Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, 26880-26882 [2019-12109]
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26880
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR part 112
Number of
respondents
Number of
disclosures
per
respondent
Total
disclosures
Average
burden per
disclosure
Total hours
Disclosure under §§ 112.2, 112.6, 112.31, 112.33, and
112.142 .............................................................................
77,165
3.459
266,914
1.422
379,551
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1 There
are no capital costs or operating or maintenance costs associated with this collection of information.
Section 112.7 (21 CFR 112.7) requires
farms eligible for the qualified
exemption in accordance with § 112.5
(21 CFR 112.5) to maintain the records
necessary to demonstrate that the farm
satisfies the criteria for the qualified
exemption, including a written record
reflecting that the owner, operator, or
agent in charge of the farm has
performed an annual review and
verification of the farm’s continued
eligibility for the qualified exemption.
We estimate that 3,285 farms are eligible
for the qualified exemption and that
each farm will spend an average of 0.5
hours per year to maintain one record.
Therefore, 3,285 recordkeepers × 0.5
average hours per recordkeeping =
1,642.5 hours (rounded to 1,643) to meet
the recordkeeping requirements of
§ 112.7.
Section 112.30 (21 CFR 112.30)
requires the maintenance of records of
required training of personnel,
including the date of training, topics
covered, and persons trained. We
estimate that 24,420 farms maintain one
record of required training and spend an
average of 7.25 hours per year on
recordkeeping. Therefore, 24,420
recordkeepers × 7.25 average hours per
recordkeeping = 177,045 hours to meet
the recordkeeping requirements of
§ 112.30.
Although compliance dates for the
agricultural water provisions (subpart E)
for covered produce other than sprouts
are delayed to January 26, 2024, for very
small businesses, January 26, 2023, for
small businesses, and January 26, 2022,
for all other businesses, we have
estimated the burden. Section 112.46
(21 CFR 112.46) requires testing
agricultural water subject to the
requirements of §§ 112.44 and 112.45
(21 CFR 112.44 and 112.45). We
estimate that 48,361 farms that will
conduct these tests. Thus, it is estimated
that about three (2.990) records for each
farm will spend an average of 0.825
hours per record on testing water.
Therefore, 48,361 farms × 2.990 records
× 0.825 average hours per recordkeeping
= 119,294.175 hours (rounded to
119,294) to meet the recordkeeping
requirements of §§ 112.44 and 112.45.
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For records related to agricultural
water, we estimate that there are
160,605 recordkeepers each maintaining
just over 2 records (2.242), with each
recordkeeping taking just over 2 hours
(2.160). Therefore, 160,605
recordkeepers × 2.242 records × 2.160
hours = 777,765.046 hours (rounded to
777,765) for the recordkeeping burden
related to agricultural water.
Sections 112.144, 112.145, and
112.147 (21 CFR 112.144, 112.145, and
112. 147) require testing for sprouts. We
estimate that 126 recordkeepers will
maintain records for these tests. Thus, it
is estimated that for about 246 (245.660)
records each recordkeeper will spend an
average of 0.825 hour per record on
testing sprouts. Therefore, 126
recordkeepers × 245.660 records × 0.825
average hours per recordkeeping =
25,536.357 hours (rounded to 25,536) to
meet the recordkeeping requirements of
§§ 112.144, 112.145, and 112.147.
We estimate that there are 126
recordkeepers for other records related
to sprouts. Thus, it is estimated that for
about 62 (62.061) records each
recordkeeper will spend an average of
1.412 hours per record. Therefore, 126
recordkeepers × 62.061 records × 1.412
average hours per recordkeeping =
11,041.397 (rounded to 11,041) hours
for the burden to maintain records
related to sprouts.
We estimate 126 recordkeepers will
utilize the recommendations in the draft
guidance document entitled
‘‘Compliance with and
Recommendations for Implementation
of the Standards for the Growing,
Harvesting, Packing, and Holding of
Produce for Human Consumption for
Sprout Operations,’’ once finalized, to
maintain additional records related to
sprouts. We estimate each recordkeeper
will keep 233 records and
recordkeeping will take about an hour
per record for a recordkeeping burden of
29,358 hours.
Section 112.2 relates to
documentation supporting compliance.
We estimate that there are 4,568
recordkeepers each maintaining a record
of compliance. We estimate that each
recordkeeper will spend 0.079 hour
maintaining their record. Therefore,
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Frm 00072
Fmt 4703
Sfmt 4703
4,568 recordkeepers × 0.079 hour =
360.872 (rounded to 361) hours for the
burden to maintain documentation
supporting compliance.
Sections 112.2, 112.6, 112.31, 112.33,
and 112.142 (21 CFR 112.2, 112.6,
112.31, 112.33, and 112.142) require
third-party disclosures. We estimate that
77,165 respondents are making these
disclosures. Thus, it is estimated that
each respondent has around three
(3.459) disclosures and will spend an
average of 1.422 hours per disclosure.
Therefore, 77,165 respondents × 3.459
disclosures × 1.422 average hours per
disclosure = 379,551.331 hours
(rounded to 379,551) for the third-party
disclosure burden to meet the
requirements of §§ 112.2, 112.6, 112.31,
112.33, and 112.142.
The burden estimate reflects
adjustments resulting in an overall
increase of 8,515 hours. Although we
removed the one-time burden that has
been realized since establishing the
regulations, we have added burden
attributed to recommendations found in
the Sprouts draft guidance.
Dated: June 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12108 Filed 6–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4735]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Safety Labeling
Changes—Implementation of Section
505(o)(4) of the Federal Food, Drug,
and Cosmetic Act
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
SUMMARY:
E:\FR\FM\10JNN1.SGM
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26881
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
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 10,
2019.
ADDRESSES: 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 0910–0734. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
Safety Labeling Changes—
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910–0734—
Extension
Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355(o)(4)) authorizes FDA to
require and, if necessary, order labeling
changes if FDA becomes aware of new
safety information that it believes
should be included in the labeling of
certain prescription drug and biological
products approved under section 505 of
the FD&C Act or section 351 of the
Public Health Service Act (PHS Act) (42
U.S.C. 262). Section 505(o)(4) of the
FD&C Act applies to prescription drug
products with an approved new drug
application (NDA) under section 505(b)
of the FD&C Act, biological products
with an approved biologics license
application under section 351 of the
PHS Act, or prescription drug products
with an approved abbreviated new drug
application under section 505(j) of the
FD&C Act if the reference listed drug
with an approved NDA is not currently
marketed. Section 505(o)(4) establishes
time frames by which application
holders must submit, and FDA staff
must review, information necessary to
ensure timely and appropriate labeling
changes. To communicate how we
implement these provisions we
developed the guidance entitled
‘‘Guidance for Industry: Safety Labeling
Changes—Implementation of Section
505(o)(4) of the Federal Food, Drug, and
Cosmetic Act,’’ which provides
instruction on: (1) A description of the
types of safety labeling changes that
ordinarily might be required; (2) how
FDA plans to determine what
constitutes new safety information; (3)
the procedures involved in requiring
safety labeling changes, and (4)
enforcement of the requirements for
safety labeling changes. The guidance is
currently posted to the docket and
available on FDA’s website at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/safetylabeling-changes-implementationsection-505o4-federal-food-drug-andcosmetic-act.
As explained in the guidance, we
send application holders a notification
letter when safety labeling changes are
required. Under section 505(o)(4)(B) of
the FD&C Act, the application holder
must respond to our notification by
either submitting a labeling supplement,
or a rebuttal statement explaining why
it believes the labeling change is
unwarranted. Based on our experience
to date with safety labeling changes
requirements under section 505(o)(4) of
the FD&C Act, we estimate that 36
application holders will elect to submit
1 rebuttal statement each year and that
each rebuttal statement will take
approximately 6 hours to prepare.
In addition, the guidance explains
that labeling prepared in response to a
safety labeling change notification
should be available on the application
holder’s website within 10 calendar
days of approval. We estimate that 351
application holders will post new
labeling one time each year in response
to a safety labeling change notification
and that the posting of the labeling will
take approximately 4 hours to prepare.
In the Federal Register of February
12, 2019 (84 FR 3461), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received. The comment offered general
support for the information collection,
provided certain statistical details
regarding potential respondents,
encouraged utilization of electronic
and/or digital technology where
possible, and offered a related topic for
which additional guidance might be
useful. We appreciate the comment and
will continue to consider the
suggestions provided. At the same time,
it was not suggested that we make
changes to our burden estimate, which
remains as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Rebuttal statement ...............................................................
36
1
36
6
216
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of submission
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Posting approval labeling on application holder’s website ..
351
1
351
4
1,404
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since last OMB review and approval,
we have adjusted our estimated annual
VerDate Sep<11>2014
16:45 Jun 07, 2019
Jkt 247001
number of respondents downward by
62. The decrease reflects that we have
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
issued fewer safety labeling
notifications, and thus fewer postings
E:\FR\FM\10JNN1.SGM
10JNN1
26882
Federal Register / Vol. 84, No. 111 / Monday, June 10, 2019 / Notices
I. Background
are required and fewer rebuttals are
expected.
Dated: June 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12109 Filed 6–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
Leveraging Randomized Clinical Trials
To Generate Real-World Evidence for
Regulatory Purposes; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Leveraging
Randomized Clinical Trials to Generate
Real-World Evidence for Regulatory
Purposes.’’ Convened by Duke
University’s Robert J. Margolis, MD,
Center for Health Policy (Duke Margolis)
and supported by a cooperative
agreement with FDA, the purpose of the
public workshop is to bring the
stakeholder community together to
explore key considerations for using
randomized designs, such as large
simple trials or those that incorporate
pragmatic elements to generate realworld evidence (RWE).
DATES: The public workshop will be
held on July 11, 2019, from 8:30 a.m. to
5 p.m., Eastern Time and July 12, 2019,
from 9 a.m. to 1 p.m., Eastern Time. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will
be held at The Westin City Center, 1400
M St. NW, Washington, DC 20005. For
additional travel and hotel information,
please refer to the following website:
https://healthpolicy.duke.edu/events/
leveraging-randomized-clinical-trialsand-real-world-data-generate-realworld-evidence. There will also be a live
webcast for those unable to attend the
meeting in person (see Streaming
Webcast of the Public Workshop).
FOR FURTHER INFORMATION CONTACT:
Dianne Paraoan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326,
Silver Spring, MD 20993, 301–796–
2500, Dianne.Paraoan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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Jkt 247001
Section 3022 of the 21st Century
Cures Act (Cures Act) amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to add section 505F,
Utilizing real world evidence (21 U.S.C.
355g). This section requires the
establishment of a program to evaluate
the potential use of RWE to help
support the approval of a new
indication for a drug approved under
section 505(c) of the FD&C Act (21
U.S.C. 355(c)) and to help to support or
satisfy postapproval study requirements.
In December 2018, FDA published the
Framework for the RWE program
(https://www.fda.gov/media/120060/
download). To inform FDA’s RWE
Framework, on September 13, 2017,
through its cooperative agreement with
Duke Margolis, FDA convened a public
meeting that explored the use of RWE
for regulatory decisions.
The RWE Framework includes
information describing sources of RWE,
gaps in data collection activities,
standards and methodologies for
collecting and analyzing RWE, and
priority areas, remaining challenges,
and potential pilot opportunities to
address the overarching Cures Act
requirements. The RWE Framework also
discusses the integration of clinical
trials into clinical care settings and
FDA’s intent to issue guidance on this
subject. The public workshop
announced in this notice is a part of
FDA’s ongoing efforts to implement the
RWE Framework by exploring the utility
of RWE for regulatory decision making.
This workshop will focus on how
randomized clinical trial designs can
use real-world data (RWD) to generate
RWE, particularly in clinical care
settings.
II. Topics for Discussion at the Public
Workshop
This workshop will explore key
considerations for using randomized
clinical trial designs and RWD to
generate RWE, particularly in clinical
care settings. Considerations for
discussion include: (1) Selection of
interventions appropriate in clinical
care settings, (2) study design elements
and study populations, (3) capturing
outcomes in clinical care settings, and
(4) addressing potential challenges
around blinding, randomization, and
bias. The workshop will also explore
regulatory considerations for
randomized clinical trials using RWD,
such as safety and product monitoring
and maintaining data integrity.
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Fmt 4703
Sfmt 4703
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://healthpolicy.duke.edu/
events/leveraging-randomized-clinicaltrials-and-real-world-data-generate-realworld-evidence. There will be no onsite
registration. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by July 10, 2019, 11:59 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
registered. We will let registrants know
if registration closes before the day of
the public workshop.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy (phone: 202–791–9561,
email: sarah.supsiri@duke.edu) no later
than July 5, 2019.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast, and archived video
footage will be available at the DukeMargolis website (https://
healthpolicy.duke.edu/events/
leveraging-randomized-clinical-trialsand-real-world-data-generate-realworld-evidence) following the
workshop. Persons interested in viewing
the live webcast are encouraged to
register in advance (see Registration).
Organizations are requested to register
all participants, but to view using one
connection per location whenever
possible. Webcast participants will be
sent technical system requirements in
advance of the event. Prior to joining the
streaming webcast of the public
workshop, it is recommended that you
review these technical system
requirements. FDA has verified the
website addresses in this document, as
of the date this document publishes in
the Federal Register, but websites are
subject to change over time.
Meeting Materials: All event materials
will be provided to registered attendees
via email prior to the workshop and
publicly available at the Duke-Margolis
website (https://healthpolicy.duke.edu/
events/leveraging-randomized-clinicaltrials-and-real-world-data-generate-realworld-evidence).
Transcripts: Transcripts of the public
workshop will not be available.
E:\FR\FM\10JNN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26880-26882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12109]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4735]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Safety Labeling
Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug,
and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the
[[Page 26881]]
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
10, 2019.
ADDRESSES: 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 [email protected]. All
comments should be identified with the OMB control number 0910-0734.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Safety Labeling Changes--Implementation of Section 505(o)(4) of the
Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910-0734--Extension
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require and, if necessary,
order labeling changes if FDA becomes aware of new safety information
that it believes should be included in the labeling of certain
prescription drug and biological products approved under section 505 of
the FD&C Act or section 351 of the Public Health Service Act (PHS Act)
(42 U.S.C. 262). Section 505(o)(4) of the FD&C Act applies to
prescription drug products with an approved new drug application (NDA)
under section 505(b) of the FD&C Act, biological products with an
approved biologics license application under section 351 of the PHS
Act, or prescription drug products with an approved abbreviated new
drug application under section 505(j) of the FD&C Act if the reference
listed drug with an approved NDA is not currently marketed. Section
505(o)(4) establishes time frames by which application holders must
submit, and FDA staff must review, information necessary to ensure
timely and appropriate labeling changes. To communicate how we
implement these provisions we developed the guidance entitled
``Guidance for Industry: Safety Labeling Changes--Implementation of
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act,'' which
provides instruction on: (1) A description of the types of safety
labeling changes that ordinarily might be required; (2) how FDA plans
to determine what constitutes new safety information; (3) the
procedures involved in requiring safety labeling changes, and (4)
enforcement of the requirements for safety labeling changes. The
guidance is currently posted to the docket and available on FDA's
website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act.
As explained in the guidance, we send application holders a
notification letter when safety labeling changes are required. Under
section 505(o)(4)(B) of the FD&C Act, the application holder must
respond to our notification by either submitting a labeling supplement,
or a rebuttal statement explaining why it believes the labeling change
is unwarranted. Based on our experience to date with safety labeling
changes requirements under section 505(o)(4) of the FD&C Act, we
estimate that 36 application holders will elect to submit 1 rebuttal
statement each year and that each rebuttal statement will take
approximately 6 hours to prepare.
In addition, the guidance explains that labeling prepared in
response to a safety labeling change notification should be available
on the application holder's website within 10 calendar days of
approval. We estimate that 351 application holders will post new
labeling one time each year in response to a safety labeling change
notification and that the posting of the labeling will take
approximately 4 hours to prepare.
In the Federal Register of February 12, 2019 (84 FR 3461), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received. The comment
offered general support for the information collection, provided
certain statistical details regarding potential respondents, encouraged
utilization of electronic and/or digital technology where possible, and
offered a related topic for which additional guidance might be useful.
We appreciate the comment and will continue to consider the suggestions
provided. At the same time, it was not suggested that we make changes
to our burden estimate, which remains as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rebuttal statement................................................. 36 1 36 6 216
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of submission Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Posting approval labeling on application holder's website.......... 351 1 351 4 1,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Since last OMB review and approval, we have adjusted our estimated
annual number of respondents downward by 62. The decrease reflects that
we have issued fewer safety labeling notifications, and thus fewer
postings
[[Page 26882]]
are required and fewer rebuttals are expected.
Dated: June 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12109 Filed 6-7-19; 8:45 am]
BILLING CODE 4164-01-P
