Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 36091-36092 [2010-15302]
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Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
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Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. 2010–15276 Filed 6–23–10; 8:45 am]
BILLING CODE 6210–01–P
GENERAL SERVICES
ADMINISTRATION
Notice of Availability of the Draft
Environmental Impact Statement for
Improvements to the Calexico West
Port of Entry, Calexico, CA
Public Buildings Service, GSA.
ACTION: Notice of Availability and
public hearing for the Draft
Environmental Impact Statement.
emcdonald on DSK2BSOYB1PROD with NOTICES
AGENCY:
SUMMARY: The General Services
Administration (GSA) announces the
availability of the Draft Environmental
Impact Statement (EIS) for
Improvements to the Calexico West Port
of Entry, Calexico, California, for public
review and comment. The EIS provides
GSA and its stakeholders an analysis of
the environmental impacts resulting
from ongoing operations as well as
reasonable alternatives for renovation,
replacement, and continued operation
of the Calexico West Port of Entry,
located in south-central California.
DATES: Comments on the Draft
Environmental Impact Statement may
be submitted during the public
comment period, which will commence
with the U.S. Environmental Protection
Agency’s publication of the Federal
Register Notice of Availability for this
document and end on August 18, 2010.
Comments may be submitted in writing,
orally, or by electronic mail to the
General Services Administration at the
address, phone number, or e-mail listed
below. Oral or written comments may
also be submitted at public meetings to
be held on June 22 and July 14, 2010,
between 3 and 7 p.m., at the Calexico
City Hall, 608 Heber Avenue, Calexico,
California. Comments submitted will be
VerDate Mar<15>2010
16:47 Jun 23, 2010
Jkt 220001
considered in preparation of the Final
Environmental Impact Statement.
FOR FURTHER INFORMATION CONTACT: Mr.
Greg Smith, GSA Regional
Environmental Quality Advisor,
Portfolio Management Division, Capital
Investment Branch (9P2PTC), U.S.
General Services Administration, 880
Front Street, Room 4236, San Diego,
California 92101, (619) 557–6169 or via
e-mail to greg.smith@gsa.gov. Oral and
written comments may also be
submitted at the public hearing
described in the DATES section. Requests
for copies of the Draft Calexico West
Port of Entry EIS or other matters
regarding this environmental review
should be referred to Greg Smith at the
address above.
SUPPLEMENTARY INFORMATION: A notice
of availability will be mailed to all
agencies, organizations, and individuals
who participated in the scoping process
or were identified during the EIS
process. GSA has distributed copies of
the Draft Calexico West Port of Entry
EIS to appropriate Congressional
members and committees, the state of
California, American Indian tribal
governments, local county governments,
other Federal agencies, and other
interested parties who have already
requested copies.
The Draft EIS was prepared pursuant
to the National Environmental Policy
Act of 1969 (NEPA) [42 U.S.C. 4321 et
seq.] and the Council on Environmental
Quality NEPA regulations [40 CFR part
1500]. GSA proposes to continue
operating the Calexico West Port of
Entry, which is located in Calexico in
south-central California. GSA has
identified and assessed several design
options for the renovation, replacement,
and continued operation of the Calexico
West Port of Entry. In addition, GSA
analyzed the No Action Alternative in
which GSA would continue the status
quo, that is, operate the port of entry in
its current configuration, with only
minor planned upgrades.
The Draft Calexico Port of Entry EIS
identifies the expected environmental
impacts from facility operations for each
alternative. For each alternative, impact
discussions are presented by resource
area (e.g., land use, geology and soils) or
topic area (e.g., traffic, environmental
justice).
After the public comment period,
which ends August 18, 2010, GSA will
consider the comments received, revise
the Draft EIS, select a preferred
alternative, and issue a Final EIS. GSA
will consider the Final EIS, along with
other economic and technical
considerations, to make a decision on
the appropriate course for
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36091
improvements at the Calexico West Port
of Entry.
ADDRESSES: Comments may be
submitted in writing to: Mr. Greg Smith,
Regional Environmental Quality
Advisor, Portfolio Management
Division, Capital Investment Branch
(9P2PTC), U.S. General Services
Administration, 880 Front Street, Room
4236, San Diego, California 92101, or
via e-mail to greg.smith@gsa.gov. Oral
and written comments may also be
submitted at the public meetings
described in the DATES section. Copies
of the Draft Calexico Environmental
Impact Statement may be downloaded
from https://www.gsa.gov/nepalibrary.
Other matters regarding this
environmental review should be
referred to Greg Smith at the address
above.
Dated: June 10, 2010.
Samuel R. Mazzola,
Director, Portfolio Management Division,
Public Building Service, Pacific Rim Region.
[FR Doc. 2010–15299 Filed 6–23–10; 8:45 am]
BILLING CODE 6820–YF–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0181]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
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 July 26,
2010.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0298. Also
include the FDA docket number found
E:\FR\FM\24JNN1.SGM
24JNN1
36092
Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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.
Threshold of Regulation for Substances
Used in Food-Contact Articles—(OMB
Control Number 0910–0298)—Extension
Under section 409(a) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 348(a)), the use of a food
additive is deemed unsafe unless one of
the following is applicable: (1) It
conforms to an exemption for
investigational use under section 409(j),
(2) it conforms to the terms of a
regulation prescribing its use, or (3) in
the case of a food additive that meets
the definition of a food-contact
substance in section 409(h)(6), there is
either a regulation authorizing its use in
accordance with section 409(a)(3)(A) or
an effective notification in accordance
with section 409(a)(3)(B).
The regulations in § 170.39 (21 CFR
170.39) established a process that
provides the manufacturer with an
opportunity to demonstrate that the
likelihood or extent of migration to food
of a substance used in a food-contact
article is so trivial that the use need not
be the subject of a food additive listing
regulation or an effective notification.
The agency has established two
thresholds for the regulation of
substances used in food-contact articles.
The first exempts those substances used
in food-contact articles where the
resulting dietary concentration would
be at or below 0.5 part per billion (ppb).
The second exempts regulated direct
food additives for use in food-contact
articles where the resulting dietary
exposure is 1 percent or less of the
acceptable daily intake for these
substances.
In order to determine whether the
intended use of a substance in a foodcontact article meets the threshold
criteria, certain information specified in
§ 170.39(c) must be submitted to FDA.
This information includes the following
components: (1) The chemical
composition of the substance for which
the request is made, (2) detailed
information on the conditions of use of
the substance, (3) a clear statement of
the basis for the request for exemption
from regulation as a food additive, (4)
data that will enable FDA to estimate
the daily dietary concentration resulting
from the proposed use of the substance,
(5) results of a literature search for
toxicological data on the substance and
its impurities, and (6) information on
the environmental impact that would
result from the proposed use.
FDA uses this information to
determine whether the food-contact
article meets the threshold criteria.
Respondents to this information
collection are individual manufacturers
and suppliers of substances used in
food-contact articles (i.e., food
packaging and food processing
equipment) or of the articles themselves.
In the Federal Register of April 9,
2010 (75 FR 18209), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
170.39
emcdonald on DSK2BSOYB1PROD with NOTICES
1 There
Annual Frequency
per Response
7
Total Annual
Responses
1
Hours
per Response
7
Total Hours
48
336
are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA
consulted its records of the number of
regulation exemption requests received
in the past 3 years. The annual hours
per response reporting estimate of 48
hours is based on information received
from representatives of the food
packaging and processing industries and
agency records.
FDA estimates that approximately 7
requests per year will be submitted
under the threshold of regulation
exemption process of § 170.39, for a
total of 336 hours. The threshold of
regulation process offers one advantage
over the premarket notification process
for food-contact substances established
by section 409(h) of the act (OMB
control number 0910–0495) in that the
use of a substance exempted by the
agency is not limited to only the
manufacturer or supplier who submitted
the request for an exemption. Other
manufacturers or suppliers may use
exempted substances in food-contact
articles as long as the conditions of use
(e.g., use levels, temperature, type of
VerDate Mar<15>2010
16:47 Jun 23, 2010
Jkt 220001
food contacted, etc.) are those for which
the exemption was issued. As a result,
the overall burden on both the agency
and the regulated industry would be
significantly less in that other
manufacturers and suppliers would not
have to prepare, and FDA would not
have to review, similar submissions for
identical components of food-contact
articles used under identical conditions.
Manufacturers and other interested
persons can easily access an up-to-date
list of exempted substances which is on
display at FDA’s Division of Dockets
Management and on the Internet at
https://www.cfsan.fda.gov. Having the
list of exempted substances publicly
available decreases the likelihood that a
company would submit a food additive
petition or a notification for the same
type of food-contact application of a
substance for which the agency has
previously granted an exemption from
the food additive listing regulation
requirement.
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Fmt 4703
Sfmt 4703
Dated: June 16, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–15302 Filed 6–23–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0273]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Current Good Manufacturing Practice
Quality System Regulations
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
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Notices]
[Pages 36091-36092]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15302]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0181]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Threshold of
Regulation for Substances Used in Food-Contact Articles
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 July
26, 2010.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0298.
Also include the FDA docket number found
[[Page 36092]]
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
Threshold of Regulation for Substances Used in Food-Contact Articles--
(OMB Control Number 0910-0298)--Extension
Under section 409(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 348(a)), the use of a food additive is deemed
unsafe unless one of the following is applicable: (1) It conforms to an
exemption for investigational use under section 409(j), (2) it conforms
to the terms of a regulation prescribing its use, or (3) in the case of
a food additive that meets the definition of a food-contact substance
in section 409(h)(6), there is either a regulation authorizing its use
in accordance with section 409(a)(3)(A) or an effective notification in
accordance with section 409(a)(3)(B).
The regulations in Sec. 170.39 (21 CFR 170.39) established a
process that provides the manufacturer with an opportunity to
demonstrate that the likelihood or extent of migration to food of a
substance used in a food-contact article is so trivial that the use
need not be the subject of a food additive listing regulation or an
effective notification. The agency has established two thresholds for
the regulation of substances used in food-contact articles. The first
exempts those substances used in food-contact articles where the
resulting dietary concentration would be at or below 0.5 part per
billion (ppb). The second exempts regulated direct food additives for
use in food-contact articles where the resulting dietary exposure is 1
percent or less of the acceptable daily intake for these substances.
In order to determine whether the intended use of a substance in a
food-contact article meets the threshold criteria, certain information
specified in Sec. 170.39(c) must be submitted to FDA. This information
includes the following components: (1) The chemical composition of the
substance for which the request is made, (2) detailed information on
the conditions of use of the substance, (3) a clear statement of the
basis for the request for exemption from regulation as a food additive,
(4) data that will enable FDA to estimate the daily dietary
concentration resulting from the proposed use of the substance, (5)
results of a literature search for toxicological data on the substance
and its impurities, and (6) information on the environmental impact
that would result from the proposed use.
FDA uses this information to determine whether the food-contact
article meets the threshold criteria. Respondents to this information
collection are individual manufacturers and suppliers of substances
used in food-contact articles (i.e., food packaging and food processing
equipment) or of the articles themselves.
In the Federal Register of April 9, 2010 (75 FR 18209), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
170.39 7 1 7 48 336
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In compiling these estimates, FDA consulted its records of the
number of regulation exemption requests received in the past 3 years.
The annual hours per response reporting estimate of 48 hours is based
on information received from representatives of the food packaging and
processing industries and agency records.
FDA estimates that approximately 7 requests per year will be
submitted under the threshold of regulation exemption process of Sec.
170.39, for a total of 336 hours. The threshold of regulation process
offers one advantage over the premarket notification process for food-
contact substances established by section 409(h) of the act (OMB
control number 0910-0495) in that the use of a substance exempted by
the agency is not limited to only the manufacturer or supplier who
submitted the request for an exemption. Other manufacturers or
suppliers may use exempted substances in food-contact articles as long
as the conditions of use (e.g., use levels, temperature, type of food
contacted, etc.) are those for which the exemption was issued. As a
result, the overall burden on both the agency and the regulated
industry would be significantly less in that other manufacturers and
suppliers would not have to prepare, and FDA would not have to review,
similar submissions for identical components of food-contact articles
used under identical conditions. Manufacturers and other interested
persons can easily access an up-to-date list of exempted substances
which is on display at FDA's Division of Dockets Management and on the
Internet at https://www.cfsan.fda.gov. Having the list of exempted
substances publicly available decreases the likelihood that a company
would submit a food additive petition or a notification for the same
type of food-contact application of a substance for which the agency
has previously granted an exemption from the food additive listing
regulation requirement.
Dated: June 16, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-15302 Filed 6-23-10; 8:45 am]
BILLING CODE 4160-01-S
