12504 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

1See Thompson v. Western States Med. Ctr., 535 

U.S. 357 (2002). 

will be posted to the docket at http://

www.regulations.gov. 

V. 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: March 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05347 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0030] 

Compounding of Human Drug 

Products Under the Federal Food, 

Drug, and Cosmetic Act; 

Establishment of a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of public 

docket. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

establishing a public docket to receive 

information, recommendations, and 

comments on matters related to the 

Agency’s regulation of compounding of 

human drug products under sections 

503A and 503B of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

This docket is intended for general 

comments related to human drug 

compounding that are not specific to 

documents or issues that are the subject 

of other dockets. 

DATES: Comments may be submitted to 

this docket at any time. 

ADDRESSES: You may submit comments, 

identified by Docket No. [FDA–2015–N– 

0030], by any of the following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written comments in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. [FDA–2015–N–0030]. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Philantha Bowen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg.51, Rm. 5175, 

Silver Spring, MD 20993–0002, 301– 

796–2466. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 503A of the FD&C Act (21 

U.S.C. 353a) 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) (21 U.S.C. 351(a)(2)(B)) 

(concerning current good manufacturing 

practice); (2) section 502(f)(1) (21 U.S.C. 

352(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 drugs under 

new drug applications or abbreviated 

new drug applications). Previously, the 

conditions of section 503A of the FD&C 

Act also included restrictions on the 

advertising or promotion of the 

compounding of any particular drug, 

class of drug, or type of drug and the 

solicitation of prescriptions for 

compounded drugs. These provisions 

were challenged in court and held 

unconstitutional by the U.S. Supreme 

Court in 2002.1

On November 27, 2013, President 

Obama signed the Drug Quality and 

Security Act (DQSA) (Pub. L. 113–54), 

which contains important provisions 

relating to the oversight of human drug 

compounding. This new law removes 

from section 503A of the FD&C Act the 

provisions that had been held 

unconstitutional by the U.S. Supreme 

Court in 2002. By removing these 

provisions, the new law clarifies that 

section 503A of the FD&C Act applies 

nationwide. In addition, the DQSA adds 

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

(21 U.S.C. 353b) 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 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), (2) 

section 505, and (3) section 582 (21 

U.S.C. 360eee), but not section 

501(a)(2)(B). 

Since enactment of the DQSA, FDA 

has sought public comment on a 

number of specific human drug 

compounding issues and has published 

several Federal Register notices seeking 

public input. These have included 

notices inviting comment on the 

registration process and product 

reporting requirements for human drug 

compounding outsourcing facilities (78 

FR 72899 and 78 FR 72897), requesting 

nominations for the list of drugs that 

present demonstrable difficulties for 

compounding (78 FR 72840), and 

seeking input on other specific matters. 

A complete list of the human drug 

compounding policy documents issued 

by the Agency for public comment can 

be found at http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Pharmacy

Compounding/ucm166743.htm. The 

Agency will continue to seek public 

comment on specific documents and 

issues through future Federal Register 

notices. The Agency recognizes, 

however, that it would be useful to have 

a docket available for submissions of 

any information related to human drug 

compounding that may be unrelated to 

the specific issues and documents 

published for public comment. 

II. Establishment of a Docket 

FDA is establishing a public docket so 

that anyone can share information, 

research, and ideas on any matters 

related to human drug compounding 

that are not specific to the documents or 

issues addressed in other dockets. This 

information will give the Agency insight 

into stakeholders’ experiences and 

views regarding human drug 

compounding as the Agency works to 

implement sections 503A and 503B of 

the FD&C Act. 

This docket will be open for comment 

simultaneously with a number of other 

dockets that are specific to particular 

human drug compounding documents 

or issues (see http://www.fda.gov/drugs/ 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12505 

guidancecompliance

regulatoryinformation/pharmacy

compounding/default.htm for a list of 

specific human drug compounding 

policy documents open for public 

comment). Please do not submit 

comments to this general docket that 

have already been submitted to specific 

dockets. Such submissions are 

duplicative and not helpful to the 

Agency. If comments on particular 

documents or issues are submitted to 

this docket rather than the docket 

specifically opened for the particular 

document or issue, the comment might 

not be considered as the specific 

documents are being finalized and 

issues considered. FDA will not respond 

to questions or requests submitted to 

this docket but will consider any 

information submitted in its work to 

implement the law. 

Information in the docket will be 

publicly available. Therefore, we 

remind commenters not to submit 

personal or confidential information. 

Interested persons may submit either 

electronic comments 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 the 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. 

Dated: March 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05376 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2015–0031] 

Missouri River Waterways Analysis 

and Management System 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of meeting and request 

for comments. 

SUMMARY: Coast Guard Sector Upper 

Mississippi River will hold a public 

listening session to present, and receive 

feedback on, the Missouri River 

Waterways Analysis and Management 

System (WAMS) study. The WAMS 

study will review and assess waterborne 

commerce as well as safe commercial 

and recreational navigation with a focus 

on the existing aids to navigation in 

Missouri River system from Sioux City, 

IA to St. Louis, MO. This listening 

session will be open to the public. 

DATES: This listening session will be 

held in Smithville, MO on February 25, 

2015, from 10:00 a.m. to 12:00 p.m. If 

all interested participants have had an 

opportunity to comment, the session 

may conclude early. Written comments 

and related material may also be 

presented to Coast Guard personnel 

specified at that meeting. Comments 

and related materials submitted after the 

meeting must be received by the Coast 

Guard on or before April 10, 2015. 

ADDRESSES: The listening session will 

be held at the Jerry Litton Visitors 

Center, (Smithville Lake) 16311 DD 

Hwy., Smithville, MO 64089. 

Submit written comments identified 

by docket number USCG–2015–0031 

using one of the listed methods, and see 

SUPPLEMENTARY INFORMATION for more 

information on public comments. To 

avoid duplication, please use only one 

of these methods. 

• Online—http://www.regulations.gov 

following Web site instructions. 

• Fax—202–493–2251. 

• Mail or hand deliver—Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590–0001. Hours for 

hand delivery are 9 a.m. to 5 p.m., 

Monday through Friday, except Federal 

holidays (telephone 202–366–9329). 

FOR FURTHER INFORMATION CONTACT: For 

information about this document call or 

email Kevin Brensinger, Coast Guard; 

telephone 314–269–2548, email 

SUMRWaterways@uscg.mil. For 

information about viewing or submitting 

material to the docket, call Cheryl 

Collins, Program Manager, Docket 

Operations, telephone 202–366–9826, 

toll free 1–800–647–5527. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Comments 

We encourage you to participate in 

this listening session by submitting 

comments (or related material) on 

Missouri River Waterways Analysis and 

Management System study. 

We recommend using the user survey 

document under docket number USCG– 

2015–0031 to provide comments. You 

should provide personal contact 

information so that we can contact you 

if we have questions regarding your 

comments; but please note that all 

comments will be posted to the online 

docket without change and that any 

personal information you include can be 

searchable online (see the Federal 

Register Privacy Act notice regarding 

our public dockets, 73 FR 3316, Jan. 17, 

2008). 

Mailed or hand-delivered comments 

should be in an unbound 81⁄2 x 11 inch 

format suitable for reproduction. The 

Docket Management Facility will 

acknowledge receipt of mailed 

comments if you enclose a stamped, 

self-addressed postcard or envelope 

with your submission. 

Documents mentioned in this notice, 

and all public comments, may be found 

in our online docket at http://

www.regulations.gov and can be viewed 

by following the Web site’s instructions. 

You can also view the docket at the 

Docket Management Facility (see the 

mailing address under ADDRESSES) 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

listening session, contact Kevin 

Brensinger at the telephone number or 

email address indicated under the FOR

FURTHER INFORMATION CONTACT section of 

this notice. 

Basis and Purpose 

The Waterways Analysis and 

Management System was implemented 

to ensure a complete and organized 

process for matching waterway 

attributes and services, most 

significantly the aids to navigation 

system, with user needs. The Missouri 

River study includes navigable waters 

from Sioux City, IA to St. Louis, MO 

and specifically targets the navigation 

channel, marking of the navigation 

channel, movement of commerce and 

navigation support for the diverse uses 

of the river. WAMS studies are 

conducted periodically to better 

understand users’ needs and facilitate 

safe and effective waterways. Some of 

the aspects addressed by WAMS are: 

• Are all the aids necessary? 

• Should aids be added, changed or 

removed? 

• Is the right aid being used for the 

job? 

• Are the aids marked in a correct 

and visible manner? 

• Are these aids being used properly 

by both the Coast Guard and the 

waterway users? 

It is the intent of Coast Guard Sector 

Upper Mississippi River to collect 

comments and materials from this 

listening session, along with navigation 

surveys and other information, to 

establish and preserve the reasonable 

needs of navigation on this river. 

This notice is issued under authority 

of 5 U.S.C. 552(a). 

mstockstill on DSK4VPTVN1PROD with NOTICES