Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 70653-70654 [E8-27714]

Download as PDF Federal Register / Vol. 73, No. 226 / Friday, November 21, 2008 / Notices Request for Comments In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research, quality improvement and information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: November 6, 2008. Carolyn M. Clancy, Director. [FR Doc. E8–27523 Filed 11–20–08; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–416] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to dwashington3 on PRODPC61 with NOTICES AGENCY: VerDate Aug<31>2005 14:24 Nov 20, 2008 Jkt 217001 be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Report; Use: States are required to submit an annual report on the provision of EPSDT services pursuant to section 1902(a)(43)(D) of the Social Security Act. These reports provide CMS with data necessary to assess the effectiveness of State EPSDT programs, to determine a State’s results in achieving its participation goal and to respond to inquiries. This collection is being submitted as a revision based on minor changes made to the form and instructions. CMS has added three additional lines of data to the form (lines 12d, 12e and 12f). This information is currently being collected; however, CMS expanded the lines to obtain a better understanding for the utilization of dental services. CMS believes there will be no additional burden for the changes made to the form. The changes were necessary to accommodate a need for more specific dental data and to preliminary notify States of a change in CPT codes. A clarification was also made to line 14 of the instructions. Form Number: CMS– 416 (OMB# 0938–0354); Frequency: Yearly; Affected Public: State, Local or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 1,568. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by January 20, 2009: 1. Electronically. You may submit your comments electronically to http:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 70653 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: November 14, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8–27711 Filed 11–20–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–P–0029] Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 milligrams/milliliter (mg/ml), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nalbuphine hydrochloride injection, 10 and 20 mg/ ml, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of E:\FR\FM\21NON1.SGM 21NON1 dwashington3 on PRODPC61 with NOTICES 70654 Federal Register / Vol. 73, No. 226 / Friday, November 21, 2008 / Notices the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Regulations also provide that the agency must make a determination as to whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved (§ 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that does not refer to a listed drug. On January 11, 2008, West-Ward Pharmaceutical Corp., on behalf of ˆ Hikma Farmaceutica of Portugal, submitted a citizen petition (Docket No. FDA–2008–P–0029) to FDA under 21 CFR 10.30. The petition requests that the agency determine whether NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/ml (NDA 18–024), manufactured by Endo Pharmaceuticals (Endo), was withdrawn from sale for reasons of safety or effectiveness. NUBAIN was approved on May 15, 1979. NUBAIN is an analgesic drug product used for the relief of moderate to severe pain. NUBAIN may be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Manufacture of NUBAIN was discontinued in 2003, and the drug product was moved from the prescription drug product list to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. FDA has reviewed its records and, under § 314.161, has determined that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/ VerDate Aug<31>2005 14:24 Nov 20, 2008 Jkt 217001 ml, was withdrawn for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/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. ANDAs that refer to NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, may be approved by the agency if all other legal and regulatory requirementsfor the approval of ANDAs are met. 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: November 14, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–27714 Filed 11–20–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0038] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on December 16, 2008, from 8 a.m. to 4 p.m. Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301–977–8900. Contact Person: Nicole Vesely, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–6793, fax: 301– 827–6776, e-mail: nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss biologics license application (BLA) 125084, trade name ERBITUX (cetuximab), ImClone Systems, Inc., and BLA 125147, trade name VECTIBIX (panitumumab), Amgen, Inc., in the context of K-ras as a predictive and/or prognostic biomarker in oncology drug development. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before December 2, 2008. Oral presentations from the public will be scheduled between approximately 11:30 a.m. to 12:30 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 24, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine E:\FR\FM\21NON1.SGM 21NON1

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[Federal Register Volume 73, Number 226 (Friday, November 21, 2008)]
[Notices]
[Pages 70653-70654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0029]


Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 
10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 
20 milligrams/milliliter (mg/ml), was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for nalbuphine 
hydrochloride injection, 10 and 20 mg/ml, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of

[[Page 70654]]

the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA). The only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162). Regulations also provide that the 
agency must make a determination as to whether a listed drug was 
withdrawn from sale for reasons of safety or effectiveness before an 
ANDA that refers to that listed drug may be approved (Sec.  
314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that 
does not refer to a listed drug.
    On January 11, 2008, West-Ward Pharmaceutical Corp., on behalf of 
Hikma Farmac[ecirc]utica of Portugal, submitted a citizen petition 
(Docket No. FDA-2008-P-0029) to FDA under 21 CFR 10.30. The petition 
requests that the agency determine whether NUBAIN (nalbuphine 
hydrochloride) injection, 10 and 20 mg/ml (NDA 18-024), manufactured by 
Endo Pharmaceuticals (Endo), was withdrawn from sale for reasons of 
safety or effectiveness. NUBAIN was approved on May 15, 1979. NUBAIN is 
an analgesic drug product used for the relief of moderate to severe 
pain. NUBAIN may be used as a supplement to balanced anesthesia, for 
preoperative and postoperative analgesia, and for obstetrical analgesia 
during labor and delivery. Manufacture of NUBAIN was discontinued in 
2003, and the drug product was moved from the prescription drug product 
list to the ``Discontinued Drug Product List'' section of the Orange 
Book.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 
mg/ml, was not withdrawn from sale for reasons of safety or 
effectiveness. The petitioner identified no data or other information 
suggesting that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 
mg/ml, was withdrawn for reasons of safety or effectiveness. FDA has 
independently evaluated relevant literature and data for possible 
postmarketing adverse events and has found no information that would 
indicate that this product was withdrawn from sale for reasons of 
safety or effectiveness. Accordingly, the agency will continue to list 
NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 mg/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. ANDAs that refer to NUBAIN (nalbuphine 
hydrochloride) injection, 10 and 20 mg/ml, may be approved by the 
agency if all other legal and regulatory requirementsfor the approval 
of ANDAs are met. 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: November 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27714 Filed 11-20-08; 8:45 am]
BILLING CODE 4160-01-S