Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions, 19152-19153 [2023-06573]
Download as PDF
<![CDATA[
19152
Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
information for use throughout the
global medicinal product development
lifecycle. In 2013, FDA established an
internal committee to determine the
conformance of FDA standards to the
ISO IDMP standards. Over several years,
the committee analyzed the structure,
format, and content of the Unique
Ingredient Identifier, Structured Product
Labeling Pharmaceutical Dosage Form
Terminology, Unified Code for Units of
Measure, and National Drug Code to
assess their conformance to ISO 11238,
ISO 11239, ISO 11240, and ISO 11615,
respectively. FDA’s internal committee
determined that the Agency’s standards
conform to the ISO IDMP standards for
regional use. Topics covered in this
guidance include:
• Introduction and scope
• Introduction to the five ISO IDMP
standards: ISO 11238 (substance), ISO
11239 (dose form), ISO 11240 (units
of measure), ISO 11615 (medicinal
product identification), and ISO
11616 (pharmaceutical product
identification)
• Benefits of IDMP implementation and
use, including drug safety and
pharmacovigilance, medicinal
product traceability for global supply
chain integrity, and regulatory
registration and exchange of
medicinal product information
• FDA’s approach to the IDMP
standards
• Phased approach to the global
implementation
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Patent Term Restoration; Due Diligence
Petitions; Filing, Format, and Content of
Petitions—21 CFR Part 60
[FR Doc. 2023–06587 Filed 3–29–23; 8:45 am]
The guidance represents the current
thinking of FDA on ‘‘Identification of
Medicinal Products—Implementation
and Use.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
ADDRESSES:
OMB Control Number 0910–0233—
Extension
This information collection supports
Agency regulations. FDA’s patent
extension activities are conducted under
the authority of section 505(j) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(j)) and the
Generic Animal Drug and Patent Term
Restoration Act of 1988 (Pub. L. 100–
670) (21 U.S.C. 301, et seq.). The
regulations are codified in 21 CFR part
60, Patent Term Restoration. New
human drug, animal drug, human
biological, medical device, food
additive, or color additive products
regulated by FDA must undergo FDA
safety, or safety and effectiveness review
before marketing is permitted. If the
product is covered by a patent, part of
the patent’s term may be consumed
during this review, which diminishes
the value of the patent.
In enacting section 505(j) of the FD&C
Act and the Generic Animal Drug and
Patent Term Restoration Act of 1988,
Congress sought to encourage
development of new, safer, and more
effective medical and food additive
products. It did so by authorizing the
U.S. Patent and Trademark Office
(USPTO) to extend the patent term by a
portion of the time during which FDA’s
safety and effectiveness review
prevented marketing of the product. The
length of the patent term extension is
generally limited to a maximum of 5
years and is calculated by USPTO based
on a statutory formula. When a patent
holder submits an application for patent
term extension to USPTO, USPTO
requests information from FDA,
including the length of the regulatory
review period for the patented product.
If USPTO concludes that the product is
eligible for patent term extension, FDA
publishes a notice that describes the
length of the regulatory review period
and the dates used to calculate that
period. Interested parties may request,
under § 60.24 (21 CFR 60.24), revision
of the length of the regulatory review
period, or may petition under § 60.30
(21 CFR 60.30) to reduce the regulatory
review period by any time where
marketing approval was not pursued
with ‘‘due diligence.’’
In 21 CFR 60.36(a) due diligence is
defined as ‘‘that degree of attention,
continuous directed effort, and
timeliness as may reasonably be
expected from, and are ordinarily
exercised by, a person during a
regulatory review period.’’ As provided
in § 60.30(c), a due diligence petition
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1393]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Patent Term
Restoration; Due Diligence Petitions;
Filing, Format, and Content of
Petitions
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
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by May 1,
2023.
DATES:
FDA tentatively concludes that this
guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0233. The title of this
information collection is ‘‘Patent Term
Restoration; Due Diligence Petitions;
Filing, Format, and Content of
Petitions.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
III. Electronic Access
FOR FURTHER INFORMATION CONTACT:
II. Paperwork Reduction Act of 1995
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4164–01–P
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
VerDate Sep<11>2014
17:22 Mar 29, 2023
Jkt 259001
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
E:\FR\FM\30MRN1.SGM
30MRN1
19153
Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
‘‘shall set forth sufficient facts,
including dates if possible, to merit an
investigation by FDA of whether the
applicant acted with due diligence.’’
Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates
whether any change in the regulatory
review period is necessary. If so, the
corrected regulatory review period is
published in the Federal Register. A
due diligence petitioner not satisfied
extension of approval is being sought is
the use of the statutorily created due
diligence petition.
In the Federal Register of August 10,
2022 (87 FR 48667), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
with FDA’s decision regarding the
petition may request, under § 60.40 (21
CFR 60.40), an informal hearing for
reconsideration of the due diligence
determination. Petitioners are likely to
include persons or organizations having
knowledge that FDA’s marketing
permission for that product was not
actively pursued throughout the
regulatory review period. The
information collection for which an
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours
Revision of regulatory review period determinations;
§ 60.24 ..............................................................................
Due diligence petitions; § 60.30 ...........................................
Due diligence hearings; § 60.40 ..........................................
4
1
1
1.25
1
1
5
1
1
100
50
10
500
50
10
Total ..............................................................................
........................
........................
........................
........................
560
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall decrease of 34 hours and 11
responses. Since publication of the 60day notice, we have adjusted our burden
estimate to reflect an annualized figure
(reducing responses associated with
§ 60.24 by one-third), which results in a
decrease to the currently approved
burden. There is also a small adjustment
decrease of one response associated
with submissions received for revision
of the regulatory review period
determination under § 60.24 since our
last review.
Dated: March 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06573 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0964]
GlaxoSmithKline Intellectual Property
Development Ltd. England;
Announcement of the Revocation of
the Biologics License for BLENREP
AGENCY:
Food and Drug Administration,
HHS.
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
21 CFR part 60—patent term restoration
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the revocation of the
biologics license for BLENREP
(belantamab mafodotin-blmf) powder
for injection. GlaxoSmithKline
SUMMARY:
VerDate Sep<11>2014
17:22 Mar 29, 2023
Jkt 259001
Intellectual Property Development Ltd.
England (GSK) requested withdrawal
(revocation) of the biologics license and
has waived its opportunity for a hearing.
DATES: The biologics license application
(BLA) is revoked as of February 6, 2023.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
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.
SUPPLEMENTARY INFORMATION: On August
5, 2020, FDA approved the BLA for
BLENREP (belantamab mafodotin-blmf)
powder for injection held by
GlaxoSmithKline Intellectual Property
Development Ltd. England (GSK), c/o
GlaxoSmithKline, 1250 South
Collegeville Rd., Collegeville, PA 19426,
indicated for the treatment of adult
patients with relapsed or refractory
multiple myeloma who have received at
least four prior therapies including an
anti-CD38 monoclonal antibody, a
proteasome inhibitor, and an
immunomodulatory agent, under the
Agency’s accelerated approval
regulations, 21 CFR part 601, subpart E.
On November 2, 2022, FDA and GSK
met to discuss the results of the
confirmatory study required as a
condition of BLENREP’s accelerated
approval, entitled ‘‘Study of Single
Agent Belantamab Mafodotin Versus
Pomalidomide Plus Low-dose
Dexamethasone (Pom/Dex) in
Participants with Relapsed/Refractory
Multiple Myeloma (DREAMM–3 trial)’’
and considerations regarding
PO 00000
Frm 00103
Fmt 4703
Sfmt 9990
withdrawal (revocation) of the biologics
license for BLENREP because the
confirmatory DREAMM–3 trial did not
meet its primary endpoint to
demonstrate superior progression-free
survival. On November 18, 2022, GSK
requested withdrawal (revocation), in
writing, of the biologics license for
BLENREP (belantamab mafodotin-blmf)
powder for injection (BLA 761158)
under § 601.5(a) (21 CFR 601.5(a)) and
waived its opportunity for a hearing. On
February 6, 2023, the Agency issued a
letter to GSK revoking the biologics
license for BLENREP (belantamab
mafodotin-blmf) powder for injection
(BLA 761158).
Therefore, under § 601.5(a), the
Agency revoked the biologics license for
BLENREP (belantamab mafodotin-blmf)
powder for injection (BLA 761158),
effective as of February 6, 2023, the date
of FDA’s letter revoking the biologics
license for BLENREP.
Dated: March 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06576 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\30MRN1.SGM
30MRN1
]]>Agencies
[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Notices]
[Pages 19152-19153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06573]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1393]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Patent Term
Restoration; Due Diligence Petitions; Filing, Format, and Content of
Petitions
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 Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by May 1, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0233. The title of this information
collection is ``Patent Term Restoration; Due Diligence Petitions;
Filing, Format, and Content of Petitions.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Patent Term Restoration; Due Diligence Petitions; Filing, Format, and
Content of Petitions--21 CFR Part 60
OMB Control Number 0910-0233--Extension
This information collection supports Agency regulations. FDA's
patent extension activities are conducted under the authority of
section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term
Restoration Act of 1988 (Pub. L. 100-670) (21 U.S.C. 301, et seq.). The
regulations are codified in 21 CFR part 60, Patent Term Restoration.
New human drug, animal drug, human biological, medical device, food
additive, or color additive products regulated by FDA must undergo FDA
safety, or safety and effectiveness review before marketing is
permitted. If the product is covered by a patent, part of the patent's
term may be consumed during this review, which diminishes the value of
the patent.
In enacting section 505(j) of the FD&C Act and the Generic Animal
Drug and Patent Term Restoration Act of 1988, Congress sought to
encourage development of new, safer, and more effective medical and
food additive products. It did so by authorizing the U.S. Patent and
Trademark Office (USPTO) to extend the patent term by a portion of the
time during which FDA's safety and effectiveness review prevented
marketing of the product. The length of the patent term extension is
generally limited to a maximum of 5 years and is calculated by USPTO
based on a statutory formula. When a patent holder submits an
application for patent term extension to USPTO, USPTO requests
information from FDA, including the length of the regulatory review
period for the patented product. If USPTO concludes that the product is
eligible for patent term extension, FDA publishes a notice that
describes the length of the regulatory review period and the dates used
to calculate that period. Interested parties may request, under Sec.
60.24 (21 CFR 60.24), revision of the length of the regulatory review
period, or may petition under Sec. 60.30 (21 CFR 60.30) to reduce the
regulatory review period by any time where marketing approval was not
pursued with ``due diligence.''
In 21 CFR 60.36(a) due diligence is defined as ``that degree of
attention, continuous directed effort, and timeliness as may reasonably
be expected from, and are ordinarily exercised by, a person during a
regulatory review period.'' As provided in Sec. 60.30(c), a due
diligence petition
[[Page 19153]]
``shall set forth sufficient facts, including dates if possible, to
merit an investigation by FDA of whether the applicant acted with due
diligence.'' Upon receipt of a due diligence petition, FDA reviews the
petition and evaluates whether any change in the regulatory review
period is necessary. If so, the corrected regulatory review period is
published in the Federal Register. A due diligence petitioner not
satisfied with FDA's decision regarding the petition may request, under
Sec. 60.40 (21 CFR 60.40), an informal hearing for reconsideration of
the due diligence determination. Petitioners are likely to include
persons or organizations having knowledge that FDA's marketing
permission for that product was not actively pursued throughout the
regulatory review period. The information collection for which an
extension of approval is being sought is the use of the statutorily
created due diligence petition.
In the Federal Register of August 10, 2022 (87 FR 48667), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 60--patent term Number of responses per Total annual Average burden Total hours
restoration respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Revision of regulatory review 4 1.25 5 100 500
period determinations; Sec.
60.24..........................
Due diligence petitions; Sec. 1 1 1 50 50
60.30..........................
Due diligence hearings; Sec. 1 1 1 10 10
60.40..........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 560
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall decrease of 34 hours and 11 responses. Since publication of the
60-day notice, we have adjusted our burden estimate to reflect an
annualized figure (reducing responses associated with Sec. 60.24 by
one-third), which results in a decrease to the currently approved
burden. There is also a small adjustment decrease of one response
associated with submissions received for revision of the regulatory
review period determination under Sec. 60.24 since our last review.
Dated: March 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06573 Filed 3-29-23; 8:45 am]
BILLING CODE 4164-01-P
