Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements, 18146-18148 [2023-06249]
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<![CDATA[
18146
Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Transition Plan for
Medical Devices Issued Emergency Use
Authorizations (EUAs) Related to
Coronavirus Disease 2019 (COVID–19)’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number GUI00020042
and complete title to identify the
guidance you are requesting.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
CFR cite referenced in this
guidance
Another guidance referenced in this guidance
800, 801, and 809 ...................
803 ...........................................
806 ...........................................
807, subparts A through D ......
807, subpart E .........................
812 ...........................................
814, subparts A through E ......
814, subpart H .........................
820 ...........................................
830 and 801.20 .......................
860, subpart D .........................
‘‘Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders’’.
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff’’.
‘‘Administrative Procedures for CLIA Categorization’’ and
‘‘Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices—Guidance for Industry and FDA Staff’’.
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
...................................................................................................
(OMB) under the Paperwork Reduction
Act of 1995 (PRA). The collections of
information in the following FDA
regulations and guidance have been
approved by OMB as listed in the table
below.
This guidance also contains new
collections of information not approved
under a current collection. These new
collections of information have been
granted a PHE waiver from the PRA by
HHS on March 19, 2020, under section
319(f) of the PHS Act. Information
concerning the PHE PRA waiver can be
found on the HHS website at https://
aspe.hhs.gov/public-health-emergencydeclaration-pra-waivers.
OMB control
No(s).
New collection covered by
PHE PRA waiver
0910–0595
0910–0756
0910–0607
0910–0485
0910–0437
0910–0359
0910–0625
0910–0120
0910–0078
0910–0231
0910–0332
0910–0073
0910–0720
0910–0844
Notification of Intent.
Transition Implementation
Plan.
Labeling Mitigation for Certain
Reusable Devices.
Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
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
(PRA).
SUMMARY:
[FR Doc. 2023–06292 Filed 3–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Submit written comments
(including recommendations) on the
collection of information by April 26,
2023.
DATES:
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2022–D–0814]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Requirements
AGENCY:
VerDate Sep<11>2014
19:19 Mar 24, 2023
Jkt 259001
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
ADDRESSES:
Food and Drug Administration,
HHS.
Notice.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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, 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:
E:\FR\FM\27MRN1.SGM
27MRN1
Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices
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
(CGMP), 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 21 CFR part 107:
Infant Formula.
We have revised the information
collection as part of the Federal
Government’s response to address
ongoing disruptions in the infant
formula supply. We communicated our
initial efforts to address the infant
formula shortage in the May 2022
guidance entitled ‘‘Infant Formula
Enforcement Discretion Policy:
Guidance for Industry’’ (May 2022
guidance; available at: https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-infant-formulaenforcement-discretion-policy). To
clarify whether products currently
subject to enforcement discretion would
be able to remain on the market, we
issued the September 2022 guidance
entitled ‘‘Infant Formula Transition Plan
for Exercise of Enforcement Discretion:
Guidance for Industry’’ (September 2022
guidance; available at: https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-infant-formulatransition-plan-exercise-enforcementdiscretion). The September 2022
guidance sets out a pathway for
manufacturers of infant formula that
began marketing infant formula
products in the United States after
receiving a letter of enforcement
discretion based on information
provided in response to the May 2022
guidance to seek to continue marketing
such products under enforcement
discretion while they work to bring their
infant formula products fully into
compliance with applicable
requirements.
18147
In the Federal Register of October 6,
2022 (87 FR 60689), FDA announced
that we had requested, and OMB had
approved, emergency processing of the
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13) and
invited public comment, instructing
comments be submitted to OMB. No
comments have been received. On our
own initiative, however, we are also
revising the collection to account for
voluntary notifications pertaining to
product samples found to be positive for
Cronobacter spp. or Salmonella, even if
the affected lot(s) have not been
distributed. FDA has requested this
information to help prevent future
Cronobacter spp. illnesses associated
with powdered infant formula. As part
of a constituent update, available at
https://www.fda.gov/food/cfsanconstituent-updates/fda-calls-enhancedsafety-measures-letter-powdered-infantformula-industry, we issued a letter on
March 8, 2023, to share current
information to assist industry in
improving the microbiological safety of
powdered infant formula. As
communicated in the letter, we shared
the information with the expectation
that infant formula manufacturers,
packers, distributors, exporters,
importers, and retailers will act to
mitigate potential food safety risks in
powdered infant formula in accordance
with FDA regulations while further
striving to improve operations,
especially given the critical nature of
these products.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ONE-TIME ANNUAL REPORTING BURDEN 1
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden per response
Total hours
Submit information in accordance
with timing and content schedule
discussed in guidance document
for both exempt and non-exempt
infant formulas.
Letter of Intent ...................................
Plan to Meet Applicable Infant Formula Requirements.
Voluntary Submission of sample results as described in constituent
update of March 8, 2023.
115
1
115
24 .....................................................
2,760
11
11
1
1
11
11
5 .......................................................
90 .....................................................
55
990
20
1
20
0.25 (15 minutes) .............................
5
Total ...........................................
........................
........................
........................
...........................................................
3,810
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate is based on submissions
received in response to the May 2022
guidance, for which we account for 115
respondents, each of whom submitted 1
VerDate Sep<11>2014
19:19 Mar 24, 2023
Jkt 259001
request. We assume it requires an
average of 24 hours to prepare each
submission, and therefore calculate a
total of 2,760 burden hours (115
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
requests × 24 hours). Although
originally we assumed 15 respondents
would initiate requesting enforcement
discretion, out of those 115 respondents,
E:\FR\FM\27MRN1.SGM
27MRN1
18148
Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices
we have issued letters of enforcement
discretion to 12 of them. We received
letters from 11 of these respondents
indicating their intent to bring their
products fully into compliance with
applicable regulatory requirements and
requesting that we continue to exercise
enforcement discretion in the interim,
and have therefore adjusted the number
of respondents associated with the
corresponding activities accordingly.
We assume each request requires an
average of 5 hours to prepare, for a total
of 55 burden hours (11 letters × 5
hours). We estimate these same
respondents will then submit a
compliance plan and assume each plan
will require an average of 90 hours to
prepare, for a total of 990 burden hours
(11 plans × 90 hours).
We estimate the burden associated
with the voluntary notification of
positive sampling results as discussed
in our March 8, 2023, letter to be 20
responses and 5 hours annually,
assuming 15 minutes is necessary for
the completion of this activity. We also
assume respondents will utilize
established notification methods found
on our website or by contacting the FDA
district office in which the positive
sampling results have occurred.
Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06249 Filed 3–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–0110]
Clinical Trial Considerations To
Support Accelerated Approval of
Oncology Therapeutics; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Clinical
Trial Considerations to Support
Accelerated Approval of Oncology
Therapeutics.’’ The purpose of this
guidance is to provide
recommendations to sponsors of anticancer drugs or biological products on
considerations for designing trials
intended to support accelerated
approval. The accelerated approval
pathway is commonly used for approval
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:19 Mar 24, 2023
Jkt 259001
of oncology drugs due to the serious and
life-threatening nature of cancer.
Although single-arm trials have been
commonly used to support accelerated
approval, a randomized controlled trial
is the preferred approach as it provides
a more robust efficacy and safety
assessment and allows for direct
comparisons to an available therapy.
This guidance describes considerations
for designing, conducting, and
analyzing data for trials intended to
support accelerated approvals of
oncology therapeutics.
DATES: Submit either electronic or
written comments on the draft guidance
by May 26, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–D–0110 for ‘‘Clinical Trial
Considerations to Support Accelerated
Approval of Oncology Therapeutics.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18146-18148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06249]
-----------------------------------------------------------------------
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
Requirements
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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by April 26, 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.
[[Page 18147]]
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 (CGMP), 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 21 CFR part 107: Infant Formula.
We have revised the information collection as part of the Federal
Government's response to address ongoing disruptions in the infant
formula supply. We communicated our initial efforts to address the
infant formula shortage in the May 2022 guidance entitled ``Infant
Formula Enforcement Discretion Policy: Guidance for Industry'' (May
2022 guidance; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy). To clarify whether products
currently subject to enforcement discretion would be able to remain on
the market, we issued the September 2022 guidance entitled ``Infant
Formula Transition Plan for Exercise of Enforcement Discretion:
Guidance for Industry'' (September 2022 guidance; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-transition-plan-exercise-enforcement-discretion). The September 2022 guidance sets out a pathway for
manufacturers of infant formula that began marketing infant formula
products in the United States after receiving a letter of enforcement
discretion based on information provided in response to the May 2022
guidance to seek to continue marketing such products under enforcement
discretion while they work to bring their infant formula products fully
into compliance with applicable requirements.
In the Federal Register of October 6, 2022 (87 FR 60689), FDA
announced that we had requested, and OMB had approved, emergency
processing of the proposed collection of information under section
3507(j) of the PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13) and invited
public comment, instructing comments be submitted to OMB. No comments
have been received. On our own initiative, however, we are also
revising the collection to account for voluntary notifications
pertaining to product samples found to be positive for Cronobacter spp.
or Salmonella, even if the affected lot(s) have not been distributed.
FDA has requested this information to help prevent future Cronobacter
spp. illnesses associated with powdered infant formula. As part of a
constituent update, available at https://www.fda.gov/food/cfsan-constituent-updates/fda-calls-enhanced-safety-measures-letter-powdered-infant-formula-industry, we issued a letter on March 8, 2023, to share
current information to assist industry in improving the microbiological
safety of powdered infant formula. As communicated in the letter, we
shared the information with the expectation that infant formula
manufacturers, packers, distributors, exporters, importers, and
retailers will act to mitigate potential food safety risks in powdered
infant formula in accordance with FDA regulations while further
striving to improve operations, especially given the critical nature of
these products.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated One-Time Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Submit information in 115 1 115 24.............. 2,760
accordance with timing and
content schedule discussed in
guidance document for both
exempt and non-exempt infant
formulas.
Letter of Intent.............. 11 1 11 5............... 55
Plan to Meet Applicable Infant 11 1 11 90.............. 990
Formula Requirements.
Voluntary Submission of sample 20 1 20 0.25 (15 5
results as described in minutes).
constituent update of March
8, 2023.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 3,810
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimate is based on submissions received in response to the
May 2022 guidance, for which we account for 115 respondents, each of
whom submitted 1 request. We assume it requires an average of 24 hours
to prepare each submission, and therefore calculate a total of 2,760
burden hours (115 requests x 24 hours). Although originally we assumed
15 respondents would initiate requesting enforcement discretion, out of
those 115 respondents,
[[Page 18148]]
we have issued letters of enforcement discretion to 12 of them. We
received letters from 11 of these respondents indicating their intent
to bring their products fully into compliance with applicable
regulatory requirements and requesting that we continue to exercise
enforcement discretion in the interim, and have therefore adjusted the
number of respondents associated with the corresponding activities
accordingly. We assume each request requires an average of 5 hours to
prepare, for a total of 55 burden hours (11 letters x 5 hours). We
estimate these same respondents will then submit a compliance plan and
assume each plan will require an average of 90 hours to prepare, for a
total of 990 burden hours (11 plans x 90 hours).
We estimate the burden associated with the voluntary notification
of positive sampling results as discussed in our March 8, 2023, letter
to be 20 responses and 5 hours annually, assuming 15 minutes is
necessary for the completion of this activity. We also assume
respondents will utilize established notification methods found on our
website or by contacting the FDA district office in which the positive
sampling results have occurred.
Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06249 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P
