Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46497 

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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

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 biological 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 biologic product KOVALTRY 

(antihemophilic factor (recombinant)). 

KOVALTRY is indicated for use in 

adults and children with hemophilia A 

for: (1) On-demand treatment and 

control of bleeding episodes; (2) 

perioperative management of bleeding; 

and (3) routine prophylaxis to reduce 

the frequency of bleeding episodes. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for KOVALTRY (U.S. Patent 

No. 5,804,420) from Bayer HealthCare 

LLC, and the USPTO requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated October 14, 2016, FDA 

advised the USPTO that this human 

biological product had undergone a 

regulatory review period and that the 

approval of KOVALTRY 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 

KOVALTRY is 2,478 days. Of this time, 

2,021 days occurred during the testing 

phase of the regulatory review period, 

while 457 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 (21 U.S.C. 355(i)) 

became effective: June 5, 2009. FDA has 

verified the Bayer HealthCare LLC’s 

claim that the date the investigational 

new drug application became effective 

was on June 5, 2009. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): December 16, 2014. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for KOVALTRY (BLA 125574/0) was 

initially submitted on December 16, 

2014. 

3. The date the application was 

approved: March 16, 2016. FDA has 

verified the applicant’s claim that BLA 

125574/0 was approved on March 16, 

2016. 

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 1,466 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: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21421 Filed 10–4–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0001] 

Science Advisory Board to the 

National Center for Toxicological 

Research Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Science Advisory Board 

(SAB) to the National Center for 

Toxicological Research (NCTR). The 

general function of the committee is to 

provide advice and recommendations to 

the Agency on FDA’s regulatory issues. 

At least one portion of the meeting will 

be closed to the public. 

DATES: The meeting will be held on 

November 6, 2017, from 8 a.m. to 5 

p.m., and on November 7, 2017, from 8 

a.m. to 11:20 a.m. 

ADDRESSES: Heifer Village, One World 

Avenue, Little Rock, AR 72202. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm and 

https://www.heifer.org/what-you-cando/experience-heifer/heifer-village/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Donna Mendrick, National Center for 

Toxicological Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 2208, Silver Spring, 

MD 20993–0002, 301–796–8892, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https:// 


ethrower on DSK3G9T082PROD with NOTICES
46498 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On November 6, 2017, the 

SAB Chair will welcome the 

participants, and the NCTR Director will 

provide a Center-wide update on 

scientific initiatives and 

accomplishments during the past year. 

The SAB will be presented with an 

overview of the Division of Systems 

Biology Subcommittee and the 

Subcommittee Site Visit Report and a 

response to this review. There will be 

updates from the NCTR Research 

Divisions and a public comment 

session. 

On November 7, 2017, the Center for 

Biologics and Evaluation and Research, 

Center for Drug Evaluation and 

Research, Center for Devices and 

Radiological Health, Center for Tobacco 

Products, Center for Veterinary 

Medicine, and the Office of Regulatory 

Affairs will each briefly discuss their 

center-specific research strategic needs 

and potential areas of collaboration. 

Following an open discussion of all 

the information presented, the open 

session of the meeting will close so the 

SAB members can discuss personnel 

issues at NCTR at the end of each day. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: On November 6, 2017, 

from 8 a.m. to 5 p.m., and November 7, 

2017, from 8 a.m. to 11:20 a.m., the 

meeting is open to the public. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the committee. Written 

submissions may be made to the contact 

person on or before October 30, 2017. 

Oral presentations from the public will 

be scheduled on November 6, 2017, 

between approximately 1:15 p.m. to 

2:15 p.m. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before October 23, 2017. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 30, 2017. 

Closed Committee Deliberations: On 

November 6, 2017, from 5 p.m. to 5:30 

p.m., and November 7, 2017, from 11:20 

a.m. to 12 noon, the meeting will be 

closed to permit discussion where 

disclosure would constitute a clearly 

unwarranted invasion of personal 

privacy (5 U.S.C. 552b(c)(6)). This 

portion of the meeting will be closed to 

permit discussion of information 

concerning individuals associated with 

the research programs at NCTR. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Donna 

Mendrick at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21440 Filed 10–4–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–E–1298] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; IMPELLA 2.5 SYSTEM 

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 IMPELLA 2.5 SYSTEM 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 medical 

device. 

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 December 4, 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 

April 3, 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 December 4, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 4, 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 


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