Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 18209-18210 [2010-8050]
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Federal Register / Vol. 75, No. 68 / Friday, April 9, 2010 / Notices
notice expired on March 30, 2010. The
Federal Reserve did not receive any
comments. The revisions will be
implemented as proposed.
srobinson on DSKHWCL6B1PROD with NOTICES
Final Approval Under OMB Delegated
Authority of the Extension for Three
Years, Without Revision, of the
Following Reports
1. Report title: Notice of Branch
Closure.
Agency form number: FR 4031.
OMB control number: 7100–0264.
Frequency: On occasion.
Reporters: State member banks.
Estimated annual reporting hours:
291 hours.
Estimated average hours per response:
Reporting requirements, 2 hours;
Disclosure requirements, customer
mailing, 0.75 hours and posted notice,
0.25 hours; and Recordkeeping
requirements, 8 hours.
Number of respondents: Reporting
requirements, 70; Disclosure
requirements, customer mailing, 70 and
posted notice, 70; and Recordkeeping
requirements, 10.
General description of report: This
information collection is mandatory (12
U.S.C. 1831r–l(a)(1)) and may be given
confidential treatment upon request (5
U.S.C. 552(b)(4)).
Abstract: The mandatory reporting,
recordkeeping, and disclosure
requirements regarding the closing of
any branch of an insured depository
institution are imposed by section 228
of the Federal Deposit Insurance
Corporation Improvement Act of 1991.
There is no reporting form associated
with the reporting portion of this
information collection; State member
banks notify the Federal Reserve by
letter prior to closing a branch. The
Federal Reserve uses the information to
fulfill its statutory obligation to
supervise State member banks.
Current Actions: On January 29, 2010,
the Federal Reserve published a notice
in the Federal Register (75 FR 4819)
requesting public comment for 60 days
on the extension, without revision, of
the FR 4031. The comment period for
this notice expired on March 30, 2010.
The Federal Reserve did not receive any
comments.
2. Report title: Reports Related to
Securities Issued by State Member
Banks as Required by Regulation H.
Agency form number: FR H–1.
OMB control number: 7100–0091.
Frequency: Quarterly and on
occasion.
Reporters: State member banks.
Estimated annual reporting hours:
1,230 hours.
Estimated average hours per response:
5.17 hours.
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17:07 Apr 08, 2010
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Number of respondents: 14.
General description of report: This
information collection is mandatory (15
U.S.C. 781(i) and 78w(a)(1)) and is not
given confidential treatment.
Abstract: The Federal Reserve’s
Regulation H requires certain State
member banks to submit information
relating to their securities to the Federal
Reserve on the same forms that bank
holding companies and nonbank
entities use to submit similar
information to the Securities and
Exchange Commission. The information
is primarily used for public disclosure
and is available to the public upon
request.
Current Actions: On January 29, 2010,
the Federal Reserve published a notice
in the Federal Register (75 FR 4819)
requesting public comment for 60 days
on the extension, without revision, of
the FR H–1. The comment period for
this notice expired on March 30, 2010.
The Federal Reserve did not receive any
comments.
Board of Governors of the Federal Reserve
System, April 6, 2010.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. 2010–8091 Filed 4–8–10; 8:45 am]
BILLING CODE 6210–01–P
GOVERNMENT PRINTING OFFICE
Depository Library Council to the
Public Printer; Meeting
The Depository Library Council to the
Public Printer (DLC) will meet on
Monday, April 26, 2010, through
Wednesday, April 28, 2010, in Buffalo,
New York. The sessions will take place
from 8 a.m. to 5:30 p.m. on Monday
through Tuesday. On Wednesday the
session will be 8 a.m. to 12 p.m. The
meeting will be held at the Adam’s
Mark Hotel located at 120 Church
Street, Buffalo, New York. The purpose
of this meeting is to discuss the Federal
Depository Library Program. All
sessions are open to the public. The
sleeping rooms available at the Adam’s
Mark, Buffalo will be at the Government
rate of $92.00 (plus applicable state and
local taxes, currently 13.75%) a night
for a single or double. The Adam’s Mark
is in compliance with the requirements
of Title III of the Americans with
Disabilities Act and meets all Fire Safety
Act regulations.
Robert C. Tapella,
Public Printer of the United States.
[FR Doc. 2010–8123 Filed 4–8–10; 8:45 am]
BILLING CODE 1520–01–P
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18209
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0181]
Agency Information Collection
Activities; Proposed Collection;
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 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
requests for exemption from the food
additive listing regulation requirements
that are submitted under part 170 (21
CFR part 170).
DATES: Submit written or electronic
comments on the collection of
information by June 8, 2010.
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 of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 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.
E:\FR\FM\09APN1.SGM
09APN1
18210
Federal Register / Vol. 75, No. 68 / Friday, April 9, 2010 / Notices
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.
Threshold of Regulation for Substances
Used in Food-Contact Articles—21 CFR
170.39 (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)
of the act, (2) it conforms to the terms
of a regulation prescribing its use, or (3)
in the case of a food additive which
meets the definition of a food-contact
substance in section 409(h)(6) of the act,
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN
No. of
Respondents
21 CFR Section
170.39
srobinson on DSKHWCL6B1PROD with NOTICES
1 There
Annual Frequency
per Response
7
1
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 three 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
VerDate Nov<24>2008
17:07 Apr 08, 2010
Jkt 220001
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
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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: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–8050 Filed 4–8–10; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 75, Number 68 (Friday, April 9, 2010)]
[Notices]
[Pages 18209-18210]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8050]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0181]
Agency Information Collection Activities; Proposed Collection;
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 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 requests for exemption from
the food additive listing regulation requirements that are submitted
under part 170 (21 CFR part 170).
DATES: Submit written or electronic comments on the collection of
information by June 8, 2010.
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 of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 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.
[[Page 18210]]
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.
Threshold of Regulation for Substances Used in Food-Contact Articles--
21 CFR 170.39 (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) of the act, (2)
it conforms to the terms of a regulation prescribing its use, or (3) in
the case of a food additive which meets the definition of a food-
contact substance in section 409(h)(6) of the act, 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.
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 three
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: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8050 Filed 4-8-10; 8:45 am]
BILLING CODE 4160-01-S
