EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS, 21558 [2016-08336]
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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
Research Center. February 11, 2008. (https://
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Literature.’’ International Journal of
Environmental Research and Public Health
10(8): 3634–3652, 2013.
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4. Taylor, P., M.H. Lopez, J. Martınez and
G.Velasco. ‘‘Language Use Among Latinos.’’
Pew Research Center. April 4, 2012. (https://
www.pewhispanic.org/2012/04/04/ivlanguage-use-among-latinos/).
5. Henley, S.C., S.E. Stein and J.J. Quinlan.
‘‘Identification of Unique Food Handling
Practices That Could Represent Food Safety
Risks for Minority Consumers.’’ Journal of
Food Protection 75: 2050–2054, 2012.
6. Marin, G., F. Sabogal, B.V. Marin, et al.
‘‘Development of a Short Acculturation Scale
for Hispanics.’’ Hispanic Journal of
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Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08332 Filed 4–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1101]
EMD Serono; Withdrawal of Approval
of a New Drug Application for LUVERIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of a new drug
application (NDA) for LUVERIS
(lutropin alpha for injection) held by
EMD Serono, One Technology Place,
Rockland, MA 02370. EMD Serono has
voluntarily requested that approval of
this application be withdrawn, thereby
waiving its opportunity for a hearing.
DATES: Effective April 12, 2016.
FOR FURTHER INFORMATION CONTACT:
Emily Helms Williams, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3381.
SUPPLEMENTARY INFORMATION: FDA
approved LUVERIS (lutropin alpha for
injection) on October 8, 2004, under the
Agency’s accelerated approval
regulations, 21 CFR part 314, subpart H.
LUVERIS is indicated for concomitant
administration with GONAL–F
(follitropin alfa for injection) for
stimulation of follicular development in
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:18 Apr 11, 2016
Jkt 238001
infertile hypogonadotropic hypogonadal
women with profound luteinizing
hormone deficiency. In a letter dated
April 30, 2012, EMD Serono requested
that FDA withdraw approval of NDA
021322 for LUVERIS under § 314.150(c).
In that letter, EMD Serono noted that, as
had been previously discussed with the
Agency, it was not feasible to complete
a trial that the company had agreed to
at the time of approval under subpart H.
By letter dated December 8, 2014, FDA
notified EMD Serono that, when studies
that are required as a condition of
approval under the Agency’s accelerated
approval regulations are not completed,
the approval of an application is
withdrawn according to the procedures
set forth in §§ 314.530 and 314.150(d)
rather than under § 314.150(c). FDA
requested that EMD Serono submit a
new withdrawal request under
§ 314.150(d).
Following additional correspondence,
by letter dated July 23, 2015, EMD
Serono requested that FDA withdraw
approval of NDA 021322 for LUVERIS
under § 314.150(d) because a
postmarketing study that was required
as a condition of approval under subpart
H was not completed. Because that
study was required to verify and
describe the clinical benefit of the drug
product, the clinical benefit of LUVERIS
has not been confirmed, and it has not
been established to be safe and effective.
In its July 23, 2015, letter, EMD Serono
waived any opportunity for a hearing
otherwise provided under §§ 314.150
and 314.530. FDA responded by letter
dated September 2, 2015,
acknowledging EMD Serono’s request
that FDA withdraw approval of
LUVERIS under § 314.150(d). FDA also
acknowledged that EMD Serono waived
its opportunity for a hearing.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and
§ 314.150(d), and under authority
delegated by the Commissioner to the
Director, Center for Drug Evaluation and
Research, approval of NDA 021322, and
all amendments and supplements
thereto, is withdrawn (see DATES).
Distribution of this product in interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the FD&C Act (21 U.S.C.
355(a) and 331(d)).
Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08336 Filed 4–11–16; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0560]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Informed Consent for In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens
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 May 12,
2016.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0582. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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
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SUMMARY:
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable—OMB
Control Number 0910–0582—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and compliant
with ethical standards. Investigators
should have freedom to pursue the least
burdensome means of accomplishing
this goal. However, to ensure that the
balance is maintained between product
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Page 21558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08336]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1101]
EMD Serono; Withdrawal of Approval of a New Drug Application for
LUVERIS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of a new drug application (NDA) for LUVERIS
(lutropin alpha for injection) held by EMD Serono, One Technology
Place, Rockland, MA 02370. EMD Serono has voluntarily requested that
approval of this application be withdrawn, thereby waiving its
opportunity for a hearing.
DATES: Effective April 12, 2016.
FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3381.
SUPPLEMENTARY INFORMATION: FDA approved LUVERIS (lutropin alpha for
injection) on October 8, 2004, under the Agency's accelerated approval
regulations, 21 CFR part 314, subpart H. LUVERIS is indicated for
concomitant administration with GONAL-F (follitropin alfa for
injection) for stimulation of follicular development in infertile
hypogonadotropic hypogonadal women with profound luteinizing hormone
deficiency. In a letter dated April 30, 2012, EMD Serono requested that
FDA withdraw approval of NDA 021322 for LUVERIS under Sec. 314.150(c).
In that letter, EMD Serono noted that, as had been previously discussed
with the Agency, it was not feasible to complete a trial that the
company had agreed to at the time of approval under subpart H. By
letter dated December 8, 2014, FDA notified EMD Serono that, when
studies that are required as a condition of approval under the Agency's
accelerated approval regulations are not completed, the approval of an
application is withdrawn according to the procedures set forth in
Sec. Sec. 314.530 and 314.150(d) rather than under Sec. 314.150(c).
FDA requested that EMD Serono submit a new withdrawal request under
Sec. 314.150(d).
Following additional correspondence, by letter dated July 23, 2015,
EMD Serono requested that FDA withdraw approval of NDA 021322 for
LUVERIS under Sec. 314.150(d) because a postmarketing study that was
required as a condition of approval under subpart H was not completed.
Because that study was required to verify and describe the clinical
benefit of the drug product, the clinical benefit of LUVERIS has not
been confirmed, and it has not been established to be safe and
effective. In its July 23, 2015, letter, EMD Serono waived any
opportunity for a hearing otherwise provided under Sec. Sec. 314.150
and 314.530. FDA responded by letter dated September 2, 2015,
acknowledging EMD Serono's request that FDA withdraw approval of
LUVERIS under Sec. 314.150(d). FDA also acknowledged that EMD Serono
waived its opportunity for a hearing.
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec. 314.150(d), and
under authority delegated by the Commissioner to the Director, Center
for Drug Evaluation and Research, approval of NDA 021322, and all
amendments and supplements thereto, is withdrawn (see DATES).
Distribution of this product in interstate commerce without an approved
application is illegal and subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08336 Filed 4-11-16; 8:45 am]
BILLING CODE 4164-01-P
