Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recalls, 67303-67304 [2023-21432]
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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
immunocompetent donor cells
recognizing and reacting to disparity
with major or minor histocompatibility
antigens on recipient tissues. The
classical approach to prevention of
GVHD involves pharmacological or
physical methods to delete alloreactive
T cells in the immediate peritransplant
setting with or without additional drugs
to prevent activation of naive T cells.
Should aGVHD or cGVHD occur despite
these measures, treatment has depended
largely on drugs that impair T cells.
Further basic science investigations
have elucidated the molecular
mechanisms behind the clinical
manifestations of aGVHD and cGVHD,
including cytokines, the innate immune
system, and components of the adaptive
immune system other than T cells.
These scientific advances have provided
opportunities for development of
biomarkers to identify the specific
immune dysfunction present in an
individual patient and for development
of drugs to modulate the immune
system with precision rather than to just
suppress the immune system globally.
Given the complexity of the clinical
manifestation of aGVHD and cGVHD
and the potential for a paradigm shift in
the management of GVHD, this guidance
provides recommendations regarding
the design and conduct of clinical trials
and the types of supporting data that
could facilitate efficient development of
drugs and/or certain devices for the
prevention or treatment of aGVHD or
cGVHD. This guidance also provides
recommendations on what should be
included in the marketing application to
facilitate review.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Graft-versus-Host Diseases:
Developing Drugs, Biological Products,
and Certain Devices for Prevention or
Treatment.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 312 have been approved
under OMB control number 0910–0014;
VerDate Sep<11>2014
21:46 Sep 28, 2023
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the collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; and
the collections of information in 21 CFR
parts 50 and 56 have been approved
under OMB control number 0910–0130.
III. Electronic Access
67303
by using the search function. The OMB
control number for this information
collection is 0910–0256. 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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
SUPPLEMENTARY INFORMATION:
Dated: September 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
This information collection supports
FDA regulations, and associated Agency
forms and guidance, pertaining to infant
formula requirements. Statutory
provisions for infant formula under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) were enacted to protect the
health of infants and include specific
current good manufacturing practice,
labeling (disclosure), and a number of
reporting and recordkeeping
requirements. Section 412 of the FD&C
Act (21 U.S.C. 350a) requires
manufacturers of infant formula to
establish and document the adherence
to quality control procedures, notify
FDA when a batch of infant formula that
has left the manufacturers’ control may
be adulterated or misbranded, and keep
records of infant formula distribution.
Notification requirements are also
included in the regulations regarding
the quantitative formulation of the
infant formula; a description of any
reformulation or change in processing;
assurances that the formula will not be
marketed until regulatory requirements
are met as demonstrated by specific
testing; and assurances that
manufacturing processes comply with
the regulations. The regulations are
found in 21 CFR part 106: Infant
Formula Requirements Pertaining to
Current Good Manufacturing Practice,
Quality Control Procedures, Quality
Factors, Records and Reports, and
Notifications; and part 107 (21 CFR part
107): Infant Formula.
In the Federal Register of October 6,
2022 (87 FR 60689), we provided notice
communicating updates to the
information collection and invited
public comment on the proposed
[FR Doc. 2023–21524 Filed 9–28–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0814]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Recalls
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the 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 October 30,
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
SUMMARY:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Infant Formula Requirements Under
the Federal Food, Drug, and Cosmetic
Act—21 CFR Parts 106 and 107
OMB Control Number 0910–0256—
Revision
E:\FR\FM\29SEN1.SGM
29SEN1
67304
Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices
collections of information. No
comments were received. On our own
initiative, for efficiency of Agency
operations, we are again revising the
information collection to include related
activities applicable to regulations in
part 107, subpart E (21 CFR 107.200
through 107.280) pertaining to infant
formula recalls. These information
collections are currently approved in
OMB control number 0910–0188.
Specifically, 21 CFR 107.230 requires
manufacturing firms conducting infant
formula recalls to:
(1) evaluate the hazard to human
health;
(2) devise a written recall strategy;
(3) promptly notify each affected
direct account (customer) about the
recall; and
(4) furnish the appropriate FDA
district office with copies of these
documents.
If the recalled formula presents a risk
to human health, the recalling firm must
also request that each establishment that
sells the recalled formula post (at point
of purchase) a notice of the recall and
provide FDA with a copy of the notice.
Similarly, Agency regulations in 21
CFR 107.240 require recalling firms to:
(1) notify the appropriate FDA district
office of the recall by telephone within
24 hours;
(2) submit a written report to that
office within 14 days; and
(3) submit a written status report at
least every 14 days until the recall is
terminated. Before terminating a recall,
recalling firms are required to submit a
recommendation for termination of the
recall to the appropriate FDA district
office and wait for written FDA
concurrence (21 CFR 107.250). Where
the recall strategy or implementation is
determined to be deficient, FDA may
require the firm to change the extent of
the recall, carry out additional
effectiveness checks, and issue
additional notifications (21 CFR
107.260). Finally, to facilitate
identifying the location of the product
being recalled, the recalling firm is
required to maintain distribution
records for at least 1 year after the
expiration of the shelf life of the infant
formula (§ 107.280 (21 CFR 107.280)).
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
107.230;
107.240;
107.250;
107.260;
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
response
Total annual
responses
Total hours
Elements of infant formula recall ..........................
Notification requirements ......................................
Termination of infant formula recall ......................
Revision of an infant formula recall ......................
2
2
2
1
1
1
1
1
2
2
2
1
4,450
1,482
120
625
8,900
2,964
240
625
Total ..............................................................................
........................
........................
........................
........................
12,729
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting and third-party
disclosure burden estimates are based
on current available data showing eight
manufacturers of infant formula and
that there have been, on average, two
infant formula recalls per year for the
past 3 years. Under 5 CFR 1320.3(b)(2),
the time, effort, and financial resources
necessary to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities.
Accordingly, because we believe that
associated records are maintained as a
usual and customary part of normal
business activities, we include no
separate burden estimate for
recordkeeping requirements found in
§ 107.280.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Average
burden per
disclosure
Total annual
disclosures
Total hours
107.230; Elements of infant formula recall ..........................
107.260; Revision of an infant formula recall ......................
2
1
1
1
2
1
50
25
100
25
Total ..............................................................................
........................
........................
........................
........................
125
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Although we have increased the
number of respondents to the
information collection since our last
request for OMB approval, we have
lotter on DSK11XQN23PROD with NOTICES1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section; activity
made no adjustments to the burden we
estimate for the time necessary to
complete activities associated with
infant formula recalls.
Dated: September 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–21432 Filed 9–28–23; 8:45 am]
BILLING CODE 4164–01–P
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Sfmt 9990
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]]>Agencies
[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67303-67304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21432]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0814]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Infant Formula
Recalls
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the 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 October 30, 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 0910-0256. 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.
Infant Formula Requirements Under the Federal Food, Drug, and Cosmetic
Act--21 CFR Parts 106 and 107
OMB Control Number 0910-0256--Revision
This information collection supports FDA regulations, and
associated Agency forms and guidance, pertaining to infant formula
requirements. Statutory provisions for infant formula under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) were enacted to protect the
health of infants and include specific current good manufacturing
practice, labeling (disclosure), and a number of reporting and
recordkeeping requirements. Section 412 of the FD&C Act (21 U.S.C.
350a) requires manufacturers of infant formula to establish and
document the adherence to quality control procedures, notify FDA when a
batch of infant formula that has left the manufacturers' control may be
adulterated or misbranded, and keep records of infant formula
distribution. Notification requirements are also included in the
regulations regarding the quantitative formulation of the infant
formula; a description of any reformulation or change in processing;
assurances that the formula will not be marketed until regulatory
requirements are met as demonstrated by specific testing; and
assurances that manufacturing processes comply with the regulations.
The regulations are found in 21 CFR part 106: Infant Formula
Requirements Pertaining to Current Good Manufacturing Practice, Quality
Control Procedures, Quality Factors, Records and Reports, and
Notifications; and part 107 (21 CFR part 107): Infant Formula.
In the Federal Register of October 6, 2022 (87 FR 60689), we
provided notice communicating updates to the information collection and
invited public comment on the proposed
[[Page 67304]]
collections of information. No comments were received. On our own
initiative, for efficiency of Agency operations, we are again revising
the information collection to include related activities applicable to
regulations in part 107, subpart E (21 CFR 107.200 through 107.280)
pertaining to infant formula recalls. These information collections are
currently approved in OMB control number 0910-0188. Specifically, 21
CFR 107.230 requires manufacturing firms conducting infant formula
recalls to:
(1) evaluate the hazard to human health;
(2) devise a written recall strategy;
(3) promptly notify each affected direct account (customer) about
the recall; and
(4) furnish the appropriate FDA district office with copies of
these documents.
If the recalled formula presents a risk to human health, the
recalling firm must also request that each establishment that sells the
recalled formula post (at point of purchase) a notice of the recall and
provide FDA with a copy of the notice.
Similarly, Agency regulations in 21 CFR 107.240 require recalling
firms to:
(1) notify the appropriate FDA district office of the recall by
telephone within 24 hours;
(2) submit a written report to that office within 14 days; and
(3) submit a written status report at least every 14 days until the
recall is terminated. Before terminating a recall, recalling firms are
required to submit a recommendation for termination of the recall to
the appropriate FDA district office and wait for written FDA
concurrence (21 CFR 107.250). Where the recall strategy or
implementation is determined to be deficient, FDA may require the firm
to change the extent of the recall, carry out additional effectiveness
checks, and issue additional notifications (21 CFR 107.260). Finally,
to facilitate identifying the location of the product being recalled,
the recalling firm is required to maintain distribution records for at
least 1 year after the expiration of the shelf life of the infant
formula (Sec. 107.280 (21 CFR 107.280)).
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant 2 1 2 4,450 8,900
formula recall.................
107.240; Notification 2 1 2 1,482 2,964
requirements...................
107.250; Termination of infant 2 1 2 120 240
formula recall.................
107.260; Revision of an infant 1 1 1 625 625
formula recall.................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 12,729
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The reporting and third-party disclosure burden estimates are based
on current available data showing eight manufacturers of infant formula
and that there have been, on average, two infant formula recalls per
year for the past 3 years. Under 5 CFR 1320.3(b)(2), the time, effort,
and financial resources necessary to comply with a collection of
information are excluded from the burden estimate if the reporting,
recordkeeping, or disclosure activities needed to comply are usual and
customary because they would occur in the normal course of activities.
Accordingly, because we believe that associated records are maintained
as a usual and customary part of normal business activities, we include
no separate burden estimate for recordkeeping requirements found in
Sec. 107.280.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
107.230; Elements of infant 2 1 2 50 100
formula recall.................
107.260; Revision of an infant 1 1 1 25 25
formula recall.................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 125
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Although we have increased the number of respondents to the
information collection since our last request for OMB approval, we have
made no adjustments to the burden we estimate for the time necessary to
complete activities associated with infant formula recalls.
Dated: September 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21432 Filed 9-28-23; 8:45 am]
BILLING CODE 4164-01-P
