Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications, 54355-54356 [2018-23528]

Download as PDF 54355 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices Description: This is a new proposed data collection from the Office of Child Care (OCC) for the Onsite Monitoring System. Section 658I of the Child Care and Development Block Grant Act and Subpart J of 45 CFR, part 98 of the Child Care and Development Fund requires the monitoring of programs funded under the CCDF for compliance with: (1) The Act; (2) CCDF Regulations; and (3) The State/Territory CCDF approved Plan. The proposed data collection will be used by the Office of Child Care (OCC) to monitor State CCDF Lead Agencies to determine and validate compliance with CCDF regulations and the approved State Plan. The data collection is designed to provide States with the flexibility to propose an approach that is feasible and sufficient to demonstrate compliance based on State circumstances and processes. State Lead Agencies will participate in onsite monitoring based on a 3-year cohort; submitting data once every three years. OCC will begin monitoring for compliance in FY 2019. The data collection for the first 3years will focus on 11 topical areas: (1) Disaster Preparedness, Response and Recovery; (2) Consumer Education: Dissemination of Information to Parents, Providers, and General Public (Monitoring Reports and Annual Aggregate Data); (3) Twelve-Month Eligibility; (4) Child: Staff Ratios and Group Sizes; (5) Health and Safety Requirements for Providers (11 Health and Safety Topics); (6) Pre-Service/ Orientation and Ongoing Training Requirements for Providers; (7) Inspections for CCDF Licensed Providers; (8) Inspections for LicenseExempt CCDF Providers; (9) Ratios for Licensing Inspectors; (10) Child Abuse and Neglect Reporting; and (11) Program Integrity. In developing the Onsite Monitoring System, OCC convened a workgroup of states to provide feedback and input on the design of the Onsite Monitoring System. As part of the workgroup discussions, states emphasized the need for individualized monitoring because of the complexity of each state’s CCDF structure and variance in implementation strategies. As a response, OCC developed the Compliance Demonstration Packet that offers states the opportunity to propose their approach to demonstrating compliance based on how their CCDF program is administered. OCC also consulted other federal programs and monitoring experts on the Onsite Monitoring System’s development and incorporated their feedback regarding the efficiency and efficacy of the proposed process. During the development of the Onsite Monitoring System, OCC conducted pilots in a number of States. Feedback received from pilot States and the pilot results were used to enhance the monitoring process and data collection method. Burden estimates below are based on an analysis of data collected through all of the pilot visits while accounting for variance in state documentation. Respondents: State grantees and the District of Columbia. ANNUAL BURDEN ESTIMATES Number of respondents Instrument amozie on DSK3GDR082PROD with NOTICES1 Compliance Demonstration Chart .................................................................... Document Submission Chart ........................................................................... Estimated Total Annual Burden Hours: 1,632 hours. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 17 17 the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2018–23536 Filed 10–26–18; 8:45 am] BILLING CODE 4184–43–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3647] Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden hours per response 1 1 ACTION: 16 80 Total burden hours 272 1,360 Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of November 28, 2018. 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 applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. SUMMARY: E:\FR\FM\29OCN1.SGM 29OCN1 54356 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices Withdrawal of approval of an application or abbreviated application Application No. Drug Applicant NDA 009165 .......... Delatestryl (testosterone enanthate) Injection, 200 milligrams (mg)/milliliter (mL). Xylocaine (lidocaine hydrochloride (HCl)) 4% Topical Solution/Sterile Injection. Xylocaine (1.5% lidocaine HCl with dextrose 7.5%) Spinal Injection, 2 mL ampules. Norinyl 1+80 (mestranol and norethindrone) 21-Day Tablets, 0.08 mg/1 mg. Norinyl 1+80 (mestranol and norethindrone) 28-Day Tablets, 0.08 mg/1 mg. Sodium Chloride 0.9% Injection USP in Plastic Container, 9 mg/mL. Dextrose 5% Injection USP in Plastic Container, 50 mg/mL Testosterone Gel, 2.5 mg/1.25 grams (g), 25 mg/2.5 g, 50 mg/5 g. Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg. Targiniq ER (naloxone HCl and oxycodone HCl) ExtendedRelease Tablets, 5 mg/10 mg, 10 mg/20 mg, and 20 mg/ 40 mg. Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA 19355. Fresenius Kabi, USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. Do. NDA 010417 .......... NDA 016297 .......... NDA 016724 .......... NDA 016725 .......... NDA 019217 .......... NDA 019222 .......... NDA 203098 .......... NDA 204031 .......... NDA 205777 .......... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 28, 2018. 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 the table that are in inventory on November 28, 2018 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: October 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23528 Filed 10–26–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0821] amozie on DSK3GDR082PROD with NOTICES1 under § 314.150(c) is without prejudice to refiling. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims AGENCY: Food and Drug Administration, HHS. ACTION: GD Searle LLC, a subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017. Do. ICU Medical, Inc., 600 N. Field Dr., Lake Forest, IL 60045. Do. Perrigo Co., U.S. Agent for Perrigo Israel Pharmaceuticals Ltd., 3490 Quebec Ave. North, Minneapolis, MN 55427. Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042. Purdue Pharma, LP, One Stamford Forum, Stamford, CT 06901–3431. 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 November 28, 2018. 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–NEW and title ‘‘Investigation of Consumer Perceptions of Expressed Modified Risk Claims.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, 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. Investigation of Consumer Perceptions of Expressed Modified Risk Claims OMB Control Number 0910—NEW Notice. The Food and Drug Administration (FDA, Agency, or we) is SUMMARY: VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 I. Background FDA’s Center for Tobacco Products proposes to conduct a study to develop PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 generalizable scientific knowledge to help inform its implementation of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be evaluating information submitted to the Agency about how consumers understand and perceive modified risk tobacco products (MRTPs). Section 911 of the FD&C Act authorizes FDA to grant orders to persons to allow the marketing of MRTPs. The term ‘‘modified risk tobacco product’’ means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. FDA can issue a risk modification order under section 911(g)(1) of the FD&C Act authorizing the marketing of an MRTP only if the Agency determines that the product, as it is used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products (section 911(g)(1) of the FD&C Act). Alternatively, with respect to tobacco products that may not be commercially marketed under section 911(g)(1) of the FD&C Act, FDA may issue an exposure modification order under section 911(g)(2) of the FD&C Act authorizing the marketing of an MRTP if the Agency determines that the standard in section 911(g)(2) of the FD&C Act is met, including, among other requirements, that: Any aspect of the label, labeling, or advertising that would cause the product to be an MRTP E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54355-54356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3647]


Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 10 new drug applications (NDAs) from multiple 
applicants. The applicants notified the Agency in writing that the drug 
products were no longer marketed and requested that the approval of the 
applications be withdrawn.

DATES: Approval is withdrawn as of November 28, 2018.

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 applicants listed in the table have 
informed FDA that these drug products are no longer marketed and have 
requested that FDA withdraw approval of the applications under the 
process in Sec.  314.150(c) (21 CFR 314.150(c)). The applicants have 
also, by their requests, waived their opportunity for a hearing.

[[Page 54356]]

Withdrawal of approval of an application or abbreviated application 
under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
     Application No.               Drug                  Applicant
------------------------------------------------------------------------
NDA 009165..............  Delatestryl             Endo Pharmaceuticals,
                           (testosterone           Inc., 1400 Atwater
                           enanthate) Injection,   Dr., Malvern, PA
                           200 milligrams (mg)/    19355.
                           milliliter (mL).
NDA 010417..............  Xylocaine (lidocaine    Fresenius Kabi, USA,
                           hydrochloride (HCl))    LLC, Three Corporate
                           4% Topical Solution/    Dr., Lake Zurich, IL
                           Sterile Injection.      60047.
NDA 016297..............  Xylocaine (1.5%         Do.
                           lidocaine HCl with
                           dextrose 7.5%) Spinal
                           Injection, 2 mL
                           ampules.
NDA 016724..............  Norinyl 1+80            GD Searle LLC, a
                           (mestranol and          subsidiary of Pfizer
                           norethindrone) 21-Day   Inc., 235 East 42nd
                           Tablets, 0.08 mg/1 mg.  St., New York, NY
                                                   10017.
NDA 016725..............  Norinyl 1+80            Do.
                           (mestranol and
                           norethindrone) 28-Day
                           Tablets, 0.08 mg/1 mg.
NDA 019217..............  Sodium Chloride 0.9%    ICU Medical, Inc., 600
                           Injection USP in        N. Field Dr., Lake
                           Plastic Container, 9    Forest, IL 60045.
                           mg/mL.
NDA 019222..............  Dextrose 5% Injection   Do.
                           USP in Plastic
                           Container, 50 mg/mL.
NDA 203098..............  Testosterone Gel, 2.5   Perrigo Co., U.S.
                           mg/1.25 grams (g), 25   Agent for Perrigo
                           mg/2.5 g, 50 mg/5 g.    Israel
                                                   Pharmaceuticals Ltd.,
                                                   3490 Quebec Ave.
                                                   North, Minneapolis,
                                                   MN 55427.
NDA 204031..............  Xartemis XR (oxycodone  Mallinckrodt Inc., 675
                           HCl and                 McDonnell Blvd.,
                           acetaminophen)          Hazelwood, MO 63042.
                           Extended-Release
                           Tablets, 7.5 mg/325
                           mg.
NDA 205777..............  Targiniq ER (naloxone   Purdue Pharma, LP, One
                           HCl and oxycodone       Stamford Forum,
                           HCl) Extended-Release   Stamford, CT 06901-
                           Tablets, 5 mg/10 mg,    3431.
                           10 mg/20 mg, and 20
                           mg/40 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
November 28, 2018. 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 the 
table that are in inventory on November 28, 2018 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: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23528 Filed 10-26-18; 8:45 am]
 BILLING CODE 4164-01-P