80 FR 76697 - Determination of Regulatory Review Period for Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 237 (December 10, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 237 (December 10, 2015)
| Page Range | 76697-76699 | |
| FR Document | 2015-31095 |
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)] [Notices] [Pages 76697-76699] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31095] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-0271] Determination of Regulatory Review Period for Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ARGUS II VISUAL STIMULATION 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 [[Page 76698]] 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 February 8, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 7, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-E-0271 for Determination of Regulatory Review Period for Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.: For access to the docket to read background documents or the electronic and written/ paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device ARGUS II VISUAL STIMULATION SYSTEM. ARGUS II VISUAL STIMULATION SYSTEM is indicated for patients aged 25 years and older with bare or no light perception vision caused by advanced retinitis pigmentosa. Subsequent to this approval, the USPTO received a patent term restoration application for ARGUS II VISUAL STIMULATION SYSTEM (U.S. Patent No. 7,668,599) from Second Sight Medical Products, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 22, 2014, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of ARGUS II VISUAL STIMULATION 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. [[Page 76699]] II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ARGUS II VISUAL STIMULATION SYSTEM is 2,282 days. Of this time, 1,630 days occurred during the testing phase of the regulatory review period, while 652 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: November 17, 2006. 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 December 31, 2004. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on November 17, 2006, 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): May 4, 2011. The applicant claims May 3, 2011, as the date the humanitarian device exemption (HDE) for Argus II Visual Stimulation System (HDE H110002) was initially submitted. However, FDA records indicate that HDE H110002 was submitted on May 4, 2011. 3. The date the application was approved: February 13, 2013. The applicant claims that HDE H110002 was approved on February 14, 2013. However, FDA records indicate that ARGUS II VISUAL STIMULATION SYSTEM was approved on February 13, 2013. 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 1,735 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31095 Filed 12-9-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76697
http://www.regulations.gov. Submit review period may count toward the potential length of a patent extension.
both copies to the Division of Dockets actual amount of extension that the However, the USPTO applies several
Management. If you do not wish your Director of USPTO may award (for statutory limitations in its calculations
name and contact information to be example, half the testing phase must be of the actual period for patent extension.
made publicly available, you can subtracted as well as any time that may In its application for patent extension,
provide this information on the cover have occurred before the patent was this applicant seeks 1,424 days of patent
sheet and not in the body of your issued), FDA’s determination of the term extension.
comments and you must identify this length of a regulatory review period for
III. Petitions
information as ‘‘confidential.’’ Any a human drug product will include all
information marked as ‘‘confidential’’ of the testing phase and approval phase Anyone with knowledge that any of
will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may
accordance with 21 CFR 10.20 and other FDA has approved for marketing the submit either electronic or written
applicable disclosure law. For more human drug product ELIQUIS comments and ask for a redetermination
information about FDA’s posting of (apixaban). ELIQUIS is indicated to (see DATES). Furthermore, any interested
comments to public dockets, see 80 FR reduce the risk of stroke and systemic person may petition FDA for a
56469, September 18, 2015, or access embolism in patients with nonvalvular determination regarding whether the
the information at: http://www.fda.gov/ atrial fibrillation. Subsequent to this applicant for extension acted with due
regulatoryinformation/dockets/ approval, the USPTO received a patent diligence during the regulatory review
default.htm. term restoration application for period. To meet its burden, the petition
Docket: For access to the docket to ELIQUIS (U.S. Patent No. 6,967,208) must be timely (see DATES) and contain
read background documents or the from Bristol-Myers Squibb Company, sufficient facts to merit an FDA
electronic and written/paper comments and the USPTO requested FDA’s investigation. (See H. Rept. 857, part 1,
received, go to http:// assistance in determining this patent’s 98th Cong., 2d sess., pp. 41–42, 1984.)
www.regulations.gov and insert the eligibility for patent term restoration. In Petitions should be in the format
docket number, found in brackets in the a letter dated March 27, 2014, FDA specified in 21 CFR 10.30.
advised the USPTO that this human Submit petitions electronically to
heading of this document, into the
drug product had undergone a http://www.regulations.gov at Docket
‘‘Search’’ box and follow the prompts
regulatory review period and that the No. FDA–2013–S–0610. Submit written
and/or go to the Division of Dockets
approval of ELIQUIS represented the petitions (two copies are required) to the
Management, 5630 Fishers Lane, Rm.
first permitted commercial marketing or Division of Dockets Management (HFA–
1061, Rockville, MD 20852.
use of the product. Thereafter, the 305), Food and Drug Administration,
FOR FURTHER INFORMATION CONTACT: 5630 Fishers Lane, Rm. 1061, Rockville,
Beverly Friedman, Office of Regulatory USPTO requested that FDA determine
the product’s regulatory review period. MD 20852. Petitions that have not been
Policy, Food and Drug Administration, made publicly available on http://
10903 New Hampshire Ave., Bldg. 51, II. Determination of Regulatory Review www.regulations.gov may be viewed in
Rm. 6250, Silver Spring, MD 20993, Period the Division of Dockets Management
301–796–3600. FDA has determined that the between 9 a.m. and 4 p.m., Monday
SUPPLEMENTARY INFORMATION: applicable regulatory review period for through Friday.
I. Background ELIQUIS is 3,685 days. Of this time, Dated: December 4, 2015.
3,227 days occurred during the testing Leslie Kux,
The Drug Price Competition and phase of the regulatory review period,
Patent Term Restoration Act of 1984 Associate Commissioner for Policy.
while 458 days occurred during the
(Pub. L. 98–417) and the Generic [FR Doc. 2015–31096 Filed 12–9–15; 8:45 am]
approval phase. These periods of time
Animal Drug and Patent Term were derived from the following dates: BILLING CODE 4164–01–P
Restoration Act (Pub. L. 100–670) 1. The date an exemption under
generally provide that a patent may be section 505(i) of the Federal Food, Drug,
extended for a period of up to 5 years DEPARTMENT OF HEALTH AND
and Cosmetic Act (the FD&C Act) (21
so long as the patented item (human HUMAN SERVICES
U.S.C. 355(i)) became effective:
drug product, animal drug product, November 28, 2002. FDA has verified Food and Drug Administration
medical device, food additive, or color the applicant’s claim that the date the
additive) was subject to regulatory investigational new drug application [Docket No. FDA–2014–E–0271]
review by FDA before the item was became effective was on November 28,
marketed. Under these acts, a product’s Determination of Regulatory Review
2002.
regulatory review period forms the basis 2. The date the application was Period for Purposes of Patent
for determining the amount of extension initially submitted with respect to the Extension; ARGUS II VISUAL
an applicant may receive. human drug product under section STIMULATION SYSTEM
A regulatory review period consists of 505(b) of the FD&C Act: September 28, AGENCY: Food and Drug Administration,
two periods of time: A testing phase and 2011. FDA has verified the applicant’s HHS.
an approval phase. For human drug claim that the new drug application ACTION: Notice.
products, the testing phase begins when (NDA) for ELIQUIS (NDA 202155) was
the exemption to permit the clinical initially submitted on September 28, SUMMARY: The Food and Drug
mstockstill on DSK4VPTVN1PROD with NOTICES
investigations of the drug becomes 2011. Administration (FDA) has determined
effective and runs until the approval 3. The date the application was the regulatory review period for ARGUS
phase begins. The approval phase starts approved: December 28, 2012. FDA has II VISUAL STIMULATION SYSTEM
with the initial submission of an verified the applicant’s claim that NDA and is publishing this notice of that
application to market the human drug 202155 was approved on December 28, determination as required by law. FDA
product and continues until FDA grants 2012. has made the determination because of
permission to market the drug product. This determination of the regulatory the submission of an application to the
Although only a portion of a regulatory review period establishes the maximum Director of the U.S. Patent and
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![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76699
II. Determination of Regulatory Review investigation. (See H. Rept. 857, part 1, Program is part of the FDA performance
Period 98th Cong., 2d sess., pp. 41–42, 1984.) commitments under the fifth
FDA has determined that the Petitions should be in the format authorization of the Prescription Drug
applicable regulatory review period for specified in 21 CFR 10.30. User Fee Act (PDUFA), which allows
ARGUS II VISUAL STIMULATION Submit petitions electronically to FDA to collect user fees for the review
SYSTEM is 2,282 days. Of this time, http://www.regulations.gov at Docket of human drug and biologics
1,630 days occurred during the testing No. FDA–2013–S–0610. Submit written applications for FYs 2013–2017.
phase of the regulatory review period, petitions (two copies are required) to the DATES: Submit either electronic or
while 652 days occurred during the Division of Dockets Management (HFA– written comments on the collection of
approval phase. These periods of time 305), Food and Drug Administration, information by February 8, 2016.
were derived from the following dates: 5630 Fishers Lane, Rm. 1061, Rockville, ADDRESSES: You may submit comments
1. The date an exemption under MD 20852. Petitions that have not been as follows:
section 520(g) of the Federal Food, Drug, made publicly available on http://
www.regulations.gov may be viewed in Electronic Submissions
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360j(g)) involving this device the Division of Dockets Management Submit electronic comments in the
became effective: November 17, 2006. between 9 a.m. and 4 p.m., Monday following way:
The applicant claims that the through Friday. • Federal eRulemaking Portal: http://
investigational device exemption (IDE) Dated: December 4, 2015. www.regulations.gov. Follow the
required under section 520(g) of the Leslie Kux, instructions for submitting comments.
FD&C act for human tests to begin Associate Commissioner for Policy. Comments submitted electronically,
became effective on December 31, 2004. [FR Doc. 2015–31095 Filed 12–9–15; 8:45 am] including attachments, to http://
However, FDA records indicate that the BILLING CODE 4164–01–P
www.regulations.gov will be posted to
IDE was determined substantially the docket unchanged. Because your
complete for clinical studies to have comment will be made public, you are
begun on November 17, 2006, which DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
represents the IDE effective date. HUMAN SERVICES comment does not include any
2. The date an application was confidential information that you or a
initially submitted with respect to the Food and Drug Administration third party may not wish to be posted,
device under section 515 of the FD&C such as medical information, your or
[Docket No. FDA–2013–N–0093]
Act (21 U.S.C. 360e): May 4, 2011. The anyone else’s Social Security number, or
applicant claims May 3, 2011, as the Agency Information Collection confidential business information, such
date the humanitarian device exemption Activities: Proposed Collection; as a manufacturing process. Please note
(HDE) for Argus II Visual Stimulation Comment Request; Evaluation of the that if you include your name, contact
System (HDE H110002) was initially Program for Enhanced Review information, or other information that
submitted. However, FDA records Transparency and Communication for identifies you in the body of your
indicate that HDE H110002 was New Molecular Entity New Drug comments, that information will be
submitted on May 4, 2011. Applications and Original Biologics posted on http://www.regulations.gov.
3. The date the application was License Applications in Prescription • If you want to submit a comment
approved: February 13, 2013. The Drug User Fee Acts with confidential information that you
applicant claims that HDE H110002 was do not wish to be made available to the
approved on February 14, 2013. AGENCY: Food and Drug Administration, public, submit the comment as a
However, FDA records indicate that HHS. written/paper submission and in the
ARGUS II VISUAL STIMULATION ACTION: Notice. manner detailed (see ‘‘Written/Paper
SYSTEM was approved on February 13, Submissions’’ and ‘‘Instructions’’).
2013. SUMMARY: The Food and Drug
Administration (FDA) is announcing an Written/Paper Submissions
This determination of the regulatory
review period establishes the maximum opportunity for public comment on the Submit written/paper submissions as
potential length of a patent extension. proposed collection of certain follows:
However, the USPTO applies several information by the Agency. Under the • Mail/Hand delivery/Courier (for
statutory limitations in its calculations Paperwork Reduction Act of 1995 (the written/paper submissions): Division of
of the actual period for patent extension. PRA), Federal Agencies are required to Dockets Management (HFA–305), Food
In its application for patent extension, publish notice in the Federal Register and Drug Administration, 5630 Fishers
this applicant seeks 1,735 days of patent concerning each proposed collection of Lane, Rm. 1061, Rockville, MD 20852.
term extension. information, including each proposed • For written/paper comments
extension of an existing collection of submitted to the Division of Dockets
III. Petitions information, and to allow 60 days for Management, FDA will post your
Anyone with knowledge that any of public comment in response to the comment, as well as any attachments,
the dates as published are incorrect may notice. This notice solicits comments on except for information submitted,
submit either electronic or written the information collection involving marked and identified, as confidential,
comments and ask for a redetermination interviews of pharmaceutical if submitted as detailed in
mstockstill on DSK4VPTVN1PROD with NOTICES
(see DATES). Furthermore, any manufacturers who submit new ‘‘Instructions.’’
interested person may petition FDA for molecular entity (NME) new drug Instructions: All submissions received
a determination regarding whether the applications (NDAs) and original must include the Docket No. [FDA–
applicant for extension acted with due biologics license applications (BLAs) to 2013–N–0093] for ‘‘Agency Information
diligence during the regulatory review FDA under the Program for Enhanced Collection Activities: Proposed
period. To meet its burden, the petition Review Transparency and Collection; Comment Request;
must be timely (see DATES) and contain Communication (the Program) during Evaluation of the Program for Enhanced
sufficient facts to merit an FDA fiscal years (FYs) 2013–2017. The Review Transparency and
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Document Created: 2015-12-14 13:28:24
Document Modified: 2015-12-14 13:28:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 8, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 7, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 80 FR 76697 |
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