80 FR 77638 - Determination of Regulatory Review Period for Purposes of Patent Extension; Trivascular Ovation Abdominal Stent Graft System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 240 (December 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77638-77640 | |
| FR Document | 2015-31397 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Notices] [Pages 77638-77640] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31397] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-E-1694] Determination of Regulatory Review Period for Purposes of Patent Extension; Trivascular Ovation Abdominal Stent Graft System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic [[Page 77639]] or written comments and ask for a redetermination by February 16, 2016. 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 June 13, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-E-1694 for Determination of Regulatory Review Period for Purposes of Patent Extension; TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device, TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM. TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM is indicated for the treatment of patients with abdominal aortic aneurysms having vascular morphology suitable for endovascular repair. Subsequent to this approval, the USPTO received a patent term restoration application for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM (U.S. Patent No. 6,395,019) from TriVascular, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 20, 2014, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM [[Page 77640]] is 3,607 days. Of this time, 3,429 days occurred during the testing phase of the regulatory review period, while 178 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: November 22, 2002. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective on October 24, 2002. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on November 22, 2002, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): April 11, 2012. FDA has verified the applicant's claim that the premarket approval application (PMA) for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM (PMA P120006) was initially submitted April 11, 2012. 3. The date the application was approved: October 5, 2012. FDA has verified the applicant's claim that PMA P120006 was approved on October 5, 2012. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,802 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). 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. To meet its burden, the petition must be timely (see DATES) and 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. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31397 Filed 12-14-15; 8:45 am] BILLING CODE 4164-01-P
![77638 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
Docket: For access to the docket to With respect to the following components, the rule specifies the
read background documents or the collection of information, FDA invites minimum contents of the machine-
electronic and written/paper comments comments on: (1) Whether the proposed readable information in a format
received, go to http:// collection of information is necessary approved by the Center for Biologics
www.regulations.gov and insert the for the proper performance of FDA’s Evaluation and Research Director as
docket number, found in brackets in the functions, including whether the blood centers have generally agreed
heading of this document, into the information will have practical utility; upon the information to be encoded on
‘‘Search’’ box and follow the prompts (2) the accuracy of FDA’ s estimate of the label. The rule is intended to help
and/or go to the Division of Dockets the burden of the proposed collection of reduce the number of medication errors
Management, 5630 Fishers Lane, Rm. information, including the validity of in hospitals and other health care
1061, Rockville, MD 20852. the methodology and assumptions used; settings by allowing health care
FOR FURTHER INFORMATION CONTACT: FDA (3) ways to enhance the quality, utility, professionals to use bar code scanning
PRA Staff, Office of Operations, Food and clarity of the information to be equipment to verify that the right drug
and Drug Administration, 8455 collected; and (4) ways to minimize the (in the right dose and right route of
Colesville Rd., COLE–14526, Silver burden of the collection of information administration) is being given to the
Spring, MD 20993–0002, PRAStaff@ on respondents, including through the right patient at the right time.
fda.hhs.gov. use of automated collection techniques,
when appropriate, and other forms of Most of the information collection
SUPPLEMENTARY INFORMATION: Under the information technology. burden resulting from the final rule, as
PRA (44 U.S.C. 3501–3520) Federal calculated in table 1 of the final rule (69
Agencies must obtain approval from the Bar Code Label Requirement for FR at 9149), was a one-time burden that
Office of Management and Budget Human Drug and Biological Products does not occur after the rule’s
(OMB) for each collection of OMB Control Number 0910–0537— compliance date of April 26, 2006. In
information they conduct or sponsor. Extension addition, some of the information
‘‘Collection of information’’ is defined In the Federal Register of February collection burden estimated in the final
in 44 U.S.C. 3502(3) and 5 CFR 26, 2004 (69 FR 9120), we issued a final rule is now covered in other OMB
1320.3(c) and includes Agency requests rule that required human drug product approved information collection
or requirements that members of the and biological product labels to have bar packages for FDA. However, parties may
public submit reports, keep records, or codes. The rule required bar codes on continue to seek an exemption from the
provide information to a third party. most human prescription drug products bar code requirement under certain,
Section 3506(c)(2)(A) of the PRA (44 and on over-the-counter (OTC) drug limited circumstances. Section
U.S.C. 3506(c)(2)(A)) requires Federal products that are dispensed pursuant to 201.25(d) (21 CFR 201.25(d)) requires
Agencies to provide a 60-day notice in an order and commonly used in health submission of a written request for an
the Federal Register concerning each care facilities. The rule also required exemption and describes the contents of
proposed collection of information, machine-readable information on blood such requests. Based on the number of
including each proposed extension of an and blood components. For human exemption requests we have received,
existing collection of information, prescription drug products and OTC we estimate that approximately 2
before submitting the collection to OMB drug products that are dispensed exemption requests may be submitted
for approval. To comply with this pursuant to an order and commonly annually, and that each exemption
requirement, FDA is publishing notice used in health care facilities, the bar request will require 24 hours to
of the proposed collection of code must contain the NDC number for complete. This would result in an
information set forth in this document. the product. For blood and blood annual reporting burden of 48 hours.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent response
201.25(d) .............................................................................. 2 1 2 24 48
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 7, 2015. DEPARTMENT OF HEALTH AND the regulatory review period for
Leslie Kux, HUMAN SERVICES TRIVASCULAR OVATION
Associate Commissioner for Policy. ABDOMINAL STENT GRAFT SYSTEM
Food and Drug Administration and is publishing this notice of that
[FR Doc. 2015–31402 Filed 12–14–15; 8:45 am]
[Docket No. FDA–2013–E–1694] determination as required by law. FDA
BILLING CODE 4164–01–P
has made the determination because of
Determination of Regulatory Review the submission of an application to the
Period for Purposes of Patent Director of the U.S. Patent and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Extension; Trivascular Ovation Trademark Office (USPTO), Department
Abdominal Stent Graft System of Commerce, for the extension of a
patent which claims that medical
AGENCY: Food and Drug Administration, device.
HHS.
ACTION: Notice. DATES: Anyone with knowledge that any
of the dates as published (see the
SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION section) are
Administration (FDA) has determined incorrect may submit either electronic
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![77640 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
is 3,607 days. Of this time, 3,429 days 5630 Fishers Lane, Rm. 1061, Rockville, solely responsible for ensuring that your
occurred during the testing phase of the MD 20852. Petitions that have not been comment does not include any
regulatory review period, while 178 made publicly available on http:// confidential information that you or a
days occurred during the approval www.regulations.gov may be viewed in third party may not wish to be posted,
phase. These periods of time were the Division of Dockets Management such as medical information, your or
derived from the following dates: between 9 a.m. and 4 p.m., Monday anyone else’s Social Security number, or
1. The date an exemption under through Friday. confidential business information, such
section 520(g) of the Federal Food, Drug, Dated: December 8, 2015. as a manufacturing process. Please note
and Cosmetic Act (the FD&C Act) (21 that if you include your name, contact
Leslie Kux,
U.S.C. 360j(g)) involving this device information, or other information that
became effective: November 22, 2002. Associate Commissioner for Policy. identifies you in the body of your
The applicant claims that the [FR Doc. 2015–31397 Filed 12–14–15; 8:45 am] comments, that information will be
investigational device exemption (IDE) BILLING CODE 4164–01–P posted on http://www.regulations.gov.
required under section 520(g) of the • If you want to submit a comment
FD&C Act for human tests to begin with confidential information that you
became effective on October 24, 2002. DEPARTMENT OF HEALTH AND do not wish to be made available to the
However, FDA records indicate that the HUMAN SERVICES public, submit the comment as a
IDE was determined substantially written/paper submission and in the
complete for clinical studies to have Food and Drug Administration manner detailed (see ‘‘Written/Paper
begun on November 22, 2002, which [Docket No. FDA–2014–E–0182] Submissions’’ and ‘‘Instructions’’).
represents the IDE effective date.
2. The date an application was Determination of Regulatory Review Written/Paper Submissions
initially submitted with respect to the Period for Purposes of Patent Submit written/paper submissions as
device under section 515 of the FD&C Extension; VIZAMYL follows:
Act (21 U.S.C. 360e): April 11, 2012. • Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, written/paper submissions): Division of
FDA has verified the applicant’s claim
HHS. Dockets Management (HFA–305), Food
that the premarket approval application
(PMA) for TRIVASCULAR OVATION ACTION: Notice. and Drug Administration, 5630 Fishers
ABDOMINAL STENT GRAFT SYSTEM Lane, rm. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments
(PMA P120006) was initially submitted Administration (FDA) has determined
April 11, 2012. submitted to the Division of Dockets
the regulatory review period for Management, FDA will post your
3. The date the application was
VIZAMYL and is publishing this notice comment, as well as any attachments,
approved: October 5, 2012. FDA has
of that determination as required by except for information submitted,
verified the applicant’s claim that PMA
law. FDA has made the determination marked and identified, as confidential,
P120006 was approved on October 5,
because of the submission of an if submitted as detailed in
2012.
application to the Director of the U.S. ‘‘Instructions.’’
This determination of the regulatory
Patent and Trademark Office (USPTO), Instructions: All submissions received
review period establishes the maximum
Department of Commerce, for the must include the Docket No. FDA–
potential length of a patent extension.
extension of a patent which claims that 2014–E–0182 for Determination of
However, the USPTO applies several
human drug product. Regulatory Review Period for Purposes
statutory limitations in its calculations
of the actual period for patent extension. DATES: Anyone with knowledge that any of Patent Extension; VIZAMYL.
In its application for patent extension, of the dates as published (in the Received comments will be placed in
this applicant seeks 1,802 days of patent SUPPLEMENTARY INFORMATION section) are the docket and, except for those
term extension. incorrect may submit either electronic submitted as ‘‘Confidential
or written comments and ask for a Submissions,’’ publicly viewable at
III. Petitions redetermination by February 16, 2016. http://www.regulations.gov or at the
Anyone with knowledge that any of Furthermore, any interested person may Division of Dockets Management
the dates as published are incorrect may petition FDA for a determination between 9 a.m. and 4 p.m., Monday
submit either electronic or written regarding whether the applicant for through Friday.
comments and ask for a redetermination extension acted with due diligence • Confidential Submissions—To
(see DATES). Furthermore, any during the regulatory review period by submit a comment with confidential
interested person may petition FDA for June 13, 2016. See ‘‘Petitions’’ in the information that you do not wish to be
a determination regarding whether the SUPPLEMENTARY INFORMATION section for made publicly available, submit your
applicant for extension acted with due more information. comments only as a written/paper
diligence during the regulatory review ADDRESSES: You may submit comments submission. You should submit two
period. To meet its burden, the petition as follows: copies total. One copy will include the
must be timely (see DATES) and contain information you claim to be confidential
sufficient facts to merit an FDA Electronic Submissions with a heading or cover note that states
investigation. (See H. Rept. 857, part 1, Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
98th Cong., 2d sess., pp. 41–42, 1984.) following way: CONFIDENTIAL INFORMATION’’. The
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Petitions should be in the format • Federal eRulemaking Portal: http:// Agency will review this copy, including
specified in 21 CFR 10.30. www.regulations.gov. Follow the the claimed confidential information, in
Submit petitions electronically to instructions for submitting comments. its consideration of comments. The
http://www.regulations.gov at Docket Comments submitted electronically, second copy, which will have the
No. FDA–2013–S–0610. Submit written including attachments, to http:// claimed confidential information
petitions (two copies are required) to the www.regulations.gov will be posted to redacted/blacked out, will be available
Division of Dockets Management (HFA– the docket unchanged. Because your for public viewing and posted on http://
305), Food and Drug Administration, comment will be made public, you are www.regulations.gov. Submit both
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Document Created: 2018-03-02 09:15:18
Document Modified: 2018-03-02 09:15:18
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 16, 2016. 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 June 13, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 80 FR 77638 |
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