Determination of Regulatory Review Period for Purposes of Patent Extension; Edwards Pericardial Aortic Bioprosthesis, 47960-47962 [2019-19600]

Download as PDF 47960 Federal Register / Vol. 84, No. 176 / Wednesday, September 11, 2019 / Notices included in this submission complies with this statutory requirement. The purpose of the occupational mix adjustment is to control for the effect of hospitals’ employment choices on the wage index. For example, hospitals may choose to employ different combinations of registered nurses, licensed practical nurses, nursing aides, and medical assistants for the purpose of providing nursing care to their patients. The varying labor costs associated with these choices reflect hospital management decisions rather than geographic differences in the costs of labor. Form Number: CMS–10079 (OMB control number: 0938–0907); Frequency: Yearly; Affected Public: Business or Other for-Profits, Not-forProfit Institutions; Number of Respondents: 3,300; Total Annual Responses: 3,300; Total Annual Hours: 1,584,000. (For policy questions regarding this collection contact Tehila Lipschutz at 410–786–1344.) Dated: September 6, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–19677 Filed 9–10–19; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Tribal Child Support Enforcement Direct Funding Request: (OMB #0970–0218) Office of Child Support Enforcement; Administration for Children and Families; HHS ACTION: Request for Public Comment. AGENCY: The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a 3-year extension of the Tribal IV–D plan (OMB #0970–0218, expiration 3/21/2020). There are no changes requested to this form. DATES: Comments due within 60 days of publication. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. ADDRESSES: Copies of the proposed collection of information can be obtained and comments may be forwarded by emailing infocollection@ acf.hhs.gov. Alternatively, copies can also be obtained by writing to the Administration for Children and Families, Office of Planning, Research, SUMMARY: and Evaluation, 330 C Street, SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests, emailed or written, should be identified by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: The final rule within 45 CFR part 309, published in the Federal Register on March 30, 2004, contains a regulatory reporting requirement that, in order to receive funding for a Tribal IV– D program a Tribe or Tribal organization must submit a plan describing how the Tribe or Tribal organization meets or plans to meet the objectives of section 455(f) of the Social Security Act, including establishing paternity; establishing, modifying, and enforcing support orders; and locating noncustodial parents. The plan is required for all Tribes requesting funding; however, once a Tribe has met the requirements to operate a comprehensive program, a new plan is not required annually unless a Tribe makes changes to its title IV–D program. If a Tribe or Tribal organization intends to make any substantial or material changes, a Tribal IV–D plan amendment must be submitted for approval. Tribes and Tribal organizations must have an approved plan and submit any required plan amendments in order to receive funding to operate a Tribal IV–D program. This paperwork collection activity is set to expire in March 2020. Respondents: Tribes and Tribal Organizations. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Number of responses per respondent 60 2 1 1 45 CFR 309-Plan ............................................................................................. 45 CFR 309-New Plan .................................................................................... Average burden hours per response Annual burden hours 120 480 7,200 960 jspears on DSK3GMQ082PROD with NOTICES Estimated Total Annual Burden Hours: 8,160. Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given VerDate Sep<11>2014 17:44 Sep 10, 2019 Jkt 247001 to comments and suggestions submitted within 60 days of this publication. Authority: 45 CFR 309. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–19580 Filed 9–10–19; 8:45 am] [Docket Nos. FDA–2018–E–0298; FDA– 2018–E–0299; FDA–2018–E–0301; and FDA– 2018–E–0321] BILLING CODE 4184–41–P PO 00000 Determination of Regulatory Review Period for Purposes of Patent Extension; Edwards Pericardial Aortic Bioprosthesis AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has SUMMARY: Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1 Federal Register / Vol. 84, No. 176 / Wednesday, September 11, 2019 / Notices determined the regulatory review period for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (Models 11000A and 11500A) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 November 12, 2019. 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 March 9, 2020. 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 November 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 12, 2019. 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. jspears on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 17:44 Sep 10, 2019 Jkt 247001 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– 2018–E–0298; FDA–2018–E–0299; FDA–2018–E–0301; and FDA–2018–E– 0321 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS.’’ 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 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 47961 of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS. EDWARDS PERICARDIAL AORTIC E:\FR\FM\11SEN1.SGM 11SEN1 47962 Federal Register / Vol. 84, No. 176 / Wednesday, September 11, 2019 / Notices jspears on DSK3GMQ082PROD with NOTICES BIOPROSTHESIS MODEL 11000A and MODEL 11500A are indicated for the replacement of native or prosthetic aortic heart valves. Subsequent to this approval, the USPTO received patent term restoration applications for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS MODEL 11000A and MODEL 11500A (U.S. Patent Nos. 7,972,376; 8,007,992; 8,357,387; and 9,029,418) from Edwards Lifesciences Corporation, and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated April 5, 2018, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS 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 EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS is 1,858 days. Of this time, 1,491 days occurred during the testing phase of the regulatory review period, while 367 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption for this device, under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)), became effective: May 30, 2012. FDA has verified the applicant’s claim that the date the investigational device exemption (IDE) for human tests to begin, as required under section 520(g) of the FD&C Act, became effective May 30, 2012. 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): June 28, 2016. FDA has verified the applicant’s claim that the premarket approval application (PMA) for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (PMA P150048) was initially submitted June 28, 2016. 3. The date the application was approved: June 29, 2017. FDA has verified the applicant’s claim that PMA P150048 was approved on June 29, 2017. 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 VerDate Sep<11>2014 17:44 Sep 10, 2019 Jkt 247001 of the actual period for patent extension. In its applications for patent extension, this applicant seeks 572 days, 992 days, or 1,111 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 § 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 § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 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 4, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–19600 Filed 9–10–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which PO 00000 Frm 00032 Fmt 4703 Sfmt 9990 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel: Exploratory Research on RNA Modifications Environment and Disease (FRAMED). Date: September 16, 2019. Time: 8:00 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: DoubleTree by Hilton Hotel, Raleigh-Durham Airport, 4810 Page Creek Lane, Durham, NC 27703. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30/ Room 3171, Research Triangle Park, NC 27709, 919/541–0670, worth@niehs.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel: Investigator-Initiated Functional RNA Modifications Environment and Disease (FRAMED). Date: September 16–17, 2019. Time: 3:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: DoubleTree by Hilton Hotel, Raleigh-Durham Airport, 4810 Page Creek Lane, Durham, NC 27703. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30/ Room 3171, Research Triangle Park, NC 27709, 919/541–0670, worth@niehs.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: September 5, 2019. Tyeshia M. Roberson, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–19606 Filed 9–10–19; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\11SEN1.SGM 11SEN1

Agencies

[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Pages 47960-47962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19600]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-E-0298; FDA-2018-E-0299; FDA-2018-E-0301; and 
FDA-2018-E-0321]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Edwards Pericardial Aortic Bioprosthesis

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has

[[Page 47961]]

determined the regulatory review period for EDWARDS PERICARDIAL AORTIC 
BIOPROSTHESIS (Models 11000A and 11500A) and is publishing this notice 
of that determination as required by law. FDA has made the 
determination because of the submission of applications 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 
November 12, 2019. 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 March 9, 
2020. 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 November 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 12, 2019. 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 information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-E-0298; FDA-2018-E-0299; FDA-2018-E-0301; and FDA-2018-E-0321 
for ``Determination of Regulatory Review Period for Purposes of Patent 
Extension; EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS.'' 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 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.gpo.gov/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 EDWARDS 
PERICARDIAL AORTIC BIOPROSTHESIS. EDWARDS PERICARDIAL AORTIC

[[Page 47962]]

BIOPROSTHESIS MODEL 11000A and MODEL 11500A are indicated for the 
replacement of native or prosthetic aortic heart valves. Subsequent to 
this approval, the USPTO received patent term restoration applications 
for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS MODEL 11000A and MODEL 
11500A (U.S. Patent Nos. 7,972,376; 8,007,992; 8,357,387; and 
9,029,418) from Edwards Lifesciences Corporation, and the USPTO 
requested FDA's assistance in determining the patents' eligibility for 
patent term restoration. In a letter dated April 5, 2018, FDA advised 
the USPTO that this medical device had undergone a regulatory review 
period and that the approval of EDWARDS PERICARDIAL AORTIC 
BIOPROSTHESIS 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 
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS is 1,858 days. Of this time, 
1,491 days occurred during the testing phase of the regulatory review 
period, while 367 days occurred during the approval phase. These 
periods of time were derived from the following dates:
    1. The date an exemption for this device, under section 520(g) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360j(g)), became effective: May 30, 2012. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) for human tests to begin, as required under section 520(g) of the 
FD&C Act, became effective May 30, 2012.
    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): June 28, 
2016. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS 
(PMA P150048) was initially submitted June 28, 2016.
    3. The date the application was approved: June 29, 2017. FDA has 
verified the applicant's claim that PMA P150048 was approved on June 
29, 2017.
    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 applications for patent extension, 
this applicant seeks 572 days, 992 days, or 1,111 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 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19600 Filed 9-10-19; 8:45 am]
 BILLING CODE 4164-01-P
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