80 FR 77641 - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 240 (December 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77641-77643 | |
| FR Document | 2015-31404 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Notices] [Pages 77641-77643] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31404] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-4462] Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following public workshop entitled [[Page 77642]] ``Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.'' The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA's process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness. DATES: The public workshop will be held on January 25, 2016, from 8 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by February 25, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-N-4462 for ``Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, rm. 1503 (the Great Room), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Rachel Goehe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Rm. 5533, Silver Spring, MD 20993, 240-402-6565, email: Rachel.Goehe@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Warfarin, an oral vitamin K antagonist, is a commonly prescribed anticoagulant drug used to reduce the risk of thromboembolic events. Warfarin inhibits the synthesis of clotting factors II, VII, IX, and X, in addition to the naturally occurring endogenous anticoagulant proteins C and S. The response of individual patients to warfarin is highly variable because of factors such as diet, age, and interaction with other drugs. As a consequence, it is important that warfarin dosage be tailored individually to maintain clinical benefit. The PT test is used to determine a patient's clotting time, which the Clinical and Laboratory Standards Institute defines as the time in seconds required for a fibrin clot to form in a plasma sample after tissue thromboplastin and an optimal amount of calcium chloride have been added to the sample. It is well-recognized that a PT result obtained with one test system cannot be compared to a PT result obtained with another test system because of the variety of thromboplastins used in different test systems. Therefore, PT test results are converted into a standardized unit known as the INR, which was adopted by the World Health Organization with the intent to reduce intersystem variation in test results. The INR result is used to monitor patients' response to warfarin. POC PT/INR devices offer an alternative to laboratory-based testing and venipuncture, enabling a rapid INR determination from a finger stick sample of whole blood. POC devices can be [[Page 77643]] used in a variety of settings including, but not limited to, physician's office laboratory, anti-coagulation clinic, patient bedside, hospital emergency department, and prescription home use. The purpose of POC PT/INR testing is to monitor warfarin and to provide immediate information to physicians about the patient's anticoagulation status so that this information can be integrated into appropriate treatment decisions that can improve patient outcomes. POC PT/INR testing is increasingly being viewed as a testing modality with performance expectations similar to that of traditional laboratory testing. From a regulatory standpoint, POC PT/INR devices have been reviewed and cleared for prescription use under appropriate professional supervision or prescription home use (patient self- testing), depending on the claimed intended use. For this workshop, both settings will be open for discussion. II. Topics for Discussion at the Public Workshop This public workshop will consist of presentations covering the topics listed in this document. Following the presentations, there will be a moderated panel discussion where participants will be asked to provide their perspectives. The workshop panel discussion will focus on identifying potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices. In advance of the meeting, FDA plans to post a discussion paper outlining FDA's current thinking on the various topics mentioned in the following list, and invite comment on this from the community. Topics to be discussed at the public workshop include, but are not limited to, the following: Current regulatory process involved with the clearance of POC PT/INR devices. Current benefit/risk balance of POC PT/INR devices. Technological differences amongst marketed POC PT/INR devices, advantages and limitations of each technology, and comparability of test results obtained using different technologies. Challenges associated with correlating results from whole blood POC PT/INR devices to conventional plasma-based laboratory tests. Appropriate study design for validation and usability studies from the perspectives of the Agency, manufacturers and end users to help improve our understanding of the accuracy, reliability and safety of POC PT/INR devices. Types of quality control and the test system elements assessed by the controls. Challenges associated with different sample matrices (venous, fingerstick, arterial). Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m., January 15, 2016. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Office of Communication and Education, 301-796-5661, email: Susan.Monahan@fda.hhs.gov no later than January 11, 2016. To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Susan Monahan (contact for special accommodations) to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. The Webcast link will be available on the workshop Web page after January 18, 2016. Please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Dated: December 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31404 Filed 12-14-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices 77641
copies to the Division of Dockets actual amount of extension that the 203137 was approved on October 25,
Management. If you do not wish your Director of USPTO may award (for 2013.
name and contact information to be example, half the testing phase must be This determination of the regulatory
made publicly available, you can subtracted as well as any time that may review period establishes the maximum
provide this information on the cover have occurred before the patent was potential length of a patent extension.
sheet and not in the body of your issued), FDA’s determination of the However, the USPTO applies several
comments and you must identify this length of a regulatory review period for statutory limitations in its calculations
information as ‘‘confidential.’’ Any a human drug product will include all of the actual period for patent extension.
information marked as ‘‘confidential’’ of the testing phase and approval phase In its application for patent extension,
will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). this applicant seeks 951 days of patent
accordance with 21 CFR 10.20 and other FDA has approved for marketing the term extension.
applicable disclosure law. For more human drug product VIZAMYL III. Petitions
information about FDA’s posting of (flumetamol F18 injection). VIZAMYL is
comments to public dockets, see 80 FR a radioactive diagnostic agent indicated Anyone with knowledge that any of
56469, September 18, 2015, or access for Positron Emission Tomography the dates as published are incorrect may
the information at: http://www.fda.gov/ submit either electronic or written
imaging of the brain to estimate b
regulatoryinformation/dockets/ comments and ask for a redetermination
amyloid neuritic plaque density in adult
default.htm. (see DATES). Furthermore, any interested
patients with cognitive impairment who
Docket: For access to the docket to person may petition FDA for a
are being evaluated for Alzheimer’s
read background documents or the determination regarding whether the
disease or other causes of cognitive
electronic and written/paper comments applicant for extension acted with due
decline. Subsequent to this approval,
received, go to http:// diligence during the regulatory review
the USPTO received a patent term
www.regulations.gov and insert the period. To meet its burden, the petition
restoration application for VIZAMYL
docket number, found in brackets in the must be timely (see DATES) and contain
(U.S. Patent No. 7,270,800) from GE
heading of this document, into the sufficient facts to merit an FDA
Healthcare Limited, and the USPTO
‘‘Search’’ box and follow the prompts investigation. (See H. Rept. 857, part 1,
requested FDA’s assistance in
and/or go to the Division of Dockets 98th Cong., 2d sess., pp. 41–42, 1984.)
determining this patent’s eligibility for
Management, 5630 Fishers Lane, Rm. Petitions should be in the format
patent term restoration. In a letter dated
1061, Rockville, MD 20852. specified in 21 CFR 10.30.
March 27, 2014, FDA advised the Submit petitions electronically to
FOR FURTHER INFORMATION CONTACT: USPTO that this human drug product http://www.regulations.gov at Docket
Beverly Friedman, Office of Regulatory had undergone a regulatory review No. FDA–2013–S–0610. Submit written
Policy, Food and Drug Administration, period and that the approval of petitions (two copies are required) to the
10903 New Hampshire Ave., Bldg. 51, VIZAMYL represented the first Division of Dockets Management (HFA–
Rm. 6250, Silver Spring, MD 20993, permitted commercial marketing or use 305), Food and Drug Administration,
301–796–3600. of the product. Thereafter, the USPTO 5630 Fishers Lane, Rm. 1061, Rockville,
SUPPLEMENTARY INFORMATION: requested that FDA determine the MD 20852. Petitions that have not been
product’s regulatory review period. made publicly available on http://
I. Background
II. Determination of Regulatory Review www.regulations.gov may be viewed in
The Drug Price Competition and Period the Division of Dockets Management
Patent Term Restoration Act of 1984 between 9 a.m. and 4 p.m., Monday
(Pub. L. 98–417) and the Generic FDA has determined that the
through Friday.
Animal Drug and Patent Term applicable regulatory review period for
VIZAMYL is 1,541 days. Of this time, Dated: December 8, 2015.
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be 1,176 days occurred during the testing Leslie Kux,
extended for a period of up to 5 years phase of the regulatory review period, Associate Commissioner for Policy.
so long as the patented item (human while 365 days occurred during the [FR Doc. 2015–31401 Filed 12–14–15; 8:45 am]
drug product, animal drug product, approval phase. These periods of time BILLING CODE 4164–01–P
medical device, food additive, or color were derived from the following dates:
additive) was subject to regulatory 1. The date an exemption under
review by FDA before the item was section 505(i) of the Federal Food, Drug, DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s and Cosmetic Act (the FD&C Act) (21 HUMAN SERVICES
regulatory review period forms the basis U.S.C. 355(i)) became effective: August
8, 2009. FDA has verified the Food and Drug Administration
for determining the amount of extension
an applicant may receive. applicant’s claim that the date the [Docket No. FDA–2015–N–4462]
A regulatory review period consists of investigational new drug application
two periods of time: A testing phase and (IND) became effective was on August 8, Point of Care Prothrombin Time/
an approval phase. For human drug 2009. International Normalized Ratio Devices
products, the testing phase begins when 2. The date the application was for Monitoring Warfarin Therapy;
the exemption to permit the clinical initially submitted with respect to the Public Workshop; Request for
investigations of the drug becomes human drug product under section Comments
asabaliauskas on DSK5VPTVN1PROD with NOTICES
effective and runs until the approval 505(b) of the FD&C Act: October 26, AGENCY: Food and Drug Administration,
phase begins. The approval phase starts 2012. FDA has verified the applicant’s HHS.
with the initial submission of an claim that the new drug application ACTION: Notice of public workshop;
application to market the human drug (NDA) for VIZAMYL (NDA 203137) was request for comments.
product and continues until FDA grants initially submitted on October 26, 2012.
permission to market the drug product. 3. The date the application was SUMMARY: The Food and Drug
Although only a portion of a regulatory approved: October 25, 2013. FDA has Administration (FDA) is announcing the
review period may count toward the verified the applicant’s claim that NDA following public workshop entitled
VerDate Sep<11>2014 17:08 Dec 14, 2015 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\15DEN1.SGM 15DEN1](https://thefederalregister.org/doc/80_FR_77881/page/1.svg)
![Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices 77643
used in a variety of settings including, accuracy, reliability and safety of POC Transcripts: Please be advised that as
but not limited to, physician’s office PT/INR devices. soon as a transcript is available, it will
laboratory, anti-coagulation clinic, • Types of quality control and the test be accessible at http://
patient bedside, hospital emergency system elements assessed by the www.regulations.gov. It may be viewed
department, and prescription home use. controls. at the Division of Dockets Management
The purpose of POC PT/INR testing is • Challenges associated with different (see ADDRESSES). A transcript will also
to monitor warfarin and to provide sample matrices (venous, fingerstick, be available in either hardcopy or on
immediate information to physicians arterial). CD–ROM, after submission of a
about the patient’s anticoagulation Registration: Registration is free and Freedom of Information request. The
status so that this information can be available on a first-come, first-served Freedom of Information office address is
integrated into appropriate treatment basis. Persons interested in attending available on the Agency’s Web site at
decisions that can improve patient this public workshop must register http://www.fda.gov. A link to the
outcomes. POC PT/INR testing is online by 4 p.m., January 15, 2016. Early transcripts will also be available
increasingly being viewed as a testing registration is recommended because approximately 45 days after the public
modality with performance expectations facilities are limited and, therefore, FDA workshop on the Internet at http://
similar to that of traditional laboratory may limit the number of participants www.fda.gov/MedicalDevices/
testing. From a regulatory standpoint, from each organization. If time and NewsEvents/WorkshopsConferences/
POC PT/INR devices have been space permits, onsite registration on the default.htm. (Select this public
reviewed and cleared for prescription day of the public workshop will be workshop from the posted events list).
use under appropriate professional provided beginning at 7 a.m.
If you need special accommodations Dated: December 7, 2015.
supervision or prescription home use Leslie Kux,
due to a disability, please contact Susan
(patient self-testing), depending on the
Monahan, Center for Devices and Associate Commissioner for Policy.
claimed intended use. For this
Radiological Health, Office of [FR Doc. 2015–31404 Filed 12–14–15; 8:45 am]
workshop, both settings will be open for
Communication and Education, 301– BILLING CODE 4164–01–P
discussion.
796–5661, email: Susan.Monahan@
II. Topics for Discussion at the Public fda.hhs.gov no later than January 11,
Workshop 2016. DEPARTMENT OF HEALTH AND
To register for the public workshop, HUMAN SERVICES
This public workshop will consist of please visit FDA’s Medical Devices
presentations covering the topics listed News & Events—Workshops & Food and Drug Administration
in this document. Following the Conferences calendar at http://
presentations, there will be a moderated www.fda.gov/MedicalDevices/
panel discussion where participants [Docket No. FDA–2013–E–1575]
NewsEvents/WorkshopsConferences/
will be asked to provide their default.htm. (Select this public Determination of Regulatory Review
perspectives. The workshop panel workshop from the posted events list.) Period for Purposes of Patent
discussion will focus on identifying Please provide complete contact Extension; RAXIBACUMAB
potential solutions to address the information for each attendee, including
scientific and regulatory challenges name, title, affiliation, address, email, AGENCY: Food and Drug Administration,
associated with POC PT/INR devices. In and telephone number. Those without HHS.
advance of the meeting, FDA plans to Internet access should contact Susan ACTION: Notice.
post a discussion paper outlining FDA’s Monahan (contact for special
current thinking on the various topics accommodations) to register. Registrants SUMMARY: The Food and Drug
mentioned in the following list, and will receive confirmation after they have Administration (FDA) has determined
invite comment on this from the been accepted. You will be notified if the regulatory review period for
community. you are on a waiting list. RAXIBACUMAB and is publishing this
Topics to be discussed at the public Streaming Webcast of the Public notice of that determination as required
workshop include, but are not limited Workshop: This public workshop will by law. FDA has made the
to, the following: also be Webcast. The Webcast link will determination because of the
• Current regulatory process involved be available on the workshop Web page submission of an application to the
with the clearance of POC PT/INR after January 18, 2016. Please visit Director of the U.S. Patent and
devices. FDA’s Medical Devices News & Trademark Office (USPTO), Department
• Current benefit/risk balance of POC Events—Workshops & Conferences of Commerce, for the extension of a
PT/INR devices. calendar at http://www.fda.gov/ patent which claims that human
• Technological differences amongst MedicalDevices/NewsEvents/ biological product.
marketed POC PT/INR devices, WorkshopsConferences/default.htm. DATES: Anyone with knowledge that any
advantages and limitations of each (Select this public workshop from the of the dates as published (see the
technology, and comparability of test posted events list.) If you have never SUPPLEMENTARY INFORMATION section) are
results obtained using different attended a Connect Pro event before, incorrect may submit either electronic
technologies. test your connection at https:// or written comments and ask for a
• Challenges associated with collaboration.fda.gov/common/help/en/ redetermination by February 16, 2016.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
correlating results from whole blood support/meeting_test.htm. To get a Furthermore, any interested person may
POC PT/INR devices to conventional quick overview of the Connect Pro petition FDA for a determination
plasma-based laboratory tests. program, visit http://www.adobe.com/ regarding whether the applicant for
• Appropriate study design for go/connectpro_overview. FDA has extension acted with due diligence
validation and usability studies from the verified the Web site addresses, as of the during the regulatory review period by
perspectives of the Agency, date this document publishes in the June 13, 2016. See ‘‘Petitions’’ in the
manufacturers and end users to help Federal Register, but Web sites are SUPPLEMENTARY INFORMATION section for
improve our understanding of the subject to change over time. more information.
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Document Created: 2018-03-02 09:16:39
Document Modified: 2018-03-02 09:16:39
| 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 of public workshop; request for comments. | |
| Dates | The public workshop will be held on January 25, 2016, from 8 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by February 25, 2016. | |
| Contact | Rachel Goehe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Rm. 5533, Silver Spring, MD 20993, 240-402-6565, email: [email protected] | |
| FR Citation | 80 FR 77641 |
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