82 FR 27261 - Determination of Regulatory Review Period for Purposes of Patent Extension; HETLIOZ
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 113 (June 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 113 (June 14, 2017)
| Page Range | 27261-27263 | |
| FR Document | 2017-12323 |
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)] [Notices] [Pages 27261-27263] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12323] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2370] Determination of Regulatory Review Period for Purposes of Patent Extension; HETLIOZ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for HETLIOZ 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 14, 2017. 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 11, 2017. 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 August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 14, 2017. 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. [[Page 27262]] 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-2370 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; HETLIOZ.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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: 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 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 HETLIOZ (tasimelteon). HETLIOZ is indicated for treatment of Non-24-Hour Sleep- Wake Disorder. Subsequent to this approval, the USPTO received a patent term restoration application for HETLIOZ (U.S. Patent No. 5,856,529) from Vanda Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 20, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of HETLIOZ 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 HETLIOZ is 5,802 days. Of this time, 5,556 days occurred during the testing phase of the regulatory review period, while 246 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: March 16, 1998. FDA has verified the Vanda Pharmaceuticals, Inc. claim that March 16, 1998, is the date the investigational new drug application (IND) became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: May 31, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for HETLIOZ (NDA 205677) was initially submitted on May 31, 2013. 3. The date the application was approved: January 31, 2014. FDA has verified the applicant's claim that NDA 205677 was approved on January 31, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see ADDRESSES) 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 https://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, [[Page 27263]] 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12323 Filed 6-13-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27261
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
21 CFR section/activity responses per Total hours
respondents responses response
respondent
80.21; Request for Certification ................................ 38 198 7,524 0.17 (10 minutes) ..... 1,279
80.22; Sample to Accompany Request .................... 38 198 7,524 0.05 (3 minutes) ....... 376
Total ................................................................... ........................ ........................ ........................ 0.22 (13 minutes) ..... 1,655
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden per
21 CFR section/activity records per Total hours
recordkeepers records recordkeeping
recordkeeper
80.39; Record of Distribution .................................... 38 198 7,524 .25 (15 minutes) ....... 1,881
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate on our review DEPARTMENT OF HEALTH AND at the end of August 14, 2017.
of the certification requests received HUMAN SERVICES Comments received by mail/hand
over the past 3 fiscal years (FY). The delivery/courier (for written/paper
annual burden estimate for this Food and Drug Administration submissions) will be considered timely
information collection is 3,536 hours. [Docket No. FDA–2014–E–2370] if they are postmarked or the delivery
The estimated reporting burden for this service acceptance receipt is on or
information collection is 1,655 hours Determination of Regulatory Review before that date.
and the estimated recordkeeping burden Period for Purposes of Patent Electronic Submissions
for this information collection is 1,881 Extension; HETLIOZ
Submit electronic comments in the
hours. From FY 2014 to FY 2016, we AGENCY: Food and Drug Administration, following way:
processed an average of 7,524 responses HHS. • Federal eRulemaking Portal:
(requests for certification of batches of ACTION: Notice. https://www.regulations.gov. Follow the
color additives) per year. There were 38 instructions for submitting comments.
different respondents, corresponding to SUMMARY: The Food and Drug Comments submitted electronically,
an average of approximately 198 Administration (FDA) has determined including attachments, to https://
responses from each respondent per the regulatory review period for www.regulations.gov will be posted to
year. Using information from industry HETLIOZ and is publishing this notice the docket unchanged. Because your
personnel, we estimate that an average of that determination as required by comment will be made public, you are
of 0.22 hour per response is required for law. FDA has made the determination solely responsible for ensuring that your
because of the submission of an comment does not include any
reporting (preparing certification
application to the Director of the U.S. confidential information that you or a
requests and accompanying samples) Patent and Trademark Office (USPTO),
and an average of 0.25 hour per third party may not wish to be posted,
Department of Commerce, for the such as medical information, your or
response is required for recordkeeping. extension of a patent which claims that anyone else’s Social Security number, or
Our Web-based Color Certification human drug product. confidential business information, such
information system allows submitters to DATES: Anyone with knowledge that any as a manufacturing process. Please note
request color certification online, follow of the dates as published (in the that if you include your name, contact
their submissions through the process, SUPPLEMENTARY INFORMATION section) are information, or other information that
and obtain information on account incorrect may submit either electronic identifies you in the body of your
status. The system sends back the or written comments and ask for a comments, that information will be
certification results electronically, redetermination by August 14, 2017. posted on https://www.regulations.gov.
allowing submitters to sell their Furthermore, any interested person may • If you want to submit a comment
certified color before receiving hardcopy petition FDA for a determination with confidential information that you
certificates. Any delays in the system regarding whether the applicant for do not wish to be made available to the
result only from shipment of color extension acted with due diligence public, submit the comment as a
additive samples to FDA’s Office of during the regulatory review period by written/paper submission and in the
December 11, 2017. See ‘‘Petitions’’ in manner detailed (see ‘‘Written/Paper
Cosmetics and Colors for analysis.
the SUPPLEMENTARY INFORMATION section Submissions’’ and ‘‘Instructions’’).
Dated: June 9, 2017. for more information.
Anna K. Abram, ADDRESSES: You may submit comments Written/Paper Submissions
mstockstill on DSK30JT082PROD with NOTICES
Deputy Commissioner for Policy, Planning, as follows: Please note that late, Submit written/paper submissions as
Legislation, and Analysis. untimely filed comments will not be follows:
[FR Doc. 2017–12328 Filed 6–13–17; 8:45 am] considered. Electronic comments must • Mail/Hand delivery/Courier (for
BILLING CODE 4164–01–P
be submitted on or before August 14, written/paper submissions): Division of
2017. The https://www.regulations.gov Dockets Management (HFA–305), Food
electronic filing system will accept and Drug Administration, 5630 Fishers
comments until midnight Eastern Time Lane, Rm. 1061, Rockville, MD 20852.
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![Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27263
5630 Fishers Lane, Rm. 1061, Rockville, the instructions for submitting claimed confidential information, in our
MD 20852. comments. Comments submitted consideration of comments. The second
Dated: June 9, 2017. electronically, including attachments, to copy, which will have the claimed
Anna K. Abram,
https://www.regulations.gov/ will be confidential information redacted/
posted to the docket unchanged. blacked out, will be available for public
Deputy Commissioner for Policy, Planning,
Because your comment will be made viewing and posted on https://
Legislation, and Analysis.
public, you are solely responsible for www.regulations.gov/. Submit both
[FR Doc. 2017–12323 Filed 6–13–17; 8:45 am]
ensuring that your comment does not copies to the Division of Dockets
BILLING CODE 4164–01–P
include any confidential information Management. If you do not wish your
that you or a third party may not wish name and contact information to be
to be posted, such as medical made publicly available, you can
DEPARTMENT OF HEALTH AND
information, your or anyone else’s provide this information on the cover
HUMAN SERVICES Social Security number, or confidential sheet and not in the body of your
Food and Drug Administration business information, such as a comments and you must identify this
manufacturing process. Please note that information as ‘‘confidential.’’ Any
[Docket No. FDA–2011–N–0016] if you include your name, contact information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
Agency Information Collection identifies you in the body of your accordance with 21 CFR 10.20 and other
Activities; Proposed Collection; comments, that information will be applicable disclosure law. For more
Comment Request; Recordkeeping posted on https://www.regulations.gov/. information about FDA’s posting of
and Records Access Requirements for If you want to submit a comment with comments to public dockets, see 80 FR
Food Facilities confidential information that you do not 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, wish to be made available to the public, the information at: https://www.gpo.gov/
HHS. submit the comment as a written/paper fdsys/pkg/FR-2015-09-18/pdf/2015-
submission and in the manner detailed 23389.pdf.
ACTION: Notice.
(see ‘‘Written/Paper Submissions’’ and Docket: For access to the docket to
SUMMARY: The Food and Drug ‘‘Instructions’’).
read background documents or the
Administration (FDA or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing an opportunity for public received, go to https://
comment on the proposed collection of Submit written/paper submissions as
follows: www.regulations.gov/ and insert the
certain information by the Agency. docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
Under the Paperwork Reduction Act of heading of this document, into the
written/paper submissions): Division of
1995 (PRA), Federal Agencies are ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
required to publish notice in the and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
Federal Register concerning each Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852.
proposed collection of information, • For written/paper comments 1061, Rockville, MD 20852.
including each proposed extension of an submitted to the Division of Dockets
existing collection of information, and FOR FURTHER INFORMATION CONTACT:
Management, FDA will post your JonnaLynn Capezzuto, Office of
to allow 60 days for public comment in comment, as well as any attachments,
response to the notice. This notice Operations, Food and Drug
except for information submitted, Administration, Three White Flint
solicits comments on the information marked and identified, as confidential,
collection provisions of our North, 10A63, 11601 Landsdown St.,
if submitted as detailed in North Bethesda, MD 20852, 301–796–
recordkeeping and records access ‘‘Instructions.’’
requirements for food facilities. 3794.
Instructions: All submissions received
DATES: Submit either electronic or must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
written comments on the collection of 2011–N–0016 for ‘‘Recordkeeping and PRA (44 U.S.C. 3501–3520), Federal
information by August 14, 2017. Records Access Requirements for Food Agencies must obtain approval from the
ADDRESSES: You may submit comments Facilities.’’ Received comments, those Office of Management and Budget
as follows. Please note that late, filed in a timely manner (see (OMB) for each collection of
untimely filed comments will not be ADDRESSES), will be placed in the docket information they conduct or sponsor.
considered. Electronic comments must and, except for those submitted as ‘‘Collection of information’’ is defined
be submitted on or before August 14, ‘‘Confidential Submissions,’’ publicly in 44 U.S.C. 3502(3) and 5 CFR
2017. The https://www.regulations.gov viewable at https:// 1320.3(c) and includes Agency requests
electronic filing system will accept www.regulations.gov/ or at the Division or requirements that members of the
comments until midnight Eastern Time of Dockets Management between 9 a.m. public submit reports, keep records, or
at the end of August 14, 2017. and 4 p.m., Monday through Friday. provide information to a third party.
Comments received by mail/hand • Confidential Submissions—To Section 3506(c)(2)(A) of the PRA (44
delivery/courier (for written/paper submit a comment with confidential U.S.C. 3506(c)(2)(A)) requires Federal
submissions) will be considered timely information that you do not wish to be Agencies to provide a 60-day notice in
if they are postmarked or the delivery made publicly available, submit your the Federal Register concerning each
service acceptance receipt is on or comments only as a written/paper proposed collection of information,
mstockstill on DSK30JT082PROD with NOTICES
before that date. submission. You should submit two including each proposed extension of an
copies total. One copy will include the existing collection of information,
Electronic Submissions information you claim to be confidential before submitting the collection to OMB
Submit electronic comments in the with a heading or cover note that states for approval. To comply with this
following way: ‘‘THIS DOCUMENT CONTAINS requirement, FDA is publishing notice
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ We of the proposed collection of
https://www.regulations.gov/. Follow will review this copy, including the information set forth in this document.
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Document Created: 2017-06-14 01:24:00
Document Modified: 2017-06-14 01:24:00
| 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 14, 2017. 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 11, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 82 FR 27261 |
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