Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 59831-59832 [2019-24230]
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Federal Register / Vol. 84, No. 215 / Wednesday, November 6, 2019 / Notices
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 22 U.S. Code 7104 and 22 U.S.
Code 7105(c)(4).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–24200 Filed 11–5–19; 8:45 am]
BILLING CODE 4184–47–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Threshold of Regulation for Substances
Used in Food-Contact Articles—21 CFR
170.39
Food and Drug Administration
[Docket No. FDA–2019–N–2778]
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:
395–7285, or emailed 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
in brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Notice.
The Food and Drug
Administration (FDA or we) 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 December
6, 2019.
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–
SUMMARY:
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 that
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 § 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.
59831
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. 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
§ 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. 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.
In the Federal Register of June 21,
2019 (84 FR 29209), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
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 .......................................................................
7
1
7
48
336
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 no
adjustments. We estimate that
approximately seven requests per year
VerDate Sep<11>2014
17:43 Nov 05, 2019
Jkt 250001
will be submitted under the threshold of
regulation exemption process of
§ 170.39, for a total of 336 hours. In the
Federal Register of June 21, 2019, we
estimated four requests per year. In
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
reconsideration of the two to three
requests that were received but did not
become effective, we retain our previous
estimate of seven requests per year, with
E:\FR\FM\06NON1.SGM
06NON1
59832
Federal Register / Vol. 84, No. 215 / Wednesday, November 6, 2019 / Notices
four of those requests becoming
effective.
The threshold of regulation process
offers one 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
granted an exemption from the food
additive listing regulation requirement.
Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24230 Filed 11–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2312]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Allergenic
Products Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:43 Nov 05, 2019
Jkt 250001
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Allergenic
Products Advisory Committee (APAC)
for the Center for Biologics Evaluation
and Research notify FDA in writing.
FDA is also requesting nominations for
a nonvoting industry representative(s) to
serve on the APAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by December 6, 2019 (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by December 6,
2019.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent via email to
Prabhakara Atreya (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
must be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website
at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6306, Silver Spring, MD
20993–0002, 240–402–8006, Fax: 301–
595–1307, email: Prabhakara.Atreya@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUMMARY:
I. Allergenic Products Advisory
Committee
The APAC reviews and evaluates data
concerning the safety, effectiveness, and
adequacy of labeling of marketed and
investigational allergenic biological
products or materials that are
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
administered to humans for the
diagnosis, prevention, or treatment of
allergies and allergic diseases, and
makes appropriate recommendations to
the Commissioner of Food and Drugs
(the Commissioner) of its findings
regarding the affirmation or revocation
of biological product licenses; on the
safety, effectiveness, and labeling of the
products; on clinical and laboratory
studies of such products; on
amendments or revisions to regulations
governing the manufacture, testing, and
licensing of allergenic biological
products; and on the quality and
relevance of FDA’s research programs
which provide the scientific support for
regulating these agents.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter via email stating that interest to
the FDA contact (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). Within the subsequent 30 days,
FDA will send a notification to each
organization that has expressed an
interest, attaching a complete list of all
such organizations; and a list of all
nominees along with their current
resumes. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
APAC. The interested organizations are
not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
E:\FR\FM\06NON1.SGM
06NON1
]]>Agencies
[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59831-59832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24230]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2778]
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 or we) 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
December 6, 2019.
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 emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0298.
Also include the FDA docket number found in brackets in the heading of
this document.
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: 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--
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 that 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. 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; (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.
In the Federal Register of June 21, 2019 (84 FR 29209), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments. We estimate that
approximately seven requests per year will be submitted under the
threshold of regulation exemption process of Sec. 170.39, for a total
of 336 hours. In the Federal Register of June 21, 2019, we estimated
four requests per year. In reconsideration of the two to three requests
that were received but did not become effective, we retain our previous
estimate of seven requests per year, with
[[Page 59832]]
four of those requests becoming effective.
The threshold of regulation process offers one 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: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24230 Filed 11-5-19; 8:45 am]
BILLING CODE 4164-01-P
