Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 38909 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

In particular, the written request for 

confidential treatment that accompanies 

the comment must include the factual 

and legal basis for the request, and must 

identify the specific portions of the 

comment to be withheld from the public 

record. See FTC Rule 4.9(c). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted on the public FTC Web 

site—as legally required by FTC Rule 

4.9(b)—we cannot redact or remove 

your comment from the FTC Web site, 

unless you submit a confidentiality 

request that meets the requirements for 

such treatment under FTC Rule 4.9(c), 

and the General Counsel grants that 

request. 

Visit the Commission Web site at 

https://www.ftc.gov to read this Notice. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before October 16, 2017. You can find 

more information, including routine 

uses permitted by the Privacy Act, in 

the Commission’s privacy policy, at 

https://www.ftc.gov/site-information/ 

privacy-policy. 

David C. Shonka, 

Acting General Counsel. 

[FR Doc. 2017–17318 Filed 8–15–17; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4836] 

Joint Meeting of the Anesthetic and 

Analgesic Drug Products Advisory 

Committee and the Drug Safety and 

Risk Management 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 or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Anesthetic and Analgesic Drug Products 

Advisory Committee and the Drug 

Safety and Risk Management Advisory 

Committee. The general function of the 

committees is to provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The public meeting will be held 

on September 14, 2017, from 8 a.m. to 

12:30 p.m. 

ADDRESSES: Tommy Douglas Conference 

Center, the Ballroom, 10000 New 

Hampshire Ave., Silver Spring, MD 

20903. Answers to commonly asked 

questions about FDA Advisory 

Committee meetings may be accessed at: 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. Information about the 

Tommy Douglas Conference Center can 

be accessed at: https://

www.tommydouglascenter.com/. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–4836. 

The docket will close on September 13, 

2017. Submit either electronic or 

written comments on this public 

meeting by September 13, 2017. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before September 13, 2017. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

September 13, 2017. 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 

August 30, 2017, will be provided to the 

committees. Comments received after 

that date will be taken into 

consideration by the Agency. 

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– 

2017–N–4836 for ‘‘Anesthetic and 

Analgesic Drug Products Advisory 

Committee and the Drug Safety and Risk 

Management Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
38910 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 

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.’’ The 

Agency 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 to 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 this 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: 

Stephanie L. Begansky, 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: 

AADPAC@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 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 committees will discuss 

supplemental new drug application 

(sNDA) 021306, for BUTRANS 

(buprenorphine) transdermal system 

submitted by Purdue Pharma L.P., 

evaluating BUTRANS in pediatric 

patients ages 7 through 16 years for 

management of pain severe enough to 

require daily, around-the-clock, longterm opioid treatment and for which 

alternative treatment options are 

inadequate. The committees will be 

asked to discuss the findings of the 

clinical study of BUTRANS conducted 

in pediatric patients, and whether they 

support additional labeling. 

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 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 committees. All electronic 

and written submissions submitted to 

the docket (see ADDRESSES) on or before 

August 30, 2017, will be provided to the 

committees. Oral presentations from the 

public will be scheduled between 

approximately 10:15 a.m. and 11:15 a.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 August 22, 2017. 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 August 23, 2017. 

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 special accommodations 

due to a disability, please contact 

Stephanie L. Begansky 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 

https://www.fda.gov/ 

AdvisoryCommittees/ 

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: August 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17303 Filed 8–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–0495] 

Determination That CORDARONE 

(Amiodarone Hydrochloride) Tablets, 

200 milligrams, Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that CORDARONE 

(amiodarone hydrochloride) tablets, 200 

milligrams (mg), were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

this drug product, and it will allow FDA 

to continue to approve ANDAs that refer 

to the product as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Forde, Center for Drug 


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