83 FR 4211 - Determination of Regulatory Review Period for Purposes of Patent Extension; Cardiomems HF Monitoring System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 20 (January 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 20 (January 30, 2018)
| Page Range | 4211-4213 | |
| FR Document | 2018-01644 |
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)] [Notices] [Pages 4211-4213] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01644] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2082] Determination of Regulatory Review Period for Purposes of Patent Extension; Cardiomems HF Monitoring 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 CARDIOMEMS HF MONITORING 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 or written comments and ask for a redetermination by April 2, 2018. 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 July 30, 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 April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 2, 2018. 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 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, FDA will post your comment, as well as any attachments, except for [[Page 4212]] information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-E-2082 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; CARDIOMEMS HF MONITORING 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. 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 20993-0002, 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 CARDIOMEMS HF MONITORING SYSTEM. CARDIOMEMS HF MONITORING SYSTEM is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in New York Heart Association Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations. Subsequent to this approval, the USPTO received a patent term restoration application for CARDIOMEMS HF MONITORING SYSTEM (U.S. Patent No. 7,839,153) from CardioMEMS, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of CARDIOMEMS HF MONITORING 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 CARDIOMEMS HF MONITORING SYSTEM is 2,786 days. Of this time, 1,525 days occurred during the testing phase of the regulatory review period, while 1,261 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 (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: October 13, 2006. FDA has verified the applicant's claim that the date the investigational device exemption required under section 520(g) of the FD&C Act for human tests to begin became effective October 13, 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): December 15, 2010. The applicant claims December 14, 2010, as the date the premarket approval application (PMA) for CARDIOMEMS HF MONITORING SYSTEM (PMA P100045) was initially submitted. However, FDA records indicate that PMA P100045 was submitted on December 15, 2010. 3. The date the application was approved: May 28, 2014. FDA has verified the applicant's claim that PMA P100045 was approved on May 28, 2014. 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 1,026 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 [[Page 4213]] 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: January 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01644 Filed 1-29-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices 4211
regulatoryinformation/guidances/ website (https://healthpolicy.duke.edu/ redetermination by April 2, 2018.
ucm126396.pdf). events/evaluating-inclusion-and- Furthermore, any interested person may
exclusion-criteria-clinical-trials) petition FDA for a determination
II. Topics for Discussion at the Public
following the meeting. Organizations are regarding whether the applicant for
Meeting
requested to register all participants, but extension acted with due diligence
Topics for discussion during this to view using one connection per during the regulatory review period by
meeting include: location whenever possible. Webcast July 30, 2018. See ‘‘Petitions’’ in the
• The risks and benefits of participants will be sent technical SUPPLEMENTARY INFORMATION section for
participation in clinical trials as well as system requirements in advance of the more information.
potential regulatory, geographical, and event. Prior to joining the streaming ADDRESSES: You may submit comments
socioeconomic barriers to participation. webcast of the public workshop, we as follows. Please note that late,
• the rationale for eligibility criteria recommend that you review these untimely filed comments will not be
in clinical trials, as well as the impact technical system requirements in considered. Electronic comments must
of exclusion criteria on the enrollment advance. be submitted on or before April 2, 2018.
of populations, such as infants, Transcripts: Please be advised that The https://www.regulations.gov
children, pregnant and lactating women, transcripts will not be available. electronic filing system will accept
elderly, individuals with advanced FDA has verified the website comments until midnight Eastern Time
disease, and individuals with co-morbid addresses in this document, as of the at the end of April 2, 2018. Comments
conditions. date this document publishes in the received by mail/hand delivery/courier
• alternative clinical trial designs that Federal Register, but websites are (for written/paper submissions) will be
may increase enrollment of more subject to change over time. considered timely if they are
diverse patient populations, while Meeting Materials: All event materials postmarked or the delivery service
facilitating the collection of data to will be provided to registered attendees acceptance receipt is on or before that
establish safety and effectiveness. via email prior to the workshop and date.
• how appropriate patient publicly available at the Duke-Margolis
populations can benefit from the results Electronic Submissions
website: https://healthpolicy.duke.edu/
of trials that employ alternative designs. events/evaluating-inclusion-and- Submit electronic comments in the
• how changes to eligibility criteria exclusion-criteria-clinical-trials. following way:
may impact the complexity and length • Federal eRulemaking Portal:
of clinical trials, as well as the strength Dated: January 24, 2018. https://www.regulations.gov. Follow the
of data necessary to demonstrate safety Leslie Kux, instructions for submitting comments.
and effectiveness. Associate Commissioner for Policy. Comments submitted electronically,
• opportunities for using data from [FR Doc. 2018–01643 Filed 1–29–18; 8:45 am] including attachments, to https://
expanded access trials. BILLING CODE 4164–01–P www.regulations.gov will be posted to
III. Participating in the Public Meeting the docket unchanged. Because your
comment will be made public, you are
Registration: To register for the public DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
meeting, please visit the following HUMAN SERVICES comment does not include any
website: https://healthpolicy.duke.edu/ confidential information that you or a
events/evaluating-inclusion-and- Food and Drug Administration third party may not wish to be posted,
exclusion-criteria-clinical-trials. Please [Docket No. FDA–2015–E–2082] such as medical information, your or
provide complete contact information anyone else’s Social Security number, or
for each attendee, including name, title, Determination of Regulatory Review confidential business information, such
affiliation, address, email, and Period for Purposes of Patent as a manufacturing process. Please note
telephone. Registration is free and based Extension; Cardiomems HF Monitoring that if you include your name, contact
on space availability, with priority given System information, or other information that
to early registrants. Persons interested in identifies you in the body of your
attending this public meeting must AGENCY: Food and Drug Administration,
comments, that information will be
register by April 12, 2018, midnight HHS.
posted on https://www.regulations.gov.
Eastern Time. There will be no onsite ACTION: Notice. • If you want to submit a comment
registration. Early registration is with confidential information that you
recommended because seating is SUMMARY: The Food and Drug
do not wish to be made available to the
limited; therefore, FDA may limit the Administration (FDA or the Agency) has
public, submit the comment as a
number of participants from each determined the regulatory review period
written/paper submission and in the
organization. Registrants will receive for CARDIOMEMS HF MONITORING
manner detailed (see ‘‘Written/Paper
confirmation when they have been SYSTEM and is publishing this notice
Submissions’’ and ‘‘Instructions’’).
accepted. Duke-Margolis will post on its of that determination as required by
website if registration closes before the law. FDA has made the determination Written/Paper Submissions
day of the public meeting. because of the submission of an Submit written/paper submissions as
If you need special accommodations application to the Director of the U.S. follows:
due to a disability, please contact Sarah Patent and Trademark Office (USPTO), • Mail/Hand delivery/Courier (for
Supsiri at the Duke-Margolis Center for Department of Commerce, for the written/paper submissions): Dockets
daltland on DSKBBV9HB2PROD with NOTICES
Health Policy, 202–791–9561, extension of a patent which claims that Management Staff (HFA–305), Food and
sarah.supsiri@duke.edu, no later than medical device. Drug Administration, 5630 Fishers
April 12, 2018. DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
Streaming Webcast of the Public of the dates as published (see the • For written/paper comments
Meeting: This public meeting will also SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
be webcast; archived video footage will incorrect may submit either electronic Staff, FDA will post your comment, as
be available at the Duke-Margolis or written comments and ask for a well as any attachments, except for
VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1](https://thefederalregister.org/doc/83_FR_4231/page/1.svg)
![Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices 4213
during the regulatory review period. To SUPPLEMENTARY INFORMATION section for of Patent Extension; ZEPATIER.’’
meet its burden, the petition must more information. Received comments, those filed in a
comply with all the requirements of ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be
§ 60.30, including but not limited to: as follows. Please note that late, placed in the docket and, except for
Must be timely (see DATES), must be untimely filed comments will not be those submitted as ‘‘Confidential
filed in accordance with § 10.20, must considered. Electronic comments must Submissions,’’ publicly viewable at
contain sufficient facts to merit an FDA be submitted on or before April 2, 2018. https://www.regulations.gov or at the
investigation, and must certify that a The https://www.regulations.gov Dockets Management Staff between 9
true and complete copy of the petition electronic filing system will accept a.m. and 4 p.m., Monday through
has been served upon the patent comments until midnight Eastern Time Friday.
applicant. (See H. Rept. 857, part 1, 98th at the end of April 2, 2018. Comments
Cong., 2d sess., pp. 41–42, 1984.) received by mail/hand delivery/courier • Confidential Submissions—To
Petitions should be in the format (for written/paper submissions) will be submit a comment with confidential
specified in 21 CFR 10.30. considered timely if they are information that you do not wish to be
Submit petitions electronically to postmarked or the delivery service made publicly available, submit your
https://www.regulations.gov at Docket acceptance receipt is on or before that comments only as a written/paper
No. FDA–2013–S–0610. Submit written date. submission. You should submit two
petitions (two copies are required) to the copies total. One copy will include the
Electronic Submissions information you claim to be confidential
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630 Submit electronic comments in the with a heading or cover note that states
Fishers Lane, Rm. 1061, Rockville, MD following way: ‘‘THIS DOCUMENT CONTAINS
20852. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
Dated: January 24, 2018.
instructions for submitting comments. the claimed confidential information, in
Leslie Kux, Comments submitted electronically, its consideration of comments. The
Associate Commissioner for Policy. including attachments, to https:// second copy, which will have the
[FR Doc. 2018–01644 Filed 1–29–18; 8:45 am] www.regulations.gov will be posted to claimed confidential information
BILLING CODE 4164–01–P the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
DEPARTMENT OF HEALTH AND comment does not include any
HUMAN SERVICES both copies to the Dockets Management
confidential information that you or a
Staff. If you do not wish your name and
third party may not wish to be posted,
Food and Drug Administration contact information to be made publicly
such as medical information, your or
available, you can provide this
[Docket No. FDA–2016–E–2521] anyone else’s Social Security number, or
confidential business information, such information on the cover sheet and not
Determination of Regulatory Review as a manufacturing process. Please note in the body of your comments and you
Period for Purposes of Patent that if you include your name, contact must identify this information as
Extension; ZEPATIER information, or other information that ‘‘confidential.’’ Any information marked
identifies you in the body of your as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, except in accordance with § 10.20 (21
HHS. comments, that information will be
posted on https://www.regulations.gov. CFR 10.20) and other applicable
ACTION: Notice. • If you want to submit a comment disclosure law. For more information
SUMMARY: The Food and Drug with confidential information that you about FDA’s posting of comments to
Administration (FDA or the Agency) has do not wish to be made available to the public dockets, see 80 FR 56469,
determined the regulatory review period public, submit the comment as a September 18, 2015, or access the
for ZEPATIER and is publishing this written/paper submission and in the information at: https://www.gpo.gov/
notice of that determination as required manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
by law. FDA has made the Submissions’’ and ‘‘Instructions’’). 23389.pdf.
determination because of the Written/Paper Submissions Docket: For access to the docket to
submission of an application to the read background documents or the
Director of the U.S. Patent and Submit written/paper submissions as electronic and written/paper comments
Trademark Office (USPTO), Department follows:
received, go to https://
• Mail/Hand delivery/Courier (for
of Commerce, for the extension of a www.regulations.gov and insert the
written/paper submissions): Dockets
patent which claims that human drug docket number, found in brackets in the
Management Staff (HFA–305), Food and
product. heading of this document, into the
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
of the dates as published (in the • For written/paper comments and/or go to the Dockets Management
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
incorrect may submit either electronic Staff, FDA will post your comment, as Rockville, MD 20852.
or written comments and ask for a well as any attachments, except for FOR FURTHER INFORMATION CONTACT:
daltland on DSKBBV9HB2PROD with NOTICES
redetermination by April 2, 2018. information submitted, marked and Beverly Friedman, Office of Regulatory
Furthermore, any interested person may identified, as confidential, if submitted Policy, Food and Drug Administration,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 10903 New Hampshire Ave., Bldg. 51,
regarding whether the applicant for Instructions: All submissions received
Rm. 6250, Silver Spring, MD 20993,
extension acted with due diligence must include the Docket No. FDA–
301–796–3600.
during the regulatory review period by 2016–E–2521 for ‘‘Determination of
July 30, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes SUPPLEMENTARY INFORMATION:
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Document Created: 2018-10-26 10:09:37
Document Modified: 2018-10-26 10:09:37
| 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 April 2, 2018. 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 July 30, 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 20993-0002, 301-796-3600. | |
| FR Citation | 83 FR 4211 |
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