PROD1PC70 with NOTICES
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
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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]
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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]
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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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[Federal Register Volume 73, Number 167 (Wednesday, August 27, 2008)]
[Notices]
[Page 50630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19805]
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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
