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
Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Notices 3003 

Communication Guide for relaying 

Newborn Screening results. 

HRSA will post the agenda two days 

prior to the meeting on the Committee’s 

website: https://www.hrsa.gov/advisorycommittees/heritable-disorders/

index.html. Please note that agenda 

items are subject to changes as priorities 

dictate. 

Members of the public will have the 

opportunity to provide comments and 

may submit written comments in 

advance of the meeting. All comments 

are part of the official Committee record. 

To submit written comments or request 

time for an oral comment at the meeting, 

please register online by 12:00 p.m. ET 

on January 31, 2018, at http://

www.achdncmeetings.org/. To 

accommodate all individuals who have 

registered and requested time for oral 

comments, the allocated time for 

comments may be limited. The 

ACHDNC may ask individuals 

associated with groups, or individuals 

who plan to provide comments on 

similar topics, to combine their 

comments and present them through a 

single representative. Audiovisual 

presentations are not permitted. Written 

comments should identify the 

individual’s name, address, email, 

telephone number, professional or 

organization affiliation, background or 

area of expertise (i.e., parent, family 

member, researcher, clinician, public 

health, etc.) and the topic/subject 

matter. Individuals who plan to attend 

and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

notify Ann Ferrero using the address 

and phone number above at least 10 

days prior to the meeting. 

Amy McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–00978 Filed 1–19–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Partnerships for the 

Development of Vaccines and 

Immunophrophylactics Targeting Multiple 

Antibiotic-Resistant Bacteria (R01). 

Date: February 12–13, 2018. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Kelly Y. Poe, Ph.D., 

Scientific Review Program, Division of 

Extramural Activities, Room 3F40B, National 

Institutes of Health, NIAID, 5601 Fishers 

Lane, MSC 9823, Bethesda, MD 20892–9823, 

(240) 669–5036, poeky@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: January 16, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00959 Filed 1–19–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel; NIDCR Clinical Research, 

Clinical Trials, and Clinical Trials Planning 

Grants. 

Date: February 12, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892. 

Contact Person: Marilyn Moore-Hoon, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute of Dental 

and Craniofacial Research, 6701 Democracy 

Blvd., Rm. 676, Bethesda, MD 20892–4878, 

301–594–4861, mooremar@nidcr.nih.gov. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel; NIDCR DSR Member 

Conflict SEP. 

Date: February 14, 2018. 

Time: 11:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Marilyn Moore-Hoon, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, National Institute of Dental 

and Craniofacial Research, 6701 Democracy 

Blvd., Rm. 676, Bethesda, MD 20892–4878, 

301–594–4861, mooremar@nidcr.nih.gov. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel. 

Date: February 28, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Garden Inn Bethesda, 7301 

Waverly Street, Bethesda, MD 20814. 

Contact Person: Nisan Bhattacharyya, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, NIDCR, NIH, 6701 

Democracy Boulevard, Suite 668, Bethesda, 

MD 20892, 301–451–2405, nisan_

bhattacharyya@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: January 16, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00962 Filed 1–19–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Cancer 

Advisory Board. 

The meeting will be open to the 

public as indicated below, with 


ethrower on DSK3G9T082PROD with NOTICES