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, 3934-3935 [2020-01084]
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3934
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CARDENE (nicardipine
hydrochloride) injection, 25 mg/10 mL,
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01062 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
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.
DATES: Fax written comments on the
collection of information by February
24, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0233. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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 the Drug Price
Competition and Patent Term
Restoration Act of 1984 (21 U.S.C.
355(j)) and the Generic Animal Drug
and Patent Term Restoration Act of 1988
(35 U.S.C. 156). 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 the Drug Price
Competition and Patent Term
Restoration Act of 1984 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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.’’
The statute (21 CFR 60.36) defines
due diligence 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
‘‘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 petition not satisfied with
FDA’s decision regarding the petition
may, under § 60.40 (21 CFR 60.40),
request 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.
During the calendar years 2016
through 2018, 16 requests for revision of
the regulatory review period were
submitted under § 60.24(a). In addition,
a total of three due diligence petitions
were submitted under § 60.30. There
have been no requests for hearings
under § 60.40; however, for purposes of
this information collection approval, we
estimate that we may receive one
submission annually.
In the Federal Register of August 21,
2019 (84 FR 43606), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\23JAN1.SGM
23JAN1
3935
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
responses
(2016–2018)
Average
burden per
response
Total hours
(2016–2018)
Average
annual burden
hours
60.24; revision of regulatory review period determinations ...............................
60.30; due diligence petitions ..................
60.40; due diligence hearings ..................
12
1
1
1.333
1
1
16
3
1
100
50
10
1,600
150
10
533.33
50
3.3
Total ..................................................
........................
........................
........................
........................
........................
586.63
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 a small
increase (+7 responses) associated with
submissions received under § 60.24 in
previous years.
Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01084 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that VYONDYS 53
(golodirsen), manufactured by Sarepta
Therapeutics, Inc., meets the criteria for
a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR part 60—Patent term restoration
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that VYONDYS 53
(golodirsen), manufactured by Sarepta
Therapeutics, Inc., meets the criteria for
a priority review voucher. VYONDYS 53
(golodirsen) is indicated for the
treatment of Duchenne muscular
dystrophy (DMD) in patients who have
a confirmed mutation of the DMD gene
that is amenable to exon 53 skipping.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about VYONDYS (golodirsen), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01059 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Sickle Cell
Disease Treatment Demonstration
Regional Collaborative Program, OMB
No. 0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
PO 00000
Notice.
Frm 00045
Fmt 4703
Sfmt 4703
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 23, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Sickle Cell Disease Treatment
Demonstration Regional Collaborative
Program.
OMB No.: 0906–xxxx–New.
Abstract: The Sickle Cell Disease
Treatment Demonstration Regional
Collaborative Program (SCDTDRCP) was
reauthorized and amended in 2018 by
the Sickle Cell Disease and Other
Heritable Blood Disorders Research,
Surveillance, Prevention, and Treatment
Act (Pub. L. 115–327), 42 U.S.C. 300b–
5. The purpose of the proposed data
collection is to monitor the progress of
the SCDTDRCP in improving health
outcomes in individuals living with
sickle cell disease.
The goals of the program are to
improve health outcomes in individuals
with sickle cell disease; reduce
morbidity and mortality caused by
SUMMARY:
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3934-3935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01084]
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by
February 24, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0233.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 the
Drug Price Competition and Patent Term Restoration Act of 1984 (21
U.S.C. 355(j)) and the Generic Animal Drug and Patent Term Restoration
Act of 1988 (35 U.S.C. 156). 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 the Drug Price Competition and Patent Term Restoration
Act of 1984 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.''
The statute (21 CFR 60.36) defines due diligence 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 ``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 petition not satisfied with FDA's decision regarding the
petition may, under Sec. 60.40 (21 CFR 60.40), request 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.
During the calendar years 2016 through 2018, 16 requests for
revision of the regulatory review period were submitted under Sec.
60.24(a). In addition, a total of three due diligence petitions were
submitted under Sec. 60.30. There have been no requests for hearings
under Sec. 60.40; however, for purposes of this information collection
approval, we estimate that we may receive one submission annually.
In the Federal Register of August 21, 2019 (84 FR 43606), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 3935]]
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total Average Average
21 CFR part 60--Patent term restoration Number of responses per responses burden per Total hours annual burden
respondents respondent (2016-2018) response (2016-2018) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
60.24; revision of regulatory review period 12 1.333 16 100 1,600 533.33
determinations.........................................
60.30; due diligence petitions.......................... 1 1 3 50 150 50
60.40; due diligence hearings........................... 1 1 1 10 10 3.3
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 586.63
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 a
small increase (+7 responses) associated with submissions received
under Sec. 60.24 in previous years.
Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01084 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P
