81 FR 38712 - Health IT Standards Committee Advisory Meeting; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 81, Issue 114 (June 14, 2016)
Federal Register Volume 81, Issue 114 (June 14, 2016)
| Page Range | 38712-38713 | |
| FR Document | 2016-13997 |
[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)] [Notices] [Pages 38712-38713] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13997] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health IT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting. ----------------------------------------------------------------------- This notice announces updated dates for meetings of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). These meetings are open to the public. Name of Committee: Health IT Standards Committee. General Function of the Committee: To provide recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. 2016 Meeting Dates and TimesMay 17, 2016, from 9:00 a.m. to 3:00 p.m./Eastern Time [cir] This will be an in-person meeting at the Omni Shoreham Hotel, 2500 Calvert Street NW., Washington, DC 20008 June 8, 2016, from 9:30 a.m. to 12:00 p.m./Eastern Time [cir] This will be a virtual meeting June 23, 2016, from 9:00 a.m. to 3:00 p.m./Eastern Time [cir] This will be an in-person meeting at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA 22202 July 27, 2016 from 10:00 a.m. to 1:00 p.m./Eastern Time (replacing the formerly announced July 13 and August 7 meetings) [cir] This will be a virtual meeting For meeting locations, web conference information, and the most up-to- date information, please visit the calendar on the ONC Web site, http://www.healthit.gov/FACAS/calendar. Contact Person: Michelle Consolazio, email: [email protected]. Please email Michelle Consolazio for the most current information about meetings. 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. Agenda: The committee will hear reports from its workgroups/task forces [[Page 38713]] and updates from ONC and other federal agencies. ONC intends to make background material available to the public no later than 24 hours prior to the meeting start time. If ONC is unable to post the background material on its Web site prior to the meeting, it will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on ONC's Web site after the meeting, at http://www.healthit.gov/facas/health-it-standards-committee. 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 prior to the meeting date. Oral comments from the public will be scheduled prior to the lunch break and at the conclusion of each meeting. Time allotted for each presentation will be limited to three minutes. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public session, ONC will take written comments after the meeting. Persons attending ONC's advisory committee meetings are advised that the agency is not responsible for providing wireless access or access to electrical outlets. ONC welcomes the attendance of the public at its advisory committee meetings. Seating is limited at the location, and ONC will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Michelle Consolazio at least seven (7) days in advance of the meeting. ONC is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://healthit.hhs.gov for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App. 2). Dated: June 2, 2016. Michelle Consolazio, FACA Program Director, Office of Policy, Office of the National Coordinator for Health Information Technology. [FR Doc. 2016-13997 Filed 6-13-16; 8:45 am] BILLING CODE 4150-45-P
![38712 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices
Submissions,’’ publicly viewable at Drug Administration, 10903 New DEPARTMENT OF HEALTH AND
http://www.regulations.gov or at the Hampshire Ave., Bldg. 22, Rm. 5374, HUMAN SERVICES
Division of Dockets Management Silver Spring, MD 20993–0002, 301–
between 9 a.m. and 4 p.m., Monday 796–1243. Health IT Standards Committee
through Friday. Advisory Meeting; Notice of Meeting
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
AGENCY: Office of the National
submit a comment with confidential I. Background Coordinator for Health Information
information that you do not wish to be
Technology, HHS.
made publicly available, submit your FDA is announcing the availability of
comments only as a written/paper a draft guidance for industry entitled ACTION: Notice of meeting.
submission. You should submit two ‘‘Osteoporosis: Nonclinical Evaluation This notice announces updated dates
copies total. One copy will include the of Drugs Intended for Treatment.’’ This for meetings of a public advisory
information you claim to be confidential draft guidance provides committee of the Office of the National
with a heading or cover note that states recommendations to industry for Coordinator for Health Information
‘‘THIS DOCUMENT CONTAINS designing a nonclinical development Technology (ONC). These meetings are
CONFIDENTIAL INFORMATION.’’ The program to support approval of drugs to open to the public.
Agency will review this copy, including treat osteoporosis. In addition to the Name of Committee: Health IT
the claimed confidential information, in pharmacology and toxicology studies Standards Committee.
its consideration of comments. The required to support development of a General Function of the Committee:
second copy, which will have the new drug or biologic, long-term To provide recommendations to the
claimed confidential information nonclinical studies to evaluate effects National Coordinator on standards,
redacted/blacked out, will be available on bone quality in adequate animal implementation specifications, and
for public viewing and posted on http:// models and including bone-specific certification criteria for the electronic
www.regulations.gov. Submit both pharmacologic and toxicologic exchange and use of health information
copies to the Division of Dockets endpoints are needed. for purposes of adoption, consistent
Management. If you do not wish your with the implementation of the Federal
name and contact information to be This draft guidance is being issued
consistent with FDA’s good guidance Health IT Strategic Plan, and in
made publicly available, you can accordance with policies developed by
provide this information on the cover practices regulation (21 CFR 10.115).
the Health IT Policy Committee.
sheet and not in the body of your The draft guidance, when finalized, will
comments and you must identify this represent the current thinking of FDA 2016 Meeting Dates and Times
information as ‘‘confidential.’’ Any on nonclinical evaluation of drugs • May 17, 2016, from 9:00 a.m. to 3:00
information marked as ‘‘confidential’’ intended for the treatment of p.m./Eastern Time
will not be disclosed except in osteoporosis. It does not establish any Æ This will be an in-person meeting
accordance with 21 CFR 10.20 and other rights for any person and is not binding at the Omni Shoreham Hotel, 2500
applicable disclosure law. For more on FDA or the public. You can use an Calvert Street NW., Washington, DC
information about FDA’s posting of alternative approach if it satisfies the 20008
comments to public dockets, see 80 FR requirements of the applicable statutes • June 8, 2016, from 9:30 a.m. to 12:00
56469, September 18, 2015, or access and regulations. p.m./Eastern Time
the information at: http://www.fda.gov/ Æ This will be a virtual meeting
regulatoryinformation/dockets/ II. The Paperwork Reduction Act of • June 23, 2016, from 9:00 a.m. to 3:00
default.htm. 1995 p.m./Eastern Time
Docket: For access to the docket to This guidance refers to previously Æ This will be an in-person meeting
read background documents or the at the Hyatt Regency Crystal City,
approved collections of information that
electronic and written/paper comments 2799 Jefferson Davis Highway,
are subject to review by the Office of
received, go to http:// Arlington, VA 22202
Management and Budget (OMB) under
www.regulations.gov and insert the • July 27, 2016 from 10:00 a.m. to 1:00
the Paperwork Reduction Act of 1995
docket number, found in brackets in the p.m./Eastern Time (replacing the
heading of this document, into the (44 U.S.C. 3501–3520). The collections
formerly announced July 13 and
‘‘Search’’ box and follow the prompts of information in 21 CFR parts 312 and
August 7 meetings)
and/or go to the Division of Dockets 314 have been approved under OMB Æ This will be a virtual meeting
Management, 5630 Fishers Lane, Rm. control numbers 0910–0014 and 0910–
0001, respectively. For meeting locations, web conference
1061, Rockville, MD 20852. information, and the most up-to-date
Submit written requests for single III. Electronic Access information, please visit the calendar on
copies of the draft guidance to the the ONC Web site, http://
Division of Drug Information, Center for Persons with access to the Internet www.healthit.gov/FACAS/calendar.
Drug Evaluation and Research, Food may obtain the draft guidance at either Contact Person: Michelle Consolazio,
and Drug Administration, 10001 New http://www.fda.gov/Drugs/ email: michelle.consolazio@hhs.gov.
Hampshire Ave., Hillandale Building, GuidanceCompliance Please email Michelle Consolazio for the
4th Floor, Silver Spring, MD 20993– RegulatoryInformation/Guidances/ most current information about
0002. Send one self-addressed adhesive default.htm or http:// meetings. A notice in the Federal
srobinson on DSK5SPTVN1PROD with NOTICES
label to assist that office in processing www.regulations.gov. Register about last minute modifications
your requests. See the SUPPLEMENTARY that impact a previously announced
Dated: June 8, 2016.
INFORMATION section for electronic advisory committee meeting cannot
access to the draft guidance document. Leslie Kux,
always be published quickly enough to
FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. provide timely notice.
Gemma Kuijpers, Center for Drug [FR Doc. 2016–13988 Filed 6–13–16; 8:45 am] Agenda: The committee will hear
Evaluation and Research, Food and BILLING CODE 4164–01–P reports from its workgroups/task forces
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![Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Notices 38713
and updates from ONC and other federal DEPARTMENT OF HEALTH AND always be published quickly enough to
agencies. ONC intends to make HUMAN SERVICES provide timely notice.
background material available to the Agenda: The committee will hear
public no later than 24 hours prior to Health IT Policy Committee Advisory
reports from its workgroups/task forces
the meeting start time. If ONC is unable Meeting; Notice of Meeting
and updates from ONC and other federal
to post the background material on its AGENCY: Office of the National agencies. ONC intends to make
Web site prior to the meeting, it will be Coordinator for Health Information background material available to the
made publicly available at the location Technology, HHS. public no later than 24 hours prior to
of the advisory committee meeting, and ACTION: Notice of meeting. the meeting start time. If ONC is unable
the background material will be posted to post the background material on its
on ONC’s Web site after the meeting, at This notice announces updated dates Web site prior to the meeting, it will be
http://www.healthit.gov/facas/health-it- for meetings of a public advisory made publicly available at the location
standards-committee. committee of the Office of the National of the advisory committee meeting, and
Coordinator for Health Information the background material will be posted
Procedure: Interested persons may
Technology (ONC). These meeting will on ONC’s Web site after the meeting, at
present data, information, or views,
be open to the public. http://www.healthit.gov/FACAS/health-
orally or in writing, on issues pending Name of Committee: Health IT Policy
before the Committee. Written it-policy-committee.
Committee.
submissions may be made to the contact General Function of the Committee: Procedure: Interested persons may
person prior to the meeting date. Oral To provide recommendations to the present data, information, or views,
comments from the public will be National Coordinator on a policy orally or in writing, on issues pending
scheduled prior to the lunch break and framework for the development and before the Committee. Written
at the conclusion of each meeting. Time adoption of a nationwide health submissions may be made to the contact
allotted for each presentation will be information technology infrastructure person prior to the meeting date. Oral
limited to three minutes. If the number that permits the electronic exchange and comments from the public will be
of speakers requesting to comment is use of health information as is scheduled prior to the lunch break and
greater than can be reasonably consistent with the Federal Health IT at the conclusion of each meeting. Time
accommodated during the scheduled Strategic Plan and that includes allotted for each presentation will be
open public session, ONC will take recommendations on the areas in which limited to three minutes. If the number
written comments after the meeting. standards, implementation of speakers requesting to comment is
Persons attending ONC’s advisory specifications, and certification criteria greater than can be reasonably
are needed. accommodated during the scheduled
committee meetings are advised that the
agency is not responsible for providing 2016 Meeting Dates and Times open public session, ONC will take
wireless access or access to electrical written comments after the meeting.
• May 17, 2016, from 9:00 a.m. to 3:00
outlets. p.m./Eastern Time Persons attending ONC’s advisory
ONC welcomes the attendance of the Æ This will be an in-person meeting committee meetings are advised that the
public at its advisory committee at the Omni Shoreham Hotel, 2500 agency is not responsible for providing
meetings. Seating is limited at the Calvert Street NW., Washington, DC wireless access or access to electrical
location, and ONC will make every 20008 outlets.
effort to accommodate persons with • June 8, 2016, from 10:00 a.m. to 1:00 ONC welcomes the attendance of the
physical disabilities or special needs. If p.m./Eastern Time (replacing the public at its advisory committee
you require special accommodations June 7, 2016 meeting) meetings. Seating is limited at the
due to a disability, please contact Æ This will be a virtual meeting location, and ONC will make every
Michelle Consolazio at least seven (7) • June 23, 2016, from 9:00 a.m. to 3:00 effort to accommodate persons with
p.m./Eastern Time physical disabilities or special needs. If
days in advance of the meeting.
Æ This will be an in-person meeting you require special accommodations
ONC is committed to the orderly at the Hyatt Regency Crystal City,
conduct of its advisory committee due to a disability, please contact
2799 Jefferson Davis Highway, Michelle Consolazio at least seven (7)
meetings. Please visit our Web site at Arlington, VA 22202
days in advance of the meeting.
http://healthit.hhs.gov for procedures • July 27, 2016 from 9:30 a.m. to 1:00
on public conduct during advisory p.m./Eastern Time (replacing the ONC is committed to the orderly
committee meetings. formerly announced July 12 and conduct of its advisory committee
August 9 meetings) meetings. Please visit our Web site at
Notice of this meeting is given under
Æ This will be a virtual meeting http://healthit.hhs.gov for procedures
the Federal Advisory Committee Act
For meeting locations, web conference on public conduct during advisory
(Pub. L. 92–463, 5 U.S.C., App. 2).
information, and the most up-to-date committee meetings.
Dated: June 2, 2016. information, please visit the calendar on Notice of this meeting is given under
Michelle Consolazio, the ONC Web site, http:// the Federal Advisory Committee Act
FACA Program Director, Office of Policy, www.healthit.gov/FACAS/calendar (Pub. L. 92–463, 5 U.S.C., App. 2).
Office of the National Coordinator for Health Contact Person: Michelle Consolazio,
srobinson on DSK5SPTVN1PROD with NOTICES
Information Technology. Dated: June 1, 2016.
email: michelle.consolazio@hhs.gov.
[FR Doc. 2016–13997 Filed 6–13–16; 8:45 am] Please email Michelle Consolazio for the Michelle Consolazio,
BILLING CODE 4150–45–P most current information about FACA Program Director, Office of Policy,
meetings. A notice in the Federal Office of the National Coordinator for Health
Register about last minute modifications Information Technology.
that impact a previously announced [FR Doc. 2016–13998 Filed 6–13–16; 8:45 am]
advisory committee meeting cannot BILLING CODE 4150–45–P
VerDate Sep<11>2014 19:36 Jun 13, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 9990 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/81_FR_38826/page/2.svg)
Document Created: 2016-06-14 02:58:48
Document Modified: 2016-06-14 02:58:48
| 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 meeting. | |
| FR Citation | 81 FR 38712 |
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