83 FR 17557 - National Advisory Council on Nurse Education and Practice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 77 (April 20, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 77 (April 20, 2018)
| Page Range | 17557-17558 | |
| FR Document | 2018-08263 |
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)] [Notices] [Pages 17557-17558] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08263] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Nurse Education and Practice AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of Federal Advisory Committee meeting. ----------------------------------------------------------------------- SUMMARY: In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) will hold a public meeting. DATES: Wednesday, May 16, 2018, from 11:00 a.m. to 4:00 p.m. ET. ADDRESSES: This meeting is a teleconference and webinar. The conference call-in number is 1-800-619-2521 and the passcode is 9271697. The webinar link is https://hrsa.connectsolutions.com/nacnep/. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding the NACNEP meeting should contact CDR Antoine Smith, Designated Federal Official (DFO), Bureau of Health Workforce (BHW), HRSA, in one of three ways: (1) Send a request to the following address: CDR Antoine Smith, DFO, BHW, HRSA, 5600 Fishers Lane, Room 11N120, Rockville, Maryland 20857; (2) call 301-443-3726; or (3) send an email to [email protected]. SUPPLEMENTARY INFORMATION: NACNEP provides advice and recommendations [[Page 17558]] to the Secretary of HHS and the U.S. Congress on policy issues related to the activities under section 851 of Title VIII of the Public Health Service Act (PHSA). The Secretary of HHS, and by delegation the Administrator of HRSA, is charged under Title VIII of the PHSA as amended, with responsibility for a wide range of activities in support of nursing education and practice which include: enhancement of the composition of the nursing workforce; improvement of the distribution and utilization of nurses to meet the health needs of the nation; expansion of the knowledge, skills, and capabilities of nurses to enhance the quality of nursing practice; development and dissemination of improved models of organization; financing and delivery of nursing services; and promotion of interdisciplinary approaches to the delivery of health services particularly in the context of public health and primary care. During the May 16, 2018, meeting, NACNEP members will be oriented to the work of the Council and identify a topic for 2018. The NACNEP final agenda will be available on the NACNEP website three (3) days prior to the meeting at https://www.hrsa.gov/advisory-committees/nursing/index.html. Please note that agenda items are subject to change as priorities dictate. Members of the public will have the opportunity to provide comments, which are part of the official Committee record. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the NACNEP should be sent to CDR Antoine Smith, DFO, using the contact information above, at least three (3) business days prior to the meeting. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018-08263 Filed 4-19-18; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices 17557
as ‘‘confidential’’ will not be disclosed the world have participated in many establish any rights for any person and
except in accordance with 21 CFR 10.20 important initiatives to promote is not binding on FDA or the public.
and other applicable disclosure law. For international harmonization of You can use an alternative approach if
more information about FDA’s posting regulatory requirements under ICH. it satisfies the requirements of the
of comments to public dockets, see 80 FDA has participated in several ICH applicable statutes and regulations. This
FR 56469, September 18, 2015, or access meetings designed to enhance guidance is not subject to Executive
the information at: https://www.gpo.gov/ harmonization, and FDA is committed Order 12866.
fdsys/pkg/FR-2015-09-18/pdf/2015- to seeking scientifically based
harmonized technical procedures for II. Electronic Access
23389.pdf.
Docket: For access to the docket to pharmaceutical development. One of Persons with access to the internet
read background documents or the the goals of harmonization is to identify may obtain the guidance at https://
electronic and written/paper comments and reduce differences in technical www.regulations.gov, https://
received, go to https:// requirements for drug development www.fda.gov/Drugs/Guidance
www.regulations.gov and insert the among regulatory agencies. ComplianceRegulatoryInformation/
docket number, found in brackets in the ICH was established to provide an Guidances/default.htm, or https://
heading of this document, into the opportunity for harmonization www.fda.gov/BiologicsBloodVaccines/
‘‘Search’’ box and follow the prompts initiatives to be developed with input GuidanceComplianceRegulatory
and/or go to the Dockets Management from both regulatory and industry Information/Guidances/default.htm.
Staff, 5630 Fishers Lane, Rm. 1061, representatives. FDA also seeks input Dated: April 13, 2018.
Rockville, MD 20852. from consumer representatives and
Leslie Kux,
You may submit comments on any others. ICH is concerned with
harmonization of technical Associate Commissioner for Policy.
guidance at any time (see 21 CFR
requirements for the registration of [FR Doc. 2018–08252 Filed 4–19–18; 8:45 am]
10.115(g)(5)).
Submit written requests for single pharmaceutical products for human use BILLING CODE 4164–01–P
copies of this guidance to the Division among regulators around the world. The
of Drug Information, Center for Drug six founding members of ICH are the
European Commission; the European DEPARTMENT OF HEALTH AND
Evaluation and Research, Food and
Federation of Pharmaceutical Industries HUMAN SERVICES
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, Associations; FDA; the Japanese
Ministry of Health, Labour, and Welfare; Health Resources and Services
4th Floor, Silver Spring, MD 20993– Administration
0002, or the Office of Communication, the Japanese Pharmaceutical
Outreach and Development, Center for Manufacturers Association; and the National Advisory Council on Nurse
Biologics Evaluation and Research Pharmaceutical Research and Education and Practice
(CBER), Food and Drug Administration, Manufacturers of America. The
10903 New Hampshire Ave., Bldg. 71, Standing Members of the ICH AGENCY: Health Resources and Services
Rm. 3128, Silver Spring, MD 20993– Association also include Health Canada Administration (HRSA), Department of
0002. Send one self-addressed adhesive and Swissmedic. Any party eligible as a Health and Human Services (HHS).
label to assist that office in processing Member in accordance with the ICH ACTION: Notice of Federal Advisory
your requests. The guidance may also be Articles of Association can apply for Committee meeting.
obtained by mail by calling CBER at 1– membership in writing to the ICH
800–835–4709 or 240–402–8010. See Secretariat. The ICH Secretariat, which SUMMARY: In accordance with the
the SUPPLEMENTARY INFORMATION section coordinates the preparation of Federal Advisory Committee Act, this
for electronic access to the guidance documentation, operates as an notice announces that the National
document. international nonprofit organization and Advisory Council on Nurse Education
is funded by the Members of the ICH and Practice (NACNEP) will hold a
FOR FURTHER INFORMATION CONTACT: Association. public meeting.
Regarding the guidance: Alicia The ICH Assembly is the overarching DATES: Wednesday, May 16, 2018, from
Mozzachio, Center for Drug Evaluation body of the Association and includes 11:00 a.m. to 4:00 p.m. ET.
and Research, Food and Drug representatives from each ICH member
Administration, 10903 New Hampshire ADDRESSES: This meeting is a
and observer. The Assembly is
Ave., Bldg. 51, Rm. 3308, Silver Spring, teleconference and webinar. The
responsible for the endorsement of draft
MD 20993–0002, 301–796–3206; or conference call-in number is 1–800–
guidelines and adoption of final
Anna Flynn, Center for Biologics 619–2521 and the passcode is 9271697.
guidelines. FDA publishes ICH
Evaluation and Research, Food and The webinar link is https://
guidelines as FDA guidance.
Drug Administration, 10903 New A final draft of the guidance was hrsa.connectsolutions.com/nacnep/.
Hampshire Ave., Bldg. 71, Rm. 5070, submitted to the ICH Assembly and FOR FURTHER INFORMATION CONTACT:
Silver Spring, MD 20993–0002, 240– endorsed by the regulatory agencies in Anyone requesting information
402–9156. June 2015. The guidance provides regarding the NACNEP meeting should
Regarding the ICH: Amanda Roache, clarification on the implementation of contact CDR Antoine Smith, Designated
Center for Drug Evaluation and good manufacturing practices for APIs, Federal Official (DFO), Bureau of Health
Research, Food and Drug as described in ICH Q7. Workforce (BHW), HRSA, in one of
Administration, 10903 New Hampshire This guidance is being issued three ways: (1) Send a request to the
sradovich on DSK3GMQ082PROD with NOTICES
Ave., Bldg. 51, Rm. 1176, Silver Spring, consistent with FDA’s good guidance following address: CDR Antoine Smith,
MD 20993–0002, 301–796–4548. practices regulation (21 CFR 10.115). DFO, BHW, HRSA, 5600 Fishers Lane,
SUPPLEMENTARY INFORMATION: The guidance represents the current Room 11N120, Rockville, Maryland
thinking of FDA on ‘‘Q7 Good 20857; (2) call 301–443–3726; or (3)
I. Background Manufacturing Practice Guidance for send an email to asmith@hrsa.gov.
In recent years, regulatory authorities Active Pharmaceutical Ingredients: SUPPLEMENTARY INFORMATION: NACNEP
and industry associations from around Questions and Answers.’’ It does not provides advice and recommendations
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![17558 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
to the Secretary of HHS and the U.S. Department of Health and Human Dated: April 9, 2018.
Congress on policy issues related to the Services is hereby giving notice that the Robert P. Kadlec,
activities under section 851 of Title VIII National Advisory Committee on Assistant Secretary for Preparedness and
of the Public Health Service Act Children and Disasters (NACCD) will Response.
(PHSA). The Secretary of HHS, and by hold a public teleconference on May 1, [FR Doc. 2018–08278 Filed 4–19–18; 8:45 am]
delegation the Administrator of HRSA, 2018. BILLING CODE P
is charged under Title VIII of the PHSA
as amended, with responsibility for a DATES: The NACCD Teleconference is
wide range of activities in support of May 1, 2018, from 3:00 p.m. to 4:00 p.m. DEPARTMENT OF HEALTH AND
nursing education and practice which Eastern Standard Time EST. HUMAN SERVICES
include: enhancement of the ADDRESSES: We encourage members of
composition of the nursing workforce; National Institutes of Health
the public to attend the teleconference.
improvement of the distribution and To register, send an email to naccd@
utilization of nurses to meet the health Proposed Collection; 60-Day Comment
hhs.gov with ‘‘NACCD Registration’’ in Request; NIH NeuroBioBank Tissue
needs of the nation; expansion of the
the subject line. Submit your comments Access Request Form, National
knowledge, skills, and capabilities of
to naccd@hhs.gov or on the NACCD Institute of Mental Health
nurses to enhance the quality of nursing
practice; development and Contact Form located at https://
www.phe.gov/Preparedness/legal/ AGENCY: National Institutes of Health,
dissemination of improved models of HHS.
organization; financing and delivery of boards/naccd/Pages/contact.aspx. For
additional information, visit the NACCD ACTION: Notice.
nursing services; and promotion of
interdisciplinary approaches to the website located at https://www.phe.gov/
SUMMARY: In compliance with the
delivery of health services particularly naccd.
requirement of the Paperwork
in the context of public health and SUPPLEMENTARY INFORMATION: Pursuant Reduction Act of 1995 to provide
primary care. to the Federal Advisory Committee Act opportunity for public comment on
During the May 16, 2018, meeting, of 1972 (5 U.S.C., Appendix, as proposed data collection projects, the
NACNEP members will be oriented to amended), and section 2811A of the National Institute of Mental Health
the work of the Council and identify a Public Health Service Act (42 U.S.C. (NIMH) will publish periodic
topic for 2018. The NACNEP final summaries of proposed projects to be
300hh–10a), as added by section 103 of
agenda will be available on the submitted to the Office of Management
the Pandemic and All Hazards
NACNEP website three (3) days prior to and Budget (OMB) for review and
Preparedness Reauthorization Act of
the meeting at https://www.hrsa.gov/ approval.
2013 (Pub. L. 113–5), the HHS
advisory-committees/nursing/
index.html. Please note that agenda Secretary, in consultation with the DATES: Comments regarding this
items are subject to change as priorities Secretary of the U.S. Department of information collection are best assured
dictate. Homeland Security, established the of having their full effect if received
Members of the public will have the NACCD. The purpose of the NACCD is within 60 days of the date of this
opportunity to provide comments, to provide advice and consultation to publication.
which are part of the official Committee the HHS Secretary with respect to the FOR FURTHER INFORMATION CONTACT: To
record. Oral comments will be honored medical and public health needs of obtain a copy of the data collection
in the order they are requested and may children in relation to disasters. plans and instruments, submit
be limited as time allows. Requests to Background: The NACCD Public comments in writing, or request more
make oral comments or provide written Teleconference on May 1, 2018, is information on the proposed project,
comments to the NACNEP should be dedicated to the presentation, contact: Melba Rojas, NIMH Project
sent to CDR Antoine Smith, DFO, using deliberation, and vote on the NACCD Clearance Liaison, Science Policy and
the contact information above, at least Funding Strategies Report. Evaluation Branch, Office of Science
three (3) business days prior to the Policy, Planning and Communications,
Availability of Materials: We will post
meeting. NIMH, Neuroscience Center, 6001
all teleconference materials and any
Amy P. McNulty, modifications to the agenda prior to Executive Boulevard, MSC 9667,
Acting Director, Division of the Executive May 1, 2018, on the NACCD website, Bethesda, Maryland 20892, call 301–
Secretariat. 443–4335, or email your request,
located at https://www.phe.gov/naccd.
[FR Doc. 2018–08263 Filed 4–19–18; 8:45 am]
including your mailing address, to
Procedures for Providing Public Input: nimhprapubliccomments@mail.nih.gov.
BILLING CODE 4165–15–P Members of the public may attend the Formal requests for additional plans and
teleconference via a toll-free call-in instruments must be requested in
phone number, which is available on writing.
DEPARTMENT OF HEALTH AND
the NACCD website at https://
HUMAN SERVICES SUPPLEMENTARY INFORMATION: Section
www.phe.gov/naccd.
3506(c)(2)(A) of the Paperwork
National Advisory Committee on We encourage members of the public Reduction Act of 1995 requires: Written
Children and Disasters Public to provide written comments that are comments and/or suggestions from the
Teleconference relevant to the NACCD Teleconference public and affected agencies are invited
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Office of the Secretary, prior to May 1, 2018. Send written to address one or more of the following
Department of Health and Human comments by email to naccd@hhs.gov points: (1) Whether the proposed
Services (HHS). with ‘‘NACCD Public Comment’’ in the collection of information is necessary
ACTION: Notice.
subject line. The NACCD Chair will for the proper performance of the
respond during the meeting to function of the agency, including
SUMMARY: As stipulated by the Federal comments received by April 30, 2018, whether the information will have
Advisory Committee Act, the during the teleconference. practical utility; (2) The accuracy of the
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Document Created: 2018-04-20 00:03:29
Document Modified: 2018-04-20 00:03:29
| 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 Federal Advisory Committee meeting. | |
| Dates | Wednesday, May 16, 2018, from 11:00 a.m. to 4:00 p.m. ET. | |
| Contact | Anyone requesting information regarding the NACNEP meeting should contact CDR Antoine Smith, Designated Federal Official (DFO), Bureau of Health Workforce (BHW), HRSA, in one of three ways: (1) Send a request to the following | |
| FR Citation | 83 FR 17557 |
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