Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cooperative Manufacturing Arrangements for Licensed Biologics, 14810 [2012-6021]

Download as PDF 14810 Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FDA 3792 ............................................................................. 1 There Annual frequency per response Number of respondents Form 9 1 this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. [FR Doc. 2012–6034 Filed 3–12–12; 8:45 am] Dated: March 6, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. BILLING CODE 4160–01–P [FR Doc. 2012–6021 Filed 3–12–12; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0085] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cooperative Manufacturing Arrangements for Licensed Biologics Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Cooperative Manufacturing Arrangements for Licensed Biologics’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: AIla S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, ila.mizrachi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On August 10, 2011, the Agency submitted a proposed collection of information entitled ‘‘Cooperative Manufacturing Arrangements for Licensed Biologics’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0629. The approval expires on February 28, 2015. A copy of the supporting statement for SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Hours per response 9 Total hours 0.5 4.5 are no capital costs or operating maintenance costs associated with this collection of information. Dated: March 7, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. AGENCY: Total annual responses Food and Drug Administration [Docket No. FDA–2008–P–0527] Determination That DURANEST (Etidocaine Hydrochloride) Injection, 0.5%, and Five Other DURANEST Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that the DURANEST (etidocaine hydrochloride) drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these drug products if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Rachel Bressler, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6302, Silver Spring, MD 20993–0002, 301– 796–4288. 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 under an SUMMARY: 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 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). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. The drug products listed in the table in this document are no longer being marketed. DURANEST is indicated for infiltration anesthesia, peripheral nerve blocks (e.g., brachial plexus, intercostal retrobular, ulnar, inferior alveolar), and central nerve block (i.e., lumbar or caudal epidural blocks). Application No. Drug Applicant NDA 17–751 DURANEST (epinephrine bitartrate; etidocaine hydrochloride) Injection 1%. AstraZeneca Pharmaceutical .......... VerDate Mar<15>2010 18:29 Mar 12, 2012 Jkt 226001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\13MRN1.SGM 13MRN1 Initial approval date August 30, 1976.

Agencies

[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Page 14810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6021]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0085]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Cooperative Manufacturing 
Arrangements for Licensed Biologics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Cooperative Manufacturing 
Arrangements for Licensed Biologics'' has been approved by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 
1995.

FOR FURTHER INFORMATION CONTACT: AIla S. Mizrachi, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7726, ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On August 10, 2011, the Agency submitted a 
proposed collection of information entitled ``Cooperative Manufacturing 
Arrangements for Licensed Biologics'' to OMB for review and clearance 
under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has now 
approved the information collection and has assigned OMB control number 
0910-0629. The approval expires on February 28, 2015. A copy of the 
supporting statement for this information collection is available on 
the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6021 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P

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