82_FR_43563 82 FR 43385 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

82 FR 43385 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 178 (September 15, 2017)

Page Range43385-43386
FR Document2017-19607

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.

Federal Register, Volume 82 Issue 178 (Friday, September 15, 2017) 
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43385-43386]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19607]


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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.

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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.thefederalregister.org/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

[[Page 43386]]

reconsideration of an FDA action under Sec.  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
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         PMA No./Docket No.                 Applicant                 Trade name               Approval date
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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.
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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

Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43385 withdrawn for reasons of safety or effectiveness summaries of approved • Confidential Submissions—To effectiveness. We have carefully PMAs through the internet and the submit a comment with confidential reviewed our files for records Agency’s Dockets Management Staff. information that you do not wish to be concerning the withdrawal of ADDRESSES: You may submit comments made publicly available, submit your TIMOPTIC (timolol maleate ophthalmic as follows: comments only as a written/paper solution), 0.25 percent and 0.5 percent, submission. You should submit two from sale. We have also independently Electronic Submissions copies total. One copy will include the evaluated relevant literature and data Submit electronic comments in the information you claim to be confidential for possible postmarketing adverse following way: with a heading or cover note that states events. We have found no information • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS that would indicate that this drug https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The product was withdrawn from sale for instructions for submitting comments. Agency will review this copy, including reasons of safety or effectiveness. Comments submitted electronically, the claimed confidential information, in Accordingly, the Agency will including attachments, to https:// its consideration of comments. The continue to list TIMOPTIC (timolol www.regulations.gov will be posted to second copy, which will have the maleate ophthalmic solution), 0.25 the docket unchanged. Because your claimed confidential information percent and 0.5 percent, in the comment will be made public, you are redacted/blacked out, will be available ‘‘Discontinued Drug Product List’’ solely responsible for ensuring that your for public viewing and posted on section of the Orange Book. The comment does not include any https://www.regulations.gov. Submit ‘‘Discontinued Drug Product List’’ confidential information that you or a both copies to the Dockets Management delineates, among other items, drug Staff Office. If you do not wish your third party may not wish to be posted, products that have been discontinued name and contact information to be such as medical information, your or from marketing for reasons other than made publicly available, you can anyone else’s Social Security number, or safety or effectiveness. FDA will not provide this information on the cover confidential business information, such begin procedures to withdraw approval sheet and not in the body of your as a manufacturing process. Please note of approved ANDAs that refer to this comments and you must identify this that if you include your name, contact drug product. Additional ANDAs for information as ‘‘confidential.’’ Any information, or other information that this drug product may also be approved information marked as ‘‘confidential’’ identifies you in the body of your by the Agency as long as they meet all will not be disclosed except in comments, that information will be other legal and regulatory requirements accordance with 21 CFR 10.20 and other posted on https://www.regulations.gov. for the approval of ANDAs. If FDA • If you want to submit a comment applicable disclosure law. For more determines that labeling for this drug information about FDA’s posting of with confidential information that you product should be revised to meet comments to public dockets, see 80 FR do not wish to be made available to the current standards, the Agency will 56469, September 18, 2015, or access public, submit the comment as a advise ANDA applicants to submit such the information at: https://www.gpo.gov/ written/paper submission and in the labeling. fdsys/pkg/FR-2015-09-18/pdf/2015- manner detailed (see ‘‘Written/Paper Dated: September 11, 2017. Submissions’’ and ‘‘Instructions’’). 23389.pdf. Anna K. Abram, Docket: For access to the docket to Deputy Commissioner for Policy, Planning, Written/Paper Submissions read background documents or the Legislation, and Analysis. Submit written/paper submissions as electronic and written/paper comments [FR Doc. 2017–19610 Filed 9–14–17; 8:45 am] follows: received, go to https:// BILLING CODE 4164–01–P • Mail/Hand delivery/Courier (for www.regulations.gov and insert the written/paper submissions): Dockets docket number, found in brackets in the Management Staff (HFA–305), Food and heading of this document, into the DEPARTMENT OF HEALTH AND Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts HUMAN SERVICES Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management • For written/paper comments Staff office, 5630 Fishers Lane, Rm. Food and Drug Administration submitted to the Dockets Management 1061, Rockville, MD 20852. [Docket Nos. FDA–2016–M–4529 and FDA– Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT: 2017–M–3899] well as any attachments, except for Jonathan McKnight, Center for Biologics information submitted, marked and Evaluation and Research, Food and Medical Devices Regulated by the identified, as confidential, if submitted Drug Administration, 10903 New Center for Biologics Evaluation and as detailed in ‘‘Instructions.’’ Hampshire Ave., Bldg. 71, Rm. 7301, Research; Availability of Safety and Instructions: All submissions received Silver Spring, MD 20993–0002, 240– Effectiveness Summaries for must include the Docket Nos. FDA– 402–7911. Premarket Approval Applications 2016–M–4529 and FDA–2017–M–3899 SUPPLEMENTARY INFORMATION: AGENCY: Food and Drug Administration, for ‘‘Medical Devices Regulated by the Center for Biologics Evaluation and I. Background HHS. ACTION: Notice. Research; Availability of Safety and In accordance with sections 515(d)(4) Effectiveness Summaries for Premarket and (e)(2) of the Federal Food, Drug, and SUMMARY: The Food and Drug Approval Applications.’’ Received Cosmetic Act (the FD&C Act) (21 U.S.C. mstockstill on DSK30JT082PROD with NOTICES Administration (FDA or Agency) is comments will be placed in the docket 360e(d)(4) and (e)(2)), notification of an publishing a list of premarket approval and, except for those submitted as order approving, denying, or applications (PMAs) that have been ‘‘Confidential Submissions,’’ publicly withdrawing approval of a PMA will approved by the Center for Biologics viewable at https://www.regulations.gov continue to include a notice of Evaluation and Research (CBER). This or at the Dockets Management Staff opportunity to request review of the list is intended to inform the public of Office between 9 a.m. and 4 p.m., order under section 515(g) of the FD&C the availability of safety and Monday through Friday. Act. The 30-day period for requesting VerDate Sep<11>2014 18:16 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1

43386 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices reconsideration of an FDA action under applicant; in these cases, the 30-day following is a list of PMAs approved by § 10.33(b) (21 CFR 10.33(b)) for notices period will begin when the applicant is CBER for which safety and effectiveness announcing approval of a PMA begins notified by FDA in writing of its summaries were placed on the internet on the day the notice is placed on the decision. from October 1, 2016, through June 30, internet. Section 10.33(b) provides that The regulations (21 CFR 814.44(d) 2017. There were no denial actions FDA may, for good cause, extend this and 814.45(d)) provide that FDA during this period. The list provides the 30-day period. Reconsideration of a publish a quarterly list of available manufacturer’s name, the product’s denial or withdrawal of approval of a safety and effectiveness summaries of generic name or the trade name, and the PMA may be sought only by the PMA approvals and denials that were approval date. announced during that quarter. The 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 replaces a previously issued final Written/Paper Submissions Persons with access to the internet guidance entitled ‘‘Establishing the Submit written/paper submissions as may obtain the documents at https:// Performance Characteristics of In Vitro follows: www.fda.gov/BiologicsBloodVaccines/ Diagnostic Devices for the Detection, or • Mail/Hand delivery/Courier (for BloodBloodProducts/ Detection and Differentiation of Human written/paper submissions): Dockets ApprovedProducts/ Papillomaviruses,’’ dated November 28, Management Staff (HFA–305), Food and PremarketApprovalsPMAs/default.htm. 2011. Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: September 11, 2017. DATES: The announcement of the • For written/paper comments Anna K. Abram, guidance is published in the Federal submitted to the Dockets Management Deputy Commissioner for Policy, Planning, Register on September 15, 2017. Staff, FDA will post your comment, as Legislation, and Analysis. well as any attachments, except for ADDRESSES: You may submit either [FR Doc. 2017–19607 Filed 9–14–17; 8:45 am] written or electronic comments on information submitted, marked and BILLING CODE 4164–01–P Agency guidances at any time as identified, as confidential, if submitted follows: as detailed in ‘‘Instructions.’’ Instructions: All submissions received DEPARTMENT OF HEALTH AND Electronic Submissions must include the Docket No. FDA– HUMAN SERVICES 2009–D–0386 for ‘‘Establishing the Submit electronic comments in the Performance Characteristics of In Vitro Food and Drug Administration following way: Diagnostic Devices for the Detection or [Docket No. FDA–2009–D–0386] • Federal eRulemaking Portal: Detection and Differentiation of Human https://www.regulations.gov. Follow the Papillomaviruses.’’ Received comments Establishing the Performance instructions for submitting comments. will be placed in the docket and, except Characteristics of In Vitro Diagnostic Comments submitted electronically, for those submitted as ‘‘Confidential Devices for the Detection or Detection including attachments, to https:// Submissions,’’ publicly viewable at and Differentiation of Human www.regulations.gov will be posted to https://www.regulations.gov or at the Papillomaviruses; Guidance for the docket unchanged. Because your Dockets Management Staff between 9 Industry and Food and Drug comment will be made public, you are a.m. and 4 p.m., Monday through Administration Staff; Availability solely responsible for ensuring that your Friday. comment does not include any • Confidential Submissions—To AGENCY: Food and Drug Administration, confidential information that you or a submit a comment with confidential HHS. information that you do not wish to be third party may not wish to be posted, ACTION: Notice of availability. such as medical information, your or made publicly available, submit your anyone else’s Social Security number, or comments only as a written/paper SUMMARY: The Food and Drug submission. You should submit two Administration (FDA or Agency) is confidential business information, such copies total. One copy will include the announcing the availability of the as a manufacturing process. Please note information you claim to be confidential guidance entitled ‘‘Establishing the that if you include your name, contact with a heading or cover note that states Performance Characteristics of In Vitro information, or other information that ‘‘THIS DOCUMENT CONTAINS Diagnostic Devices for the Detection or identifies you in the body of your CONFIDENTIAL INFORMATION.’’ The Detection and Differentiation of Human comments, that information will be Agency will review this copy, including Papillomaviruses.’’ This guidance posted on https://www.regulations.gov. the claimed confidential information, in mstockstill on DSK30JT082PROD with NOTICES provides recommendations to facilitate • If you want to submit a comment its consideration of comments. The study designs to establish the with confidential information that you second copy, which will have the performance characteristics of in vitro do not wish to be made available to the claimed confidential information diagnostic devices (IVDs) intended for public, submit the comment as a redacted/blacked out, will be available the detection, or detection and written/paper submission and in the for public viewing and posted on differentiation, of human manner detailed (see ‘‘Written/Paper https://www.regulations.gov. Submit papillomaviruses (HPVs). This guidance Submissions’’ and ‘‘Instructions’’). both copies to the Dockets Management VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1


Document Created: 2017-09-15 00:18:53
Document Modified: 2017-09-15 00:18:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactJonathan 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.
FR Citation82 FR 43385 
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