Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations, 1508-1510 [2021-00125]
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Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
All nominations for
nonvoting industry representatives
should be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Division of
Management Services, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5213,
Silver Spring, MD 20993, 301–796–
5960, email: margaret.ames@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency is requesting nominations for
nonvoting industry representative on
the National Mammography Quality
Assurance Advisory Committee:
tkelley on DSKBCP9HB2PROD with NOTICES
CONTACT).
I. General Description of the Committee
Duties
The Committee shall advise FDA on:
(1) Developing appropriate quality
standards and regulations for
mammography facilities; (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program; (3)
developing regulations with respect to
sanctions; (4) developing procedures for
monitoring compliance with standards;
(5) establishing a mechanism to
investigate consumer complaints; (6)
reporting new developments concerning
breast imaging that should be
considered in the oversight of
mammography facilities; (7)
determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in these areas; (8)
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999; and (9)
determining the costs and benefits of
compliance with these requirements.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
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21:23 Jan 07, 2021
Jkt 253001
contact (see FOR FURTHER INFORMATION
within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current re´sume´s. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
CONTACT)
III. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nominations
must include a current, complete
re´sume´ or curriculum vitae for each
nominee including current business
address and telephone number, email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.)
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for a nonvoting
representative of industry interests are
encouraged from the mammography
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
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Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–00122 Filed 1–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1031]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration 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
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 associated with
FDA recalls for products regulated by
the Agency.
DATES: Submit either electronic or
written comments on the collection of
information by March 9, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 9,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 9, 2021. 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.
SUMMARY:
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
E:\FR\FM\08JAN1.SGM
08JAN1
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
tkelley on DSKBCP9HB2PROD with NOTICES
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–1031 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; FDA
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, 240–402–7500.
• 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
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
PO 00000
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1509
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.
FDA Recall Regulations—21 CFR Part 7
OMB Control Number 0910–0249—
Extension
This information collection helps
support implementation of section 701
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371) pertaining to
product recalls, and regulations in part
7 (21 CFR part 7), subpart C
promulgated to clarify and explain
associated practices and procedures.
Regulations in part 7, subpart C §§ 7.49,
7.50, and 7.59 (21 CFR 7.49, 7.50, and
7.59) apply specifically to product
recalls, which may be undertaken
voluntarily and at any time by
manufacturers and distributors, or at the
request of the Agency. Recalls are
terminated when all reasonable efforts
have been made to remove or correct the
product in accordance with the recall
strategy. The regulations also provide
for corrective actions to be taken
regarding violative products and
establish specific requirements that
enable us to monitor and assess the
adequacy of a firm’s efforts in this
regard. The provisions include reporting
to FDA on the initiation and termination
of a recall, as well as submitting recall
status reports and making required
communication disclosures. Specific
guidance regarding recalls is set forth in
§ 7.59, although product-specific
guidance documents may also be
developed to assist respondents to the
information collection. Agency
guidance documents are issued in
accordance with our good guidance
regulations in 21 CFR 10.115, which
provide for public comment at any time.
Consistent with § 7.50, all recalls
monitored by FDA are included in an
‘‘Enforcement Report’’ once they are
classified and may be listed prior to
classification when FDA determines the
firm’s removal or correction of a
marketed product(s) meets the
definition of a recall. Recall data in the
Enforcement Report can be accessed
through the weekly report publication,
the quick and advanced search
functionalities, and an Application
E:\FR\FM\08JAN1.SGM
08JAN1
1510
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
Programming Interface (API).
Instructions for navigating the report,
accessing and using the API, and
definitions of the report contents are
found at https://www.fda.gov/safety/
enforcement-reports/enforcementreport-information-and-definitions.com.
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; 21 CFR section
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Firm initiated recall; § 7.46 ...................................................
Termination of recall; § 7.55 ................................................
Recall status reports; § 7.53 ................................................
2,779
2,095
2,779
1
1
13
2,779
2,095
36,127
25
10
10
69,475
20,950
361,270
Total ..............................................................................
........................
........................
41,001
........................
451,695
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
A review of Agency data shows that
8,337 recalls were conducted during
fiscal years 2017 through 2019, for an
average of 2,779 recalls annually. We
assume an average of 25 hours is needed
to submit the requisite notification to
FDA, for a total annual burden of 69,475
hours. Similarly, during the same
submissions (36,127) by the average
number of annual respondents (2,779)
and assume 10 hours is necessary for
the corresponding information
collection, resulting in 361,270 hours
annually.
period, 6,287 recalls were terminated,
for an average of 2,095 recall
terminations annually, and we assume
an average of 10 hours is needed for the
corresponding information collection
activity. To determine burden
associated with recall status reports we
divided the average number of annual
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Recall communications;
§ 7.49.
2,779 ...........................
1 There
445
Total
annual
disclosures
Average burden per
disclosure
1,236,655 ....................
0.05 (3 minutes) ..........
Total hours
61,832.75
are no capital costs or operating and maintenance costs associated with this collection of information.
To determine burden associated with
recall communication disclosures
described in § 7.49, we calculated an
average of 445 disclosures per recall and
attribute 3 minutes for each disclosure,
resulting in 61,832.75 burden hours
annually.
These estimates reflect an overall
decrease in the average number of
annual responses by 245,846 and a
decrease in the average number of
annual burden hours by 70,949.25 since
our last submission for OMB review and
approval of the information collection.
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–00125 Filed 1–7–21; 8:45 am]
BILLING CODE 4164–01–P
tkelley on DSKBCP9HB2PROD with NOTICES
Number of
disclosures
per
respondent
Activity; 21 CFR part
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21:23 Jan 07, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may be self-nominated or
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
may be nominated by a consumer
organization. FDA seeks to include the
views of women and men, members of
all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by January 29, 2021, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by February 8,
2021. Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2021.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
should be submitted electronically to
ACOMSSubmissions@fda.hhs.gov, by
E:\FR\FM\08JAN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1508-1510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00125]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1031]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration 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
associated with FDA recalls for products regulated by the Agency.
DATES: Submit either electronic or written comments on the collection
of information by March 9, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 9, 2021. 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
[[Page 1509]]
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-1031 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; FDA 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, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
FDA Recall Regulations--21 CFR Part 7
OMB Control Number 0910-0249--Extension
This information collection helps support implementation of section
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371)
pertaining to product recalls, and regulations in part 7 (21 CFR part
7), subpart C promulgated to clarify and explain associated practices
and procedures. Regulations in part 7, subpart C Sec. Sec. 7.49, 7.50,
and 7.59 (21 CFR 7.49, 7.50, and 7.59) apply specifically to product
recalls, which may be undertaken voluntarily and at any time by
manufacturers and distributors, or at the request of the Agency.
Recalls are terminated when all reasonable efforts have been made to
remove or correct the product in accordance with the recall strategy.
The regulations also provide for corrective actions to be taken
regarding violative products and establish specific requirements that
enable us to monitor and assess the adequacy of a firm's efforts in
this regard. The provisions include reporting to FDA on the initiation
and termination of a recall, as well as submitting recall status
reports and making required communication disclosures. Specific
guidance regarding recalls is set forth in Sec. 7.59, although
product-specific guidance documents may also be developed to assist
respondents to the information collection. Agency guidance documents
are issued in accordance with our good guidance regulations in 21 CFR
10.115, which provide for public comment at any time.
Consistent with Sec. 7.50, all recalls monitored by FDA are
included in an ``Enforcement Report'' once they are classified and may
be listed prior to classification when FDA determines the firm's
removal or correction of a marketed product(s) meets the definition of
a recall. Recall data in the Enforcement Report can be accessed through
the weekly report publication, the quick and advanced search
functionalities, and an Application
[[Page 1510]]
Programming Interface (API). Instructions for navigating the report,
accessing and using the API, and definitions of the report contents are
found at https://www.fda.gov/safety/enforcement-reports/enforcement-report-information-and-definitions.com.
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Firm initiated recall; Sec. 2,779 1 2,779 25 69,475
7.46...........................
Termination of recall; Sec. 2,095 1 2,095 10 20,950
7.55...........................
Recall status reports; Sec. 2,779 13 36,127 10 361,270
7.53...........................
-------------------------------------------------------------------------------
Total....................... .............. .............. 41,001 .............. 451,695
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
A review of Agency data shows that 8,337 recalls were conducted
during fiscal years 2017 through 2019, for an average of 2,779 recalls
annually. We assume an average of 25 hours is needed to submit the
requisite notification to FDA, for a total annual burden of 69,475
hours. Similarly, during the same period, 6,287 recalls were
terminated, for an average of 2,095 recall terminations annually, and
we assume an average of 10 hours is needed for the corresponding
information collection activity. To determine burden associated with
recall status reports we divided the average number of annual
submissions (36,127) by the average number of annual respondents
(2,779) and assume 10 hours is necessary for the corresponding
information collection, resulting in 361,270 hours annually.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR part Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Recall communications; Sec. 2,779.......... 445 1,236,655...... 0.05 (3 61,832.75
7.49. minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
To determine burden associated with recall communication
disclosures described in Sec. 7.49, we calculated an average of 445
disclosures per recall and attribute 3 minutes for each disclosure,
resulting in 61,832.75 burden hours annually.
These estimates reflect an overall decrease in the average number
of annual responses by 245,846 and a decrease in the average number of
annual burden hours by 70,949.25 since our last submission for OMB
review and approval of the information collection.
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00125 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P
