Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49033 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

ELAVIL (amitriptyline hydrochloride) 

oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 

100 mg, and 150 mg, are the subject of 

NDA 012703, held by AstraZeneca, and 

initially approved on April 7, 1961. 

ELAVIL is indicated for the relief of 

symptoms of depression. ELAVIL 

(amitriptyline hydrochloride) oral 

tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 

mg, and 150 mg, are currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. In the 

Federal Register of June 16, 2006 (71 FR 

34940), FDA announced that it was 

withdrawing approval of NDA 012703, 

effective June 16, 2006. 

Alembic Pharmaceuticals Limited 

submitted a citizen petition dated June 

5, 2017 (Docket No. FDA–2017–P– 

3581), under 21 CFR 10.30, requesting 

that the Agency determine whether 

ELAVIL (amitriptyline hydrochloride) 

oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 

100 mg, and 150 mg, were withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that ELAVIL (amitriptyline 

hydrochloride) oral tablets, 10 mg, 25 

mg, 50 mg, 75 mg, 100 mg, and 150 mg, 

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that these 

products were withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of ELAVIL 

(amitriptyline hydrochloride) oral 

tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 

mg, and 150 mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ELAVIL (amitriptyline 

hydrochloride) oral tablets, 10 mg, 25 

mg, 50 mg, 75 mg, 100 mg, and 150 mg, 

in the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to ELAVIL (amitriptyline hydrochloride) 

oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 

100 mg, and 150 mg, may be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: October 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22892 Filed 10–20–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidance for 

Methylphenidate Hydrochloride; New 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

new draft guidance for industry on 

generic methylphenidate hydrochloride 

oral extended-release tablets entitled 

‘‘Draft Guidance on Methylphenidate 

Hydrochloride.’’ The new draft 

guidance, when finalized, will provide 

product-specific recommendations on, 

among other things, the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for methylphenidate 

hydrochloride oral extended-release 

tablets. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 22, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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 


ethrower on DSK3G9T082PROD with NOTICES
49034 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Draft Guidance on 

Methylphenidate Hydrochloride.’’ 

Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 75, Rm. 

4730, Silver Spring, MD 20993–0002, 

301–796–5850. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s Web site at https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

new draft guidance for generic 

methylphenidate hydrochloride oral 

extended-release tablets. 

FDA initially approved new drug 

application 018029 for RITALIN–SR 

(methylphenidate hydrochloride oral 

extended-release tablets) in March 1982. 

We are now issuing a new draft 

guidance for industry on 

methylphenidate hydrochloride oral 

extended-release tablets (‘‘Draft 

Guidance on Methylphenidate 

Hydrochloride’’). 

In May 2016, KVK-Tech, Inc. (KVKTech) submitted a citizen petition 

requesting, among other things, that 

FDA not accept for filing any new 

ANDAs or approve any already received 

ANDAs for methylphenidate 

hydrochloride oral extended-release 

tablets unless certain BE criteria are 

met. FDA will consider any comments 

on the draft guidance on BE 

recommendations for generic 

methylphenidate hydrochloride oral 

extended-release tablets before 

responding to KVK-Tech’s citizen 

petition. (Docket No. FDA–2016–P– 

1247, available at https://

www.regulations.gov). 

The new draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The new draft guidance, when 

finalized, will represent the current 

thinking of FDA on the design of BE 

studies to support ANDAs for 

methylphenidate hydrochloride oral 

extended-release tablets. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: October 17, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22891 Filed 10–20–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Performance Review Board Members 

Title 5, U.S.C. Section 4314(c)(4) of 

the Civil Service Reform Act of 1978, 

Public Law 95–454, requires that the 

appointment of Performance Review 

Board Members be published in the 

Federal Register. The following persons 

may be named to serve on the 

Performance Review Boards or Panels, 

which oversee the evaluation of 

performance appraisals of Senior 

Executive Service members of the 

Department of Health and Human 

Services. 

Employee Name 

Barry, Daniel 

Barlow, Amanda 

Coughlin, Janis 

Fantinato, Jessica 

Gentile, John 

Johnson, Jeffrey 

Katz, Ruth 

Kretschmaier, Michon 

Lewis, Lisa 

McDaniel, Eileen 

Novy, Steve 

Sample, Allen 

Skeadas, Christos 

Tobias, Constance 

Weber, Mark 


ethrower on DSK3G9T082PROD with NOTICES