AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of public docket; request for comments.
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Antimicrobial Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on April 13, 2017, from 8:30 a.m. to 5
p.m. The docket number is FDA-2017-N-1813. The docket will close on
April 12, 2017. Comments received on or before April 10, 2017, will be
provided to the committee. Comments received after that date will be
taken into consideration by the Agency.
ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New
Hampshire Ave., Silver Spring, MD 20903. The conference center's
telephone number is 240-645-4000. Answers to commonly asked questions
including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
You may submit comments as follows:
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://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'').
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-2017-N-1813 for "Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
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 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 https://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: https://www.gpo.gov/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 Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: 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, AMDAC@fda.hhs.gov, 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.