Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43385 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

TIMOPTIC (timolol maleate ophthalmic 

solution), 0.25 percent and 0.5 percent, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list TIMOPTIC (timolol 

maleate ophthalmic solution), 0.25 

percent and 0.5 percent, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: September 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19610 Filed 9–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2016–M–4529 and FDA– 

2017–M–3899] 

Medical Devices Regulated by the 

Center for Biologics Evaluation and 

Research; Availability of Safety and 

Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

publishing a list of premarket approval 

applications (PMAs) that have been 

approved by the Center for Biologics 

Evaluation and Research (CBER). This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the internet and the 

Agency’s Dockets Management Staff. 

ADDRESSES: 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 Nos. FDA– 

2016–M–4529 and FDA–2017–M–3899 

for ‘‘Medical Devices Regulated by the 

Center for Biologics Evaluation and 

Research; Availability of Safety and 

Effectiveness Summaries for Premarket 

Approval Applications.’’ Received 

comments 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 

Office 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 Office. 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 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 office, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan McKnight, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with sections 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

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

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the FD&C 

Act. The 30-day period for requesting 

mstockstill on DSK30JT082PROD with NOTICES

43386 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations (21 CFR 814.44(d) 

and 814.45(d)) provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of PMAs approved by 

CBER for which safety and effectiveness 

summaries were placed on the internet 

from October 1, 2016, through June 30, 

2017. There were no denial actions 

during this period. The list provides the 

manufacturer’s name, the product’s 

generic name or the trade name, and the 

approval date. 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1, 

2016, THROUGH JUNE 30, 2017 

PMA No./Docket No. Applicant Trade name Approval date 

BP150318, FDA–2016–M–4529 Hologic, Inc ............................... Aptima HIV-1 Quant Assay .................... December 22, 2016. 

BP160050, FDA–2017–M–3899 Roche Diagnostics .................... Elecsys HIV Combi-PT .......................... June 21, 2017. 

II. Electronic Access 

Persons with access to the internet 

may obtain the documents at https://

www.fda.gov/BiologicsBloodVaccines/ 

BloodBloodProducts/ 

ApprovedProducts/ 

PremarketApprovalsPMAs/default.htm. 

Dated: September 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19607 Filed 9–14–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0386] 

Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection or Detection 

and Differentiation of Human 

Papillomaviruses; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the 

guidance entitled ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection or 

Detection and Differentiation of Human 

Papillomaviruses.’’ This guidance 

provides recommendations to facilitate 

study designs to establish the 

performance characteristics of in vitro 

diagnostic devices (IVDs) intended for 

the detection, or detection and 

differentiation, of human 

papillomaviruses (HPVs). This guidance 

replaces a previously issued final 

guidance entitled ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection, or 

Detection and Differentiation of Human 

Papillomaviruses,’’ dated November 28, 

2011. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 15, 2017. 

ADDRESSES: You may submit either 

written or electronic comments on 

Agency guidances at any time 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– 

2009–D–0386 for ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection or 

Detection and Differentiation of Human 

Papillomaviruses.’’ Received comments 

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 

mstockstill on DSK30JT082PROD with NOTICES