Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels, 4614-4615 [2022-01792]
Download as PDF
<![CDATA[
4614
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY
DRUG—Continued
Drug
Route of
administration
Action taken
Therapeutic
category
Omadacycline ................
Injection, Oral ................
FDA updated disk breakpoints for Streptococcus
pneumoniae for community acquired bacterial
pneumonia.
Antibacterial ..................
Dated: January 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
20852, 301–796–7726, 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.
[FR Doc. 2022–01693 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Reporting Associated With Food
Additive Petitions, Investigational Food
Additive Files Exemptions, and
Declaration of Color Additives on
Animal Food Labels—21 CFR 501.22(k),
570.17, 571.1, and 571.6
Food and Drug Administration
[Docket No. FDA–2021–N–1022]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reporting
Associated With Food Additive
Petitions, Investigational Food
Additive Files Exemptions, and
Declaration of Color Additives on
Animal Food Labels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, 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: Submit written comments
(including recommendations) on the
collection of information by February
28, 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 0910–0546. Also include
the FDA docket number found in
brackets in the heading of this
document.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
OMB Control Number 0910–0546—
Extension
This information collection supports
FDA regulations as discussed below. In
this notice, we are combining all
reporting burden associated with FDA’s
regulations at §§ 501.22(k), 570.17,
571.1, and 571.6 (21 CFR 501.22(k),
570.17, 571.1, and 571.6) into one
collection and are consolidating the
burden for OMB control numbers 0910–
0546 and 0910–0721. Upon approval of
the consolidated collection OMB control
number 0910–0546, we will ask OMB to
discontinue OMB control number 0910–
0721. The information collection
provisions approved under OMB control
numbers 0910–0546 and 0910–0721 are
similar in that they support FDA’s
regulations at §§ 501.22(k), 570.17,
571.1, and 571.6. Thus, with this notice,
FDA proposes to consolidate these
collections of information into one OMB
control number for government
efficiency and to allow the public to
look to one OMB control number for all
reporting associated with FDA’s
regulations at §§ 501.22(k), 570.17,
571.1, and 571.6.
Food Additive Petitions and
Investigational Food Additive Files
Exemptions
Section 409(a) of the Federal Food,
Drug and Cosmetic Act (FD&C Act) (21
U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe
unless its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of FD&C Act specifies the
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Date
8/25/20
information that must be submitted by
a petitioner in order to establish the
safety of a food additive and to secure
the issuance of a regulation permitting
its use.
To implement the provisions of
section 409 of the FD&C Act, we issued
procedural regulations under 21 CFR
part 571. These procedural regulations
are designed to specify more thoroughly
the information that must be submitted
to meet the requirement set down in
broader terms by the FD&C Act. The
regulations add no substantive
requirements to those indicated in the
FD&C Act but attempt to explain these
requirements and provide a standard
format for submission to speed
processing of the food additive petition.
Labeling requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in parts 501, 573, and 579 (21
CFR parts 501, 573, and 579). The
labeling regulations are considered by
FDA to be cross-referenced to § 571.1,
which is the subject of this same OMB
clearance for food additive petitions.
Regarding the investigational use of
food additives, section 409(j) of the
FD&C Act provides that any food
additive or any food bearing or
containing such an additive may be
exempted from the requirements of this
section if intended solely for
investigational use by qualified experts.
Investigational use of a food additive is
typically to address the safety and/or
intended physical or technical effect of
the additive. To implement the
provisions of section 409(j) of the FD&C
Act, we issued regulations under
§ 570.17. These regulations are designed
to specify more thoroughly the
information that must be submitted to
meet the requirement set down in broad
terms by the FD&C Act. Labeling
requirements for investigational food
additive files are also set forth in
various regulations contained in part
501. The labeling regulations are
considered by FDA to be crossreferenced to § 570.17, which is the
subject of this same OMB clearance for
investigational food additive files.
The information collected is
necessary to protect the public health.
We use the information submitted by
E:\FR\FM\28JAN1.SGM
28JAN1
4615
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
food manufacturers or food additive
manufacturers to ascertain whether the
data establish the identity of the
substance, justify its intended effect in/
on the food, and establish that its
intended use in/on food is safe.
Animal Food Labeling; Declaration of
Certified and Non-Certified Color
Additives
FDA has the authority under the
FD&C Act to issue regulations
concerning animal food. Specifically,
section 403(i) of the FD&C Act (21
U.S.C. 343(i)) requires that certified
color additives used in or on a food
must be declared by their common or
usual names and not be designated by
the collective term ‘‘colorings.’’ Our
regulations in part 501 set forth the
requirements for animal food labeling.
Under § 501.22(k), animal food
manufacturers must declare on the
animal food label the presence of
certified and noncertified color
additives in their animal food products.
Our animal food labeling regulation at
§ 501.22(k) is consistent with the
regulations requiring the declaration of
color additives on human food labels.
The purpose of the labeling is to provide
animal owners with information on the
color additives used in animal food.
Animal owners use the information to
become knowledgeable about the foods
they purchase for their animals.
Description of Respondents:
Respondents to this collection of
information are manufacturers of animal
food products that contain color
additives or are manufacturers of food
additives.
In the Federal Register of October 8,
2021 (86 FR 56277), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although three comments
were received, they were not responsive
to the four collection of information
topics solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Food Additive Petitions:
571.1(c); Moderate Category ............................
571.1(c); Complex Category .............................
571.6; Amendment of Petition ..........................
Investigational Food Additive Files:
570.17; Moderate Category ..............................
570.17; Complex Category ...............................
Color Additives:
501.22(k); labeling of color additive or lake of
color additive; labeling of color additives not
subject to certification.
Total ...........................................................
jspears on DSK121TN23PROD with NOTICES1
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden
per response
Total hours
6
5
5
1
1
1
6
5
5
3,000 .........................
10,000 .......................
1,300 .........................
18,000
50,000
6,500
6
7
1
1
6
7
1,500 .........................
5,000 .........................
9,000
35,000
3,120
0.8292
2,587
0.25 (15 minutes) ......
647
........................
........................
........................
....................................
119,147
are no capital costs or operating and maintenance costs associated with this collection of information.
For the purpose of this consolidation,
we base our estimate of the total annual
responses on submissions received
during fiscal years 2019 and 2020. We
base our estimate of the hours per
response on our experience with the
labeling, food additive petition, and
filing processes.
The information collection reflects a
net decrease of 70,453 hours (189,600
OMB approved hours—119,147
estimated hours). We also experienced a
net increase of 2,587 responses from 35
OMB approved annual responses to
2,616 estimated annual responses.
These changes were due to the
consolidating of the information
collection covered by OMB control
number 0910–0721 and due to
estimated changes of the number of
respondents for food additive petitions
and investigational food additive files.
Section 571.1(c) Moderate Category:
The estimated time requirement per
food additive petition remains at
approximately 3,000 hours; however,
we now estimate that the number of
annual respondents has decreased from
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
12 to 6 respondents for a total of 18,000
hours.
Section 571.1(c) Complex Category:
The estimated time requirement per
food additive petition remains at
approximately 10,000 hours; however,
we now estimate that the number of
annual respondents has decreased from
12 to 5 respondents for a total of 50,000
hours.
Section 571.6 Amendment of
Petition: We estimated that the number
of annual respondents that will submit
an amendment has increased from two
to five respondents who will each
submit one amendment for a total of
6,500 hours. This is an increase of three
respondents and 3,900 hours from the
burden approved by OMB.
Section 570.17 Moderate Category:
We estimated that the number of annual
respondents for investigational food
additive files has increased from four to
six respondents who will each submit
one file for a total of 9,000 hours. This
is an increase of two respondents and
3,000 hours from the burden approved
by OMB.
PO 00000
Frm 00064
Fmt 4703
Sfmt 9990
Section 570.17 Complex Category: We
estimated that the number of annual
respondents for investigational food
additive files has increased from five to
seven respondents who will each
submit one such file, for a total of
35,000 hours. This is an increase of
10,000 hours from the burden approved
by OMB.
Section 501.22(k) Labeling of Color
Additive or Lake of Color Additive;
Labeling of Color Additives Not Subject
to Certification: The information
collection reflects an adjustment in
burden by 647 hours and 2,587
responses. We attribute this adjustment
due to the consolidation of OMB control
numbers 0910–0546 and 0910–0721.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01792 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\28JAN1.SGM
28JAN1
]]>Agencies
[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4614-4615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01792]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1022]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Associated
With Food Additive Petitions, Investigational Food Additive Files
Exemptions, and Declaration of Color Additives on Animal Food Labels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, 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: Submit written comments (including recommendations) on the
collection of information by February 28, 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 0910-0546. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Reporting Associated With Food Additive Petitions, Investigational Food
Additive Files Exemptions, and Declaration of Color Additives on Animal
Food Labels--21 CFR 501.22(k), 570.17, 571.1, and 571.6
OMB Control Number 0910-0546--Extension
This information collection supports FDA regulations as discussed
below. In this notice, we are combining all reporting burden associated
with FDA's regulations at Sec. Sec. 501.22(k), 570.17, 571.1, and
571.6 (21 CFR 501.22(k), 570.17, 571.1, and 571.6) into one collection
and are consolidating the burden for OMB control numbers 0910-0546 and
0910-0721. Upon approval of the consolidated collection OMB control
number 0910-0546, we will ask OMB to discontinue OMB control number
0910-0721. The information collection provisions approved under OMB
control numbers 0910-0546 and 0910-0721 are similar in that they
support FDA's regulations at Sec. Sec. 501.22(k), 570.17, 571.1, and
571.6. Thus, with this notice, FDA proposes to consolidate these
collections of information into one OMB control number for government
efficiency and to allow the public to look to one OMB control number
for all reporting associated with FDA's regulations at Sec. Sec.
501.22(k), 570.17, 571.1, and 571.6.
Food Additive Petitions and Investigational Food Additive Files
Exemptions
Section 409(a) of the Federal Food, Drug and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of FD&C Act specifies the information that must be submitted by
a petitioner in order to establish the safety of a food additive and to
secure the issuance of a regulation permitting its use.
To implement the provisions of section 409 of the FD&C Act, we
issued procedural regulations under 21 CFR part 571. These procedural
regulations are designed to specify more thoroughly the information
that must be submitted to meet the requirement set down in broader
terms by the FD&C Act. The regulations add no substantive requirements
to those indicated in the FD&C Act but attempt to explain these
requirements and provide a standard format for submission to speed
processing of the food additive petition. Labeling requirements for
food additives intended for animal consumption are also set forth in
various regulations contained in parts 501, 573, and 579 (21 CFR parts
501, 573, and 579). The labeling regulations are considered by FDA to
be cross-referenced to Sec. 571.1, which is the subject of this same
OMB clearance for food additive petitions.
Regarding the investigational use of food additives, section 409(j)
of the FD&C Act provides that any food additive or any food bearing or
containing such an additive may be exempted from the requirements of
this section if intended solely for investigational use by qualified
experts. Investigational use of a food additive is typically to address
the safety and/or intended physical or technical effect of the
additive. To implement the provisions of section 409(j) of the FD&C
Act, we issued regulations under Sec. 570.17. These regulations are
designed to specify more thoroughly the information that must be
submitted to meet the requirement set down in broad terms by the FD&C
Act. Labeling requirements for investigational food additive files are
also set forth in various regulations contained in part 501. The
labeling regulations are considered by FDA to be cross-referenced to
Sec. 570.17, which is the subject of this same OMB clearance for
investigational food additive files.
The information collected is necessary to protect the public
health. We use the information submitted by
[[Page 4615]]
food manufacturers or food additive manufacturers to ascertain whether
the data establish the identity of the substance, justify its intended
effect in/on the food, and establish that its intended use in/on food
is safe.
Animal Food Labeling; Declaration of Certified and Non-Certified Color
Additives
FDA has the authority under the FD&C Act to issue regulations
concerning animal food. Specifically, section 403(i) of the FD&C Act
(21 U.S.C. 343(i)) requires that certified color additives used in or
on a food must be declared by their common or usual names and not be
designated by the collective term ``colorings.'' Our regulations in
part 501 set forth the requirements for animal food labeling. Under
Sec. 501.22(k), animal food manufacturers must declare on the animal
food label the presence of certified and noncertified color additives
in their animal food products. Our animal food labeling regulation at
Sec. 501.22(k) is consistent with the regulations requiring the
declaration of color additives on human food labels. The purpose of the
labeling is to provide animal owners with information on the color
additives used in animal food. Animal owners use the information to
become knowledgeable about the foods they purchase for their animals.
Description of Respondents: Respondents to this collection of
information are manufacturers of animal food products that contain
color additives or are manufacturers of food additives.
In the Federal Register of October 8, 2021 (86 FR 56277), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, they
were not responsive to the four collection of information topics
solicited and therefore will not be discussed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petitions:
571.1(c); Moderate Category............. 6 1 6 3,000..................................... 18,000
571.1(c); Complex Category.............. 5 1 5 10,000.................................... 50,000
571.6; Amendment of Petition............ 5 1 5 1,300..................................... 6,500
Investigational Food Additive Files:
570.17; Moderate Category............... 6 1 6 1,500..................................... 9,000
570.17; Complex Category................ 7 1 7 5,000..................................... 35,000
Color Additives:
501.22(k); labeling of color additive or 3,120 0.8292 2,587 0.25 (15 minutes)......................... 647
lake of color additive; labeling of
color additives not subject to
certification.
-----------------------------------------------------------------------------------------------------------
Total............................... .............. .............. .............. .......................................... 119,147
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
For the purpose of this consolidation, we base our estimate of the
total annual responses on submissions received during fiscal years 2019
and 2020. We base our estimate of the hours per response on our
experience with the labeling, food additive petition, and filing
processes.
The information collection reflects a net decrease of 70,453 hours
(189,600 OMB approved hours--119,147 estimated hours). We also
experienced a net increase of 2,587 responses from 35 OMB approved
annual responses to 2,616 estimated annual responses. These changes
were due to the consolidating of the information collection covered by
OMB control number 0910-0721 and due to estimated changes of the number
of respondents for food additive petitions and investigational food
additive files.
Section 571.1(c) Moderate Category: The estimated time requirement
per food additive petition remains at approximately 3,000 hours;
however, we now estimate that the number of annual respondents has
decreased from 12 to 6 respondents for a total of 18,000 hours.
Section 571.1(c) Complex Category: The estimated time requirement
per food additive petition remains at approximately 10,000 hours;
however, we now estimate that the number of annual respondents has
decreased from 12 to 5 respondents for a total of 50,000 hours.
Section 571.6 Amendment of Petition: We estimated that the number
of annual respondents that will submit an amendment has increased from
two to five respondents who will each submit one amendment for a total
of 6,500 hours. This is an increase of three respondents and 3,900
hours from the burden approved by OMB.
Section 570.17 Moderate Category: We estimated that the number of
annual respondents for investigational food additive files has
increased from four to six respondents who will each submit one file
for a total of 9,000 hours. This is an increase of two respondents and
3,000 hours from the burden approved by OMB.
Section 570.17 Complex Category: We estimated that the number of
annual respondents for investigational food additive files has
increased from five to seven respondents who will each submit one such
file, for a total of 35,000 hours. This is an increase of 10,000 hours
from the burden approved by OMB.
Section 501.22(k) Labeling of Color Additive or Lake of Color
Additive; Labeling of Color Additives Not Subject to Certification: The
information collection reflects an adjustment in burden by 647 hours
and 2,587 responses. We attribute this adjustment due to the
consolidation of OMB control numbers 0910-0546 and 0910-0721.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01792 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P
