Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2451 

1FDA acknowledges that many databases may not 

use the term ‘‘administrator’’ or may have a 

committee of individuals that oversee the database. 

Therefore, for the purpose of this guidance, a 

genetic variant database administrator is the entity 

or entities that oversee database operations. 

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 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00678 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–7012] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Use of Public 

Human Genetic Variant Databases To 

Support Clinical Validity for Genetic 

and Genomic-Based In Vitro 

Diagnostics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

16, 2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Use of Public Human Genetic 

Variant Databases to Support Clinical 

Validity for Genetic and Genomic-Based 

In Vitro Diagnostics.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Use of Public Human Genetic Variant 

Databases To Support Clinical Validity 

for Genetic and Genomic-Based In 

Vitro Diagnostics—OMB Control 

Number 0910—NEW 

This information collection supports 

the above captioned Agency guidance 

document. In the Federal Register of 

July 8, 2016 (81 FR 44611), FDA 

announced the availability of a draft 

guidance for industry entitled ‘‘Use of 

Public Human Genetic Variant 

Databases To Support Clinical Validity 

for Next Generation Sequencing (NGS)- 

Based In Vitro Diagnostics,’’ and 

included an analysis of the associated 

information collection. 

The draft guidance described FDA’s 

considerations in determining whether a 

genetic variant database is a source of 

valid scientific evidence that could 

support the clinical validity of an NGSbased test. This draft guidance further 

outlines the process by which 

administrators 1 of genetic variant 

databases could voluntarily apply to 

FDA for recognition, and how FDA 

would review such applications and 

periodically reevaluate recognized 

databases. The draft guidance also 

recommends that, at the time of 

recognition, the database administrator 

make information regarding policies, 

procedures, and conflicts of interest 

publicly available and accessible on the 

genetic variant database’s website. 

Based on our experience and the 

nature of the information, we estimate 

that it will take an average of 80 hours 

to complete and submit an application 

for recognition. We estimate that 

maintenance of recognition activities 

will take approximately one-fourth of 

that time (20 hours) annually. We 

estimate that it will take approximately 

1 hour to post the information on the 

website. 

Respondents are administrators of 

genetic databases. Our estimate of five 

respondents per year is based on the 

current number of databases that may 

meet FDA recommendations for 

recognition and seek such recognition. 

FDA received 36 comments on the 

draft guidance, none of which pertained 

to the information collection burden 

estimate. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Application for recognition of genetic database .................. 5 1 5 80 400 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Maintenance of recognition activities ................................... 5 1 5 20 100 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


ethrower on DSK3G9T082PROD with NOTICES
2452 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Public disclosure of policies, procedures, and conflicts of 

interest .............................................................................. 5 1 5 1 5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The draft guidance also refers to 

previously approved collections of 

information. These collections of 

information are subject to review by the 

OMB under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in the 

guidance document ‘‘Requests for 

Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ have been 

approved under OMB control number 

0910–0756. The collections of 

information regarding premarket 

submissions have been approved as 

follows: The collections of information 

in 21 CFR part 807, subpart E, have been 

approved under OMB control number 

0910–0120 and the collections of 

information in 21 CFR part 814, 

subparts A through E, have been 

approved under OMB control number 

0910–0231. 

Dated: January 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00685 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–E–2227] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SYNERGY EVEROLIMUS– 

ELUTING PLATINUM CHROMIUM 

CORONARY STENT 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 SYNERGY EVEROLIMUS–ELUTING 

PLATINUM CHROMIUM CORONARY 

STENT 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 March 19, 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 16, 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 19, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 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 No. FDA– 

2016–E–2227 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; SYNERGY 

EVEROLIMUS–ELUTING PLATINUM 

CHROMIUM CORONARY STENT 

SYSTEM.’’ 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 


ethrower on DSK3G9T082PROD with NOTICES