81 FR 85965 - Determination of Regulatory Review Period for Purposes of Patent Extension; IXINITY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 229 (November 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 229 (November 29, 2016)
| Page Range | 85965-85966 | |
| FR Document | 2016-28653 |
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)] [Notices] [Pages 85965-85966] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28653] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-E-4669 and FDA-2015-E-4659] Determination of Regulatory Review Period for Purposes of Patent Extension; IXINITY AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for IXINITY 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 biological product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 30, 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 May 30, 2017. 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: 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. 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 Nos. FDA-2015-E-4669 and FDA-2015-E-4659 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; IXINITY.'' Received comments will be placed in the dockets and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets [[Page 85966]] 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: 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 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of the 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 biological 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 biologic product IXINITY (Coagulation Factor IX (recombinant)). IXINITY is indicated for control and prevention of bleeding episodes and for perioperative management, in adults and children >=12 years of age with hemophilia B. Subsequent to this approval, the USPTO received patent term restoration applications for IXINITY (U.S. Patent Nos. 7,645,602 and 8,603,823) from the University of North Carolina at Chapel Hill, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated March 10, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of IXINITY 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 IXINITY is 2,437 days. Of this time, 1,318 days occurred during the testing phase of the regulatory review period, while 1,119 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 (21 U.S.C. 355(i)) became effective: August 28, 2008. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 28, 2008. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): April 6, 2012. The applicant claims April 5, 2012, as the date the biologics license application (BLA) for IXINITY (BLA 125426) was initially submitted. However, FDA records indicate that BLA 125426 was submitted on April 6, 2012. 3. The date the application was approved: April 29, 2015. FDA has verified the applicant's claim that BLA 125426 was approved on April 29, 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 applications for patent extension, this applicant seeks 1,526 days or 505 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to 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, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: November 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28653 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85965
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total annual
Instrument responses per burden hours
respondents burden hours
respondent per response
Virtual Conference (VC) Session Surveys ...................................................... 450 6 .08 216
VC Focus Group Guide ................................................................................... 30 1 1 30
VC Interview Guide .......................................................................................... 20 1 .5 10
VC Registration Data ....................................................................................... 1000 1 .03 30
Tailored Services Practice Model Survey ........................................................ 130 1 .25 32.5
Assessment Observation—group debrief ........................................................ 50 1 .25 12.5
Service Delivery and Tracking and Adjustment Observation—group debrief 45 1 .25 11.3
Assessment and Service Delivery and Tracking and Adjustment State Lead
Interviews ..................................................................................................... 20 1 .5 10
Annual Assessment Update (8 systematic questions) .................................... 54 1 .08 4.3
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to
Hours: 356.6. HUMAN SERVICES the docket unchanged. Because your
In compliance with the requirements comment will be made public, you are
Food and Drug Administration solely responsible for ensuring that your
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the [Docket Nos. FDA–2015–E–4669 and FDA– comment does not include any
2015–E–4659] confidential information that you or a
Administration for Children and
third party may not wish to be posted,
Families is soliciting public comment
Determination of Regulatory Review such as medical information, your or
on the specific aspects of the anyone else’s Social Security number, or
Period for Purposes of Patent
information collection described above. Extension; IXINITY confidential business information, such
Copies of the proposed collection of as a manufacturing process. Please note
information can be obtained and AGENCY: Food and Drug Administration, that if you include your name, contact
comments may be forwarded by writing HHS. information, or other information that
to the Administration for Children and ACTION: Notice. identifies you in the body of your
Families, Office of Planning, Research comments, that information will be
SUMMARY: The Food and Drug
and Evaluation, 330 C Street SW., posted on https://www.regulations.gov.
Administration (FDA) has determined
Washington, DC 20201. Attn: ACF
the regulatory review period for • If you want to submit a comment
Reports Clearance Officer. Email with confidential information that you
IXINITY and is publishing this notice of
address: infocollection@acf.hhs.gov. All that determination as required by law. do not wish to be made available to the
requests should be identified by the title FDA has made the determination public, submit the comment as a
of the information collection. because of the submission of written/paper submission and in the
The Department specifically requests applications to the Director of the U.S. manner detailed (see ‘‘Written/Paper
comments on (a) whether the proposed Patent and Trademark Office (USPTO), Submissions’’ and ‘‘Instructions’’).
collection of information is necessary Department of Commerce, for the Written/Paper Submissions
for the proper performance of the extension of a patent which claims that
functions of the agency, including human biological product. Submit written/paper submissions as
whether the information shall have DATES: Anyone with knowledge that any
follows:
practical utility; (b) the accuracy of the of the dates as published (see the • Mail/Hand delivery/Courier (for
agency’s estimate of the burden of the SUPPLEMENTARY INFORMATION section) are written/paper submissions): Division of
proposed collection of information; (c) incorrect may submit either electronic Dockets Management (HFA–305), Food
or written comments and ask for a and Drug Administration, 5630 Fishers
the quality, utility, and clarity of the
redetermination by January 30, 2017. Lane, Rm. 1061, Rockville, MD 20852.
information to be collected; and (d)
ways to minimize the burden of the Furthermore, any interested person may • For written/paper comments
petition FDA for a determination submitted to the Division of Dockets
collection of information on
regarding whether the applicant for Management, FDA will post your
respondents, including through the use
extension acted with due diligence comment, as well as any attachments,
of automated collection techniques or except for information submitted,
other forms of information technology. during the regulatory review period by
May 30, 2017. See ‘‘Petitions’’ in the marked and identified, as confidential,
Consideration will be given to if submitted as detailed in
SUPPLEMENTARY INFORMATION section for
comments and suggestions submitted ‘‘Instructions.’’
more information.
within 60 days of this publication. Instructions: All submissions received
ADDRESSES: You may submit comments
Robert Sargis, as follows: must include the Docket Nos. FDA–
2015–E–4669 and FDA–2015–E–4659
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Reports Clearance Officer. Electronic Submissions for ‘‘Determination of Regulatory
[FR Doc. 2016–28678 Filed 11–28–16; 8:45 am]
Submit electronic comments in the Review Period for Purposes of Patent
BILLING CODE 4184–01–P
following way: Extension; IXINITY.’’ Received
• Federal eRulemaking Portal: comments will be placed in the dockets
https://www.regulations.gov. Follow the and, except for those submitted as
instructions for submitting comments. ‘‘Confidential Submissions,’’ publicly
Comments submitted electronically, viewable at https://www.regulations.gov
including attachments, to https:// or at the Division of Dockets
VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/81_FR_86194/page/1.svg)
![85966 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
Management between 9 a.m. and 4 p.m., medical device, food additive, or color 1. The date an exemption under
Monday through Friday. additive) was subject to regulatory section 505(i) of the Federal Food, Drug,
• Confidential Submissions—To review by FDA before the item was and Cosmetic Act (21 U.S.C. 355(i))
submit a comment with confidential marketed. Under these acts, a product’s became effective: August 28, 2008. FDA
information that you do not wish to be regulatory review period forms the basis has verified the applicant’s claim that
made publicly available, submit your for determining the amount of extension the date the investigational new drug
comments only as a written/paper an applicant may receive. application became effective was on
submission. You should submit two A regulatory review period consists of August 28, 2008.
copies total. One copy will include the two periods of time: A testing phase and
information you claim to be confidential an approval phase. For human 2. The date the application was
with a heading or cover note that states biological products, the testing phase initially submitted with respect to the
‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit human biological product under section
CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the 351 of the Public Health Service Act (42
Agency will review this copy, including biological becomes effective and runs U.S.C. 262): April 6, 2012. The
the claimed confidential information, in until the approval phase begins. The applicant claims April 5, 2012, as the
its consideration of comments. The approval phase starts with the initial date the biologics license application
second copy, which will have the submission of an application to market (BLA) for IXINITY (BLA 125426) was
claimed confidential information the human biological product and initially submitted. However, FDA
redacted/blacked out, will be available continues until FDA grants permission records indicate that BLA 125426 was
for public viewing and posted on to market the biological product. submitted on April 6, 2012.
https://www.regulations.gov. Submit Although only a portion of a regulatory
review period may count toward the 3. The date the application was
both copies to the Division of Dockets approved: April 29, 2015. FDA has
Management. If you do not wish your actual amount of extension that the
Director of the USPTO may award (for verified the applicant’s claim that BLA
name and contact information to be
example, half the testing phase must be 125426 was approved on April 29, 2015.
made publicly available, you can
provide this information on the cover subtracted as well as any time that may This determination of the regulatory
sheet and not in the body of your have occurred before the patent was review period establishes the maximum
comments and you must identify this issued), FDA’s determination of the potential length of a patent extension.
information as ‘‘confidential.’’ Any length of a regulatory review period for However, the USPTO applies several
information marked as ‘‘confidential’’ a human biological product will include statutory limitations in its calculations
will not be disclosed except in all of the testing phase and approval of the actual period for patent extension.
accordance with 21 CFR 10.20 and other phase as specified in 35 U.S.C. In its applications for patent extension,
applicable disclosure law. For more 156(g)(1)(B). this applicant seeks 1,526 days or 505
information about FDA’s posting of FDA has approved for marketing the
human biologic product IXINITY days of patent term extension.
comments to public dockets, see 80 FR
(Coagulation Factor IX (recombinant)). III. Petitions
56469, September 18, 2015, or access
IXINITY is indicated for control and
the information at: http://www.fda.gov/ Anyone with knowledge that any of
prevention of bleeding episodes and for
regulatoryinformation/dockets/
perioperative management, in adults the dates as published are incorrect may
default.htm.
and children ≥12 years of age with submit either electronic or written
Docket: For access to the docket to
hemophilia B. Subsequent to this comments and ask for a redetermination
read background documents or the
approval, the USPTO received patent (see DATES). Furthermore, any interested
electronic and written/paper comments
term restoration applications for person may petition FDA for a
received, go to https://
IXINITY (U.S. Patent Nos. 7,645,602 and determination regarding whether the
www.regulations.gov and insert the
8,603,823) from the University of North applicant for extension acted with due
docket number, found in brackets in the
Carolina at Chapel Hill, and the USPTO diligence during the regulatory review
heading of this document, into the requested FDA’s assistance in
‘‘Search’’ box and follow the prompts period. To meet its burden, the petition
determining the patents’ eligibility for must be timely (see DATES) and contain
and/or go to the Division of Dockets patent term restoration. In a letter dated
Management, 5630 Fishers Lane, Rm. sufficient facts to merit an FDA
March 10, 2016, FDA advised the
1061, Rockville, MD 20852. investigation. (See H. Rept. 857, part 1,
USPTO that this human biological
FOR FURTHER INFORMATION CONTACT: 98th Cong., 2d sess., pp. 41–42, 1984.)
product had undergone a regulatory
Beverly Friedman, Office of Regulatory Petitions should be in the format
review period and that the approval of
Policy, Food and Drug Administration, IXINITY represented the first permitted specified in 21 CFR 10.30.
10903 New Hampshire Ave., Bldg. 51, commercial marketing or use of the Submit petitions electronically to
Rm. 6250, Silver Spring, MD 20993, product. Thereafter, the USPTO https://www.regulations.gov at Docket
301–796–3600. requested that FDA determine the No. FDA–2013–S–0610. Submit written
SUPPLEMENTARY INFORMATION: product’s regulatory review period. petitions (two copies are required) to the
I. Background II. Determination of Regulatory Review Division of Dockets Management (HFA–
Period 305), Food and Drug Administration,
The Drug Price Competition and
asabaliauskas on DSK3SPTVN1PROD with NOTICES
5630 Fishers Lane, Rm. 1061, Rockville,
Patent Term Restoration Act of 1984 FDA has determined that the MD 20852.
(Pub. L. 98–417) and the Generic applicable regulatory review period for
Animal Drug and Patent Term IXINITY is 2,437 days. Of this time, Dated: November 22, 2016.
Restoration Act (Pub. L. 100–670) 1,318 days occurred during the testing Leslie Kux,
generally provide that a patent may be phase of the regulatory review period, Associate Commissioner for Policy.
extended for a period of up to 5 years while 1,119 days occurred during the [FR Doc. 2016–28653 Filed 11–28–16; 8:45 am]
so long as the patented item (human approval phase. These periods of time BILLING CODE 4164–01–P
drug product, animal drug product, were derived from the following dates:
VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/81_FR_86194/page/2.svg)
Document Created: 2016-11-29 00:32:54
Document Modified: 2016-11-29 00:32:54
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 30, 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 May 30, 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 | 81 FR 85965 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR