National Committee on Vital and Health Statistics: Meeting, 22670 [2017-09982]

Download as PDF 22670 Federal Register / Vol. 82, No. 94 / Wednesday, May 17, 2017 / Notices 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug product listed in the table in this document is no longer being marketed. Application No. Drug name Active ingredient Strength(s) Dosage form/route NDA 018874 CALCIJEX .... Calcitriol ....... 1 microgram (mcg)/milliliter (mL); 2 mcg/mL ............... Injectable; Injection ...... FDA has reviewed its records and, under § 314.161, has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness.1 Accordingly, the Agency will continue to list the drug product listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDA listed in this document are unaffected by the discontinued marketing of the products subject to that NDA. Additional ANDAs that refer to this product may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. This is not a significant regulatory action subject to Executive Order 12866 and does not impose any additional burden on regulated entities. Dated: May 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–09960 Filed 5–16–17; 8:45 am] nlaroche on DSK30NT082PROD with NOTICES BILLING CODE 4164–01–P 1 We have also determined that the previous CALCIJEX formulation originally approved on September 25, 1986, and superseded by the currently approved formulation was not withdrawn for reasons of safety or effectiveness. VerDate Sep<11>2014 15:18 May 16, 2017 Jkt 241001 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- PO 00000 Frm 00028 Fmt 4703 Sfmt 9990 Applicant AbbVie, Inc. 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 E:\FR\FM\17MYN1.SGM 17MYN1

Agencies

[Federal Register Volume 82, Number 94 (Wednesday, May 17, 2017)]
[Notices]
[Page 22670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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