81 FR 39649 - Determination of Regulatory Review Period for Purposes of Patent Extension; ORBACTIV
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 117 (June 17, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 117 (June 17, 2016)
| Page Range | 39649-39651 | |
| FR Document | 2016-14353 |
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)] [Notices] [Pages 39649-39651] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14353] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2585] Determination of Regulatory Review Period for Purposes of Patent Extension; ORBACTIV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ORBACTIV 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 August 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 December 14, 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 [[Page 39650]] 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-2015-E-2585 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; ORBACTIV.'' 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 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 ORBACTIV (oritavancin diphosphate). ORBACTIV is indicated for treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram- positive microorganisms. Subsequent to this approval, the USPTO received a patent term restoration application for ORBACTIV (U.S. Patent No. 5,840,684) from Eli Lilly and Co., 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 human drug product had undergone a regulatory review period and that the approval of ORBACTIV 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 ORBACTIV is 6,539 days. Of this time, 6,295 days occurred during the testing phase of the regulatory review period, while 244 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: September 12, 1996. The applicant claims September 11, 1996, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was September 12, 1996, 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 6, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for ORBACTIV (NDA 206334) was initially submitted on December 6, 2013. 3. The date the application was approved: August 6, 2014. FDA has verified the applicant's claim that NDA 206334 was approved on August 6, 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. [[Page 39651]] 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: June 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14353 Filed 6-16-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39649
that the Director of USPTO may award 2. The date an application was DEPARTMENT OF HEALTH AND
(half the testing phase must be initially submitted with respect to the HUMAN SERVICES
subtracted as well as any time that may device under section 515 of the FD&C
have occurred before the patent was Act (21 U.S.C. 360e): June 4, 2010. The Food and Drug Administration
issued), FDA’s determination of the applicant claims April 1, 2009, as the [Docket No. FDA–2015–E–2585]
length of a regulatory review period for date the premarket approval application
a medical device will include all of the (PMA) for ZILVER PTX DRUG ELUTING Determination of Regulatory Review
testing phase and approval phase as PERIPHERAL STENT (PMA P100022) Period for Purposes of Patent
specified in 35 U.S.C. 156(g)(3)(B). was initially submitted. However, FDA Extension; ORBACTIV
FDA has approved for marketing the
records indicate that PMA P100022 was AGENCY: Food and Drug Administration,
medical device, ZILVER PTX DRUG
ELUTING PERIPHERAL STENT. submitted in full on June 4, 2010. HHS.
ZILVER PTX DRUG ELUTING 3. The date the application was ACTION: Notice.
PERIPHERAL STENT is indicated for approved: November 14, 2012. The
SUMMARY: The Food and Drug
improving luminal diameter for the applicant claims that the PMA P100022
Administration (FDA) has determined
treatment of de novo or restenotic was approved on November 15, 2012.
symptomatic lesions in native vascular the regulatory review period for
However, FDA records indicate that ORBACTIV and is publishing this notice
disease of the above-the-knee PMA P100022 was approved on
femoropopliteal arteries having of that determination as required by
November 14, 2012. law. FDA has made the determination
reference vessel diameters from 4
millimeters (mm) to 9 mm and total This determination of the regulatory because of the submission of an
lesion lengths up to 140 mm per limb review period establishes the maximum application to the Director of the U.S.
and 280 mm per patient. Subsequent to potential length of a patent extension. Patent and Trademark Office (USPTO),
this approval, the USPTO received a However, the USPTO applies several Department of Commerce, for the
patent term restoration application for statutory limitations in its calculations extension of a patent which claims that
ZILVER PTX DRUG ELUTING of the actual period for patent extension. human drug product.
PERIPHERAL STENT (U.S. Patent Nos. In its applications for patent extension, DATES: Anyone with knowledge that any
6,515,009 and 7,820,193) from Boston this applicant seeks 1,826 days or 751 of the dates as published (in the
Scientific Scimed, Inc., and the USPTO days of patent term extension. SUPPLEMENTARY INFORMATION section) are
requested FDA’s assistance in incorrect may submit either electronic
determining this patent’s eligibility for III. Petitions or written comments and ask for a
patent term restoration. In a letter dated redetermination by August 16, 2016.
Anyone with knowledge that any of
May 11, 2015, FDA advised the USPTO Furthermore, any interested person may
the dates as published are incorrect may
that this medical device had undergone petition FDA for a determination
submit either electronic or written
a regulatory review period and that the regarding whether the applicant for
comments and ask for a redetermination extension acted with due diligence
approval of ZILVER PTX DRUG
(see DATES). Furthermore, any interested during the regulatory review period by
ELUTING PERIPHERAL STENT
person may petition FDA for a December 14, 2016. See ‘‘Petitions’’ in
represented the first permitted
commercial marketing or use of the determination regarding whether the the SUPPLEMENTARY INFORMATION section
product. Thereafter, the USPTO applicant for extension acted with due for more information.
requested that FDA determine the diligence during the regulatory review ADDRESSES: You may submit comments
product’s regulatory review period. period. To meet its burden, the petition as follows:
must be timely (see DATES) and contain
II. Determination of Regulatory Review sufficient facts to merit an FDA Electronic Submissions
Period investigation. (See H. Rept. 857, part 1, Submit electronic comments in the
FDA has determined that the 98th Cong., 2d sess., pp. 41–42, 1984.) following way:
applicable regulatory review period for Petitions should be in the format • Federal eRulemaking Portal: http://
ZILVER PTX DRUG ELUTING specified in 21 CFR 10.30. www.regulations.gov. Follow the
PERIPHERAL STENT is 3,075 days. Of instructions for submitting comments.
Submit petitions electronically to
this time, 2,180 days occurred during Comments submitted electronically,
the testing phase of the regulatory http://www.regulations.gov at Docket including attachments, to http://
review period, while 895 days occurred No. FDA–2013–S–0610. Submit written www.regulations.gov will be posted to
during the approval phase. These petitions (two copies are required) to the the docket unchanged. Because your
periods of time were derived from the Division of Dockets Management (HFA– comment will be made public, you are
following dates: 305), Food and Drug Administration, solely responsible for ensuring that your
1. The date an exemption under 5630 Fishers Lane, Rm. 1061, Rockville, comment does not include any
section 520(g) of the Federal Food, Drug, MD 20852. confidential information that you or a
and Cosmetic Act (the FD&C Act) (21 Dated: June 13, 2016. third party may not wish to be posted,
U.S.C. 360j(g)) involving this device such as medical information, your or
Leslie Kux,
became effective: June 16, 2004. The anyone else’s Social Security number, or
applicant claims that the investigational Associate Commissioner for Policy.
confidential business information, such
device exemption (IDE) required under [FR Doc. 2016–14357 Filed 6–16–16; 8:45 am] as a manufacturing process. Please note
sradovich on DSK3TPTVN1PROD with NOTICES
section 520(g) of the FD&C Act for BILLING CODE 4164–01–P that if you include your name, contact
human tests to begin became effective information, or other information that
on July 28, 2004. However, FDA records identifies you in the body of your
indicate that the IDE was determined comments, that information will be
substantially complete for clinical posted on http://www.regulations.gov.
studies to have begun on June 16, 2004, • If you want to submit a comment
which represents the IDE effective date. with confidential information that you
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![Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39651
III. Petitions DATES: Submit either electronic or • Confidential Submissions—To
written comments on Agency guidances submit a comment with confidential
Anyone with knowledge that any of at any time. information that you do not wish to be
the dates as published are incorrect may made publicly available, submit your
submit either electronic or written ADDRESSES: You may submit comments
as follows: comments only as a written/paper
comments and ask for a redetermination
submission. You should submit two
(see DATES). Furthermore, any interested Electronic Submissions copies total. One copy will include the
person may petition FDA for a
Submit electronic comments in the information you claim to be confidential
determination regarding whether the
following way: with a heading or cover note that states
applicant for extension acted with due
diligence during the regulatory review • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
period. To meet its burden, the petition
instructions for submitting comments. Agency will review this copy, including
must be timely (see DATES) and contain
Comments submitted electronically, the claimed confidential information, in
sufficient facts to merit an FDA
including attachments, to http:// its consideration of comments. The
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov will be posted to second copy, which will have the
Petitions should be in the format the docket unchanged. Because your claimed confidential information
specified in 21 CFR 10.30. comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on http://
Submit petitions electronically to comment does not include any www.regulations.gov. Submit both
http://www.regulations.gov at Docket confidential information that you or a copies to the Division of Dockets
No. FDA–2013–S–0610. Submit written third party may not wish to be posted, Management. If you do not wish your
petitions (two copies are required) to the such as medical information, your or name and contact information to be
Division of Dockets Management (HFA– anyone else’s Social Security number, or made publicly available, you can
305), Food and Drug Administration, confidential business information, such provide this information on the cover
5630 Fishers Lane, Rm. 1061, Rockville, as a manufacturing process. Please note sheet and not in the body of your
MD 20852. that if you include your name, contact comments and you must identify this
Dated: June 13, 2016. information, or other information that information as ‘‘confidential.’’ Any
Leslie Kux, identifies you in the body of your information marked as ‘‘confidential’’
Associate Commissioner for Policy. comments, that information will be will not be disclosed except in
[FR Doc. 2016–14353 Filed 6–16–16; 8:45 am] posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
BILLING CODE 4164–01–P • If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
DEPARTMENT OF HEALTH AND public, submit the comment as a 56469, September 18, 2015, or access
HUMAN SERVICES written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). default.htm.
Written/Paper Submissions Docket: For access to the docket to
[Docket No. FDA–2015–N–4563] read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
Modified Release Veterinary Parenteral follows:
received, go to http://
Dosage Forms: Development, • Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
Evaluation, and Establishment of written/paper submissions): Division of
docket number, found in brackets in the
Specifications; Guidance for Industry; Dockets Management (HFA–305), Food
heading of this document, into the
Availability and Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, and/or go to the Division of Dockets
• For written/paper comments Management, 5630 Fishers Lane, Rm.
HHS. submitted to the Division of Dockets 1061, Rockville, MD 20852.
ACTION: Notice. Management, FDA will post your
comment, as well as any attachments, Submit written requests for single
SUMMARY: The Food and Drug except for information submitted, copies of the guidance to the Policy and
Administration (FDA) is announcing the marked and identified, as confidential, Regulations Staff (HFV–6), Center for
availability of guidance for industry if submitted as detailed in Veterinary Medicine, Food and Drug
#238 entitled ‘‘Modified Release ‘‘Instructions.’’ Administration, 7519 Standish Pl.,
Veterinary Parenteral Dosage Forms: Instructions: All submissions received Rockville, MD 20855. Send one self-
Development, Evaluation, and must include the Docket No. FDA– addressed adhesive label to assist that
Establishment of Specifications.’’ This 2015–N–4563 for ‘‘Modified Release office in processing your requests. See
guidance provides recommendations on Veterinary Parenteral Dosage Forms: the SUPPLEMENTARY INFORMATION section
the submission of chemistry, Development, Evaluation, and for electronic access to the guidance
manufacturing, and controls and Establishment of Specifications.’’ document.
pharmacokinetic information, as well as Received comments will be placed in
sradovich on DSK3TPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
procedures to follow, to support the the docket and, except for those
Gregory Hunter, Center for Veterinary
approval of modified release parenteral submitted as ‘‘Confidential
Medicine (HFV–142), Food and Drug
drug products intended for use in Submissions,’’ publicly viewable at
Administration, 7500 Standish Pl.,
veterinary species. This guidance is http://www.regulations.gov or at the
Rockville, MD 20855, 240–402–0675,
applicable to both new animal drug Division of Dockets Management
Gregory.Hunter@fda.hhs.gov.
applications and abbreviated new between 9 a.m. and 4 p.m., Monday
animal drug application products. through Friday. SUPPLEMENTARY INFORMATION:
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Document Created: 2016-06-17 01:05:18
Document Modified: 2016-06-17 01:05:18
| 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 August 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 December 14, 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 | 81 FR 39649 |
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