Federal Register / Vol. 80, No. 29 / Thursday, February 12, 2015 / Notices 7871 

the extent to which progress has been made 

toward eliminating tuberculosis. 

Matters for Discussion: Agenda items 

include the following topics: (1) Update on 

Global TB Coordination Activities; (2) Profile 

of Foreign-Born TB cases; (3) Impact of 

funding cuts on TB programs in the field; and 

(4) other tuberculosis-related issues. 

Agenda items are subject to change as 

priorities dictate. Contact Person for More 

Information: Margie Scott-Cseh, Centers for 

Disease Control and Prevention, 1600 Clifton 

Road NE., M/S E–07, Atlanta, Georgia 30333, 

telephone (404) 639–8317; Email: 

zkr7@cdc.gov 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register Notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Catherine Ramadei, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2015–02887 Filed 2–11–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Advisory Committee Renewals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of certain FDA advisory 

committees by the Commissioner of 

Food and Drugs (the Commissioner). 

The Commissioner has determined that 

it is in the public interest to renew the 

charters of the committees listed in the 

following table for an additional 2 years 

beyond charter expiration date. The new 

charters will be in effect until the dates 

of expiration listed in the following 

table. This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). 

DATES: Authority for these committees 

will expire on the dates indicated in the 

following table unless the 

Commissioner formally determines that 

renewal is in the public interest. 

Name of committee Date of 

expiration 

Cardio and Renal Drugs Advisory Committee.August 27, 

2016. 

Endocrinologic and Metabolic 

Drugs Advisory Committee.

August 27, 

2016. 

Name of committee Date of 

expiration 

Oncologic Drugs Advisory 

Committee.

September 1, 

2016. 

Anti-Infective Drugs Advisory 

Committee.

October 7, 

2016. 

Dermatologic and Ophthalmic 

Drugs Advisory Committee.

October 7, 

2016. 

Cellular, Tissue, and Gene 

Therapies Advisory Committee.

October 28, 

2016. 

Technical Electronic Product 

Radiation Safety Standards 

Committee.

December 24, 

2016. 

FOR FURTHER INFORMATION CONTACT: 

Michael Ortwerth, Director, Advisory 

Committee Oversight and Management 

Staff, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–443–0572 

or 1–800–741–8138. For further 

information related to FDA advisory 

committees, please visit us at http://

www.fda.gov/AdvisoryCommittees/

default.htm. 

Dated: February 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02909 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–D–0152] 

Alcoholism: Developing Drugs for 

Treatment; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Alcoholism: 

Developing Drugs for Treatment.’’ The 

purpose of this guidance is to assist 

sponsors in the development of drugs 

for the treatment of alcoholism. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by April 13, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Skeete, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 3191, 

Silver Spring, MD 20993–0002, 301– 

796–2280. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Alcoholism: Developing Drugs for 

Treatment.’’ There is a need for 

additional pharmacologic treatments for 

alcoholism. Traditionally, alcoholism 

treatments have been assessed based on 

the number of patients who refrain from 

drinking altogether. Patients who attain 

and sustain complete abstinence from 

alcohol may be assumed to accrue 

clinical benefit. However, other patterns 

of drinking also may be valid surrogates 

for clinical benefit. This guidance 

provides supporting information for 

endpoints based on patterns of drinking 

that may be considered appropriate 

measures of clinical benefit. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the development of drugs for the 

treatment of alcoholism and appropriate 

endpoints for clinical trials of drugs to 

treat alcoholism. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 


Rmajette on DSK2VPTVN1PROD with NOTICES
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 


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