82 FR 46498 - Determination of Regulatory Review Period for Purposes of Patent Extension; IMPELLA 2.5 SYSTEM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 192 (October 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 192 (October 5, 2017)
| Page Range | 46498-46500 | |
| FR Document | 2017-21436 |
[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)] [Notices] [Pages 46498-46500] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21436] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-1298] Determination of Regulatory Review Period for Purposes of Patent Extension; IMPELLA 2.5 SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMPELLA 2.5 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 4, 2017. 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 April 3, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 4, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are [[Page 46499]] 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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff Office, 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-2016-E-1298 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; IMPELLA 2.5 SYSTEM.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff Office. 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 Sec. 10.20 (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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 IMPELLA 2.5 SYSTEM. IMPELLA 2.5 SYSTEM is indicated for temporary (<=6 hours) ventricular support during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Subsequent to this approval, the USPTO received a patent term restoration application for IMPELLA 2.5 SYSTEM (U.S. Patent No. 5,911,685) from Abiomed Europe GmbH, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of IMPELLA 2.5 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 IMPELLA 2.5 SYSTEM is 3,227 days. Of this time, 2,858 days occurred during the testing phase of the regulatory review period, while 369 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: May 24, 2006. FDA has verified the applicant's claim that the date the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective was May 24, 2006. 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): March 20, 2014. FDA has verified the applicant's claim that the premarket approval application (PMA) for IMPELLA 2.5 SYSTEM (PMA [[Page 46500]] P140003) was initially submitted on March 20, 2014. 3. The date the application was approved: March 23, 2015. FDA has verified the applicant's claim that PMA P140003 was approved on March 23, 2015. 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 1,796 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, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements of Sec. 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: September 29, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21436 Filed 10-4-17; 8:45 am] BILLING CODE 4164-01-P
![46498 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices
www.fda.gov/AdvisoryCommittees/ submit a brief statement of the general DEPARTMENT OF HEALTH AND
default.htm and scroll down to the nature of the evidence or arguments HUMAN SERVICES
appropriate advisory committee meeting they wish to present, the names and
link, or call the advisory committee addresses of proposed participants, and Food and Drug Administration
information line to learn about possible an indication of the approximate time [Docket No. FDA–2016–E–1298]
modifications before coming to the requested to make their presentation on
meeting. or before October 23, 2017. Time Determination of Regulatory Review
SUPPLEMENTARY INFORMATION: allotted for each presentation may be Period for Purposes of Patent
Agenda: On November 6, 2017, the limited. If the number of registrants Extension; IMPELLA 2.5 SYSTEM
SAB Chair will welcome the requesting to speak is greater than can AGENCY: Food and Drug Administration,
participants, and the NCTR Director will be reasonably accommodated during the HHS.
provide a Center-wide update on scheduled open public hearing session,
scientific initiatives and ACTION: Notice.
FDA may conduct a lottery to determine
accomplishments during the past year. the speakers for the scheduled open SUMMARY: The Food and Drug
The SAB will be presented with an public hearing session. The contact Administration (FDA or the Agency) has
overview of the Division of Systems person will notify interested persons determined the regulatory review period
Biology Subcommittee and the regarding their request to speak by for IMPELLA 2.5 SYSTEM and is
Subcommittee Site Visit Report and a October 30, 2017. publishing this notice of that
response to this review. There will be determination as required by law. FDA
updates from the NCTR Research Closed Committee Deliberations: On
November 6, 2017, from 5 p.m. to 5:30 has made the determination because of
Divisions and a public comment the submission of an application to the
session. p.m., and November 7, 2017, from 11:20
a.m. to 12 noon, the meeting will be Director of the U.S. Patent and
On November 7, 2017, the Center for Trademark Office (USPTO), Department
Biologics and Evaluation and Research, closed to permit discussion where
of Commerce, for the extension of a
Center for Drug Evaluation and disclosure would constitute a clearly
patent which claims that medical
Research, Center for Devices and unwarranted invasion of personal
device.
Radiological Health, Center for Tobacco privacy (5 U.S.C. 552b(c)(6)). This
Products, Center for Veterinary portion of the meeting will be closed to DATES: Anyone with knowledge that any
Medicine, and the Office of Regulatory permit discussion of information of the dates as published (in the
Affairs will each briefly discuss their concerning individuals associated with SUPPLEMENTARY INFORMATION section) are
center-specific research strategic needs the research programs at NCTR. incorrect may submit either electronic
and potential areas of collaboration. or written comments and ask for a
Persons attending FDA’s advisory redetermination by December 4, 2017.
Following an open discussion of all
committee meetings are advised that the Furthermore, any interested person may
the information presented, the open
session of the meeting will close so the Agency is not responsible for providing petition FDA for a determination
SAB members can discuss personnel access to electrical outlets. regarding whether the applicant for
issues at NCTR at the end of each day. FDA welcomes the attendance of the extension acted with due diligence
FDA intends to make background public at its advisory committee during the regulatory review period by
material available to the public no later meetings and will make every effort to April 3, 2018. See ‘‘Petitions’’ in the
than 2 business days before the meeting. accommodate persons with disabilities. SUPPLEMENTARY INFORMATION section for
If FDA is unable to post the background If you require accommodations due to a more information.
material on its Web site prior to the disability, please contact Donna ADDRESSES: You may submit comments
meeting, the background material will Mendrick at least 7 days in advance of as follows. Please note that late,
be made publicly available at the the meeting. untimely filed comments will not be
location of the advisory committee considered. Electronic comments must
meeting, and the background material FDA is committed to the orderly
be submitted on or before December 4,
will be posted on FDA’s Web site after conduct of its advisory committee 2017. The https://www.regulations.gov
the meeting. Background material is meetings. Please visit our Web site at electronic filing system will accept
available at https://www.fda.gov/ https://www.fda.gov/Advisory comments until midnight Eastern Time
AdvisoryCommittees/Calendar/ Committees/AboutAdvisoryCommittees/ at the end of December 4, 2017.
default.htm. Scroll down to the ucm111462.htm for procedures on Comments received by mail/hand
appropriate advisory committee meeting public conduct during advisory delivery/courier (for written/paper
link. committee meetings. submissions) will be considered timely
Procedure: On November 6, 2017, Notice of this meeting is given under if they are postmarked or the delivery
from 8 a.m. to 5 p.m., and November 7, the Federal Advisory Committee Act (5 service acceptance receipt is on or
2017, from 8 a.m. to 11:20 a.m., the U.S.C. app. 2). before that date.
meeting is open to the public. Interested
persons may present data, information, Dated: September 29, 2017. Electronic Submissions
or views, orally or in writing, on issues Anna K. Abram, Submit electronic comments in the
pending before the committee. Written Deputy Commissioner for Policy, Planning, following way:
submissions may be made to the contact Legislation, and Analysis. • Federal eRulemaking Portal:
ethrower on DSK3G9T082PROD with NOTICES
person on or before October 30, 2017. [FR Doc. 2017–21440 Filed 10–4–17; 8:45 am] https://www.regulations.gov. Follow the
Oral presentations from the public will BILLING CODE 4164–01–P instructions for submitting comments.
be scheduled on November 6, 2017, Comments submitted electronically,
between approximately 1:15 p.m. to including attachments, to https://
2:15 p.m. Those individuals interested www.regulations.gov will be posted to
in making formal oral presentations the docket unchanged. Because your
should notify the contact person and comment will be made public, you are
VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/82_FR_46690/page/1.svg)
![46500 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices
P140003) was initially submitted on DEPARTMENT OF HEALTH AND comments, that information will be
March 20, 2014. HUMAN SERVICES posted on https://www.regulations.gov.
• If you want to submit a comment
3. The date the application was
Food and Drug Administration with confidential information that you
approved: March 23, 2015. FDA has
do not wish to be made available to the
verified the applicant’s claim that PMA [Docket No. FDA–2016–D–4482] public, submit the comment as a
P140003 was approved on March 23, written/paper submission and in the
2015. Clarification of the Food and Drug
manner detailed (see ‘‘Written/Paper
Administration and Environmental
This determination of the regulatory Submissions’’ and ‘‘Instructions’’).
Protection Agency Jurisdiction Over
review period establishes the maximum Written/Paper Submissions
Mosquito-Related Products; Guidance
potential length of a patent extension. for Industry; Availability
However, the USPTO applies several Submit written/paper submissions as
statutory limitations in its calculations AGENCY: Food and Drug Administration, follows:
HHS. • Mail/Hand delivery/Courier (for
of the actual period for patent extension.
written/paper submissions): Dockets
In its application for patent extension, ACTION: Notice of availability. Management Staff (HFA–305), Food and
this applicant seeks 1,796 days of patent Drug Administration, 5630 Fishers
term extension. SUMMARY: The Food and Drug
Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
III. Petitions • For written/paper comments
announcing the availability of a
submitted to the Dockets Management
guidance for industry #236 entitled
Anyone with knowledge that any of Staff, FDA will post your comment, as
‘‘Clarification of FDA and EPA
the dates as published are incorrect may well as any attachments, except for
Jurisdiction Over Mosquito-Related
submit either electronic or written information submitted, marked and
Products.’’ This guidance provides
comments and, under 21 CFR 60.24, ask identified, as confidential, if submitted
information regarding regulatory
for a redetermination (see DATES). as detailed in ‘‘Instructions.’’
oversight of mosquito-related products, Instructions: All submissions received
Furthermore, as specified in § 60.30 (21 defined as those articles for use in or on
CFR 60.30), any interested person may must include the Docket No. FDA–
mosquitoes. We are clarifying 2016–D–4482 for ‘‘Regulation of
petition FDA for a determination circumstances under which such Mosquito-Related Products.’’ Received
regarding whether the applicant for products are regulated by the Food and comments will be placed in the docket
extension acted with due diligence Drug Administration (FDA) as new and, except for those submitted as
during the regulatory review period. To animal drugs under the Federal Food, ‘‘Confidential Submissions,’’ publicly
meet its burden, the petition must Drug, and Cosmetic Act (the FD&C Act) viewable at https://www.regulations.gov
comply with all the requirements of and other circumstances under which or at the Dockets Management Staff
§ 60.30, including but not limited to: such products are regulated by the between 9 a.m. and 4 p.m., Monday
must be timely (see DATES), must be Environmental Protection Agency (EPA) through Friday.
filed in accordance with § 10.20, must as pesticides under the Federal • Confidential Submissions—To
contain sufficient facts to merit an FDA Insecticide, Fungicide, and Rodenticide submit a comment with confidential
investigation, and must certify that a Act (FIFRA). information that you do not wish to be
true and complete copy of the petition DATES: The announcement of the made publicly available, submit your
has been served upon the patent guidance is published in the Federal comments only as a written/paper
applicant. (See H. Rept. 857, part 1, 98th Register on October 5, 2017. submission. You should submit two
Cong., 2d sess., pp. 41–42, 1984.) ADDRESSES: You may submit either copies total. One copy will include the
Petitions should be in the format electronic or written comments on information you claim to be confidential
specified in 21 CFR 10.30. Agency guidances at any time as with a heading or cover note that states
follows: ‘‘THIS DOCUMENT CONTAINS
Submit petitions electronically to
CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov at Docket Electronic Submissions Agency will review this copy, including
No. FDA–2013–S–0610. Submit written Submit electronic comments in the the claimed confidential information, in
petitions (two copies are required) to the following way: its consideration of comments. The
Dockets Management Staff (HFA–305), • Federal eRulemaking Portal: second copy, which will have the
Food and Drug Administration, 5630 https://www.regulations.gov. Follow the claimed confidential information
Fishers Lane, Rm. 1061, Rockville, MD instructions for submitting comments. redacted/blacked out, will be available
20852. Comments submitted electronically, for public viewing and posted on
Dated: September 29, 2017. including attachments, to https:// https://www.regulations.gov. Submit
Anna K. Abram, www.regulations.gov will be posted to both copies to the Dockets Management
the docket unchanged. Because your Staff. If you do not wish your name and
Deputy Commissioner for Policy, Planning,
comment will be made public, you are contact information to be made publicly
Legislation, and Analysis.
solely responsible for ensuring that your available, you can provide this
[FR Doc. 2017–21436 Filed 10–4–17; 8:45 am]
comment does not include any information on the cover sheet and not
BILLING CODE 4164–01–P confidential information that you or a in the body of your comments and you
third party may not wish to be posted, must identify this information as
ethrower on DSK3G9T082PROD with NOTICES
such as medical information, your or ‘‘confidential.’’ Any information marked
anyone else’s Social Security number, or as ‘‘confidential’’ will not be disclosed
confidential business information, such except in accordance with 21 CFR 10.20
as a manufacturing process. Please note and other applicable disclosure law. For
that if you include your name, contact more information about FDA’s posting
information, or other information that of comments to public dockets, see 80
identifies you in the body of your FR 56469, September 18, 2015, or access
VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/82_FR_46690/page/3.svg)
Document Created: 2017-10-05 00:53:46
Document Modified: 2017-10-05 00:53:46
| 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 4, 2017. 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 April 3, 2018. 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 | 82 FR 46498 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR