82 FR 56978 - National Committee on Vital and Health Statistics: Teleconference

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 230 (December 1, 2017)

Page Range		56978-56979
FR Document		2017-25895

Federal Register, Volume 82 Issue 230 (Friday, December 1, 2017)

[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56978-56979]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25895]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Committee on Vital and Health Statistics: Teleconference

    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:
Tuesday, January 9, 2018: 9:00 a.m.-5:30 p.m. ET
Wednesday, January 10, 2018: 8:45 a.m.-3:00 p.m. ET
    Place: U.S. Department of Health and Human Services, Hubert H. 
Humphrey Building, 200 Independence Avenue SW., Rm. 705A, Washington, 
DC 20201.
    Status: Open.
    Purpose: At the January 9-10, 2018 full meeting, the Committee will 
hear presentations, hold discussions on several health data policy 
topics and begin work on activities outlined in the NCVHS 2018 
workplan. An environmental scan report will be reviewed and discussed 
by the full Committee as part of the Health Information Privacy and 
Security Beyond HIPAA project. This effort includes an exploration of 
challenges that extend beyond HIPAA and the range of policy options 
that may be available to the Department related to privacy, security 
and access measures to

[[Page 56979]]

protect individually identifiable health information in an environment 
of electronic networking and multiple uses of data. The Population 
Health Subcommittee will focus on Next Generation Vital Statistics in 
follow up to the hearing held September 11-12, 2017 and subsequent 
analyses conducted following the hearing. The purpose of the hearing 
was to assess the current state of the national vital statistics system 
(NVSS) to address concerns regarding sustainability and viability of 
the system infrastructure. Also addressed was the system's capacity to 
provide timely, high quality, secure vital administrative and 
statistical data for identity establishment and protection, 
identification of trends in disease and epidemics, e.g., the recent 
surge in opioid-related deaths, and a host of critical uses for 
research, finance, planning, public records and services. The Committee 
will discuss concerns regarding decreased access to county and 
community-level data and potential plans to conduct work to address the 
issue. The Committee will also discuss the Predictability Roadmap as 
part of the Standards Subcommittee's project to identify possible 
approaches to improve the predictability and improvements in the 
adoption and processes related to updating standards and operating 
rules for electronic administrative transactions (e.g. claims, 
eligibility, electronic funds transfer); health terminology & 
vocabulary development, maintenance, and dissemination processes; and 
mapping out activities and timelines for the Committee's 2018 work.
    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: November 27, 2017.
Laina Bush,
Deputy Assistant Secretary for Planning and Evaluation, Office of the 
Assistant Secretary for Planning and Evaluation.
[FR Doc. 2017-25895 Filed 11-30-17; 8:45 am]
 BILLING CODE 4151-05-P

56978 Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices

TABLE 1—Continued
Application No. Drug Applicant

ANDA 087191 ......... Triamcinolone Acetonide Lotion USP, 0.025% ..................... Alpharma U.S. Pharms, Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 087398 ......... Spironolactone and Hydrochlorothiazide Tablets USP, 25 Watson Laboratories, Inc., Subsidiary of Teva Pharma-
mg/25 mg. ceuticals USA, Inc.
ANDA 088229 ......... Thioridazine HCl Oral Solution USP, 100 mg/mL ................. Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 088563 ......... Thioridazine HCl Tablets USP, 50 mg .................................. Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 088567 ......... Thioridazine HCl Tablets USP, 25 mg .................................. Do.
ANDA 088733 ......... Meclizine HCl Tablets, 25 mg (Chewable) ............................ Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 088869 ......... Thioridazine HCl Tablets USP, 150 mg ................................ Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 090800 ......... Quinapril Tablets USP, EQ 5 mg base, EQ 10 mg base, Sun Pharmaceutical Industries, Ltd.
EQ 20 mg base, and EQ 40 mg base.
ANDA 091177 ......... Anastrozole Tablets, 1 mg .................................................... Do.
ANDA 091466 ......... Letrozole Tablets USP, 2.5 mg ............................................. Do.
ANDA 200486 ......... Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/ Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
0.035 mg, 0.75 mg/0.035 mg, and 1 mg/0.035 mg. 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
ANDA 200488 ......... Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/ Do.
0.035 mg.
ANDA 200489 ......... Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/ Do.
0.035 mg.
ANDA 201250 ......... Vancomycin HCl for Injection USP, EQ 5 g base/vial and Teva Pharmaceuticals USA, Inc.
EQ 10 g base/vial (Pharmacy Bulk Package).
ANDA 201251 ......... Vancomycin HCl for Injection USP, EQ 500 mg base/vial Do.
and EQ 1 g base/vial.
ANDA 201828 ......... Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 Mylan Laboratories, Ltd.
mg.
ANDA 202203 ......... Topotecan HCl for Injection, EQ 4 mg base/vial .................. Sun Pharmaceutical Industries, Ltd.
ANDA 202746 ......... Zoledronic Acid Injection, EQ 4 mg base/5 mL .................... Sun Pharma Global FZE, c/o Sun Pharmaceutical Indus-
tries, Inc., 2 Independence Way, Princeton, NJ 08540.
ANDA 202875 ......... Norgestrel and Ethinyl Estradiol Tablets USP, 0.5 mg/0.05 Mylan Laboratories, Ltd.
mg.
ANDA 203476 ......... Zolmitriptan Tablets, 2.5 mg and 5 mg ................................. Sun Pharma Global FZE.
ANDA 203685 ......... Irbesartan Tablets USP, 75 mg, 150 mg, and 300 mg ......... Ajanta Pharma Ltd., c/o Ajanta Pharma USA, Inc., One
Grande Commons, 440 US Highway 22 East, Suite 150,
Bridgewater, NJ 08807.
ANDA 203838 ......... Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Tris Pharma, Inc., 2033 Route 130, Monmouth Junction, NJ
Pseudoephedrine HCl Oral Solution, 5 mg/4 mg/60 mg 08852.
per 5 mL.
ANDA 203839 ......... Hydrocodone Bitartrate and Pseudoephedrine HCl Oral So- Do.
lution, 5 mg/60 mg per 5 mL.

Therefore, approval of the Dated: November 27, 2017. Wednesday, January 10, 2018: 8:45
applications listed in table 1 of this Leslie Kux, a.m.–3:00 p.m. ET
document, and all amendments and Associate Commissioner for Policy.. Place: U.S. Department of Health and
supplements thereto, is hereby [FR Doc. 2017–25920 Filed 11–30–17; 8:45 am] Human Services, Hubert H. Humphrey
withdrawn as of January 2, 2018. BILLING CODE 4164–01–P Building, 200 Independence Avenue
Introduction or delivery for introduction SW., Rm. 705A, Washington, DC 20201.
into interstate commerce of products Status: Open.
without approved new drug DEPARTMENT OF HEALTH AND Purpose: At the January 9–10, 2018
applications violates section 301(a) and HUMAN SERVICES full meeting, the Committee will hear
(d) of the Federal Food, Drug, and presentations, hold discussions on
National Committee on Vital and Health several health data policy topics and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Statistics: Teleconference begin work on activities outlined in the
Drug products that are listed in table 1
that are in inventory on the date that Pursuant to the Federal Advisory NCVHS 2018 workplan. An
this notice becomes effective (see the Committee Act, the Department of environmental scan report will be
DATES section) may continue to be Health and Human Services (HHS) reviewed and discussed by the full
Committee as part of the Health
sradovich on DSK3GMQ082PROD with NOTICES

dispensed until the inventories have announces the following advisory
been depleted or the drug products have committee meeting. Information Privacy and Security
reached their expiration dates or Name: National Committee on Vital Beyond HIPAA project. This effort
otherwise become violative, whichever and Health Statistics (NCVHS), Full includes an exploration of challenges
occurs first. Committee Meeting. that extend beyond HIPAA and the
Dates and Times: range of policy options that may be
Tuesday, January 9, 2018: 9:00 a.m.– available to the Department related to
5:30 p.m. ET privacy, security and access measures to

VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1

Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices 56979

protect individually identifiable health Dated: November 27, 2017. be obtained by accessing the Council’s
information in an environment of Laina Bush, page on the HIV.gov site at https://
electronic networking and multiple uses Deputy Assistant Secretary for Planning and www.hiv.gov/federal-response/pacha/
of data. The Population Health Evaluation, Office of the Assistant Secretary about-pacha.
Subcommittee will focus on Next for Planning and Evaluation. SUPPLEMENTARY INFORMATION: PACHA
Generation Vital Statistics in follow up [FR Doc. 2017–25895 Filed 11–30–17; 8:45 am] was established by Executive Order
to the hearing held September 11–12, BILLING CODE 4151–05–P 12963, dated June 14, 1995, as amended
2017 and subsequent analyses by Executive Order 13009, dated June
conducted following the hearing. The 14, 1996, and is currently operating
purpose of the hearing was to assess the DEPARTMENT OF HEALTH AND under the authority given in Executive
current state of the national vital HUMAN SERVICES Order 13811, dated September 29, 2017.
statistics system (NVSS) to address The Council was established to provide
concerns regarding sustainability and Nominations to the Presidential
advice, information, and
viability of the system infrastructure. Advisory Council on HIV/AIDS
recommendations to the Secretary
Also addressed was the system’s AGENCY: Office of the Secretary, Office regarding programs and policies
capacity to provide timely, high quality, of the Assistant Secretary for Health, intended to promote effective
secure vital administrative and Department of Health and Human prevention and care of HIV infection
statistical data for identity Services. and AIDS. The functions of the Council
establishment and protection, ACTION: Notice. are solely advisory in nature.
identification of trends in disease and The Council consists of not more than
epidemics, e.g., the recent surge in SUMMARY: The Office of the Assistant 25 members. Council members are
opioid-related deaths, and a host of Secretary for Health (OASH) is seeking selected from prominent community
critical uses for research, finance, nominations of qualified individuals to leaders with particular expertise in, or
planning, public records and services. be considered for appointment as knowledge of, matters concerning HIV
The Committee will discuss concerns members of the Presidential Advisory and AIDS, public health, global health,
regarding decreased access to county Council on HIV/AIDS (PACHA). The philanthropy, marketing or business, as
and community-level data and potential PACHA is a federal advisory committee well as other national leaders held in
plans to conduct work to address the within the Department of Health and high esteem from other sectors of
issue. The Committee will also discuss Human Services (HHS). Management society. Council members are appointed
the Predictability Roadmap as part of support for the activities of this Council by the Secretary or designee, in
the Standards Subcommittee’s project to is the responsibility of the Office of consultation with the White House.
identify possible approaches to improve HIV/AIDS and Infectious Disease Policy Pursuant to advance written agreement,
the predictability and improvements in in the OASH. The qualified individuals Council members shall receive no
the adoption and processes related to will be nominated to the Secretary of stipend for the advisory service they
updating standards and operating rules Health and Human Services for render as members of PACHA. However,
for electronic administrative consideration for appointment as as authorized by law and in accordance
transactions (e.g. claims, eligibility, members of the PACHA. Members of the with federal travel regulations, PACHA
electronic funds transfer); health Council, including the Chair, are members may receive per diem and
terminology & vocabulary development, appointed by the Secretary. Members reimbursement for travel expenses
maintenance, and dissemination are invited to serve on the Council for incurred in relation to performing duties
processes; and mapping out activities up to four-year terms. The Council was for the Council.
and timelines for the Committee’s 2018 established to provide advice, This announcement is to solicit
work. information, and recommendations to nominations of qualified candidates to
The times and topics are subject to the Secretary regarding programs and fill vacancies on the PACHA.
change. Please refer to the posted policies intended to promote effective Nominations: In accordance with the
agenda for any updates. prevention and care of HIV infection PACHA charter, persons nominated for
and AIDS. The functions of the Council appointment as members of the PACHA
Contact Person for More Information: are solely advisory in nature. should be among prominent community
Substantive program information may leaders and authorities with particular
DATES: All nominations must be
be obtained from Rebecca Hines, MHS, expertise in, of knowledge of, matters
received no later than 5:00 p.m. (ET) on
Executive Secretary, NCVHS, National concerning HIV and AIDS, public
January 2, 2018 to the address listed
Center for Health Statistics, Centers for health, global health, philanthropy,
below.
Disease Control and Prevention, 3311 marketing or business, as well as other
Toledo Road, Hyattsville, Maryland ADDRESSES: All nominations should be national leaders held in high esteem
20782, telephone (301) 458–4715. mailed or delivered to Ms. B. Kaye from other sectors of society. The
Summaries of meetings and a roster of Hayes, Executive Director, PACHA, following information should be
Committee members are available on the Department of Health and Human included in the package of material
home page of the NCVHS Web site: Services, Office of HIV/AIDS and submitted for each individual being
http://www.ncvhs.hhs.gov/, where Infectious Disease Policy, 330 C Street nominated for consideration of
further information including an agenda SW., Room L100B, Washington, DC appointment:
and instructions to access the audio 20024. • Name, return address, and daytime
sradovich on DSK3GMQ082PROD with NOTICES

broadcast of the meetings will also be FOR FURTHER INFORMATION CONTACT: Ms. telephone number and affiliation(s) of
posted. Caroline Talev, Public Health Analyst, the individual being nominated, the
Should you require reasonable Presidential Advisory Council on HIV/ basis for the individual’s nomination,
accommodation, please contact the CDC AIDS, 330 C Street SW., Room L106B, and a statement bearing an original
Office of Equal Employment Washington, DC 20024; (202) 795–7622 signature of the nominated individual
Opportunity on (770) 488–3210 as soon or Caroline.Talev@hhs.gov. More that, if appointed, he or she is willing
as possible. detailed information about PACHA can to serve as a member of the Council;

VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1

Document Created: 2018-10-25 10:46:04
Document Modified: 2018-10-25 10:46:04

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 56978