Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 3969 

FDA intends to make background 

material available to the public at 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: 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 February 9, 2015. 

Oral presentations from the public will 

be scheduled between approximately 

10:15 a.m. to 10:45 a.m. and 3:35 p.m. 

to 3:50 p.m. on February 23, 2015, and 

between approximately 9:30 a.m. to 9:45 

a.m. and 11:45 a.m. to noon on February 

24, 2015. 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 February 12, 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 

February 13, 2015. 

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 physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Jayne E. 

Peterson 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/

AdvisoryCommittees/

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: January 21, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–01267 Filed 1–23–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Dermatologic and Ophthalmic Drugs 

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). The meeting will be open to the 

public. 

Name of Committee: Dermatologic 

and Ophthalmic Drugs 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 March 9, 2015, from 8 a.m. to 

5:15 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

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

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Jennifer Shepherd, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: DODAC@

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 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: During the morning session, 

the committee will discuss new drug 

application (NDA) 206333, deoxycholic 

acid injection, a cytolytic drug, 

submitted by Kythera 

Biopharmaceuticals, proposed for the 

improvement in the appearance of 

moderate-to-severe convexity or fullness 

associated with submental fat in adults. 

During the afternoon session, the 

committee will discuss pediatric 

development of systemic products for 

the treatment of atopic dermatitis with 

inadequate response to topical 

prescription therapy. 

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: 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 February 23, 2015. 

Oral presentations from the public will 

be scheduled between approximately 

10:30 a.m. to 11 a.m., and 3:30 p.m. to 

4 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 February 12, 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 


emcdonald on DSK67QTVN1PROD with NOTICES
3970 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 

person will notify interested persons 

regarding their request to speak by 

February 13, 2015. 

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 physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Jennifer 

Shepherd 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/

AdvisoryCommittees/

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: January 20, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–01268 Filed 1–23–15; 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, Serious 

STEM Games—SBIR/STTR Applications. 

Date: February 12–13, 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: Sergei Ruvinov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4158, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1180, ruvinser@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Urolithiasis 

Applications. 

Date: February 13, 2015. 

Time: 2:30 p.m. to 4:30 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: Ryan G Morris, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4205, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1501, morrisr@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, PAR–13– 

169: Academic Industrial Partnership. 

Date: February 17, 2015. 

Time: 8:00 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. 

Contact Person: Donald S Wright, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5108, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

8363, wrightds@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Systemic 

Injury From Environmental Exposure. 

Date: February 18–19, 2015. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Patricia Greenwel, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2178, 

MSC 7818, Bethesda, MD 20892, 301–435– 

1169, greenwep@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Small 

Business: Neuro/Psychopathology, Lifespan 

Development, and STEM Education. 

Date: February 18–19, 2015. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Mayflower Hotel, 1127 

Connecticut Avenue NW., Washington, DC 

20036. 

Contact Person: John H Newman, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3222, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

0628, newmanjh@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group, Drug Discovery for the 

Nervous System Study Section. 

Date: February 19–20, 2015. 

Time: 8:00 a.m. to 10:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco Alexandria, 480 King 

Street, Alexandria, VA 22314. 

Contact Person: Mary Custer, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4148, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1164, custerm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Small 

Business: Risk Prevention and Health 

Behavior. 

Date: February 19–20, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The St. Regis Washington, DC, 923 

16th Street, NW., Washington, DC 20006. 

Contact Person: Claire E Gutkin, Ph.D., 

MPH, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3106, 

MSC 7808, Bethesda, MD 20892, (301) 594– 

3139, gutkincl@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Molecular 

Neurodegeneration. 

Date: February 19, 2015. 

Time: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Best Western Tuscan Inn, 425 North 

Point Street, San Francisco, CA 94133. 

Contact Person: Laurent Taupenot, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4188, 

MSC 7850, Bethesda, MD 20892, 301–435– 

1203, laurent.taupenot@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: January 20, 2015. 

Carolyn Baum, 

Program Analyst, Director, Office of Federal 

Advisory Committee Policy. 

[FR Doc. 2015–01224 Filed 1–23–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center; Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the Fogarty 

International Center Advisory Board. 

The meeting will be open to the 

public as indicated below, with 


emcdonald on DSK67QTVN1PROD with NOTICES