7000 Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 

This revised draft guidance also refers 

to previously approved collections of 

information found in FDA regulations 

with respect to the brief summary 

requirement. These collections of 

information are subject to review by 

OMB under the PRA. The collection of 

information in 21 CFR 202.1 has been 

approved under OMB control number 

0910–0686. 

III. Comments 

In addition to general comments, FDA 

specifically requests comments on the 

following issues: 

• In the revised draft guidance, FDA 

provides recommendations regarding 

the content and format of the consumer 

brief summary. Is this the most useful 

information for consumers to use in 

determining whether to take a 

medication or seek more information 

about a product, and if not, what 

information would be more useful? 

• FDA is also interested in relevant 

research that has been conducted or 

alternative formats that were developed 

after we received comments on the 2004 

draft guidance. 

• In the revised draft guidance, FDA 

suggests that the adequate directions for 

use requirement be fulfilled by 

providing the consumer brief summary 

rather than the full PI for the product. 

FDA seeks comments regarding this 

recommendation. 

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 http://www.

fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http://

www.regulations.gov. 

Dated: February 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02527 Filed 2–6–15; 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 Pulmonary-Allergy 

Drugs Advisory Committee and the 

Drug Safety and Risk Management 

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 Committees: PulmonaryAllergy Drugs Advisory Committee and 

the Drug Safety and Risk Management 

Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 19, 2015, from 8 a.m. to 

5 p.m. 

Location: Holiday Inn Gaithersburg 

Ballroom, 2 Montgomery Village Ave., 

Gaithersburg, MD 20879. The hotel 

telephone number is 301–948–8900. 

Contact Person: Cindy Hong, 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, 

PADAC@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: The committees will discuss 

supplemental new drug application 

204275–S001, for fluticasone furoate 

and vilanterol inhalation powder 

(tradename Breo Ellipta) submitted by 

GlaxoSmithKline for the once daily 

maintenance treatment of asthma in 

patients 12 years of age and older. The 

discussion will include efficacy data, 

but the focus of the meeting will be 

safety, including the adequacy of the 

safety database to support approval, and 

whether a large safety trial to evaluate 

serious asthma outcomes is 

recommended. 

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 March 5, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 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 

25, 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 26, 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 Cindy Hong 

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 

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Federal Register / Vol. 80, No. 26 / Monday, February 9, 2015 / Notices 7001 

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 28, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–02554 Filed 2–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

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 meeting. 

The meeting 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 on 

Aging Special Emphasis Panel; Inflammation. 

Date: March 4, 2015. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 2C212, 7201 Wisconsin 

Ave., Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Alicja L. Markowska, 

Ph.D., DSC Scientific Review Branch, 

National Institute on Aging, 7201 Wisconsin 

Avenue, Suite 2C212, Bethesda, MD 20892, 

301–496–9666, markowsa@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: February 3, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–02438 Filed 2–6–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; 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 Eye Institute 

Special Emphasis Panel; NEI Career 

Development (K08) and Pathway to 

Independence (K99) Grant Applications. 

Date: March 3–4, 2015. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Brian Hoshaw, Ph.D., 

Scientific Review Officer, National Eye 

Institute, National Institutes of Health, 

Division of Extramural Research, 5635 

Fishers Lane, Suite 1300, Rockville, MD 

20892, 301–451–2020, 

hoshawb@mail.nih.gov. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; NEI Clinical and 

Epidemiological Grant and Cooperative 

Agreement Applications. 

Date: March 17–18, 2015. 

Time: 8:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Garden Inn Bethesda, 7301 

Waverly Street, Bethesda, MD 20814. 

Contact Person: Jeanette M Hosseini, Ph.D., 

Scientific Review Officer, 5635 Fishers Lane, 

Suite 1300, Bethesda, MD 20892, 301–451– 

2020, jeanetteh@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: February 3, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–02439 Filed 2–6–15; 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 Meeting 

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 meeting. 

The meeting 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; DSR Member Conflict 

Application Review Panel. 

Date: February 25, 2015. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892. 

Contact Person: Victor Henriquez, Ph.D., 

Scientific Review Officer, DEA/SRB/NIDCR, 

6701 Democracy Blvd., Room 668, Bethesda, 

MD 20892–4878, 301–451–2405, 

henriquv@nidcr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: February 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–02442 Filed 2–6–15; 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., 

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