83 FR 5431 - Determination of Regulatory Review Period for Purposes of Patent Extension; GENVOYA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 26 (February 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 26 (February 7, 2018)
| Page Range | 5431-5433 | |
| FR Document | 2018-02403 |
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)] [Notices] [Pages 5431-5433] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02403] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-2179 and FDA-2016-E-2180] Determination of Regulatory Review Period for Purposes of Patent Extension; GENVOYA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GENVOYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 April 9, 2018. 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 August 6, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 9, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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 Nos. FDA-2016-E-2179 and FDA-2016-E-2180 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; GENVOYA.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at [[Page 5432]] https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 Sec. 10.20 (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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 GENVOYA (cobicistat, emtricitabine, elvitegravir, and tenofovir alafenamide fumarate). GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically- suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA. Subsequent to this approval, the USPTO received patent term restoration applications for GENVOYA (U.S. Patent Nos. 7,390,791 and 7,803,788) from Gilead Sciences, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated August 26, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of GENVOYA 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 GENVOYA is 5,031 days. Of this time, 4,665 days occurred during the testing phase of the regulatory review period, while 366 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 28, 2002. The applicant claims January 25, 2002, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 28, 2002, which was the first date after receipt of the IND that the investigational studies were allowed to proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 5, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for GENVOYA (NDA 207561) was initially submitted on November 5, 2014. 3. The date the application was approved: November 5, 2015. FDA has verified the applicant's claim that NDA 207561 was approved on November 5, 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 1,116 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, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements of Sec. 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent [[Page 5433]] applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: January 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02403 Filed 2-6-18; 8:45 am] BILLING CODE 4164-01-P
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II. Determination of Regulatory Review true and complete copy of the petition The https://www.regulations.gov
Period has been served upon the patent electronic filing system will accept
FDA has determined that the applicant. (See H. Rept. 857, part 1, 98th comments until midnight Eastern Time
applicable regulatory review period for Cong., 2d sess., pp. 41–42, 1984.) at the end of April 9, 2018. Comments
SEDASYS SYSTEM is 2,816 days. Of Petitions should be in the format received by mail/hand delivery/courier
this time, 950 days occurred during the specified in 21 CFR 10.30. (for written/paper submissions) will be
Submit petitions electronically to considered timely if they are
testing phase of the regulatory review
https://www.regulations.gov at Docket postmarked or the delivery service
period, while 1,866 days occurred
No. FDA–2013–S–0610. Submit written acceptance receipt is on or before that
during the approval phase. These
petitions (two copies are required) to the date.
periods of time were derived from the
Dockets Management Staff (HFA–305),
following dates: Electronic Submissions
1. The date an exemption under Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD Submit electronic comments in the
section 520(g) of the Federal Food, Drug, following way:
and Cosmetic Act (the FD&C Act) (21 20852.
• Federal eRulemaking Portal:
U.S.C. 360j(g)) involving this device Dated: January 31, 2018.
https://www.regulations.gov. Follow the
became effective: August 19, 2005. The Leslie Kux, instructions for submitting comments.
applicant claims that the investigational Associate Commissioner for Policy. Comments submitted electronically,
device exemption (IDE) required under [FR Doc. 2018–02432 Filed 2–6–18; 8:45 am] including attachments, to https://
section 520(g) of the FD&C Act for BILLING CODE 4164–01–P www.regulations.gov will be posted to
human tests to begin became effective the docket unchanged. Because your
on November 30, 2005. However, FDA comment will be made public, you are
records indicate that the IDE was DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
determined substantially complete for HUMAN SERVICES comment does not include any
clinical studies to have begun on August confidential information that you or a
19, 2005, which represents the IDE Food and Drug Administration
third party may not wish to be posted,
effective date. [Docket Nos. FDA–2016–E–2179 and FDA– such as medical information, your or
2. The date an application was 2016–E–2180] anyone else’s Social Security number, or
initially submitted with respect to the confidential business information, such
device under section 515 of the FD&C Determination of Regulatory Review as a manufacturing process. Please note
Act (21 U.S.C. 360e): March 25, 2008. Period for Purposes of Patent that if you include your name, contact
FDA has verified the applicant’s claim Extension; GENVOYA information, or other information that
that the premarket approval application identifies you in the body of your
(PMA) for SEDASYS SYSTEM (PMA AGENCY: Food and Drug Administration,
HHS. comments, that information will be
P080009) was initially submitted March posted on https://www.regulations.gov.
25, 2008. ACTION: Notice.
• If you want to submit a comment
3. The date the application was SUMMARY: The Food and Drug with confidential information that you
approved: May 3, 2013. FDA has Administration (FDA or the Agency) has do not wish to be made available to the
verified the applicant’s claim that PMA determined the regulatory review period public, submit the comment as a
P080009 was approved on May 3, 2013. for GENVOYA and is publishing this written/paper submission and in the
This determination of the regulatory notice of that determination as required manner detailed (see ‘‘Written/Paper
review period establishes the maximum by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
potential length of a patent extension. determination because of the
However, the USPTO applies several Written/Paper Submissions
submission of applications to the
statutory limitations in its calculations Director of the U.S. Patent and Submit written/paper submissions as
of the actual period for patent extension. Trademark Office (USPTO), Department follows:
In its application for patent extension, of Commerce, for the extension of a • Mail/Hand delivery/Courier (for
this applicant seeks 2,283 days of patent patent which claims that human drug written/paper submissions): Dockets
term extension. product. Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
III. Petitions DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
Anyone with knowledge that any of of the dates as published (in the • For written/paper comments
the dates as published are incorrect may SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
submit either electronic or written incorrect may submit either electronic Staff, FDA will post your comment, as
comments and, under 21 CFR 60.24, ask or written comments and ask for a well as any attachments, except for
for a redetermination (see DATES). redetermination by April 9, 2018. information submitted, marked and
Furthermore, as specified in § 60.30 (21 Furthermore, any interested person may identified, as confidential, if submitted
CFR 60.30), any interested person may petition FDA for a determination as detailed in ‘‘Instructions.’’
petition FDA for a determination regarding whether the applicant for Instructions: All submissions received
regarding whether the applicant for extension acted with due diligence must include the Docket Nos. FDA–
extension acted with due diligence during the regulatory review period by 2016–E–2179 and FDA–2016–E–2180
during the regulatory review period. To August 6, 2018. See ‘‘Petitions’’ in the for ‘‘Determination of Regulatory
sradovich on DSK3GMQ082PROD with NOTICES
meet its burden, the petition must SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent
comply with all the requirements of more information. Extension; GENVOYA.’’ Received
§ 60.30, including but not limited to: ADDRESSES: You may submit comments comments, those filed in a timely
Must be timely (see DATES), must be as follows. Please note that late, manner (see ADDRESSES), will be placed
filed in accordance with § 10.20, must untimely filed comments will not be in the docket and, except for those
contain sufficient facts to merit an FDA considered. Electronic comments must submitted as ‘‘Confidential
investigation, and must certify that a be submitted on or before April 9, 2018. Submissions,’’ publicly viewable at
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![Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices 5433
applicant. (See H. Rept. 857, part 1, 98th considered timely if they are information that you do not wish to be
Cong., 2d sess., pp. 41–42, 1984.) postmarked or the delivery service made publicly available, submit your
Petitions should be in the format acceptance receipt is on or before that comments only as a written/paper
specified in 21 CFR 10.30. date. submission. You should submit two
Submit petitions electronically to copies total. One copy will include the
Electronic Submissions information you claim to be confidential
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written Submit electronic comments in the with a heading or cover note that states
petitions (two copies are required) to the following way: ‘‘THIS DOCUMENT CONTAINS
Dockets Management Staff (HFA–305), • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Food and Drug Administration, 5630 https://www.regulations.gov. Follow the Agency will review this copy, including
Fishers Lane, Rm. 1061, Rockville, MD instructions for submitting comments. the claimed confidential information, in
20852. Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
Dated: January 31, 2018.
www.regulations.gov will be posted to claimed confidential information
Leslie Kux, the docket unchanged. Because your redacted/blacked out, will be available
Associate Commissioner for Policy. comment will be made public, you are for public viewing and posted on
[FR Doc. 2018–02403 Filed 2–6–18; 8:45 am] solely responsible for ensuring that your https://www.regulations.gov. Submit
BILLING CODE 4164–01–P comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
DEPARTMENT OF HEALTH AND such as medical information, your or available, you can provide this
HUMAN SERVICES anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Food and Drug Administration
as a manufacturing process. Please note must identify this information as
[Docket No. FDA–2012–N–0547] that if you include your name, contact ‘‘confidential.’’ Any information marked
information, or other information that as ‘‘confidential’’ will not be disclosed
Agency Information Collection identifies you in the body of your except in accordance with 21 CFR 10.20
Activities; Proposed Collection; comments, that information will be and other applicable disclosure law. For
Comment Request; Survey on the posted on https://www.regulations.gov. more information about FDA’s posting
Occurrence of Foodborne Illness Risk • If you want to submit a comment of comments to public dockets, see 80
Factors in Selected Retail and with confidential information that you FR 56469, September 18, 2015, or access
Foodservice Facility Types do not wish to be made available to the the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). read background documents or the
SUMMARY: The Food and Drug Written/Paper Submissions electronic and written/paper comments
Administration (FDA or Agency) is received, go to https://
announcing an opportunity for public Submit written/paper submissions as www.regulations.gov and insert the
comment on the proposed collection of follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
certain information by the Agency.
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Under the Paperwork Reduction Act of
Management Staff (HFA–305), Food and and/or go to the Dockets Management
1995 (PRA), Federal Agencies are
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
required to publish notice in the
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
Federal Register concerning each • For written/paper comments
proposed collection of information, FOR FURTHER INFORMATION CONTACT: Ila
submitted to the Dockets Management
including each proposed extension of an S. Mizrachi, Office of Operations, Food
Staff, FDA will post your comment, as
existing collection of information, and and Drug Administration, Three White
well as any attachments, except for
to allow 60 days for public comment in Flint North, 10A–12M, 11601
information submitted, marked and
response to the notice. This notice Landsdown St., North Bethesda, MD
identified, as confidential, if submitted
solicits comments on ‘‘Survey on the 20852, 301–796–7726, PRAStaff@
as detailed in ‘‘Instructions.’’
Occurrence of Foodborne Illness Risk Instructions: All submissions received fda.hhs.gov.
Factors in Selected Retail and must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
Foodservice Facility Types.’’ 2012–N–0547 for ‘‘Survey on the PRA (44 U.S.C. 3501–3520), Federal
DATES: Submit either electronic or Occurrence of Foodborne Illness Risk Agencies must obtain approval from the
written comments on the collection of Factors in Selected Retail and Office of Management and Budget
information by April 9, 2018. Foodservice Facility Types.’’ Received (OMB) for each collection of
ADDRESSES: You may submit comments comments, those filed in a timely information they conduct or sponsor.
as follows. Please note that late, manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
untimely filed comments will not be in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
considered. Electronic comments must 1320.3(c) and includes Agency requests
sradovich on DSK3GMQ082PROD with NOTICES
submitted as ‘‘Confidential
be submitted on or before April 9, 2018. Submissions,’’ publicly viewable at or requirements that members of the
The https://www.regulations.gov https://www.regulations.gov or at the public submit reports, keep records, or
electronic filing system will accept Dockets Management Staff between 9 provide information to a third party.
comments until midnight Eastern Time a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44
at the end of April 9, 2018. Comments Friday. U.S.C. 3506(c)(2)(A)) requires Federal
received by mail/hand delivery/courier • Confidential Submissions—To Agencies to provide a 60-day notice in
(for written/paper submissions) will be submit a comment with confidential the Federal Register concerning each
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Document Created: 2018-10-26 13:57:01
Document Modified: 2018-10-26 13:57:01
| 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 April 9, 2018. 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 August 6, 2018. 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 | 83 FR 5431 |
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