Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 38348-38349 [2013-15233]
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38348
Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
1991), Feeds Materials Production Center
(Fernald, Ohio); Site Profile reviews for:
General Steel Industries, Brookhaven
National Laboratory; Procedures Review
Subcommittee Report; SEC Issues Work
Group Report on ‘‘Sufficient Accuracy’’;
Discussion of Co-Worker Dose Modeling;
Idaho National Laboratory Site Profile
Revisions Update; SEC Petitions Update, and
Board Work Sessions.
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provided below. Any written comments
received will be provided at the meeting and
should be submitted to the contact person
below well in advance of the meeting.
Policy on Redaction of Board Meeting
Transcripts (Public Comment): (1) If a person
making a comment gives his or her name, no
attempt will be made to redact that name. (2)
NIOSH will take reasonable steps to ensure
that individuals making public comment are
aware of the fact that their comments
(including their name, if provided) will
appear in a transcript of the meeting posted
on a public Web site. Such reasonable steps
include: (a) A statement read at the start of
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transcripts will be posted and names of
speakers will not be redacted; (b) A printed
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doing so in a public forum, the DFO will
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with the Federal Advisory Committee Act, to
find a way that the Board can hear such
comments.
Contact Person for More Information:
Theodore Katz, Designated Federal Official,
NIOSH, CDC, 1600 Clifton Road, MS E–20,
Atlanta GA 30333, telephone: (513)533–6800,
toll free: 1–800–CDC–INFO, email:
dcas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
VerDate Mar<15>2010
20:26 Jun 25, 2013
Jkt 229001
both CDC and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2013–15193 Filed 6–25–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0730]
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.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information. 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
Threshold of Regulation for Substances
Used in Food-Contact Articles.
DATES: Submit either electronic or
written comments on the collection of
information by August 26, 2013.
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
(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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
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
FD&C 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 FD&C 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 foodcontact substance in section 409(h)(6) of
the FD&C 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
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26JNN1
Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
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 parts per billion
(ppb). The second exempts regulated
direct food additives for use in foodcontact 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
38349
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.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR 170.39
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Threshold of regulation for substances used in food-contact articles .......................................................................
7
1
7
48
336
mstockstill on DSK4VPTVN1PROD with NOTICES
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 § 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 FD&C 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
VerDate Mar<15>2010
20:26 Jun 25, 2013
Jkt 229001
https://www.fda.gov/Food/
IngredientsPackagingLabeling/
PackagingFCS/default.htm. 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 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–15233 Filed 6–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0575]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics.’’ The purpose of this draft
guidance is to provide a single resource
for information on FDA’s policies and
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 26,
2013. Submit either electronic or
written comments concerning the
proposed collection of information by
August 26, 2013.
DATES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research (CDER),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm.
2201, Silver Spring, MD 20993–0002; or
the Office of Communication, Outreach,
and Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance document.
ADDRESSES:
Draft Guidance for Industry on
Expedited Programs for Serious
Conditions—Drugs and Biologics;
Availability
AGENCY:
procedures related to expedited drug
development and review programs. The
following programs are intended to
facilitate and expedite development and
review of new drugs to address unmet
medical need in the treatment of serious
or life-threatening conditions (expedited
programs): Fast track designation,
breakthrough therapy designation,
accelerated approval, and priority
review designation.
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38348-38349]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0730]
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 or we) is announcing an
opportunity for public comment on the proposed collection of certain
information. 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 Threshold of
Regulation for Substances Used in Food-Contact Articles.
DATES: Submit either electronic or written comments on the collection
of information by August 26, 2013.
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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
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 FD&C 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 FD&C 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 FD&C 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
[[Page 38349]]
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 parts 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.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR 170.39 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Threshold of regulation for substances used in food-contact 7 1 7 48 336
articles..........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 FD&C 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.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm. 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 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15233 Filed 6-25-13; 8:45 am]
BILLING CODE 4160-01-P
