41274 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 

mg, and 1.25 mg, were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for these 

products, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Bronwen Blass, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, Rm. 6228, 

Silver Spring, MD 20993–0002, 301– 

796–5092. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

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was withdrawn from sale for reasons of 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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. 

CENESTIN (estrogens, conjugated 

synthetic A) Tablets, 0.3 mg, 0.45 mg, 

0.625 mg, 0.9 mg, and 1.25 mg, is the 

subject of NDA 020992, held by Teva 

Branded Pharmaceutical Products R&D, 

Inc. (Teva), and was initially approved 

on March 24, 1999. CENESTIN is 

indicated for treatment of moderate to 

severe vasomotor symptoms due to 

menopause and treatment of moderate 

to severe symptoms of vulvar and 

vaginal atrophy due to menopause. 

In 2016, Teva notified FDA that 

CENESTIN (estrogens, conjugated 

synthetic A) Tablets, 0.3 mg, 0.45 mg, 

0.625 mg, 0.9 mg, and 1.25 mg, were 

being discontinued, and FDA moved the 

drug product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Foley & Lardner submitted a citizen 

petition dated March 8, 2017 (Docket 

No. FDA–2017–P–1461), under 21 CFR 

10.30, requesting that the Agency 

determine whether CENESTIN 

(estrogens, conjugated synthetic A) 

Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 

mg, and 1.25 mg, were withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen and 

reviewing Agency records and based on 

the information we have at this time, 

FDA has determined under § 314.161 

that CENESTIN (estrogens, conjugated 

synthetic A) Tablets, 0.3 mg, 0.45 mg, 

0.625 mg, 0.9 mg, and 1.25 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 these 

products 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 these drug products were 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list CENESTIN (estrogens, 

conjugated synthetic A) Tablets, 0.3 mg, 

0.45 mg, 0.625 mg, 0.9 mg, and 1.25 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 CENESTIN (estrogens, conjugated 

synthetic A) Tablets, 0.3 mg, 0.45 mg, 

0.625 mg, 0.9 mg, and 1.25 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: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18376 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2016–E–1283; FDA– 

2016–E–1291] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; KENGREAL 

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 KENGREAL and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications 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. 

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: 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41275 

• 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 Nos. FDA– 

2016–E–1283 and FDA–2016–E–1291 

for ’’Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; KENGREAL.’’ 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 Office, 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 KENGREAL 

(cangrelor tetrasodium). KENGREAL is 

indicated as an adjunct to percutaneous 

coronary intervention for reducing the 

risk of periprocedural myocardial 

infarction, repeat coronary 

revascularization, and stent thrombosis 

in patients who have not been treated 

with a P2Y12 platelet inhibitor and are 

not being given a glycoprotein IIb/IIIa 

inhibitor. Subsequent to this approval, 

the USPTO received patent term 

restoration applications for KENGREAL 

(U.S. Patent Nos. 6,114,313 and 

6,130,208) from AstraZeneca UK 

Limited, and the USPTO requested 

FDA’s assistance in determining the 

patents’ eligibility for patent term 

restoration. In a letter dated July 12, 

2016, FDA advised the USPTO that this 

human drug product had undergone a 

regulatory review period and that the 

approval of KENGREAL 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 

KENGREAL is 6,122 days. Of this time, 

5,338 days occurred during the testing 

phase of the regulatory review period, 

while 784 days occurred during the 

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: 

September 19, 1998. The applicant 

claims August 20, 1998, as the date the 

investigational new drug application 

(IND) became effective. However, FDA 

records indicate that the IND effective 

date was September 19, 1998, which 

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41276 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 

was 30 days after FDA receipt of the 

IND. 

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 30, 2013. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

KENGREAL (NDA 204958) was initially 

submitted on April 30, 2013. 

3. The date the application was 

approved: June 22, 2015. FDA has 

verified the applicant’s claim that NDA 

204958 was approved on June 22, 2015. 

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 5 years of patent 

term extension. 

III. Petitions 

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. 2017–18380 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

CDC/HRSA Advisory Committee on 

HIV, Viral Hepatitis and STD Prevention 

and Treatment 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, notice 

is hereby given that a meeting is 

scheduled for the Centers for Disease 

Control and Prevention (CDC)/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment. This meeting will be open to 

the public. Information about the CDC/ 

HRSA Advisory Committee on HIV, 

Viral Hepatitis and STD Prevention and 

Treatment and the agenda for this 

meeting can be obtained by contacting 

CDR Holly Berilla at (301) 443–9965 or 

hberilla@hrsa.gov. 

DATES: October 25, 2017, 9:00 a.m. to 

5:30 p.m. (Eastern) and October 26, 

2017, 9:00 a.m. to 4:15 p.m. (Eastern). 

ADDRESSES: This meeting will be held in 

person and offer virtual access through 

teleconference and Adobe Connect. The 

address for the meeting is 5600 Fishers 

Lane, Pavilion, Rockville, Maryland 

20857. The conference call-in number is 

(888) 469–0566 and passcode is 

6012320. The webinar link is https://

hrsa.connectsolutions.com/october_

chac_meeting/. 

FOR FURTHER INFORMATION CONTACT: 

Those requesting information regarding 

the CDC/HRSA Advisory Committee on 

HIV, Viral Hepatitis and STD Prevention 

and Treatment should contact CDR 

Holly Berilla, Senior Public Health 

Analyst, Division of Policy and Data 

(DPD), HIV/AIDS Bureau (HAB), HRSA, 

in one of three ways: (1) Mail a request 

to CDR Holly Berilla, Senior Public 

Health Analyst, HRSA/HAB/DPD, 5600 

Fishers Lane, 9N164C, Rockville, 

Maryland 20857; (2) call (301) 443– 

9965; or (3) send an email to hberilla@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: The CDC/ 

HRSA Advisory Committee on HIV, 

Viral Hepatitis and STD Prevention and 

Treatment was established under 

Section 222 of the Public Health Service 

Act, [42 U.S.C. Section 217a], as 

amended. 

The purpose of the CDC/HRSA 

Advisory Committee on HIV, Viral 

Hepatitis and STD Prevention and 

Treatment is to advise the Secretary of 

HHS, the Director of CDC, and the 

Administrator of HRSA regarding 

objectives, strategies, policies, and 

priorities for HIV, viral hepatitis, and 

other STDs; prevention and treatment 

efforts including surveillance of HIV 

infection, AIDS, viral hepatitis and 

other STDs, and related behaviors; 

epidemiologic, behavioral, health 

services, and laboratory research on 

HIV/AIDS, viral hepatitis, and other 

STDs; identification of policy issues 

related to HIV/viral hepatitis/STD 

professional education, patient 

healthcare delivery, and prevention 

services; HHS policies about prevention 

of HIV/AIDS, viral hepatitis and other 

STDs; treatment, healthcare delivery, 

and research and training; strategic 

issues influencing the ability of CDC 

and HRSA to fulfill their missions of 

providing prevention and treatment 

services; programmatic efforts to 

prevent and treat HIV, viral hepatitis, 

and other STDs; and support to CDC 

and HRSA in their development of 

responses to emerging health needs 

related to HIV, viral hepatitis, and other 

STDs. 

During the October 25 to 26, 2017, 

meeting, the CDC/HRSA Advisory 

Committee on HIV, Viral Hepatitis and 

STD Prevention and Treatment will 

discuss strategies to link, retain, and reengage people living with HIV into the 

Ryan White HIV/AIDS Program system 

of care; HAB’s benchmarking and risk 

adjustment initiatives; HRSA and CDC 

initiatives regarding congenital syphilis; 

and committee workgroup reports. 

Agenda items are subject to change as 

priorities dictate. 

Members of the public will have the 

opportunity to provide comments. Oral 

comments will be honored in the order 

they are requested and may be limited 

as time allows. Requests to make oral 

comments or provide written comments 

to the CDC/HRSA Advisory Committee 

on HIV, Viral Hepatitis and STD 

Prevention and Treatment should be 

sent to CDR Holly Berilla, using the 

contact information listed above, by 

October 11, 2017. 

The building at 5600 Fishers Lane, 

Rockville, MD 20857, requires a security 

screening on entry. To facilitate your 

access to the building please contact 

CDR Holly Berilla (contact information 

provided above). Individuals who plan 

to attend and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should notify CDR Holly Berilla (contact 

information provided above) at least 10 

days prior to the meeting. 

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