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

Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43387 

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 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. 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection or 

Detection and Differentiation of Human 

Papillomaviruses’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Natalia Comella, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4536, Silver Spring, 

MD 20993–0002, 301–796–6226, 

Natalia.Comella@fda.hhs.gov or Marina 

Kondratovich, Center for Devices and 

Radiological Health, Food and Drug 

Administration, New Hampshire Ave., 

Bldg. 66, Rm. 4672, Silver Spring, MD 

20993–0002, 301–796–6036, 

Marina.Kondratovich@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance provides 

recommendations to facilitate study 

designs to establish the performance 

characteristics of IVDs intended for the 

detection, or detection and 

differentiation, of high risk HPV 

genotypes. These devices are used either 

in conjunction with cervical cytology to 

aid in screening for cervical cancer or as 

first-line primary cervical cancer 

screening devices. This guidance 

provides recommendations for HPV 

devices that detect a group of HPV 

genotypes, particularly high risk HPVs, 

as well as devices that detect more than 

one genotype of HPV and further 

differentiate among them to indicate 

which genotypes of HPV are present. 

This guidance is expected to provide 

detailed information on the types of 

studies FDA recommends to support a 

premarket application for these devices. 

This guidance is limited to studies 

intended to establish the performance 

characteristics of in vitro diagnostic 

HPV devices that are used in 

conjunction with cervical cytology for 

cancer screening or as first-line primary 

cervical cancer screening devices. While 

this guidance specifically addresses 

devices that qualitatively detect HPV 

nucleic acid from cervical specimens, 

but many of the recommendations will 

also be applicable to devices that detect 

HPV proteins. This guidance provides 

FDA’s recommendations for three types 

of cervical cancer screening modalities, 

however, FDA does not make any 

assertions on which method of 

screening is preferred. This guidance 

does not address HPV testing from noncervical specimens such as pharyngeal, 

vaginal, penile, or anal specimens, or 

testing for susceptibility to HPV 

infection. It does not address 

quantitative or semi-quantitative assays 

for HPV. 

In the Federal Register of August 14, 

2015 (80 FR 48879), FDA announced the 

availability of the draft of this guidance 

and interested persons were invited to 

comment by November 12, 2015. FDA 

has considered all of the public 

comments received in finalizing this 

guidance. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the current 

thinking of FDA on ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection or 

Detection and Differentiation of Human 

Papillomaviruses.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection or Detection 

and Differentiation of Human 

Papillomaviruses’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1740 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 814 have been approved 

under OMB control number 0910–0231; 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

parts 801 and 809 have been approved 

under OMB control number 0910–0485; 

the collections of information in the 

guidance document entitled ‘‘Informed 

Consent For In Vitro Diagnostic Device 

Studies Using Leftover Human 

Specimens That Are Not Individually 

Identifiable’’ have been approved under 

OMB control number 0910–0582; and 

the collections of information in the 

guidance document entitled ‘‘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. 

Dated: September 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19612 Filed 9–14–17; 8:45 am] 

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