Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA; Correction, 31697 [E8-12300]

Download as PDF 31697 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued Annual Frequency per Response No. of Respondents 21 CFR Section Total Annual Responses Hours Per Response Total Hours Recall Status Reports and Follow-up 7.53 2,166 4 8,664 10 86,640 Termination of a Recall 7.55(b) 2,166 1 2,166 10 21,660 Total 1 There 216,600 are no capital costs or operating and maintenance costs associated with this collection of information. The annual reporting burdens are explained as follows: accepted by FDA only through FDMS at https://www.regulations.gov. I. Reporting Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12339 Filed 6–2–08; 8:45 am] A. Recall Strategy Request firms develop a recall strategy including provision for public warnings and effectiveness checks. Under this portion of the collection of information, the agency estimates it will receive 2,166 responses annually. B. Firm Initiated Recall and Recall Communications Request firms voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, and biologicals to immediately notify the appropriate FDA district office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced, distribution information, firms’ recall strategy and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under these portions of the collection of information, the agency estimates it will receive 2,166 responses annually for each. C. Recall Status Reports Request that recalling firms provide periodic status reports so the FDA can ascertain the progress of the recall. This collection of information will generate approximately 8,664 responses annually. ebenthall on PRODPC60 with NOTICES D. Termination of a Recall Provide the firms an opportunity to request in writing that FDA end the recall. The agency estimates it will receive 2,166 responses annually. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12300 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2007–E–0458 (formerly Docket No. 2007E–0144) and Docket No. FDA–2007–E–0460 (formerly Docket No. 2007E–0176)] [Docket No. FDA–2007–E–0335] (formerly Docket No. 2007E–0133) and [Docket No. FDA–2007–E–0227] (formerly Docket No. 2007E–0148) Determination of Regulatory Review Period for Purposes of Patent Extension; VEREGEN Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 15, 2008 (73 FR 28119), announcing FDA’s determination of the regulatory review period for TYZEKA. The document published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Planning and Preparedness (HF–27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 7630. In FR Doc. E8–10857, published on May 15, 2008 (73 FR 28119), the following correction is made: On page 28119, in the third column, in the Docket No. heading, ‘‘Docket No. FDA–2007–E–0035’’ is corrected to read ‘‘Docket No. FDA–2007–E–0335’’. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for VEREGEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Page 31697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0335] (formerly Docket No. 2007E-0133) and 
[Docket No. FDA-2007-E-0227] (formerly Docket No. 2007E-0148)


Determination of Regulatory Review Period for Purposes of Patent 
Extension; TYZEKA; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of May 15, 2008 (73 FR 28119), 
announcing FDA's determination of the regulatory review period for 
TYZEKA. The document published with an incorrect docket number. This 
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, 
Planning and Preparedness (HF-27), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7630.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-10857, published on May 15, 
2008 (73 FR 28119), the following correction is made:
    On page 28119, in the third column, in the Docket No. heading, 
``Docket No. FDA-2007-E-0035'' is corrected to read ``Docket No. FDA-
2007-E-0335''.

    Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12300 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S
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