Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1371 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(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 medical device will include all of the 

testing phase and approval phase as 

specified in 35 U.S.C. 156(g)(3)(B). 

FDA has approved for marketing the 

medical device MICRA 

TRANSCATHETER PACING SYSTEM. 

MICRA TRANSCATHETER PACING 

SYSTEM is indicated for use in patients 

who have experienced one or more of 

the following conditions: (1) 

Symptomatic paroxysmal or permanent 

high-grade atrioventricular (AV) block 

in the presence of atrial fibrillation (AF); 

(2) symptomatic paroxysmal or 

permanent high-grade AV block in the 

absence of AF, as an alternative to dual 

chamber pacing, when atrial lead 

placement is considered difficult, high 

risk, or not deemed necessary for 

effective therapy; (3) symptomatic 

bradycardia-tachycardia syndrome or 

sinus node dysfunction (sinus 

bradycardia or sinus pauses), as an 

alternative to atrial or dual chamber 

pacing when atrial lead placement is 

considered difficult, high risk, or not 

deemed necessary for effective therapy. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for MICRA 

TRANSCATHETER PACING SYSTEM 

(U.S. Patent Nos. 7,824,805 and 

8,129,622) from Medtronic, Inc., and the 

USPTO requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

March 13, 2017, FDA advised the 

USPTO that this medical device had 

undergone a regulatory review period 

and that the approval of MICRA 

TRANSCATHETER PACING SYSTEM 

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 

MICRA TRANSCATHETER PACING 

SYSTEM is 788 days. Of this time, 585 

days occurred during the testing phase 

of the regulatory review period, while 

203 days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360j(g)) involving this device became 

effective: February 10, 2014. The 

applicant claims that the investigational 

device exemption (IDE) required under 

section 520(g) of the FD&C Act for 

human tests to begin became effective 

on April 3, 2014. However, FDA records 

indicate that the IDE was determined 

substantially complete for clinical 

studies to have begun on February 10, 

2014, which represents the IDE effective 

date. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): September 17, 

2015. FDA has verified the applicant’s 

claim that the premarket approval 

application (PMA) for MICRA 

TRANSCATHETER PACING SYSTEM 

(PMA P150033) was initially submitted 

September 17, 2015. 

3. The date the application was 

approved: April 6, 2016. FDA has 

verified the applicant’s claim that PMA 

P150033 was approved on April 6, 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 applications for patent extension, 

this applicant seeks 457 days and 494 

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 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00355 Filed 1–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6826] 

Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice, establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Anesthetic and Analgesic 

Drug Products Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

FDA on regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

February 14, 2018, from 1:30 p.m. to 5 

p.m., and February 15, 2018, from 8 a.m. 

to 5 p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Avenue, Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

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/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–6826. 

The docket will close on February 13, 

2018. Submit either electronic or 

written comments on this public 

meeting by February 13, 2018. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before February 13, 2018. The https://

www.regulations.gov electronic filing 


srobinson on DSK9F5VC42PROD with NOTICES
1372 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 

system will accept comments until 

midnight Eastern Time at the end of 

February 13, 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. 

Comments received on or before 

January 31, 2018, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by FDA. 

You may submit comments as 

follows: 

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– 

2017–N–6826 for ‘‘Anesthetic and 

Analgesic Drug Products Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ 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.’’ FDA 

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 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 the 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: 

Moon Hee V. Choi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

AADPAC@fda.hhs.gov, 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 

FDA’s website at https://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: The committee will discuss 

supplemental new drug application 

(sNDA) 022496/S–009, for EXPAREL 

(bupivacaine liposomal injectable 

suspension), submitted by Pacira 

Pharmaceuticals, Inc., to produce local 

analgesia and as a nerve block to 

produce regional analgesia. 

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 website 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 website 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: 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 January 31, 2018. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. on February 15, 2018. 

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 January 23, 2018. 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 


srobinson on DSK9F5VC42PROD with NOTICES
Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1373 

regarding their request to speak by 

January 24, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

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 Moon Hee V. 

Choi at least 7 days in advance of the 

meeting (See FOR FURTHER INFORMATION

CONTACT). 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

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: January 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00359 Filed 1–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 on 

Aging Special Emphasis Panel; Revision 

Requests for ADCCs and ADRCs. 

Date: February 6, 2018. 

Time: 12:01 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, Suite 2W200, 7201 

Wisconsin Avenue, Bethesda, MD 20892. 

Contact Person: Maurizio Grimaldi, MD, 

Ph.D., Scientific Review Officer, National 

Institute on Aging, National Institutes of 

Health, 7201 Wisconsin Avenue, Room 

2C218, Bethesda, MD 20892, 301–496–9374, 

grimaldim2@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: January 8, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–00389 Filed 1–10–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; 

Undiagnosed Diseases Network Phase II. 

Date: January 30, 2018. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Wallace Ip, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5128, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1191, ipws@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Cell Biology 

Integrated Review Group; Development—2 

Study Section. 

Date: February 8–9, 2018. 

Time: 8:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda Downtown, 

7335 Wisconsin Avenue, Bethesda, MD 

20814. 

Contact Person: Rass M Shayiq, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2182, 

MSC 7818, Bethesda, MD 20892, (301) 435– 

2359, shayiqr@csr.nih.gov. 

Name of Committee: Healthcare Delivery 

and Methodologies Integrated Review Group; 

Community-Level Health Promotion Study 

Section. 

Date: February 12–13, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Nikko San Francisco, 222 

Mason Street, San Francisco, CA 94102. 

Contact Person: Ping Wu, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 3166, Bethesda, MD 20892, 301– 

451–8428, wup4@csr.nih.gov. 

Name of Committee: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group; 

Musculoskeletal Tissue Engineering Study 

Section. 

Date: February 12–13, 2018. 

Time: 8:00 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Virginian Suites, 1500 Arlington 

Boulevard, Arlington, VA 22209. 

Contact Person: Baljit S Moonga, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1777, moongabs@mail.nih.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

Addiction Risks and Mechanisms Study 

Section. 

Date: February 12–13, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Dupont Hotel, 1500 New 

Hampshire Avenue NW, Washington, DC 

20036. 

Contact Person: Kristen Prentice, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3112, 

MSC 7808, Bethesda, MD 20892, (301) 496– 

0726, prenticekj@mail.nih.gov. 

Name of Committee: Digestive, Kidney and 

Urological Systems Integrated Review Group; 

Pathobiology of Kidney Disease Study 

Section. 

Date: February 13–14, 2018. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Atul Sahai, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2188, 

MSC 7818, Bethesda, MD 20892, 301–435– 

1198, sahaia@csr.nih.gov. 

Name of Committee: Cell Biology 

Integrated Review Group; Molecular and 


srobinson on DSK9F5VC42PROD with NOTICES