Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations, 48705-48706 [2020-17542]
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Federal Register / Vol. 85, No. 156 / Wednesday, August 12, 2020 / Notices
Infant Formula Recall Regulations—21
CFR 107.230, 107.240, 107.250, 107.260,
and 107.280
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1027]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Recall Regulations
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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 September
11, 2020.
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 0910–0188. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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:
OMB Control Number 0910–0188—
Extension
Section 412(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
350a(e)) (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 (21 CFR 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 (21 CFR 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 (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 (§ 107.260 (21
CFR 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 (21
CFR 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.
In the Federal Register of April 27,
2020 (85 FR 23367), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
khammond on DSKJM1Z7X2PROD with NOTICES
107.230;
107.240;
107.250;
107.260;
Elements of infant formula recall ..........................
Notification requirements ......................................
Termination of infant formula recall ......................
Revision of an infant formula recall ......................
VerDate Sep<11>2014
16:37 Aug 11, 2020
Jkt 250001
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
PO 00000
Frm 00041
2
2
2
1
Fmt 4703
Sfmt 4703
Average
burden per
response
Total annual
responses
1
1
1
1
E:\FR\FM\12AUN1.SGM
2
2
2
1
12AUN1
4,450
1,482
120
625
Total hours
8,900
2,964
240
625
48706
Federal Register / Vol. 85, No. 156 / Wednesday, August 12, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section; activity
Total 2 ............................................................................
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
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.
The reporting and third-party
disclosure burden estimates are based
on Agency data, which shows 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. We
estimate that two respondents will
conduct infant formula recalls under
§ 107.230 and that it takes 4,450 hours
to comply with the requirements of that
section, for a total of 8,900 hours. We
estimate 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.
We estimate 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, we estimate
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
khammond on DSKJM1Z7X2PROD with NOTICES
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 our experience with
the information collection. The thirdparty 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. We
estimate 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
VerDate Sep<11>2014
16:37 Aug 11, 2020
Jkt 250001
disclosure burden in § 107.260 is the
requirement to issue additional
notifications where the recall strategy or
implementation is determined to be
deficient. We estimate 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).
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
PO 00000
Dated: August 6, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–17542 Filed 8–11–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2966]
Male Breast Cancer: Developing Drugs
for Treatment; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Frm 00042
Fmt 4703
Sfmt 4703
E:\FR\FM\12AUN1.SGM
Notice of availability.
12AUN1
]]>Agencies
[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Notices]
[Pages 48705-48706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17542]
[[Page 48705]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1027]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Infant Formula Recall
Regulations
AGENCY: Food and Drug Administration, Health and Human Services (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 September 11, 2020.
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 0910-0188. 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 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)) (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 (21 CFR 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 (21 CFR 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 (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
(Sec. 107.260 (21 CFR 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 (21 CFR
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.
In the Federal Register of April 27, 2020 (85 FR 23367), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection 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.................
-------------------------------------------------------------------------------
[[Page 48706]]
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.
The reporting and third-party disclosure burden estimates are based
on Agency data, which shows 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. We estimate that two respondents
will conduct infant formula recalls under Sec. 107.230 and that it
takes 4,450 hours to comply with the requirements of that section, for
a total of 8,900 hours. We estimate 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. We estimate 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, we
estimate 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
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.
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 our experience with the information
collection. 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. We estimate 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. We estimate 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: August 6, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17542 Filed 8-11-20; 8:45 am]
BILLING CODE 4164-01-P
