81 FR 64913 - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 183 (September 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 183 (September 21, 2016)
| Page Range | 64913-64914 | |
| FR Document | 2016-22711 |
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)] [Notices] [Pages 64913-64914] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22711] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2561] Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.'' This draft guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 21, 2016. 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 No. FDA-2016-D-2561 for ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.'' 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 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 [[Page 64914]] 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. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Alternatively, you may submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to the office that you are ordering from to assist in processing your request. FOR FURTHER INFORMATION CONTACT: Ribhi Shawar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4604, Silver Spring, MD 20993-0002, 301-796-6698; or Joseph Toerner, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301- 796-1400. SUPPLEMENTARY INFORMATION: I. Background This guidance, when finalized, is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and AST devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. Specifically, the guidance intends to describe the interactions between drug sponsors and device manufacturers for coordinated development of a new antimicrobial drug and an AST device; explain the considerations for submitting separate applications to the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) when seeking clearance of an AST device coincident with, or soon following, antimicrobial drug approval; and clarify that the review of the new antimicrobial drug product and AST device(s) will remain independent, and that coordinated development does not influence the review timelines for either product. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, and a search capability for all Center for Drug Evaluation and Research guidance documents is available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400061 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120, the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078, the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014, and the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information in the guidance document ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. Dated: September 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22711 Filed 9-20-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 64913
decision about whether to require a DEPARTMENT OF HEALTH AND • If you want to submit a comment
REMS: HUMAN SERVICES with confidential information that you
• The seriousness of any known or do not wish to be made available to the
potential adverse events that may be Food and Drug Administration public, submit the comment as a
related to the drug and the background [Docket No. FDA–2016–D–2561] written/paper submission and in the
incidence of such events in the manner detailed (see ‘‘Written/Paper
population likely to use the drug Coordinated Development of Submissions’’ and ‘‘Instructions’’).
Antimicrobial Drugs and Antimicrobial
• The expected benefit of the drug Written/Paper Submissions
Susceptibility Test Devices; Draft
with respect to the disease or condition Submit written/paper submissions as
Guidance for Industry and Food and
• The seriousness of the disease or Drug Administration Staff; Availability follows:
condition that is to be treated with the • Mail/Hand delivery/Courier (for
drug AGENCY: Food and Drug Administration, written/paper submissions): Division of
HHS. Dockets Management (HFA–305), Food
• Whether the drug is a new
ACTION: Notice of availability. and Drug Administration, 5630 Fishers
molecular entity
Lane, Rm. 1061, Rockville, MD 20852.
• The expected or actual duration of SUMMARY: The Food and Drug • For written/paper comments
treatment with the drug Administration (FDA or Agency) is submitted to the Division of Dockets
• The estimated size of the announcing the availability of a draft Management, FDA will post your
population likely to use the drug guidance entitled ‘‘Coordinated comment, as well as any attachments,
Development of Antimicrobial Drugs except for information submitted,
These six factors influence FDA’s and Antimicrobial Susceptibility Test marked and identified, as confidential,
decisions with respect to both whether Devices.’’ This draft guidance is if submitted as detailed in
a REMS is required for a particular drug intended to assist drug sponsors and ‘‘Instructions.’’
and what type of REMS might be device manufacturers who are planning Instructions: All submissions received
necessary (i.e., what specific elements/ to develop new antimicrobial drugs and must include the Docket No. FDA–
tools should be included as part of the antimicrobial susceptibility test (AST) 2016–D–2561 for ‘‘Coordinated
REMS). FDA makes decisions about devices and who seek to coordinate Development of Antimicrobial Drugs
requiring a REMS as part of a benefit- development of these products such that and Antimicrobial Susceptibility Test
risk determination for a drug after an the AST device could be cleared either Devices.’’ Received comments will be
evaluation that includes integrated at the time of new drug approval or placed in the docket and, except for
consideration of each of the statutory shortly thereafter. This draft guidance is those submitted as ‘‘Confidential
factors. No single factor, by itself, is not final nor is it in effect at this time. Submissions,’’ publicly viewable at
determinative as to whether a REMS is DATES: Although you can comment on http://www.regulations.gov or at the
necessary to ensure that the benefits of any guidance at any time (see 21 CFR Division of Dockets Management
a drug outweigh its risks. This guidance 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday
describes how FDA considers each of considers your comment of this draft through Friday.
these factors in conducting its REMS guidance before it begins work on the • Confidential Submissions—To
analysis. final version of the guidance, submit submit a comment with confidential
This draft guidance is being issued either electronic or written comments information that you do not wish to be
consistent with FDA’s good guidance on the draft guidance by November 21, made publicly available, submit your
practices regulation (21 CFR 10.115). 2016. comments only as a written/paper
The draft guidance, when finalized, will ADDRESSES: You may submit comments submission. You should submit two
represent the current thinking of FDA as follows: copies total. One copy will include the
on how the Agency applies statutory information you claim to be confidential
factors in determining when a REMS is Electronic Submissions with a heading or cover note that states
necessary. It does not establish any Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
rights for any person and is not binding following way: CONFIDENTIAL INFORMATION.’’ The
on FDA or the public. You can use an • Federal eRulemaking Portal: http:// Agency will review this copy, including
alternative approach if it satisfies the www.regulations.gov. Follow the the claimed confidential information, in
requirements of the applicable statutes instructions for submitting comments. its consideration of comments. The
and regulations. Comments submitted electronically, second copy, which will have the
including attachments, to http:// claimed confidential information
II. Electronic Access www.regulations.gov will be posted to redacted/blacked out, will be available
Persons with access to the Internet the docket unchanged. Because your for public viewing and posted on http://
may obtain the draft guidance at either comment will be made public, you are www.regulations.gov. Submit both
http://www.fda.gov/Drugs/Guidance solely responsible for ensuring that your copies to the Division of Dockets
ComplianceRegulatoryInformation/ comment does not include any Management. If you do not wish your
Guidances/default.htm, http:// confidential information that you or a name and contact information to be
www.fda.gov/BiologicsBloodVaccines/ third party may not wish to be posted, made publicly available, you can
GuidanceComplianceRegulatory such as medical information, your or provide this information on the cover
anyone else’s Social Security number, or sheet and not in the body of your
mstockstill on DSK3G9T082PROD with NOTICES
Information/Guidances/default.htm, or
http://www.regulations.gov. confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Dated: September 15, 2016. that if you include your name, contact information marked as ‘‘confidential’’
Leslie Kux, information, or other information that will not be disclosed except in
Associate Commissioner for Policy. identifies you in the body of your accordance with 21 CFR 10.20 and other
[FR Doc. 2016–22689 Filed 9–20–16; 8:45 am] comments, that information will be applicable disclosure law. For more
BILLING CODE 4164–01–P posted on http://www.regulations.gov. information about FDA’s posting of
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![64914 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
comments to public dockets, see 80 FR sponsors and device manufacturers for Act of 1995 (44 U.S.C. 3501–3520). The
56469, September 18, 2015, or access coordinated development of a new collections of information in 21 CFR
the information at: http://www.fda.gov/ antimicrobial drug and an AST device; part 807, subpart E have been approved
regulatoryinformation/dockets/ explain the considerations for under OMB control number 0910–0120,
default.htm. submitting separate applications to the the collections of information in 21 CFR
Docket: For access to the docket to Center for Drug Evaluation and Research part 812 have been approved under
read background documents or the (CDER) and the Center for Devices and OMB control number 0910–0078, the
electronic and written/paper comments Radiological Health (CDRH) when collections of information in 21 CFR
received, go to http:// seeking clearance of an AST device part 312 have been approved under
www.regulations.gov and insert the coincident with, or soon following, OMB control number 0910–0014, and
docket number, found in brackets in the antimicrobial drug approval; and clarify the collections of information in 21 CFR
heading of this document, into the that the review of the new antimicrobial part 314 have been approved under
‘‘Search’’ box and follow the prompts drug product and AST device(s) will OMB control number 0910–0001. The
and/or go to the Division of Dockets remain independent, and that collections of information in the
Management, 5630 Fishers Lane, Rm. coordinated development does not guidance document ‘‘Requests for
1061, Rockville, MD 20852. influence the review timelines for either Feedback on Medical Device
An electronic copy of the guidance product. Submissions: The Pre-Submission
document is available for download II. Significance of Guidance Program and Meetings with Food and
from the Internet. See the Drug Administration Staff’’ have been
SUPPLEMENTARY INFORMATION section for This draft guidance is being issued approved under OMB control number
information on electronic access to the consistent with FDA’s good guidance 0910–0756.
guidance. Submit written requests for a practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will Dated: September 15, 2016.
single hard copy of the draft guidance Leslie Kux,
document entitled ‘‘Coordinated represent the current thinking of FDA
on coordinated development of Associate Commissioner for Policy.
Development of Antimicrobial Drugs
and Antimicrobial Susceptibility Test antimicrobial drugs and antimicrobial [FR Doc. 2016–22711 Filed 9–20–16; 8:45 am]
Devices’’ to the Office of the Center susceptibility test devices. It does not BILLING CODE 4164–01–P
Director, Guidance and Policy establish any rights for any person and
Development, Center for Devices and is not binding on FDA or the public.
Radiological Health, Food and Drug You can use an alternative approach if DEPARTMENT OF HEALTH AND
Administration, 10903 New Hampshire it satisfies the requirements of the HUMAN SERVICES
Ave., Bldg. 66, Rm. 5431, Silver Spring, applicable statutes and regulations.
Food and Drug Administration
MD 20993–0002. Alternatively, you may III. Electronic Access
submit written requests for single copies Persons interested in obtaining a copy
[Docket No. FDA–2011–P–0081]
of the guidance to the Division of Drug of the draft guidance may do so by
Information, Center for Drug Evaluation Armenpharm, Ltd.; Suspension of
downloading an electronic copy from Approval of an Abbreviated New Drug
and Research, Food and Drug the Internet. A search capability for all
Administration, 10903 New Hampshire Application for Chloramphenicol
Center for Devices and Radiological Capsules, 250 Milligrams;
Ave., Bldg. 51, Rm. 2201, Silver Spring, Health guidance documents is available
MD 20993–0002. Send one self- Determination That CHLOROMYCETIN
at http://www.fda.gov/MedicalDevices/ (Chloramphenicol) Capsules, 50
addressed adhesive label to the office DeviceRegulationandGuidance/
that you are ordering from to assist in Milligrams and 100 Milligrams, and
GuidanceDocuments/default.htm, and a Three Other Products Were Withdrawn
processing your request. search capability for all Center for Drug From Sale for Reasons of Safety or
FOR FURTHER INFORMATION CONTACT: Evaluation and Research guidance Effectiveness
Ribhi Shawar, Center for Devices and documents is available at http://
Radiological Health, Food and Drug www.fda.gov/Drugs/ AGENCY: Food and Drug Administration,
Administration, 10903 New Hampshire GuidanceCompliance HHS.
Ave., Bldg. 66, Rm. 4604, Silver Spring, RegulatoryInformation/Guidances/ ACTION: Notice.
MD 20993–0002, 301–796–6698; or default.htm. Guidance documents are
Joseph Toerner, Center for Drug also available at http:// SUMMARY: The Food and Drug
Evaluation and Research, 10903 New www.regulations.gov. Persons unable to Administration (FDA or Agency) is
Hampshire Ave., Bldg. 22, Rm. 6244, download an electronic copy of suspending approval of abbreviated new
Silver Spring, MD 20993–0002, 301– ‘‘Coordinated Development of drug application (ANDA) 060851 for
796–1400. Antimicrobial Drugs and Antimicrobial chloramphenicol capsules, 250
SUPPLEMENTARY INFORMATION: Susceptibility Test Devices’’ may send milligrams (mg), held by Armenpharm,
an email request to CDRH-Guidance@ Ltd. (Armenpharm), 49 South Ridge Rd.,
I. Background P.O. Box D1400, Pomona, NY 10970.
fda.hhs.gov to receive an electronic
This guidance, when finalized, is copy of the document. Please use the FDA has also determined that
intended to assist drug sponsors and document number 1400061 to identify CHLOROMYCETIN (chloramphenicol)
device manufacturers who are planning the guidance you are requesting. Capsules, 50 mg and 100 mg;
to develop new antimicrobial drugs and AMPHICOL (chloramphenicol)
mstockstill on DSK3G9T082PROD with NOTICES
AST devices and who seek to coordinate IV. Paperwork Reduction Act of 1995 Capsules, 100 mg; and
development of these products such that This draft guidance refers to CHLOROMYCETIN PALMITATE
the AST device could be cleared either previously approved collections of (chloramphenicol palmitate) Oral
at the time of new drug approval or information. These collections of Suspension, 150 mg/5 milliliters (mL),
shortly thereafter. information are subject to review by the were withdrawn from sale for reasons of
Specifically, the guidance intends to Office of Management and Budget safety or effectiveness. The Agency will
describe the interactions between drug (OMB) under the Paperwork Reduction not accept or approve ANDAs for
VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1](https://thefederalregister.org/doc/81_FR_65096/page/2.svg)
Document Created: 2016-09-21 01:31:24
Document Modified: 2016-09-21 01:31:24
| 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 of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 21, 2016. | |
| Contact | Ribhi Shawar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4604, Silver Spring, MD 20993-0002, 301-796-6698; or Joseph Toerner, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301- 796-1400. | |
| FR Citation | 81 FR 64913 |
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