82 FR 22670 - National Committee on Vital and Health Statistics: Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 94 (May 17, 2017)

Page Range		22670-22670
FR Document		2017-09982

Federal Register, Volume 82 Issue 94 (Wednesday, May 17, 2017)

[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Page 22670]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09982]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Committee on Vital and Health Statistics: Meeting

    Pursuant to the Federal Advisory Committee Act, the Department of 
Health and Human Services (HHS) announces the following advisory 
committee meeting.
    Name: National Committee on Vital and Health Statistics (NCVHS), 
Full Committee Meeting.
    Dates and Times: Wednesday, June 21, 2017: 9:00 a.m.-5:30 p.m.
    Thursday, June 22, 2017: 8:30 a.m.-3:15 p.m.
    Place: U.S. Department of Health and Human Services, Hubert H. 
Humphrey Building, 200 Independence Avenue SW., Room 705A, Washington, 
DC 20201, (202) 690-7100.
    Status: Open.
    Purpose: At the June 21-22, 2017 meeting, the Committee will hear 
presentations, hold discussions on several health data policy topics, 
and receive updates from HHS, the Office of the National Coordinator 
for Health IT, the CDC National Center for Health Statistics, the 
National Library of Medicine, and Centers for Medicare and Medicaid 
Services. On the first day, the Committee will focus on two items 
anticipated for action: A recommendation letter that addresses the 
Health Plan Identifier in follow up to the May 3, 2017 HPID Hearing, 
and follow up on the NCVHS June 2016 Hearing on claims-based databases 
for policy development and evaluation. The Committee will review status 
reports on various NCVHS products; an upcoming hearing on the next 
generation of vital statistics; and the Predictability Roadmap under 
development by the Standards Subcommittee. Significant time will be 
devoted to discussion and formulation of two new complex long-term 
project topics--an environmental scan of terminology & vocabulary 
development, maintenance and dissemination processes on the first day; 
on the second day, building on past work, exploration of a range of 
challenges beyond HIPAA and the range of policy options that may be 
available to the Department related to privacy, security and access 
measures to protect individually identifiable health information in an 
environment of electronic networking and multiple uses of data. In 
addition, the Committee will continue to focus on planning efforts and 
follow-up items on actions from the previous day.
    The times and topics are subject to change. Please refer to the 
posted agenda for any updates.
    Contact Person for More Information: Substantive program 
information may be obtained from Rebecca Hines, MHS, Executive 
Secretary, NCVHS, National Center for Health Statistics, Centers for 
Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 
20782, telephone (301) 458-4715. Summaries of meetings and a roster of 
Committee members are available on the home page of the NCVHS Web site: 
http://www.ncvhs.hhs.gov/, where further information including an 
agenda and instructions to access the audio broadcast of the meetings 
will also be posted. Should you require reasonable accommodation, 
please contact the CDC Office of Equal Employment Opportunity on (770) 
488-3210 as soon as possible.

    Dated: May 9, 2017.
Laina Bush,
Deputy Assistant Secretary for Planning and Evaluation, Office of the 
Assistant Secretary for Planning and Evaluation.
[FR Doc. 2017-09982 Filed 5-16-17; 8:45 am]
BILLING CODE 4151-05-P

22670 Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices

355(j)(7)), which requires FDA to was withdrawn from sale for reasons of petitions for such a determination under
publish a list of all approved drugs. safety or effectiveness (21 CFR 314.162). 21 CFR 10.25(a) and 10.30. Section
FDA publishes this list as part of the Under § 314.161(a) (21 CFR 314.161(d) provides that if FDA
‘‘Approved Drug Products With 314.161(a)), the Agency must determine determines that a listed drug was
Therapeutic Equivalence Evaluations,’’ whether a listed drug was withdrawn withdrawn from sale for safety or
which is generally known as the from sale for reasons of safety or effectiveness reasons, the Agency will
‘‘Orange Book.’’ Under FDA regulations, effectiveness: (1) Before an ANDA that initiate proceedings that could result in
a drug is removed from the list if the refers to that listed drug may be the withdrawal of approval of the
Agency withdraws or suspends approved, (2) whenever a listed drug is ANDAs that refer to the listed drug.
approval of the drug’s NDA or ANDA voluntarily withdrawn from sale and FDA has become aware that the drug
for reasons of safety or effectiveness, or ANDAs that refer to the listed drug have product listed in the table in this
if FDA determines that the listed drug been approved, and (3) when a person document is no longer being marketed.

Application Active
Drug name Strength(s) Dosage form/route Applicant
No. ingredient

NDA 018874 CALCIJEX .... Calcitriol ....... 1 microgram (mcg)/milliliter (mL); 2 mcg/mL ............... Injectable; Injection ...... AbbVie, Inc.

FDA has reviewed its records and, DEPARTMENT OF HEALTH AND term project topics—an environmental
under § 314.161, has determined that HUMAN SERVICES scan of terminology & vocabulary
the drug product listed in this document development, maintenance and
was not withdrawn from sale for reasons National Committee on Vital and Health dissemination processes on the first day;
of safety or effectiveness.1 Accordingly, Statistics: Meeting on the second day, building on past
the Agency will continue to list the drug Pursuant to the Federal Advisory work, exploration of a range of
product listed in this document in the Committee Act, the Department of challenges beyond HIPAA and the range
‘‘Discontinued Drug Product List’’ Health and Human Services (HHS) of policy options that may be available
section of the Orange Book. The announces the following advisory to the Department related to privacy,
‘‘Discontinued Drug Product List’’ committee meeting. security and access measures to protect
identifies, among other items, drug Name: National Committee on Vital individually identifiable health
products that have been discontinued and Health Statistics (NCVHS), Full information in an environment of
from marketing for reasons other than Committee Meeting. electronic networking and multiple uses
safety or effectiveness. Dates and Times: Wednesday, June of data. In addition, the Committee will
Approved ANDAs that refer to the 21, 2017: 9:00 a.m.–5:30 p.m. continue to focus on planning efforts
NDA listed in this document are Thursday, June 22, 2017: 8:30 a.m.– and follow-up items on actions from the
unaffected by the discontinued 3:15 p.m. previous day.
Place: U.S. Department of Health and The times and topics are subject to
marketing of the products subject to that
Human Services, Hubert H. Humphrey change. Please refer to the posted
NDA. Additional ANDAs that refer to
Building, 200 Independence Avenue agenda for any updates.
this product may also be approved by SW., Room 705A, Washington, DC
the Agency if they comply with relevant 20201, (202) 690–7100. Contact Person for More Information:
legal and regulatory requirements. If Status: Open. Substantive program information may
FDA determines that labeling for this Purpose: At the June 21–22, 2017 be obtained from Rebecca Hines, MHS,
drug product should be revised to meet meeting, the Committee will hear Executive Secretary, NCVHS, National
current standards, the Agency will presentations, hold discussions on Center for Health Statistics, Centers for
advise ANDA applicants to submit such several health data policy topics, and Disease Control and Prevention, 3311
labeling. receive updates from HHS, the Office of Toledo Road, Hyattsville, Maryland
This is not a significant regulatory the National Coordinator for Health IT, 20782, telephone (301) 458–4715.
action subject to Executive Order 12866 the CDC National Center for Health Summaries of meetings and a roster of
and does not impose any additional Statistics, the National Library of Committee members are available on the
burden on regulated entities. Medicine, and Centers for Medicare and home page of the NCVHS Web site:
Medicaid Services. On the first day, the http://www.ncvhs.hhs.gov/, where
Dated: May 11, 2017. Committee will focus on two items further information including an agenda
Anna K. Abram, anticipated for action: A and instructions to access the audio
Deputy Commissioner for Policy, Planning, recommendation letter that addresses broadcast of the meetings will also be
Legislation, and Analysis. the Health Plan Identifier in follow up posted. Should you require reasonable
[FR Doc. 2017–09960 Filed 5–16–17; 8:45 am] to the May 3, 2017 HPID Hearing, and accommodation, please contact the CDC
BILLING CODE 4164–01–P follow up on the NCVHS June 2016 Office of Equal Employment
Hearing on claims-based databases for Opportunity on (770) 488–3210 as soon
policy development and evaluation. The as possible.
Committee will review status reports on
nlaroche on DSK30NT082PROD with NOTICES

Dated: May 9, 2017.
various NCVHS products; an upcoming
hearing on the next generation of vital Laina Bush,
statistics; and the Predictability Deputy Assistant Secretary for Planning and
1 We have also determined that the previous
Roadmap under development by the Evaluation, Office of the Assistant Secretary
CALCIJEX formulation originally approved on
Standards Subcommittee. Significant for Planning and Evaluation.
September 25, 1986, and superseded by the
currently approved formulation was not withdrawn time will be devoted to discussion and [FR Doc. 2017–09982 Filed 5–16–17; 8:45 am]
for reasons of safety or effectiveness. formulation of two new complex long- BILLING CODE 4151–05–P

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Document Created: 2017-05-17 01:41:59
Document Modified: 2017-05-17 01:41:59

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
FR Citation		82 FR 22670