80 FR 77640 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIZAMYL
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 240 (December 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77640-77641 | |
| FR Document | 2015-31401 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Notices] [Pages 77640-77641] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31401] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-0182] Determination of Regulatory Review Period for Purposes of Patent Extension; VIZAMYL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for VIZAMYL 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 February 16, 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 13, 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-0182 for Determination of Regulatory Review Period for Purposes of Patent Extension; VIZAMYL. 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 [[Page 77641]] 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 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 VIZAMYL (flumetamol F18 injection). VIZAMYL is a radioactive diagnostic agent indicated for Positron Emission Tomography imaging of the brain to estimate [beta] amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease or other causes of cognitive decline. Subsequent to this approval, the USPTO received a patent term restoration application for VIZAMYL (U.S. Patent No. 7,270,800) from GE Healthcare Limited, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 27, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VIZAMYL 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 VIZAMYL is 1,541 days. Of this time, 1,176 days occurred during the testing phase of the regulatory review period, while 365 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: August 8, 2009. FDA has verified the applicant's claim that the date the investigational new drug application (IND) became effective was on August 8, 2009. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: October 26, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for VIZAMYL (NDA 203137) was initially submitted on October 26, 2012. 3. The date the application was approved: October 25, 2013. FDA has verified the applicant's claim that NDA 203137 was approved on October 25, 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 951 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 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31401 Filed 12-14-15; 8:45 am] BILLING CODE 4164-01-P
![77640 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
is 3,607 days. Of this time, 3,429 days 5630 Fishers Lane, Rm. 1061, Rockville, solely responsible for ensuring that your
occurred during the testing phase of the MD 20852. Petitions that have not been comment does not include any
regulatory review period, while 178 made publicly available on http:// confidential information that you or a
days occurred during the approval www.regulations.gov may be viewed in third party may not wish to be posted,
phase. These periods of time were the Division of Dockets Management such as medical information, your or
derived from the following dates: between 9 a.m. and 4 p.m., Monday anyone else’s Social Security number, or
1. The date an exemption under through Friday. confidential business information, such
section 520(g) of the Federal Food, Drug, Dated: December 8, 2015. as a manufacturing process. Please note
and Cosmetic Act (the FD&C Act) (21 that if you include your name, contact
Leslie Kux,
U.S.C. 360j(g)) involving this device information, or other information that
became effective: November 22, 2002. Associate Commissioner for Policy. identifies you in the body of your
The applicant claims that the [FR Doc. 2015–31397 Filed 12–14–15; 8:45 am] comments, that information will be
investigational device exemption (IDE) BILLING CODE 4164–01–P posted on http://www.regulations.gov.
required under section 520(g) of the • If you want to submit a comment
FD&C Act for human tests to begin with confidential information that you
became effective on October 24, 2002. DEPARTMENT OF HEALTH AND do not wish to be made available to the
However, FDA records indicate that the HUMAN SERVICES public, submit the comment as a
IDE was determined substantially written/paper submission and in the
complete for clinical studies to have Food and Drug Administration manner detailed (see ‘‘Written/Paper
begun on November 22, 2002, which [Docket No. FDA–2014–E–0182] Submissions’’ and ‘‘Instructions’’).
represents the IDE effective date.
2. The date an application was Determination of Regulatory Review Written/Paper Submissions
initially submitted with respect to the Period for Purposes of Patent Submit written/paper submissions as
device under section 515 of the FD&C Extension; VIZAMYL follows:
Act (21 U.S.C. 360e): April 11, 2012. • Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, written/paper submissions): Division of
FDA has verified the applicant’s claim
HHS. Dockets Management (HFA–305), Food
that the premarket approval application
(PMA) for TRIVASCULAR OVATION ACTION: Notice. and Drug Administration, 5630 Fishers
ABDOMINAL STENT GRAFT SYSTEM Lane, rm. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments
(PMA P120006) was initially submitted Administration (FDA) has determined
April 11, 2012. submitted to the Division of Dockets
the regulatory review period for Management, FDA will post your
3. The date the application was
VIZAMYL and is publishing this notice comment, as well as any attachments,
approved: October 5, 2012. FDA has
of that determination as required by except for information submitted,
verified the applicant’s claim that PMA
law. FDA has made the determination marked and identified, as confidential,
P120006 was approved on October 5,
because of the submission of an if submitted as detailed in
2012.
application to the Director of the U.S. ‘‘Instructions.’’
This determination of the regulatory
Patent and Trademark Office (USPTO), Instructions: All submissions received
review period establishes the maximum
Department of Commerce, for the must include the Docket No. FDA–
potential length of a patent extension.
extension of a patent which claims that 2014–E–0182 for Determination of
However, the USPTO applies several
human drug product. Regulatory Review Period for Purposes
statutory limitations in its calculations
of the actual period for patent extension. DATES: Anyone with knowledge that any of Patent Extension; VIZAMYL.
In its application for patent extension, of the dates as published (in the Received comments will be placed in
this applicant seeks 1,802 days of patent SUPPLEMENTARY INFORMATION section) are the docket and, except for those
term extension. incorrect may submit either electronic submitted as ‘‘Confidential
or written comments and ask for a Submissions,’’ publicly viewable at
III. Petitions redetermination by February 16, 2016. http://www.regulations.gov or at the
Anyone with knowledge that any of Furthermore, any interested person may Division of Dockets Management
the dates as published are incorrect may petition FDA for a determination between 9 a.m. and 4 p.m., Monday
submit either electronic or written regarding whether the applicant for through Friday.
comments and ask for a redetermination extension acted with due diligence • Confidential Submissions—To
(see DATES). Furthermore, any during the regulatory review period by submit a comment with confidential
interested person may petition FDA for June 13, 2016. See ‘‘Petitions’’ in the information that you do not wish to be
a determination regarding whether the SUPPLEMENTARY INFORMATION section for made publicly available, submit your
applicant for extension acted with due more information. comments only as a written/paper
diligence during the regulatory review ADDRESSES: You may submit comments submission. You should submit two
period. To meet its burden, the petition as follows: copies total. One copy will include the
must be timely (see DATES) and contain information you claim to be confidential
sufficient facts to merit an FDA Electronic Submissions with a heading or cover note that states
investigation. (See H. Rept. 857, part 1, Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
98th Cong., 2d sess., pp. 41–42, 1984.) following way: CONFIDENTIAL INFORMATION’’. The
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Petitions should be in the format • Federal eRulemaking Portal: http:// Agency will review this copy, including
specified in 21 CFR 10.30. www.regulations.gov. Follow the the claimed confidential information, in
Submit petitions electronically to instructions for submitting comments. its consideration of comments. The
http://www.regulations.gov at Docket Comments submitted electronically, second copy, which will have the
No. FDA–2013–S–0610. Submit written including attachments, to http:// claimed confidential information
petitions (two copies are required) to the www.regulations.gov will be posted to redacted/blacked out, will be available
Division of Dockets Management (HFA– the docket unchanged. Because your for public viewing and posted on http://
305), Food and Drug Administration, comment will be made public, you are www.regulations.gov. Submit both
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![Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices 77641
copies to the Division of Dockets actual amount of extension that the 203137 was approved on October 25,
Management. If you do not wish your Director of USPTO may award (for 2013.
name and contact information to be example, half the testing phase must be This determination of the regulatory
made publicly available, you can subtracted as well as any time that may review period establishes the maximum
provide this information on the cover have occurred before the patent was potential length of a patent extension.
sheet and not in the body of your issued), FDA’s determination of the However, the USPTO applies several
comments and you must identify this length of a regulatory review period for statutory limitations in its calculations
information as ‘‘confidential.’’ Any a human drug product will include all of the actual period for patent extension.
information marked as ‘‘confidential’’ of the testing phase and approval phase In its application for patent extension,
will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). this applicant seeks 951 days of patent
accordance with 21 CFR 10.20 and other FDA has approved for marketing the term extension.
applicable disclosure law. For more human drug product VIZAMYL III. Petitions
information about FDA’s posting of (flumetamol F18 injection). VIZAMYL is
comments to public dockets, see 80 FR a radioactive diagnostic agent indicated Anyone with knowledge that any of
56469, September 18, 2015, or access for Positron Emission Tomography the dates as published are incorrect may
the information at: http://www.fda.gov/ submit either electronic or written
imaging of the brain to estimate b
regulatoryinformation/dockets/ comments and ask for a redetermination
amyloid neuritic plaque density in adult
default.htm. (see DATES). Furthermore, any interested
patients with cognitive impairment who
Docket: For access to the docket to person may petition FDA for a
are being evaluated for Alzheimer’s
read background documents or the determination regarding whether the
disease or other causes of cognitive
electronic and written/paper comments applicant for extension acted with due
decline. Subsequent to this approval,
received, go to http:// diligence during the regulatory review
the USPTO received a patent term
www.regulations.gov and insert the period. To meet its burden, the petition
restoration application for VIZAMYL
docket number, found in brackets in the must be timely (see DATES) and contain
(U.S. Patent No. 7,270,800) from GE
heading of this document, into the sufficient facts to merit an FDA
Healthcare Limited, and the USPTO
‘‘Search’’ box and follow the prompts investigation. (See H. Rept. 857, part 1,
requested FDA’s assistance in
and/or go to the Division of Dockets 98th Cong., 2d sess., pp. 41–42, 1984.)
determining this patent’s eligibility for
Management, 5630 Fishers Lane, Rm. Petitions should be in the format
patent term restoration. In a letter dated
1061, Rockville, MD 20852. specified in 21 CFR 10.30.
March 27, 2014, FDA advised the Submit petitions electronically to
FOR FURTHER INFORMATION CONTACT: USPTO that this human drug product http://www.regulations.gov at Docket
Beverly Friedman, Office of Regulatory had undergone a regulatory review No. FDA–2013–S–0610. Submit written
Policy, Food and Drug Administration, period and that the approval of petitions (two copies are required) to the
10903 New Hampshire Ave., Bldg. 51, VIZAMYL represented the first Division of Dockets Management (HFA–
Rm. 6250, Silver Spring, MD 20993, permitted commercial marketing or use 305), Food and Drug Administration,
301–796–3600. of the product. Thereafter, the USPTO 5630 Fishers Lane, Rm. 1061, Rockville,
SUPPLEMENTARY INFORMATION: requested that FDA determine the MD 20852. Petitions that have not been
product’s regulatory review period. made publicly available on http://
I. Background
II. Determination of Regulatory Review www.regulations.gov may be viewed in
The Drug Price Competition and Period the Division of Dockets Management
Patent Term Restoration Act of 1984 between 9 a.m. and 4 p.m., Monday
(Pub. L. 98–417) and the Generic FDA has determined that the
through Friday.
Animal Drug and Patent Term applicable regulatory review period for
VIZAMYL is 1,541 days. Of this time, Dated: December 8, 2015.
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be 1,176 days occurred during the testing Leslie Kux,
extended for a period of up to 5 years phase of the regulatory review period, Associate Commissioner for Policy.
so long as the patented item (human while 365 days occurred during the [FR Doc. 2015–31401 Filed 12–14–15; 8:45 am]
drug product, animal drug product, approval phase. These periods of time BILLING CODE 4164–01–P
medical device, food additive, or color were derived from the following dates:
additive) was subject to regulatory 1. The date an exemption under
review by FDA before the item was section 505(i) of the Federal Food, Drug, DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s and Cosmetic Act (the FD&C Act) (21 HUMAN SERVICES
regulatory review period forms the basis U.S.C. 355(i)) became effective: August
8, 2009. FDA has verified the Food and Drug Administration
for determining the amount of extension
an applicant may receive. applicant’s claim that the date the [Docket No. FDA–2015–N–4462]
A regulatory review period consists of investigational new drug application
two periods of time: A testing phase and (IND) became effective was on August 8, Point of Care Prothrombin Time/
an approval phase. For human drug 2009. International Normalized Ratio Devices
products, the testing phase begins when 2. The date the application was for Monitoring Warfarin Therapy;
the exemption to permit the clinical initially submitted with respect to the Public Workshop; Request for
investigations of the drug becomes human drug product under section Comments
asabaliauskas on DSK5VPTVN1PROD with NOTICES
effective and runs until the approval 505(b) of the FD&C Act: October 26, AGENCY: Food and Drug Administration,
phase begins. The approval phase starts 2012. FDA has verified the applicant’s HHS.
with the initial submission of an claim that the new drug application ACTION: Notice of public workshop;
application to market the human drug (NDA) for VIZAMYL (NDA 203137) was request for comments.
product and continues until FDA grants initially submitted on October 26, 2012.
permission to market the drug product. 3. The date the application was SUMMARY: The Food and Drug
Although only a portion of a regulatory approved: October 25, 2013. FDA has Administration (FDA) is announcing the
review period may count toward the verified the applicant’s claim that NDA following public workshop entitled
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Document Created: 2018-03-02 09:15:35
Document Modified: 2018-03-02 09:15:35
| 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 February 16, 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 13, 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 77640 |
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