Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3157 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5154, Silver Spring, 

MD 20993, 240–402–3838, email: 

marieann.brill@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 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 PAC and EMDAC will 

meet to discuss the major objectives of 

a phase 3 drug development program 

indicated for the treatment of children 

with achondroplasia (ACH). The 

following elements of a phase 3 program 

should be considered for discussion: 

Evidence required to establish doseresponse, study design, e.g., placebo 

control, study duration, intended 

population, e.g., infants and toddlers 

and/or older children and adolescents, 

and endpoints that have a clinically 

meaningful impact on the patient’s 

functional or psychological well-being. 

Comments about the upcoming advisory 

committee meeting should be submitted 

to Docket No. FDA–2018–N–0045. 

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: On March 22, 2018, from 

10:30 a.m. to 5:30 p.m., the meeting is 

open to the public. 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 15, 2018. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.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 March 7, 

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 March 8, 2017. 

Closed Committee Deliberations: On 

March 22, 2018, from 8:30 a.m. to 10 

a.m., the meeting will be closed to 

permit committee review and 

discussion of trade secret and/or 

confidential commercial information (5 

U.S.C. 552b(c)(4)) included in an 

Investigational New Drug application 

for an investigational product indicated 

for the treatment of children with ACH. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA 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 Marieann Brill 

(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/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: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01120 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0021] 

Watson Laboratories, Inc.; Withdrawal 

of Approval of Abbreviated New Drug 

Applications for Prescription Pain 

Medications Containing More Than 325 

Milligrams of Acetaminophen 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA and Agency) is 

withdrawing approval of an abbreviated 

new drug application (ANDA), held by 

Watson Laboratories, Inc. (Watson), for 

prescription pain medications that 

contain more than 325 milligrams (mg) 

of acetaminophen. Watson has 

voluntarily requested that approval of 

this application be withdrawn and has 

waived its opportunity for a hearing. 

DATES: Approval is withdrawn as of 

January 23, 2018. 

FOR FURTHER INFORMATION CONTACT: Jane 

Baluss, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6278, Silver Spring, 

MD 20993–0002, 301–796–3469. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 14, 2011 (76 

FR 2691), FDA announced its plans to 

reduce the maximum dosage unit 

strength of acetaminophen in 

prescription drug products. The 

document announced FDA’s conclusion 

that, based on a reevaluation of the 

relative risks and benefits of 

prescription acetaminophen products, 

fixed-combination prescription drugs 

containing more than 325 mg of 

acetaminophen per dosage unit (tablet 

or capsule) do not provide a sufficient 

margin of safety to protect the public 

against the serious risk of 

acetaminophen-induced liver injury. 

Accordingly, we asked product sponsors 

to limit the maximum amount of 

acetaminophen per dosage unit to 325 

mg and, for those products containing 

more than 325 mg of acetaminophen per 

dosage unit, to submit requests that FDA 

withdraw approval of their applications 

under § 314.150(d) (21 CFR 314.150(d)). 

FDA asked that all such requests be 

made before January 14, 2014, after 

which date the Agency planned to 

initiate proceedings under section 

505(e) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(e)). In a Federal Register document 

dated March 27, 2014 (79 FR 17613), 


sradovich on DSK3GMQ082PROD with NOTICES
3158 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

FDA withdrew the approval of multiple 

applications containing more than 325 

mg of acetaminophen whose sponsors 

voluntarily requested withdrawal and 

waived their opportunity for a hearing 

on or before that date. 

In a letter dated November 22, 2016, 

Watson voluntarily requested that FDA 

withdraw approval of its ANDA 074699 

for Pentazocine and Acetaminophen 

Tablets, 25 mg/650 mg, and waived its 

opportunity for a hearing. The letter also 

stated that the product was not 

manufactured or distributed after 

January 14, 2014. 

Therefore, under § 314.150(d), 

approval of this ANDA, and all 

amendments and supplements thereto, 

is withdrawn (see DATES). Distribution 

of this product in interstate commerce 

without an approved application is 

illegal and subject to regulatory action 

(see sections 505(a) and 301(d) of the 

FD&C Act (21 U.S.C. 355(a) and 331(d)). 

The safety issue discussed in this 

document and the January 14, 2011, 

Federal Register document is limited to 

products containing more than 325 mg 

of acetaminophen per dosage unit. 

Thus, the withdrawal of approval of this 

product does not change the approval 

status of any product with 325 mg or 

less of acetaminophen per dosage unit 

that is approved under the same 

application, or that refers to or relies on 

the withdrawn application. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01118 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0071] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Draft Guidance for 

Industry: Modified Risk Tobacco 

Product Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

‘‘Draft Guidance for Industry: Modified 

Risk Tobacco Product Applications’’ 

(MRTPA). 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 26, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 26, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 26, 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. 

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– 

2012–D–0071 for ‘‘Draft Guidance for 

Industry: Modified Risk Tobacco 

Product Applications’’ Received 

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.’’ 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: 

Amber Sanford, Office of Operations, 


sradovich on DSK3GMQ082PROD with NOTICES