Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL, 52035-52036 [2012-21239]

Download as PDF srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices used to falsely represent Respondent’s own experiment for bone nodules formed in osteoblastic niche cells from young and aged mice. • Respondent falsely represented eight (8) flow cytometry contour plots as different experimental results by using identical plots but with different labels and different numerical percentages. Specifically, the following contour plots in the Blood paper, the Nature paper, an earlier version of the Nature paper submitted to Science (hereafter referred to as the ‘‘Science manuscript’’), and a July 2008 PowerPoint presentation were identical but were labeled differently: a. Panels 4 and 2 in Figure 6C, Blood paper, and panels 1 and 2, respectively, in supplementary Figure 3b, Nature paper b. Panel 3 in Figure 6C, Blood paper, and panel 1 in Figure 2, July 2008 PowerPoint presentation c. Panels 1 and 2, Figure 2b, Science manuscript, and panels 2 and 3, respectively, in Figure 2, July 2008 PowerPoint presentation d. Panels 2, 3, and 4, supplemental Figure 4A, Blood paper, and panels 3, 1, and 2, respectively, in Figure 4B, Science manuscript Both the Respondent and HHS want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement to resolve this matter. Respondent neither admits nor denies ORI’s finding of research misconduct. This settlement does not constitute an admission of liability on the part of the Respondent. Dr. Mayack has voluntarily agreed: (1) If within three (3) years from the effective date of the Agreement, Respondent does receive or apply for U.S. Public Health Service (PHS) support, Respondent agrees to have her research supervised for a period of three (3) years beginning on the date of her employment in a research position in which she receives or applies for PHS support and to notify her employer(s)/ institution(s) of the terms of this supervision; Respondent agrees that prior to the submission of an application for PHS support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent’s duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agrees that she shall not participate in any PHS-supported VerDate Mar<15>2010 16:39 Aug 27, 2012 Jkt 226001 research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) If within three (3) years from the effective date of the Agreement, Respondent does receive or apply for PHS support, Respondent agrees that any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) To exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years, beginning on July 27, 2012. FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8800. John Dahlberg, Director, Division of Investigative Oversight, Office of Research Integrity. [FR Doc. 2012–21236 Filed 8–27–12; 8:45 am] BILLING CODE 4150–31–P 52035 I. Background In the FR Doc. 2012–16514 of July 6, 2012 (77 FR 40064), we published a Paperwork Reduction Act notice requesting a 60-day public comment period for the document entitled ‘‘Notice of Denial of Medical Coverage (or Payment).’’ In the July 6, 2012 notice, we listed the incorrect contact information. Therefore, we are correcting that error in this notice. II. Correction of Error In FR Doc. 2012–16514 of July 6, 2012 (77 FR 40064), make the following correction: On page 40068, first column, fourth full paragraph, on the fifteenth line in the paragraph beginning with ‘‘(For policy questions regarding, ’’ and ending with, ‘‘410–786–0273),’’ is corrected to read as follows. ‘‘(For policy questions regarding this collection contact Kathryn McCann Smith at 410–786–7623.)’’ Dated: August 22, 2012. Martique Jones, Director, Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2012–21076 Filed 8–23–12; 11:15 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–E–0102] DEPARTMENT OF HEALTH AND HUMAN SERVICES Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL Centers for Medicare & Medicaid Services AGENCY: [Document Identifier: CMS–10003] ACTION: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction SUMMARY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Correction of notice. AGENCY: This document corrects a technical error in the notice [Document Identifier: CMS–10003] entitled ‘‘Notice of Denial of Medical Coverage (or Payment)’’ that was published in the July 6, 2012 (77 FR 40064) Federal Register. SUMMARY: FOR FURTHER INFORMATION CONTACT: William Parham, (410) 786–4669. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for TORISEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. E:\FR\FM\28AUN1.SGM 28AUN1 52036 Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices 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. The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA approved for marketing the human drug product TORISEL (temsirolimus). TORISEL is indicated for the treatment of advanced renal cell carcinoma. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for TORISEL (U.S. Patent No. 5,362,718) from Wyeth, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration and that FDA determine the product’s regulatory review period. In a letter dated August 7, 2012, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of TORISEL represented the first permitted srobinson on DSK4SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:39 Aug 27, 2012 Jkt 226001 commercial marketing or use of the product. FDA has determined that the applicable regulatory review period for TORISEL is 3,290 days. Of this time, 3,052 days occurred during the testing phase of the regulatory review period, while 238 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: May 29, 1998. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on May 29, 1998. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: October 5, 2006. FDA has verified the applicant’s claim that the new drug application (NDA) for TORISEL (NDA 22–088) was submitted on October 5, 2006. 3. The date the application was approved: May 30, 2007. FDA has verified the applicant’s claim that NDA 22–088 was approved on May 30, 2007. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,764 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by October 29, 2012. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by February 25, 2013. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https:// www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 12, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–21239 Filed 8–27–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0253] Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research Misconduct Proceedings AGENCY: Food and Drug Administration, HHS. Notice of a Privacy Act system of records. ACTION: In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration’s (FDA’s) regulations for the protection of privacy, FDA is publishing notice of a new Privacy Act system of records entitled ‘‘FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC’’ System No. 09–10–0020. Under the Department of Health and Human Services’ (HHS’ or the Department’s) Public Health Service Policies on Research Misconduct, FDA has responsibilities for addressing research integrity and misconduct issues related to FDA supported activities. This system contains records related to the processing and reviewing of allegations of scientific research misconduct levied against an individual (the respondent) who is an agent of, or affiliated by contract or agreement with, FDA, or an FDA employee involved in intramural research. Research misconduct proceedings include allegation assessments, inquiries, investigations, oversight reviews by HHS’ Office of Research Integrity (ORI), hearings, and administrative appeals. DATES: Effective Date: The new system of records will be effective on August 28, 2012, with the exception of the routine uses and the requested exemptions. The routine uses will become effective on October 12, 2012. As detailed in the companion SUMMARY: E:\FR\FM\28AUN1.SGM 28AUN1

Agencies

[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Pages 52035-52036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21239]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0102]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; TORISEL

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for TORISEL and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an application to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human drug product.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 52036]]


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 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 100-670) generally provide 
that a patent may be extended for a period of up to 5 years so long as 
the patented item (human drug product, animal drug product, medical 
device, food additive, or color additive) was subject to regulatory 
review by FDA before the item was marketed. Under these acts, a 
product's regulatory review period forms the basis for determining the 
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Director of Patents and 
Trademarks may award (for example, half the testing phase must be 
subtracted as well as any time that may have occurred before the patent 
was issued), FDA's determination of the length of a regulatory review 
period for a human drug product will include all of the testing phase 
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA approved for marketing the human drug product TORISEL 
(temsirolimus). TORISEL is indicated for the treatment of advanced 
renal cell carcinoma. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
TORISEL (U.S. Patent No. 5,362,718) from Wyeth, and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration and that FDA determine 
the product's regulatory review period. In a letter dated August 7, 
2012, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of TORISEL represented the first permitted commercial marketing or use 
of the product.
    FDA has determined that the applicable regulatory review period for 
TORISEL is 3,290 days. Of this time, 3,052 days occurred during the 
testing phase of the regulatory review period, while 238 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: May 29, 1998. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on May 29, 1998.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: October 5, 
2006. FDA has verified the applicant's claim that the new drug 
application (NDA) for TORISEL (NDA 22-088) was submitted on October 5, 
2006.
    3. The date the application was approved: May 30, 2007. FDA has 
verified the applicant's claim that NDA 22-088 was approved on May 30, 
2007.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 1,764 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) either electronic or written comments and ask for a 
redetermination by October 29, 2012. Furthermore, any interested person 
may petition FDA for a determination regarding whether the applicant 
for extension acted with due diligence during the regulatory review 
period by February 25, 2013. To meet its burden, the petition must 
contain sufficient facts to merit an FDA investigation. (See H. Rept. 
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should 
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. It is no longer 
necessary to send three copies of mailed comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on http:[sol][sol]www.regulations.gov may be viewed in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 12, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-21239 Filed 8-27-12; 8:45 am]
BILLING CODE 4160-01-P

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