83 FR 3732 - Determination of Regulatory Review Period for Purposes of Patent Extension; VARUBI
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 18 (January 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 18 (January 26, 2018)
| Page Range | 3732-3734 | |
| FR Document | 2018-01373 |
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)] [Notices] [Pages 3732-3734] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01373] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2475] Determination of Regulatory Review Period for Purposes of Patent Extension; VARUBI 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 VARUBI 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 March 27, 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 July 25, 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 March 27, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 27, 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: [[Page 3733]] 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 No. FDA-2016-E-2475 for ''Determination of Regulatory Review Period for Purposes of Patent Extension; VARUBI.'' 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 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 VARUBI (rolapitant). VARUBI is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Subsequent to this approval, the USPTO received a patent term restoration application for VARUBI (U.S. Patent No. 7,049,320) from OPKO Health, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 2, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VARUBI 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 VARUBI is 3,070 days. Of this time, 2,708 days occurred during the testing phase of the regulatory review period, while 362 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: April 8, 2007. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on April 8, 2007. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 5, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for VARUBI (NDA 206500) was initially submitted on September 5, 2014. 3. The date the application was approved: September 1, 2015. FDA has verified the applicant's claim that NDA 206500 was approved on September 1, 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 1,716 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 [[Page 3734]] 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 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 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01373 Filed 1-25-18; 8:45 am] BILLING CODE 4164-01-P
![3732 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices
information in the NDNH supports Secretary of the U.S. Department of and conditions of a computer matching
OCSE’s strategic mission, goals, and Health and Human Services to disclose program; and, (3) the Government
objectives. OCSE will provide the information maintained in the NDNH to Performance and Results Modernization
annual SNAP performance outcomes to state agencies administering SNAP Act of 2010 (Pub. L. 111–352), which
OMB. under the Nutrition Act of 2008, as requires agencies to report program
The information collection activities amended by the Agriculture Act of performance outcomes to the Office of
for the SNAP performance outcomes 2014; (2) the Privacy Act of 1974, as Management and Budget and for the
reports are authorized by: (1) Subsection amended by the Computer Matching reports to be available to the public.
453 (j)(10) of the Social Security Act (42 and Privacy Protection Act of 1988 (5
U.S.C. 653(j)(10)), which allows the U.S.C. 552a), which sets forth the terms Respondents: State SNAP Agencies.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses Total burden
Information collection title burden hours
respondents per hours
per response
respondent
SNAP Matching Program Performance Outcomes ......................................... 53 1 1.92 101.76
Estimated Total Annual Burden Hours: .................................................... ........................ ........................ ........................ 101.76
In compliance with the requirements DEPARTMENT OF HEALTH AND 2018. The https://www.regulations.gov
of the Paperwork Reduction Act of 1995 HUMAN SERVICES electronic filing system will accept
(Pub. L. 104–13, 44 U.S.C. Chap 35), the comments until midnight Eastern Time
Administration for Children and Food and Drug Administration at the end of March 27, 2018. Comments
Families is soliciting public comment received by mail/hand delivery/courier
[Docket No. FDA–2016–E–2475]
on the specific aspects of the (for written/paper submissions) will be
information collection described above. Determination of Regulatory Review considered timely if they are
Copies of the proposed collection of Period for Purposes of Patent postmarked or the delivery service
information can be obtained and Extension; VARUBI acceptance receipt is on or before that
comments may be forwarded by writing date.
AGENCY: Food and Drug Administration,
to the Administration for Children and Electronic Submissions
HHS.
Families, Office of Planning, Research
and Evaluation, 330 C Street SW, ACTION: Notice. Submit electronic comments in the
following way:
Washington DC 20201. Attn: ACF SUMMARY: The Food and Drug
Reports Clearance Officer. Email • Federal eRulemaking Portal:
Administration (FDA or the Agency) has https://www.regulations.gov. Follow the
address: infocollection@acf.hhs.gov. All determined the regulatory review period
requests should be identified by the title instructions for submitting comments.
for VARUBI and is publishing this Comments submitted electronically,
of the information collection. notice of that determination as required including attachments, to https://
The Department specifically requests by law. FDA has made the www.regulations.gov will be posted to
comments on: (a) Whether the proposed determination because of the the docket unchanged. Because your
collection of information is necessary submission of an application to the comment will be made public, you are
for the proper performance of the Director of the U.S. Patent and solely responsible for ensuring that your
functions of the agency, including Trademark Office (USPTO), Department comment does not include any
whether the information shall have of Commerce, for the extension of a confidential information that you or a
practical utility; (b) the accuracy of the patent which claims that human drug third party may not wish to be posted,
product. such as medical information, your or
agency’s estimate of the burden of the
proposed collection of information; (c) DATES: Anyone with knowledge that any anyone else’s Social Security number, or
the quality, utility, and clarity of the of the dates as published (in the confidential business information, such
information to be collected; and (d) SUPPLEMENTARY INFORMATION section) are as a manufacturing process. Please note
ways to minimize the burden of the incorrect may submit either electronic that if you include your name, contact
collection of information on or written comments and ask for a information, or other information that
respondents, including through the use redetermination by March 27, 2018. identifies you in the body of your
of automated collection techniques or Furthermore, any interested person may comments, that information will be
other forms of information technology. petition FDA for a determination posted on https://www.regulations.gov.
Consideration will be given to regarding whether the applicant for • If you want to submit a comment
extension acted with due diligence with confidential information that you
comments and suggestions submitted
during the regulatory review period by do not wish to be made available to the
within 60 days of this publication.
July 25, 2018. See ‘‘Petitions’’ in the public, submit the comment as a
daltland on DSKBBV9HB2PROD with NOTICES
Robert Sargis, SUPPLEMENTARY INFORMATION section for written/paper submission and in the
Reports Clearance Officer. more information. manner detailed (see ‘‘Written/Paper
[FR Doc. 2018–01388 Filed 1–25–18; 8:45 am] ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’).
BILLING CODE 4184–41–P
as follows. Please note that late, Written/Paper Submissions
untimely filed comments will not be
considered. Electronic comments must Submit written/paper submissions as
be submitted on or before March 27, follows:
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![3734 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices
§ 60.30, including but not limited to: 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
Must be timely (see DATES), must be electronic filing system will accept https://www.regulations.gov or at the
filed in accordance with § 10.20, must comments until midnight Eastern Time Dockets Management Staff between 9
contain sufficient facts to merit an FDA at the end of March 27, 2018. Comments a.m. and 4 p.m., Monday through
investigation, and must certify that a received by mail/hand delivery/courier Friday.
true and complete copy of the petition (for written/paper submissions) will be • Confidential Submissions—To
has been served upon the patent considered timely if they are submit a comment with confidential
applicant. (See H. Rept. 857, part 1, 98th postmarked or the delivery service information that you do not wish to be
Cong., 2d sess., pp. 41–42, 1984.) acceptance receipt is on or before that made publicly available, submit your
Petitions should be in the format date. comments only as a written/paper
specified in 21 CFR 10.30. submission. You should submit two
Submit petitions electronically to Electronic Submissions copies total. One copy will include the
https://www.regulations.gov at Docket Submit electronic comments in the information you claim to be confidential
No. FDA–2013–S–0610. Submit written following way: with a heading or cover note that states
petitions (two copies are required) to the • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Dockets Management Staff (HFA–305), https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Food and Drug Administration, 5630 instructions for submitting comments. Agency will review this copy, including
Fishers Lane, Rm. 1061, Rockville, MD Comments submitted electronically, the claimed confidential information, in
20852. including attachments, to https:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
Dated: January 19, 2018.
the docket unchanged. Because your claimed confidential information
Leslie Kux,
comment will be made public, you are redacted/blacked out, will be available
Associate Commissioner for Policy. solely responsible for ensuring that your for public viewing and posted on
[FR Doc. 2018–01373 Filed 1–25–18; 8:45 am] comment does not include any https://www.regulations.gov. Submit
BILLING CODE 4164–01–P confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
such as medical information, your or contact information to be made publicly
DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or available, you can provide this
HUMAN SERVICES confidential business information, such information on the cover sheet and not
as a manufacturing process. Please note in the body of your comments and you
Food and Drug Administration
that if you include your name, contact must identify this information as
[Docket No. FDA–2018–N–0073] information, or other information that ‘‘confidential.’’ Any information marked
identifies you in the body of your as ‘‘confidential’’ will not be disclosed
Agency Information Collection comments, that information will be except in accordance with 21 CFR 10.20
Activities; Proposed Collection; posted on https://www.regulations.gov. and other applicable disclosure law. For
Comment Request; Irradiation in the • If you want to submit a comment more information about FDA’s posting
Production, Processing, and Handling with confidential information that you of comments to public dockets, see 80
of Food do not wish to be made available to the FR 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, public, submit the comment as a the information at: https://www.gpo.gov/
HHS. written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper 23389.pdf.
ACTION: Notice.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
SUMMARY: The Food and Drug Written/Paper Submissions read background documents or the
Administration (FDA or Agency) is electronic and written/paper comments
announcing an opportunity for public Submit written/paper submissions as received, go to https://
comment on the proposed collection of follows: www.regulations.gov and insert the
certain information by the Agency. • Mail/Hand delivery/Courier (for docket number, found in brackets in the
Under the Paperwork Reduction Act of written/paper submissions): Dockets heading of this document, into the
1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
required to publish notice in the Drug Administration, 5630 Fishers and/or go to the Dockets Management
Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
• For written/paper comments
proposed collection of information, Rockville, MD 20852.
submitted to the Dockets Management
including each proposed extension of an FOR FURTHER INFORMATION CONTACT:
Staff, FDA will post your comment, as
existing collection of information, and Domini Bean, Office of Operations,
well as any attachments, except for
to allow 60 days for public comment in Food and Drug Administration, Three
information submitted, marked and
response to the notice. This notice White Flint North, 10A–12M, 11601
identified, as confidential, if submitted
solicits comments on the information Landsdown St., North Bethesda, MD
as detailed in ‘‘Instructions.’’
collection provisions of our Instructions: All submissions received 20852, 301–796–5733, PRAStaff@
requirements for food irradiation must include the Docket No. FDA– fda.hhs.gov.
processors. 2018–N–0073 for ‘‘Agency Information SUPPLEMENTARY INFORMATION: Under the
DATES: Submit either electronic or Collection Activities; Proposed PRA (44 U.S.C. 3501–3520), Federal
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the collection of Collection; Comment Request; Agencies must obtain approval from the
information by March 27, 2018. Irradiation in the Production, Office of Management and Budget
ADDRESSES: You may submit comments Processing, and Handling of Food.’’ (OMB) for each collection of
as follows: Please note that late, Received comments, those filed in a information they conduct or sponsor.
untimely filed comments will not be timely manner (see ADDRESSES), will be ‘‘Collection of information’’ is defined
considered. Electronic comments must placed in the docket and, except for in 44 U.S.C. 3502(3) and 5 CFR
be submitted on or before March 27, those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1](https://thefederalregister.org/doc/83_FR_3750/page/3.svg)
Document Created: 2018-10-26 10:04:28
Document Modified: 2018-10-26 10:04:28
| 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 March 27, 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 July 25, 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 3732 |
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