Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 81782-81783 [2016-27769]

Download as PDF 81782 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 050624 ....... ROCEPHIN W/DEXTROSE IN PLASTIC CONTAINER. OMNICEF ......................... OMNICEF ......................... V–CILLIN K ...................... Ceftriaxone Sodium ......... Injectable; Injection .......... Hoffmann-La Roche, Inc. Capsule; Oral ................... For Suspension; Oral ....... Tablet; Oral ...................... AbbVie Inc. AbbVie Inc. Eli Lilly and Company. Gentamicin Sulfate ........... Cyproheptadine HCl ......... EQ 10 mg Base/mL; EQ 20 mg Base/mL; EQ 40 mg Base/mL. 300 mg .................................. 125 mg/5 mL; 250 mg/5 mL EQ 125 mg Base; EQ 250 mg Base; EQ 500 mg Base. EQ 0.1% Base ...................... 2 mg/5mL .............................. Ointment; Topical ............. Syrup; Oral ....................... Schering-Plough Corp. Actavis Mid Atlantic LLC. Benztropine Mesylate ...... 0.5 mg ................................... Tablet; Oral ...................... Lannett Holdings, Inc. Benztropine Mesylate ...... 1 mg ...................................... Tablet; Oral ...................... Lannett Holdings, Inc. Benztropine Mesylate ...... 2 mg ...................................... Tablet; Oral ...................... Lannett Holdings, Inc. NDA 050739 ....... NDA 050749 ....... ANDA 060003 ..... ANDA 060463 ..... ANDA 086833 ..... ANDA 088877 ..... ANDA 088894 ..... ANDA 088895 ..... GARAMYCIN ................... CYPROHEPTADINE HYDROCHLORIDE. BENZTROPINE MESYLATE. BENZTROPINE MESYLATE. BENZTROPINE MESYLATE. Cefdinir ............................. Cefdinir ............................. Penicillin V Potassium ..... FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–27855 Filed 11–17–16; 8:45 am] mstockstill on DSK3G9T082PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2015–M–3249, FDA– 2015–M–3251, FDA–2015–M–3253, FDA– 2015–M–4130, FDA 2015–M–3254, FDA– 2016–M–2210, FDA–2014–M–0740, FDA– 2016–M–1072, FDA–2014–M–2304, FDA– 2014–M–2305, FDA–2015–M–2100, FDA– 2015–M–3255, FDA–2015–M–4981] 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) 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 Division of Dockets Management. ADDRESSES: You may submit comments as follows: SUMMARY: 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Applicant 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2015–M–3249, FDA–2015–M–3251, FDA–2015–M–3253, FDA–2015–M– 4130, 2015–M–3254, FDA–2016–M– 2210, FDA–2014–M–0740, FDA–2016– M–1072, FDA–2014–M–2304, FDA– 2014–M–2305, FDA–2015–M–2100, FDA–2015–M–3255, FDA–2015–M– 4981 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 Division of Dockets E:\FR\FM\18NON1.SGM 18NON1 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices Management 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 Division of Dockets Management. 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 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 81783 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 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, 2010, through September 30, 2016. 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, 2010, THROUGH SEPTEMBER 30, 2016 PMA No., Docket No. Applicant Trade name Approval date INSTI HIV–1 Antibody Test Kit ....................... GS HIV Combo Ag/Ab EIA ............................. OraQuick® In-Home HIV Test ......................... DPP HIV 1⁄2 Assay .......................................... Alere DetermineTM HIV–1/2 Ag/Ab Combo .... CliniMACs CD34 Reagent System ................. Immucor PreciseTypeTM Human Erythrocyte Antigen Molecular BeadChip Test. Bio-Rad Geenius HIV 1⁄2 Supplemental Assay INTERCEPT® Blood System for Plasma ........ INTERCEPT® Blood System for Platelets ...... ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay. BioPlex® 2200 HIV Ag-Ab ............................... Cobas HIV–1 ................................................... November 29, 2010. July 22, 2011. July 3, 2012. December 12, 2012. August 9, 2013. January 23, 2014. May 21, 2014. BP090032, FDA–2015–M–3249 BP100064, FDA–2015–M–3251 BP120001, FDA–2015–M–3253 BP120032, FDA–2015–M–4130 BP120037, FDA–2015–M–3254 BH110018, FDA–2016–M–2210 BP130026, FDA–2014–M–0740 ...................... ...................... ...................... ...................... ...................... ...................... ...................... bioLytical Laboratories Inc .............................. Bio-Rad Laboratories, Inc ............................... OraSure Technologies, Inc ............................. Chembio Diagnostic Systems, Inc .................. Alere Scarborough, Inc ................................... Miltenyi Biotec, Inc .......................................... BioArray Solutions, Ltd .................................... BP140120, BP130076, BP140143, BP140103, ...................... ...................... ...................... ...................... Bio-Rad Laboratories, Inc ............................... Cerus Corporation ........................................... Cerus Corporation ........................................... Siemens Healthcare Diagnostics, Inc ............. BP140111, FDA–2015–M–3255 ...................... BP150262, FDA–2015–M–4981 ...................... Bio-Rad Laboratories, Inc ............................... Roche Molecular Systems, Inc ....................... FDA–2016–M–1072 FDA–2014–M–2304 FDA–2014–M–2305 FDA–2015–M–2100 II. Electronic Access mstockstill on DSK3G9T082PROD with NOTICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/BiologicsBloodVaccines/ BloodBloodProducts/Approved Products/PremarketApprovalsPMAs/ default.htm. Dated: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–27769 Filed 11–17–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–2148] Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: HHS. ACTION: VerDate Sep<11>2014 20:21 Nov 17, 2016 Food and Drug Administration, Jkt 241001 PO 00000 Notice of availability. Frm 00065 Fmt 4703 Sfmt 4703 October 24, 2014. December 16, 2014. December 18, 2014. June 8, 2015. July 22, 2015. December 18, 2015. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.’’ This guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). SUMMARY: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. DATES: E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81782-81783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27769]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-3249, FDA-2015-M-3251, FDA-2015-M-3253, FDA-
2015-M-4130, FDA 2015-M-3254, FDA-2016-M-2210, FDA-2014-M-0740, FDA-
2016-M-1072, FDA-2014-M-2304, FDA-2014-M-2305, FDA-2015-M-2100, FDA-
2015-M-3255, FDA-2015-M-4981]

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) 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 Division of Dockets Management.

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2015-M-3249, FDA-2015-M-3251, FDA-2015-M-3253, FDA-2015-M-4130,
2015-M-3254, FDA-2016-M-2210, FDA-2014-M-0740, FDA-2016-M-1072, FDA-
2014-M-2304, FDA-2014-M-2305, FDA-2015-M-2100, FDA-2015-M-3255, FDA-
2015-M-4981 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 Division of Dockets

[[Page 81783]]

Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 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 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, 2010, through September 30, 2016. 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, 2010,
Through September 30, 2016
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
BP090032, FDA-2015-M-3249.......... bioLytical INSTI HIV-1 Antibody November 29, 2010.
Laboratories Inc. Test Kit.
BP100064, FDA-2015-M-3251.......... Bio-Rad Laboratories, GS HIV Combo Ag/Ab EIA July 22, 2011.
Inc.
BP120001, FDA-2015-M-3253.......... OraSure Technologies, OraQuick[supreg] In- July 3, 2012.
Inc. Home HIV Test.
BP120032, FDA-2015-M-4130.......... Chembio Diagnostic DPP HIV \1/2\ Assay... December 12, 2012.
Systems, Inc.
BP120037, FDA-2015-M-3254.......... Alere Scarborough, Inc Alere DetermineTM HIV- August 9, 2013.
1/2 Ag/Ab Combo.
BH110018, FDA-2016-M-2210.......... Miltenyi Biotec, Inc.. CliniMACs CD34 Reagent January 23, 2014.
System.
BP130026, FDA-2014-M-0740.......... BioArray Solutions, Immucor PreciseTypeTM May 21, 2014.
Ltd. Human Erythrocyte
Antigen Molecular
BeadChip Test.
BP140120, FDA-2016-M-1072.......... Bio-Rad Laboratories, Bio-Rad Geenius HIV \1/ October 24, 2014.
Inc. 2\ Supplemental Assay.
BP130076, FDA-2014-M-2304.......... Cerus Corporation..... INTERCEPT[supreg] December 16, 2014.
Blood System for
Plasma.
BP140143, FDA-2014-M-2305.......... Cerus Corporation..... INTERCEPT[supreg] December 18, 2014.
Blood System for
Platelets.
BP140103, FDA-2015-M-2100.......... Siemens Healthcare ADVIA Centaur HIV Ag/ June 8, 2015.
Diagnostics, Inc. Ab Combo (CHIV) Assay.
BP140111, FDA-2015-M-3255.......... Bio-Rad Laboratories, BioPlex[supreg] 2200 July 22, 2015.
Inc. HIV Ag-Ab.
BP150262, FDA-2015-M-4981.......... Roche Molecular Cobas HIV-1........... December 18, 2015.
Systems, Inc.
----------------------------------------------------------------------------------------------------------------

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: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27769 Filed 11-17-16; 8:45 am]
BILLING CODE 4164-01-P

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