83 FR 2997 - Determination of Regulatory Review Period for Purposes of Patent Extension; PERCEVAL SUTURELESS HEART VALVE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 14 (January 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 14 (January 22, 2018)
| Page Range | 2997-2999 | |
| FR Document | 2018-00995 |
[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)] [Notices] [Pages 2997-2999] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00995] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2520] Determination of Regulatory Review Period for Purposes of Patent Extension; PERCEVAL SUTURELESS HEART VALVE 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 PERCEVAL SUTURELESS HEART VALVE 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 March 23, 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 23, 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 March 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 23, 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 [[Page 2998]] 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 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-2520 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; PERCEVAL SUTURELESS HEART VALVE.'' 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, 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 PERCEVAL SUTURELESS HEART VALVE. PERCEVAL SUTURELESS HEART VALVE is indicated for replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Subsequent to this approval, the USPTO received a patent term restoration application for PERCEVAL SUTURELESS HEART VALVE (U.S. Patent No. 8,540,768) from Sorin Group Italia S.r.l., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 10, 2016, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of PERCEVAL SUTURELESS HEART VALVE 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 PERCEVAL SUTURELESS HEART VALVE is 1,003 days. Of this time, 694 days occurred during the testing phase of the regulatory review period, while 309 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: April 12, 2013. 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 February 29, 2012. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on April 12, 2013, 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): March 6, 2015. The applicant claims February 27, 2015, as the date the premarket approval application (PMA) for PERCEVAL SUTURELESS HEART VALVE (PMA P150011) was initially submitted. However, FDA records indicate that PMA P150011 was submitted on March 6, 2015. 3. The date the application was approved: January 8, 2016. FDA has verified the applicant's claim that PMA P150011 was approved on January 8, 2016. [[Page 2999]] 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 576 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: January 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00995 Filed 1-19-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 2997
children in poverty and their families in (2) Adolescent interviews will collect them, and how they feel about these
order to improve how human services information about adolescents’ circumstances, including public
programs can help families achieve self- understanding of their family’s benefits, if applicable.
sufficiency. economic circumstances, how they (4) A phone screener will be used
The information collection activities communicate with their parents about with prospective families to assess their
them, and how they feel about these
to be submitted in the package include: eligibility for the study and, for those
circumstances, including public
(1) Adult interviews will collect who are eligible, provide them with
benefits, if applicable.
information about household income (3) Child interviews will collect additional materials about the study,
and finances, conversations parents information about children’s including any risks, to assess their
have with their children about finances, understanding of their family’s interest in participating.
and their experiences, if applicable, economic circumstances, how they Respondents: Children and their
receiving public benefits. communicate with their parents about parents who are living in poverty.
ANNUAL BURDEN ESTIMATES
Total Annual Number of Average Annual
Instrument number of number of responses per burden hours burden hours
respondents respondents respondent per response
Adult Interview Guide ........................................................... 45 15 1 1.5 23
Adolescent Interview Guide ................................................. 20 7 1 .875 6
Child Interview Guide ........................................................... 30 10 1 .50 5
Phone Screener for Prospective Families ........................... 120 40 1 .50 20
Estimated Total Annual Burden comments and suggestions submitted petition FDA for a determination
Hours: 54. within 60 days of this publication. regarding whether the applicant for
In compliance with the requirements extension acted with due diligence
Mary Jones,
of Section 3506(c)(2)(A) of the during the regulatory review period by
ACF/OPRE Certifying Officer. July 23, 2018 See ‘‘Petitions’’ in the
Paperwork Reduction Act of 1995, the [FR Doc. 2018–00993 Filed 1–19–18; 8:45 am] SUPPLEMENTARY INFORMATION section for
Administration for Children and BILLING CODE 4184–09–P more information.
Families is soliciting public comment
on the specific aspects of the ADDRESSES: You may submit comments
information collection described above. DEPARTMENT OF HEALTH AND as follows. Please note that late,
Copies of the proposed collection of HUMAN SERVICES untimely filed comments will not be
information can be obtained and considered. Electronic comments must
Food and Drug Administration be submitted on or before March 23,
comments may be forwarded by writing
2018. The https://www.regulations.gov
to the Administration for Children and [Docket No. FDA–2016–E–2520] electronic filing system will accept
Families, Office of Planning, Research,
Determination of Regulatory Review comments until midnight Eastern Time
and Evaluation, 330 C Street SW, at the end of March 23, 2018. Comments
Washington, DC 20201, Attn: OPRE Period for Purposes of Patent
Extension; PERCEVAL SUTURELESS received by mail/hand delivery/courier
Reports Clearance Officer. Email (for written/paper submissions) will be
address: OPREinfocollection@ HEART VALVE
considered timely if they are
acf.hhs.gov. All requests should be AGENCY: Food and Drug Administration, postmarked or the delivery service
identified by the title of the information HHS. acceptance receipt is on or before that
collection. ACTION: Notice. date.
The Department specifically requests Electronic Submissions
comments on (a) whether the proposed SUMMARY: The Food and Drug
collection of information is necessary Administration (FDA or the Agency) has Submit electronic comments in the
for the proper performance of the determined the regulatory review period following way:
functions of the agency, including
for PERCEVAL SUTURELESS HEART • Federal eRulemaking Portal:
VALVE and is publishing this notice of https://www.regulations.gov. Follow the
whether the information shall have
that determination as required by law. instructions for submitting comments.
practical utility; (b) the accuracy of the
FDA has made the determination Comments submitted electronically,
agency’s estimate of the burden of the because of the submission of an including attachments, to https://
proposed collection of information; (c) application to the Director of the U.S. www.regulations.gov will be posted to
the quality, utility, and clarity of the Patent and Trademark Office (USPTO), the docket unchanged. Because your
information to be collected; and (d) Department of Commerce, for the comment will be made public, you are
ways to minimize the burden of the extension of a patent which claims that solely responsible for ensuring that your
collection of information on medical device. comment does not include any
ethrower on DSK3G9T082PROD with NOTICES
respondents, including through the use DATES: Anyone with knowledge that any confidential information that you or a
of automated collection techniques or of the dates as published (see the third party may not wish to be posted,
other forms of information technology. SUPPLEMENTARY INFORMATION section) are such as medical information, your or
Consideration will be given to incorrect may submit either electronic anyone else’s Social Security number, or
or written comments and ask for a confidential business information, such
redetermination by March 23, 2018. as a manufacturing process. Please note
Furthermore, any interested person may that if you include your name, contact
VerDate Sep<11>2014 19:00 Jan 19, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1](https://thefederalregister.org/doc/83_FR_3011/page/1.svg)
![Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 2999
This determination of the regulatory for ZURAMPIC and is publishing this written/paper submission and in the
review period establishes the maximum notice of that determination as required manner detailed (see ‘‘Written/Paper
potential length of a patent extension. by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
However, the USPTO applies several determination because of the
Written/Paper Submissions
statutory limitations in its calculations submission of applications to the
of the actual period for patent extension. Director of the U.S. Patent and Submit written/paper submissions as
In its application for patent extension, Trademark Office (USPTO), Department follows:
this applicant seeks 576 days of patent of Commerce, for the extension of a • Mail/Hand delivery/Courier (for
term extension. patent which claims that human drug written/paper submissions): Dockets
product. Management Staff (HFA–305), Food and
III. Petitions Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
Anyone with knowledge that any of
the dates as published are incorrect may
of the dates as published (see the • For written/paper comments
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
submit either electronic or written
incorrect may submit either electronic Staff, FDA will post your comment, as
comments and, under 21 CFR 60.24, ask
or written comments and ask for a well as any attachments, except for
for a redetermination (see DATES).
redetermination by March 23, 2018. information submitted, marked and
Furthermore, as specified in § 60.30 (21
Furthermore, any interested person may identified, as confidential, if submitted
CFR 60.30), any interested person may
petition FDA for a determination as detailed in ‘‘Instructions.’’
petition FDA for a determination
regarding whether the applicant for Instructions: All submissions received
regarding whether the applicant for
extension acted with due diligence must include the Docket Nos. FDA–
extension acted with due diligence
during the regulatory review period by 2016–E–2503, FDA–2016–E–2504,
during the regulatory review period. To
July 23, 2018. See ‘‘Petitions’’ in the FDA–2016–E–2505, FDA–2016–E–2506,
meet its burden, the petition must
SUPPLEMENTARY INFORMATION section for and FDA–2016–E–2507 for
comply with all the requirements of
more information. ‘‘Determination of Regulatory Review
§ 60.30, including but not limited to:
Must be timely (see DATES), must be ADDRESSES: You may submit comments Period for Purposes of Patent Extension;
filed in accordance with § 10.20, must as follows. Please note that late, ZURAMPIC.’’ Received comments,
untimely filed comments will not be those filed in a timely manner (see
contain sufficient facts to merit an FDA
considered. Electronic comments must ADDRESSES), will be placed in the docket
investigation, and must certify that a
be submitted on or before March 23, and, except for those submitted as
true and complete copy of the petition
2018. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly
has been served upon the patent
electronic filing system will accept viewable at https://www.regulations.gov
applicant. (See H. Rept. 857, part 1, 98th
comments until midnight Eastern Time or at the Dockets Management Staff
Cong., 2d sess., pp. 41–42, 1984.)
at the end of March 23, 2018. Comments between 9 a.m. and 4 p.m., Monday
Petitions should be in the format
received by mail/hand delivery/courier through Friday.
specified in 21 CFR 10.30. • Confidential Submissions—To
Submit petitions electronically to (for written/paper submissions) will be
considered timely if they are submit a comment with confidential
https://www.regulations.gov at Docket
postmarked or the delivery service information that you do not wish to be
No. FDA–2013–S–0610. Submit written
acceptance receipt is on or before that made publicly available, submit your
petitions (two copies are required) to the
date. comments only as a written/paper
Dockets Management Staff (HFA–305),
submission. You should submit two
Food and Drug Administration, 5630 Electronic Submissions copies total. One copy will include the
Fishers Lane, Rm. 1061, Rockville, MD
Submit electronic comments in the information you claim to be confidential
20852.
following way: with a heading or cover note that states
Dated: January 16, 2018. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Leslie Kux, https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Associate Commissioner for Policy. instructions for submitting comments. Agency will review this copy, including
[FR Doc. 2018–00995 Filed 1–19–18; 8:45 am] Comments submitted electronically, the claimed confidential information, in
BILLING CODE 4164–01–P including attachments, to https:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
DEPARTMENT OF HEALTH AND comment will be made public, you are redacted/blacked out, will be available
HUMAN SERVICES solely responsible for ensuring that your for public viewing and posted on
comment does not include any https://www.regulations.gov. Submit
Food and Drug Administration confidential information that you or a both copies to the Dockets Management
[Docket Nos. FDA–2016–E–2503, FDA– third party may not wish to be posted, Staff. If you do not wish your name and
2016–E–2504, FDA–2016–E–2505, FDA– such as medical information, your or contact information to be made publicly
2016–E–2506, and FDA–2016–E–2507] anyone else’s Social Security number, or available, you can provide this
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; ZURAMPIC information, or other information that ‘‘confidential.’’ Any information marked
ethrower on DSK3G9T082PROD with NOTICES
AGENCY: Food and Drug Administration, identifies you in the body of your as ‘‘confidential’’ will not be disclosed
HHS. comments, that information will be except in accordance with § 10.20 (21
ACTION: Notice. posted on https://www.regulations.gov. CFR 10.20) and other applicable
• 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
VerDate Sep<11>2014 19:00 Jan 19, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\22JAN1.SGM 22JAN1](https://thefederalregister.org/doc/83_FR_3011/page/3.svg)
Document Created: 2018-01-23 21:35:31
Document Modified: 2018-01-23 21:35:31
| 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 March 23, 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 23, 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 | 83 FR 2997 |
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