Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting, 77515-77519 [2024-21675]
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
CMS has contracted with an outside
vendor to assist in the administration of
the RDS program; this effort is called the
RDS Center. Plan Sponsors will apply
on-line for the retiree drug subsidy by
logging on to the RDS Secure website.
42 CFR 423.844 describes the
requirement for qualified retiree
prescription drug plans who want to
receive the retiree drug subsidy. Once
the Plan Sponsor submits the RDS
application via the RDS Secure website
(and a valid initial retiree list) CMS,
using its contractor, will analyze the
application to determine whether the
Plan Sponsor qualifies for the RDS. To
qualify for the subsidy, the Plan
Sponsor must show that its coverage is
as generous as, or more generous than,
the defined standard coverage under the
Medicare Part D prescription drug
benefit. The information within the
application includes sponsor account
registration information, plan
information, benefit options under the
plan, actuary information and actuarial
attestation. The RDS center has various
checks within each section of the
application. Applications can be denied
if issues cannot be resolved. Form
Number: CMS–10170 (OMB control
number: 0938–0977); Frequency: Yearly;
Affected Public: Private Sector; Business
or other for-profits, and Not-for Profits;
Number of Respondents: 1,245; Number
of Responses: 1,245; Total Annual
Hours: 79,680. (For questions regarding
this collection, contact Ivan Iveljic at
410–786–3312 or Ivan.iveljic@
cms.hhs.gov.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–21631 Filed 9–20–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2219]
Progynon Associates, et al.;
Withdrawal of Approval of Four New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of four new drug applications
(NDAs) from multiple holders of those
NDAs. The basis for the withdrawal is
that these NDA holders have repeatedly
failed to file required annual reports for
the identified NDAs.
DATES: Approval is withdrawn as of
September 23, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
SUMMARY:
77515
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
The
holder of an approved application to
market a new drug for human use is
required to submit annual reports to
FDA concerning its approved
application in accordance with § 314.81
(21 CFR 314.81).
In the Federal Register of May 28,
2024 (89 FR 46139), FDA published a
notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of four NDAs
because the holders of those NDAs had
repeatedly failed to submit the required
annual reports for those NDAs. The
holders of those NDAs did not respond
to the NOOH. Failure to file a written
notice of participation and request for
hearing as required by § 314.200 (21
CFR 314.200) constitutes an election by
those holders of the NDAs not to make
use of the opportunity for a hearing
concerning the proposal to withdraw
approval of their NDAs and a waiver of
any contentions concerning the legal
status of the drug products. Therefore,
FDA is withdrawing approval of the
four applications listed in table 1 of this
document.
SUPPLEMENTARY INFORMATION:
TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
NDA 004652 .....
ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg).
WINSTEROID (stanozolol) Tablets, 2 mg ................................
Copper T Model TCu 200B (copper) Intrauterine Device ........
NDA 013268 .....
NDA 017455 .....
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NDA 205003 .....
Holder
PRESTALIA (amlodipine besylate/perindopril arginine) Tablets, equivalent to (EQ) 2.5 mg base/3.5mg, EQ 5 mg base/
7 mg, and EQ 10 mg base/14 mg.
FDA finds that the holders of the
NDAs listed in table 1 have repeatedly
failed to submit reports required by
§ 314.81. In addition, under § 314.200,
FDA finds that the holders of the NDAs
have waived any contentions
concerning the legal status of the drug
products. Therefore, under these
findings, approval of the NDAs listed in
table 1 and all amendments and
supplements thereto are hereby
withdrawn as of September 23, 2024.
Progynon Associates, 9300 Wilshire Blvd., Beverly Hills, CA
90212.
Sterling Winthrop Inc., 90 Park Ave., New York, NY 10016.
Duramed Research, Inc., 425 Privet Rd., Horsham, PA
19044.
Adhera Therapeutics, Inc., 224 Holding Ave., Wake Forest,
NC 27588.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21680 Filed 9–20–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3112]
BILLING CODE 4164–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Experience Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
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 postmarketing
reporting and recordkeeping of adverse
experiences for drug and biological
products.
Either electronic or written
comments on the collection of
information must be submitted by
November 22, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 22, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
DATES:
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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:
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• 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–
2024–N–3112 for ‘‘Postmarketing
Adverse Experience Reporting.’’
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-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
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and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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: 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.
Postmarketing Adverse Experience
Reporting
OMB Control Number 0910–0230—
Revision
This information collection helps
support provisions found in sections
201, 502, 505, 701, and 760 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 321, 352, 355,
371, and 379aa) governing adverse
experience reporting (AER) and
associated recordkeeping for FDAregulated drug products. FDA has
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promulgated applicable regulations in
part 4 and §§ 310.305, 314.80, 314.81,
314.98, and 329.100 (21 CFR part 4 and
21 CFR 310.305, 314.80, 314.81, 314.98,
and 329.100) that implement the
statutory requirements, identify specific
content and format elements, and
establish reporting and retention
schedules for the required information.
Postmarketing safety data collection and
adverse event reporting are critical
elements of FDA’s monitoring of drugs.
For more information, please visit
https://www.fda.gov/drugs/surveillance/
postmarketing-adverse-event-reportingcompliance-program.
Respondents to the information
collection are manufacturers, packers,
distributors, and applicants of FDAregulated drug and biologic products
marketed with or without an FDAapproved application, including overthe-counter (OTC) drug products
marketed without an approved
application; OTC drug products
marketed under the OTC Drug
Monograph Review process (whether
subject to a final monograph or not); and
drug products marketed outside the
monograph system. All reports and
followup reports must be submitted to
FDA in electronic format, although
waivers of the electronic requirements
are available for good cause.
Adverse experience reporting for
products associated with drug
marketing applications are governed by
regulations in §§ 314.80, 314.81, and
314.98. The regulations identify
required reporting content and format
elements, as well as establish followup
reporting requirements and mandatory
reporting schedules. The regulations
also establish associated recordkeeping
and require that written procedures be
developed for the surveillance, receipt,
evaluation, and reporting of
postmarketing adverse experiences to
FDA. The regulations require reporting
in an electronic format that FDA can
process, although temporary waivers
may be granted on a limited basis for
good cause. A final guidance for
industry entitled ‘‘Providing
Submissions in Electronic Format—
Postmarketing Safety Reports’’ (April
2022) is available for general
information pertaining to electronic
submission of postmarketing safety
reports for certain human drugs,
biological products, and combination
products. The guidance is available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/providing-submissionselectronic-format-postmarketing-safetyreports.
We have established and maintain the
FDA Adverse Event Reporting System
(FAERS) at https://www.fda.gov/drugs/
questions-and-answers-fdas-adverseevent-reporting-system-faers/fdaadverse-event-reporting-system-faerselectronic-submissions. Information
may be submitted via FDA’s Electronic
Submissions Gateway or utilizing the
‘‘Safety Reporting Portal,’’ developed by
FDA and the National Institutes of
Health to streamline reporting and
review of adverse events.
The primary purpose of FDA’s
adverse drug experience reporting
system is to enable identification of
signals for potentially serious safety
problems with marketed drugs.
Although premarket testing discloses a
general safety profile of a new drug’s
comparatively common adverse effects,
the larger and more diverse patient
populations exposed to the marketed
product provide the opportunity to
collect information on rare, latent, and
long-term effects. Signals are obtained
from a variety of sources, including
reports from patients, treating
physicians, foreign regulatory agencies,
clinical investigators, and literature.
Information derived from the adverse
drug experience reporting system
contributes directly to increased public
health protection because the
information enables FDA to make
important changes to the product’s
labeling (such as adding a new
warning), to make decisions about risk
evaluation and mitigation strategies; the
need for postmarketing studies or
clinical trials; and, when necessary, to
initiate removal of a product from the
market.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 3
Number of
responses per
respondent
Total
annual
responses
36
682
682
312
88.8
1,832.84
1,228.73
62.522
3,197
1,250,000
838,000
19,507
1
1
60
6
3,197
1,250,000
50,280,000
117,042
471
8.885
4,185
1
4,185
1,115
16.254
18,123
2
36,246
1
1
1
8
8
1
1
1
24
24
4 2,618
........................
2,133,014
....................
51,690,702
Number of
respondents
21 CFR section or guidance; activity
310.305(c)(5); AERs for prescription products not the subject of a marketing application
314.80(c)(1); 15-day alerts for approved products ...............................................................
314.80(c)(2); periodic reports for approved products ...........................................................
329.100; AERs for non-prescription drug products ..............................................................
ICH E2C(R2) Guidance; Periodic safety updates; Applicants w/waiver for an approved
application (section III.A.) ..................................................................................................
ICH E2C(R2) Guidance; Periodic safety updates; Applicants w/no waiver for an approved
application (section III.B.) ..................................................................................................
AER During Pandemic Guidance; notifying FDA when normal reporting is not feasible
(section III.C.) ....................................................................................................................
4.103, 4.104, 4.105, 310.305, 314.80, 314.98, 329.100(c); Waiver requests from electronic reporting requirements ............................................................................................
Total ...............................................................................................................................
Average
burden per
response
Total hours
1 There
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are no capital costs associated with this collection. The operating and maintenance costs associated with this collection of information are approximately
$25,000 annually.
2 The reporting burdens for § 310.305(c)(1), (2), and (3), and voluntary reports by healthcare providers received under § 314.80(c)(1)(i) and (ii) are covered under
OMB control number 0910–0291.
3 Totals may not sum due to rounding.
4 Total of unique respondents.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
310.305; AER records—prescription product not the subject of a marketing application.
314.80(j); AER records—product associated w/marketing application .......
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Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section or guidance section; activity
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36
I
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841
Total
annual
records
88.8
I
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1,814.0606
I
Average burden per
recordkeeping
Total hours
3,197
16 .............................
51,152
1,525,625
16 .............................
24,410,000
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section or guidance section; activity
Total
annual
records
Average burden per
recordkeeping
Total hours
Postmarket AER for Nonprescription Drug Products Guidance;
(§ 329.100).
AERs During Pandemic Guidance; Continuity of operations planning (section III.B.).
AERs During Pandemic Guidance; documenting conditions and resultant
high absenteeism (section III.C.2).
AERs During Pandemic Guidance; documenting AER process (section
III.C.1.).
4.105; Postmarketing safety recordkeeping for combination products and
constituent parts.
312
62.5224
19,507
8 ...............................
156,056
100
1
100
50 .............................
5,000
350
1
350
8 ...............................
2,800
350
1
350
8 ...............................
2,800
11
18
198
0.1 (6 minutes) .........
19.8
Total ......................................................................................................
3 1,650
........................
1,549,327
...................................
24,627,827.8
1 There
are no capital costs associated with this collection of information. There are operating and maintenance costs associated with this collection of information
of approximately $22,000 annually.
2 Totals may not sum due to rounding.
3 Total of unique respondents.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section; activity
4.103; Postmarketing Safety reporting for Combination products—Sharing
information with other constituent part applicants.
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1 There
Number of
disclosures
per respondent
11
Total
annual
disclosures
18
198
Average burden per
disclosure
0.35 (21 minutes) .......
Total hours
69.3
are no capital costs or operating and maintenance costs associated with this collection of information.
All applicants who have received
marketing approval for drug products
(including combination products that
are administered as drug products) are
required to report serious, unexpected
adverse drug experiences (15-day ‘‘Alert
reports’’) (§ 314.80(c)(1)(i)), as well as
followup reports (§ 314.80(c)(1)(ii)) to
FDA. These include all foreign or
domestic AERs as well as AERs based
on information from applicable
scientific literature and certain reports
from post marketing studies. Section
314.80(c)(1)(iii) pertains to AERs
submitted by nonapplicants. For
operational efficiency, we have adjusted
this information collection and burden
table to include all 15-day alert reports
submitted by applicants, manufacturers,
packers, and distributors. Voluntary
reports from healthcare providers are
included under OMB control number
0910–0291.
Under § 314.80(c)(2), applicants
(including combination products that
are administered as drug products) must
also provide periodic reports of adverse
drug experiences. For the reporting
interval, a periodic report includes
reports of serious, expected adverse
drug experiences, all nonserious adverse
drug experiences, and an index of these
reports; a narrative summary and
analysis of adverse drug experiences; an
analysis of the 15-day Alert reports
submitted during the reporting interval;
and a history of actions taken because
of adverse drug experiences. Under
§ 314.80(j), applicants must keep
records of all adverse drug experience
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reports known to the applicant for 10
years.
For marketed prescription drug
products without approved new drug
applications (NDAs) or abbreviated new
drug applications (ANDAs),
manufacturers, packers, and distributors
of these products are required to report
to FDA serious, unexpected adverse
drug experiences as well as followup
reports (§ 310.305(c)). Section
310.305(c)(5) pertains to the submission
of followup reports to reports forwarded
to the manufacturers, packers, and
distributors by FDA. Under
§ 310.305(g), each manufacturer, packer,
and distributor shall maintain records of
all adverse drug experiences required to
be reported for 10 years. All 15-day
Alert reports and followup reports must
be submitted to FDA in electronic
format.
Section 760 of the FD&C Act also
provides for mandatory safety reporting
for over-the-counter human drug
products not subject to applications
approved under section 505 of the FD&C
Act (NDAs or ANDAs). These
requirements apply to all OTC drug
products marketed without an approved
application, including those marketed
under the OTC Drug Monograph Review
process (whether or not subject to a final
monograph), those marketed outside the
monograph system, and including those
that have been discontinued from
marketing but for which a report of an
adverse event was received. Under
§ 329.100, respondents must submit
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reports according to section 760 of the
FD&C Act in an electronic format.
To assist respondents with
implementation of section 760 of the
FD&C Act, FDA developed the guidance
for industry entitled ‘‘Postmarketing
Adverse Event Reporting for
Nonprescription Human Drug Products
Marketed Without an Approved
Application,’’ (July, 2009) available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/postmarketing-adverseevent-reporting-nonprescription-humandrug-products-marketed-withoutapproved. The guidance document
discusses what should be included in a
serious adverse drug event report
submitted under section 760(b)(1) of the
FD&C Act, including how to submit
these reports and followup reports
under section 760(c)(2) of the FD&C Act.
Section 760(e) of the FD&C Act also
requires that responsible persons
maintain records of nonprescription
drug adverse event reports, whether the
event is serious or not, for a period of
6 years. FDA’s guidance recommends
that respondents maintain records of
efforts to obtain the minimum data
elements for a report of a serious
adverse drug event and any followup
reports.
In addition, this information
collection includes an International
Council for Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use (ICH) guidance for industry
entitled ‘‘Providing Postmarketing
Periodic Safety Reports in the ICH
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E2C(R2) Format (Periodic Benefit-Risk
Evaluation Report), (November 2016)’’
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/providingpostmarket-periodic-safety-reports-iche2cr2-format-periodic-benefit-riskevaluation. The ICH E2C(R2) guidance
describes the conditions under which
applicants may use the ICH E2C(R2)
Periodic Benefit-Risk Evaluation Report
format for certain types of adverse event
reporting.
FDA regulations in §§ 314.80(c)(2)
and 600.80(c)(2) require applicants to
submit postmarketing periodic safety
reports for each approved application.
The reports must be submitted quarterly
for the first 3 years following the U.S.
approval date and annually thereafter
and must contain the information
described in §§ 314.80(c)(2)(ii) and
600.80(c)(2)(ii) (the information
collection associated with 21 CFR part
600—Biological Products, is approved
under OMB control number 0910–0308).
The Agency guidance assists
respondents with satisfying the
regulatory requirements in an
alternative format, noting that the
process differs depending on whether
an applicable periodic safety update
report waiver is in place.
Similarly, this information collection
accounts for burden that may be
applicable to the guidance document,
‘‘Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During a
Pandemic (May 2020),’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/postmarketing-adverseevent-reporting-medical-products-anddietary-supplements-during-pandemic.
In response to the Coronavirus Disease
2019 public health emergency, we
revised the Agency guidance document
to provide recommendations for
recordkeeping applicable to any
pandemic, not just influenza, including
recommendations for planning,
notification, and documentation for
continuity of operations for firms that
report postmarketing adverse events
during any pandemic.
For operational efficiency, on March
20, 2023, OMB approved the addition of
burden attributable to provisions related
to postmarketing safety reporting for
combination products as outlined in
part 4, subpart B, and previously
included in OMB control number 0910–
VerDate Sep<11>2014
16:57 Sep 20, 2024
Jkt 262001
0834. When information regarding an
event that involves a death or serious
injury, or an adverse event, associated
with the use of a combination product
that includes a drug product, is received
by the product sponsor, the information
must be provided to the other
constituent part applicant(s) no later
than 5 calendar days after receipt under
§ 4.103 (21 CFR 4.103). Relatedly, 21
CFR 4.104 explains how and where to
submit reports for combination
products, and 21 CFR 4.105 provides for
associated recordkeeping. For
combination products that are
administered as drug products with a
constituent part, adverse event reports
are submitted to the drug application
under 21 CFR part 314, and constituent
applicants are notified of the AER under
§ 4.103. These provisions are also
described in the guidance document
‘‘Postmarketing Safety Reporting for
Combination Products’’ (July 2019),
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/postmarketingsafety-reporting-combination-products.
Our estimates of the number of
respondents and the total annual
responses are based on reports
submitted to the Agency. This
information collection incorporates
revisions to include the two guidances
for industry regarding submission of
adverse event reports (‘‘Postmarketing
Adverse Event Reporting for Medical
Products and Dietary Supplements
During a Pandemic’’ and ‘‘Providing
Submissions in Electronic Format—
Postmarketing Safety Reports’’) and
adjustments to include 15-day alert
reports from applicants, manufacturers,
distributors, and packers that were not
recorded previously in this information
collection. We also believe adjustments
in the information collection reflect
anticipated fluctuations in burden after
pandemic conditions, adjustments by
reporters’ and changes in electronic
reporting methodologies use of updated
technology including updates and
redefinitions of reporting software, and
changes of company business practices
over time. All reports and followup
reports must be submitted to FDA in
electronic format. Waivers of the
electronic requirements are available.
As a result of these revisions and
adjustments, including the additional
reports, the inclusion of guidance
document recommendations and the
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
77519
consolidation of the burden from OMB
control number 0910–0834 (previously
added to this information collection
March 2023), the total burden hours of
the information collection have
increased by 61,615,010.1 hours and
2,546,310 responses as compared to the
previous renewal. We invite comment
on our assumptions.
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21675 Filed 9–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–N–2030 and FDA–
2024–N–0972]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77515-77519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21675]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3112]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Adverse Experience Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public
[[Page 77516]]
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 postmarketing reporting and recordkeeping of
adverse experiences for drug and biological products.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 22, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 22, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2024-N-3112 for ``Postmarketing Adverse Experience Reporting.''
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: 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: 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.
Postmarketing Adverse Experience Reporting
OMB Control Number 0910-0230--Revision
This information collection helps support provisions found in
sections 201, 502, 505, 701, and 760 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 321, 352, 355, 371, and 379aa)
governing adverse experience reporting (AER) and associated
recordkeeping for FDA-regulated drug products. FDA has
[[Page 77517]]
promulgated applicable regulations in part 4 and Sec. Sec. 310.305,
314.80, 314.81, 314.98, and 329.100 (21 CFR part 4 and 21 CFR 310.305,
314.80, 314.81, 314.98, and 329.100) that implement the statutory
requirements, identify specific content and format elements, and
establish reporting and retention schedules for the required
information. Postmarketing safety data collection and adverse event
reporting are critical elements of FDA's monitoring of drugs. For more
information, please visit https://www.fda.gov/drugs/surveillance/postmarketing-adverse-event-reporting-compliance-program.
Respondents to the information collection are manufacturers,
packers, distributors, and applicants of FDA-regulated drug and
biologic products marketed with or without an FDA-approved application,
including over-the-counter (OTC) drug products marketed without an
approved application; OTC drug products marketed under the OTC Drug
Monograph Review process (whether subject to a final monograph or not);
and drug products marketed outside the monograph system. All reports
and followup reports must be submitted to FDA in electronic format,
although waivers of the electronic requirements are available for good
cause.
Adverse experience reporting for products associated with drug
marketing applications are governed by regulations in Sec. Sec.
314.80, 314.81, and 314.98. The regulations identify required reporting
content and format elements, as well as establish followup reporting
requirements and mandatory reporting schedules. The regulations also
establish associated recordkeeping and require that written procedures
be developed for the surveillance, receipt, evaluation, and reporting
of postmarketing adverse experiences to FDA. The regulations require
reporting in an electronic format that FDA can process, although
temporary waivers may be granted on a limited basis for good cause. A
final guidance for industry entitled ``Providing Submissions in
Electronic Format--Postmarketing Safety Reports'' (April 2022) is
available for general information pertaining to electronic submission
of postmarketing safety reports for certain human drugs, biological
products, and combination products. The guidance is available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-submissions-electronic-format-postmarketing-safety-reports.
We have established and maintain the FDA Adverse Event Reporting
System (FAERS) at https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions. Information may be submitted via
FDA's Electronic Submissions Gateway or utilizing the ``Safety
Reporting Portal,'' developed by FDA and the National Institutes of
Health to streamline reporting and review of adverse events.
The primary purpose of FDA's adverse drug experience reporting
system is to enable identification of signals for potentially serious
safety problems with marketed drugs. Although premarket testing
discloses a general safety profile of a new drug's comparatively common
adverse effects, the larger and more diverse patient populations
exposed to the marketed product provide the opportunity to collect
information on rare, latent, and long-term effects. Signals are
obtained from a variety of sources, including reports from patients,
treating physicians, foreign regulatory agencies, clinical
investigators, and literature. Information derived from the adverse
drug experience reporting system contributes directly to increased
public health protection because the information enables FDA to make
important changes to the product's labeling (such as adding a new
warning), to make decisions about risk evaluation and mitigation
strategies; the need for postmarketing studies or clinical trials; and,
when necessary, to initiate removal of a product from the market.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\ \3\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR section or guidance; activity Number of responses per annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
310.305(c)(5); AERs for prescription 36 88.8 3,197 1 3,197
products not the subject of a marketing
application................................
314.80(c)(1); 15-day alerts for approved 682 1,832.84 1,250,000 1 1,250,000
products...................................
314.80(c)(2); periodic reports for approved 682 1,228.73 838,000 60 50,280,000
products...................................
329.100; AERs for non-prescription drug 312 62.522 19,507 6 117,042
products...................................
ICH E2C(R2) Guidance; Periodic safety 471 8.885 4,185 1 4,185
updates; Applicants w/waiver for an
approved application (section III.A.)......
ICH E2C(R2) Guidance; Periodic safety 1,115 16.254 18,123 2 36,246
updates; Applicants w/no waiver for an
approved application (section III.B.)......
AER During Pandemic Guidance; notifying FDA 1 1 1 8 8
when normal reporting is not feasible
(section III.C.)...........................
4.103, 4.104, 4.105, 310.305, 314.80, 1 1 1 24 24
314.98, 329.100(c); Waiver requests from
electronic reporting requirements..........
-------------------------------------------------------------------
Total................................... \4\ 2,618 .............. 2,133,014 ........... 51,690,702
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection. The operating and maintenance costs associated
with this collection of information are approximately $25,000 annually.
\2\ The reporting burdens for Sec. 310.305(c)(1), (2), and (3), and voluntary reports by healthcare providers
received under Sec. 314.80(c)(1)(i) and (ii) are covered under OMB control number 0910-0291.
\3\ Totals may not sum due to rounding.
\4\ Total of unique respondents.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section or guidance section; activity Number of records per annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305; AER records--prescription product not 36 88.8 3,197 16....................................... 51,152
the subject of a marketing application.
314.80(j); AER records--product associated w/ 841 1,814.0606 1,525,625 16....................................... 24,410,000
marketing application.
[[Page 77518]]
Postmarket AER for Nonprescription Drug 312 62.5224 19,507 8........................................ 156,056
Products Guidance; (Sec. 329.100).
AERs During Pandemic Guidance; Continuity of 100 1 100 50....................................... 5,000
operations planning (section III.B.).
AERs During Pandemic Guidance; documenting 350 1 350 8........................................ 2,800
conditions and resultant high absenteeism
(section III.C.2).
AERs During Pandemic Guidance; documenting AER 350 1 350 8........................................ 2,800
process (section III.C.1.).
4.105; Postmarketing safety recordkeeping for 11 18 198 0.1 (6 minutes).......................... 19.8
combination products and constituent parts.
--------------------------------------------------------------------------------------------------------
Total...................................... \3\ 1,650 .............. 1,549,327 ......................................... 24,627,827.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information. There are operating and maintenance costs associated with this collection
of information of approximately $22,000 annually.
\2\ Totals may not sum due to rounding.
\3\ Total of unique respondents.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.103; Postmarketing Safety reporting for 11 18 198 0.35 (21 minutes).......................... 69.3
Combination products--Sharing information with
other constituent part applicants.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
All applicants who have received marketing approval for drug
products (including combination products that are administered as drug
products) are required to report serious, unexpected adverse drug
experiences (15-day ``Alert reports'') (Sec. 314.80(c)(1)(i)), as well
as followup reports (Sec. 314.80(c)(1)(ii)) to FDA. These include all
foreign or domestic AERs as well as AERs based on information from
applicable scientific literature and certain reports from post
marketing studies. Section 314.80(c)(1)(iii) pertains to AERs submitted
by nonapplicants. For operational efficiency, we have adjusted this
information collection and burden table to include all 15-day alert
reports submitted by applicants, manufacturers, packers, and
distributors. Voluntary reports from healthcare providers are included
under OMB control number 0910-0291.
Under Sec. 314.80(c)(2), applicants (including combination
products that are administered as drug products) must also provide
periodic reports of adverse drug experiences. For the reporting
interval, a periodic report includes reports of serious, expected
adverse drug experiences, all nonserious adverse drug experiences, and
an index of these reports; a narrative summary and analysis of adverse
drug experiences; an analysis of the 15-day Alert reports submitted
during the reporting interval; and a history of actions taken because
of adverse drug experiences. Under Sec. 314.80(j), applicants must
keep records of all adverse drug experience reports known to the
applicant for 10 years.
For marketed prescription drug products without approved new drug
applications (NDAs) or abbreviated new drug applications (ANDAs),
manufacturers, packers, and distributors of these products are required
to report to FDA serious, unexpected adverse drug experiences as well
as followup reports (Sec. 310.305(c)). Section 310.305(c)(5) pertains
to the submission of followup reports to reports forwarded to the
manufacturers, packers, and distributors by FDA. Under Sec.
310.305(g), each manufacturer, packer, and distributor shall maintain
records of all adverse drug experiences required to be reported for 10
years. All 15-day Alert reports and followup reports must be submitted
to FDA in electronic format.
Section 760 of the FD&C Act also provides for mandatory safety
reporting for over-the-counter human drug products not subject to
applications approved under section 505 of the FD&C Act (NDAs or
ANDAs). These requirements apply to all OTC drug products marketed
without an approved application, including those marketed under the OTC
Drug Monograph Review process (whether or not subject to a final
monograph), those marketed outside the monograph system, and including
those that have been discontinued from marketing but for which a report
of an adverse event was received. Under Sec. 329.100, respondents must
submit reports according to section 760 of the FD&C Act in an
electronic format.
To assist respondents with implementation of section 760 of the
FD&C Act, FDA developed the guidance for industry entitled
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application,'' (July, 2009)
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-nonprescription-human-drug-products-marketed-without-approved. The
guidance document discusses what should be included in a serious
adverse drug event report submitted under section 760(b)(1) of the FD&C
Act, including how to submit these reports and followup reports under
section 760(c)(2) of the FD&C Act. Section 760(e) of the FD&C Act also
requires that responsible persons maintain records of nonprescription
drug adverse event reports, whether the event is serious or not, for a
period of 6 years. FDA's guidance recommends that respondents maintain
records of efforts to obtain the minimum data elements for a report of
a serious adverse drug event and any followup reports.
In addition, this information collection includes an International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH) guidance for industry entitled ``Providing
Postmarketing Periodic Safety Reports in the ICH
[[Page 77519]]
E2C(R2) Format (Periodic Benefit-Risk Evaluation Report), (November
2016)'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-postmarket-periodic-safety-reports-ich-e2cr2-format-periodic-benefit-risk-evaluation. The ICH E2C(R2)
guidance describes the conditions under which applicants may use the
ICH E2C(R2) Periodic Benefit-Risk Evaluation Report format for certain
types of adverse event reporting.
FDA regulations in Sec. Sec. 314.80(c)(2) and 600.80(c)(2) require
applicants to submit postmarketing periodic safety reports for each
approved application. The reports must be submitted quarterly for the
first 3 years following the U.S. approval date and annually thereafter
and must contain the information described in Sec. Sec.
314.80(c)(2)(ii) and 600.80(c)(2)(ii) (the information collection
associated with 21 CFR part 600--Biological Products, is approved under
OMB control number 0910-0308). The Agency guidance assists respondents
with satisfying the regulatory requirements in an alternative format,
noting that the process differs depending on whether an applicable
periodic safety update report waiver is in place.
Similarly, this information collection accounts for burden that may
be applicable to the guidance document, ``Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During a
Pandemic (May 2020),'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic. In
response to the Coronavirus Disease 2019 public health emergency, we
revised the Agency guidance document to provide recommendations for
recordkeeping applicable to any pandemic, not just influenza, including
recommendations for planning, notification, and documentation for
continuity of operations for firms that report postmarketing adverse
events during any pandemic.
For operational efficiency, on March 20, 2023, OMB approved the
addition of burden attributable to provisions related to postmarketing
safety reporting for combination products as outlined in part 4,
subpart B, and previously included in OMB control number 0910-0834.
When information regarding an event that involves a death or serious
injury, or an adverse event, associated with the use of a combination
product that includes a drug product, is received by the product
sponsor, the information must be provided to the other constituent part
applicant(s) no later than 5 calendar days after receipt under Sec.
4.103 (21 CFR 4.103). Relatedly, 21 CFR 4.104 explains how and where to
submit reports for combination products, and 21 CFR 4.105 provides for
associated recordkeeping. For combination products that are
administered as drug products with a constituent part, adverse event
reports are submitted to the drug application under 21 CFR part 314,
and constituent applicants are notified of the AER under Sec. 4.103.
These provisions are also described in the guidance document
``Postmarketing Safety Reporting for Combination Products'' (July
2019), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-safety-reporting-combination-products.
Our estimates of the number of respondents and the total annual
responses are based on reports submitted to the Agency. This
information collection incorporates revisions to include the two
guidances for industry regarding submission of adverse event reports
(``Postmarketing Adverse Event Reporting for Medical Products and
Dietary Supplements During a Pandemic'' and ``Providing Submissions in
Electronic Format--Postmarketing Safety Reports'') and adjustments to
include 15-day alert reports from applicants, manufacturers,
distributors, and packers that were not recorded previously in this
information collection. We also believe adjustments in the information
collection reflect anticipated fluctuations in burden after pandemic
conditions, adjustments by reporters' and changes in electronic
reporting methodologies use of updated technology including updates and
redefinitions of reporting software, and changes of company business
practices over time. All reports and followup reports must be submitted
to FDA in electronic format. Waivers of the electronic requirements are
available. As a result of these revisions and adjustments, including
the additional reports, the inclusion of guidance document
recommendations and the consolidation of the burden from OMB control
number 0910-0834 (previously added to this information collection March
2023), the total burden hours of the information collection have
increased by 61,615,010.1 hours and 2,546,310 responses as compared to
the previous renewal. We invite comment on our assumptions.
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21675 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
