81 FR 63770 - Determination of Regulatory Review Period for Purposes of Patent Extension; LUMASON
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 | 63770-63771 | |
| FR Document | 2016-22345 |
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)] [Notices] [Pages 63770-63771] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22345] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2372] Determination of Regulatory Review Period for Purposes of Patent Extension; LUMASON AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for LUMASON 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 human drug product. 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 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 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-2372 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; LUMASON.'' 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 human drug products, the testing phase begins when the exemption to permit the clinical [[Page 63771]] investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, 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 human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product, LUMASON (sulfur hexafluoride microbubbles). LUMASON is an ultrasound contrast agent indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Subsequent to this approval, the USPTO received a patent term restoration application for LUMASON (U.S. Patent No. 5,686,060) from Bracco Suisse SA, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 22, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of LUMASON 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 LUMASON is 7,199 days. Of this time, 6,174 days occurred during the testing phase of the regulatory review period, while 1,025 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: January 26, 1995. The applicant claims December 23, 1994, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 26, 1995, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 21, 2011. The applicant claims December 20, 2011, as the date the NDA for LUMASON was initially submitted. However, FDA records indicate that NDA 203684 was submitted on December 21, 2011. 3. The date the application was approved: October 10, 2014. FDA has verified the applicant's claim that NDA 203684 was approved on October 10, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 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 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. 2016-22345 Filed 9-15-16; 8:45 am] BILLING CODE 4164-01-P
![63770 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices
4 Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the cat-
egory may involve fewer total annual responses.
5 Rounded to three decimals. Total Hours reflects a more precise, non-rounded Average Burden per Response. An approximate (non-rounded)
conversion to minutes is shown in square brackets.
6 Total Hours is based on a more precise Burden per Response than the rounded value shown in this table.
Dated: September 12, 2016. confidential information that you or a claimed confidential information
Leslie Kux, third party may not wish to be posted, redacted/blacked out, will be available
Associate Commissioner for Policy. such as medical information, your or for public viewing and posted on http://
[FR Doc. 2016–22340 Filed 9–15–16; 8:45 am] anyone else’s Social Security number, or www.regulations.gov. Submit both
BILLING CODE 4164–01–P confidential business information, such copies to the Division of Dockets
as a manufacturing process. Please note Management. If you do not wish your
that if you include your name, contact name and contact information to be
DEPARTMENT OF HEALTH AND information, or other information that made publicly available, you can
HUMAN SERVICES identifies you in the body of your provide this information on the cover
comments, that information will be sheet and not in the body of your
Food and Drug Administration posted on http://www.regulations.gov. comments and you must identify this
[Docket No. FDA–2014–E–2372]
• If you want to submit a comment information as ‘‘confidential.’’ Any
with confidential information that you information marked as ‘‘confidential’’
Determination of Regulatory Review do not wish to be made available to the will not be disclosed except in
Period for Purposes of Patent public, submit the comment as a accordance with 21 CFR 10.20 and other
Extension; LUMASON written/paper submission and in the applicable disclosure law. For more
manner detailed (see ‘‘Written/Paper information about FDA’s posting of
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). comments to public dockets, see 80 FR
HHS. 56469, September 18, 2015, or access
ACTION: Notice. Written/Paper Submissions the information at: http://www.fda.gov/
Submit written/paper submissions as regulatoryinformation/dockets/
SUMMARY: The Food and Drug follows: default.htm.
Administration (FDA) has determined • Mail/Hand delivery/Courier (for Docket: For access to the docket to
the regulatory review period for written/paper submissions): Division of read background documents or the
LUMASON and is publishing this notice Dockets Management (HFA–305), Food electronic and written/paper comments
of that determination as required by and Drug Administration, 5630 Fishers received, go to http://
law. FDA has made the determination Lane, Rm. 1061, Rockville, MD 20852. www.regulations.gov and insert the
because of the submission of an • For written/paper comments docket number, found in brackets in the
application to the Director of the U.S. submitted to the Division of Dockets heading of this document, into the
Patent and Trademark Office (USPTO), Management, FDA will post your ‘‘Search’’ box and follow the prompts
Department of Commerce, for the comment, as well as any attachments, and/or go to the Division of Dockets
extension of a patent which claims that except for information submitted, Management, 5630 Fishers Lane, Rm.
human drug product. marked and identified, as confidential, 1061, Rockville, MD 20852.
DATES: Anyone with knowledge that any if submitted as detailed in FOR FURTHER INFORMATION CONTACT:
of the dates as published (in the ‘‘Instructions.’’ Beverly Friedman, Office of Regulatory
SUPPLEMENTARY INFORMATION section) are Instructions: All submissions received Policy, Food and Drug Administration,
incorrect may submit either electronic must include the Docket No. FDA– 10903 New Hampshire Ave., Bldg. 51,
or written comments and ask for a 2014–E–2372 for ‘‘Determination of Rm. 6250, Silver Spring, MD 20993,
redetermination by November 15, 2016. Regulatory Review Period for Purposes 301–796–3600.
Furthermore, any interested person may of Patent Extension; LUMASON.’’ SUPPLEMENTARY INFORMATION:
petition FDA for a determination Received comments will be placed in
regarding whether the applicant for the docket and, except for those I. Background
extension acted with due diligence submitted as ‘‘Confidential The Drug Price Competition and
during the regulatory review period by Submissions,’’ publicly viewable at Patent Term Restoration Act of 1984
March 15, 2017. See ‘‘Petitions’’ in the http://www.regulations.gov or at the (Pub. L. 98–417) and the Generic
SUPPLEMENTARY INFORMATION section for Division of Dockets Management Animal Drug and Patent Term
more information. between 9 a.m. and 4 p.m., Monday Restoration Act (Pub. L. 100–670)
ADDRESSES: You may submit comments through Friday. generally provide that a patent may be
as follows: • Confidential Submissions—To extended for a period of up to 5 years
submit a comment with confidential so long as the patented item (human
Electronic Submissions information that you do not wish to be drug product, animal drug product,
Submit electronic comments in the made publicly available, submit your medical device, food additive, or color
following way: comments only as a written/paper additive) was subject to regulatory
• Federal eRulemaking Portal: http:// submission. You should submit two review by FDA before the item was
www.regulations.gov. Follow the copies total. One copy will include the marketed. Under these acts, a product’s
instructions for submitting comments. information you claim to be confidential regulatory review period forms the basis
mstockstill on DSK3G9T082PROD with NOTICES
Comments submitted electronically, with a heading or cover note that states for determining the amount of extension
including attachments, to http:// ‘‘THIS DOCUMENT CONTAINS an applicant may receive.
www.regulations.gov will be posted to CONFIDENTIAL INFORMATION.’’ The A regulatory review period consists of
the docket unchanged. Because your Agency will review this copy, including two periods of time: A testing phase and
comment will be made public, you are the claimed confidential information, in an approval phase. For human drug
solely responsible for ensuring that your its consideration of comments. The products, the testing phase begins when
comment does not include any second copy, which will have the the exemption to permit the clinical
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![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
VerDate Sep<11>2014 17:55 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\16SEN1.SGM 16SEN1](https://thefederalregister.org/doc/81_FR_63950/page/2.svg)
Document Created: 2016-09-16 00:24:37
Document Modified: 2016-09-16 00:24:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Anyone with knowledge that any of the dates as published (in 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 63770 |
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