Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 43385-43386 [2017-19607]

Download as PDF Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices withdrawn for reasons of safety or effectiveness.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 We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.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. 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 Food and Drug Administration, HHS. mstockstill on DSK30JT082PROD with NOTICES ACTION: Notice. 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 SUMMARY: VerDate Sep<11>2014 18:16 Sep 14, 2017 Jkt 241001 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 [FR Doc. 2017–19610 Filed 9–14–17; 8:45 am] AGENCY: effectiveness summaries of approved PMAs through the internet and the Agency’s Dockets Management Staff. ADDRESSES: You may submit comments as follows: 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. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 43385 • 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/201523389.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 E:\FR\FM\15SEN1.SGM 15SEN1 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 Hologic, Inc ............................... Roche Diagnostics .................... BP150318, FDA–2016–M–4529 BP160050, FDA–2017–M–3899 Trade name Aptima HIV-1 Quant Assay .................... Elecsys HIV Combi-PT .......................... II. Electronic Access Persons with access to the internet may obtain the documents at https:// www.fda.gov/BiologicsBloodVaccines/ BloodBloodProducts/ ApprovedProducts/ PremarketApprovalsPMAs/default.htm. The announcement of the guidance is published in the Federal Register on September 15, 2017. DATES: Dated: September 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. You may submit either written or electronic comments on Agency guidances at any time as follows: ADDRESSES: [FR Doc. 2017–19607 Filed 9–14–17; 8:45 am] BILLING CODE 4164–01–P Electronic Submissions 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. 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 mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 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. 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’’). PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Approval date December 22, 2016. June 21, 2017. 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 E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43385-43386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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

[[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
----------------------------------------------------------------------------------------------------------------
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

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