[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]


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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.

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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, PRAStaff@fda.hhs.gov.

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\
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                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
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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
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\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\
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                                                     Number of
                                     Number of      disclosures    Total annual   Average burden
    21 CFR section; activity        respondents         per         disclosures   per disclosure    Total hours
                                                    respondent
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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
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\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


