83 FR 16104 - 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 72 (April 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 72 (April 13, 2018)
| Page Range | 16104-16106 | |
| FR Document | 2018-07747 |
[Federal Register Volume 83, Number 72 (Friday, April 13, 2018)] [Notices] [Pages 16104-16106] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07747] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1073] 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. [[Page 16105]] DATES: The meeting will be held on May 1, 2018, from 10 a.m. to 3:30 p.m. ADDRESSES: DoubleTree by Hilton Hotel Bethesda/Washington DC, Grand Ballroom, 8120 Wisconsin Ave., Bethesda, MD 20814-3624. The conference center's telephone number is 301-652-2000. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the DoubleTree by Hilton Hotel Bethesda-- Washington DC Conference Center can be accessed at: http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-bethesda-washington-dc-WASBHDT/index.html. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-1073. The docket will close on April 30, 2018. Submit either electronic or written comments on this public meeting by April 30, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 30, 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 April 26, 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-1073 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 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.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: Cindy Chee, 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 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) 208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients. This product was developed under the Animal Rule (21 CFR part 314, subpart I). 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 [[Page 16106]] 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 Docket (see the ADDRESSES section) on or before April 26, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:15 p.m. and 2:15 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 April 24, 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 April 25, 2018. Persons attending FDAs 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 Cindy Chee (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: April 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07747 Filed 4-12-18; 8:45 am] BILLING CODE 4164-01-P
![16104 Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
is used by the State agencies to enter Title: Child Care and Development The CCDF final rule at 45 CFR
new providers into the Automated Fund, Quarterly Case Record Report 98.71(a)(11) requires that States and
Survey Process Environment (ASPEN). (ACF–801). Territories report new information on
Form Number: CMS–1856 (OMB control OMB No.: 0970–0167. the ACF–801. With this extension, ACF
number: 0938–0065); Frequency: Description: Section 658K of the Child is proposing to add two new data
Annually, occasionally; Affected Public: Care and Development Block Grant elements to the existing reporting
Private sector—Business or other for- (CCDBG) Act (42 U.S.C. 9858, as requirements. These proposed revisions
profit and Not-for-profit institutions; amended by Pub. L. 113–186) requires to the ACF–801 would allow ACF to
Number of Respondents: 350; Total that States and Territories submit collect the amount charged per child by
Annual Responses: 350; Total Annual monthly case-level data on the children those providers who charge the family
Hours: 88. (For policy questions and families receiving direct services more than the required copayment in
regarding this collection contact Peter under the Child Care and Development
Ajuonuma at 410–786–3580.) instances where the provider’s price
Fund (CCDF). The implementing exceeds the subsidy payment. We are
Dated: April 9, 2018. regulations for the statutorily required particularly interested in receiving
William N. Parham, III, reporting are at 45 CFR 98.70 and 98.71. comments on the availability of these
Director, Paperwork Reduction Staff, Office Case-level reports, submitted quarterly data at the State and Territory level, the
of Strategic Operations and Regulatory or monthly (at grantee option), include
quality of that data, and feedback on
Affairs. monthly sample or full population case-
approaches to obtain this type of
[FR Doc. 2018–07680 Filed 4–12–18; 8:45 am] level data. The data elements to be
included in these reports are information.
BILLING CODE 4120–01–P
represented in the ACF–801. ACF uses Respondents: States, the District of
disaggregate data to determine program Columbia, and Territories including
DEPARTMENT OF HEALTH AND and participant characteristics as well as Puerto Rico, Guam, the Virgin Islands,
HUMAN SERVICES costs and levels of child care services American Samoa, and the Northern
provided. This provides ACF with the Marianna Islands.
Administration for Children and information necessary to make reports
Families to Congress, address national child care
needs, offer technical assistance to
Proposed Information Collection
grantees, meet performance measures,
Activity; Comment Request
and conduct research. ACF requests
Proposed Projects: extension of the ACF–801 with changes.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of responses Total burden
Instrument burden hours
respondents per hours
per response
respondent
ACF–801 .......................................................................................................... 56 4 27 6,048
Estimated Total Annual Burden agency’s estimate of the burden of the DEPARTMENT OF HEALTH AND
Hours: 6,048. proposed collection of information; (c) HUMAN SERVICES
In compliance with the requirements the quality, utility, and clarity of the
of the Paperwork Reduction Act of 1995 information to be collected; and (d) Food and Drug Administration
(Pub. L. 104–13, 44 U.S.C. Chap 35), the ways to minimize the burden of the
Administration for Children and [Docket No. FDA–2018–N–1073]
collection of information on
Families is soliciting public comment respondents, including through the use Antimicrobial Drugs Advisory
on the specific aspects of the of automated collection techniques or Committee; Notice of Meeting;
information collection described above. other forms of information technology. Establishment of a Public Docket;
Copies of the proposed collection of Consideration will be given to Request for Comments
information can be obtained and
comments and suggestions submitted
comments may be forwarded by writing AGENCY: Food and Drug Administration,
within 60 days of this publication.
to the Administration for Children and HHS.
Families, Office of Planning, Research Robert Sargis, ACTION: Notice; establishment of a
and Evaluation, 330 C Street SW, Reports Clearance Officer. public docket; request for comments.
Washington, DC 20201. Attn: ACF [FR Doc. 2018–07646 Filed 4–12–18; 8:45 am]
Reports Clearance Officer. Email SUMMARY: The Food and Drug
BILLING CODE 4184–01–P
address: infocollection@acf.hhs.gov. All Administration (FDA) announces a
requests should be identified by the title forthcoming public advisory committee
of the information collection. meeting of the Antimicrobial Drugs
daltland on DSKBBV9HB2PROD with NOTICES
The Department specifically requests Advisory Committee. The general
comments on: (a) Whether the proposed function of the committee is to provide
collection of information is necessary advice and recommendations to FDA on
for the proper performance of the regulatory issues. The meeting will be
functions of the agency, including open to the public. FDA is establishing
whether the information shall have a docket for public comment on this
practical utility; (b) the accuracy of the document.
VerDate Sep<11>2014 19:04 Apr 12, 2018 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1](https://thefederalregister.org/doc/83_FR_16176/page/1.svg)
![16106 Federal Register / Vol. 83, No. 72 / Friday, April 13, 2018 / Notices
appropriate advisory committee meeting DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to
link. HUMAN SERVICES the docket unchanged. Because your
Procedure: Interested persons may comment will be made public, you are
Food and Drug Administration solely responsible for ensuring that your
present data, information, or views,
orally or in writing, on issues pending [Docket No. FDA–2016–D–1270] comment does not include any
before the committee. All electronic and confidential information that you or a
written submissions submitted to the Considerations for Design, third party may not wish to be posted,
Development, and Analytical Validation such as medical information, your or
Docket (see the ADDRESSES section) on
of Next Generation Sequencing-Based anyone else’s Social Security number, or
or before April 26, 2018, will be
In Vitro Diagnostics Intended To Aid in confidential business information, such
provided to the committee. Oral
the Diagnosis of Suspected Germline as a manufacturing process. Please note
presentations from the public will be
Diseases; Guidance for Stakeholders that if you include your name, contact
scheduled between approximately 1:15
and Food and Drug Administration information, or other information that
p.m. and 2:15 p.m. Those individuals identifies you in the body of your
interested in making formal oral Staff; Availability
comments, that information will be
presentations should notify the contact AGENCY: Food and Drug Administration, posted on https://www.regulations.gov.
person and submit a brief statement of HHS. • If you want to submit a comment
the general nature of the evidence or ACTION: Notice of availability. with confidential information that you
arguments they wish to present, the do not wish to be made available to the
names and addresses of proposed SUMMARY: The Food and Drug
public, submit the comment as a
participants, and an indication of the Administration (FDA or Agency) is
written/paper submission and in the
approximate time requested to make announcing the availability of the final
manner detailed (see ‘‘Written/Paper
their presentation on or before April 24, guidance entitled ‘‘Considerations for
Submissions’’ and ‘‘Instructions’’).
2018. Time allotted for each Design, Development, and Analytical
presentation may be limited. If the Validation of Next Generation Written/Paper Submissions
number of registrants requesting to Sequencing (NGS)-Based In Vitro Submit written/paper submissions as
speak is greater than can be reasonably Diagnostics (IVDs) Intended to Aid in follows:
accommodated during the scheduled the Diagnosis of Suspected Germline • Mail/Hand delivery/Courier (for
open public hearing session, FDA may Diseases; Guidance for Stakeholders and written/paper submissions): Dockets
conduct a lottery to determine the Food and Drug Administration Staff.’’ Management Staff (HFA–305), Food and
speakers for the scheduled open public FDA’s vision is that NGS-based tests can Drug Administration, 5630 Fishers
hearing session. The contact person will be developed, validated, and offered for Lane, Rm. 1061, Rockville, MD 20852.
notify interested persons regarding their clinical use through a process that • For written/paper comments
request to speak by April 25, 2018. leverages appropriate standards, quality submitted to the Dockets Management
systems controls, and community Staff, FDA will post your comment, as
Persons attending FDAs advisory assessment of clinical validity to well as any attachments, except for
committee meetings are advised that streamline the premarket review information submitted, marked and
FDA is not responsible for providing process. This guidance provides identified, as confidential, if submitted
access to electrical outlets. recommendations for designing, as detailed in ‘‘Instructions.’’
For press inquiries, please contact the developing, and establishing analytical Instructions: All submissions received
Office of Media Affairs at fdaoma@ performance for NGS-based tests used must include the Docket No. FDA–
fda.hhs.gov or 301–796–4540. for whole exome human DNA 2016–D–1270 for ‘‘Considerations for
FDA welcomes the attendance of the sequencing (WES) or targeted human Design, Development, and Analytical
public at its advisory committee DNA sequencing intended to aid in the Validation of Next Generation
meetings and will make every effort to diagnosis of symptomatic individuals Sequencing (NGS)-Based In Vitro
accommodate persons with disabilities. with suspected germline diseases or Diagnostics (IVDs) Intended to Aid in
If you require accommodations due to a other conditions. These the Diagnosis of Suspected Germline
disability, please contact Cindy Chee recommendations are based on FDA’s Diseases; Guidance for Stakeholders and
(see FOR FURTHER INFORMATION CONTACT) understanding of the tools and Food and Drug Administration Staff.’’
at least 7 days in advance of the processes needed to run an NGS-based Received comments will be placed in
meeting. test along with the design and analytical the docket and, except for those
validation considerations appropriate submitted as ‘‘Confidential
FDA is committed to the orderly for such tests. Submissions,’’ publicly viewable at
conduct of its advisory committee https://www.regulations.gov or at the
DATES: The announcement of the
meetings. Please visit our website at Dockets Management Staff between 9
guidance is published in the Federal
https://www.fda.gov/Advisory a.m. and 4 p.m., Monday through
Register on April 13, 2018.
Committees/AboutAdvisoryCommittees/ Friday.
ADDRESSES: You may submit either
ucm111462.htm for procedures on • Confidential Submissions—To
public conduct during advisory electronic or written comments on
Agency guidances at any time as submit a comment with confidential
committee meetings. information that you do not wish to be
follows:
Notice of this meeting is given under made publicly available, submit your
the Federal Advisory Committee Act (5 Electronic Submissions comments only as a written/paper
daltland on DSKBBV9HB2PROD with NOTICES
U.S.C. app. 2). Submit electronic comments in the submission. You should submit two
Dated: April 10, 2018. following way: copies total. One copy will include the
• Federal eRulemaking Portal: information you claim to be confidential
Leslie Kux,
https://www.regulations.gov. Follow the with a heading or cover note that states
Associate Commissioner for Policy. instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2018–07747 Filed 4–12–18; 8:45 am] Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P including attachments, to https:// Agency will review this copy, including
VerDate Sep<11>2014 17:41 Apr 12, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1](https://thefederalregister.org/doc/83_FR_16176/page/3.svg)
Document Created: 2018-04-13 00:18:03
Document Modified: 2018-04-13 00:18:03
| 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 May 1, 2018, from 10 a.m. to 3:30 p.m. | |
| Contact | Cindy Chee, 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 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 16104 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR