81 FR 81782 - 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 81, Issue 223 (November 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81782-81783 | |
| FR Document | 2016-27769 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81782-81783] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://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
![81782 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
NDA 050624 ....... ROCEPHIN W/DEX- Ceftriaxone Sodium ......... EQ 10 mg Base/mL; EQ 20 Injectable; Injection .......... Hoffmann-La Roche, Inc.
TROSE IN PLASTIC mg Base/mL; EQ 40 mg
CONTAINER. Base/mL.
NDA 050739 ....... OMNICEF ......................... Cefdinir ............................. 300 mg .................................. Capsule; Oral ................... AbbVie Inc.
NDA 050749 ....... OMNICEF ......................... Cefdinir ............................. 125 mg/5 mL; 250 mg/5 mL For Suspension; Oral ....... AbbVie Inc.
ANDA 060003 ..... V–CILLIN K ...................... Penicillin V Potassium ..... EQ 125 mg Base; EQ 250 Tablet; Oral ...................... Eli Lilly and Company.
mg Base; EQ 500 mg
Base.
ANDA 060463 ..... GARAMYCIN ................... Gentamicin Sulfate ........... EQ 0.1% Base ...................... Ointment; Topical ............. Schering-Plough Corp.
ANDA 086833 ..... CYPROHEPTADINE HY- Cyproheptadine HCl ......... 2 mg/5mL .............................. Syrup; Oral ....................... Actavis Mid Atlantic LLC.
DROCHLORIDE.
ANDA 088877 ..... BENZTROPINE Benztropine Mesylate ...... 0.5 mg ................................... Tablet; Oral ...................... Lannett Holdings, Inc.
MESYLATE.
ANDA 088894 ..... BENZTROPINE Benztropine Mesylate ...... 1 mg ...................................... Tablet; Oral ...................... Lannett Holdings, Inc.
MESYLATE.
ANDA 088895 ..... BENZTROPINE Benztropine Mesylate ...... 2 mg ...................................... Tablet; Oral ...................... Lannett Holdings, Inc.
MESYLATE.
FDA has reviewed its records and, DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
under § 314.161, has determined that HUMAN SERVICES confidential business information, such
the drug products listed in this as a manufacturing process. Please note
document were not withdrawn from Food and Drug Administration that if you include your name, contact
sale for reasons of safety or [Docket Nos. FDA–2015–M–3249, FDA– information, or other information that
effectiveness. Accordingly, the Agency 2015–M–3251, FDA–2015–M–3253, FDA– identifies you in the body of your
will continue to list the drug products 2015–M–4130, FDA 2015–M–3254, FDA– comments, that information will be
listed in this document in the 2016–M–2210, FDA–2014–M–0740, FDA– posted on http://www.regulations.gov.
‘‘Discontinued Drug Product List’’
2016–M–1072, FDA–2014–M–2304, FDA– • If you want to submit a comment
2014–M–2305, FDA–2015–M–2100, FDA– with confidential information that you
section of the Orange Book. The 2015–M–3255, FDA–2015–M–4981] do not wish to be made available to the
‘‘Discontinued Drug Product List’’
Medical Devices Regulated by the public submit the comment as a written/
identifies, among other items, drug
Center for Biologics Evaluation and paper submission and in the manner
products that have been discontinued
Research; Availability of Safety and detailed (see ‘‘Written/Paper
from marketing for reasons other than Submissions’’ and ‘‘Instructions’’).
safety or effectiveness. Effectiveness Summaries for
Premarket Approval Applications Written/Paper Submissions
Approved ANDAs that refer to the
NDAs and ANDAs listed in this AGENCY: Food and Drug Administration, Submit written/paper submissions as
document are unaffected by the HHS. follows:
discontinued marketing of the products ACTION: Notice. • Mail/Hand delivery/Courier (for
subject to those NDAs and ANDAs. written/paper submissions): Division of
SUMMARY: The Food and Drug Dockets Management (HFA–305), Food
Additional ANDAs that refer to these
Administration (FDA) is publishing a and Drug Administration, 5630 Fishers
products may also be approved by the
list of premarket approval applications Lane, Rm. 1061, Rockville, MD 20852.
Agency if they comply with relevant (PMAs) that have been approved by the • For written/paper comments
legal and regulatory requirements. If Center for Biologics Evaluation and submitted to the Division of Dockets
FDA determines that labeling for these Research (CBER). This list is intended to Management, FDA will post your
drug products should be revised to meet inform the public of the availability of comment, as well as any attachments,
current standards, the Agency will safety and effectiveness summaries of except for information submitted,
advise ANDA applicants to submit such approved PMAs through the Internet marked and identified, as confidential,
labeling. and the Agency’s Division of Dockets if submitted as detailed in
Dated: November 14, 2016. Management. ‘‘Instructions.’’
Leslie Kux, ADDRESSES: You may submit comments Instructions: All submissions received
as follows: must include the Docket Nos. FDA–
Associate Commissioner for Policy.
2015–M–3249, FDA–2015–M–3251,
[FR Doc. 2016–27855 Filed 11–17–16; 8:45 am] Electronic Submissions FDA–2015–M–3253, FDA–2015–M–
BILLING CODE 4164–01–P Submit electronic comments in the 4130, 2015–M–3254, FDA–2016–M–
following way: 2210, FDA–2014–M–0740, FDA–2016–
• Federal eRulemaking Portal: http:// M–1072, FDA–2014–M–2304, FDA–
www.regulations.gov. Follow the 2014–M–2305, FDA–2015–M–2100,
instructions for submitting comments. FDA–2015–M–3255, FDA–2015–M–
Comments submitted electronically, 4981 for ‘‘Medical Devices Regulated by
including attachments, to http:// the Center for Biologics Evaluation and
www.regulations.gov will be posted to Research; Availability of Safety and
mstockstill on DSK3G9T082PROD with NOTICES
the docket unchanged. Because your Effectiveness Summaries for Premarket
comment will be made public, you are Approval Applications.’’ Received
solely responsible for ensuring that your comments will be placed in the docket
comment does not include any and, except for those submitted as
confidential information that you or a ‘‘Confidential Submissions,’’ publicly
third party may not wish to be posted, viewable at http://www.regulations.gov
such as medical information, your or or at the Division of Dockets
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![Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 81783
Management between 9 a.m. and 4 p.m., information about FDA’s posting of continue to include a notice of
Monday through Friday. comments to public dockets, see 80 FR opportunity to request review of the
• Confidential Submissions—To 56469, September 18, 2015, or access order under section 515(g) of the FD&C
submit a comment with confidential the information at: http://www.fda.gov/ Act. The 30-day period for requesting
information that you do not wish to be regulatoryinformation/dockets/ reconsideration of an FDA action under
made publicly available submit your default.htm. § 10.33(b) (21 CFR 10.33(b)) for notices
comments only as a written/paper Docket: For access to the docket to announcing approval of a PMA begins
submission. You should submit two read background documents or the on the day the notice is placed on the
copies total. One copy will include the electronic and written/paper comments Internet. Section 10.33(b) provides that
information you claim to be confidential received, go to http:// FDA may, for good cause, extend this
with a heading or cover note that states www.regulations.gov and insert the 30-day period. Reconsideration of a
‘‘THIS DOCUMENT CONTAINS docket number, found in brackets in the denial or withdrawal of approval of a
CONFIDENTIAL INFORMATION.’’ The heading of this document, into the PMA may be sought only by the
Agency will review this copy, including ‘‘Search’’ box and follow the prompts
applicant; in these cases, the 30-day
the claimed confidential information, in and/or go to the Division of Dockets
period will begin when the applicant is
its consideration of comments. The Management, 5630 Fishers Lane, rm.
notified by FDA in writing of its
second copy, which will have the 1061, Rockville, MD 20852.
decision.
claimed confidential information FOR FURTHER INFORMATION CONTACT:
redacted/blacked out, will be available Jonathan McKnight, Center for Biologics The regulations (21 CFR 814.44(d)
for public viewing and posted on http:// Evaluation and Research, Food and and 814.45(d)) provide that FDA
www.regulations.gov. Submit both Drug Administration, 10903 New publish a quarterly list of available
copies to the Division of Dockets Hampshire Ave., Bldg. 71, Rm. 7301, safety and effectiveness summaries of
Management. If you do not wish your Silver Spring, MD 20993–0002, 240– PMA approvals and denials that were
name and contact information to be 402–7911. announced during that quarter. The
made publicly available, you can SUPPLEMENTARY INFORMATION: following is a list of PMAs approved by
provide this information on the cover CBER for which safety and effectiveness
sheet and not in the body of your I. Background summaries were placed on the Internet
comments and you must identify this In accordance with sections 515(d)(4) from October 1, 2010, through
information as ‘‘confidential.’’ Any and (e)(2) of the Federal Food, Drug, and September 30, 2016. There were no
information marked as ‘‘confidential’’ Cosmetic Act (the FD&C Act) (21 U.S.C. denial actions during this period. The
will not be disclosed except in 360e(d)(4) and (e)(2)), notification of an list provides the manufacturer’s name,
accordance with 21 CFR 10.20 and other order approving, denying, or the product’s generic name or the trade
applicable disclosure law. For more withdrawing approval of a PMA will 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 Laboratories Inc .............................. INSTI HIV–1 Antibody Test Kit ....................... November 29, 2010.
BP100064, FDA–2015–M–3251 ...................... Bio-Rad Laboratories, Inc ............................... GS HIV Combo Ag/Ab EIA ............................. July 22, 2011.
BP120001, FDA–2015–M–3253 ...................... OraSure Technologies, Inc ............................. OraQuick® In-Home HIV Test ......................... July 3, 2012.
BP120032, FDA–2015–M–4130 ...................... Chembio Diagnostic Systems, Inc .................. DPP HIV 1⁄2 Assay .......................................... December 12, 2012.
BP120037, FDA–2015–M–3254 ...................... Alere Scarborough, Inc ................................... Alere DetermineTM HIV–1/2 Ag/Ab Combo .... August 9, 2013.
BH110018, FDA–2016–M–2210 ...................... Miltenyi Biotec, Inc .......................................... CliniMACs CD34 Reagent System ................. January 23, 2014.
BP130026, FDA–2014–M–0740 ...................... BioArray Solutions, Ltd .................................... Immucor PreciseTypeTM Human Erythrocyte May 21, 2014.
Antigen Molecular BeadChip Test.
BP140120, FDA–2016–M–1072 ...................... Bio-Rad Laboratories, Inc ............................... Bio-Rad Geenius HIV 1⁄2 Supplemental Assay October 24, 2014.
BP130076, FDA–2014–M–2304 ...................... Cerus Corporation ........................................... INTERCEPT® Blood System for Plasma ........ December 16, 2014.
BP140143, FDA–2014–M–2305 ...................... Cerus Corporation ........................................... INTERCEPT® Blood System for Platelets ...... December 18, 2014.
BP140103, FDA–2015–M–2100 ...................... Siemens Healthcare Diagnostics, Inc ............. ADVIA Centaur HIV Ag/Ab Combo (CHIV) June 8, 2015.
Assay.
BP140111, FDA–2015–M–3255 ...................... Bio-Rad Laboratories, Inc ............................... BioPlex® 2200 HIV Ag-Ab ............................... July 22, 2015.
BP150262, FDA–2015–M–4981 ...................... Roche Molecular Systems, Inc ....................... Cobas HIV–1 ................................................... December 18, 2015.
II. Electronic Access DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
HUMAN SERVICES Administration (FDA) is announcing the
Persons with access to the Internet availability of the guidance entitled
may obtain the documents at http:// Food and Drug Administration ‘‘Submission of Premarket Notifications
www.fda.gov/BiologicsBloodVaccines/ for Magnetic Resonance Diagnostic
BloodBloodProducts/Approved [Docket No. FDA–2015–D–2148] Devices.’’ This guidance provides a
Products/PremarketApprovalsPMAs/ detailed description of the information
default.htm. Submission of Premarket Notifications
for Magnetic Resonance Diagnostic that should be included in a premarket
mstockstill on DSK3G9T082PROD with NOTICES
Dated: November 14, 2016. Devices; Guidance for Industry and notification for a magnetic resonance
Leslie Kux, Food and Drug Administration Staff; diagnostic device (MRDD).
Associate Commissioner for Policy. Availability DATES: Submit either electronic or
[FR Doc. 2016–27769 Filed 11–17–16; 8:45 am]
AGENCY: Food and Drug Administration, written comments on this guidance at
BILLING CODE 4164–01–P HHS. any time. General comments on Agency
guidance documents are welcome at any
ACTION: Notice of availability.
time.
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Document Created: 2018-02-14 08:32:02
Document Modified: 2018-02-14 08:32:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 81 FR 81782 |
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