[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27509-27512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12437]
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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 August 14, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
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untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 14, 2017. 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.gpo.gov/fdsys/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 http://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, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 (the
FD&C Act) (21 U.S.C. 350a(e)) 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
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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 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.
FDA estimates 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 \2\.............
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Total \2\................... .............. .............. .............. .............. ..............
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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.
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, FDA
estimates that there will be, on average, approximately two infant
formula recalls per year over the next 3 years.
Thus, FDA estimates that two respondents will conduct recalls
annually under Sec. Sec. 107.230, 107.240, and 107.250. The estimated
number of respondents for Sec. 107.260 is minimal because FDA seldom
uses this section; therefore, FDA estimates that there will be one or
fewer respondents annually for Sec. 107.260. The estimated number of
hours per response is an average based on FDA's 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 will take 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 will conduct infant formula recalls under Sec.
107.240 and that it will take 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 will submit recommendations for
termination of infant formula recalls under Sec. 107.250 and that it
will take a respondent 120 hours to comply with the requirements of
that section, for a total of 240 hours. Finally, FDA estimates that one
respondent will need to carry out additional effectiveness checks and
issue additional notifications, for a total of 625 hours.
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
21 CFR section; activity Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
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107.230; Elements of infant 2 1 2 50 100
formula recall.................
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107.260; Revision of an infant 1 1 1 25 25
formula recall.................
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Total \2\................... .............. .............. .............. .............. ..............
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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 will conduct infant formula recalls
under Sec. 107.230 and that it will take 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 will issue additional notifications under
Sec. 107.260 and that it will take a respondent 25 hours to comply
with the third-party disclosure requirements of that section, for a
total of 25 hours.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12437 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P