80 FR 12495 - Advisory Commission on Childhood Vaccines; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 45 (March 9, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 45 (March 9, 2015)
| Page Range | 12495-12496 | |
| FR Document | 2015-05200 |
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)] [Notices] [Pages 12495-12496] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05200] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: Name: Advisory Commission on Childhood Vaccines (ACCV). Date and Time: March 5, 2015, 10:00 a.m. to 4:00 p.m. EDT. Place: Audio Conference Call and Adobe Connect Pro. The ACCV will meet on Thursday, March 5, 2015, from 10:00 a.m. to 4:00 p.m. (EDT). The public can join the meeting by: 1. (Audio Portion) Calling the conference Phone Number 877-917-4913 and providing the following information: Leader's Name: Dr. A. Melissa Houston. Password: ACCV. 2. (Visual Portion) Connecting to the ACCV Adobe Connect Pro Meeting using the following URL: https://hrsa.connectsolutions.com/accv/ (copy and paste the link into your browser if it does not work directly, and enter as a guest). Participants should call and connect 15 minutes prior to the meeting in order for logistics to be set up. If you have never attended an Adobe Connect meeting, please test your connection using the following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm and get a quick overview by following URL: http://www.adobe.com/go/connectpro_overview. Call (301) 443-6634 or send an email to [email protected] if you are having trouble connecting to the meeting site. Agenda: The agenda items for the March 2015 meeting will include, but are not limited to: updates from the Division of Injury Compensation Programs (DICP), Department of Justice (DOJ), National Vaccine Program Office (NVPO), Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health) and Center for Biologics, Evaluation and Research (Food and Drug Administration). A draft agenda and additional meeting materials will be posted on the ACCV Web site (http://www.hrsa.gov/vaccinecompensation/accv.htm) prior to the meeting. Agenda items are subject to change as priorities dictate. Public Comment: Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation to: Annie Herzog, DICP, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C- 26, 5600 Fishers Lane, Rockville, MD 20857 or email: [email protected]. Requests should contain the name, address, telephone number, email address, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DICP will notify each presenter by email, mail, or telephone of their assigned presentation [[Page 12496]] time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the public comment period. Public participation and ability to comment will be limited to space and time as it permits. The logistical challenges of scheduling this meeting delayed an earlier publication of this notice. FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding the ACCV should contact Annie Herzog, DICP, HSB, HRSA, Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857, telephone (301) 443-6593, or email: [email protected]. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-05200 Filed 3-6-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12495
Abstract: The Rural Health Care Need and Proposed Use of the Likely Respondents: The respondents
Services Outreach (Outreach) Program is Information: For this program, would be recipients of the Rural Health
authorized by section 330A(e) of the performance measures were drafted to Care Services Outreach grant funding.
Public Health Service (PHS) Act (42 provide data to the program and to Burden Statement: Burden in this
U.S.C. 254c(e)), as amended, to enable HRSA to provide aggregate context means the time expended by
‘‘promote rural health care services program data required by Congress persons to generate, maintain, retain,
outreach by expanding the delivery of under the Government Performance and disclose or provide the information
health care services to include new and Results Act (GPRA) of 1993. These
enhanced services in rural areas.’’ The requested. This includes the time
measures cover the principal topic areas needed to review instructions; to
goals for the Outreach Program are the of interest to the Federal Office of Rural
following: (1) Expand the delivery of develop, acquire, install and utilize
Health Policy (FORHP), including: (a) technology and systems for the purpose
health care services to include new and Access to care; (b) population
enhanced services exclusively in rural of collecting, validating and verifying
demographics; (c) staffing; (d) information, processing and
communities; (2) deliver health care consortium/network; (e) sustainability;
services through a strong consortium, in maintaining information, and disclosing
and (f) project specific domains. Several and providing information; to train
which every consortium member
measures will be used for the Outreach personnel and to be able to respond to
organization is actively involved and
Program. All measures will speak to a collection of information; to search
engaged in the planning and delivery of
services; (3) utilize and/or adapt an FORHP’s progress toward meeting the data sources; to complete and review
evidence-based or promising practice goals. the collection of information; and to
model(s) in the delivery of health care A 60-day Federal Register Notice was transmit or otherwise disclose the
services; and (4) improve population published in the Federal Register on information. The total annual burden
health and demonstrate health outcomes December 22, 2014, (79 FR 76334). hours estimated for this ICR are
and sustainability. There were no comments. summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of Total burden per
Form name responses per burden
respondents responses response
respondent hours
(in hours)
Rural Health Care Services Outreach Grant Program Measures ....... 50 1 50 3 150
Total .............................................................................................. 50 1 50 3 150
Jackie Painter, Leader’s Name: Dr. A. Melissa (National Institutes of Health) and
Director, Division of the Executive Secretariat. Houston. Center for Biologics, Evaluation and
[FR Doc. 2015–05414 Filed 3–6–15; 8:45 am] Password: ACCV. Research (Food and Drug
BILLING CODE 4165–15–P
2. (Visual Portion) Connecting to the Administration). A draft agenda and
ACCV Adobe Connect Pro Meeting additional meeting materials will be
using the following URL: https:// posted on the ACCV Web site (http://
DEPARTMENT OF HEALTH AND hrsa.connectsolutions.com/accv/ (copy www.hrsa.gov/vaccinecompensation/
HUMAN SERVICES and paste the link into your browser if accv.htm) prior to the meeting. Agenda
it does not work directly, and enter as items are subject to change as priorities
Health Resources and Services a guest). Participants should call and dictate.
Administration connect 15 minutes prior to the meeting
in order for logistics to be set up. If you Public Comment: Persons interested
Advisory Commission on Childhood have never attended an Adobe Connect in providing an oral presentation should
Vaccines; Notice of Meeting meeting, please test your connection submit a written request, along with a
using the following URL: https:// copy of their presentation to: Annie
In accordance with section 10(a)(2) of hrsa.connectsolutions.com/common/ Herzog, DICP, Healthcare Systems
the Federal Advisory Committee Act help/en/support/meeting_test.htm and Bureau (HSB), Health Resources and
(Pub. L. 92–463), notice is hereby given get a quick overview by following URL: Services Administration (HRSA), Room
of the following meeting: http://www.adobe.com/go/connectpro_ 11C–26, 5600 Fishers Lane, Rockville,
Name: Advisory Commission on overview. Call (301) 443–6634 or send MD 20857 or email: aherzog@hrsa.gov.
Childhood Vaccines (ACCV). an email to aherzog@hrsa.gov if you are Requests should contain the name,
Date and Time: March 5, 2015, 10:00 having trouble connecting to the address, telephone number, email
a.m. to 4:00 p.m. EDT. meeting site. address, and any business or
Place: Audio Conference Call and Agenda: The agenda items for the professional affiliation of the person
Adobe Connect Pro. March 2015 meeting will include, but desiring to make an oral presentation.
mstockstill on DSK4VPTVN1PROD with NOTICES
The ACCV will meet on Thursday, are not limited to: updates from the Groups having similar interests are
March 5, 2015, from 10:00 a.m. to 4:00 Division of Injury Compensation requested to combine their comments
p.m. (EDT). The public can join the Programs (DICP), Department of Justice and present them through a single
meeting by: (DOJ), National Vaccine Program Office representative. The allocation of time
1. (Audio Portion) Calling the (NVPO), Immunization Safety Office may be adjusted to accommodate the
conference Phone Number 877–917– (Centers for Disease Control and level of expressed interest. DICP will
4913 and providing the following Prevention), National Institute of notify each presenter by email, mail, or
information: Allergy and Infectious Diseases telephone of their assigned presentation
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![12496 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
time. Persons who do not file an Microbiology and Infectious Diseases (Catalogue of Federal Domestic Assistance
advance request for a presentation, but Research, National Institutes of Health, HHS) Program Nos. 93.847, Diabetes,
desire to make an oral statement, may Dated: March 3, 2015. Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
announce it at the time of the public David Clary, Research; 93.849, Kidney Diseases, Urology
comment period. Public participation Program Analyst, Office of Federal Advisory and Hematology Research, National Institutes
and ability to comment will be limited Committee Policy. of Health, HHS)
to space and time as it permits. [FR Doc. 2015–05309 Filed 3–6–15; 8:45 am] Dated: March 3, 2015.
The logistical challenges of BILLING CODE 4140–01–P David Clary,
scheduling this meeting delayed an
Program Analyst, Office of Federal Advisory
earlier publication of this notice.
Committee Policy.
FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND
[FR Doc. 2015–05308 Filed 3–6–15; 8:45 am]
Anyone requiring information regarding HUMAN SERVICES
BILLING CODE 4140–01P
the ACCV should contact Annie Herzog,
National Institutes of Health
DICP, HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, Maryland National Institute of Diabetes and DEPARTMENT OF HEALTH AND
20857, telephone (301) 443–6593, or Digestive and Kidney Diseases; Notice HUMAN SERVICES
email: aherzog@hrsa.gov. of Closed Meetings
Food and Drug Administration
Jackie Painter, Pursuant to section 10(d) of the
Director, Division of the Executive Secretariat. [Docket No. FDA–2015–D–0390]
Federal Advisory Committee Act, as
[FR Doc. 2015–05200 Filed 3–6–15; 8:45 am] amended (5 U.S.C. App.), notice is Use of an Electronic Informed Consent
BILLING CODE 4165–15–P hereby given of the following meetings. in Clinical Investigations: Questions
The meetings will be closed to the
and Answers; Draft Guidance for
public in accordance with the
Industry, Clinical Investigators, and
DEPARTMENT OF HEALTH AND provisions set forth in sections
Institutional Review Boards;
HUMAN SERVICES 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Availability
as amended. The grant applications and
National Institutes of Health the discussions could disclose AGENCY: Food and Drug Administration,
confidential trade secrets or commercial HHS.
National Institute of Allergy and
property such as patentable material, ACTION: Notice.
Infectious Diseases; Notice of Closed
and personal information concerning
Meeting SUMMARY: The Food and Drug
individuals associated with the grant
applications, the disclosure of which Administration (FDA or the Agency) is
Pursuant to section 10(d) of the
would constitute a clearly unwarranted announcing the availability of a draft
Federal Advisory Committee Act, as
invasion of personal privacy. guidance for industry, clinical
amended (5 U.S.C. App.), notice is
investigators, and institutional review
hereby given of the following meeting. Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
boards entitled ‘‘Use of Electronic
The meeting will be closed to the Informed Consent in Clinical
public in accordance with the Special Emphasis Panel; Time-Sensitive
Obesity Meeting. Investigations: Questions and Answers.’’
provisions set forth in sections The guidance provides
Date: March 26, 2015.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 1:00 p.m. to 3:00 p.m. recommendations for clinical
as amended. The grant applications and Agenda: To review and evaluate grant investigators, sponsors, and institutional
the discussions could disclose applications. review boards (IRBs) on the use of
confidential trade secrets or commercial Place: National Institutes of Health, Two electronic media and processes to obtain
property such as patentable material, Democracy Plaza, 6707 Democracy informed consent for FDA-regulated
and personal information concerning Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
clinical investigations of medical
individuals associated with the grant products, including human drug and
applications, the disclosure of which Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch, biological products, medical devices,
would constitute a clearly unwarranted and combinations thereof.
DEA, NIDDK, National Institutes of Health,
invasion of personal privacy. Room 753, 6707 Democracy Boulevard, DATES: Although you can comment on
Name of Committee: National Institute of Bethesda, MD 20892–2542, (301) 594–8898, any guidance at any time (see 21 CFR
Allergy and Infectious Diseases Special barnardm@extra.niddk.nih.gov. 10.115(g)(5)), to ensure that the Agency
Emphasis Panel; ‘‘NIAID Resource-Related Name of Committee: National Institute of considers your comment on this draft
Research Projects (R24): Fecal Microbiome Diabetes and Digestive and Kidney Diseases
Transplant National Registry’’.
guidance before it begins work on the
Special Emphasis Panel; NIDDK—Planning final version of the guidance, submit
Date: April 2, 2015. Grant in Chronic Kidney Disease (U34).
Time: 1:00 p.m. to 3:00 p.m. Date: April 8, 2015.
either electronic or written comments
Agenda: To review and evaluate grant Time: 1:00 p.m. to 2:30 p.m. on the draft guidance by May 8, 2015.
applications. Agenda: To review and evaluate grant ADDRESSES: Submit written requests for
Place: National Institutes of Health, Room applications. single copies of the draft guidance to the
3G61, 5601 Fishers Lane, Rockville, MD Place: National Institutes of Health, Two Division of Drug Information, Center for
20892, (Telephone Conference Call). Democracy Plaza, 6707 Democracy
mstockstill on DSK4VPTVN1PROD with NOTICES
Drug Evaluation and Research, Food
Contact Person: Travis J. Taylor, Ph.D., Boulevard, Bethesda, MD 20892, (Telephone
Scientific Review Program, DEA/NIAID/NIH/
and Drug Administration, 10001 New
Conference Call). Hampshire Ave., Hillandale Building,
DHHS, 5601 Fishers Lane, Rockville, MD Contact Person: Najma Begum, Ph.D.,
20892, 240–669–5082, Travis.Taylor@ Scientific Review Officer, Review Branch,
4th Floor, Silver Spring, MD 20993; or
nih.gov. DEA, NIDDK, National Institutes of Health, Office of Good Clinical Practice, Office
(Catalogue of Federal Domestic Assistance Room 749, 6707 Democracy Boulevard, of Special Medical Programs, Office of
Program Nos. 93.855, Allergy, Immunology, Bethesda, MD 20892–5452, (301) 594–8894, the Commissioner, Food and Drug
and Transplantation Research; 93.856, begumn@niddk.nih.gov. Administration, 10903 New Hampshire
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Document Created: 2015-12-18 12:05:30
Document Modified: 2015-12-18 12:05:30
| 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 | |
| Contact | Anyone requiring information regarding the ACCV should contact Annie Herzog, DICP, HSB, HRSA, Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857, telephone (301) 443-6593, or email: [email protected] | |
| FR Citation | 80 FR 12495 |
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