81_FR_59807 81 FR 59639 - Antimicrobial Drugs Advisory Committee; Notice of Meeting

81 FR 59639 - Antimicrobial Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 168 (August 30, 2016)

Page Range59639-59640
FR Document2016-20765

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.

Federal Register, Volume 81 Issue 168 (Tuesday, August 30, 2016) 
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59639-59640]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20765]


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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.

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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.

DATES: The meeting will be held on November 4, 2016, from 8:30 a.m. to 
5 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

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 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: The committee will discuss new drug applications 209006 and 
209007, solithromycin capsules and solithromycin for injection, 
sponsored by Cempra Pharmaceuticals, Inc., respectively, for the 
proposed indication of treatment of community-acquired bacterial 
pneumonia.
    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

[[Page 59640]]

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 
October 21, 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 October 13, 2016. 
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 October 14, 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: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20765 Filed 8-29-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices 59639 MD 20993–0002. Send one self- Policy on National Health Related Item function of the committee is to provide addressed adhesive label to assist that Code and National Drug Code Numbers advice and recommendations to the office in processing your request. Assigned to Devices’’. It does not Agency on FDA’s regulatory issues. The FOR FURTHER INFORMATION CONTACT: UDI establish any rights for any person and meeting will be open to the public. Regulatory Policy Support, Center for is not binding on FDA or the public. DATES: The meeting will be held on Devices and Radiological Health, Food You can use an alternative approach if November 4, 2016, from 8:30 a.m. to 5 and Drug Administration, 10903 New it satisfies the requirements of the p.m. Hampshire Ave., Bldg. 66, Rm. 3303, applicable statutes and regulations. ADDRESSES: FDA White Oak Campus, Silver Spring, MD 20993–0002, 301– III. Electronic Access 10903 New Hampshire Ave., Bldg. 31 796–5995, GUDIDSupport@fda.hhs.gov. Conference Center, the Great Room (Rm. Persons interested in obtaining a copy SUPPLEMENTARY INFORMATION: of the guidance may do so by 1503), Silver Spring, MD 20993–0002. downloading an electronic copy from Answers to commonly asked questions I. Background the Internet. A search capability for all including information regarding special In the Federal Register of February 3, Center for Devices and Radiological accommodations due to a disability, 2016, FDA announced the availability of Health guidance documents is available visitor parking, and transportation may ‘‘Draft Guidance for Industry and Food at http://www.fda.gov/MedicalDevices/ be accessed at: http://www.fda.gov/ and Drug Administration Staff: DeviceRegulationandGuidance/ AdvisoryCommittees/ Enforcement Policy on National Health GuidanceDocuments/default.htm. AboutAdvisoryCommittees/ Related Item Code and National Drug Guidance documents are also available ucm408555.htm. Code Numbers Assigned to Devices’’ (81 at http://www.regulations.gov. Persons FOR FURTHER INFORMATION CONTACT: FR 5760) (the ‘‘Draft Guidance’’). The unable to download an electronic copy Lauren D. Tesh, Center for Drug Draft Guidance described FDA’s intent of ‘‘Enforcement Policy on National Evaluation and Research, Food and not to enforce before September 24, Health Related Item Code and National Drug Administration, 10903 New 2021, the prohibition against providing Drug Code Numbers Assigned to Hampshire Ave., Bldg. 31, Rm. 2417, NHRIC and NDC numbers on device Devices’’ may send an email request to Silver Spring, MD 20993–0002, 301– labels and device packages of certain CDRH-Guidance@fda.hhs.gov to receive 796–9001, Fax: 301–847–8533, devices that are manufactured and an electronic copy of the document. AMDAC@fda.hhs.gov, or FDA Advisory labeled prior to September 24, 2018. Please use the document number Committee Information Line, 1–800– Interested persons were invited to GUD1500044 to identify the guidance 741–8138 (301–443–0572 in the comment by April 4, 2016. you are requesting. Washington, DC area). A notice in the FDA received 13 sets of comments on IV. Paperwork Reduction Act of 1995 Federal Register about last minute the Draft Guidance, the majority of modifications that impact a previously which commented that stakeholders, This guidance refers to previously announced advisory committee meeting including supply chain participants, approved collections of information cannot always be published quickly pharmacies, and payers, would not be found in FDA regulations. These enough to provide timely notice. able to complete the work to transition collections of information are subject to Therefore, you should always check the away from use of NHRIC and NDC review by the Office of Management and Agency’s Web site at http:// numbers by September 24, 2018. Some Budget (OMB) under the Paperwork www.fda.gov/AdvisoryCommittees/ commenters also expressed concern that Reduction Act of 1995 (44 U.S.C. 3501– default.htm and scroll down to the after September 24, 2021, retailers and 3520). The collections of information in appropriate advisory committee meeting pharmacies would need to send some 21 CFR part 801, subparts A and B have link, or call the advisory committee devices with shelf lives exceeding 3 been approved under OMB control information line to learn about possible years, and with NHRIC or NDC numbers number 0910–0720. modifications before coming to the on their labels or device packages, back Dated: August 24, 2016. meeting. to the device labelers. Leslie Kux, SUPPLEMENTARY INFORMATION: FDA has revised the guidance to reflect the Agency’s intent not to enforce Associate Commissioner for Policy. Agenda: The committee will discuss the prohibition against providing [FR Doc. 2016–20766 Filed 8–29–16; 8:45 am] new drug applications 209006 and NHRIC and NDC numbers on device BILLING CODE 4164–01–P 209007, solithromycin capsules and labels and device packages, with respect solithromycin for injection, sponsored to finished devices that are by Cempra Pharmaceuticals, Inc., manufactured and labeled prior to DEPARTMENT OF HEALTH AND respectively, for the proposed indication September 24, 2021. We expect the UDI HUMAN SERVICES of treatment of community-acquired labeling requirements will be fully bacterial pneumonia. Food and Drug Administration implemented by September 24, 2021. FDA intends to make background We also believe additional time is [Docket No. FDA–2016–N–0001] material available to the public no later appropriate for stakeholders to adopt than 2 business days before the meeting. medical device reimbursement, supply Antimicrobial Drugs Advisory If FDA is unable to post the background chain, and procurement systems, which Committee; Notice of Meeting material on its Web site prior to the do not depend on having an NHRIC or AGENCY: Food and Drug Administration, meeting, the background material will be made publicly available at the mstockstill on DSK3G9T082PROD with NOTICES NDC number on the device label. HHS. ACTION: Notice. location of the advisory committee II. Significance of Guidance meeting, and the background material This guidance is being issued SUMMARY: The Food and Drug will be posted on FDA’s Web site after consistent with FDA’s good guidance Administration (FDA) announces a the meeting. Background material is practices regulation (21 CFR 10.115). forthcoming public advisory committee available at http://www.fda.gov/ The guidance represents the current meeting of the Antimicrobial Drugs AdvisoryCommittees/Calendar/ thinking of FDA on ‘‘Enforcement Advisory Committee. The general default.htm. Scroll down to the VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1

59640 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices appropriate advisory committee meeting DEPARTMENT OF HEALTH AND as a manufacturing process. Please note link. HUMAN SERVICES that if you include your name, contact Procedure: Interested persons may information, or other information that Food and Drug Administration identifies you in the body of your present data, information, or views, [Docket No. FDA–2014–D–0055] comments, that information will be orally or in writing, on issues pending posted on http://www.regulations.gov. before the committee. Written • If you want to submit a comment submissions may be made to the contact Voluntary Sodium Reduction Goals: Target Mean and Upper Bound with confidential information that you person on or before October 21, 2016. do not wish to be made available to the Concentrations for Sodium in Oral presentations from the public will public, submit the comment as a Commercially Processed, Packaged, be scheduled between approximately and Prepared Foods; Draft Guidance written/paper submission and in the 1:30 p.m. and 2:30 p.m. Those for Industry; Extension of Comment manner detailed (see ‘‘Written/Paper individuals interested in making formal Periods Submissions’’ and ‘‘Instructions’’). oral presentations should notify the AGENCY: Food and Drug Administration, Written/Paper Submissions contact person and submit a brief statement of the general nature of the HHS. Submit written/paper submissions as evidence or arguments they wish to ACTION:Notice of availability; extension follows: present, the names and addresses of of comment periods. • Mail/Hand delivery/Courier (for proposed participants, and an written/paper submissions): Division of SUMMARY: The Food and Drug Dockets Management (HFA–305), Food indication of the approximate time Administration (FDA or we) is and Drug Administration, 5630 Fishers requested to make their presentation on extending the comment periods for the Lane, Rm. 1061, Rockville, MD 20852. or before October 13, 2016. Time Draft Guidance entitled, ‘‘Voluntary • For written/paper comments allotted for each presentation may be Sodium Reduction Goals: Target Mean submitted to the Division of Dockets limited. If the number of registrants and Upper Bound Concentrations for Management, FDA will post your requesting to speak is greater than can Sodium in Commercially Processed, comment, as well as any attachments, be reasonably accommodated during the Packaged, and Prepared Foods’’ that except for information submitted, scheduled open public hearing session, appeared in the Federal Register of June marked and identified, as confidential, FDA may conduct a lottery to determine 2, 2016. In the notice, we requested if submitted as detailed in the speakers for the scheduled open comments on developing the sodium ‘‘Instructions.’’ public hearing session. The contact targets and for implementation of the Instructions: All submissions received person will notify interested persons guidance document. We are taking this must include the Docket No. FDA– regarding their request to speak by action in response to requests to extend 2014–D–0055 for ‘‘Voluntary Sodium October 14, 2016. the two comment periods to allow Reduction Goals: Target Mean and interested persons additional time to Upper Bound Concentrations for Persons attending FDA’s advisory submit comments. Sodium in Commercially Processed, committee meetings are advised that the Packaged, and Prepared Foods; Draft DATES: We are extending the comment Agency is not responsible for providing Guidance for Industry.’’ Received periods on the draft guidance published access to electrical outlets. June 2, 2016 (81 FR 35363). Submit comments will be placed in the docket FDA welcomes the attendance of the either electronic or written comments and, except for those submitted as public at its advisory committee on Issues 1 through 4 in section IV of ‘‘Confidential Submissions,’’ publicly meetings and will make every effort to the notice of availability that published viewable at http://www.regulations.gov accommodate persons with disabilities. on June 2, 2016, by October 17, 2016. or at the Division of Dockets If you require accommodations due to a Submit either electronic or written Management between 9 a.m. and 4 p.m., disability, please contact Lauren D. Tesh comments on Issues 5 through 8 in Monday through Friday. at least 7 days in advance of the section IV of the notice of availability • Confidential Submissions—To meeting. that published on June 2, 2016, by submit a comment with confidential December 2, 2016. information that you do not wish to be FDA is committed to the orderly made publicly available, submit your ADDRESSES: You may submit comments conduct of its advisory committee comments only as a written/paper as follows: meetings. Please visit our Web site at submission. You should submit two http://www.fda.gov/ Electronic Submissions copies total. One copy will include the AdvisoryCommittees/ Submit electronic comments in the information you claim to be confidential AboutAdvisoryCommittees/ following way: with a heading or cover note that states ucm111462.htm for procedures on • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS public conduct during advisory www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The committee meetings. instructions for submitting comments. Agency will review this copy, including Notice of this meeting is given under Comments submitted electronically, the claimed confidential information, in the Federal Advisory Committee Act (5 including attachments, to http:// its consideration of comments. The U.S.C. app. 2). www.regulations.gov will be posted to second copy, which will have the the docket unchanged. Because your claimed confidential information Dated: August 25, 2016. comment will be made public, you are redacted/blacked out, will be available mstockstill on DSK3G9T082PROD with NOTICES Leslie Kux, solely responsible for ensuring that your for public viewing and posted on http:// Associate Commissioner for Policy. comment does not include any www.regulations.gov. Submit both [FR Doc. 2016–20765 Filed 8–29–16; 8:45 am] confidential information that you or a copies to the Division of Dockets BILLING CODE 4164–01–P third party may not wish to be posted, Management. If you do not wish your such as medical information, your or name and contact information to be anyone else’s Social Security number, or made publicly available, you can confidential business information, such provide this information on the cover VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1


Document Created: 2018-02-09 11:42:17
Document Modified: 2018-02-09 11:42:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on November 4, 2016, from 8:30 a.m. to 5 p.m.
ContactLauren 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.
FR Citation81 FR 59639 
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