7352 Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 

to lead to an adverse effect on the safety 

or effectiveness of the drug or category 

of drugs, taking into account the risks 

and benefits to patients, or the drug is 

compounded in accordance with all 

applicable conditions identified on the 

list as conditions that are necessary to 

prevent the drug or category of drugs 

from presenting such demonstrable 

difficulties (see section 503B(a)(6)(A) 

and (B) of the FD&C Act). 

FDA will discuss with the committee 

drugs proposed for inclusion on the 

section 503A bulk drug substances list 

and on the demonstrably difficult to 

compound list under sections 503A and 

503B of the FD&C Act. 

Agenda: On March 8, 2016, the 

committee will discuss six bulk drug 

substances nominated for inclusion on 

the section 503A bulk drug substances 

list. FDA will discuss the following 

nominated bulk drug substances: 

Quinacrine hydrochloride, boswellia, 

aloe vera 200:1 freeze dried, D-ribose, 

chondroitin sulfate, and acetyl-Lcarnitine. The nominators of these 

substances will be invited to make a 

short presentation supporting the 

nomination. 

On March 9, 2016, the committee will 

discuss two categories of drug products 

nominated for the list of drug products 

that present demonstrable difficulties 

for compounding. These categories of 

drug products are metered dose inhalers 

and dry powder inhalers. The 

nominators who nominated the category 

of drugs or specific drug products in the 

category will be invited to make a short 

presentation supporting the nomination. 

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 1, 2016. Oral 

presentations from the public will be 

scheduled between approximately 11 

a.m. to 11:15 a.m. and 3:15 p.m. to 3:30 

p.m. on March 8, 2016, and between 

approximately 11:30 a.m. to 12 noon on 

March 9, 2016. 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 

24, 2016. 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 25, 2016. 

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 disabilities. 

If you require 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 

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 8, 2016. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2016–02786 Filed 2–8–16; 4:15 pm] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; 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 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel; Career Award and 

Conference Grant Review (2016/05). 

Date: March 18, 2016. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, Suite 920, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Mark Martin, Ph.D., 

Scientific Review Officer, 6707 Democracy 

Boulevard, Suite 920, Bethesda, MD 20892, 

(240) 447–2148, mark.martin@mail.nih.gov. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel; P41 BTRC review 

(2016/05). 

Date: March 23–25, 2016. 

Time: 6:00 p.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham Boston Beacon Hill, 5 

Blossom Street, Boston, MA 02114. 

Contact Person: Dennis Hlasta, Ph.D., 

Scientific Review Officer, National Institute 

of Biomedical Imaging and Bioengineering, 

National Institutes of Health, 6707 

Democracy Blvd., Bethesda, MD 20892, (301) 

451–4794, dennis.hlasta@nih.gov. 

Dated: February 4, 2016. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2016–02709 Filed 2–10–16; 8:45 am] 

BILLING CODE 4140–01–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. 

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