Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41271 

• 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– 

2007–D–0369 for ‘‘Draft Guidance on 

Digoxin.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ will be publicly viewable 

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

Dockets Management Staff office 

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 office, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Submit written requests for single 

copies of the draft revised 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 revised guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research, 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 

draft revised product-specific guidance 

for generic digoxin tablets. 

FDA initially approved new drug 

application (NDA) 020405 for LANOXIN 

(digoxin tablets) in September 1997. In 

May 2008, we issued a final guidance 

for industry on generic digoxin tablets. 

We are now issuing a draft revised 

guidance for industry on generic 

digoxin tablets (‘‘Draft Guidance on 

Digoxin’’). 

In December 2015, Concordia 

Pharmaceuticals submitted a citizen 

petition requesting, among other things, 

that FDA amend the guidance for 

industry on BE recommendations for 

generic digoxin tablets issued in 2008. 

FDA has reviewed the issues raised in 

the citizen petition and is responding to 

the citizen petition (Docket No. FDA– 

2015–P–4566, available at https://

www.regulations.gov). 

This draft revised guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft revised guidance, 

when finalized, will represent the 

current thinking of FDA on the design 

of BE studies to support ANDAs for 

digoxin 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. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft revised guidance at 

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

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18386 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–E–0624] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; XTORO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for XTORO and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of the U.S. 

Patent and Trademark Office (USPTO), 

Department of Commerce, for the 

extension of a patent which claims that 

human drug product. 

DATES: Anyone with knowledge that any 

of the dates as published (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by October 30, 2017. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

February 26, 2018. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

mstockstill on DSK30JT082PROD with NOTICES

41272 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 

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 October 30, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 30, 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. 

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– 

2016–E–0624 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; XTORO.’’ 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 Office 

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 Office. 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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product XTORO 

(finafloxacin). XTORO is indicated for 

treatment of acute otitis externa caused 

by susceptible strains of Pseudomonas 

aeruginosa and Staphylococcus aureus. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for XTORO (U.S. Patent No. 

6,133,260) from Alcon Pharmaceutials 

Ltd. for Bayer Intellectual Property 

GmbH, and the USPTO requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated May 2, 2016, FDA advised 

the USPTO that this human drug 

product had undergone a regulatory 

review period and that the approval of 

XTORO represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

XTORO is 1,880 days. Of this time, 

1,643 days occurred during the testing 

phase of the regulatory review period, 

while 237 days occurred during the 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41273 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: October 

26, 2009. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on October 26, 

2009. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: April 25, 2014. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

XTORO (NDA 206307) was initially 

submitted on April 25, 2014. 

3. The date the application was 

approved: December 17, 2014. FDA has 

verified the applicant’s claim that NDA 

206307 was approved on December 17, 

2014. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,058 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in 21 CFR 

60.30, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 21 

CFR 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with 21 CFR 10.20, 

must contain sufficient facts to merit an 

FDA investigation, and must certify that 

a true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18379 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0002] 

Upsher-Smith Laboratories, Inc.; 

Withdrawal of Approval of an 

Abbreviated New Drug Application for 

PROPRANOLOL HYDROCHLORIDE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of an abbreviated 

new drug application (ANDA) for 

PROPRANOLOL HYDROCHLORIDE 

Extended-Release Capsules, held by 

Upsher-Smith Laboratories, Inc. 

(Upsher-Smith), 6701 Evenstad Dr., 

Maple Grove, MN 55369. Upsher-Smith 

has voluntarily requested that approval 

of this application be withdrawn and 

has waived its opportunity for a hearing. 

DATES: August 30, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Stefanie Kraus, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6215, 

Silver Spring, MD 20993–0002, 301– 

796–9585. 

SUPPLEMENTARY INFORMATION: On March 

6, 2009, FDA approved abbreviated new 

drug application (ANDA) 078311 for 

PROPRANOLOL HYDROCHLORIDE 

Extended-Release Capsules, USP, 60 

milligrams (mg), 80 mg, 120 mg, and 

160 mg. In a letter dated August 9, 2011, 

FDA informed Upsher-Smith that it had 

concerns about the validity of 

bioequivalence data submitted with 

ANDA 078311 from studies conducted 

by a certain contract research 

organization, establishing 

bioequivalence of Upsher-Smith’s 

product to the reference listed drug 

(RLD), INDERAL LA (propranolol 

hydrochloride) Extended Release 

Capsules, 60 mg, 80 mg, 120 mg, and 

160 mg. In that letter, FDA directed 

Upsher-Smith to supplement its ANDA 

with either: (1) New bioequivalence 

studies or (2) re-assays of the samples 

from the original bioequivalence 

studies. Upsher-Smith submitted new 

fasted and fed bioequivalence studies to 

supplement ANDA 078311 in paper 

format on August 29, 2013, and in 

electronic format on May 9, 2014. 

On April 14, 2016, FDA informed 

Upsher-Smith that the applicant’s fed 

bioequivalence study failed to meet 

FDA’s bioequivalence criteria and, 

therefore, requested that Upsher-Smith 

voluntarily seek withdrawal of ANDA 

078311 under § 314.150(d) (21 CFR 

314.150(d)). 

In a letter dated May 13, 2016, 

Upsher-Smith requested that FDA 

withdraw approval of ANDA 078311 for 

PROPRANOLOL HYDROCHLORIDE 

Extended-Release Capsules under 

§ 314.150(d) because the new 

bioequivalence data did not 

demonstrate therapeutic equivalence of 

its product to the RLD, INDERAL LA. In 

that letter, Upsher-Smith also waived 

any opportunity for a hearing otherwise 

provided under § 314.150(a). 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

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

§ 314.150(d), and under authority 

delegated by the Commissioner of Food 

and Drugs to the Director, Center for 

Drug Evaluation and Research, approval 

of ANDA 078311, 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)). 

Dated: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18375 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–1461] 

Determination That CENESTIN 

(Estrogens, Conjugated Synthetic A) 

Tablets, 0.3 Milligrams, 0.45 Milligrams, 

0.625 Milligrams, 0.9 Milligrams, and 

1.25 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 CENESTIN (estrogens, 

conjugated synthetic A) Tablets, 0.3 

milligrams (mg), 0.45 mg, 0.625 mg, 0.9 

mstockstill on DSK30JT082PROD with NOTICES