Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 7351 

ensure their efficiency and 

effectiveness, and ensuring that these 

entities conform to federal laws, 

regulations, policies, and procedures 

governing the programs. 

V. Continuation of Policy. Except as 

inconsistent with this reorganization, all 

statements of policy and interpretations 

with respect to organizational 

components affected by this notice 

within ACF, heretofore issued and in 

effect on this date of this reorganization 

are continued in full force and effect. 

VI. Delegation of Authority. All 

delegations and re-delegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them, or 

their successors, pending further redelegations, provided they are 

consistent with this reorganization. 

VII. Funds, Personnel, and 

Equipment. Transfer of organizations 

and functions affected by this 

reorganization shall be accompanied in 

each instance by direct and support 

funds, positions, personnel, records, 

equipment, supplies, and other 

resources. 

FOR FURTHER INFORMATION CONTACT: 

Linda K. Smith, Office of the Deputy 

Assistant Secretary for Early Childhood 

Development, 901 D Street SW., 

Washington, DC 20447, (202) 401–9200. 

This reorganization will be effective 

upon date of signature. 

Dated: February 5, 2016. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2016–02784 Filed 2–10–16; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0001] 

Pharmacy Compounding Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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: Pharmacy 

Compounding Advisory Committee 

(PCAC). 

General Function of the Committee: 

To provide advice on scientific, 

technical, and medical issues 

concerning drug compounding under 

sections 503A and 503B (21 U.S.C. 353A 

and 353B) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), and, as 

required, any other product for which 

FDA has regulatory responsibility, and 

make appropriate recommendations to 

the Commissioner of Food and Drugs. 

Date and Time: The meeting will be 

held on March 8, 2016, from 8:30 a.m. 

to 4:30 p.m., and on March 9, 2016, 

from 8:30 a.m. to 1 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/AboutAdvisory

Committees/ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

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, email: PCAC@

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. 

SUPPLEMENTARY INFORMATION: 

Background: Section 503A of the 

FD&C Act describes the conditions that 

must be satisfied for human drug 

products compounded by a licensed 

pharmacist or licensed physician to be 

exempt from the following three 

sections of the FD&C Act: (1) Section 

501(a)(2)(B) (concerning current good 

manufacturing practice (CGMP)); (2) 

section 502(f)(1) (concerning the 

labeling of drugs with adequate 

directions for use); and (3) section 505 

(21 U.S.C. 355) (concerning the approval 

of human drug products under new 

drug applications (NDAs) or abbreviated 

new drug applications (ANDAs)). 

The Drug Quality and Security Act 

adds a new section, 503B, to the FD&C 

Act that creates a new category of 

‘‘outsourcing facilities.’’ Outsourcing 

facilities, as defined in section 503B of 

the FD&C Act, are facilities that meet 

certain conditions described in section 

503B, including registration with FDA 

as an outsourcing facility. If these 

conditions are satisfied, a drug product 

compounded for human use by or under 

the direct supervision of a licensed 

pharmacist in an outsourcing facility is 

exempt from three sections of the FD&C 

Act: (1) Section 502(f)(1), concerning the 

labeling of drugs with adequate 

directions for use; (2) section 505, 

concerning the approval of human drug 

products under NDAs or ANDAs; and 

(3) section 582, concerning the track and 

trace requirements in the Drug Supply 

Chain Security Act (Pub. L. 113–53). 

Outsourcing facilities are not exempt 

from CGMP requirements in section 

501(a)(2)(B) of the FD&C Act. 

One of the conditions that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that a bulk drug substance (active 

pharmaceutical ingredient) used in a 

compounded drug product must meet 

one of the following criteria: (1) 

Complies with the standards of an 

applicable United States Pharmacopoeia 

(USP) or National Formulary 

monograph, if a monograph exists, and 

the USP chapter on pharmacy 

compounding; (2) if an applicable 

monograph does not exist, is a 

component of a drug approved by the 

Secretary of Health and Human Services 

(the Secretary); or (3) if such a 

monograph does not exist and the drug 

substance is not a component of a drug 

approved by the Secretary, appears on a 

list (the ‘‘section 503A bulk drug 

substances list’’) developed by the 

Secretary through regulations issued by 

the Secretary (see section 

503A(b)(1)(A)(i) of the FD&C Act). 

Another condition that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that the compounded drug product is 

not a drug product identified by the 

Secretary by regulation as a drug 

product that presents demonstrable 

difficulties for compounding that 

reasonably demonstrate an adverse 

effect on the safety or effectiveness of 

that drug product (see section 

503A(b)(3)(A) of the FD&C Act). 

A condition that must be satisfied to 

qualify for the exemptions in section 

503B of the FD&C Act is that the 

compounded drug is not identified 

(directly or as part of a category of 

drugs) on a list published by the 

Secretary, by regulation after consulting 

with the Pharmacy Compounding 

Advisory Committee, of drugs or 

categories of drugs that present 

demonstrable difficulties for 

compounding that are reasonably likely 

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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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