Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503, 65173-65174 [2023-20451]
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Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices
I. Background
Menopause is often a time of
tremendous transition and change for
women. The effects of menopause on
the PK and PD of drugs are largely
unknown. Sex hormone changes during
menopause may affect the metabolic
pathways of drugs by affecting drug
metabolizing enzymes. Hormone
changes may also affect other pathways
that play an important role for drug
disposition and excretion. In addition,
many women experience weight gain at
menopause. Together, these changes
associated with menopausal transition
have the potential to affect the PK of
medications used for indications not
related to menopause. Furthermore,
physiologic changes in menopause may
result in altered sensitivity to drug
response independent of changes in PK.
This public workshop will provide
insight into identifying the research and
data gaps regarding the potential impact
of menopause on PK/PD, highlighting
areas with the greatest need for further
research and exploration.
II. Topics for Discussion at the Public
Workshop
This public workshop will include
presentations and session discussions
by experts in the fields of clinical
pharmacology, obstetrics and
gynecology, endocrinology, and clinical
care. Each session will include a Q&A
session to respond to questions from
attendees.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://www.fda.gov/
consumers/public-meetings-workshopsand-webinars/menopause-potentialimpact-clinical-pharmacology-andopportunities-future-research-10112023.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Registrants will receive
confirmation when they have been
accepted. If you need special
accommodations due to a disability,
please contact Lisa Lineberger at
OWHmeetings@fda.hhs.gov no later
than October 10, 2023.
Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20454 Filed 9–20–23; 8:45 am]
BILLING CODE 4164–01–P
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17:11 Sep 20, 2023
Jkt 259001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0908]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling),
Submission of Information to a Master
File in Support of Petitions; and
Electronic Submission Using Food and
Drug Administration Form 3503
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 October 23,
2023.
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 0910–0016. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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.
Submission of Petitions: Food
Additive, Color Additive (Including
Labeling), Submission of Information to
a Master File in Support of Petitions;
and Electronic Submission Using Form
FDA 3503–21 CFR 70.25, 71.1, and
171.1 and 21 CFR parts 172, 173, 179,
and 180 OMB Control Number 0910–
0016—Extension.
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 4703
65173
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: (1) the additive and its use, or
intended use, are in conformity with a
regulation issued under section 409 that
describes the condition(s) under which
the additive may be safely used; (2) the
additive and its use, or intended use,
conform to the terms of an exemption
for investigational use; or (3) a food
contact notification submitted under
section 409(h) is effective. Food
Additive Petitions (FAPs) are submitted
by individuals or companies to obtain
approval of a new food additive or to
amend the conditions of use permitted
under an existing food additive
regulation. Section 171.1 of FDA’s
regulations (21 CFR 171.1) specifies the
information that a petitioner must
submit in order to establish that the
proposed use of a food additive is safe
and to secure the publication of a food
additive regulation describing the
conditions under which the additive
may be safely used. Parts 172, 173, 179,
and 180 (21 CFR parts 172, 173, 179,
and 180) contain labeling requirements
for certain food additives to ensure their
safe use.
Section 721(a) of the FD&C Act (21
U.S.C. 379e(a)) provides that a color
additive shall be deemed to be unsafe
unless the additive and its use are in
conformity with a regulation that
describes the condition(s) under which
the additive may safely be used, or the
additive and its use conform to the
terms of an exemption for
investigational use issued under section
721(f). Color Additive Petitions (CAPs)
are submitted by individuals or
companies to obtain approval of a new
color additive or a change in the
conditions of use permitted for a color
additive that is already approved.
Section 71.1 of the Agency’s regulations
(21 CFR 71.1) specifies the information
that a petitioner must submit to
establish the safety of a color additive
and to secure the issuance of a
regulation permitting its use. FDA’s
color additive labeling requirements in
§ 70.25 (21 CFR 70.25) require that color
additives that are to be used in food,
drugs, cosmetics, or medical devices be
labeled with sufficient information to
ensure their safe use.
FDA scientific personnel review FAPs
to ensure the safety of the intended use
of the additive in or on food, or that may
be present in food as a result of its use
in articles that contact food. Likewise,
FDA personnel review CAPs to ensure
the safety of the color additive prior to
its use in food, drugs, cosmetics, or
medical devices.
E:\FR\FM\21SEN1.SGM
21SEN1
65174
Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices
Respondents may transmit FAP or
CAP regulatory submissions in
electronic format or paper format to the
Office of Food Additive Safety in the
Center for Food Safety and Applied
Nutrition (CFSAN) using Form FDA
3503. Form FDA 3503 helps the
respondent organize their submission to
focus on the information needed for
FDA’s safety review. Form FDA 3503
can also be used to organize information
within a master file submitted in
support of petitions according to the
items listed on the form. Master files
can be used as repositories for
information that can be referenced in
multiple submissions to the Agency,
submissions/cfsan-online-submissionmodule-cosm.
Description of respondents:
Respondents are businesses engaged in
the manufacture or sale of food, food
ingredients, color additives, or
substances used in materials that come
into contact with food.
In the Federal Register of February 1,
2023 (88 FR 6757), FDA published a 60day notice requesting public comment
on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
We estimate the burden of this
collection of information as follows:
thus minimizing paperwork burden for
food and color additive approvals.
We improved the information
collection by using the CFSAN Online
Submission Module (COSM). COSM
provides a real-time user interface
process that assists respondents in
preparing and making submissions to
CFSAN. COSM is a web-based tool that
supports electronic submissions,
thereby eliminating the need for
printing and mailing of paper
submissions. COSM is available 24
hours a day and 7 days a week. Further
information about COSM, including
user instruction, is available on the
internet at: https://www.fda.gov/food/
registration-food-facilities-and-other-
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/21 CFR section; or FDA form No.
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Total
operating
and
maintenance
costs
Submission of Petitions: Color Additive
Including Labeling—70.25 and 71.1 ....
Submission of Petitions: Food Additive
Including Labeling—171.1 ....................
Form FDA 3503 2 .....................................
2
1
2
1,337
2,674
$5,600
3
5
1
1
3
5
7,093
1
21,279
5
0
0
Total ..................................................
........................
........................
........................
........................
23,958
5,600
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
are no capital costs associated with this collection of information.
2 Form FDA 3503 is used for both CAPs and FAPs.
We have adjusted our burden
estimate, which has resulted in a
decrease to the currently approved
burden by 1 hour. Our estimate of
burden attributable to FAPs or CAPs is
based on our experience with the
information collection, which has not
changed since our last review, and
reflects the average number of petitions
we have received annually over a period
of 10 years. The attendant burden we
estimate also reflects an industry
average, although burden associated
with individual petitions may vary
depending on the complexity of the
petition, and the amount and type of
data needed for scientific analysis.
CAPs are subject to fees. The listing
fee for a CAP ranges from $1,600 to
$3,000, depending on the intended use
of the color additive and the scope of
the requested amendment. A complete
schedule of fees is set forth in 21 CFR
70.19. An average of one Category A and
one Category B CAP is expected per
year. The maximum CAP fee for a
Category A petition is $2,600, and the
maximum CAP fee for a Category B
petition is $3,000. Because an average of
two CAPs are expected per calendar
year, the estimated total annual cost
burden to petitioners for this startup
VerDate Sep<11>2014
17:11 Sep 20, 2023
Jkt 259001
cost would be less than or equal to
$5,600 ((1 × $2,600) + (1 × $3,000)
listing fees). There are no capital costs
associated with CAPs.
The labeling requirements for food
and color additives were designed to
specify the minimum information
needed for labeling in order that food
and color manufacturers may comply
with all applicable provisions of the
FD&C Act and other specific labeling
Acts administered by FDA. Label
information does not require any
additional information gathering beyond
what is already required to assure
conformance with all specifications and
limitations in any given food or color
additive regulation. Label information
does not have any specific
recordkeeping requirements unique to
preparing the label. Therefore, because
labeling requirements under § 70.25 for
a particular color additive involve
information required as part of the CAP
safety review process, the estimate for
number of respondents is the same for
§§ 70.25 and 71.1, and the burden hours
for labeling are included in the estimate
for § 71.1. Also, because labeling
requirements under parts 172, 173, 179,
and 180 for particular food additives
involve information required as part of
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
the FAP safety review process under
§ 171.1, the burden hours for labeling
are included in the estimate for § 171.1.
Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20451 Filed 9–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3742]
Scientific Challenges and
Opportunities To Advance the
Development of Individualized Cellular
and Gene Therapies; Request for
Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for information
and comments.
ACTION:
The Food and Drug
Administration (FDA or Agency), Center
for Biologics Evaluation and Research
(CBER) is requesting information from
stakeholders regarding critical scientific
SUMMARY:
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65173-65174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20451]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0908]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Petitions: Food Additive, Color Additive (Including Labeling),
Submission of Information to a Master File in Support of Petitions; and
Electronic Submission Using Food and Drug Administration Form 3503
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 October 23, 2023.
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 0910-0016. 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.
Submission of Petitions: Food Additive, Color Additive (Including
Labeling), Submission of Information to a Master File in Support of
Petitions; and Electronic Submission Using Form FDA 3503-21 CFR 70.25,
71.1, and 171.1 and 21 CFR parts 172, 173, 179, and 180 OMB Control
Number 0910-0016--Extension.
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: (1) the additive and its use, or intended use,
are in conformity with a regulation issued under section 409 that
describes the condition(s) under which the additive may be safely used;
(2) the additive and its use, or intended use, conform to the terms of
an exemption for investigational use; or (3) a food contact
notification submitted under section 409(h) is effective. Food Additive
Petitions (FAPs) are submitted by individuals or companies to obtain
approval of a new food additive or to amend the conditions of use
permitted under an existing food additive regulation. Section 171.1 of
FDA's regulations (21 CFR 171.1) specifies the information that a
petitioner must submit in order to establish that the proposed use of a
food additive is safe and to secure the publication of a food additive
regulation describing the conditions under which the additive may be
safely used. Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179,
and 180) contain labeling requirements for certain food additives to
ensure their safe use.
Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under section 721(f). Color Additive Petitions (CAPs) are submitted by
individuals or companies to obtain approval of a new color additive or
a change in the conditions of use permitted for a color additive that
is already approved. Section 71.1 of the Agency's regulations (21 CFR
71.1) specifies the information that a petitioner must submit to
establish the safety of a color additive and to secure the issuance of
a regulation permitting its use. FDA's color additive labeling
requirements in Sec. 70.25 (21 CFR 70.25) require that color additives
that are to be used in food, drugs, cosmetics, or medical devices be
labeled with sufficient information to ensure their safe use.
FDA scientific personnel review FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, cosmetics, or medical devices.
[[Page 65174]]
Respondents may transmit FAP or CAP regulatory submissions in
electronic format or paper format to the Office of Food Additive Safety
in the Center for Food Safety and Applied Nutrition (CFSAN) using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of petitions according to the items listed on the
form. Master files can be used as repositories for information that can
be referenced in multiple submissions to the Agency, thus minimizing
paperwork burden for food and color additive approvals.
We improved the information collection by using the CFSAN Online
Submission Module (COSM). COSM provides a real-time user interface
process that assists respondents in preparing and making submissions to
CFSAN. COSM is a web-based tool that supports electronic submissions,
thereby eliminating the need for printing and mailing of paper
submissions. COSM is available 24 hours a day and 7 days a week.
Further information about COSM, including user instruction, is
available on the internet at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm.
Description of respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
In the Federal Register of February 1, 2023 (88 FR 6757), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden operating and
Activity/21 CFR section; or FDA form No. respondents responses per responses per response Total hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Petitions: Color Additive Including 2 1 2 1,337 2,674 $5,600
Labeling--70.25 and 71.1...............................
Submission of Petitions: Food Additive Including 3 1 3 7,093 21,279 0
Labeling--171.1........................................
Form FDA 3503 \2\....................................... 5 1 5 1 5 0
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 23,958 5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
\2\ Form FDA 3503 is used for both CAPs and FAPs.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden by 1 hour. Our estimate of
burden attributable to FAPs or CAPs is based on our experience with the
information collection, which has not changed since our last review,
and reflects the average number of petitions we have received annually
over a period of 10 years. The attendant burden we estimate also
reflects an industry average, although burden associated with
individual petitions may vary depending on the complexity of the
petition, and the amount and type of data needed for scientific
analysis.
CAPs are subject to fees. The listing fee for a CAP ranges from
$1,600 to $3,000, depending on the intended use of the color additive
and the scope of the requested amendment. A complete schedule of fees
is set forth in 21 CFR 70.19. An average of one Category A and one
Category B CAP is expected per year. The maximum CAP fee for a Category
A petition is $2,600, and the maximum CAP fee for a Category B petition
is $3,000. Because an average of two CAPs are expected per calendar
year, the estimated total annual cost burden to petitioners for this
startup cost would be less than or equal to $5,600 ((1 x $2,600) + (1 x
$3,000) listing fees). There are no capital costs associated with CAPs.
The labeling requirements for food and color additives were
designed to specify the minimum information needed for labeling in
order that food and color manufacturers may comply with all applicable
provisions of the FD&C Act and other specific labeling Acts
administered by FDA. Label information does not require any additional
information gathering beyond what is already required to assure
conformance with all specifications and limitations in any given food
or color additive regulation. Label information does not have any
specific recordkeeping requirements unique to preparing the label.
Therefore, because labeling requirements under Sec. 70.25 for a
particular color additive involve information required as part of the
CAP safety review process, the estimate for number of respondents is
the same for Sec. Sec. 70.25 and 71.1, and the burden hours for
labeling are included in the estimate for Sec. 71.1. Also, because
labeling requirements under parts 172, 173, 179, and 180 for particular
food additives involve information required as part of the FAP safety
review process under Sec. 171.1, the burden hours for labeling are
included in the estimate for Sec. 171.1.
Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20451 Filed 9-20-23; 8:45 am]
BILLING CODE 4164-01-P
