Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices 40773 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Vaccines and Related Biological 

Products Advisory Committee 

(VRBPAC). The general function of the 

committee is to provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. Members will 

participate via teleconference. 

DATES: The meeting will be held on 

October 3, 2018, from 11 a.m. to 3:30 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Avenue, Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

For those unable to attend in person, the 

meeting will also be webcast and will be 

available at the following link: https:// 

collaboration.fda.gov/vrbpac1018. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Serina Hunter-Thomas, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–5771, 

serina.hunter-thomas@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On October 3, 2018, the 

VRBPAC will meet in an open session 

to discuss and make recommendations 

on the selection of strains to be included 

in an influenza virus vaccine for the 

2019 southern hemisphere influenza 

season. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before September 26, 2018. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 18, 2018. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 19, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Serina HunterThomas at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17702 Filed 8–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Advisory Committee on Rural 

Health and Human Services 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The Secretary’s National 

Advisory Committee on Rural Health 

and Human Services (NACRHHS) has 

scheduled a public meeting. Information 

about NACRHHS and the agenda for this 

meeting can be found on the NACRHHS 

website at https://www.hrsa.gov/ 

advisory-committees/rural-health/ 

index.html. 

DATES: September 10, 2018, 8:30 a.m.– 

5:15 p.m. ET; September 11, 2018, 8:30 

a.m.–5:15 p.m. ET; September 12, 2018, 

8:30 a.m.–11:15 a.m. ET. 

ADDRESSES: On September 10, the 

address for the meeting is The Duke 

Endowment, 800 East Morehead Street, 

Charlotte, NC 28202. 

On the morning of September 11, 

NACRHHS will break into 

subcommittees. One subcommittee will 

travel to Happy Valley Medical Center, 

1345 NC Highway 268, Lenoir, NC 

28645. The other subcommittee will 

travel to Winnsboro Smiles Dental 

Clinic, 124 N Congress Street, 

Winnsboro, SC 29180. In the afternoon, 

at approximately 4:00 p.m. ET., 

NACRHHS will reconvene at the AC 

Hotel Charlotte City Center, 220 E Trade 

Street, Charlotte, NC 28202. 

On September 12, the address for the 

meeting is AC Hotel Charlotte City 

Center, 220 E Trade Street, Charlotte, 

NC 28202. 

FOR FURTHER INFORMATION CONTACT: 

Steven Hirsch, Administrative 

Coordinator at the Federal Office of 

Rural Health Policy, HRSA, 5600 

Fishers Lane, 17W59D, Rockville, 

Maryland 20857; 301–443–7322; or 

shirsch@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

NACRHHS provides advice and 

recommendations to the Secretary of 

HHS (Secretary) on policy, program 

development, and other matters of 

significance concerning both rural 

health and rural human services. 

During the September meetings, 

NACRHHS will discuss the issues of 

chronic obstructive pulmonary disease, 

one of the leading causes of mortality in 

rural areas, and the provision of oral 

health services in rural areas. Agenda 

items are subject to change as priorities 

dictate. 

Members of the public will have the 

opportunity to provide comments. 


sradovich on DSK3GMQ082PROD with NOTICES
40774 Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices 

Public participants may submit written 

statements in advance of the scheduled 

meeting. Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to NACRHHS 

should be sent to Steven Hirsch, using 

the contact information above at least 3 

business days prior to the meeting. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Steven Hirsch at the address and 

phone number listed above at least 10 

business days prior to the meeting. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–17623 Filed 8–15–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Opportunity to Co-Sponsor Office of 

Research Integrity Workshops 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: The Office of Research 

Integrity (ORI) announces the 

opportunity for non-federal public and 

private sector entities to co-sponsor ORI 

conferences or workshops (ORI 

Workshops). Potential co-sponsors must 

have a demonstrated interest and 

experience in the responsible conduct of 

research (RCR) or the handling of 

research misconduct allegations. 

Potential co-sponsors must be willing to 

participate substantively in the cosponsored activity. 

Expressions of interest for cosponsorships of ORI Workshops are 

received throughout the year at the 

email address below. ORI co-sponsors a 

limited number of workshops with other 

entities each year. Expressions of 

interest are being received for ORI 

Workshops that will take place in the 

next fiscal year (October 2018 through 

September 2019) or beyond. 

Expressions of interest for cosponsorships should be sent by email to 

AskORI@HHS.GOV with ‘‘Cosponsorship for ORI Workshops’’ in the 

subject field or by mail to ORI at 1101 

Wootton Parkway, Suite 750, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Tracey Randolph, Program Analyst, 

Office of Research Integrity, 1101 

Wootton Parkway, Suite 750, Rockville, 

MD 20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: ORI 

oversees and directs U.S. Public Health 

Service (PHS) research integrity 

activities on behalf of the Secretary of 

U.S. Department of Health and Human 

Services (HHS), with the exception of 

the regulatory research integrity 

activities of the Food and Drug 

Administration. ORI is a program office 

within the Office of the Assistant 

Secretary for Health, Office of the 

Secretary, HHS. 

ORI’s Division of Education and 

Integrity (DEI) has among its duties the 

responsibility to develop and 

implement activities and programs to 

teach RCR and train Research Integrity 

Officers (RIOs) as well as others that are 

involved in research integrity, such as 

Institutional Officials (IOs) and 

institutional counsel. 

Consistent with ORI’s mission and the 

applicable statutory authority, 42 U.S.C. 

289b, ORI Workshops aim to provide 

clarification and technical information 

on the HHS regulations for handling 

research misconduct allegations and on 

education in RCR to foster integrity in 

research. ORI Workshops are 

moderately sized, convening over one to 

three days, and typically accepting 

between 20 and 50 attendees. 

Co-sponsors will assist with 

workshop and agenda development, 

coordination, financial management, 

and meeting logistics in conjunction 

with ORI staff. 

Co-sponsors can charge registration 

fees to recover costs associated with the 

events; however, co-sponsors may not 

set registration fees at an amount higher 

than necessary to recover related event 

expenses. Further, co-sponsors are 

solely responsible for collecting and 

handling any registration fees collected. 

Eligibility for Co-Sponsorship: The cosponsoring entity must have a 

demonstrated interest and experience in 

the RCR or the handling of research 

misconduct allegations. The cosponsoring entity must participate 

substantively in the co-sponsored 

activity, not just provide funding or 

logistical support. 

Each co-sponsorship expression of 

interest shall describe: (1) The entity’s 

interest and goals in promoting research 

integrity or the RCR, (2) the entity’s 

prior experience and current readiness 

to undertake the responsibilities 

described above, (3) the type of event(s) 

that the entity is interested in cosponsoring with ORI, (4) facilities 

available for the event(s), and (5) any 

current constraints with respect to dates 

or facilities. The type of event may be 

an event from ORI’s regular program of 

recurring events (e.g., RCR Instructor’s 

Workshop) or a special topic of mutual 

interest to be developed jointly. The 

expression of interest should be a 

bulleted outline, no more than two 

pages in length, single-spaced, and 11- 

point font. An entity may submit an 

expression of interest individually or 

jointly with other entities describing 

their relative contributions. 

Evaluation Criteria: After engaging in 

exploratory discussions with potential 

co-sponsors that respond to this notice, 

the following considerations will be 

used by HHS officials, as appropriate 

and relevant, to select the co-sponsor(s): 

• Qualifications and capability to fulfill 

co-sponsorship responsibilities 

• suitability of the location of the 

proposed event in terms of the overall 

geographical distribution of ORI 

events 

• potential for reaching, generating, and 

engaging adequate number of 

attendees from stakeholders 

• availability and description of 

facilities needed to support the 

workshop 

• availability of administrative support 

for the logistics of hosting such 

workshops 

The selected co-sponsoring 

organization(s) shall furnish the 

necessary personnel, materials, services, 

and facilities to administer its 

responsibility for the workshop. These 

duties will be outlined in a cosponsorship agreement with ORI that 

will set forth the details of the cosponsored activity, including the 

requirements that any fees collected by 

the co-sponsor shall be limited to the 

amount necessary to cover the cosponsor’s related event expenses. This 

co-sponsorship agreement does not 

represent an endorsement by ORI of an 

individual co-sponsor’s policies, 

positions, or activities. Additionally, 

this agreement will not affect any 

determination concerning activities by 

the co-sponsors that are regulated by 

ORI. 

Dated: August 9, 2018. 

Scott J. Moore, 

Deputy Director, Office of Research Integrity. 

[FR Doc. 2018–17615 Filed 8–15–18; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Blood and Tissue Safety and 

Availability 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health. 


sradovich on DSK3GMQ082PROD with NOTICES