18412 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 

672, Bethesda, MD 20892, 301–594–4859, 

makridessc@mail.nih.gov. 

Name of Committee: National Institute of 

Dental and Craniofacial Research; Special 

Emphasis Panel, Oral Health Disparities in 

Children: Data Coordinating Center (U01). 

Date: May 6, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Washington National 

Airport, 1489 Crystal Drive, Arlington, VA 

20220. 

Contact Person: Jayalakshmi Raman, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute of Dental and 

Craniofacial Research, One Democracy Plaza, 

Room 670, Bethesda, MD 20892–4878, 301– 

594–2904, ramanj@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: March 31, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07739 Filed 4–3–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Blood Products 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on May 13, 2015, from 8 a.m. to 

5:30 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., 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 

available via Web cast. The Web cast 

will be available at the following link: 

https://collaboration.fda.gov/bpac2015/. 

When accessing the Web cast please 

enter as a guest. Answers to commonly 

asked questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Bryan Emery or 

Joanne Lipkind, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 6132, 

Silver Spring, MD 20993–0002, 240– 

402–8054 or 240–402–8129, 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 Web site at http://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. 

Agenda: On May 13, 2015, the Blood 

Products Advisory Committee will meet 

in open session to discuss strategies for 

implementation of serological and 

nucleic acid testing for Babesia microti 

in blood donors. In the afternoon, the 

committee will hear update 

presentations on the following topics: 

(1) FDA considerations for Hemoglobin 

S Testing in blood donors; and (2) FDA 

considerations for a revised blood donor 

deferral policy for men who have sex 

with men. Following the update 

presentations, the committee will hear 

presentations on the research programs 

of the Laboratory of Cellular 

Hematology, Division of Hematology 

Research and Review, Office of Blood 

Research and Review, Center for 

Biologics Evaluation and Research, 

FDA. 

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 Web site 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 Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: On May 13, 2015, from 

8:30 a.m. to approximately 5 p.m., the 

meeting is open to the public. 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 May 6, 2015. Oral 

presentations from the public on May 

13, 2015, will be scheduled between 

approximately 11:15 a.m. and 12:15 

p.m. and 4:30 p.m. until 5 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 April 28, 2015. 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 April 29, 2015. 

Closed Committee Deliberations: On 

May 13, 2015, from approximately 5 

p.m. to 5:30 p.m., the meeting will be 

closed to the public to permit 

discussion where disclosure would 

constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c) (6)). The committee will discuss 

the site visit report of the intramural 

research programs of the Laboratory of 

Cellular Hematology and make 

recommendations regarding personnel 

staffing decisions. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. Seating for 

this meeting may be limited, so the 

public is encouraged to watch the free 

Web cast if you are unable to attend. 

The Web cast will be available at 8:30 

a.m. on May 13, 2015, at the link 

provided. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Bryan Emery 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meeting. 


tkelley on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18413 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 31, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07816 Filed 4–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Society of Clinical Research 

Associates—Food and Drug 

Administration Clinical Trial 

Requirements, Regulations, 

Compliance and Good Clinical Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

educational conference cosponsored 

with the Society of Clinical Research 

Associates (SOCRA). The public 

conference regarding FDA’s clinical trial 

requirements is designed to aid the 

clinical research professional’s 

understanding of the mission, 

responsibilities, and authority of FDA 

and to facilitate interaction with FDA 

representatives. The program will focus 

on the relationships among FDA and 

clinical trial staff, investigators, and 

institutional review boards (IRBs). 

Individual FDA representatives will 

discuss the informed consent process 

including informed consent documents, 

regulations relating to drugs, devices, 

and biologics, as well as inspections of 

clinical investigators, IRBs, and research 

sponsors. 

Date and Time: The public conference 

will be held on May 13 and 14, 2015, 

from 8 a.m. to 5 p.m. 

Location: The conference will be held 

at The Westin Cincinnati, 21 East Fifth 

Street, Cincinnati, OH 45202; 513–621– 

7700. Attendees are responsible for their 

own accommodations. Please mention 

SOCRA to receive the hotel room rate of 

$169 plus applicable taxes (available 

until April 15, 2015, or until the SOCRA 

room block is filled). 

Contact: John Fraser, Cincinnati 

District Office, Food and Drug 

Administration, 6751 Steger Dr., 

Cincinnati OH 45237, 513–679–2700, 

FAX: 513–679–2771 or Society of 

Clinical Research Associates (SOCRA), 

530 West Butler Ave., Suite 109, 

Chalfont, PA 18914, 800–762–7292 or 

215–822–8644, FAX: 215–822–8633, 

email: Office@socra.org, Web site: 

http://www.socra.org. (FDA has verified 

the Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Registration: The registration fee will 

cover actual expenses including 

refreshments, lunch, materials, and 

speaker expenses. Seats are limited; 

please submit your registration as soon 

as possible. Workshop space will be 

filled in order of receipt of registration. 

Those accepted into the workshop will 

receive confirmation. The cost of the 

registration is as follows: SOCRA 

member, $575; SOCRA nonmember 

(includes membership), $650; Federal 

Government member, $450; Federal 

Government nonmember, $525; FDA 

employee, free (fee waived). 

If you need special accommodations 

due to a disability, please contact 

SOCRA (see Contact) at least 21 days in 

advance. 

Extended periods of question and 

answer and discussion have been 

included in the program schedule. 

SOCRA designates this education 

activity for a maximum of 13.3 

Continuing Education (CE) Credits for 

SOCRA CE and Continuing Nurse 

Education (CNE). SOCRA designates 

this live activity for a maximum of 13.3 

American Medical Association 

Physicians Recognition Award Category 

1 Credit(s)TM. Physicians should claim 

only the credit commensurate with the 

extent of their participation. Continuing 

Medical Education for physicians: 

SOCRA is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide 

continuing medical education for 

physicians. CNE for nurses: SOCRA is 

an approved provider of continuing 

nursing education by the Pennsylvania 

State Nurses Association (PSNA), an 

accredited approver by the American 

Nurses Credentialing Center’s 

Commission on Accreditation(ANCC). 

ANCC/PSNA Provider Reference 

Number: 205–3–A–09. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and email, along 

with a check or money order payable to 

‘‘SOCRA’’. Mail to: SOCRA (see Contact 

for address). To register via the Internet, 

go to http://www.socra.org/html/FDA_

Conference.htm. Payment by major 

credit card is accepted (Visa/

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the workshop, 

contact SOCRA (see Contact). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, institutional review board 

inspections, electronic record 

requirements, and investigator-initiated 

research. 

Topics for discussion include the 

following: (1) The Role of the FDA 

District Office Relative to the 

Bioresearch Monitoring Program; (2) 

Modernizing FDA’s Clinical Trials/

BIMO Programs; (3) What FDA Expects 

in a Pharmaceutical Clinical Trial; (4) 

Medical Device Aspects of Clinical 

Research; (5) Adverse Event Reporting— 

Science, Regulation, Error and Safety; 

(6) Working with FDA’s Center for 

Biologics Evaluation and Research; (7) 

Ethical Issues in Subject Enrollment; (8) 

Keeping Informed and Working 

Together; (9) FDA Conduct of Clinical 

Investigator Inspections; (10) 

Investigator Initiated Research; (11) 

Meetings with the FDA—Why, When, 

and How; (12) Part 11 Compliance— 

Electronic Signatures; (13) IRB 

Regulations and FDA Inspections; (14) 

Informed Consent Regulations; (15) The 

Inspection is Over—What Happens 

Next? Possible FDA Compliance 

Actions; (16) Question and Answer 

Session/Panel Discussion. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The workshop helps to achieve 

objectives set forth in section 406 of the 

Food and Drug Administration 

Modernization Act of 1997 (21 U.S.C. 

393), which includes working closely 

with stakeholders and maximizing the 

availability and clarity of information to 

stakeholders and the public. The 

workshop also is consistent with the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

as outreach activities by Government 

agencies to small businesses. 

Dated: April 1, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07810 Filed 4–3–15; 8:45 am] 

BILLING CODE 4164–01–P 


tkelley on DSK4VPTVN1PROD with NOTICES