Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 77519-77520 [2024-21672]
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
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–
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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
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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:
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Title of collection
OMB control No.
Applications for FDA Approval to Market a New Drug ...............................................................................
Regulations Under the Federal Import Milk Act ..........................................................................................
Dated: September 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
written/paper submissions) will be
considered timely if they are received
on or before that date.
[FR Doc. 2024–21672 Filed 9–20–24; 8:45 am]
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’’).
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–1081; FDA–
2019–E–1082; FDA–2019–E–1083; FDA–
2019–E–1084; FDA–2019–E–1085; and FDA–
2019–E–1844]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SYMDEKO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for SYMDEKO and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by November 22, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
March 24, 2025. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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
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SUMMARY:
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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 Nos. FDA–
2019–E–1081; FDA–2019–E–1082;
FDA–2019–E–1083; FDA–2019–E–1084;
FDA–2019–E–1085; and FDA–2019–E–
1844 for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; SYMDEKO.’’ Received
comments, those filed in a timely
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0910–0001
0910–0212
Date approval
expires
8/31/2025
8/31/2027
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 § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
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[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77519-77520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21672]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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,
[email protected].
SUPPLEMENTARY INFORMATION: 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.
[[Page 77520]]
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
Date approval
Title of collection OMB control No. expires
------------------------------------------------------------------------
Applications for FDA Approval to 0910-0001 8/31/2025
Market a New Drug................
Regulations Under the Federal 0910-0212 8/31/2027
Import Milk Act..................
------------------------------------------------------------------------
Dated: September 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21672 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
