Guerbet Group; Withdrawal of Approval of Two New Drug Applications, 18916-18917 [2017-08179]
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18916
Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
animal origin from firms or processors
not on lists of eligible exporters for
these products are not eligible for export
certificates for these products, and these
products may be detained at EU ports of
entry.
Description of Respondents: The
respondents to this collection of
information include U.S. producers of
shell eggs, game meat and game meat
products, gelatin, and collagen.
In the Federal Register of October 4,
2016 (81 FR 68424), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment which was not PRA-related,
and therefore is not addressed in this
supporting statement.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Products
Number of
responses per
respondent
Total annual
responses
Shell Eggs .....................................................
Game Meat and Game Meat Products ........
Gelatin ...........................................................
Collagen ........................................................
10
5
7
18
1
1
1
1
10
5
7
18
Total .......................................................
........................
........................
........................
1There
.25
.25
.25
.25
(15
(15
(15
(15
minutes)
minutes)
minutes)
minutes)
Total hours
...................
...................
...................
...................
3
1
2
5
...............................................
11
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates of the number
of respondents and total annual
responses on the submissions that we
have received in the past 3 years for
each product type. To calculate the
estimate for the hours per response
values, we assumed that the information
requested is readily available to the
submitter. We expect that the submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for submission. We believe
that this effort should take no longer
than 15 minutes (0.25 hour) per
response. We estimate that we will
receive 1 submission from 10 shell egg
producers annually, for a total of 10
annual responses. Each submission is
estimated to take 0.25 hour per response
for a total of 2.5 hours, rounded to 3
hours. This collection has previously
covered information collected to
maintain lists of eligible exporters of
dairy products; dairy products will be
covered under OMB control number
0910–0509, so the estimated burden has
been removed from this collection. We
estimate that we will receive one
submission from five game meat and
game meat product producers annually,
for a total of five annual responses. Each
submission is estimated to take 0.25
hour per response for a total of 1.25
hours, rounded to 1 hour. We estimate
that we will receive one submission
from seven gelatin producers annually,
jstallworth on DSK7TPTVN1PROD with NOTICES
Average burden
per response
for a total of seven annual responses.
Each submission is estimated to take
0.25 hour per response for a total of 1.75
hours, rounded to 2 hours. We estimate
that we will receive 1 submission from
18 collagen producers annually, for a
total of 18 annual responses. Each
submission is estimated to take 0.25
hour per response for a total of 4.5
hours, rounded to 5 hours. The
estimated burden for collagen producers
includes animal casings, which have
been listed separately in previous
notices. Therefore, the proposed annual
burden for this information collection is
11 hours.
Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08181 Filed 4–21–17; 8:45 am]
BILLING CODE 4164–01–P
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of two new drug applications
(NDAs) held by Guerbet Group. Guerbet
Group notified the Agency in writing
that the drug products were no longer
marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
Withdrawal of approval is
effective May 24, 2017.
DATES:
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
applications listed in table 1 in this
document are no longer marketed, and
Guerbet Group has requested that FDA
withdraw approval of the applications
pursuant to the process in § 314.150(c)
(21 CFR 314.150(c)). The company has
also, by its request, waived its
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1748]
Guerbet Group; Withdrawal of
Approval of Two New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1
Application No.
Drug
Applicant
NDA 018905 ..........
Hexabrix (ioxaglate meglumine and ioxaglate sodium) Injection
USP, 39.3%/19.6%.
Guerbet Group, 821 Alexander Rd., Suite 204, Princeton,
NJ 08540.
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Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
18917
TABLE 1—Continued
Application No.
Drug
NDA 020316 ..........
Oxilan-300 and Oxilan-350 (ioxilan) Injection, 62% and 73% ....
Therefore, under authority delegated
to the Director, Center for Drug
Evaluation and Research, by the
Commissioner, approval of the
applications listed in table 1 in this
document, and all amendments and
supplements thereto, is hereby
withdrawn, effective May 24, 2017.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in table 1
that are in inventory on the date that
this notice becomes effective (see the
DATES section) may continue to be
dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08179 Filed 4–21–17; 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: Delta States
Rural Development Network Grant
Program, OMB No. 0915–0386—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
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Applicant
Do.
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 must be
received no later than June 23, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 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 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, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Delta States Rural Development
Network Grant Program, OMB No.
0915–0386—Revision
Abstract: The Delta States Rural
Development Network Grant (Delta)
Program is authorized by the Public
Health Service Act, Section 330A(f) (42
U.S.C. 254c(f)), as Public Law 114–53.
The Delta Program supports projects
that demonstrate evidence-based and/or
promising approaches around
cardiovascular disease, diabetes, acute
ischemic stroke, or obesity to improve
health status in rural communities
throughout the Delta Region. Key
features of projects are adoption of an
evidence-based approach,
demonstration of health outcomes,
program replicability, and
sustainability.
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Need and Proposed Use of the
Information: For this program,
performance measures include: (a)
Access to care, (b) population
demographics, (c) staffing, (d)
sustainability, (e) project specific
domains, and (f) health related clinical
measures. These performance measures
enable HRSA’s Federal Office of Rural
Health Policy to aggregate program data
required by Congress under the
Government Performance and Results
Act of 1993 (Pub. L. 103–62). The
proposed revisions to the performance
measures include reducing the number
of reported measures and showing
annual progress compared to baseline
data submitted in the grant applications.
Examples of the measures that will be
removed include the number of people
reached through indirect services and
the number of quality improvement
clinical guidelines/benchmarks
adopted.
Likely Respondents: The respondents
are the recipients of the Delta States
Rural Development Network Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
As a result of the reduction in
performance measures, annualized
burden is decreasing from 72 hours to
32 hours. The total annual burden hours
estimated for this ICR are summarized
in the table below.
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]]>Agencies
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18916-18917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08179]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1748]
Guerbet Group; Withdrawal of Approval of Two New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two new drug applications (NDAs) held by Guerbet Group. Guerbet
Group notified the Agency in writing that the drug products were no
longer marketed and requested that the approval of the applications be
withdrawn.
DATES: Withdrawal of approval is effective May 24, 2017.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The applications listed in table 1 in this
document are no longer marketed, and Guerbet Group has requested that
FDA withdraw approval of the applications pursuant to the process in
Sec. 314.150(c) (21 CFR 314.150(c)). The company has also, by its
request, waived its opportunity for a hearing. Withdrawal of approval
of an application or abbreviated application under Sec. 314.150(c) is
without prejudice to refiling.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 018905.............. Hexabrix (ioxaglate Guerbet Group, 821
meglumine and Alexander Rd., Suite
ioxaglate sodium) 204, Princeton, NJ
Injection USP, 39.3%/ 08540.
19.6%.
[[Page 18917]]
NDA 020316.............. Oxilan-300 and Oxilan- Do.
350 (ioxilan)
Injection, 62% and 73%.
------------------------------------------------------------------------
Therefore, under authority delegated to the Director, Center for
Drug Evaluation and Research, by the Commissioner, approval of the
applications listed in table 1 in this document, and all amendments and
supplements thereto, is hereby withdrawn, effective May 24, 2017.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in table 1 that are in
inventory on the date that this notice becomes effective (see the DATES
section) may continue to be dispensed until the inventories have been
depleted or the drug products have reached their expiration dates or
otherwise become violative, whichever occurs first.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08179 Filed 4-21-17; 8:45 am]
BILLING CODE 4164-01-P
