Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18411 

for drugs. Dr. Ruth Day, a social 

scientist researcher at Duke University, 

has worked as a special government 

employee on the labeling for drugs. Ron 

Charnock is CEO of Kwikpoint, which is 

a visual language developer for 

instructions for use. His company 

worked on a Cooperative Research and 

Development Agreement with the 

Center for Devices and Radiological 

Health to determine if visual language 

could be used in lieu of words on 

certain portions of device labeling. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 1

Capital 

costs 

Screener ........................................................................... 60 1 60 0.08 5 ....................

Health care professionals participating at a hospital ....... 24 1 24 1.5 36 ....................

Health care professionals participating at FDA ............... 12 1 12 3.5 42 $240 

Total .......................................................................... .................... .................... .................... .................... 83 $240 

1 Numbers have been rounded. 

We plan to screen approximately 60 

potential respondents prior to being 

included in the study. The screener will 

be done using email. We estimate that 

the screener will only take 

approximately 5 minutes per person. 

We will conduct the studies at three 

different sites including two area 

hospitals using their devices, existing 

labeling, and HCPs. We expect that the 

maximum time for testing will be 1.5 

hours. Given a sample of 6 devices with 

2 different labeling types, there will be 

12 different labeling types to be tested. 

We plan to have 24 people test each 

type of the labeling. 

We will also conduct the studies on 

FDA’s campus using medical devices 

received from medical device industry 

representatives through a material 

transfer agreement. To account for travel 

time we have included 2 additional 

hours per response in the burden 

estimate for the 12 health care 

professionals participating at FDA. 

Dated: March 31, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07817 Filed 4–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA–OD– 

15–001: Building Interdisciplinary Research 

Careers in Women’s Health K12s. 

Date: April 28, 2015. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health; 6701 

Rockledge Drive; Bethesda, MD 20892; 

(Virtual Meeting). 

Contact Person: Suzanne Ryan, Ph.D.; 

Scientific Review Officer; Center for 

Scientific Review; National Institutes of 

Health; 6701 Rockledge Drive, Room 3139, 

MSC 7770; Bethesda, MD 20892; (301) 435– 

1712; ryansj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Conference 

and Meetings: Office of Research 

Infrastructure Programs (ORIP). 

Date: April 29, 2015. 

Time: 3:00 p.m. to 4:40 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health; 6701 

Rockledge Drive; Bethesda, MD 20892; 

(Telephone Conference Call). 

Contact Person: Cathleen L Cooper, Ph.D.; 

Scientific Review Officer; Center for 

Scientific Review; National Institutes of 

Health; 6701 Rockledge Drive, Room 4208, 

MSC 7812; Bethesda, MD 20892; 301–443– 

4512; cooperc@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 31, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07740 Filed 4–3–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel Review of UH2 grant 

applications. 

Date: May 5–6, 2015. 

Time: 8:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Washington National 

Airport, 1489 Jefferson Davis Hwy, Arlington, 

VA 20220. 

Contact Person: Savvas C Makrides, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Boulevard, Suite 


tkelley on DSK4VPTVN1PROD with NOTICES
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