81_FR_46832 81 FR 46695 - National Eye Institute; Notice of Closed Meeting

81 FR 46695 - National Eye Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 137 (July 18, 2016)

Page Range46695-46696
FR Document2016-16833

Federal Register, Volume 81 Issue 137 (Monday, July 18, 2016) 
[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46695-46696]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Eye Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meeting.
    The meeting will be closed to the public in accordance with the

[[Page 46696]]

provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Eye Institute Special Emphasis 
Panel; NEI Translational Research (R24) and Patient-Oriented 
Mentored Training (K23) Grant Applications.
    Date: August 4, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Embassy Suites at the Chevy Chase Pavilion, Tenleytown 
Ballroom II, 4300 Military Road NW., Washington, DC 20015.
    Contact Person: Anne E. Schaffner, Ph.D., Chief, Scientific 
Review Branch Division of Extramural Research, National Eye 
Institute, 5635 Fishers Lane, Suite 1300, MSC 9300, Bethesda, MD 
20892-9300, (301) 451-2020, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.867, 
Vision Research, National Institutes of Health, HHS)

    Dated: July 12, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-16833 Filed 7-15-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices 46695 FOR FURTHER INFORMATION CONTACT: • Determine whether specific accommodate requests to make public Felicia Brayboy, Center for Devices and procedures are necessary for each comments and participate in the Radiological Health, Food and Drug activity as it relates to third-party focused sessions. Individuals and Administration, 10903 New Hampshire services performed. organizations with common interests are Ave., Bldg. 66, Rm. 3464, Silver Spring, Registration: Registration is free and urged to consolidate or coordinate their MD 20993, 301–796–8086, available on a first-come, first-served presentations, and request time for a Felicia.Brayboy@fda.hhs.gov. basis. Persons interested in attending joint presentation, or submit requests for SUPPLEMENTARY INFORMATION: this public workshop must register designated representatives to participate online by September 23, 2016, by 4 p.m. I. Background in the focused sessions. Following the Early registration is recommended close of registration, FDA will On March 4, 2016, FDA published in because facilities are limited and, therefore, FDA may limit the number of determine the amount of time allotted to the Federal Register a notice (81 FR each presenter and the approximate 11477) requesting comments from participants from each organization. If time and space permits, onsite time each oral presentation is to begin, interested persons, including those and will select and notify participants engaged or otherwise interested in the registration on the day of the public workshop; will be provided beginning at by September 30, 2016. All requests to ‘‘Refurbishing, Reconditioning, make oral presentations must be Rebuilding, Remarketing, 7:30 a.m. If you need special accommodations received by the close of registration on Remanufacturing, and Servicing of due to a disability, please contact Peggy September 23, 2016, by 4 p.m. (EDT). If Medical Devices,’’ including radiation- Roney, Office of Communication, selected as a presenter, any presentation emitting devices subject to the Education, and Radiation Programs, materials must be emailed to Felicia electronic product radiation control 301–796–5671, email: Peggy.roney@ Brayboy (see FOR FURTHER INFORMATION provisions of the Federal Food, Drug, fda.hhs.gov, no later than October 13, CONTACT) no later than October 13, 2016. and Cosmetic Act. FDA took this action, 2016. in part, because various stakeholders No commercial or promotional material To register for the public workshop, will be permitted to be presented or have expressed concerns about the please visit FDA’s Medical Devices quality, safety, and continued distributed at the public workshop. News & Events—Workshops & effectiveness of medical devices that Conferences calendar at http:// Transcripts: Please be advised that as have been subject to one or more of www.fda.gov/MedicalDevices/ soon as a transcript is available, it will these activities. This docket asked that NewsEvents/WorkshopsConferences/ be accessible at http:// interested persons, including Original default.htm. (Select this meeting/public www.regulations.gov. It may be viewed equipment manufacturers (OEMs), workshop from the posted events list.) at the Division of Dockets Management health care establishments, and third- Please provide complete contact (see ADDRESSES). A transcript will also party entities review proposed terms information for each attendee, including be available in either hardcopy or on and definitions and provide edits if name, title, affiliation, address, email, CD–ROM, after submission of a applicable. The docket also sought and telephone number. Those without Freedom of Information request. The insights into basic concepts with regard Internet access should contact Peggy Freedom of Information office address is to these activities. FDA is currently Roney to register (see special available on the Agency’s Web site at reviewing all of the comments and will accomodations contact). Registrants will http://www.fda.gov. A link to the use them to inform a set of working receive confirmation after they have questions designed to promote an transcripts will also be available been accepted. You will be notified if approximately 45 days after the public understanding of challenges and best you are on a waiting list. practices to mitigate risks associated Streaming Webcast of the Public workshop on the Internet at http:// with these activities. These working Workshop: This public workshop will www.fda.gov/MedicalDevices/ questions will be addressed in group also be Webcast. The Webcast link will NewsEvents/WorkshopsConferences/ discussions on both days of the be available on the registration Web default.htm. (Select this public workshop. page after October 20, 2016. If you have workshop from the posted events list). II. Topics for Discussion at the Public never attended a Connect Pro event Dated: July 13, 2016. Workshop before, test your connection at https:// Leslie Kux, collaboration.fda.gov/common/help/en/ The public workshop sessions will Associate Commissioner for Policy. support/meeting_test.htm. To get a incorporate the following general [FR Doc. 2016–16887 Filed 7–15–16; 8:45 am] quick overview of the Connect Pro themes pertaining to the refurbishing, program, visit http://www.adobe.com/ BILLING CODE 4164–01–P reconditioning, rebuilding, remarketing, go/connectpro_overview. FDA has remanufacturing, and servicing of verified the Web site addresses in this medical devices: document, as of the date this document DEPARTMENT OF HEALTH AND • Establish working definitions for publishes in the Federal Register, but HUMAN SERVICES third-party and OEM activities. Web sites are subject to change over • Discuss benefits and challenges that time. National Institutes of Health stakeholders encounter, potential Requests for Oral Presentations: This benefits and risks to patients/users, and National Eye Institute; Notice of Closed public workshop includes a public asabaliauskas on DSK3SPTVN1PROD with NOTICES failure modes of devices introduced as comment session and topic-focused Meeting a result of performing activities sessions. During online registration you Pursuant to section 10(d) of the associated with third-party entities. may indicate if you wish to present Federal Advisory Committee Act, as • Identify current best practices and during a public comment session or discuss alternative methods to mitigate participate in a specific session, and amended (5 U.S.C. App.), notice is risks associated with performing which topics you wish to address. FDA hereby given of the following meeting. activities associated with third-party has included general topics in this The meeting will be closed to the entities. document. FDA will do its best to public in accordance with the VerDate Sep<11>2014 18:40 Jul 15, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1

46696 Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices provisions set forth in sections FOR FURTHER INFORMATION CONTACT: Dr. submitted or for its use of that 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Warren Casey, Director, NICEATM; information. as amended. The grant applications and email: warren.casey@nih.gov; telephone: Background Information on the discussions could disclose (919) 316–4729. NICEATM: NICEATM conducts data confidential trade secrets or commercial SUPPLEMENTARY INFORMATION: analyses, workshops, independent property such as patentable material, Background: Acute systemic toxicity validation studies, and other activities and personal information concerning tests are conducted to determine the to assess new, revised, and alternative individuals associated with the grant potential for a single or short-term dose test methods and strategies. NICEATM applications, the disclosure of which of a substance to cause illness or death also provides support for the would constitute a clearly unwarranted when inhaled (inhalation toxicity Interagency Coordinating Committee on invasion of personal privacy. testing), swallowed (oral toxicity the Validation of Alternative Methods Name of Committee: National Eye Institute testing), or absorbed through the skin (ICCVAM). The ICCVAM Authorization Special Emphasis Panel; NEI Translational (dermal toxicity testing). These tests are Act of 2000 (42 U.S.C. 285l–3) provides Research (R24) and Patient-Oriented required by multiple regulatory agencies authority for ICCVAM and NICEATM in Mentored Training (K23) Grant Applications. and can use large numbers of animals. the development of alternative test Date: August 4, 2016. NICEATM, which fosters the evaluation methods. Information about NICEATM Time: 8:00 a.m. to 5:00 p.m. and ICCVAM is found at http:// Agenda: To review and evaluate grant and promotion of alternative test methods for regulatory use, supports ntp.niehs.nih.gov/go/niceatm and applications. efforts to develop, validate, and http://ntp.niehs.nih.gov/go/iccvam. Place: Embassy Suites at the Chevy Chase Pavilion, Tenleytown Ballroom II, 4300 implement alternative approaches for Dated: July 12, 2016. Military Road NW., Washington, DC 20015. acute systemic toxicity testing that John R. Bucher, Contact Person: Anne E. Schaffner, Ph.D., replace, reduce, or refine use of animals Associate Director, National Toxicology Chief, Scientific Review Branch Division of in testing. Program. Extramural Research, National Eye Institute, Request for Information: NICEATM 5635 Fishers Lane, Suite 1300, MSC 9300, [FR Doc. 2016–16840 Filed 7–15–16; 8:45 am] Bethesda, MD 20892–9300, (301) 451–2020, requests data and information on BILLING CODE 4140–01–P aes@nei.nih.gov. approaches and/or technologies (Catalogue of Federal Domestic Assistance currently used to identify substances Program Nos. 93.867, Vision Research, with the potential to cause acute DEPARTMENT OF HEALTH AND National Institutes of Health, HHS) systemic toxicity. Respondents should HUMAN SERVICES provide information on any activities Dated: July 12, 2016. relevant to the development or National Institutes of Health Natasha M. Copeland, validation of alternatives to in vivo tests Program Analyst, Office of Federal Advisory currently required by regulatory Notice of Kidney Interagency Committee Policy. agencies that assess acute oral, dermal, Coordinating Committee Meeting [FR Doc. 2016–16833 Filed 7–15–16; 8:45 am] or inhalation toxicity. Of specific SUMMARY: The Kidney Interagency BILLING CODE 4140–01–P interest are chemical-specific data from Coordinating Committee (KICC) will non-animal tests for acute systemic hold a meeting on September 19, 2016, toxicity hazard, as well as available data on ‘‘CRIC and CKiD: Using longitudinal DEPARTMENT OF HEALTH AND on the same chemicals from in vivo HUMAN SERVICES CKD cohort study findings to plan acute systemic toxicity tests, such as population health interventions.’’ The National Institutes of Health ethical human or animal studies or meeting is open to the public. accidental human exposures. DATES: The meeting will be held on Request for Data and Information on Respondents to this request for September 19, 2016, 9 a.m. to 12 p.m. Technologies Used To Identify information should include their name, Individuals wanting to present oral Substances With the Potential To affiliation (if applicable), mailing comments must notify the contact Cause Acute Systemic Toxicity address, telephone, email, and person at least 10 days before the sponsoring organization (if any) with SUMMARY: The National Toxicology meeting date. their communications. The deadline for Program (NTP) Interagency Center for receipt of the requested information is ADDRESSES: The meeting will be held in the Evaluation of Alternative September 1, 2016. Responses to this the Natcher Conference Center on the Toxicological Methods (NICEATM) notice will be posted at http:// NIH Campus at 9000 Rockville Pike, requests data and information on ntp.niehs.nih.gov/go/iv-data. Persons Bethesda, MD 20894. approaches and/or technologies submitting responses will be identified FOR FURTHER INFORMATION CONTACT: For currently used to identify substances on the Web page by name and affiliation further information concerning this with the potential to cause acute or sponsoring organization, if meeting, contact Dr. Andrew S. Narva, systemic toxicity when swallowed, applicable. Executive Secretary of the Kidney inhaled, or absorbed through the skin. Responses to this request are Interagency Coordinating Committee, Submitted information will be used to voluntary. No proprietary, classified, National Institute of Diabetes and assess the state of the science and confidential, or sensitive information Digestive and Kidney Diseases, 6707 determine technical needs for non- should be included in responses. This Democracy Blvd., MSC 5458, Bethesda, asabaliauskas on DSK3SPTVN1PROD with NOTICES animal test methods used to evaluate request for information is for planning MD 20892–5458, telephone: 301–594– the potential of chemicals to induce purposes only and is not a solicitation 8864; FAX: 301–480–3510; email: acute systemic toxicity. for applications or an obligation on the healthinfo@niddk.nih.gov. DATES: Receipt of information: Deadline part of the U.S. Government to provide SUPPLEMENTARY INFORMATION: The KICC, is September 1, 2016. support for any ideas identified in chaired by the National Institute of ADDRESSES: Data and information response to the request. Please note that Diabetes and Digestive and Kidney should be submitted electronically to the U.S. Government will not pay for Diseases (NIDDK), comprises members niceatm@niehs.nih.gov. the preparation of any information of the Department of Health and Human VerDate Sep<11>2014 17:52 Jul 15, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1


Document Created: 2016-07-16 02:28:23
Document Modified: 2016-07-16 02:28:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesAugust 4, 2016.
FR Citation81 FR 46695 
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