Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53507 

default.htm, or https://

www.regulations.gov. 

Dated: November 13, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24831 Filed 11–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1981–N–0245 (Formerly 

81N–0080)] 

Mepergan Fortis Capsules; Final 

Decision on Proposal To Refuse 

Approval of Supplemental New Drug 

Application; Availability of Final 

Decision 

AGENCY: Food and Drug Administration; 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing that the Initial Decision of 

the Administrative Law Judge (ALJ), to 

refuse approval of the supplemental 

new drug application (sNDA) for 

Mepergan Fortis Capsules (MFC) 

(meperidine HCl, promethazine HCl), is 

the final decision of the Commissioner 

by operation of law. In the Initial 

Decision, the ALJ found that MFC had 

not been shown to be supported by 

substantial evidence consisting of 

adequate and well-controlled studies to 

be effective for sedation and analgesia in 

patients with concurrent moderate pain 

and apprehension, such as 

postoperative and post-trauma patients 

with those symptoms; that the drug did 

not satisfy the combination drug policy; 

and that it is a ‘‘new drug.’’ The sNDA 

applicant filed exceptions to the ALJ’s 

Initial Decision. FDA recently requested 

that the current owner of the sNDA 

application affirm its desire to pursue 

the appeal of the ALJ’s Initial Decision; 

however, the applicant did not affirm its 

desire to pursue the appeal within the 

specified timeframe. Accordingly, FDA 

now deems those exceptions as 

withdrawn. Consequently, the 

proceeding is in the same procedural 

position as if no exceptions to the ALJ’s 

Initial Decision had been filed; 

therefore, the ALJ’s Initial Decision has 

become the final decision of the 

Commissioner by operation of law. 

DATES: This final decision is effective 

November 16, 2017. 

ADDRESSES: For access to the docket, 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 

between 9 a.m. and 4 p.m., Monday 

through Friday. Publicly available 

submissions may be seen in the docket. 

FOR FURTHER INFORMATION CONTACT: 

Rachael Vieder Linowes, Office of 

Scientific Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4206, Silver Spring, 

MD 20993, 240–402–5931. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In 1962, the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) was 

amended by the Drug Amendments Act 

of 1962, and these amendments 

provided that new drugs could no 

longer be approved unless both safety 

and efficacy had been established for 

them. As amended, the FD&C Act also 

required FDA to evaluate drugs 

approved as safe between 1938 and 

1962 to determine whether such drugs 

were effective and to withdraw approval 

for any new drug application (NDA) 

where there was not substantial 

evidence of the drug’s effectiveness. The 

person contesting the withdrawal of the 

approval had the burden of coming 

forward with evidence of effectiveness 

for the drug. FDA’s review of these pre1962 drugs is known as the Drug 

Efficacy Study Implementation (DESI) 

program. 

In a document published in the 

Federal Register of April 20, 1972 (37 

FR 7827), after evaluating reports 

received from the National Academy of 

Sciences/National Research Council, 

Drug Efficacy Study Group, and other 

available evidence, FDA classified MFC 

as ‘‘possibly effective’’ for moderate to 

moderately severe pain. This document 

also stated that no NDA had been 

approved or deemed approved for MFC 

and that additional evidence needed to 

be submitted to FDA to establish MFC’s 

effectiveness. Thereafter, Wyeth, a 

division of American Home Products 

(Wyeth), submitted a supplement to its 

approved NDA 11–730 (Mepergan 

Injection) for MFC (NDA 11–730, S– 

003). In a document published in the 

Federal Register of September 18, 1981 

(46 FR 46404), the Director of the 

Bureau of Drugs (now the Center for 

Drug Evaluation and Research) 

proposed to refuse approval of the 

sNDA and offered Wyeth the 

opportunity for a hearing. 

Wyeth submitted its request for a 

hearing and, by a document published 

in the Federal Register of December 31, 

1984 (49 FR 50788), the Office of the 

Commissioner granted the hearing 

request. Following the submission of 

written testimony and documentary 

evidence, an ALJ, Daniel J. Davidson, 

conducted a hearing from January 14 to 

17, 1986. He issued his Initial Decision 

on December 4, 1987. The ALJ found 

that: (1) The effectiveness of MFC had 

not been proven by substantial evidence 

of adequate and well-controlled clinical 

trials, (2) the requirements of the 

combination drug policy had not been 

met, and (3) MFC is a new drug under 

21 U.S.C. 321(p). Wyeth timely 

appealed the ALJ’s Initial Decision by 

filing exceptions with the Commissioner 

under 21 CFR 12.125. 

On August 23, 2017, FDA sent a letter 

to West-Ward Pharmaceuticals 

Corporation (West-Ward), successor to 

Wyeth, to determine whether WestWard remained interested in pursuing 

its appeal of the ALJ’s Initial Decision. 

FDA informed the company that if it did 

not respond and affirm its desire to 

pursue its appeal by September 21, 

2017, the Office of the Commissioner 

would conclude that West-Ward no 

longer wishes to pursue the appeal of 

the ALJ’s Initial Decision and will 

proceed as if the appeal has been 

withdrawn. The Office of the 

Commissioner did not receive a 

response from West-Ward by the given 

date; therefore, the Commissioner now 

deems the exceptions withdrawn. 

II. Conclusion and Order 

Given that the exceptions have been 

deemed withdrawn, this proceeding is 

now in the same procedural posture as 

if no exceptions had ever been filed. 

When parties do not file exceptions to 

the ALJ’s Initial Decision, and the 

Commissioner does not file a notice of 

review, the ALJ’s Initial Decision 

becomes the final decision of the 

Commissioner (see 21 CFR 12.120(e)). 

FDA will publish a notice in the Federal 

Register when an initial decision 

becomes the final decision of the 

Commissioner without appeal to or 

review by the Commissioner (see 21 

CFR 12.120(f)). 

Therefore, the ALJ’s Initial Decision is 

the final decision of the Commissioner 

effective November 16, 2017. Pursuant 

to the findings in the ALJ’s Initial 

Decision, under section 505(d) of the 

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

the authority delegated by the Secretary 

of Health and Human Services, the 

Commissioner finds that there is a lack 

of substantial evidence that MFC will 

have the effect it purports or is 

represented to have under the 

conditions of use prescribed, 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
53508 Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 

recommended, or suggested in its 

labeling for sedation and analgesia in 

patients with concurrent moderate pain 

and apprehension, such as 

postoperative and post-trauma patients 

with those symptoms. The 

Commissioner further finds that MFC 

does not meet the combination drug 

policy in 21 CFR 300.50 and that it is 

a ‘‘new drug’’ within the meaning of 21 

U.S.C. 321(p). Therefore, approval of the 

sNDA for MFC is denied. Distribution of 

products subject to the ALJ’s Initial 

Decision in interstate commerce without 

an approved application is prohibited 

and subject to regulatory action (see, 

e.g., sections 505(a) and 301(d) (21 

U.S.C. 331(d)) of the FD&C Act). 

The full text of the ALJ’s Initial 

Decision may be seen in the Dockets 

Management Staff and in this docket 

(see ADDRESSES). 

Dated: November 7, 2017. 

Denise Hinton, 

Acting Chief Scientist. 

[FR Doc. 2017–24806 Filed 11–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6292] 

Bone, Reproductive and Urologic 

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 or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Bone, Reproductive and Urologic Drugs 

Advisory Committee. The general 

function of the committee 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 meeting will be held on 

January 10, 2018, from 8 a.m. to 5 p.m. 

ADDRESSES: College Park Marriott Hotel 

and Conference Center, Chesapeake 

Ballroom, 3501 University Blvd. East, 

Hyattsville, MD 20783. The conference 

center’s telephone number is 301–985– 

7300. Answers to commonly asked 

questions about FDA Advisory 

Committee meetings may be accessed at: 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–6292. 

The docket will close on January 9, 

2018. Submit either electronic or 

written comments on this public 

meeting by January 9, 2018. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before January 

9, 2018. The https://www.regulations.

gov electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 9, 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 

December 22, 2017, will be provided to 

the committee. 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–6292 for ‘‘Bone, Reproductive 

and Urologic Drugs 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 

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 


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