28850 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: National Institute for 

Occupational Safety and Health, NIOSH 

Docket Office, 1090 Tusculum Avenue, 

MS C–34, Cincinnati, Ohio 45226–1998. 

Instructions: All submissions received 

in response to this notice must include 

the agency name and docket number 

[CDC–2018–0050; NIOSH–314]. All 

relevant comments received will be 

posted without change to https://

www.regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

https://www.regulations.gov. All 

information received in response to this 

notice will also be available for public 

examination and copying at the NIOSH 

Docket Office, 1150 Tusculum Avenue, 

Room 155, Cincinnati, OH 45226–1998. 

FOR FURTHER INFORMATION CONTACT: 

Emily Novicki NORACoordinator@

cdc.gov), National Institute for 

Occupational Safety and Health, Centers 

for Disease Control and Prevention, 

Mailstop E–20, 1600 Clifton Road NE, 

Atlanta, GA 30329, phone (404) 498– 

2581 (not a toll free number). 

SUPPLEMENTARY INFORMATION: The 

National Occupational Research Agenda 

(NORA) is a partnership program 

created to stimulate innovative research 

and improved workplace practices. The 

national agenda is developed and 

implemented through the NORA sector 

and cross-sector councils. Each council 

develops and maintains an agenda for 

its sector or cross-sector. 

Background: The National 

Occupational Research Agenda for 

Healthcare and Social Assistance 

(HCSA) is intended to identify the 

research, information, and actions most 

urgently needed to prevent occupational 

injuries. The National Occupational 

Research Agenda for HCSA provides a 

vehicle for stakeholders to describe the 

most relevant issues, gaps, and safety 

and health needs for the sector. Each 

NORA research agenda is meant to 

guide or promote high priority research 

efforts on a national level, conducted by 

various entities, including: government, 

higher education, and the private sector. 

The first National Occupational 

Research Agenda for HCSA was 

published in 2009 for the second decade 

of NORA (2006–2016). The revised 

agenda was developed considering new 

information about injuries and illnesses, 

the state of the science, and the 

probability that new information and 

approaches will make a difference. As 

the steward of the NORA process, 

NIOSH invites comments on the draft 

National Occupational Research 

Agenda for HCSA. Comments 

expressing support or with specific 

recommendations to improve the 

Agenda are requested. A copy of the 

draft Agenda is available at https://

www.regulations.gov (see Docket 

Number CDC–2018–0050). 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–13308 Filed 6–20–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1073] 

Antimicrobial Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Antimicrobial Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held on 

August 8, 2018, from 8:30 a.m. to 1 p.m. 

ADDRESSES: 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: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2018–N–1073. 

The docket will close on August 7, 

2018. Submit either electronic or 

written comments on this public 

meeting by August 7, 2018. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before August 

7, 2018. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

August 7, 2018. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Comments received on or before July 

24, 2018, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–1073 for ‘‘Antimicrobial Drugs 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ Received 


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Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 28851 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify the information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Lauren D. Tesh, 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: 

AMDAC@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 

FDA’s website at https://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: 

Agenda: The committee will discuss 

new drug applications 209816, for 

omadacycline tablets, and 209817, for 

omadacycline injection, sponsored by 

Paratek Pharmaceuticals, Inc., for the 

proposed indications for the treatment 

of community acquired bacterial 

pneumonia and acute bacterial skin and 

skin structure infections. 

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 website 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 website after 

the meeting. Background material is 

available at https://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. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

July 24, 2018, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 11 a.m. and 12 noon. 

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 July 16, 2018. 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 July 17, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

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 Lauren Tesh 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/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: June 15, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13296 Filed 6–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1919] 

Major Depressive Disorder: Developing 

Drugs for Treatment; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Major 

Depressive Disorder: Developing Drugs 

for Treatment.’’ The purpose of this 

draft guidance is to assist sponsors in 

the clinical development of drugs for 

the monotherapeutic, combination, and 

adjunctive treatment of major 

depressive disorder (MDD). Specifically, 

this draft guidance addresses FDA’s 

current thinking regarding the overall 

development program and clinical trial 

designs for antidepressant drug 

products. This draft guidance is 

intended to serve as a focus for 

continued discussions among FDA, 

pharmaceutical sponsors, the academic 

community, and the public. This draft 


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