3000 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 

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 numbers, 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 ZURAMPIC 

(lesinurad). ZURAMPIC is indicated in 

combination with a xanthine oxidase 

inhibitor for the treatment of 

hyperuricemia associated with gout in 

patients who have not achieved target 

serum uric acid levels with a xanthine 

oxidase inhibitor alone. Subsequent to 

this approval, the USPTO received 

patent term restoration applications for 

ZURAMPIC (U.S. Patent Nos. 8,003,681; 

8,084,483; 8,283,369; 8,357,713; and 

8,546,437) from Ardea Biosciences, Inc., 

and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated November 10, 2016, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of ZURAMPIC 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 

ZURAMPIC is 2,245 days. Of this time, 

1,886 days occurred during the testing 

phase of the regulatory review period, 

while 359 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 (FD&C Act) (21 U.S.C. 

355(i)) became effective: October 31, 

2009. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on October 31, 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: December 29, 

2014. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for ZURAMPIC (NDA 207988) 

was initially submitted on December 29, 

2014. 

3. The date the application was 

approved: December 22, 2015. FDA has 

verified the applicant’s claim that NDA 

207988 was approved on December 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 applications for patent extension, 

this applicant seeks 971 days, 127 days, 

391 days, and 237 days 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 § 60.30 (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 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 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: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00992 Filed 1–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2016–E–2463; FDA– 

2016–E–2464; FDA–2016–E–2465; and FDA– 

2016–E–2466] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NINLARO 

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 NINLARO 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 (see the 

SUPPLEMENTARY INFORMATION section) are 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 3001 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by March 23, 2018. 

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 

July 23, 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 March 23, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 23, 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 Nos. FDA– 

2016–E–2463; FDA–2016–E–2464; 

FDA–2016–E–2465; and FDA–2016–E– 

2466 for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; NINLARO.’’ 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 § 10.20 (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 NINLARO 

(ixazomib). NINLARO is indicated in 

combination with lenalidomide and 

dexamethasone for the treatment of 

patients with multiple myeloma who 

have received at least one prior therapy. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for NINLARO (U.S. Patent 

Nos. 7,442,830; 7,687,662; 8,003,819; 

and 8,859,504) from Millennium 

Pharmaceuticals, Inc., and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

October 14, 2016, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 


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3002 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 

NINLARO 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 

NINLARO is 2,538 days. Of this time, 

2,404 days occurred during the testing 

phase of the regulatory review period, 

while 134 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 (FD&C Act) (21 U.S.C. 

355(i)) became effective: December 10, 

2008. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on December 10, 2008. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: July 10, 2015. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

NINLARO (NDA 208462) was initially 

submitted on July 10, 2015. 

3. The date the application was 

approved: November 20, 2015. FDA has 

verified the applicant’s claim that NDA 

208462 was approved on November 20, 

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 applications for patent extension, 

this applicant seeks 837 or 157 days 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 § 60.30 (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 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 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: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00994 Filed 1–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Service 

Administration 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

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, this 

notice announces that the Advisory 

Committee on Heritable Disorders in 

Newborns and Children (ACHDNC) will 

hold a public meeting. 

DATES: Thursday, February 8, 2018, 

from 9:30 a.m. to 5:00 p.m. and Friday, 

February 9, 2018, from 9:30 a.m. to 3:00 

p.m. ET (meeting times are tentative). 

ADDRESSES: The address for the meeting 

is 5600 Fishers Lane, 5th Floor Pavilion, 

Rockville, MD 20857. Participants may 

also access the meeting through 

Webcast. Advanced registration is 

required. Please register online at http:// 

www.achdncmeetings.org/ by 12:00 p.m. 

ET on February 5, 2018. Instructions on 

how to access the meeting via Webcast 

will be provided upon registration. 

Please note that the 5600 Fishers Lane 

building requires security screening on 

entry. Visitors must provide a driver’s 

license, passport, or other form of 

government-issued photo identification 

or they cannot enter the facility. Non-US 

Citizens planning to attend in person 

will need to provide additional 

information to HRSA by January 24, 

2018, 12:00 p.m. Eastern Time. Please 

see contact information below. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requesting information 

regarding the ACHDNC should contact 

Ann Ferrero, Maternal and Child Health 

Bureau (MCHB), HRSA, in one of three 

ways: (1) Send a request to the following 

address: Ann Ferrero, MCHB, HRSA 

5600 Fishers Lane, Room 18N100C, 

Rockville, MD 20857; (2) call 301–443– 

3999; or (3) send an email to: AFerrero@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

ACHDNC provides advice to the 

Secretary of HHS on the development of 

newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. In addition, 

ACHDNC’s recommendations regarding 

inclusion of additional conditions and 

inherited disorders for screening which 

have been adopted by the Secretary are 

then included in the Recommended 

Uniform Screening Panel (RUSP). 

Conditions listed on the RUSP 

constitute part of the comprehensive 

preventive health guidelines supported 

by HRSA for infants and children under 

section 2713 of the Public Health 

Service Act, codified at 42 U.S.C. 

300gg–13. Under this provision, nongrandfathered health plans are required 

to cover screenings included in the 

HRSA-supported comprehensive 

guidelines without charging a copayment, co-insurance, or deductible for 

plan years (i.e., policy years) beginning 

on or after the date that is one year from 

the Secretary’s adoption of the 

condition for screening. Information 

about the ACHDNC is available on the 

following website: https://

www.hrsa.gov/advisory-committees/

heritable-disorders/index.html. 

The meeting agenda will include a 

final evidence-based review report on 

the spinal muscular atrophy (SMA) 

condition nomination for possible 

inclusion on the RUSP. Following this 

report, the ACHDNC expects to vote on 

whether to recommend to the Secretary 

adding SMA to the RUSP. ACHDNC 

members will also hear presentations on 

states’ activities to achieve newborn 

screening timeliness goals. An overview 

of cutoff determinations and risk 

assessment methods used for dried 

bloodspot newborn screening will also 

be given. The Committee expects to vote 

on whether to support a guidance 

document on cutoff determinations and 

risk assessment methods. Finally, the 

ACHDNC members will hear updates 

from the Laboratory Standards and 

Procedures workgroup; the Follow-up 

and Treatment workgroup, including a 

presentation of the final draft of a report 

on Quality Measures in Newborn 

Screening; and the Education and 

Training workgroup, including a 

presentation of the final draft of a 


ethrower on DSK3G9T082PROD with NOTICES