80 FR 60687 - Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 194 (October 7, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 194 (October 7, 2015)
| Page Range | 60687-60688 | |
| FR Document | 2015-25525 |
[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)] [Notices] [Pages 60687-60688] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25525] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0007] Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration is correcting a notice entitled ``Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016'' that appeared in the Federal Register of September 28, 2015 (80 FR 58262). The document announced the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2016. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Food and Drug Administration, Bldg. 32, Rm. 3330, Silver Spring, MD 20993, 301-796- 9115, [email protected]. [[Page 60688]] SUPPLEMENTARY INFORMATION: In FR Doc. 2015-24508, appearing on page 58262 in the Federal Register of Monday, September 28, 2015, the following correction is made: On page 58262, in the third column, in the headings section of the document, ``FDA-2014-N-0007'' is corrected to read ``FDA-2015-N-0007''. Dated: October 2, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-25525 Filed 10-6-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices 60687
operated heater and a sensor which became effective. Some examples of the public hearing session. The contact
provides temperature control/feedback. means by which these devices perform person will notify interested persons
Æ IFU/IU: Intended to provide these functions and their respective regarding their request to speak by
temporary relief of the symptoms of IFU/IU statements are as follows: November 3, 2015.
hemorrhoids through the application of • Utilizes a continuous flow Persons attending FDA’s advisory
mild heating. centrifuge (max speed 3000 rpm) to committee meetings are advised that the
• Uses speculum like plastic separate source blood from a subject Agency is not responsible for providing
container containing liquid to cool into blood components. access to electrical outlets.
hemorrhoidal veins Æ IFU/IU: May be used to perform FDA welcomes the attendance of the
Æ IFU/IU: Treatment of external therapeutic plasma exchange. public at its advisory committee
hemorrhoids by applying cold therapy Æ IFU/IU: May be used to perform meetings and will make every effort to
(cryotherapy) directly to swollen Red Blood Cell Exchange procedures for accommodate persons with disabilities.
hemorrhoidal veins. the transfusion management of Sickle If you require accommodations due to a
The committee will also discuss and Cell Disease in adults and children. disability, please contact Artair Mallett
make recommendations regarding the • Uses continuous flow access to a at artair.mallett@fda.hhs.gov, or 301–
classification of the product code rotating centrifuge to separate blood 796–9638, at least 7 days in advance of
‘‘LRL’’, and the associated device components. the meeting.
classification name, ‘‘Cushion, Æ IFU/IU: May be used to harvest FDA is committed to the orderly
Hemorrhoid’’. The product code LRL cellular components from the blood of conduct of its advisory committee
represents a category of devices certain patients where the attending meetings. Please visit our Web site at
intended to temporarily relieve pain and physician feels the removal of such http://www.fda.gov/
pressure caused by hemorrhoids. These component may benefit the patient. AdvisoryCommittees/
devices are considered preamendments Æ IFU/IU: May be used to remove AboutAdvisoryCommittees/
devices since they were in commercial plasma components and/or fluid ucm111462.htm for procedures on
distribution prior to May 28, 1976, selected by the attending physicians. public conduct during advisory
when the Medical Devices Amendments FDA intends to make background committee meetings.
became effective. Some examples of the material available to the public no later Notice of this meeting is given under
means by which these devices perform than 2 business days before the meeting. the Federal Advisory Committee Act (5
these functions and their respective If FDA is unable to post the background U.S.C. app. 2).
IFU/IU statements are as follows: material on its Web site prior to the
Dated: October 1, 2015.
• Uses an injection molded meeting, the background material will
Jill Hartzler Warner,
polypropylene copolymer plastic seat be made publicly available at the
location of the advisory committee Associate Commissioner for Special Medical
attached to a toilet seat (the product is Programs.
adjustable and is available in round and meeting, and the background material
will be posted on FDA’s Web site after [FR Doc. 2015–25466 Filed 10–6–15; 8:45 am]
elongated versions). BILLING CODE 4164–01–P
Æ IFU/IU: For the temporary relief the meeting. Background material is
from the pain and pressure of available at http://www.fda.gov/
hemorrhoids. The device is for external AdvisoryCommittees/Calendar/
DEPARTMENT OF HEALTH AND
use only. default.htm. Scroll down to the
HUMAN SERVICES
• Uses a cushion with an inflatable appropriate advisory committee meeting
vinyl exterior and a foam center. An air link. Food and Drug Administration
chamber, when filled, prevents the Procedure: Interested persons may
present data, information, or views, [Docket No. FDA–2015–N–0007]
cushion from compressing the foam. A
urethane foam center adds comfort. orally or in writing, on issues pending
before the committee. Written Fee for Using a Rare Pediatric Disease
Æ IFU/IU: Intended for the home
submissions may be made to the contact Priority Review Voucher in Fiscal Year
convalescent patient with perineal
person on or before November 10, 2015. 2016; Correction
discomfort.
• Uses a cushion that contains two Oral presentations from the public will AGENCY: Food and Drug Administration,
internal molded structures that conform be scheduled on November 18, 2015, HHS.
to the patient’s shape. Exerts ‘‘slight’’ between approximately 1 p.m. and 2 ACTION: Notice; correction.
pressure on hemorrhoid. IFU/IU not p.m. and on November 19, 2015,
provided. between approximately 8:30 a.m. and SUMMARY: The Food and Drug
The committee will also discuss and 9:30 a.m. Those individuals interested Administration is correcting a notice
make recommendations regarding the in making formal oral presentations entitled ‘‘Fee for Using a Rare Pediatric
classification of the product code should notify the contact person and Disease Priority Review Voucher in
‘‘LKN’’, and the associated device submit a brief statement of the general Fiscal Year 2016’’ that appeared in the
classification name, ‘‘Separator, nature of the evidence or arguments Federal Register of September 28, 2015
automated, blood cell and plasma, they wish to present, the names and (80 FR 58262). The document
therapeutic’’. The product code LKN addresses of proposed participants, and announced the fee rate for using a rare
represents a category of centrifuge-type an indication of the approximate time pediatric disease priority review
devices intended to separate blood requested to make their presentation on voucher for fiscal year 2016. The
asabaliauskas on DSK5VPTVN1PROD with NOTICES
components and perform therapeutic or before November 2, 2015. Time document was published with the
plasma exchange for the management of allotted for each presentation may be incorrect docket number. This
serious medical conditions in adults limited. If the number of registrants document corrects that error.
and children. These devices are requesting to speak is greater than can FOR FURTHER INFORMATION CONTACT: Lisa
considered preamendments devices be reasonably accommodated during the Granger, Food and Drug Administration,
since they were in commercial scheduled open public hearing session, Bldg. 32, Rm. 3330, Silver Spring, MD
distribution prior to May 28, 1976, FDA may conduct a lottery to determine 20993, 301–796–9115, Lisa.Granger@
when the Medical Devices Amendments the speakers for the scheduled open fda.hhs.gov.
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![60688 Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices
SUPPLEMENTARY INFORMATION: In FR Doc. advisory committee meeting cannot DEPARTMENT OF HEALTH AND
2015–24508, appearing on page 58262 always be published quickly enough to HUMAN SERVICES
in the Federal Register of Monday, provide timely notice.
September 28, 2015, the following Agenda: The committee will hear Health IT Standards Committee
correction is made: reports from its workgroups/task forces Advisory Meeting; Notice of Meeting
On page 58262, in the third column, and updates from ONC and other federal AGENCY: Office of the National
in the headings section of the document, agencies. ONC intends to make Coordinator for Health Information
‘‘FDA–2014–N–0007’’ is corrected to
background material available to the Technology, HHS.
read ‘‘FDA–2015–N–0007’’.
public no later than 24 hours prior to ACTION: Notice of meeting.
Dated: October 2, 2015. the meeting start time. If ONC is unable
Jill Hartzler Warner, to post the background material on its This notice announces updated dates
Associate Commissioner for Special Medical Web site prior to the meeting, it will be for meetings of a public advisory
Programs. made publicly available at the location committee of the Office of the National
[FR Doc. 2015–25525 Filed 10–6–15; 8:45 am] of the advisory committee meeting, and Coordinator for Health Information
BILLING CODE 4164–01–P the background material will be posted Technology (ONC). These meetings will
on ONC’s Web site after the meeting, at be open to the public.
http://www.healthit.gov/FACAS/health- Name of Committee: Health IT
DEPARTMENT OF HEALTH AND it-policy-committee. Standards Committee.
HUMAN SERVICES General Function of the Committee:
Procedure: Interested persons may To provide recommendations to the
Health IT Policy Committee Advisory present data, information, or views, National Coordinator on standards,
Meeting; Notice of Meeting orally or in writing, on issues pending implementation specifications, and
before the Committee. Written certification criteria for the electronic
AGENCY: Office of the National submissions may be made to the contact exchange and use of health information
Coordinator for Health Information person prior to the meeting date. Oral for purposes of adoption, consistent
Technology, HHS comments from the public will be with the implementation of the Federal
ACTION: Notice of meeting. scheduled prior to the lunch break and Health IT Strategic Plan, and in
at the conclusion of each meeting. Time accordance with policies developed by
This notice announces updated dates allotted for each presentation will be
for meetings of a public advisory the Health IT Policy Committee.
limited to three minutes. If the number 2015 Meeting Dates and Times:
committee of the Office of the National
of speakers requesting to comment is • October 6, 2015, from 9:30 a.m. to
Coordinator for Health Information
greater than can be reasonably 3:00 p.m./Eastern Time
Technology (ONC). These meetings will
accommodated during the scheduled • November 3, 2015, from 9:30 a.m. to
be open to the public.
Name of Committee: Health IT Policy open public session, ONC will take 3:00 p.m./Eastern Time
Committee. written comments after the meeting. • December 10, 2015, from 9:30 a.m. to
General Function of the Committee: Persons attending ONC’s advisory 12:30 p.m./Eastern Time
To provide recommendations to the committee meetings are advised that the For meeting locations, Web
National Coordinator on a policy agency is not responsible for providing conference information, and the most
framework for the development and wireless access or access to electrical up-to-date information, please visit the
adoption of a nationwide health outlets. calendar on the ONC Web site, http://
information technology infrastructure ONC welcomes the attendance of the www.healthit.gov/FACAS/calendar
that permits the electronic exchange and public at its advisory committee Contact Person: Michelle Consolazio,
use of health information as is meetings. Seating is limited at the email: michelle.consolazio@hhs.gov.
consistent with the Federal Health IT location, and ONC will make every Please email Michelle Consolazio for the
Strategic Plan and that includes effort to accommodate persons with most current information about
recommendations on the areas in which physical disabilities or special needs. If meetings. A notice in the Federal
standards, implementation you require special accommodations Register about last minute modifications
specifications, and certification criteria due to a disability, please contact that impact a previously announced
are needed. Michelle Consolazio at least seven (7) advisory committee meeting cannot
2015 Meeting Dates and Times: always be published quickly enough to
days in advance of the meeting.
• October 6, 2015, from 9:30 a.m. to provide timely notice.
3:00 p.m./Eastern Time ONC is committed to the orderly Agenda: The committee will hear
• November 10, 2015, from 9:30 a.m. to conduct of its advisory committee reports from its workgroups/task forces
3:00 p.m./Eastern Time meetings. Please visit our Web site at and updates from ONC and other federal
• December 8, 2015, from 9:30 a.m. to http://www.healthit.gov/facas/ for agencies. ONC intends to make
3:00 p.m./Eastern Time procedures on public conduct during background material available to the
For meeting locations, web conference advisory committee meetings. public no later than 24 hours prior to
information, and the most up-to-date Notice of this meeting is given under the meeting start time. If ONC is unable
information, please visit the calendar on the Federal Advisory Committee Act to post the background material on its
the ONC Web site, http:// Web site prior to the meeting, it will be
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(Pub. L. 92–463, 5 U.S.C., App. 2).
www.healthit.gov/FACAS/calendar. made publicly available at the location
Dated: September 30, 2015.
Contact Person: Michelle Consolazio, of the advisory committee meeting, and
email: michelle.consolazio@hhs.gov. Michelle Consolazio, the background material will be posted
Please email Michelle Consolazio for the FACA lead, Office of Policy, Office of the on ONC’s Web site after the meeting, at
most current information about National Coordinator for Health Information http://www.healthit.gov/facas/health-it-
meetings. A notice in the Federal Technology. standards-committee.
Register about last minute modifications [FR Doc. 2015–25562 Filed 10–6–15; 8:45 am] Procedure: Interested persons may
that impact a previously announced BILLING CODE 4150–45–P present data, information, or views,
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Document Created: 2015-12-15 08:49:19
Document Modified: 2015-12-15 08:49:19
| 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; correction. | |
| Contact | Lisa Granger, Food and Drug Administration, Bldg. 32, Rm. 3330, Silver Spring, MD 20993, 301-796- 9115, [email protected] | |
| FR Citation | 80 FR 60687 |
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