83 FR 31154 - Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 128 (July 3, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 128 (July 3, 2018)
| Page Range | 31154-31155 | |
| FR Document | 2018-14240 |
[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)] [Notices] [Pages 31154-31155] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14240] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2490] Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a 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 FDA on 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 August 7, 2018, from 8:30 a.m. to 4 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-1073. The docket will close on August 6, 2018. Submit either electronic or written comments on this public meeting by August 6, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 6, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 6, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before July 24, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows: Electronic Submissions 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''). 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 No. FDA-2018-N-2490 for ``Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see the ADDRESSES section), 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.'' FDA 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 be made publicly available, you can provide this information on the cover sheet and not [[Page 31155]] in the body of your comments and you must identify the 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. 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, email: [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 FDA's website at https://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. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss new drug application (NDA) 207356, amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen. 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 website 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 website after the meeting. Background material is available at https://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. All electronic and written submissions submitted to the Dockets Management Staff (see the ADDRESSES section) on or before July 24, 2018, will be provided to the committee. 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 July 16, 2018. Time allotted for each 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 July 17, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540. 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 Tesh (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://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: June 27, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14240 Filed 7-2-18; 8:45 am] BILLING CODE 4164-01-P
![31154 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
351(k) Applications Number of Total annual
responses per burden per Total hours
(42 U.S.C. 262(k)) respondents responses
respondent response
351(l)(6)(C) Patent Infringement Notifications ..................... 4 2.25 9 2 18
Total .............................................................................. ........................ ........................ ........................ ........................ 9,478
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information FDA is establishing a docket for manner detailed (see ‘‘Written/Paper
collection since our last request for public comment on this meeting. The Submissions’’ and ‘‘Instructions’’).
OMB approval, the estimated burden for docket number is FDA–2018–N–1073.
Written/Paper Submissions
the information collection reflects an The docket will close on August 6,
overall increase in total hours and 2018. Submit either electronic or Submit written/paper submissions as
responses. We attribute this adjustment written comments on this public follows:
to an increase in the number of meeting by August 6, 2018. Please note • Mail/Hand delivery/Courier (for
submissions received over the last few that late, untimely filed comments will written/paper submissions): Dockets
years and additional interest in the not be considered. Electronic comments Management Staff (HFA–305), Food and
biosimilars program. must be submitted on or before August Drug Administration, 5630 Fishers
Dated: June 28, 2018. 6, 2018. The https:// Lane, Rm. 1061, Rockville, MD 20852.
Leslie Kux, www.regulations.gov electronic filing • For written/paper comments
Associate Commissioner for Policy. system will accept comments until submitted to the Dockets Management
midnight Eastern Time at the end of Staff, FDA will post your comment, as
[FR Doc. 2018–14265 Filed 7–2–18; 8:45 am]
August 6, 2018. Comments received by well as any attachments, except for
BILLING CODE 4164–01–P
mail/hand delivery/courier (for written/ information submitted, marked and
paper submissions) will be considered identified, as confidential, if submitted
DEPARTMENT OF HEALTH AND timely if they are postmarked or the as detailed in ‘‘Instructions.’’
HUMAN SERVICES delivery service acceptance receipt is on Instructions: All submissions received
or before that date. must include the Docket No. FDA–
Food and Drug Administration Comments received on or before July 2018–N–2490 for ‘‘Antimicrobial Drugs
24, 2018, will be provided to the Advisory Committee; Notice of Meeting;
[Docket No. FDA–2018–N–2490] Establishment of a Public Docket;
committee. Comments received after
Antimicrobial Drugs Advisory that date will be taken into Request for Comments.’’ Received
Committee; Notice of Meeting; consideration by FDA. comments, those filed in a timely
Establishment of a Public Docket; You may submit comments as manner (see the ADDRESSES section),
Request for Comments follows: will be placed in the docket and, except
for those submitted as ‘‘Confidential
AGENCY: Food and Drug Administration, Electronic Submissions Submissions,’’ publicly viewable at
HHS. Submit electronic comments in the https://www.regulations.gov or at the
ACTION: Notice; establishment of a following way: Dockets Management Staff between 9
public docket; request for comments. • Federal eRulemaking Portal: a.m. and 4 p.m., Monday through
https://www.regulations.gov. Follow the Friday.
SUMMARY: The Food and Drug instructions for submitting comments. • Confidential Submissions—To
Administration (FDA) announces a Comments submitted electronically, submit a comment with confidential
forthcoming public advisory committee including attachments, to https:// information that you do not wish to be
meeting of the Antimicrobial Drugs www.regulations.gov will be posted to made publicly available, submit your
Advisory Committee. The general the docket unchanged. Because your comments only as a written/paper
function of the committee is to provide comment will be made public, you are submission. You should submit two
advice and recommendations to FDA on solely responsible for ensuring that your copies total. One copy will include the
regulatory issues. The meeting will be comment does not include any information you claim to be confidential
open to the public. FDA is establishing confidential information that you or a with a heading or cover note that states
a docket for public comment on this third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
document. such as medical information, your or CONFIDENTIAL INFORMATION.’’ FDA
DATES: The meeting will be held on anyone else’s Social Security number, or will review this copy, including the
August 7, 2018, from 8:30 a.m. to 4 p.m. confidential business information, such claimed confidential information, in its
ADDRESSES: FDA White Oak Campus, as a manufacturing process. Please note consideration of comments. The second
10903 New Hampshire Ave., Bldg. 31 that if you include your name, contact copy, which will have the claimed
Conference Center, the Great Room (Rm. information, or other information that confidential information redacted/
1503), Silver Spring, MD 20993–0002. identifies you in the body of your blacked out, will be available for public
sradovich on DSK3GMQ082PROD with NOTICES
Answers to commonly asked questions comments, that information will be viewing and posted on https://
including information regarding special posted on https://www.regulations.gov. www.regulations.gov. Submit both
accommodations due to a disability, • If you want to submit a comment copies to the Dockets Management Staff.
visitor parking, and transportation may with confidential information that you If you do not wish your name and
be accessed at: https://www.fda.gov/ do not wish to be made available to the contact information be made publicly
AdvisoryCommittees/AboutAdvisory public, submit the comment as a available, you can provide this
Committees/ucm408555.htm. written/paper submission and in the information on the cover sheet and not
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![Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 31155
in the body of your comments and you available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND
must identify the information as AdvisoryCommittees/Calendar/ HUMAN SERVICES
‘‘confidential.’’ Any information marked default.htm. Scroll down to the
as ‘‘confidential’’ will not be disclosed appropriate advisory committee meeting Food and Drug Administration
except in accordance with 21 CFR 10.20 link. [Docket No. FDA–2012–N–0369]
and other applicable disclosure law. For Procedure: Interested persons may
more information about FDA’s posting present data, information, or views, Agency Information Collection
of comments to public dockets, see 80 orally or in writing, on issues pending Activities; Submission for Office of
FR 56469, September 18, 2015, or access before the committee. All electronic and Management and Budget Review;
the information at: https://www.gpo.gov/ written submissions submitted to the Comment Request; Regulations Under
fdsys/pkg/FR-2015-09-18/pdf/2015- Dockets Management Staff (see the the Federal Import Milk Act
23389.pdf. ADDRESSES section) on or before July 24,
Docket: For access to the docket to 2018, will be provided to the committee. AGENCY: Food and Drug Administration,
read background documents or the Oral presentations from the public will HHS.
electronic and written/paper comments be scheduled between approximately ACTION: Notice.
received, go to https:// 1:30 p.m. and 2:30 p.m. Those
individuals interested in making formal SUMMARY: The Food and Drug
www.regulations.gov and insert the
oral presentations should notify the Administration (FDA) is announcing
docket number, found in brackets in the
contact person and submit a brief that a proposed collection of
heading of this document, into the
statement of the general nature of the information has been submitted to the
‘‘Search’’ box and follow the prompts
evidence or arguments they wish to Office of Management and Budget
and/or go to the Dockets Management
present, the names and addresses of (OMB) for review and clearance under
Staff, 5630 Fishers Lane, Rm. 1061,
proposed participants, and an the Paperwork Reduction Act of 1995
Rockville, MD 20852.
indication of the approximate time (PRA).
FOR FURTHER INFORMATION CONTACT:
Lauren D. Tesh, Center for Drug requested to make their presentation on DATES: Fax written comments on the
Evaluation and Research, Food and or before July 16, 2018. Time allotted for collection of information by August 2,
Drug Administration, 10903 New each presentation may be limited. If the 2018.
Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to ADDRESSES: To ensure that comments on
Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably the information collection are received,
796–9001, Fax: 301–847–8533, email: accommodated during the scheduled OMB recommends that written
AMDAC@fda.hhs.gov, or FDA Advisory open public hearing session, FDA may comments be faxed to the Office of
Committee Information Line, 1–800– conduct a lottery to determine the Information and Regulatory Affairs,
741–8138 (301–443–0572 in the speakers for the scheduled open public OMB, Attn: FDA Desk Officer, Fax: 202–
Washington, DC area). A notice in the hearing session. The contact person will 395–7285, or emailed to oira_
Federal Register about last minute notify interested persons regarding their submission@omb.eop.gov. All
modifications that impact a previously request to speak by July 17, 2018. comments should be identified with the
announced advisory committee meeting Persons attending FDA’s advisory OMB control number 0910–0212. Also
cannot always be published quickly committee meetings are advised that include the FDA docket number found
enough to provide timely notice. FDA is not responsible for providing in brackets in the heading of this
Therefore, you should always check the access to electrical outlets. document.
FDA’s website at https://www.fda.gov/ For press inquiries, please contact the
Office of Media Affairs at fdaoma@ FOR FURTHER INFORMATION CONTACT:
AdvisoryCommittees/default.htm and Domini Bean, Office of Operations,
scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the Food and Drug Administration, Three
committee meeting link, or call the White Flint North, 10A–12M, 11601
advisory committee information line to public at its advisory committee
meetings and will make every effort to Landsdown St., North Bethesda, MD
learn about possible modifications 20852, 301–796–5733, PRAStaff@
before coming to the meeting. accommodate persons with disabilities.
If you require accommodations due to a fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
disability, please contact Lauren Tesh SUPPLEMENTARY INFORMATION: In
Agenda: The committee will discuss (see FOR FURTHER INFORMATION CONTACT)
new drug application (NDA) 207356, compliance with 44 U.S.C. 3507, FDA
at least 7 days in advance of the has submitted the following proposed
amikacin liposome inhalation meeting.
suspension, sponsored by Insmed, Inc., collection of information to OMB for
FDA is committed to the orderly review and clearance.
for the proposed indication of treatment conduct of its advisory committee
of nontuberculous mycobacterial lung meetings. Please visit our website at Regulations Under the Federal Import
disease caused by Mycobacterium https://www.fda.gov/Advisory Milk Act (FIMA)—21 CFR Part 1210
avium complex in adults as part of a Committees/AboutAdvisoryCommittees/
combination antibacterial drug regimen. OMB Control Number 0910–0212—
ucm111462.htm for procedures on Extension
FDA intends to make background public conduct during advisory
material available to the public no later committee meetings. Under FIMA (21 U.S.C. 141–149),
than 2 business days before the meeting. Notice of this meeting is given under milk or cream may be imported into the
If FDA is unable to post the background United States only by the holder of a
sradovich on DSK3GMQ082PROD with NOTICES
the Federal Advisory Committee Act
material on its website prior to the (5 U.S.C. app. 2). valid import milk permit (21 U.S.C.
meeting, the background material will 141). Before such permit is issued: (1)
be made publicly available at the Dated: June 27, 2018. All cows from which import milk or
location of the advisory committee Leslie Kux, cream is produced must be physically
meeting, and the background material Associate Commissioner for Policy. examined and found healthy; (2) if the
will be posted on FDA’s website after [FR Doc. 2018–14240 Filed 7–2–18; 8:45 am] milk or cream is imported raw, all such
the meeting. Background material is BILLING CODE 4164–01–P cows must pass a tuberculin test; (3) the
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Document Created: 2018-07-02 23:55:53
Document Modified: 2018-07-02 23:55:53
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on August 7, 2018, from 8:30 a.m. to 4 p.m. | |
| 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, email: [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 FDA's website at https://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. | |
| FR Citation | 83 FR 31154 |
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