83 FR 23686 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 99 (May 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 99 (May 22, 2018)
| Page Range | 23686-23688 | |
| FR Document | 2018-10924 |
[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)] [Notices] [Pages 23686-23688] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10924] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA- 2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA- 2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA- 2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA- 2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA- 2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA- 2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA- 2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA- 2017-M-6800, and FDA-2017-M-6896] Medical Devices; 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. 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: httpss://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-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and FDA-2017-M-6896 for ``Medical Devices; 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 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.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, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. [[Page 23687]] FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (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 provide that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the internet from July 1, 2017, through December 31, 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 July 1, 2017, Through December 31, 2017 ---------------------------------------------------------------------------------------------------------------- PMA No., Docket No. Applicant Trade name Approval date ---------------------------------------------------------------------------------------------------------------- P160015, FDA-2017-M-3372.............. Zoll Medical Corporation. AED Plus[supreg] and Fully 5/26/2017 Automatic AED Plus[supreg]. P970003/S207, FDA-2017-M-3951......... Cyberonics, Inc.......... VNS Therapy System........... 6/23/2017 P150048, FDA-2017-M-3990.............. Edwards Lifesciences, LLC Edwards Pericardial Aortic 6/29/2017 Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. P930016/S048, FDA-2017-M-4022......... AMO Manufacturing USA, STAR S4 IR Excimer Laser 6/30/2017 LLC. System and iDesign Advanced WaveScan Studio System. P130021/S033, FDA-2017-M-4271......... Medtronic CoreValve LLC.. Medtronic CoreValveTM System, 7/10/2017 Medtronic CoreValveTM EvolutTM R System and Medtronic CoreValveTM EvolutTM PRO Systems. P160049, FDA-2017-M-4498.............. Spectranetics Corp....... Stellarex 0.035'' OTW Drug- 7/26/2017 coated Angioplasty Balloon. P170006, FDA-2017-M-4756.............. Medtronic, Inc........... AvalusTM Bioprosthesis....... 7/31/2017 P170005, FDA-2017-M-4757.............. Abbott Molecular, Inc.... Abbott RealTime IDH2......... 8/1/2017 P160042, FDA-2017-M-4711.............. Prollenium Medical Ravanesse Ultra.............. 8/4/2017 Technologies, Inc. P030017/S275, FDA-2017-M-4904......... Boston Scientific PrecisionTM Spinal Cord 8/11/2017 Neuromodulation Stimulator System, Precision Corporation. SpectraTM Spinal Cord Stimulator System, PrecisionTM NoviTM Spinal Cord Stimulator System, PrecisionTM MontageTM MRI Spinal Cord Stimulator System, PrecisionTM MontageTM Spinal Cord Stimulator System and Spectra WaveWriterTM Spinal Cord Stimulator System. P160054, FDA-2017-M-5320.............. Thoratec Corporation..... HeartMate 3TM Left 8/23/2017 Ventricular Assist System. P140015/S020, FDA-2017-M-5262......... Tandem Diabetes Care, Inc t:slim X2 Insulin Pump with 8/25/2017 Dexcom G5 Mobile CGM. P170003, FDA-2017-M-5334.............. Lutonix, Inc............. Lutonix[supreg] 035 Drug 8/25/2017 Coated Balloon PTA Catheter, Model 9010. P170007, FDA-2017-M-5438.............. Bioventus LLC............ DUROLANE[supreg]............. 8/29/2017 P150025/S003, FDA-2017-M-5813......... Dako North America, Inc.. PD-L1 IHC 28-8 pharmDx....... 9/15/2017 P150042, FDA-2017-M-5863.............. ZEUS Scientific, Inc..... ZEUS ELISA Parvovirus B19 IgM 9/19/2017 Test System. P150045, FDA-2017-M-5864.............. ZEUS Scientific, Inc..... ZEUS ELISA Parvovirus B19 IgG 9/19/2017 Test System. P170011, FDA-2017-M-5884.............. ABIOMED, Inc............. Impella RP[supreg] System.... 9/20/2017 P150013/S006, FDA-2017-M-5929......... Dako North America, Inc.. PD-L1 IHC 22C3 pharmDx....... 9/22/2017 P160030, FDA-2017-M-5969.............. Abbott Diabetes Care, Inc Freestyle Libre Flash Glucose 9/27/2017 Monitoring System. P100047/S090, FDA-2017-M-5968......... Medtronic, Inc........... HeartWareTM HVADTM System.... 9/27/2017 P100021/S063, FDA-2017-M-5997......... Medtronic Vascular....... Endurant II/Endurant IIs 9/29/2017 Stent Graft System. P160039, FDA-2017-M-6223.............. Respicardia, Inc......... remed[emacr][supreg] System.. 10/6/2017 P170002, FDA-2017-M-6232.............. Teoxane S.A.............. RHA[supreg] 2, RHA[supreg] 3 10/19/2017 and RHA[supreg] 4. P150028/S001, FDA-2017-M-6290......... NuMED, Inc............... Cheatham Platinum (CP) Stent 10/24/2017 System (Covered CP Stent, Model 427; Covered Mounted (CP) Stent, Model 428; CP Stent, Model 425; Mounted CP Stent, Model 426). H020002/S046, FDA-2017-M-6524......... Stryker Neurovascular.... Neuroform AtlasTM Stent 11/2/2017 System. P160057, FDA-2017-M-6525.............. OrthogenRx, Inc.......... TriVisc...................... 11/13/2017 P160043/S001, FDA-2017-M-6550......... Medtronic Vascular....... Resolute OnyxTM Zotarolimus- 11/16/2017 Eluting Coronary Stent System. P160055, FDA-2017-M-6614.............. RxSight, Inc............. Light Adjustable Lens (LAL) 11/22/2017 and Light Delivery Device (LDD). P170008, FDA-2017-M-6650.............. Medinol Ltd.............. EluNIR[supreg] Ridaforolimus 11/28/2017 Eluting Coronary Stent System. P170019, FDA-2017-M-6799.............. Foundation Medicine, Inc. FoundationOne CDx............ 11/30/2017 [[Page 23688]] P150031, FDA-2017-M-6800.............. Boston Scientific Vercise Deep Brain 12/8/2017 Corporation. Stimulation (DBS) System. P170012, FDA-2017-M-6896.............. Biom'Up SA............... HEMOBLASTTM Bellows.......... 12/15/2017 ---------------------------------------------------------------------------------------------------------------- II. Electronic Access Persons with access to the internet may obtain the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm. Dated: May 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10924 Filed 5-21-18; 8:45 am] BILLING CODE 4164-01-P
![23686 Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
voting members. The Agency’s (PMAs) that have been approved. This 5884, FDA–2017–M–5929, FDA–2017–
regulations (21 CFR 14.22(d)) authorize list is intended to inform the public of M–5969, FDA–2017–M–5968, FDA–
a committee charter to specify quorum the availability of safety and 2017–M–5997, FDA–2017–M–6223,
requirements. effectiveness summaries of approved FDA–2017–M–6232, FDA–2017–M–
If functioning as a medical device PMAs through the internet and the 6290, FDA–2017–M–6524, FDA–2017–
panel, a non-voting representative of Agency’s Dockets Management Staff. M–6525, FDA–2017–M–6550, FDA–
consumer interests and a non-voting ADDRESSES: You may submit comments 2017–M–6614, FDA–2017–M–6650,
representative of industry interests will as follows: FDA–2017–M–6799, FDA–2017–M–
be included in addition to the voting 6800, and FDA–2017–M–6896 for
members. Electronic Submissions
‘‘Medical Devices; Availability of Safety
Further information regarding the Submit electronic comments in the and Effectiveness Summaries for
most recent charter and other following way: Premarket Approval Applications.’’
information can be found at https:// • Federal eRulemaking Portal: Received comments will be placed in
www.fda.gov/AdvisoryCommittees/ httpss://www.regulations.gov. Follow the docket and, except for those
CommitteesMeetingMaterials/Blood the instructions for submitting submitted as ‘‘Confidential
VaccinesandOtherBiologics/ comments. Comments submitted Submissions,’’ publicly viewable at
BloodProductsAdvisoryCommittee/ electronically, including attachments, to https://www.regulations.gov or at the
ucm121602.htm or by contacting the https://www.regulations.gov will be Dockets Management Staff between 9
Designated Federal Officer (see FOR posted to the docket unchanged.
a.m. and 4 p.m., Monday through
FURTHER INFORMATION CONTACT). In light Because your comment will be made
Friday.
of the fact that no change has been made public, you are solely responsible for
to the committee name or description of ensuring that your comment does not • Confidential Submissions—To
duties, no amendment will be made to include any confidential information submit a comment with confidential
21 CFR 14.100. that you or a third party may not wish information that you do not wish to be
This document is issued under the to be posted, such as medical made publicly available, submit your
Federal Advisory Committee Act (5 information, your or anyone else’s comments only as a written/paper
U.S.C. app.). For general information Social Security number, or confidential submission. You should submit two
related to FDA advisory committees, business information, such as a copies total. One copy will include the
please visit us at https://www.fda.gov/ manufacturing process. Please note that information you claim to be confidential
AdvisoryCommittees/default.htm. if you include your name, contact with a heading or cover note that states
information, or other information that ‘‘THIS DOCUMENT CONTAINS
Dated: May 15, 2018.
identifies you in the body of your CONFIDENTIAL INFORMATION.’’ The
Leslie Kux, Agency will review this copy, including
comments, that information will be
Associate Commissioner for Policy. posted on https://www.regulations.gov. the claimed confidential information, in
[FR Doc. 2018–10848 Filed 5–21–18; 8:45 am] • If you want to submit a comment its consideration of comments. The
BILLING CODE 4164–01–P with confidential information that you second copy, which will have the
do not wish to be made available to the claimed confidential information
public, submit the comment as a redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND written/paper submission and in the for public viewing and posted on
HUMAN SERVICES manner detailed (see ‘‘Written/Paper https://www.regulations.gov. Submit
Submissions’’ and ‘‘Instructions’’). both copies to the Dockets Management
Food and Drug Administration
Written/Paper Submissions Staff. If you do not wish your name and
[Docket Nos. FDA–2017–M–3372, FDA– contact information to be made publicly
2017–M–3951, FDA–2017–M–3990, FDA– Submit written/paper submissions as available, you can provide this
2017–M–4022, FDA–2017–M–4271, FDA– follows: information on the cover sheet and not
2017–M–4498, FDA–2017–M–4756, FDA– • Mail/Hand delivery/Courier (for in the body of your comments and you
2017–M–4757, FDA–2017–M–4711, FDA– written/paper submissions): Dockets
2017–M–4904, FDA–2017–M–5320, FDA– must identify this information as
Management Staff (HFA–305), Food and ‘‘confidential.’’ Any information marked
2017–M–5262, FDA–2017–M–5334, FDA– Drug Administration, 5630 Fishers
2017–M–5438, FDA–2017–M–5813, FDA– as ‘‘confidential’’ will not be disclosed
Lane, Rm. 1061, Rockville, MD 20852. except in accordance with 21 CFR 10.20
2017–M–5863, FDA–2017–M–5864, FDA–
• For written/paper comments
2017–M–5884, FDA–2017–M–5929, FDA– and other applicable disclosure law. For
2017–M–5969, FDA–2017–M–5968, FDA– submitted to the Dockets Management
more information about FDA’s posting
2017–M–5997, FDA–2017–M–6223, FDA– Staff, FDA will post your comment, as
of comments to public dockets, see 80
2017–M–6232, FDA–2017–M–6290, FDA– well as any attachments, except for
FR 56469, September 18, 2015, or access
2017–M–6524, FDA–2017–M–6525, FDA– information submitted, marked and
the information at: https://www.gpo.gov/
2017–M–6550, FDA–2017–M–6614, FDA– identified, as confidential, if submitted
2017–M–6650, FDA–2017–M–6799, FDA– as detailed in ‘‘Instructions.’’ fdsys/pkg/FR-2015-09-18/pdf/2015-
2017–M–6800, and FDA–2017–M–6896] Instructions: All submissions received 23389.pdf.
must include the Docket Nos. FDA– Docket: For access to the docket to
Medical Devices; Availability of Safety 2017–M–3372, FDA–2017–M–3951, read background documents or the
and Effectiveness Summaries for FDA–2017–M–3990, FDA–2017–M– electronic and written/paper comments
Premarket Approval Applications 4022, FDA–2017–M–4271, FDA–2017– received, go to https://
amozie on DSK3GDR082PROD with NOTICES1
AGENCY: Food and Drug Administration, M–4498, FDA–2017–M–4756, FDA– www.regulations.gov and insert the
HHS. 2017–M–4757, FDA–2017–M–4711, docket number, found in brackets in the
ACTION: Notice. FDA–2017–M–4904, FDA–2017–M– heading of this document, into the
5320, FDA–2017–M–5262, FDA–2017– ‘‘Search’’ box and follow the prompts
SUMMARY: The Food and Drug M–5334, FDA–2017–M–5438, FDA– and/or go to the Dockets Management
Administration (FDA) is publishing a 2017–M–5813, FDA–2017–M–5863, Staff, 5630 Fishers Lane, Rm. 1061,
list of premarket approval applications FDA–2017–M–5864, FDA–2017–M– Rockville, MD 20852.
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![23688 Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2017, THROUGH DECEMBER 31, 2017—Continued
PMA No., Docket No. Applicant Trade name Approval date
P150031, FDA–2017–M–6800 Boston Scientific Corporation Vercise Deep Brain Stimulation (DBS) System ....................... 12/8/2017
P170012, FDA–2017–M–6896 Biom’Up SA ............................ HEMOBLASTTM Bellows ......................................................... 12/15/2017
II. Electronic Access be submitted on or before July 23, 2018. Instructions: All submissions received
Persons with access to the internet The https://www.regulations.gov must include the Docket No. FDA–
may obtain the documents at http:// electronic filing system will accept 2018–N–1820 for ‘‘Framework for
www.fda.gov/MedicalDevices/ comments until midnight Eastern Time Assessing pH-dependent Drug-Drug
ProductsandMedicalProcedures/ at the end of July 23, 2018. Comments Interactions; Establishment of Public
DeviceApprovalsandClearances/ received by mail/hand delivery/courier Docket; Request for Comments.’’
PMAApprovals/default.htm. (for written/paper submissions) will be Received comments, those filed in a
considered timely if they are timely manner (see ADDRESSES), will be
Dated: May 17, 2018.
postmarked or the delivery service placed in the docket and, except for
Leslie Kux, acceptance receipt is on or before that those submitted as ‘‘Confidential
Associate Commissioner for Policy. date. Submissions,’’ publicly viewable at
[FR Doc. 2018–10924 Filed 5–21–18; 8:45 am] https://www.regulations.gov or at the
Electronic Submissions
BILLING CODE 4164–01–P Dockets Management Staff between 9
Submit electronic comments in the a.m. and 4 p.m., Monday through
following way: Friday.
DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: • Confidential Submissions—To
HUMAN SERVICES https://www.regulations.gov. Follow the submit a comment with confidential
Food and Drug Administration instructions for submitting comments. information that you do not wish to be
Comments submitted electronically, made publicly available, submit your
[Docket No. FDA–2018–N–1820] including attachments, to https:// comments only as a written/paper
www.regulations.gov will be posted to submission. You should submit two
Framework for Assessing pH- the docket unchanged. Because your copies total. One copy will include the
Dependent Drug-Drug Interactions; comment will be made public, you are information you claim to be confidential
Establishment of a Public Docket; solely responsible for ensuring that your with a heading or cover note that states
Request for Comments comment does not include any ‘‘THIS DOCUMENT CONTAINS
AGENCY: Food and Drug Administration, confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
HHS. third party may not wish to be posted, Agency will review this copy, including
ACTION: Notice; establishment of a such as medical information, your or the claimed confidential information, in
public docket; request for comments. anyone else’s Social Security number, or its consideration of comments. The
confidential business information, such second copy, which will have the
SUMMARY: The Food and Drug as a manufacturing process. Please note claimed confidential information
Administration (FDA) is establishing a that if you include your name, contact redacted/blacked out, will be available
public docket to assist with the information, or other information that for public viewing and posted on
development of a policy or guidance identifies you in the body of your https://www.regulations.gov. Submit
document on the assessment of pH- comments, that information will be both copies to the Dockets Management
dependent drug-drug interactions posted on https://www.regulations.gov. Staff. If you do not wish your name and
(DDIs). In October 2017, FDA published • If you want to submit a comment contact information to be made publicly
two draft guidance documents on DDIs with confidential information that you available, you can provide this
entitled ‘‘In Vitro Metabolism- and do not wish to be made available to the information on the cover sheet and not
Transporter-Mediated Drug-Drug public, submit the comment as a in the body of your comments and you
Interaction Studies’’ (In Vitro Studies written/paper submission and in the must identify this information as
Draft Guidance) and ‘‘Clinical Drug manner detailed (see ‘‘Written/Paper ‘‘confidential.’’ Any information marked
Interaction Studies—Study Design, Data Submissions’’ and ‘‘Instructions’’). as ‘‘confidential’’ will not be disclosed
Analysis, and Clinical Implications’’ except in accordance with 21 CFR 10.20
(Clinical Drug Interaction Studies Draft Written/Paper Submissions
and other applicable disclosure law. For
Guidance). These two draft guidances Submit written/paper submissions as more information about FDA’s posting
focus on enzyme- and transporter-based follows: of comments to public dockets, see 80
DDIs and do not include a framework to • Mail/Hand delivery/Courier (for FR 56469, September 18, 2015, or access
assess pH-dependent DDIs. FDA is written/paper submissions): Dockets the information at: https://www.gpo.gov/
seeking public input on best practices in Management Staff (HFA–305), Food and fdsys/pkg/FR-2015-09-18/pdf/2015-
the planning and evaluation of pH- Drug Administration, 5630 Fishers 23389.pdf.
dependent DDIs. Lane, Rm. 1061, Rockville, MD 20852. Docket: For access to the docket to
amozie on DSK3GDR082PROD with NOTICES1
DATES: Submit either electronic or • For written/paper comments read background documents or the
written comments on this notice by July submitted to the Dockets Management electronic and written/paper comments
23, 2018. Staff, FDA will post your comment, as received, go to https://
ADDRESSES: You may submit comments well as any attachments, except for www.regulations.gov and insert the
as follows. Please note that late, information submitted, marked and docket number, found in brackets in the
untimely filed comments will not be identified, as confidential, if submitted heading of this document, into the
considered. Electronic comments must as detailed in ‘‘Instructions.’’ ‘‘Search’’ box and follow the prompts
VerDate Sep<11>2014 16:47 May 21, 2018 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\22MYN1.SGM 22MYN1](https://thefederalregister.org/doc/83_FR_23785/page/3.svg)
Document Created: 2018-11-02 11:10:16
Document Modified: 2018-11-02 11:10:16
| 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 | Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524. | |
| FR Citation | 83 FR 23686 |
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