Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 29209-29211 [2019-13117]
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Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405, telephone 202–501–4755.
Please cite OMB Control No. 9000–
0074, Contract Funding—Limitation of
Costs/Funds, in all correspondence.
Dated: June 14, 2019.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2019–13138 Filed 6–20–19; 8:45 am]
BILLING CODE 6820–EP–P
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Request for Nominations for the
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ACTION: Request for letters of
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AGENCY:
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established the Physician-Focused
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DATES: Letters of nomination and
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ADDRESSES: Submit letters of
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Include PTAC Nominations in the
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SUMMARY:
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Authority: Pub. L. 114–10, Sec. 101(e), 129
Stat. 87, 115 (2015).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Gene L. Dodaro,
Comptroller General of the United States.
Food and Drug Administration
[FR Doc. 2019–13249 Filed 6–20–19; 8:45 am]
[Docket No. FDA–2019–N–2778]
BILLING CODE 1610–02–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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, and the Determination of
the Chief Operating Officer, CDC,
pursuant to Public Law 92–463. The
grant applications and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–TS–19–002, Multi-Site Study of
the Health Implications of Exposure to
PFAS-Contaminated Drinking Water.
Date: July 24–25, 2019.
Time: 8:30 a.m.–5:00 p.m., EDT.
Place: W Atlanta-Buckhead, 3377
Peachtree Rd, NE, Atlanta, GA 30326.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Mikel Walters, Ph.D., Scientific Review
Official, NCIPC, CDC, 4770 Buford
Highway NE, Mailstop F–63, Atlanta,
Georgia 30341, Telephone (404) 639–
0913, MWalters@cdc.gov.
The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–13178 Filed 6–20–19; 8:45 am]
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Food and Drug Administration,
HHS.
ACTION:
Notice of Closed Meeting
BILLING CODE 4163–18–P
AGENCY:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 data
needed to evaluate requests for
threshold of regulation exemptions for
substances used in food-contact articles.
DATES: Submit either electronic or
written comments on the collection of
information by August 20, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 20,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 20, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–2778 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Threshold of Regulation for Substances
Used in Food-Contact Articles.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
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available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
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, 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
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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 (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
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. 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;
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(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.
We use this information to determine
whether the food-contact substance
meets the threshold criteria:
Description of Respondents:
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.
We estimate the burden of this
collection of information as follows:
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 .......................................................................
4
1
4
48
192
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made
adjustments to decrease our burden
estimate due to the decrease in the
number of respondents. The adjustment
resulted in decreases of 3 responses and
144 total burden hours.
We estimate that approximately 4
requests per year will be submitted
under the threshold of regulation
exemption process of § 170.39, for a
total of 192 hours. The threshold of
regulation process offers an advantage
over the premarket notification process
for food-contact substances established
by section 409(h) of FD&C Act (OMB
control number 0910–0495) in that the
use of a substance exempted by FDA 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 Agency and the
regulated industry would be
significantly less in that other
manufacturers and suppliers would not
have to prepare, and we 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 Dockets Management
Staff and on the internet at https://
www.fda.gov/food/packaging-foodcontact-substances-fcs/thresholdregulation-exemptions-substances-usedfood-contact-articles. 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 foodcontact application of a substance for
which the Agency has previously
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granted an exemption from the food
additive listing regulation requirement.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13117 Filed 6–20–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1536]
Opioid Analgesic Drugs:
Considerations for Benefit-Risk
Assessment Framework; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Opioid
Analgesic Drugs: Considerations for
Benefit-Risk Assessment Framework.’’
The purpose of this guidance is to
describe the benefit-risk framework the
Agency uses in evaluating applications
for opioid analgesic drugs. This
guidance summarizes the information
that should be included in a new drug
application (NDA) for an opioid
analgesic drug to facilitate the Agency’s
benefit-risk assessment.
DATES: Submit either electronic or
written comments on the draft guidance
by August 20, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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Sfmt 4703
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–1536 for ‘‘Opioid Analgesic
Drugs: Considerations for Benefit-Risk
Assessment Framework.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
E:\FR\FM\21JNN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29209-29211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13117]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2778]
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 data needed to evaluate
requests for threshold of regulation exemptions for substances used in
food-contact articles.
DATES: Submit either electronic or written comments on the collection
of information by August 20, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 20, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 20, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or
[[Page 29210]]
anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-2778 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Threshold of Regulation for
Substances Used in Food-Contact Articles.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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 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
(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 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. 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;
[[Page 29211]]
(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.
We use this information to determine whether the food-contact
substance meets the threshold criteria:
Description of Respondents: 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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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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 4 1 4 48 192
articles..........................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made adjustments to decrease our
burden estimate due to the decrease in the number of respondents. The
adjustment resulted in decreases of 3 responses and 144 total burden
hours.
We estimate that approximately 4 requests per year will be
submitted under the threshold of regulation exemption process of Sec.
170.39, for a total of 192 hours. The threshold of regulation process
offers an advantage over the premarket notification process for food-
contact substances established by section 409(h) of FD&C Act (OMB
control number 0910-0495) in that the use of a substance exempted by
FDA 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 Agency and the regulated industry would be significantly
less in that other manufacturers and suppliers would not have to
prepare, and we 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 Dockets Management Staff and on the internet at https://www.fda.gov/food/packaging-food-contact-substances-fcs/threshold-regulation-exemptions-substances-used-food-contact-articles. 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 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13117 Filed 6-20-19; 8:45 am]
BILLING CODE 4164-01-P
