Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations, 23367-23369 [2020-08894]
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Federal Register / Vol. 85, No. 81 / Monday, April 27, 2020 / Notices
Silver Spring, MD 20993, 301–796–
8453, Fax: 301–847–8601, email:
Christine.merenda@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 3, 2020 (85
FR 316), FDA opened a public docket to
solicit input and comments from
interested stakeholders, including racial
and ethnic minority, underrepresented,
and underserved populations in
establishing strategic priorities for
OMHHE.
Interested persons were originally
given until February 28, 2020, to
comment on the OMHHE.
Following publication of the January
3, 2020, notice, FDA received a request
to allow interested persons additional
time to comment. The requester asserted
that the time period of 60 days was
insufficient to respond fully to FDA’s
specific requests for comments and to
allow potential respondents to
thoroughly evaluate and address
pertinent issues.
FDA is reopening the comment period
until June 26, 2020. The Agency
believes that an additional 60 days will
allow adequate time for interested
persons to respond to FDA’s specific
requests for comments and to receive
any new information.
Dated: April 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08878 Filed 4–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1027]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
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solicits comments on information
collection provisions in FDA’s infant
formula recall regulations.
DATES: Submit either electronic or
written comments on the collection of
information by June 26, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 26, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 26, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
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Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1027 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Infant
Formula Recall Regulations.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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.
• 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.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 85, No. 81 / Monday, April 27, 2020 / Notices
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Infant Formula Recall Regulations—21
CFR 107.230, 107.240, 107.250, 107.260,
and 107.280
OMB Control Number 0910–0188—
Extension
Section 412(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
350a(e)) (the FD&C Act) provides that if
the manufacturer of an infant formula
has knowledge that reasonably supports
the conclusion that an infant formula
processed by that manufacturer has left
its control and may not provide the
nutrients required in section 412(i) of
the FD&C Act or is otherwise
adulterated or misbranded, the
manufacturer must promptly notify the
Secretary of Health and Human Services
(the Secretary). If the Secretary
determines that the infant formula
presents a risk to human health, the
manufacturer must immediately take all
actions necessary to recall shipments of
such infant formula from all wholesale
and retail establishments, consistent
with recall regulations and guidelines
issued by the Secretary. Section
412(f)(2) of the FD&C Act states that the
Secretary shall by regulation prescribe
the scope and extent of recalls of infant
formula necessary and appropriate for
the degree of risk to human health
presented by the formula subject to
recall. FDA’s infant formula recall
regulations in part 107 (21 CFR part
107) implement these statutory
provisions.
Section 107.230 requires each
recalling firm to conduct an infant
formula recall with the following
elements: (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.
Section 107.240 requires the recalling
firm to conduct an infant formula recall
with the following elements: (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, the recalling firm is
required to submit a recommendation
for termination of the recall to the
appropriate FDA district office and wait
for FDA’s written concurrence
(§ 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
(§ 107.260). In addition, to facilitate
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).
The reporting and recordkeeping
requirements described previously are
designed to enable FDA to monitor the
effectiveness of infant formula recalls in
order to protect babies from infant
formula that may be unsafe because of
contamination, nutritional inadequacy,
or is otherwise adulterated or
misbranded. FDA uses the information
collected under these regulations to
help ensure that such products are
quickly and efficiently removed from
the market.
Description of Respondents:
Respondents to this collection of
information are manufacturers of infant
formula who are for-profit businesses in
the private sector.
FDA estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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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 2 ............................................................................
........................
........................
........................
........................
12,729
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine
business practice.
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Federal Register / Vol. 85, No. 81 / Monday, April 27, 2020 / Notices
The reporting and third-party
disclosure burden estimates are based
on FDA’s records, which show that
there are six manufacturers of infant
formula and that there have been, on
average, two infant formula recalls per
year for the past 3 years. Based on this
information, we estimate that there are,
on average, approximately two infant
formula recalls per year.
Thus, we estimate that two
respondents conduct recalls annually
pursuant to §§ 107.230, 107.240, and
107.250. The estimated number of
respondents for § 107.260 is minimal
because we seldom use this section;
therefore, we estimate that there are one
or fewer respondents annually for
§ 107.260. The estimated number of
hours per response is an average based
on our experience and information from
firms that have conducted recalls. FDA
estimates that two respondents will
conduct infant formula recalls under
§ 107.230 and that it takes a respondent
4,450 hours to comply with the
requirements of that section, for a total
of 8,900 hours. FDA estimates that two
respondents conduct infant formula
recalls under § 107.240 and that it takes
a respondent 1,482 hours to comply
with the requirements of that section,
for a total of 2,964 hours. FDA estimates
that two respondents submit
recommendations for termination of
infant formula recalls under § 107.250
and that it takes a respondent 120 hours
to comply with the requirements of that
section, for a total of 240 hours. Finally,
FDA estimates that one respondent
needs to carry out additional
effectiveness checks and issue
additional notifications, for a total of
625 hours. Therefore, the total annual
burden hours for reporting is 12,729
hours (8,900 + 2,964 + 240 + 625).
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. No
burden has been estimated for the
recordkeeping requirement in § 107.280
because these records are maintained as
a usual and customary part of normal
business activities. Manufacturers keep
infant formula distribution records for
the prescribed period as a matter of
routine business practice.
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
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Number of
disclosures
per
respondent
Number of
respondents
21 CFR section; activity
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2 reports FDA’s third-party
disclosure burden estimates for
§§ 107.230 and 107.260. The estimated
burden hours per disclosure is an
average based on FDA’s experience. The
third-party disclosure burden in
§ 107.230 is the requirement to
promptly notify each affected direct
account (customer) about the recall, and
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 a notice
of the recall at the point of purchase.
FDA estimates that two respondents
conduct infant formula recalls under
§ 107.230 and that it takes a respondent
50 hours to comply with the third-party
disclosure requirements of that section,
for a total of 100 hours. The third-party
disclosure burden in § 107.260 is the
requirement to issue additional
notifications where the recall strategy or
implementation is determined to be
deficient. FDA estimates that one
respondent issues additional
notifications under § 107.260 and that it
takes a respondent 25 hours to comply
with the third-party disclosure
requirements of that section, for a total
of 25 hours. The total annual third-party
disclosure burden is 125 hours (100 +
25).
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Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: April 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08894 Filed 4–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5664]
Standardized Medicated Feed Assay
Limits; Draft Guidance for Industry;
Availability; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
extending the comment period for the
notice of availability that published in
the Federal Register on February 27,
2020. In that notice, FDA requested
SUMMARY:
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comments on the draft guidance for
industry (GFI) #264 entitled
‘‘Standardized Medicated Feed Assay
Limits.’’ The Agency is taking this
action in response to a request for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment
period on the document published
February 27, 2020 (85 FR 11369).
Submit either electronic or written
comments on the draft guidance by June
26, 2020, to ensure that the Agency
considers your comments 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
E:\FR\FM\27APN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 81 (Monday, April 27, 2020)]
[Notices]
[Pages 23367-23369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08894]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1027]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Infant Formula Recall Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection provisions in FDA's
infant formula recall regulations.
DATES: Submit either electronic or written comments on the collection
of information by June 26, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 26, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 26, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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 identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1027 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Infant Formula Recall
Regulations.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.
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-2015-09-18/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.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD
[[Page 23368]]
20852, 301-796-7726, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Infant Formula Recall Regulations--21 CFR 107.230, 107.240, 107.250,
107.260, and 107.280
OMB Control Number 0910-0188--Extension
Section 412(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350a(e)) (the FD&C Act) provides that if the manufacturer of an
infant formula has knowledge that reasonably supports the conclusion
that an infant formula processed by that manufacturer has left its
control and may not provide the nutrients required in section 412(i) of
the FD&C Act or is otherwise adulterated or misbranded, the
manufacturer must promptly notify the Secretary of Health and Human
Services (the Secretary). If the Secretary determines that the infant
formula presents a risk to human health, the manufacturer must
immediately take all actions necessary to recall shipments of such
infant formula from all wholesale and retail establishments, consistent
with recall regulations and guidelines issued by the Secretary. Section
412(f)(2) of the FD&C Act states that the Secretary shall by regulation
prescribe the scope and extent of recalls of infant formula necessary
and appropriate for the degree of risk to human health presented by the
formula subject to recall. FDA's infant formula recall regulations in
part 107 (21 CFR part 107) implement these statutory provisions.
Section 107.230 requires each recalling firm to conduct an infant
formula recall with the following elements: (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. Section 107.240 requires the
recalling firm to conduct an infant formula recall with the following
elements: (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, the recalling firm is required to submit a recommendation for
termination of the recall to the appropriate FDA district office and
wait for FDA's written concurrence (Sec. 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
(Sec. 107.260). In addition, to facilitate 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).
The reporting and recordkeeping requirements described previously
are designed to enable FDA to monitor the effectiveness of infant
formula recalls in order to protect babies from infant formula that may
be unsafe because of contamination, nutritional inadequacy, or is
otherwise adulterated or misbranded. FDA uses the information collected
under these regulations to help ensure that such products are quickly
and efficiently removed from the market.
Description of Respondents: Respondents to this collection of
information are manufacturers of infant formula who are for-profit
businesses in the private sector.
FDA estimate the burden of this 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.................
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Total \2\................... .............. .............. .............. .............. 12,729
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ No burden has been estimated for the recordkeeping requirement in Sec. 107.280 because these records are
maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula
distribution records for the prescribed period as a matter of routine business practice.
[[Page 23369]]
The reporting and third-party disclosure burden estimates are based
on FDA's records, which show that there are six manufacturers of infant
formula and that there have been, on average, two infant formula
recalls per year for the past 3 years. Based on this information, we
estimate that there are, on average, approximately two infant formula
recalls per year.
Thus, we estimate that two respondents conduct recalls annually
pursuant to Sec. Sec. 107.230, 107.240, and 107.250. The estimated
number of respondents for Sec. 107.260 is minimal because we seldom
use this section; therefore, we estimate that there are one or fewer
respondents annually for Sec. 107.260. The estimated number of hours
per response is an average based on our experience and information from
firms that have conducted recalls. FDA estimates that two respondents
will conduct infant formula recalls under Sec. 107.230 and that it
takes a respondent 4,450 hours to comply with the requirements of that
section, for a total of 8,900 hours. FDA estimates that two respondents
conduct infant formula recalls under Sec. 107.240 and that it takes a
respondent 1,482 hours to comply with the requirements of that section,
for a total of 2,964 hours. FDA estimates that two respondents submit
recommendations for termination of infant formula recalls under Sec.
107.250 and that it takes a respondent 120 hours to comply with the
requirements of that section, for a total of 240 hours. Finally, FDA
estimates that one respondent needs to carry out additional
effectiveness checks and issue additional notifications, for a total of
625 hours. Therefore, the total annual burden hours for reporting is
12,729 hours (8,900 + 2,964 + 240 + 625).
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. No burden has been estimated
for the recordkeeping requirement in Sec. 107.280 because these
records are maintained as a usual and customary part of normal business
activities. Manufacturers keep infant formula distribution records for
the prescribed period as a matter of routine business practice.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden
21 CFR section; activity respondents per disclosures per disclosure Total hours
respondent
----------------------------------------------------------------------------------------------------------------
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.................
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Total....................... .............. .............. .............. .............. 125
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2 reports FDA's third-party disclosure burden estimates for
Sec. Sec. 107.230 and 107.260. The estimated burden hours per
disclosure is an average based on FDA's experience. The third-party
disclosure burden in Sec. 107.230 is the requirement to promptly
notify each affected direct account (customer) about the recall, and 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 a notice of the recall at the point of purchase. FDA
estimates that two respondents conduct infant formula recalls under
Sec. 107.230 and that it takes a respondent 50 hours to comply with
the third-party disclosure requirements of that section, for a total of
100 hours. The third-party disclosure burden in Sec. 107.260 is the
requirement to issue additional notifications where the recall strategy
or implementation is determined to be deficient. FDA estimates that one
respondent issues additional notifications under Sec. 107.260 and that
it takes a respondent 25 hours to comply with the third-party
disclosure requirements of that section, for a total of 25 hours. The
total annual third-party disclosure burden is 125 hours (100 + 25).
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: April 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08894 Filed 4-24-20; 8:45 am]
BILLING CODE 4164-01-P
