81 FR 63774 - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 180 (September 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 180 (September 16, 2016)
| Page Range | 63774-63775 | |
| FR Document | 2016-22352 |
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)] [Notices] [Pages 63774-63775] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22352] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public workshop regarding ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs).'' This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish 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. The input from this public workshop will also help in developing topics for future discussion. DATES: Dates and Times: The public workshop will be held on September 29, 2016, from 9 a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for registration information. ADDRESSES: Location: The public workshop will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's phone number is 301-589-0800. FOR FURTHER INFORMATION CONTACT: Contact Persons: Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-0002, 301- 796-1300. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, email your registration information (including name, title, firm name, address, telephone number, and fax number) to [email protected]. Persons without access to the Internet can call 301-796-1300 to register. If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see Contact Persons above) at least 7 days in advance. SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop pertaining to the coordinated development of antimicrobial drugs and ASTs. Discussions will focus on assisting drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who seek to coordinate development of these products. The goals of the workshop are to: (1) Outline the regulatory considerations for submitting separate applications to the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health for antimicrobial drugs and ASTs, respectively; (2) identify the challenges related to obtaining data supporting the clearance of an AST device coincident with or soon after antimicrobial drug approval; and (3) discuss ideas for addressing these challenges. [[Page 63775]] The Agency encourages individuals, industry, device manufacturers, health care professionals, researchers, public health organizations and other interested persons to attend this public workshop. Workshop updates will be made available on the internet at http://www.fda.gov/Drugs/NewsEvents/ucm512519.htm. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available either in hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. Transcripts will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm512519.htm approximately 45 days after the workshop. Dated: September 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22352 Filed 9-15-16; 8:45 am] BILLING CODE 4164-01-P
![63774 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices
submission of an application to market 3. The date the application was are planning to develop new
the human biological product and approved: May 20, 2014. FDA has antimicrobial drugs or ASTs and who
continues until FDA grants permission verified the applicant’s claim that BLA wish to coordinate development of these
to market the biological product. 125476 was approved on May 20, 2014. products, such that the AST device
Although only a portion of a regulatory This determination of the regulatory could be cleared either at the time of
review period may count toward the review period establishes the maximum new drug approval or shortly thereafter.
actual amount of extension that the potential length of a patent extension. The input from this public workshop
Director of Patents and Trademarks may However, the USPTO applies several will also help in developing topics for
award (for example, half the testing statutory limitations in its calculations future discussion.
phase must be subtracted as well as any of the actual period for patent extension. DATES: Dates and Times: The public
time that may have occurred before the In its application for patent extension, workshop will be held on September 29,
patent was issued), FDA’s determination this applicant seeks 1,526 days of patent 2016, from 9 a.m. to 4 p.m. See the
of the length of a regulatory review term extension. SUPPLEMENTARY INFORMATION section for
period for a human biological product III. Petitions registration information.
will include all of the testing phase and
Anyone with knowledge that any of ADDRESSES: Location: The public
approval phase as specified in 35 U.S.C.
156(g)(1)(B). the dates as published are incorrect may workshop will be held at the Sheraton
FDA has approved for marketing the submit either electronic or written Silver Spring Hotel, 8777 Georgia Ave.,
human biologic product, ENTYVIO comments and ask for a redetermination Silver Spring, MD 20910. The hotel’s
(vedolizumab). ENTYVIO is indicated (see DATES). Furthermore, any interested phone number is 301–589–0800.
for adult ulcerative colitis and adult person may petition FDA for a FOR FURTHER INFORMATION CONTACT:
Crohn’s disease. Subsequent to this determination regarding whether the Contact Persons: Lori Benner and/or
approval, the USPTO received a patent applicant for extension acted with due Jessica Barnes, Center for Drug
term restoration application for diligence during the regulatory review Evaluation and Research, Food and
ENTYVIO (U.S. Patent No. 7,147,851) period. To meet its burden, the petition Drug Administration, 10903 New
from Millenium Pharmaceuticals, Inc., must be timely (see DATES) and contain Hampshire Ave., Bldg. 22, Rm. 6221,
and the USPTO requested FDA’s sufficient facts to merit an FDA Silver Spring, MD 20993–0002, 301–
assistance in determining this patent’s investigation. (See H. Rept. 857, part 1, 796–1300.
eligibility for patent term restoration. In 98th Cong., 2d sess., pp. 41–42, 1984.) Registration: Registration is free for
a letter dated January 6, 2016, FDA Petitions should be in the format the public workshop. Interested parties
advised the USPTO that this human specified in 21 CFR 10.30. are encouraged to register early. Seating
biological product had undergone a Submit petitions electronically to will be available on a first-come, first-
regulatory review period and that the http://www.regulations.gov, Docket No. served basis. To register electronically,
approval of ENTYVIO represented the FDA–2013–S–0610. Submit written email your registration information
first permitted commercial marketing or petitions (two copies are required) to the (including name, title, firm name,
use of the product. Thereafter, the Division of Dockets Management (HFA– address, telephone number, and fax
USPTO requested that FDA determine 305), Food and Drug Administration, number) to AntimicrobialSusceptibility
the product’s regulatory review period. 5630 Fishers Lane, rm. 1061, Rockville, testingWorkshop2016@fda.hhs.gov.
MD 20852. Persons without access to the Internet
II. Determination of Regulatory Review
Period Dated: September 12, 2016. can call 301–796–1300 to register.
Leslie Kux, If you need special accommodations
FDA has determined that the due to a disability, please contact Jessica
Associate Commissioner for Policy.
applicable regulatory review period for Barnes or Lori Benner (see Contact
ENTYVIO is 5,066 days. Of this time, [FR Doc. 2016–22344 Filed 9–15–16; 8:45 am]
Persons above) at least 7 days in
4,731 days occurred during the testing BILLING CODE 4164–01–P
advance.
phase of the regulatory review period,
while 335 days occurred during the SUPPLEMENTARY INFORMATION: FDA is
approval phase. These periods of time DEPARTMENT OF HEALTH AND announcing a public workshop
were derived from the following dates: HUMAN SERVICES pertaining to the coordinated
1. The date an exemption under development of antimicrobial drugs and
Food and Drug Administration
section 505(i) of the Federal Food, Drug, ASTs. Discussions will focus on
and Cosmetic Act (21 U.S.C. 355(i)) [Docket No. FDA–2016–N–0001] assisting drug sponsors and device
became effective: July 8, 2000. The manufacturers who are planning to
applicant claims August 18, 2000, as the Coordinated Development of develop new antimicrobial drugs or
date the investigational new drug Antimicrobial Drugs and Antimicrobial ASTs and who seek to coordinate
application (IND) became effective. Susceptibility Test Devices development of these products.
However, FDA records indicate that the AGENCY: Food and Drug Administration, The goals of the workshop are to: (1)
IND effective date was July 8, 2000, HHS. Outline the regulatory considerations
which was 30 days after FDA receipt of ACTION: Notice of public workshop. for submitting separate applications to
the IND. the Center for Drug Evaluation and
2. The date the application was SUMMARY: The Food and Drug Research and the Center for Devices and
initially submitted with respect to the Administration (FDA or Agency) is Radiological Health for antimicrobial
mstockstill on DSK3G9T082PROD with NOTICES
human biological product under section announcing a public workshop drugs and ASTs, respectively; (2)
351 of the Public Health Service Act (42 regarding ‘‘Coordinated Development of identify the challenges related to
U.S.C. 262): June 20, 2013. FDA has Antimicrobial Drugs and Antimicrobial obtaining data supporting the clearance
verified the applicant’s claim that the Susceptibility Test Devices (ASTs).’’ of an AST device coincident with or
biologics license application (BLA) for This public workshop is intended to soon after antimicrobial drug approval;
ENTYVIO (BLA 125476) was initially facilitate discussion between drug and (3) discuss ideas for addressing
submitted on June 20, 2013. sponsors and device manufacturers who these challenges.
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![Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63775
The Agency encourages individuals, CVM’s Bioequivalence Guidance,1 Dockets Management (HFA–305), Food
industry, device manufacturers, health particularly the section on Criteria for and Drug Administration, 5630 Fishers
care professionals, researchers, public Waiver of In Vivo Bioequivalence Lane, Rm. 1061, Rockville, MD 20852.
health organizations and other Study. This guidance is applicable to • For written/paper comments
interested persons to attend this public generic investigational new animal drug submitted to the Division of Dockets
workshop. Workshop updates will be (JINAD) files and abbreviated new Management, FDA will post your
made available on the internet at http:// animal drug applications (ANADAs). comment, as well as any attachments,
www.fda.gov/Drugs/NewsEvents/ Although the recommendations in this except for information submitted,
ucm512519.htm. guidance reference generic drug marked and identified, as confidential,
Transcripts: Please be advised that as applications, the general principles if submitted as detailed in
soon as a transcript is available, it will described may also be applicable to new ‘‘Instructions.’’
be accessible at http:// animal drug applications (NADAs), Instructions: All submissions received
www.regulations.gov. It may be viewed investigational new animal drug (INAD) must include the Docket No. FDA–
at the Division of Dockets Management files, and supplemental NADAs. 2004–D–0045 for ‘‘Waivers from the
(HFA–305), Food and Drug DATES: Although you can comment on Requirement to Demonstrate
Administration, 5630 Fishers Lane, Rm. any guidance at any time (see 21 CFR Bioequivalence of Animal Drugs in
1061, Rockville, MD. A transcript will 10.115(g)(5)), to ensure that the Agency Soluble Powder Oral Dosage Form
also be available either in hardcopy or considers your comment on this draft Products and Type A Medicated
on CD–ROM, after submission of a revised guidance before it begins work Articles.’’ Received comments will be
Freedom of Information request. The on the final version of the guidance, placed in the docket and, except for
Freedom of Information office address is submit either electronic or written those submitted as ‘‘Confidential
available on the Agency’s Web site at comments on the draft revised guidance Submissions,’’ publicly viewable at
http://www.fda.gov. Transcripts will by November 15, 2016. http://www.regulations.gov or at the
also be available on the Internet at ADDRESSES: You may submit comments
Division of Dockets Management
http://www.fda.gov/Drugs/NewsEvents/ as follows: between 9 a.m. and 4 p.m., Monday
ucm512519.htm approximately 45 days through Friday.
Electronic Submissions • Confidential Submissions—To
after the workshop.
Submit electronic comments in the submit a comment with confidential
Dated: September 9, 2016. information that you do not wish to be
following way:
Leslie Kux, • Federal eRulemaking Portal: http:// made publicly available, submit your
Associate Commissioner for Policy. www.regulations.gov. Follow the comments only as a written/paper
[FR Doc. 2016–22352 Filed 9–15–16; 8:45 am] instructions for submitting comments. submission. You should submit two
BILLING CODE 4164–01–P Comments submitted electronically, copies total. One copy will include the
including attachments, to http:// information you claim to be confidential
www.regulations.gov will be posted to with a heading or cover note that states
DEPARTMENT OF HEALTH AND the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
HUMAN SERVICES comment will be made public, you are CONFIDENTIAL INFORMATION.’’ The
solely responsible for ensuring that your Agency will review this copy, including
Food and Drug Administration comment does not include any the claimed confidential information, in
confidential information that you or a its consideration of comments. The
[Docket No. FDA–2004–D–0045]
third party may not wish to be posted, second copy, which will have the
Waivers From the Requirement To such as medical information, your or claimed confidential information
Demonstrate Bioequivalence of Animal anyone else’s Social Security number, or redacted/blacked out, will be available
Drugs in Soluble Powder Oral Dosage confidential business information, such for public viewing and posted on http://
Form Products and Type A Medicated as a manufacturing process. Please note www.regulations.gov. Submit both
Articles; Draft Revised Guidance for that if you include your name, contact copies to the Division of Dockets
Industry; Availability information, or other information that Management. If you do not wish your
identifies you in the body of your name and contact information to be
AGENCY: Food and Drug Administration, comments, that information will be made publicly available, you can
HHS. posted on http://www.regulations.gov. provide this information on the cover
ACTION: Notice of availability. • If you want to submit a comment sheet and not in the body of your
with confidential information that you comments and you must identify this
SUMMARY: The Food and Drug do not wish to be made available to the information as ‘‘confidential.’’ Any
Administration (FDA or Agency) is public, submit the comment as a information marked as ‘‘confidential’’
announcing the availability of a draft written/paper submission and in the will not be disclosed except in
revised guidance for industry (GFI) #171 manner detailed (see ‘‘Written/Paper accordance with 21 CFR 10.20 and other
entitled ‘‘Waivers from the Requirement Submissions’’ and ‘‘Instructions’’). applicable disclosure law. For more
to Demonstrate Bioequivalence of information about FDA’s posting of
Animal Drugs in Soluble Powder Oral Written/Paper Submissions comments to public dockets, see 80 FR
Dosage Form Products and Type A Submit written/paper submissions as 56469, September 18, 2015, or access
Medicated Articles.’’ This draft revised follows: the information at: http://www.fda.gov/
guidance document describes how the • Mail/Hand delivery/Courier (for regulatoryinformation/dockets/
mstockstill on DSK3G9T082PROD with NOTICES
Center for Veterinary Medicine (CVM) written/paper submissions): Division of default.htm.
intends to evaluate requests for waiving Docket: For access to the docket to
the requirement for submitting data 1 CVM Guidance for Industry #35, read background documents or the
demonstrating the bioequivalence of ‘‘Bioequivalence Guidance,’’ November 8, 2006 (see electronic and written/paper comments
page 7): http://www.fda.gov/downloads/
animal drugs in soluble powder oral AnimalVeterinary/
received, go to http://
dosage form products and Type A GuidanceComplianceEnforcement/ www.regulations.gov and insert the
medicated articles. It expands upon GuidanceforIndustry/UCM052363.pdf. docket number, found in brackets in the
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Document Created: 2016-09-16 00:25:19
Document Modified: 2016-09-16 00:25:19
| 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 public workshop. | |
| Dates | Dates and Times: The public workshop will be held on September 29, 2016, from 9 a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for registration information. | |
| Contact | Contact Persons: Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-0002, 301- 796-1300. | |
| FR Citation | 81 FR 63774 |
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