82 FR 27509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27509-27512
FR Document		2017-12437

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.

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27509-27512]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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,

[[Page 27510]]

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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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

[[Page 27511]]

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\
----------------------------------------------------------------------------------------------------------------
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 \2\.............
-------------------------------------------------------------------------------
Total \2\................... .............. .............. .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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.................

[[Page 27512]]

107.260; Revision of an infant 1 1 1 25 25
formula recall.................
-------------------------------------------------------------------------------
Total \2\................... .............. .............. .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27509

Office of Management and Budget ways to minimize the burden of the feedback to contribute directly to the
(OMB) for each collection of collection of information on improvement of program management.
information they conduct or sponsor. respondents, including through the use Feedback collected under this generic
‘‘Collection of information’’ is defined of automated collection techniques, clearance will provide useful
in 44 U.S.C. 3502(3) and 5 CFR when appropriate, and other forms of information, but it will not yield data
1320.3(c) and includes Agency requests information technology. that can be generalized to the overall
or requirements that members of the population. This type of generic
Generic Clearance for the Collection of
public submit reports, keep records, or clearance for qualitative information
Qualitative Feedback on Agency
provide information to a third party. will not be used for quantitative
Service Delivery—OMB Control
Section 3506(c)(2)(A) of the PRA (44 information collections that are
Number 0910–0697—Extension
U.S.C. 3506(c)(2)(A)) requires Federal designed to yield reliably actionable
Agencies to provide a 60-day notice in The information collection activity
will garner qualitative customer and results, such as monitoring trends over
the Federal Register concerning each
stakeholder feedback in an efficient, time or documenting program
proposed collection of information,
timely manner, in accordance with the performance. Such data uses require
including each proposed extension of an
Administration’s commitment to more rigorous designs that address the
existing collection of information,
improving service delivery. By following: The target population to
before submitting the collection to OMB
qualitative feedback we mean which generalizations will be made, the
for approval. To comply with this
information that provides useful sampling frame, the sample design
requirement, FDA is publishing notice
insights on perceptions and opinions, (including stratification and clustering),
of the proposed collection of
but are not statistical surveys that yield the precision requirements or power
information set forth in this document.
With respect to the following quantitative results that can be calculations that justify the proposed
collection of information, FDA invites generalized to the population of study. sample size, the expected response rate,
comments on these topics: (1) Whether This feedback will provide insights into methods for assessing potential non-
the proposed collection of information customer or stakeholder perceptions, response bias, the protocols for data
is necessary for the proper performance experiences and expectations, provide collection, and any testing procedures
of FDA’s functions, including whether an early warning of issues with service, that were or will be undertaken prior
the information will have practical or focus attention on areas where fielding the study. Depending on the
utility; (2) the accuracy of FDA’s communication, training or changes in degree of influence the results are likely
estimate of the burden of the proposed operations might improve delivery of to have, such collections may still be
collection of information, including the products or services. These collections eligible for submission for other generic
validity of the methodology and will allow for ongoing, collaborative, mechanisms that are designed to yield
assumptions used; (3) ways to enhance and actionable communications quantitative results.
the quality, utility, and clarity of the between the Agency and its customers FDA estimates the burden of this
information to be collected; and (4) and stakeholders. It will also allow collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent

Focus groups ........................................................... 800 1 800 1.75 ........................... 1,400
Customer comment cards/forms .............................. 1,325 1 1,325 .25 (15 minutes) ........ 331.25
Small discussion groups .......................................... 800 1 800 1.75 ........................... 1,400
Customer satisfaction surveys ................................. 12,000 1 12,000 .33 (20 minutes) ........ 3,960

Total .................................................................. ........................ ........................ ........................ .................................... 7,091.25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: June 12, 2017. DEPARTMENT OF HEALTH AND certain information by the Agency.
Anna K. Abram, HUMAN SERVICES Under the Paperwork Reduction Act of
Deputy Commissioner for Policy, Planning, 1995 (PRA), Federal Agencies are
Legislation, and Analysis. Food and Drug Administration required to publish notice in the
[FR Doc. 2017–12450 Filed 6–14–17; 8:45 am] Federal Register concerning each
[Docket No. FDA–2014–N–1027]
proposed collection of information,
BILLING CODE 4164–01–P
Agency Information Collection including each proposed extension of an
Activities; Proposed Collection; existing collection of information, and
Comment Request; Infant Formula to allow 60 days for public comment in
Recall Regulations response to the notice. This notice
solicits comments on information
pmangrum on DSK3GDR082PROD with NOTICES

AGENCY: Food and Drug Administration, collection provisions in FDA’s infant
HHS. formula recall regulations.
ACTION: Notice. DATES: Submit either electronic or
SUMMARY: The Food and Drug written comments on the collection of
Administration (FDA or Agency) is information by August 14, 2017.
announcing an opportunity for public ADDRESSES: You may submit comments
comment on the proposed collection of as follows. Please note that late,

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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27511

recall. FDA’s infant formula recall firm to conduct an infant formula recall the recalling firm is required to
regulations in part 107 (21 CFR part with the following elements: (1) Notify maintain distribution records for at least
107) implement these statutory the appropriate FDA district office of 1 year after the expiration of the shelf
provisions. the recall by telephone within 24 hours, life of the infant formula (§ 107.280).
Section 107.230 (21 CFR 107.230) (2) submit a written report to that office
requires each recalling firm to conduct The reporting and recordkeeping
within 14 days, and (3) submit a written
an infant formula recall with the requirements described previously are
status report at least every 14 days until
following elements: (1) Evaluate the the recall is terminated. Before designed to enable FDA to monitor the
hazard to human health, (2) devise a terminating a recall, the recalling firm is effectiveness of infant formula recalls in
written recall strategy, (3) promptly required to submit a recommendation order to protect babies from infant
notify each affected direct account for termination of the recall to the formula that may be unsafe because of
(customer) about the recall, and (4) appropriate FDA district office and wait contamination, nutritional inadequacy,
furnish the appropriate FDA district for FDA’s written concurrence or is otherwise adulterated or
office with copies of these documents. (§ 107.250). Where the recall strategy or misbranded. FDA uses the information
If the recalled formula presents a risk to implementation is determined to be collected under these regulations to
human health, the recalling firm must deficient, FDA may require the firm to help ensure that such products are
also request that each establishment that change the extent of the recall, carry out quickly and efficiently removed from
sells the recalled formula post (at point additional effectiveness checks, and the market.
of purchase) a notice of the recall and issue additional notifications FDA estimates the burden of this
provide FDA with a copy of the notice. (§ 107.260). In addition, to facilitate
collection of information as follows:
Section 107.240 requires the recalling location of the product being recalled,

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section; activity responses per burden per Total hours
respondents responses
respondent response

107.230; Elements of infant formula recall .......................... 2 1 2 4,450 8,900
107.240; Notification requirements ...................................... 2 1 2 1,482 2,964
107.250; Termination of infant formula recall ...................... 2 1 2 120 240
107.260; Revision of an infant formula recall 2 .................... 1 1 1 625 625

Total 2 ............................................................................ ........................ ........................ ........................ ........................ ........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Noburden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and cus-
tomary 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 on FDA’s experience and information to carry out additional effectiveness
disclosure burden estimates are based from firms that have conducted recalls. checks and issue additional
on FDA’s records, which show that FDA estimates that two respondents notifications, for a total of 625 hours.
there are six manufacturers of infant will conduct infant formula recalls Under 5 CFR 1320.3(b)(2), the time,
formula and that there have been, on under § 107.230 and that it will take a effort, and financial resources necessary
average, two infant formula recalls per respondent 4,450 hours to comply with
to comply with a collection of
year for the past 3 years. Based on this the requirements of that section, for a
information are excluded from the
information, FDA estimates that there total of 8,900 hours. FDA estimates that
will be, on average, approximately two two respondents will conduct infant burden estimate if the reporting,
infant formula recalls per year over the formula recalls under § 107.240 and that recordkeeping, or disclosure activities
next 3 years. it will take a respondent 1,482 hours to needed to comply are usual and
Thus, FDA estimates that two comply with the requirements of that customary because they would occur in
respondents will conduct recalls section, for a total of 2,964 hours. FDA the normal course of activities. No
annually under §§ 107.230, 107.240, and estimates that two respondents will burden has been estimated for the
107.250. The estimated number of submit recommendations for recordkeeping requirement in § 107.280
respondents for § 107.260 is minimal termination of infant formula recalls because these records are maintained as
because FDA seldom uses this section; under § 107.250 and that it will take a a usual and customary part of normal
therefore, FDA estimates that there will respondent 120 hours to comply with business activities. Manufacturers keep
be one or fewer respondents annually the requirements of that section, for a infant formula distribution records for
for § 107.260. The estimated number of total of 240 hours. Finally, FDA the prescribed period as a matter of
hours per response is an average based estimates that one respondent will need routine business practice.

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
pmangrum on DSK3GDR082PROD with NOTICES

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

107.230; Elements of infant formula recall .......................... 2 1 2 50 100

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27512 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of disclosures Total annual
21 CFR section; activity burden per Total hours
respondents per disclosures disclosure
respondent

107.260; Revision of an infant formula recall ...................... 1 1 1 25 25

Total 2 ............................................................................ ........................ ........................ ........................ ........................ ........................
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2 reports FDA’s third-party DEPARTMENT OF HEALTH AND collection of information to OMB for
disclosure burden estimates for HUMAN SERVICES review and clearance.
§§ 107.230 and 107.260. The estimated Form FDA 3728, Animal Generic User
burden hours per disclosure is an Food and Drug Administration
Fee Act Cover Sheet—21 U.S.C. 379j–
average based on FDA’s experience. The [Docket No. FDA–2011–N–0655] 21—OMB Control Number 0910–0632—
third-party disclosure burden in Extension
§ 107.230 is the requirement to Agency Information Collection
promptly notify each affected direct Activities; Submission for Office of Section 741 of the Federal Food, Drug,
account (customer) about the recall, and Management and Budget Review; and Cosmetic Act (the FD&C Act) (21
if the recalled formula presents a risk to Comment Request; Animal Generic U.S.C. 379j–21) establishes three
Drug User Fee Act Cover Sheet different kinds of user fees: (1) Fees for
human health, the recalling firm must
certain types of abbreviated applications
also request that each establishment that AGENCY: Food and Drug Administration, for generic new animal drugs; (2) annual
sells the recalled formula post a notice HHS. fees for certain generic new animal drug
of the recall at the point of purchase. products; and (3) annual fees for certain
ACTION: Notice.
FDA estimates that two respondents sponsors of abbreviated applications for
will conduct infant formula recalls SUMMARY: The Food and Drug generic new animal drugs and/or
under § 107.230 and that it will take a Administration (FDA) is announcing investigational submissions for generic
respondent 50 hours to comply with the that a proposed collection of new animal drugs (21 U.S.C. 379j–
third-party disclosure requirements of information has been submitted to the 21(a)). Because concurrent submission
that section, for a total of 100 hours. The Office of Management and Budget of user fees with applications is
third-party disclosure burden in (OMB) for review and clearance under required, the review of an application
§ 107.260 is the requirement to issue the Paperwork Reduction Act of 1995. cannot begin until the fee is submitted.
additional notifications where the recall DATES: Fax written comments on the Form FDA 3728 is the Animal Generic
strategy or implementation is collection of information by July 17, Drug User Fee Act (AGDUFA) Cover
determined to be deficient. FDA 2017. Sheet, which is designed to collect the
estimates that one respondent will issue minimum necessary information to
ADDRESSES: To ensure that comments on
additional notifications under § 107.260 determine whether a fee is required for
the information collection are received,
and that it will take a respondent 25 review of an application, to determine
OMB recommends that written
hours to comply with the third-party the amount of the fee required, and to
comments be faxed to the Office of
disclosure requirements of that section, account for and track user fees. The
Information and Regulatory Affairs,
for a total of 25 hours. form, when completed electronically,
OMB, Attn: FDA Desk Officer, FAX:
will result in the generation of a unique
Dated: June 12, 2017. 202–395–7285, or emailed to oira_
payment identification number used by
Anna K. Abram, submission@omb.eop.gov. All
FDA to track the payment. It will be
comments should be identified with the
Deputy Commissioner for Policy, Planning, used by FDA’s Center for Veterinary
OMB control number 0910–0632. Also
Legislation, and Analysis. Medicine and FDA’s Office of Financial
include the FDA docket number found
[FR Doc. 2017–12437 Filed 6–14–17; 8:45 am] Management to initiate the
in brackets in the heading of this
administrative screening of new generic
BILLING CODE 4164–01–P document.
animal drug applications to determine if
FOR FURTHER INFORMATION CONTACT: Ila payment has been received.
S. Mizrachi, Office of Operations, Food In the Federal Register of September
and Drug Administration, Three White 2, 2016 (81 FR 60707), FDA published
Flint North, 10A63, 11601 Landsdown a 60-day notice requesting public
St., North Bethesda, MD 20852, 301– comment on the proposed collection of
796–7726, PRAStaff@fda.hhs.gov. information. No comments were
SUPPLEMENTARY INFORMATION: In received.
compliance with 44 U.S.C. 3507, FDA FDA estimates the burden of this
has submitted the following proposed collection of information as follows:
pmangrum on DSK3GDR082PROD with NOTICES

VerDate Sep<11>2014 14:10 Jun 14, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1

Document Created: 2017-06-15 01:03:54
Document Modified: 2017-06-15 01:03:54

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 14, 2017.
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]
FR Citation		82 FR 27509

82 FR 27509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration