Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations, 18543-18544 [2021-07287]
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18543
Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
FDA finds that the holders of the
ANDAs listed in table 1 have repeatedly
failed to submit reports required by
§§ 314.81 and 314.98 and section 505(k)
of the FD&C Act (21 U.S.C. 355).
Furthermore, the holders of the ANDAs
listed in table 1 have failed to receive
approval of a REMS for their products
in accordance with section 505–1 of the
FD&C Act. In addition, under § 314.200,
FDA finds that the holders of the
ANDAs have waived their opportunity
for a hearing and any contentions
concerning the legal status of the drug
products. Therefore, based on these
findings and pursuant to the authority
under section 505(e) of the FD&C Act,
approval of the ANDAs listed in table 1
and all amendments and supplements
thereto is hereby withdrawn as of April
9, 2021.
Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07335 Filed 4–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by May 10,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0249. Also include
the FDA docket number found in
brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FDA Recall Regulations—21 CFR Part 7
[Docket No. FDA–2014–N–1031]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
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.
Sections 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
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.
In the Federal Register of January 8,
2021 (86 FR 1508), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
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
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17:45 Apr 08, 2021
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average of 2,779 recalls annually. We
assume an average of 25 hours is needed
to submit the requisite notification to
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FDA, for a total annual burden of 69,475
hours. Similarly, during the same
period, 6,287 recalls were terminated,
E:\FR\FM\09APN1.SGM
09APN1
18544
Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
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
Recall communications; § 7.49 .........
1 There
Number of
disclosures
per
respondent
Number of
respondents
Activity; 21 CFR section
I
2,779
I
445
Total annual
disclosures
I
1,236,655
Average burden per disclosure
I 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: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07287 Filed 4–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Virtual Stakeholder Listening Session
in Preparation for the 74th World
Health Assembly
Subject: Office of Global Affairs:
Virtual Stakeholder Listening Session in
preparation for the 74th World Health
Assembly.
Time and date: The session will be
held on Thursday, May 13, 2021, from
10:00 a.m.–12:00 p.m. Eastern Time
(ET).
Place: The session will be held
virtually, and registration is required.
Please RSVP by April 29, 2021 by
sending your full name, email address,
and organization to OGA.RSVP@
hhs.gov. OGA encourages early
registration.
Status: Open, but requiring RSVP to
OGA.RSVP@hhs.gov to register.
Purpose: The U.S. Department of
Health and Human Services (HHS)—
charged with leading the U.S. delegation
to the 74th World Health Assembly—
will hold an informal Stakeholder
Listening Session on Thursday, May 13,
10:00 a.m.–12:00 p.m. ET. The listening
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session will be held virtually, and the
meeting link will be shared with
registered participants prior to the
session.
The Stakeholder Listening Session
will help the HHS Office of Global
Affairs prepare the U.S. delegation to
the World Health Assembly by taking
full advantage of the knowledge, ideas,
feedback, and suggestions from all
communities interested in and affected
by agenda items to be discussed at the
74th World Health Assembly. Your
input will contribute to U.S. positions
as we negotiate these important health
topics with our international colleagues.
The listening session will be
organized by agenda item, and
participation is welcome from
stakeholder communities, including:
• Public health and advocacy groups;
• State, local, and Tribal groups;
• Private industry;
• Minority health organizations; and
• Academic and scientific
organizations.
All agenda items to be discussed at
the 74th World Health Assembly can be
found at this website: https://
apps.who.int/gb/e/e_wha74.html.
RSVP: Registration is required for the
event. Please send your full name, email
address, and organization to
OGA.RSVP@hhs.gov to register. Please
RSVP no later than Thursday, April 29,
2021.
Written comments are welcome and
encouraged, even if you are planning on
attending the virtual session. Please
send written comments to the email
address: OGA.RSVP@hhs.gov.
We look forward to hearing your
comments related to the 74th World
Health Assembly agenda items.
Dated: March 31, 2021.
Loyce Pace,
Director, Office of Global Affairs.
[FR Doc. 2021–07299 Filed 4–8–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request—60-Day Public Comment
Request
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 8, 2021.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, or call (202)
795–7714 the Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Components
Study of REAL Essential Curriculum.
Type of Collection: New.
SUMMARY:
E:\FR\FM\09APN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18543-18544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07287]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1031]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Recall Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by May 10, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0249. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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. Sections 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 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.
In the Federal Register of January 8, 2021 (86 FR 1508), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity; 21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses 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,
[[Page 18544]]
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 section 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 minutes) 61,832.75
7.49.
----------------------------------------------------------------------------------------------------------------
\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: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07287 Filed 4-8-21; 8:45 am]
BILLING CODE 4164-01-P
