Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles, 68504-68505 [2022-24801]
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68504
Federal Register / Vol. 87, No. 219 / Tuesday, November 15, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
because the product failed to contain
adequate directions for use in its
labeling. The product was refused entry
on July 14, 2020.
On or about June 18, 2020, Mr.
Mendoza offered for import a parcel that
contained 300 tablets of CENFORCE–
100, which was a misbranded drug
because the product was determined to
be a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label. The product was refused
entry on July 15, 2020.
As a result of Mr. Mendoza’s pattern
of importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with his personal or household use) that
are not designated in an authorized
electronic data interchange system as
products regulated by FDA, in
accordance with section 306(b)(3)(D) of
the FD&C Act, FDA sent Mr. Mendoza,
by certified mail on February 17, 2022,
a notice proposing to debar him for a 5year period from importing or offering
for import any drug into the United
States.
In proposing a debarment period,
FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C
Act that it considered applicable to Mr.
Mendoza’s pattern of conduct and
concluded that his conduct warranted
the imposition of a 5-year period of
debarment.
The proposal informed Mr. Mendoza
of the proposed debarment and offered
him an opportunity to request a hearing,
providing 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Mr.
Mendoza received the proposal and
notice of opportunity for a hearing on
February 26, 2022. Mr. Mendoza failed
to request a hearing within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. David
Elias Mendoza has engaged in a pattern
of importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with his personal or household use) that
are not designated in an authorized
electronic data interchange system as
VerDate Sep<11>2014
19:16 Nov 14, 2022
Jkt 259001
products regulated by FDA. FDA finds
that this pattern of conduct should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Mendoza is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug or controlled substance by, with
the assistance of, or at the direction of
Mr. Mendoza is a prohibited act.
Any application by Mr. Mendoza for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2021–
N–0526 and sent to the Dockets
Management Staff (see ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24805 Filed 11–14–22; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or the Agency) 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: Submit written comments
(including recommendations) on the
collection of information by December
15, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0298. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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) of
the FD&C Act or an effective notification
in accordance with section 409(a)(3)(B)
of the FD&C Act.
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. The
second exempts regulated direct food
additives for use in food-contact articles
where the resulting dietary exposure is
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15NON1
68505
Federal Register / Vol. 87, No. 219 / Tuesday, November 15, 2022 / Notices
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 April 7,
2022 (87 FR 20433), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Threshold of regulation for substances used in food-contact articles .......................................................................
lotter on DSK11XQN23PROD with NOTICES1
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR 170.39
I
7
I
1
Average
burden per
response
Total annual
responses
I
I
7
48
Total hours
I
336
are no capital costs or operating and maintenance costs associated with this collection of information.
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 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.
Based on a review of the information
collection since our last request for
VerDate Sep<11>2014
19:16 Nov 14, 2022
Jkt 259001
OMB approval, we have made no
adjustments to our burden estimate.
Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24801 Filed 11–14–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
Advisory Council on Blood Stem Cell
Transplantation (ACBSCT) has
scheduled public meetings. Information
about ACBSCT and the agenda for these
meetings can be found on the ACBSCT
website at https://bloodstemcell.
hrsa.gov/about/advisory-council.
DATES:
• Monday, December 5, 2022, 12–4
p.m. Eastern Time; and
• Tuesday, December 6, 2022, 12–4
p.m. Eastern Time.
ADDRESSES: This meeting will be held
virtually by webinar. A link to register
and join the meeting will be posted at
least 10 days prior to the meeting at
https://bloodstemcell.hrsa.gov/about/
advisory-council.
SUMMARY:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Shelley Grant, Designated Federal
Official, at the HRSA’s Health Systems
Bureau, Division of Transplantation,
5600 Fishers Lane, 8W–67, Rockville,
Maryland 20857; 301–443–8036; or
ACBSCTHRSA@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACBSCT
provides advice and recommendations
to the Secretary of Health and Human
Services (Secretary) on policy, program
development, and other matters of
significance concerning the activities
under the authority of 42 U.S.C. Section
274k, Section 379 of the Public Health
Service Act, as amended, and Public
Law 109–129, and as amended.
During the December 5 and December
6, 2022, meetings, ACBSCT will discuss
the impact of COVID–19 on blood stem
cell donation and transplantation;
unmet needs in blood stem cell
transplantation and cellular therapy;
strategies to improve rates of adult
blood stem donation; and other areas to
increase blood stem cell donation and
transplantation. Agenda items are
subject to change as priorities dictate.
Refer to the ACBSCT website for any
updated information concerning the
meeting. Members of the public will
have the opportunity to provide
comments. Public participants may
submit written statements in advance of
the scheduled meetings; oral comments
will be honored in the order they are
requested and may be limited as time
allows. Requests to submit a written
statement or make oral comments to
ACBSCT should be sent to Shelley
Grant using the contact information
above at least 3 business days prior to
the meeting. Individuals who plan to
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[Federal Register Volume 87, Number 219 (Tuesday, November 15, 2022)]
[Notices]
[Pages 68504-68505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24801]
-----------------------------------------------------------------------
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 the Agency) 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: Submit written comments (including recommendations) on the
collection of information by December 15, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0298. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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 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) of the FD&C Act or an effective notification in accordance
with section 409(a)(3)(B) of the FD&C Act.
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
[[Page 68505]]
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 April 7, 2022 (87 FR 20433), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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 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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: November 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24801 Filed 11-14-22; 8:45 am]
BILLING CODE 4164-01-P
