81 FR 63771 - Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 180 (September 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 180 (September 16, 2016)
| Page Range | 63771-63773 | |
| FR Document | 2016-22343 |
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)] [Notices] [Pages 63771-63773] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22343] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2084] Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for RESQCPR 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 November 15, 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 March 15, 2017. 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 [[Page 63772]] 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-2015-E-2084 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR 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. Docket: 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 RESQCPR SYSTEM. RESQCPR SYSTEM is indicated for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest. Subsequent to this approval, the USPTO received a patent term restoration application for RESQCPR SYSTEM (U.S. Patent No. 5,454,779) from University of California and Advanced Circulatory Systems, 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 RESQCPR 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 RESQCPR SYSTEM is 3,608 days. Of this time, 2,247 days occurred during the testing phase of the regulatory review period, while 1,361 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: April 21, 2005. 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 October 3, 2005. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on April 21, 2005, 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): June 15, 2011. FDA has verified the applicant's claim that the premarket approval application (PMA) for RESQCPR SYSTEM (PMA P110024) was initially submitted June 15, 2011. 3. The date the application was approved: March 6, 2015. FDA has verified the applicant's claim that PMA P110024 was approved on March 6, 2015. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years 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 [[Page 63773]] 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. Dated: September 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22343 Filed 9-15-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63771
investigations of the drug becomes 505(b) of the FD&C Act: December 21, SUMMARY: The Food and Drug
effective and runs until the approval 2011. The applicant claims December Administration (FDA) has determined
phase begins. The approval phase starts 20, 2011, as the date the NDA for the regulatory review period for
with the initial submission of an LUMASON was initially submitted. RESQCPR SYSTEM and is publishing
application to market the human drug However, FDA records indicate that this notice of that determination as
product and continues until FDA grants NDA 203684 was submitted on required by law. FDA has made the
permission to market the drug product. December 21, 2011. determination because of the
Although only a portion of a regulatory 3. The date the application was submission of an application to the
review period may count toward the approved: October 10, 2014. FDA has Director of the U.S. Patent and
actual amount of extension that the verified the applicant’s claim that NDA Trademark Office (USPTO), Department
Director of USPTO may award (for 203684 was approved on October 10, of Commerce, for the extension of a
example, half the testing phase must be 2014. patent which claims that medical
subtracted as well as any time that may This determination of the regulatory device.
have occurred before the patent was review period establishes the maximum DATES: Anyone with knowledge that any
issued), FDA’s determination of the potential length of a patent extension. of the dates as published (see the
length of a regulatory review period for However, the USPTO applies several SUPPLEMENTARY INFORMATION section) are
a human drug product will include all statutory limitations in its calculations incorrect may submit either electronic
of the testing phase and approval phase of the actual period for patent extension. or written comments and ask for a
as specified in 35 U.S.C. 156(g)(1)(B). In its application for patent extension,
FDA has approved for marketing the redetermination by November 15, 2016.
this applicant seeks 5 years of patent Furthermore, any interested person may
human drug product, LUMASON (sulfur term extension.
hexafluoride microbubbles). LUMASON petition FDA for a determination
is an ultrasound contrast agent III. Petitions regarding whether the applicant for
indicated for use in patients with extension acted with due diligence
Anyone with knowledge that any of
suboptimal echocardiograms to opacify during the regulatory review period by
the dates as published are incorrect may
the left ventricular chamber and to March 15, 2017. See ‘‘Petitions’’ in the
submit either electronic or written
improve the delineation of the left SUPPLEMENTARY INFORMATION section for
comments and ask for a redetermination
ventricular endocardial border. more information.
(see DATES). Furthermore, any interested
Subsequent to this approval, the USPTO person may petition FDA for a ADDRESSES: You may submit comments
received a patent term restoration determination regarding whether the as follows:
application for LUMASON (U.S. Patent applicant for extension acted with due Electronic Submissions
No. 5,686,060) from Bracco Suisse SA, diligence during the regulatory review
and the USPTO requested FDA’s Submit electronic comments in the
period. To meet its burden, the petition
assistance in determining this patent’s following way:
must be timely (see DATES) and contain
eligibility for patent term restoration. In • Federal eRulemaking Portal: http://
sufficient facts to merit an FDA
a letter dated October 22, 2015, FDA www.regulations.gov. Follow the
investigation. (See H. Rept. 857, part 1,
advised the USPTO that this human instructions for submitting comments.
98th Cong., 2d sess., pp. 41–42, 1984.)
drug product had undergone a Comments submitted electronically,
Petitions should be in the format
regulatory review period and that the including attachments, to http://
specified in 21 CFR 10.30.
approval of LUMASON represented the www.regulations.gov will be posted to
Submit petitions electronically to
first permitted commercial marketing or the docket unchanged. Because your
http://www.regulations.gov at Docket
use of the product. Thereafter, the comment will be made public, you are
No. FDA–2013–S–0610. Submit written
USPTO requested that FDA determine solely responsible for ensuring that your
petitions (two copies are required) to the
the product’s regulatory review period. comment does not include any
Division of Dockets Management (HFA–
confidential information that you or a
II. Determination of Regulatory Review 305), Food and Drug Administration,
third party may not wish to be posted,
Period 5630 Fishers Lane, Rm. 1061, Rockville,
such as medical information, your or
MD 20852.
FDA has determined that the anyone else’s Social Security number, or
applicable regulatory review period for Dated: September 12, 2016. confidential business information, such
LUMASON is 7,199 days. Of this time, Leslie Kux, as a manufacturing process. Please note
6,174 days occurred during the testing Associate Commissioner for Policy. that if you include your name, contact
phase of the regulatory review period, [FR Doc. 2016–22345 Filed 9–15–16; 8:45 am] information, or other information that
while 1,025 days occurred during the BILLING CODE 4164–01–P identifies you in the body of your
approval phase. These periods of time comments, that information will be
were derived from the following dates: posted on http://www.regulations.gov.
1. The date an exemption under DEPARTMENT OF HEALTH AND • If you want to submit a comment
section 505(i) of the Federal Food, Drug, HUMAN SERVICES with confidential information that you
and Cosmetic Act (the FD&C Act) (21 do not wish to be made available to the
U.S.C. 355(i)) became effective: January Food and Drug Administration public, submit the comment as a
26, 1995. The applicant claims written/paper submission and in the
December 23, 1994, as the date the [Docket No. FDA–2015–E–2084] manner detailed (see ‘‘Written/Paper
investigational new drug application
mstockstill on DSK3G9T082PROD with NOTICES
Submissions’’ and ‘‘Instructions’’).
(IND) became effective. However, FDA Determination of Regulatory Review
records indicate that the IND effective Period for Purposes of Patent Written/Paper Submissions
date was January 26, 1995, which was Extension; RESQCPR SYSTEM Submit written/paper submissions as
30 days after FDA receipt of the IND. AGENCY: Food and Drug Administration, follows:
2. The date the application was HHS. • Mail/Hand delivery/Courier (for
initially submitted with respect to the written/paper submissions): Division of
ACTION: Notice.
human drug product under section Dockets Management (HFA–305), Food
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![Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63773
investigation. (See H. Rept. 857, part 1, Comments submitted electronically, second copy, which will have the
98th Cong., 2d sess., pp. 41–42, 1984.) including attachments, to http:// claimed confidential information
Petitions should be in the format www.regulations.gov will be posted to redacted/blacked out, will be available
specified in 21 CFR 10.30. the docket unchanged. Because your for public viewing and posted on http://
Submit petitions electronically to comment will be made public, you are www.regulations.gov. Submit both
http://www.regulations.gov at Docket solely responsible for ensuring that your copies to the Division of Dockets
No. FDA–2013–S–0610. Submit written comment does not include any Management. If you do not wish your
petitions (two copies are required) to the confidential information that you or a name and contact information to be
Division of Dockets Management (HFA– third party may not wish to be posted, made publicly available, you can
305), Food and Drug Administration, such as medical information, your or provide this information on the cover
5630 Fishers Lane, Rm. 1061, Rockville, anyone else’s Social Security number, or sheet and not in the body of your
MD 20852. confidential business information, such comments and you must identify this
Dated: September 12, 2016. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
Leslie Kux,
information, or other information that will not be disclosed except in
Associate Commissioner for Policy.
identifies you in the body of your accordance with 21 CFR 10.20 and other
[FR Doc. 2016–22343 Filed 9–15–16; 8:45 am] comments, that information will be applicable disclosure law. For more
BILLING CODE 4164–01–P posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/
HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
Food and Drug Administration
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[Docket No. FDA–2014–E–2354] Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
Determination of Regulatory Review received, go to http://
Period for Purposes of Patent Submit written/paper submissions as www.regulations.gov and insert the
Extension; ENTYVIO follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, heading of this document, into the
written/paper submissions): Division of
HHS. ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
ACTION: Notice. and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, rm.
Lane, Rm. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug 1061, Rockville, MD 20852.
• For written/paper comments
Administration (FDA) has determined FOR FURTHER INFORMATION CONTACT:
submitted to the Division of Dockets
the regulatory review period for Beverly Friedman, Office of Regulatory
Management, FDA will post your
ENTYVIO and is publishing this notice Policy, Food and Drug Administration,
comment, as well as any attachments,
of that determination as required by 10903 New Hampshire Ave., Bldg. 51,
except for information submitted,
law. FDA has made the determination Rm. 6250, Silver Spring, MD 20993,
marked and identified, as confidential,
because of the submission of an 301–796–3600.
if submitted as detailed in
application to the Director of the U.S. SUPPLEMENTARY INFORMATION:
‘‘Instructions.’’
Patents and Trademarks Office Instructions: All submissions received
(USPTO), Department of Commerce, for I. Background
must include the Docket No. FDA–
the extension of a patent which claims 2014–E–2354. The Drug Price Competition and
that human biological product. For Determination of Regulatory Patent Term Restoration Act of 1984
DATES: Anyone with knowledge that any Review Period for Purposes of Patent (Pub. L. 98–417) and the Generic
of the dates as published (see the Extension: ENTYVIO. Received Animal Drug and Patent Term
SUPPLEMENTARY INFORMATION section) are comments will be placed in the docket Restoration Act (Pub. L. 100–670)
incorrect may submit either electronic and, except for those submitted as generally provide that a patent may be
or written comments and ask for a ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years
redetermination by November 15, 2016. viewable at http://www.regulations.gov so long as the patented item (human
Furthermore, any interested person may or at the Division of Dockets drug product, animal drug product,
petition FDA for a determination Management between 9 a.m. and 4 p.m., medical device, food additive, or color
regarding whether the applicant for Monday through Friday. additive) was subject to regulatory
extension acted with due diligence • Confidential Submissions—To review by FDA before the item was
during the regulatory review period by submit a comment with confidential marketed. Under these acts, a product’s
March 15, 2017. See ‘‘Petitions’’ in the information that you do not wish to be regulatory review period forms the basis
SUPPLEMENTARY INFORMATION section for made publicly available, submit your for determining the amount of extension
more information. comments only as a written/paper an applicant may receive.
ADDRESSES: You may submit comments submission. You should submit two A regulatory review period consists of
copies total. One copy will include the two periods of time: A testing phase and
mstockstill on DSK3G9T082PROD with NOTICES
as follows:
information you claim to be confidential an approval phase. For human
Electronic Submissions with a heading or cover note that states biological products, the testing phase
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit
following way: CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the
• Federal eRulemaking Portal: http:// Agency will review this copy, including biological becomes effective and runs
www.regulations.gov. Follow the the claimed confidential information, in until the approval phase begins. The
instructions for submitting comments. its consideration of comments. The approval phase starts with the initial
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Document Created: 2016-09-16 00:25:44
Document Modified: 2016-09-16 00:25:44
| 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 November 15, 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 March 15, 2017. 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 | 81 FR 63771 |
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