Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations, 27509-27512 [2017-12437]
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
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.
Generic Clearance for the Collection of
Qualitative Feedback on Agency
Service Delivery—OMB Control
Number 0910–0697—Extension
The information collection activity
will garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative,
and actionable communications
between the Agency and its customers
and stakeholders. It will also allow
27509
feedback to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address the
following: The target population to
which generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Focus groups ...........................................................
Customer comment cards/forms ..............................
Small discussion groups ..........................................
Customer satisfaction surveys .................................
800
1,325
800
12,000
1
1
1
1
800
1,325
800
12,000
1.75 ...........................
.25 (15 minutes) ........
1.75 ...........................
.33 (20 minutes) ........
1,400
331.25
1,400
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.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–12450 Filed 6–14–17; 8:45 am]
[Docket No. FDA–2014–N–1027]
Food and Drug Administration
BILLING CODE 4164–01–P
pmangrum on DSK3GDR082PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
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Submit either electronic or
written comments on the collection of
information by August 14, 2017.
DATES:
SUMMARY:
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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.
Sfmt 4703
You may submit comments
as follows. Please note that late,
ADDRESSES:
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
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.
pmangrum on DSK3GDR082PROD with NOTICES
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
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
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 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, 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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
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
(§ 107.250). Where the recall strategy or
implementation is determined to be
deficient, FDA may require the firm to
change the extent of the recall, carry out
additional effectiveness checks, and
issue additional notifications
(§ 107.260). In addition, to facilitate
location of the product being recalled,
the recalling firm is required to
maintain distribution records for at least
1 year after the expiration of the shelf
life of the infant formula (§ 107.280).
The reporting and recordkeeping
requirements described previously are
designed to enable FDA to monitor the
effectiveness of infant formula recalls in
order to protect babies from infant
formula that may be unsafe because of
contamination, nutritional inadequacy,
or is otherwise adulterated or
misbranded. FDA uses the information
collected under these regulations to
help ensure that such products are
quickly and efficiently removed from
the market.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
107.230;
107.240;
107.250;
107.260;
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
response
Total annual
responses
Total hours
Elements of infant formula recall ..........................
Notification requirements ......................................
Termination of infant formula recall ......................
Revision of an infant formula recall 2 ....................
2
2
2
1
1
1
1
1
2
2
2
1
4,450
1,482
120
625
8,900
2,964
240
625
Total 2 ............................................................................
........................
........................
........................
........................
........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
2 No
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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 §§ 107.230, 107.240, and
107.250. The estimated number of
respondents for § 107.260 is minimal
because FDA seldom uses this section;
therefore, FDA estimates that there will
be one or fewer respondents annually
for § 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 § 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 § 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 § 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 § 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
107.230; Elements of infant formula recall ..........................
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Number of
disclosures
per
respondent
Number of
respondents
21 CFR section; activity
PO 00000
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2
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Average
burden per
disclosure
Total annual
disclosures
1
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2
15JNN1
50
Total hours
100
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
107.260; Revision of an infant formula recall ......................
Total 2
1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section; activity
Total hours
1
1
1
25
25
........................
............................................................................
........................
........................
........................
........................
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
§§ 107.230 and 107.260. The estimated
burden hours per disclosure is an
average based on FDA’s experience. The
third-party disclosure burden in
§ 107.230 is the requirement to
promptly notify each affected direct
account (customer) about the recall, and
if the recalled formula presents a risk to
human health, the recalling firm must
also request that each establishment that
sells the recalled formula post a notice
of the recall at the point of purchase.
FDA estimates that two respondents
will conduct infant formula recalls
under § 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
§ 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 § 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Form FDA 3728, Animal Generic User
Fee Act Cover Sheet—21 U.S.C. 379j–
21—OMB Control Number 0910–0632—
Extension
[Docket No. FDA–2011–N–0655]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Generic
Drug User Fee Act Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Fax written comments on the
collection of information by July 17,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0632. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
FOR FURTHER INFORMATION CONTACT:
pmangrum on DSK3GDR082PROD with NOTICES
Average
burden per
disclosure
Total annual
disclosures
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14:10 Jun 14, 2017
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PO 00000
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Sfmt 4703
Section 741 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 379j–21) establishes three
different kinds of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs; (2) annual
fees for certain generic new animal drug
products; and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). Because concurrent submission
of user fees with applications is
required, the review of an application
cannot begin until the fee is submitted.
Form FDA 3728 is the Animal Generic
Drug User Fee Act (AGDUFA) Cover
Sheet, which is designed to collect the
minimum necessary information to
determine whether a fee is required for
review of an application, to determine
the amount of the fee required, and to
account for and track user fees. The
form, when completed electronically,
will result in the generation of a unique
payment identification number used by
FDA to track the payment. It will be
used by FDA’s Center for Veterinary
Medicine and FDA’s Office of Financial
Management to initiate the
administrative screening of new generic
animal drug applications to determine if
payment has been received.
In the Federal Register of September
2, 2016 (81 FR 60707), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.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 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, 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
