82 FR 3798 - Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 8 (January 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 8 (January 12, 2017)
| Page Range | 3798-3799 | |
| FR Document | 2017-00496 |
[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)] [Notices] [Pages 3798-3799] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00496] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on March 17, 2017, from 7:30 a.m. to 4 p.m. ADDRESSES: Hilton Washington, DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's phone number is 301-977-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Aden S. Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, [email protected], 301-796-0400, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On March 17, 2017, the committee will discuss and make recommendations regarding the potential risks of misuse of peroxide- based contact lens products. Specific issues to be discussed include adequate labeling and packaging of these over-the-counter products. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 2, 2017. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 22, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 23, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at [email protected] or 301-796- 5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/AboutAdvisoryCommittees/ [[Page 3799]] ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 6, 2017. Janice M. Soreth, Associate Commissioner, Special Medical Programs. [FR Doc. 2017-00496 Filed 1-11-17; 8:45 am] BILLING CODE 4164-01-P
![3798 Federal Register / Vol. 82, No. 8 / Thursday, January 12, 2017 / Notices
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response
72-Month Follow-Up Survey ................................................ 2,000 667 1 0.75 500
Estimated Total Annual Burden SUMMARY: The Food and Drug than 2 business days before the meeting.
Hours: 500. Administration (FDA) announces a If FDA is unable to post the background
In compliance with the requirements forthcoming public advisory committee material on its Web site prior to the
of Section 3506(c)(2)(A) of the meeting of the Ophthalmic Devices meeting, the background material will
Paperwork Reduction Act of 1995, the Panel of the Medical Devices Advisory be made publicly available at the
Administration for Children and Committee and the Risk Communication location of the advisory committee
Families is soliciting public comment Advisory Committee. The general meeting, and the background material
on the specific aspects of the function of the committee is to provide will be posted on FDA’s Web site after
information collection described above. advice and recommendations to the the meeting. Background material is
Copies of the proposed collection of Agency on FDA’s regulatory issues. The available at http://www.fda.gov/
information can be obtained and meeting will be open to the public. AdvisoryCommittees/Calendar/
comments may be forwarded by writing DATES: The meeting will be held on default.htm. Scroll down to the
to the Administration for Children and March 17, 2017, from 7:30 a.m. to 4 p.m. appropriate advisory committee meeting
Families, Office of Planning, Research, ADDRESSES: Hilton Washington, DC link.
and Evaluation, 330 C Street SW., North/Gaithersburg, Salons A, B, C, and Procedure: Interested persons may
Washington, DC 20201, Attn: OPRE D, 620 Perry Pkwy., Gaithersburg, MD present data, information, or views,
Reports Clearance Officer. Email 20877. The hotel’s phone number is orally or in writing, on issues pending
address: OPREinfocollection@ 301–977–8900. Answers to commonly before the committee. Written
acf.hhs.gov. All requests should be asked questions including information submissions may be made to the contact
identified by the title of the information regarding special accommodations due person on or before March 2, 2017. Oral
collection. to a disability, visitor parking, and presentations from the public will be
The Department specifically requests transportation may be accessed at: scheduled between approximately 1
comments on (a) whether the proposed http://www.fda.gov/ p.m. and 2 p.m. Those individuals
collection of information is necessary AdvisoryCommittees/ interested in making formal oral
for the proper performance of the AboutAdvisoryCommittees/ presentations should notify the contact
functions of the agency, including ucm408555.htm. person and submit a brief statement of
whether the information shall have the general nature of the evidence or
practical utility; (b) the accuracy of the FOR FURTHER INFORMATION CONTACT: arguments they wish to present, the
agency’s estimate of the burden of the Aden S. Asefa, Center for Devices and names and addresses of proposed
proposed collection of information; (c) Radiological Health, Food and Drug participants, and an indication of the
the quality, utility, and clarity of the Administration, 10903 New Hampshire approximate time requested to make
information to be collected; and (d) Ave., Bldg. 66, Rm. G642, Silver Spring, their presentation on or before February
ways to minimize the burden of the MD 20993–0002, Aden.Asefa@ 22, 2017. Time allotted for each
collection of information on fda.hhs.gov, 301–796–0400, or FDA presentation may be limited. If the
respondents, including through the use Advisory Committee Information Line, number of registrants requesting to
of automated collection techniques or 1–800–741–8138 (301–443–0572 in the speak is greater than can be reasonably
other forms of information technology. Washington, DC area). A notice in the accommodated during the scheduled
Consideration will be given to Federal Register about last minute open public hearing session, FDA may
modifications that impact a previously conduct a lottery to determine the
comments and suggestions submitted
announced advisory committee meeting speakers for the scheduled open public
within 60 days of this publication.
cannot always be published quickly hearing session. The contact person will
Mary Jones, enough to provide timely notice. notify interested persons regarding their
ACF/OPRE Certifying Officer. Therefore, you should always check the request to speak by February 23, 2017.
[FR Doc. 2017–00570 Filed 1–11–17; 8:45 am] Agency’s Web site at http:// Persons attending FDA’s advisory
BILLING CODE 4184–72–P www.fda.gov/AdvisoryCommittees/ committee meetings are advised that the
default.htm and scroll down to the Agency is not responsible for providing
appropriate advisory committee meeting access to electrical outlets.
DEPARTMENT OF HEALTH AND link, or call the advisory committee FDA welcomes the attendance of the
HUMAN SERVICES information line to learn about possible public at its advisory committee
modifications before coming to the meetings and will make every effort to
Food and Drug Administration meeting. accommodate persons with disabilities.
[Docket No. FDA–2017–N–0001] SUPPLEMENTARY INFORMATION: If you require accommodations due to a
Agenda: On March 17, 2017, the disability, please contact AnnMarie
Joint Meeting of the Ophthalmic committee will discuss and make Williams at AnnMarie.williams@
Devices Panel of the Medical Devices recommendations regarding the fda.hhs.gov or 301–796–5966 at least 7
mstockstill on DSK3G9T082PROD with NOTICES
Advisory Committee and the Risk potential risks of misuse of peroxide- days in advance of the meeting.
Communication Advisory Committee; based contact lens products. Specific FDA is committed to the orderly
Notice of Meeting issues to be discussed include adequate conduct of its advisory committee
AGENCY: Food and Drug Administration, labeling and packaging of these over- meetings. Please visit our Web site at
HHS. the-counter products. http://www.fda.gov/
FDA intends to make background AdvisoryCommittees/
ACTION: Notice.
material available to the public no later AboutAdvisoryCommittees/
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![Federal Register / Vol. 82, No. 8 / Thursday, January 12, 2017 / Notices 3799
ucm111462.htm for procedures on MD 20993–0002, at 240–402–8006, FDA may conduct a lottery to determine
public conduct during advisory prabhakara.atreya@fda.hhs.gov and the speakers for the scheduled open
committee meetings. 240–402–8072, rosanna.harvey@ public hearing session. The contact
Notice of this meeting is given under fda.hhs.gov, or FDA Advisory person will notify interested persons
the Federal Advisory Committee Act (5 Committee Information Line, 1–800– regarding their request to speak by
U.S.C. app. 2). 741–8138 (301–443–0572 in the February 15, 2017.
Dated: January 6, 2017. Washington, DC area). A notice in the Persons attending FDA’s advisory
Janice M. Soreth, Federal Register about last minute committee meetings are advised that the
modifications that impact a previously Agency is not responsible for providing
Associate Commissioner, Special Medical
Programs. announced advisory committee meeting access to electrical outlets.
cannot always be published quickly FDA welcomes the attendance of the
[FR Doc. 2017–00496 Filed 1–11–17; 8:45 am]
enough to provide timely notice. public at its advisory committee
BILLING CODE 4164–01–P
Therefore, you should always check the meetings and will make every effort to
Agency’s Web site at http:// accommodate persons with disabilities.
www.fda.gov/AdvisoryCommittees/ If you require accommodations due to a
DEPARTMENT OF HEALTH AND
default.htm and scroll down to the disability, please contact Prabhakara
HUMAN SERVICES
appropriate advisory committee meeting Atreya at least 7 days in advance of the
Food and Drug Administration link, or call the advisory committee meeting.
information line to learn about possible FDA is committed to the orderly
[Docket No. FDA–2017–N–0001] conduct of its advisory committee
modifications before coming to the
meeting. meetings. Please visit our Web site at
Vaccines and Related Biological http://www.fda.gov/
Products Advisory Committee; Notice SUPPLEMENTARY INFORMATION:
AdvisoryCommittees/
of Meeting Agenda: On March 9, 2017, the
AboutAdvisoryCommittees/
committee will meet in open session to
AGENCY: Food and Drug Administration, ucm111462.htm for procedures on
discuss and make recommendations on
HHS. public conduct during advisory
the selection of strains to be included in
ACTION: Notice. committee meetings.
the influenza virus vaccines for the
Notice of this meeting is given under
SUMMARY: The Food and Drug 2017–2018 influenza season.
the Federal Advisory Committee Act (5
Administration (FDA) announces a FDA intends to make background
U.S.C. app. 2).
forthcoming public advisory committee material available to the public no later
than 2 business days before the meeting. Dated: January 6, 2017.
meeting of the Vaccines and Related
If FDA is unable to post the background Janice M. Soreth,
Biological Products Advisory
Committee. The general function of the material on its Web site prior to the Associate Commissioner for Special Medical
meeting, the background material will Programs.
committee is to provide advice and
recommendations to the Agency on be made publicly available at the [FR Doc. 2017–00476 Filed 1–11–17; 8:45 am]
FDA’s regulatory issues. The meeting location of the advisory committee BILLING CODE 4164–01–P
will be open to the public. meeting, and the background material
will be posted on FDA’s Web site after
DATES: The meeting will be held on
the meeting. Background material is DEPARTMENT OF HEALTH AND
March 9, 2017, from 8:30 a.m. to 3 p.m. available at http://www.fda.gov/ HUMAN SERVICES
ADDRESSES: National Institutes of Health AdvisoryCommittees/Calendar/
(NIH), Fishers Lane Conference Center, default.htm. Scroll down to the National Institutes of Health
5635 Fishers Lane, Rockville, MD appropriate advisory committee meeting
20852. Enter through the main front link. National Institute of Allergy and
entrance on Fishers Lane. Take the Procedure: Interested persons may Infectious Diseases; Notice of Closed
elevators down to the T-Terrace Level. present data, information, or views, Meetings
Follow the short hallway towards the orally or in writing, on issues pending Pursuant to section 10(d) of the
elevators and the Conference Center before the committee. Written Federal Advisory Committee Act, as
glass doors are straight ahead near the submissions may be made to the contact amended (5 U.S.C. App.), notice is
elevators. person on or before February 23, 2017. hereby given of the following meetings.
For those unable to attend in person, Oral presentations from the public will The meetings will be closed to the
the meeting will also be Web cast and be scheduled between approximately public in accordance with the
will be available at the following link: 12:50 p.m. and 1:50 p.m. Those provisions set forth in sections
https://videocast.nih.gov/. Answers to individuals interested in making formal 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
commonly asked questions including oral presentations should notify the as amended. The contract proposals and
information regarding special contact person and submit a brief the discussions could disclose
accommodations due to a disability, statement of the general nature of the confidential trade secrets or commercial
visitor parking, and transportation may evidence or arguments they wish to property such as patentable material,
be accessed at: http://www.fda.gov/ present, the names and addresses of and personal information concerning
AdvisoryCommittees/ proposed participants, and an individuals associated with the contract
AboutAdvisoryCommittees/ indication of the approximate time
mstockstill on DSK3G9T082PROD with NOTICES
proposals, the disclosure of which
ucm408555.htm. requested to make their presentation on would constitute a clearly unwarranted
FOR FURTHER INFORMATION CONTACT: or before February 14, 2017. Time invasion of personal privacy.
Prabhakara Atreya or Rosanna Harvey, allotted for each presentation may be Name of Committee: National Institute of
Center for Biologics Evaluation and limited. If the number of registrants Allergy and Infectious Diseases Special
Research, Food and Drug requesting to speak is greater than can Emphasis Panel; NIAID Investigator Initiated
Administration, 10903 New Hampshire be reasonably accommodated during the Program Project Applications (P01).
Ave., Bldg. 71, Rm. 6306, Silver Spring, scheduled open public hearing session, Date: February 7, 2017.
VerDate Sep<11>2014 18:28 Jan 11, 2017 Jkt 241001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1](https://thefederalregister.org/doc/82_FR_3806/page/2.svg)
Document Created: 2017-03-21 14:40:43
Document Modified: 2017-03-21 14:40:43
| 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 | The meeting will be held on March 17, 2017, from 7:30 a.m. to 4 p.m. | |
| Contact | Aden S. Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, [email protected], 301-796-0400, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 3798 |
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