Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49027 

Dated: October 17, 2017. 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–22893 Filed 10–20–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Proposed Collection; Public 

Comment Request; Revision of a 

Currently Approved Information 

Collection (ICR-Rev) (OMB Approval 

Number 0985–0004); Maintenance of 

Effort for Title III and Extension of, and 

Minor Revisions Due to Statutory 

Language Changes to the Certification 

of Long-Term Care Ombudsman 

Program Expenditures 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: Under the PRA, Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

The Administration for Community 

Living (ACL) is announcing that the 

proposed collection of information 

listed above has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance as 

required under section 506(c)(2)(A) of 

the Paperwork Reduction Act of 1995 

(the PRA). This 30-Day notice requests 

comments on the information collection 

requirements related to the proposed 

revision of an existing data collection 

regarding the information collection 

requirements in the Maintenance of 

Effort collection form for all ACL/AoA 

Title III Grantees. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 22, 2017. 

ADDRESSES: Submit written comments 

on the collection of information: By fax 

at 202.395.5806 or by email to OIRA_

submission@omb.eop.gov, Attn: OMB 

Desk Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Jesse Moore at (202) 795–7578 or 

Jesse.Moore@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with Section 44 U.S.C. 

3507, ACL has submitted the following 

proposed collection of information to 

OMB for review and clearance. ACL is 

requesting approval for three years of an 

extension of the currently approved data 

collection with modifications. 

The Certification of Maintenance of 

Effort under Tittle III and Certification 

of Long-Term Care Ombudsman (LTCO) 

Program Expenditures provide 

statutorily required information 

regarding each state’s contribution to 

programs funded under the Older 

Americans Act and compliance with 

legislative requirements, pertinent 

Federal regulations, and other 

applicable instructions and guidelines 

issued by ACL. 

In addition to renewing OMB 

approval of these data collection 

instruments, minor changes are being 

proposed to the LTCO Expenditures 

Certification and an accompanying 

document which provides specific 

statutory references related to 

Ombudsman program minimum 

funding, non-supplanting requirements, 

and state authorization to expend Title 

III–B funds on Ombudsman activities. 

Specifically, changes include making 

the reference to the Fiscal Year at the 

bottom of the form a fillable field to 

allow the date to be changed annually; 

listing the ‘‘Administration for 

Community Living (ACL)’’ as the 

intended recipient of the completed 

form; and updating statutory language 

references, i.e., Section 306(a)(9), which 

is provided on the second page, to 

reflect changes made during the 2016 

reauthorization of the OAA. 

Comments in Response to the 60-Day 

Federal Register Notice 

A 60-Day notice was published in the 

Federal Register in Vol. 82, No. 137, on 

June 19, 2017. No comments were 

received. 

Annual Burden Estimates 

ACL estimates the burden of this 

collection of information as follows: 56 

State Agencies on Aging respond 

annually, and it takes each agency an 

average of one half (1⁄2) hour per State 

agency per year to complete each form 

for a total of twenty-eight hours for all 

state agencies annually. The half hour 

estimate is based on prior years’ 

experience with States in completing 

these forms. 

The proposed data collection tool may 

be found on the ACL Web site for 

review at: https://www.acl.gov/aboutacl/public-input. 

Respondent/data collection activity Number of 

respondents 

Responses per 

respondent 

Hours per response Annual burden 

hours 

Certification on Maintenance of Effort under Title III ...................................... 56 1/year ............. 1⁄2 28 

Certification of Long-Term Care Ombudsman Program Expenditures ........... 56 1/year ............. 1⁄2 28 

Total .......................................................................................................... 112 2 ..................... 1 56 

Dated: October 12, 2017. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–22914 Filed 10–20–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–E–2358 and FDA– 

2014–E–2359] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; MITRACLIP CDS 

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 MITRACLIP CDS 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 medical 

device. 

DATES: Anyone with knowledge that any 

of the dates as published (in the 


ethrower on DSK3G9T082PROD with NOTICES
49028 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by December 22, 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 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 December 22, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 22, 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 

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– 

2014–E–2358 and FDA–2014–E–2359 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; MITRACLIP CDS.’’ 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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

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 MITRACLIP CDS. 

MITRACLIP CDS is indicated for the 

percutaneous reduction of significant 

symptomatic mitral regurgitation (MR ≥ 

3+) due to primary abnormality of the 

mitral apparatus (degenerative MR) in 

patients who have been determined to 

be at prohibitive risk for mitral valve 

surgery by a heart team, which includes 

a cardiac surgeon experienced in mitral 

valve surgery and a cardiologist 

experienced in mitral valve disease, and 

in whom existing comorbidities would 

not preclude the expected benefit from 

reduction of the mitral regurgitation. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for MITRACLIP CDS (U.S. 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49029 

Patent No. 7,288,097 from Abbott 

Vascular Inc., and U.S. Patent No. 

7,464,712, from The Trustees of 

Columbia University in the City of New 

York), and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated November 2, 2015, FDA 

advised the USPTO that this medical 

device had undergone a regulatory 

review period and that the approval of 

MITRACLIP CDS 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 

MITRACLIP CDS is 3,846 days. Of this 

time, 2,515 days occurred during the 

testing phase of the regulatory review 

period, while 1,331 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 (the FD&C Act) (21 

U.S.C. 360j(g)) involving this device 

became effective: April 16, 2003. FDA 

has verified the applicants’ claims that 

the date the investigational device 

exemption required under section 

520(g) of the FD&C Act for human tests 

to begin became effective was April 16, 

2003. 

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): March 4, 2010. 

The applicants claim March 30, 2009, as 

the date the premarket approval 

application (PMA) for MITRACLIP CDS 

(PMA P100009) was initially submitted. 

However, FDA records indicate that the 

PMA submitted on March 30, 2009, was 

incomplete. The complete PMA was 

submitted on March 4, 2010, which is 

considered to be the PMA initially 

submitted date. 

3. The date the application was 

approved: October 24, 2013. FDA has 

verified the applicants’ claims that PMA 

P100009 was approved on October 24, 

2013. 

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 the applications for patent extension, 

the applicants seek 1,827 days or 1,721 

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: October 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22895 Filed 10–20–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–E–3529] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Inspire Upper Airway 

Stimulation 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 Inspire Upper Airway Stimulation 

System (Inspire UAS 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 22, 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 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 December 22, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 22, 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 

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: 


ethrower on DSK3G9T082PROD with NOTICES