EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS, 21558 [2016-08336]

Download as PDF 21558 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices Research Center. February 11, 2008. (http:// pewhispanic.org/files/reports/85.pdf). 3. Quinlan, J.J. ‘‘Foodborne Illness Incidence Rates and Food Safety Risks for Populations of Low Socioeconomic Status and Minority Race/Ethnicity: A Review of the Literature.’’ International Journal of Environmental Research and Public Health 10(8): 3634–3652, 2013. ´ 4. Taylor, P., M.H. Lopez, J. Martınez and G.Velasco. ‘‘Language Use Among Latinos.’’ Pew Research Center. April 4, 2012. (http:// 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 Behavioral Sciences 9(2): 183–205, 1987. 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 EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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 review and clearance. 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