Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 8333-8334 [2019-04114]

Download as PDF Federal Register / Vol. 84, No. 45 / Thursday, March 7, 2019 / Notices Amendment of the Constitution of the United States providing for women’s suffrage.’’ The duties of the Commission, as written in the law, include: (1) To encourage, plan, develop, and execute programs, projects, and activities to commemorate the centennial of the passage and ratification of the 19th Amendment; (2) To encourage private organizations and State and local Governments to organize and participate in activities commemorating the centennial of the passage and ratification of the 19th Amendment; (3) To facilitate and coordinate activities throughout the United States relating to the centennial of the passage and ratification of the 19th Amendment; (4) To serve as a clearinghouse for the collection and dissemination of information about events and plans for the centennial of the passage and ratification of the 19th Amendment; and (5) To develop recommendations for Congress and the President for commemorating the centennial of the passage and ratification of the 19th Amendment. amozie on DSK9F9SC42PROD with NOTICES Meeting Agenda for March 27, 2019 • Welcome and Introductions • Executive Director update • Subcommittee updates • Public Comment Period • Adjourn Meeting Agenda for June 3, 2019 • Welcome and Introductions • Commission business and administrative items • Executive Director update • Presentations from informative speakers • Subcommittee updates • Public Comment Period • 2019 Meeting Schedule • Adjourn The meetings are open to the public, but preregistration is required. 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Members of the public may also choose to submit written comments by mailing them to Kim Oliver, Designated Federal Officer, 1849 C Street NW, Room 7313, Washington, DC 20240, or via email at kmoliver@blm.gov. Please contact Ms. Oliver at the email address above to obtain meeting materials. All written comments received will be provided to the Commission. Detailed minutes of the meeting will be available for public inspection within 90 days of the meeting. Individuals requiring special accommodations to access the public meeting should contact Ms. Oliver at least five business days prior to each meeting, so that appropriate arrangements can be made. Public Disclosure of Comments Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Jeffrey A. Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Governmentwide Policy, General Services Administration. [FR Doc. 2019–04143 Filed 3–6–19; 8:45 am] BILLING CODE 3420–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2017–M–6870, FDA– 2018–M–3584, and FDA–2018–M–3870] 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. 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: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 8333 effectiveness summaries of approved PMAs through the internet and FDA’s Dockets Management Staff. ADDRESSES: You may submit either electronic or written comments 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. Since 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– 2017–M–6870, FDA–2018–M–3584, and FDA–2018–M–3870 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 between 9 E:\FR\FM\07MRN1.SGM 07MRN1 8334 Federal Register / Vol. 84, No. 45 / Thursday, March 7, 2019 / Notices 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. 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, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Gretchen Opper, 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 section 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 administrative 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, 2017, through December 31, 2018. 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, 2017, THROUGH DECEMBER 31, 2018 PMA No./Docket No. Applicant Trade name BP160122, FDA–2017–M– 6870. Ortho-Clinical Diagnostics, Inc ................. BP170122, FDA–2018–M– 3584. BP170154, FDA–2018–M– 3870. Avita Medical Americas, LLC ................... VITROS Immunodiagnostic Products HIV Combo Reagent Pack & VITROS Immunodiagnostic Products HIV Combo Calibrator. RECELL Autologous Cell Harvesting Device. ID CORE XT (Reagents and Analysis Software). Progenika Biopharma, S.A ....................... II. Electronic Access Persons with access to the internet may obtain the documents at https:// www.fda.gov/BiologicsBloodVaccines/ BloodBloodProducts/Approved Products/PremarketApprovalsPMAs/ default.htm. Dated: March 4, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. amozie on DSK9F9SC42PROD with NOTICES [FR Doc. 2019–04114 Filed 3–6–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database OMB No. 0915–0310—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the requirement for an opportunity for public comment on proposed data collection projects of the Paperwork SUMMARY: VerDate Sep<11>2014 17:13 Mar 06, 2019 Jkt 247001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Approval date December 13, 2017. September 20, 2018. October 11, 2018. Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Before submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than May 6, 2019. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft E:\FR\FM\07MRN1.SGM 07MRN1

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[Federal Register Volume 84, Number 45 (Thursday, March 7, 2019)]
[Notices]
[Pages 8333-8334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-M-6870, FDA-2018-M-3584, and FDA-2018-M-3870]


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 FDA's Dockets Management Staff.

ADDRESSES: You may submit either electronic or written comments 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. Since 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-2017-M-6870, FDA-2018-M-3584, and FDA-2018-M-3870 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 between 9

[[Page 8334]]

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. 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.

FOR FURTHER INFORMATION CONTACT: Gretchen Opper, 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 section 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 administrative 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, 2017, through December 31, 2018. 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, 2017,
                                            Through December 31, 2018
----------------------------------------------------------------------------------------------------------------
        PMA No./Docket No.                   Applicant                  Trade name              Approval date
----------------------------------------------------------------------------------------------------------------
BP160122, FDA-2017-M-6870.........  Ortho-Clinical              VITROS Immunodiagnostic     December 13, 2017.
                                     Diagnostics, Inc.           Products HIV Combo
                                                                 Reagent Pack & VITROS
                                                                 Immunodiagnostic Products
                                                                 HIV Combo Calibrator.
BP170122, FDA-2018-M-3584.........  Avita Medical Americas,     RECELL Autologous Cell      September 20, 2018.
                                     LLC.                        Harvesting Device.
BP170154, FDA-2018-M-3870.........  Progenika Biopharma, S.A..  ID CORE XT (Reagents and    October 11, 2018.
                                                                 Analysis Software).
----------------------------------------------------------------------------------------------------------------

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: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04114 Filed 3-6-19; 8:45 am]
 BILLING CODE 4164-01-P
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