81 FR 22278 - Antimicrobial Drugs Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 73 (April 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 73 (April 15, 2016)
| Page Range | 22278-22279 | |
| FR Document | 2016-08637 |
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)] [Notices] [Pages 22278-22279] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08637] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Antimicrobial Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Antimicrobial Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on June 9, 2016, from 8:30 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Contact Person: Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847- 8533, [email protected], or FDA Advisory Committee Information Line, 1- 800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 25, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 17, 2016. Time allotted for each [[Page 22279]] presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 18, 2016. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren D. Tesh at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 11, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-08637 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
![22278 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
Act of 2012, includes new requirements information manufacturers must submit would form the basis of a decision on
pertaining to the process and timelines so that FDA may properly evaluate the a matter under appeal, the submission
for 10.75 appeals of ‘‘significant safety and effectiveness of medical of particular information regarding the
decisions’’ regarding 510(k) premarket devices. The information collections request itself and the data and
notifications, applications for premarket associated with these regulations are information relied on by the requestor
approvals (PMAs), and applications for currently approved by the Office of in the appeal would facilitate timely
investigational device exemptions Management and Budget as follows: The resolution of the decision under review.
(IDEs). collections of information in 21 CFR The guidance describes the collection of
A request for review under § 10.75 part 807, subpart E (premarket information not expressly specified
should be based on the information that notification) have been approved under under existing regulations such as: The
was already present in the OMB control number 0910–0120; the submission of the request for review,
administrative file at the time of the collections of information in 21 CFR minor clarifications as part of the
decision that is being reviewed as part 814 (premarket approval) have been request, and supporting information.
provided in § 10.75(d). New section approved under OMB control number In the Federal Register of October 21,
517A of the FD&C Act refers to 0910–0231; and the collections of 2015 (80 FR 63804), FDA published a
significant decisions regarding the information in 21 CFR part 812 60-day notice requesting public
information in the administrative file for (investigational device exemption) have comment on the proposed collection of
premarket notifications (section 510(k)); been approved under OMB control information. No comments were
PMAs (section 515); and IDEs (section number 0910–0078. received.
520(g)) submissions is collected under While CDRH already possesses in the FDA estimates the burden of this
existing regulations which specify the administrative file the information that collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
CDRH Appeals Processes Guidance Document ................ 50 1 50 8 400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 8, 2016. Information regarding special indication of prevention of Clostridium
Leslie Kux, accommodations due to a disability, difficile infection recurrence.
Associate Commissioner for Policy. visitor parking, and transportation may FDA intends to make background
[FR Doc. 2016–08685 Filed 4–14–16; 8:45 am] be accessed at: http://www.fda.gov/ material available to the public no later
BILLING CODE 4164–01–P AdvisoryCommittees/ than 2 business days before the meeting.
AboutAdvisoryCommittees/ If FDA is unable to post the background
ucm408555.htm. material on its Web site prior to the
DEPARTMENT OF HEALTH AND Contact Person: Lauren D. Tesh, meeting, the background material will
HUMAN SERVICES Center for Drug Evaluation and be made publicly available at the
Research, Food and Drug location of the advisory committee
Food and Drug Administration meeting, and the background material
Administration, 10903 New Hampshire
[Docket No. FDA–2016–N–0001] Ave., Bldg. 31, Rm. 2417, Silver Spring, will be posted on FDA’s Web site after
the meeting. Background material is
MD 20993–0002, 301–796–9001, FAX:
Antimicrobial Drugs Advisory available at http://www.fda.gov/
301–847–8533, AMDAC@fda.hhs.gov, or
Committee; Notice of Meeting AdvisoryCommittees/Calendar/
FDA Advisory Committee Information
default.htm. Scroll down to the
AGENCY: Food and Drug Administration, Line, 1–800–741–8138 (301–443–0572
appropriate advisory committee meeting
HHS. in the Washington, DC area). A notice in
link.
ACTION: Notice. the Federal Register about last minute
Procedure: Interested persons may
modifications that impact a previously
This notice announces a forthcoming present data, information, or views,
announced advisory committee meeting
meeting of a public advisory committee orally or in writing, on issues pending
cannot always be published quickly before the committee. Written
of the Food and Drug Administration enough to provide timely notice.
(FDA). The meeting will be open to the submissions may be made to the contact
Therefore, you should always check the person on or before May 25, 2016. Oral
public. Agency’s Web site at http://
Name of Committee: Antimicrobial presentations from the public will be
www.fda.gov/AdvisoryCommittees/ scheduled between approximately 1:30
Drugs Advisory Committee. default.htm and scroll down to the
General Function of the Committee: p.m. and 2:30 p.m. Those individuals
appropriate advisory committee meeting interested in making formal oral
To provide advice and
link, or call the advisory committee presentations should notify the contact
asabaliauskas on DSK3SPTVN1PROD with NOTICES
recommendations to the Agency on
information line to learn about possible person and submit a brief statement of
FDA’s regulatory issues.
Date and Time: The meeting will be modifications before coming to the the general nature of the evidence or
held on June 9, 2016, from 8:30 a.m. to meeting. arguments they wish to present, the
5 p.m. Agenda: The committee will discuss names and addresses of proposed
Location: FDA White Oak Campus, biologics license application (BLA) participants, and an indication of the
10903 New Hampshire Ave., Bldg. 31 761046, bezlotoxumab (MK–6072) approximate time requested to make
Conference Center, the Great Room (Rm. injection, submitted by Merck Sharpe & their presentation on or before May 17,
1503), Silver Spring, MD 20993–0002. Dohme Corp., for the proposed 2016. Time allotted for each
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![Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22279
presentation may be limited. If the project(s) that FDA establishes under • Confidential Submissions—To
number of registrants requesting to the DSCSA. submit a comment with confidential
speak is greater than can be reasonably DATES: Submit written or electronic information that you do not wish to be
accommodated during the scheduled comments and information by May 16, made publicly available, submit your
open public hearing session, FDA may 2016. comments only as a written/paper
conduct a lottery to determine the You may submit comments as submission. You should submit two
speakers for the scheduled open public follows: copies total. One copy will include the
hearing session. The contact person will information you claim to be confidential
notify interested persons regarding their Electronic Submissions
with a heading or cover note that states
request to speak by May 18, 2016. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Persons attending FDA’s advisory following way: CONFIDENTIAL INFORMATION.’’ The
committee meetings are advised that the • Federal eRulemaking Portal: http:// Agency will review this copy, including
Agency is not responsible for providing www.regulations.gov. Follow the the claimed confidential information, in
access to electrical outlets. instructions for submitting comments. its consideration of comments. The
FDA welcomes the attendance of the Comments submitted electronically, second copy, which will have the
public at its advisory committee including attachments, to http:// claimed confidential information
meetings and will make every effort to www.regulations.gov will be posted to redacted/blacked out, will be available
accommodate persons with disabilities. the docket unchanged. Because your for public viewing and posted on
If you require accommodations due to a comment will be made public, you are http://www.regulations.gov. Submit
disability, please contact Lauren D. Tesh solely responsible for ensuring that your both copies to the Division of Dockets
at least 7 days in advance of the comment does not include any Management. If you do not wish your
meeting. confidential information that you or a name and contact information to be
FDA is committed to the orderly third party may not wish to be posted, made publicly available, you can
conduct of its advisory committee such as medical information, your or provide this information on the cover
meetings. Please visit our Web site at anyone else’s Social Security number, or sheet and not in the body of your
http://www.fda.gov/ confidential business information, such comments and you must identify this
AdvisoryCommittees/ as a manufacturing process. Please note information as ‘‘confidential.’’ Any
AboutAdvisoryCommittees/ that if you include your name, contact information marked as ‘‘confidential’’
ucm111462.htm for procedures on information, or other information that will not be disclosed except in
public conduct during advisory identifies you in the body of your accordance with 21 CFR 10.20 and other
committee meetings. comments, that information will be applicable disclosure law. For more
Notice of this meeting is given under posted on http://www.regulations.gov. information about FDA’s posting of
the Federal Advisory Committee Act (5 • If you want to submit a comment comments to public dockets, see 80 FR
U.S.C. app. 2). with confidential information that you 56469, September 18, 2015, or access
Dated: April 11, 2016. do not wish to be made available to the the information at: http://www.fda.gov/
Jill Hartzler Warner, public, submit the comment as a regulatoryinformation/dockets/
Associate Commissioner for Special Medical
written/paper submission and in the default.htm.
Programs. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[FR Doc. 2016–08637 Filed 4–14–16; 8:45 am]
Submissions’’ and ‘‘Instructions’’). read background documents or the
BILLING CODE 4164–01–P Written/Paper Submissions electronic and written/paper comments
received, go to http://
Submit written/paper submissions as
www.regulations.gov and insert the
follows:
DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for docket number, found in brackets in the
HUMAN SERVICES written/paper submissions): Division of heading of this document, into the
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
Food and Drug Administration and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
[Docket No. FDA–2016–N–1114] Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
• For written/paper comments 1061, Rockville, MD 20852.
Pharmaceutical Distribution Supply submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
Chain Pilot Projects; Request for Management, FDA will post your Daniel Bellingham, Center for Drug
Information comment, as well as any attachments, Evaluation and Research, Food and
AGENCY: Food and Drug Administration, except for information submitted, Drug Administration, 10903 New
HHS. marked and identified, as confidential, Hampshire Ave., Silver Spring, MD
ACTION: Notice; request for information. if submitted as detailed in 20993–0002, 301–796–3130,
‘‘Instructions.’’ daniel.bellingham@fda.hhs.gov.
SUMMARY: The Food and Drug Instructions: All submissions received SUPPLEMENTARY INFORMATION:
Administration (FDA) is soliciting must include the Docket No. FDA–
information regarding issues related to 2016–N–1114 for ‘‘Pharmaceutical I. Background
utilizing the product identifier for Distribution Supply Chain Pilot On November 27, 2013, the DSCSA
product tracing, improving the technical Projects; Request for Information.’’ (Title II of Pub. L. 113–54) was signed
asabaliauskas on DSK3SPTVN1PROD with NOTICES
capabilities of the supply chain, and Received comments will be placed in into law. The DSCSA outlines critical
identifying system attributes that are the docket and, except for those steps to build an electronic,
necessary to implement the submitted as ‘‘Confidential interoperable system by November 27,
requirements established under the Submissions,’’ publicly viewable at 2023, which will identify and trace
Drug Supply Chain Security Act http://www.regulations.gov or at the certain prescription drugs as they are
(DSCSA). The information gathered Division of Dockets Management distributed within the United States.
from public comments will assist with between 9 a.m. and 4 p.m., Monday Section 202 of the DSCSA added new
the design and development of the pilot through Friday. sections 581 and 582 to the Food Drug
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Document Created: 2016-04-15 00:55:16
Document Modified: 2016-04-15 00:55:16
| 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. | |
| FR Citation | 81 FR 22278 |
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