7872 Federal Register / Vol. 80, No. 29 / Thursday, February 12, 2015 / Notices 

control numbers 0910–0014 and 0910– 

0001, respectively. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: February 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02908 Filed 2–11–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Joint Meeting of the Cellular, Tissue 

and Gene Therapies Advisory 

Committee and the Oncologic Drug 

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: Cellular, Tissue 

and Gene Therapies Advisory 

Committee and the Oncologic Drug 

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 April 29, 2015, from 8 a.m. to 

6 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. 

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/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Janie Kim or Rosanna 

Harvey, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 301–796–9016 or 240– 

402–8072, email: Janie.Kim@fda.hhs.gov 

or Rosanna.Harvey@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 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/Advisory

Committees/WhatsNew/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: The committees will discuss 

talimogene laherparepvec, Amgen, Inc., 

biologics license application (BLA) 

125518, an oncolytic immunotherapy 

for the treatment of patients with 

injectable regionally or distantly 

metastatic melanoma. 

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/Committees

MeetingMaterials/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 April 15, 2015. Oral 

presentations from the public will be 

scheduled between approximately 11:40 

a.m. to 12:40 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 7, 

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 8, 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 Janie Kim 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 meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: February 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02910 Filed 2–11–15; 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 


Rmajette on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 29 / Thursday, February 12, 2015 / Notices 7873 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Hematology. 

Date: March 9–10, 2015. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Bukhtiar H Shah, DVM, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4120, 

MSC 7802, Bethesda, MD 20892, 301–806– 

7314, shahb@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–13– 

204: Research in Biomedicine and 

Agriculture. 

Date: March 11, 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, 

(Virtual Meeting). 

Contact Person: Gary Hunnicutt, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6164, 

MSC 7892, Bethesda, MD 20892, 301–435– 

0229, gary.hunnicutt@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Diabetes and Obesity Research. 

Date: March 13, 2015. 

Time: 1:00 p.m. to 4:00 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: Gary Hunnicutt, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6164, 

MSC 7892, Bethesda, MD 20892, 301–435– 

0229, gary.hunnicutt@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: February 6, 2015. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–02878 Filed 2–11–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Staged Vaccine 

Development (BAA). 

Date: March 5, 2015. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health Room 

3F40A, 5601 Fisher Lane, Rockville, MD 

20892, (Telephone Conference Call). 

Contact Person: Robert C. Unfer, Ph.D., 

Scientific Review Officer Scientific Review 

Program DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, Room 3F40 MSC 9823, 

Rockville, MD 20892–9823, 240–669–5035, 

unferrc@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Immune-Based Antiviral 

Products for Suppression/Elimination of 

HIV–1. 

Date: March 6, 2015. 

Time: 9:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health Room 

3F100, 5601 Fisher Lane, Rockville, MD 

20892, (Telephone Conference Call). 

Contact Person: Roberta Binder, Ph.D., 

Scientific Review Officer Scientific Review 

Program Division of Extramural Activities, 

National Institutes of Health/NIAID, 5601 

Fishers Lane Rm 3G21A, Bethesda, MD 

20892–7616, 240–669–5050, rbinder@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 9, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–02957 Filed 2–11–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Prescription Drug Abuse Policy System 

(PDAPS) (5578). 

Date: February 26, 2015. 

Time: 10:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Lyle Furr, Scientific 

Review Officer, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 4227, MSC 9550, 6001 

Executive Boulevard, Bethesda, MD 20892– 

9550, (301) 435–1439, lf33c.nih.gov. 

This notice is being published less 

than 15 days prior to the meeting due 

to the timing limitations imposed by the 

review and funding cycle. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; HighImpact Substance Abuse Prevention (5577). 

Date: March 17, 2015. 

Time: 10:00 a.m. to 11:00 a.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Lyle Furr, Scientific 

Review Officer, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 4227, MSC 9550, 6001 

Executive Boulevard, Bethesda, MD 20892– 

9550, (301) 435–1439, lf33c.nih.gov. 


Rmajette on DSK2VPTVN1PROD with NOTICES