80 FR 34679 - Medical Device User Fee Amendments; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 116 (June 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 116 (June 17, 2015)
| Page Range | 34679-34681 | |
| FR Document | 2015-14885 |
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)] [Notices] [Pages 34679-34681] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14885] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0389] Medical Device User Fee Amendments; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- The Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2018 through 2022. The current legislative authority for the medical device user fee program expires on October 1, 2017, and new legislation will be required for FDA to continue collecting user fees for the medical device program in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on MDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA, and publish the comments on FDA's Web site. FDA invites public comment on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program. Date and Time: The public meeting will be held on July 13, 2015, from 9 a.m. to 5 p.m. Location: The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for public meeting participants (non-FDA employees) is through Building 1 where routine security screening procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Contact Person: Aaron Josephson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993, 301-796-5178, email: [email protected]. Registration: Registration is required to attend this meeting in person or to view the Webcast. Registration is free and available on a first-come, first-served basis. Persons interested in participating in the meeting must register online by July 2, 2015, at 4 p.m. Early registration is recommended because space is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the meeting will be provided beginning at 8 a.m. If you have registered and need special accommodations, please contact Susan Monahan, 301-796-5661, email: [email protected], no later than July 1, 2015. To register for the public meeting, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public meeting from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register. All registrants will receive confirmation after they have been successfully registered. Registrants not confirmed to participate, but added to a waiting list, will be notified of that as well. Streaming Webcast of the Public Meeting: This public meeting will be Webcast. Persons interested in viewing the Webcast must register online (see Web link above) by July 2, 2015, at 4 p.m. Early registration is recommended because Webcast connections are limited. FDA requests that organizations with multiple registrants in the same location register all participants individually but view the Webcast using one connection per location. Webcast participants will be sent technical system requirements upon confirmation and will be sent connection access information after July 6, 2015. If you have not previously attended an event hosted by Connect Pro, it is recommended that you test your connection in advance at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. A short overview of the Connect Pro program is available at http://www.adobe.com/go/connectpro_overview. Requests for Oral Presentations: This public meeting includes public comment and topic-focused sessions. During registration you may indicate if you wish to present during a public comment session or participate in a topic-focused session, and specify the topic(s) you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate all persons who wish to speak. FDA encourages individuals and organizations with common interests to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the topic-focused sessions. After [[Page 34680]] registration closes, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will notify selected speakers by July 7, 2015. All requests to make oral presentations must be received by the close of registration on July 2, 2015, at 4 p.m. Presenters should submit all presentation materials via email to Aaron Josephson (see Contact Person) no later than July 10, 2015. No commercial or promotional material should be presented or distributed at the public meeting. Comments: FDA is holding this public meeting to hear stakeholder views on the medical device user fee program. In order to obtain a broad range of public comment, FDA is soliciting either electronic or written comments on all aspects of the public meeting topics. The deadline for submitting comments related to this public meeting is August 12, 2015. Regardless of attendance at the public meeting, interested persons may submit either electronic comments regarding reauthorization of MDUFA to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section I, please identify the question you are addressing. Received comments may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: As soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may also be viewed in person at the Division of Dockets Management (see Comments). A link to the transcript 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 meeting from the posted events list.) SUPPLEMENTARY INFORMATION: I. Background FDA is announcing its intention to hold a public meeting on the reauthorization of the Medical Device User Fee Amendments of 2012 (MDUFA III), which currently authorizes FDA to collect user fees and use them for the process for the review of device applications until October 1, 2017. Without new legislation, referred to as reauthorization, FDA will not be able to collect user fees after fiscal year (FY) 2017 to fund the medical device review process. Prior to reauthorization, FDA must consult with the regulated industry and make recommendations to Congress regarding the goals for the process for the review of device applications (see 21 U.S.C. 379j- 1(b)(1)(F)). Before beginning negotiations with the regulated industry on user fee reauthorization, section 738A(b)(2) of the FD&C Act (21 U.S.C. 379j-1(b)(2)) requires that FDA do the following: (1) Publish a notice in the Federal Register requesting public input on the reauthorization; (2) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals set under MDUFA III; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to MDUFA; and (4) publish the comments on FDA's Web site. This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on FDA's Web site will satisfy these requirements. The purpose of the meeting is to hear stakeholder views on medical device user fee reauthorization as we consider FDA's recommendation to Congress for the next medical device user fee program. FDA is interested in responses to the following two general questions and welcomes any other pertinent information stakeholders would like to share: 1. What is your assessment of the overall performance of the medical device user fee program under MDUFA III? 2. What aspects of the medical device user fee program should be retained, changed, or discontinued to further strengthen and improve the program? The following information is provided to help potential meeting participants better understand the history and evolution of the medical device user fee program and its current status. II. What is the Medical Device User Fee Program? What does it do? In the years preceding enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), FDA's medical device program suffered a long-term, significant loss of resources that undermined the program's capacity and performance. MDUFMA was enacted ``in order to provide FDA with the resources necessary to better review medical devices, to enact needed regulatory reforms so that medical device manufacturers can bring their safe and effective devices to the American people at an earlier point in time, and to ensure that reprocessed medical devices are as safe and effective as original devices'' (H. Rept. 107-728 at 21 (2002)). MDUFMA had a 5-year life and contained two particularly important features which relate to reauthorization:User fees for the review of medical device premarket applications, reports, supplements, and premarket notification submissions provided additional resources to make FDA reviews more timely, predictable, and transparent to applicants. MDUFMA fees and appropriations for the medical device program helped FDA expand available expertise, modernized its information management systems, provided new review options, and provided more guidance to prospective submitters. The ultimate goal was for FDA to approve and clear safe and effective medical devices more rapidly, benefiting applicants, the health care community, and most importantly, patients. Negotiated performance goals for many types of premarket reviews provided FDA with benchmarks for measuring review improvements. These quantifiable goals became more demanding each year and included FDA decision goals and cycle goals (cycle goals refer to FDA actions prior to a final action on a submission). Under MDUFMA, FDA also agreed to several other commitments that did not have specific timeframes or direct measures of performance, such as expanding the use of meetings with industry, maintenance of current performance in review areas where specific performance goals had not been identified, and publication of additional guidance documents. Medical device user fees and increased appropriations are essential to support high-quality, timely medical device reviews, and other activities critical to the device review program. MDUFMA provided for fee discounts and waivers for qualifying small businesses. Small businesses make up a large proportion of the medical device industry, and these discounts and waivers helped reduce the financial impact of user fees on this sector of the medical device industry, which plays an important role in fostering innovation. Since MDUFMA was first passed in 2002, it has been reauthorized twice: The 2007 Medical Device User Fee Amendments (MDUFA II) and the 2012 Medical Device User Fee Amendments (MDUFA III). Under MDUFA III, which [[Page 34681]] has been in effect since 2012 and will expire in 2017, FDA has met or exceeded nearly all submission performance goals while implementing program enhancements designed to ensure more timely access to safe and effective medical devices. Premarket Notifications (510(k)s): Comparison of outcomes for receipt cohorts at the same levels of completion (or ``closure'') show a 16 percent decrease in total review time between FY 2010 and FY 2013 when the cohort is 99.8 percent closed, and 10 percent decrease in total review time between FY 2010 and FY 2014 when the cohort is 75.8 percent closed. Premarket Approvals (PMAs): Comparison of outcomes for receipt cohorts at the same closure levels show a 32 percent decrease in total review times between FY 2009 and FY 2012 when the cohort is 98 percent closed, and a 26 percent decrease in total review times between FY 2009 and FY 2014 when the cohort is 41 percent closed. FDA has met or exceeded all MDUFA III performance goals for FDA time to decisions in FY 2013 and FY 2014. More information about FDA's performance is available in the yearly MDUFA performance reports, which are available online at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM2007450.htm. User fees and related performance goals have played an important role in providing resources and supporting the process for the review of device applications. III. What information should you know about the meeting? Through this notice, we are announcing a public meeting to hear stakeholder views on the reauthorization of MDUFA for fiscal years 2018 through 2022, including specific suggestions for any changes to the program that we should consider. We will conduct the meeting on July 13, 2015. In general, the meeting format will include presentations by FDA and a series of panels representing different stakeholder interest groups (such as patient advocates, consumer protection groups, industry, health care professionals, and academic researchers). FDA will also provide an opportunity for individuals to make presentations during the meeting and for organizations and individuals to submit written comments to the docket after the meeting. The presentations should focus on program improvements and funding issues, including specific suggestions for changes to performance goals, and not focus on other general policy issues. Dated: June 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-14885 Filed 6-16-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34679
Format for Abbreviated 510(k)s for Early ACTION: Notice of public meeting; registration on the day of the meeting
Growth Response 1 (EGR1) Gene request for comments. will be provided beginning at 8 a.m.
Fluorescence In-Situ Hybridization If you have registered and need
(FISH) Test System for Specimen The Food and Drug Administration special accommodations, please contact
Characterization Devices.’’ It does not (FDA) is announcing a public meeting Susan Monahan, 301–796–5661, email:
establish any rights for any person and on the reauthorization of the Medical Susan.Monahan@fda.hhs.gov, no later
is not binding on FDA or the public. Device User Fee Amendments (MDUFA) than July 1, 2015.
You can use an alternative approach if for fiscal years 2018 through 2022. The To register for the public meeting,
it satisfies the requirements of the current legislative authority for the please visit FDA’s Medical Devices
applicable statutes and regulations. medical device user fee program expires News & Events—Workshops &
on October 1, 2017, and new legislation Conferences calendar at http://
III. Electronic Access will be required for FDA to continue www.fda.gov/MedicalDevices/
collecting user fees for the medical NewsEvents/WorkshopsConferences/
Persons with access to the Internet
device program in future fiscal years. default.htm. (Select this public meeting
may obtain the document at either
The Federal Food, Drug, and Cosmetic from the posted events list.) Please
http://www.fda.gov/Drugs/Guidance
Act (FD&C Act) requires that before FDA provide complete contact information
ComplianceRegulatoryInformation/
begins negotiations with the regulated for each attendee, including name, title,
Guidances/default.htm or http://
industry on MDUFA reauthorization, we affiliation, email, and telephone
www.regulations.gov.
publish a notice in the Federal Register number. Those without Internet access
IV. Paperwork Reduction Act of 1995 requesting public input on the should contact Susan Monahan to
reauthorization, hold a public meeting register. All registrants will receive
This guidance refers to currently
at which the public may present its confirmation after they have been
approved collections of information
views on the reauthorization, provide a successfully registered. Registrants not
found in FDA regulations. These
period of 30 days after the public confirmed to participate, but added to a
collections of information are subject to
meeting to obtain written comments waiting list, will be notified of that as
review by the Office of Management and
from the public suggesting changes to well.
Budget (OMB) under the Paperwork
MDUFA, and publish the comments on Streaming Webcast of the Public
Reduction Act of 1995 (44 U.S.C. 3501– Meeting: This public meeting will be
FDA’s Web site. FDA invites public
3520). The collections of information in Webcast. Persons interested in viewing
comment on the medical device user fee
21 CFR part 807, subpart E, are the Webcast must register online (see
program and suggestions regarding the
currently approved under OMB control Web link above) by July 2, 2015, at 4
commitments FDA should propose for
number 0910–0120 and the collections p.m. Early registration is recommended
the next reauthorized program.
of information in 21 CFR 809.10 are Date and Time: The public meeting because Webcast connections are
currently approved under 0910–0485. will be held on July 13, 2015, from 9 limited. FDA requests that organizations
V. Comments a.m. to 5 p.m. with multiple registrants in the same
Location: The public meeting will be location register all participants
Interested persons may submit either held at FDA’s White Oak Campus, individually but view the Webcast using
electronic comments regarding this 10903 New Hampshire Ave., Building one connection per location. Webcast
document to http://www.regulations.gov 31 Conference Center, the Great Room participants will be sent technical
or written comments to the Division of (Rm. 1503), Silver Spring, MD 20993. system requirements upon confirmation
Dockets Management (see ADDRESSES). It Entrance for public meeting participants and will be sent connection access
is only necessary to send one set of (non-FDA employees) is through information after July 6, 2015. If you
comments. Identify comments with the Building 1 where routine security have not previously attended an event
docket number found in brackets in the screening procedures will be performed. hosted by Connect Pro, it is
heading of this document. Received For parking and security information, recommended that you test your
comments may be seen in the Division please refer to http://www.fda.gov/ connection in advance at https://
of Dockets Management between 9 a.m. AboutFDA/WorkingatFDA/ collaboration.fda.gov/common/help/en/
and 4 p.m., Monday through Friday, and BuildingsandFacilities/ support/meeting_test.htm. A short
will be posted to the docket at http:// WhiteOakCampusInformation/ overview of the Connect Pro program is
www.regulations.gov. ucm241740.htm. available at http://www.adobe.com/go/
Dated: June 12, 2015. Contact Person: Aaron Josephson, connectpro_overview.
Leslie Kux, Center for Devices and Radiological Requests for Oral Presentations: This
Associate Commissioner for Policy. Health, Food and Drug Administration, public meeting includes public
10903 New Hampshire Ave., Bldg. 66, comment and topic-focused sessions.
[FR Doc. 2015–14881 Filed 6–16–15; 8:45 am]
Rm. 5449, Silver Spring, MD 20993, During registration you may indicate if
BILLING CODE 4164–01–P
301–796–5178, email: you wish to present during a public
Aaron.Josephson@fda.hhs.gov. comment session or participate in a
DEPARTMENT OF HEALTH AND Registration: Registration is required topic-focused session, and specify the
HUMAN SERVICES to attend this meeting in person or to topic(s) you wish to address. FDA has
view the Webcast. Registration is free included general topics in this
and available on a first-come, first- document. FDA will do its best to
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Food and Drug Administration
served basis. Persons interested in accommodate all persons who wish to
participating in the meeting must speak. FDA encourages individuals and
[Docket No. FDA–2010–N–0389]
register online by July 2, 2015, at 4 p.m. organizations with common interests to
Medical Device User Fee Amendments; Early registration is recommended consolidate or coordinate their
Public Meeting; Request for Comments because space is limited and, therefore, presentations, and request time for a
FDA may limit the number of joint presentation, or submit requests for
AGENCY: Food and Drug Administration, participants from each organization. If designated representatives to participate
HHS. time and space permit, onsite in the topic-focused sessions. After
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![Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34681
has been in effect since 2012 and will suggestions for changes to performance Irradiation in the Production,
expire in 2017, FDA has met or goals, and not focus on other general Processing, and Handling of Food—21
exceeded nearly all submission policy issues. CFR Part 179 (OMB Control Number
performance goals while implementing 0910–0186)—Extension
Dated: June 11, 2015.
program enhancements designed to Under sections 201(s) and 409 of the
ensure more timely access to safe and Leslie Kux,
Associate Commissioner for Policy.
Federal Food, Drug, and Cosmetic Act
effective medical devices. (the FD&C Act) (21 U.S.C. 321(s) and
• Premarket Notifications (510(k)s): [FR Doc. 2015–14885 Filed 6–16–15; 8:45 am]
348), food irradiation is subject to
Comparison of outcomes for receipt BILLING CODE 4164–01–P
regulation under the food additive
cohorts at the same levels of completion
premarket approval provisions of the
(or ‘‘closure’’) show a 16 percent
FD&C Act. The regulations providing for
decrease in total review time between DEPARTMENT OF HEALTH AND uses of irradiation in the production,
FY 2010 and FY 2013 when the cohort HUMAN SERVICES processing, and handling of food are
is 99.8 percent closed, and 10 percent
found in part 179 (21 CFR part 179). To
decrease in total review time between Food and Drug Administration
ensure safe use of a radiation source,
FY 2010 and FY 2014 when the cohort
§ 179.21(b)(1) requires that the label of
is 75.8 percent closed. [Docket No. FDA–2012–N–0473]
• Premarket Approvals (PMAs): sources bear appropriate and accurate
Comparison of outcomes for receipt information identifying the source of
Agency Information Collection radiation and the maximum (or
cohorts at the same closure levels show Activities; Submission for Office of
a 32 percent decrease in total review minimum and maximum) energy of the
Management and Budget Review; emitted radiation. Section 179.21(b)(2)
times between FY 2009 and FY 2012 Comment Request; Irradiation in the
when the cohort is 98 percent closed, requires that the label or accompanying
Production, Processing, and Handling labeling bear adequate directions for
and a 26 percent decrease in total of Food
review times between FY 2009 and FY installation and use and a statement
2014 when the cohort is 41 percent supplied by us that indicates maximum
AGENCY: Food and Drug Administration, dose of radiation allowed. Section
closed. HHS.
FDA has met or exceeded all MDUFA 179.26(c) requires that the label or
III performance goals for FDA time to ACTION: Notice. accompanying labeling bear a logo and
decisions in FY 2013 and FY 2014. a radiation disclosure statement. Section
More information about FDA’s SUMMARY: The Food and Drug 179.25(e) requires that food processors
performance is available in the yearly who treat food with radiation make and
Administration (FDA) is announcing
MDUFA performance reports, which are retain, for 1 year past the expected shelf
that a proposed collection of
available online at http://www.fda.gov/ life of the products up to a maximum of
information has been submitted to the 3 years, specified records relating to the
AboutFDA/ReportsManualsForms/ Office of Management and Budget
Reports/UserFeeReports/ irradiation process (e.g., the food
(OMB) for review and clearance under treated, lot identification, scheduled
PerformanceReports/UCM2007450.htm. the Paperwork Reduction Act of 1995.
User fees and related performance process, etc.). The records required by
goals have played an important role in DATES: Fax written comments on the § 179.25(e) are used by our inspectors to
providing resources and supporting the collection of information by July 17, assess compliance with the regulation
process for the review of device 2015. that establishes limits within which
applications. radiation may be safely used to treat
ADDRESSES: To ensure that comments on food. We cannot ensure safe use without
III. What information should you know the information collection are received, a method to assess compliance with the
about the meeting? OMB recommends that written dose limits, and there are no practicable
Through this notice, we are comments be faxed to the Office of methods for analyzing most foods to
announcing a public meeting to hear Information and Regulatory Affairs, determine whether they have been
stakeholder views on the OMB, Attn: FDA Desk Officer, FAX: treated with ionizing radiation and are
reauthorization of MDUFA for fiscal 202–395–7285, or emailed to oira_ within the limitations set forth in part
years 2018 through 2022, including submission@omb.eop.gov. All 179. Records inspection is the only way
specific suggestions for any changes to comments should be identified with the to determine whether firms are
the program that we should consider. OMB control number 0910–0186. Also complying with the regulations for
We will conduct the meeting on July 13, include the FDA docket number found treatment of foods with ionizing
2015. In general, the meeting format will in brackets in the heading of this radiation.
include presentations by FDA and a document. In the Federal Register of March 31,
series of panels representing different 2015 (80 FR 17055), FDA published a
stakeholder interest groups (such as FOR FURTHER INFORMATION CONTACT: FDA 60-day notice requesting public
patient advocates, consumer protection PRA Staff, Office of Operations, Food comment on the proposed collection of
groups, industry, health care and Drug Administration, 8455 information. One comment was received
professionals, and academic Colesville Road; COLE–14526, Silver but did not respond to any of the four
asabaliauskas on DSK5VPTVN1PROD with NOTICES
researchers). FDA will also provide an Spring, MD 20993–0002 PRAStaff@ information collection topics solicited
opportunity for individuals to make fda.hhs.gov. and is therefore not addressed by the
presentations during the meeting and Agency.
for organizations and individuals to SUPPLEMENTARY INFORMATION: In Description of respondents:
submit written comments to the docket compliance with 44 U.S.C. 3507, FDA Respondents are businesses engaged in
after the meeting. The presentations has submitted the following proposed the irradiation of food.
should focus on program improvements collection of information to OMB for We estimate the burden of this
and funding issues, including specific review and clearance. collection of information as follows:
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Document Created: 2015-12-15 14:22:33
Document Modified: 2015-12-15 14:22:33
| 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 meeting; request for comments. | |
| FR Citation | 80 FR 34679 |
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