81_FR_32041 81 FR 31943 - Advisory Committees; Filing of Closed Meeting Reports

81 FR 31943 - Advisory Committees; Filing of Closed Meeting Reports

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 98 (May 20, 2016)

Page Range31943-31944
FR Document2016-11853

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2015.

Federal Register, Volume 81 Issue 98 (Friday, May 20, 2016) 
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31943-31944]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advisory Committees; Filing of Closed Meeting Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that, as 
required by the Federal Advisory Committee Act, the Agency has filed 
with the Library of Congress the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2015.

ADDRESSES: Copies are available at the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500. You also may access the docket at 
http://www.regulations.gov for the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2015. Insert 
the docket number found in brackets in the heading of this document at 
http://www.regulations.gov into the ``Search'' box, clear filter under 
Document Type (left side of screen), and check ``Supporting and Related 
Material,'' then Sort By Best Match (from the drop-down menu; top right 
side of screen), ``ID Number (Z-A)'' or Sort By Best Match (from the 
drop-down menu) ``Title (A-Z),'' also found in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Director and 
Committee Management Officer,

[[Page 31944]]

Advisory Committee and Oversight Management Staff, Food and Drug 
Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-
0002, 301-796-8220.

SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory 
Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with 
the Library of Congress the annual reports for the following FDA 
advisory committees that held closed meetings during the period October 
1, 2014 through September 30, 2015:

Center for Biologics Evaluation and Research
    Blood Products Advisory Committee
National Center for Toxicological Research
    Science Board to the National Center for Toxicological Research
Center for Drug Evaluation and Research
    Bone, Reproductive Health Drugs Advisory Committee
    Joint Meetings of the Anesthetic and Analgesic Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee

    Annual Reports are available for public inspections between 9 a.m. 
and 4 p.m., Monday through Friday.
    1. The Library of Congress, Madison Bldg., Newspaper and Current 
Periodical Reading Room, 101 Independence Ave. SE., Rm. 133, 
Washington, DC; and
    2. The Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: May 16, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11853 Filed 5-19-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31943 presentations and comments for 508 property, must register by following the will be posted to the CMS Web site after compliance, and place compliant instructions in the ‘‘Meeting the meeting. materials on its Web site. As resources Registration Timeframe’’ section of this X. Collection of Information permit, CMS will also convert non- notice. A confirmation email will be Requirements compliant submissions to 508 compliant sent to the registrants shortly after forms, and offer assistance to submitters completing the registration process. This document does not impose who wish to make their submissions information collection requirements, VII. Security, Building, and Parking that is, reporting, recordkeeping or 508 compliant. All non-508 compliant Guidelines third-party disclosure requirements. presentations and comments will be shared with the public onsite and The following are the security, Consequently, there is no need for through the webcast and made available building, and parking guidelines: review by the Office of Management and to the public upon request. • Persons attending the meeting, Budget under the authority of the Those wishing to access such including presenters, must be pre- Paperwork Reduction Act of 1995 (44 materials should contact the DFO (the registered and on the attendance list by U.S.C. 3501 et seq.). DFO’s address, email and phone the prescribed date. Dated: April 28, 2016. number are provided below). • Individuals who are not pre- Andrew M. Slavitt, In order to consider presentations registered in advance may not be permitted to enter the building and may Acting Administrator, Centers for Medicare and/or comments, we will need to & Medicaid Services. receive the following: be unable to attend the meeting. 1. An email copy of the presentation • Attendees must present a [FR Doc. 2016–11949 Filed 5–19–16; 8:45 am] government-issued photo identification BILLING CODE 4120–01–P or comments sent to the DFO mailbox, APCPanel@cms.hhs.gov or, if unable to to the Federal Protective Service or submit by email, a hard copy sent to the Guard Service personnel before entering the building. Without a current, valid DEPARTMENT OF HEALTH AND DFO at the address noted under FOR photo ID, persons may not be permitted HUMAN SERVICES FURTHER INFORMATION CONTACT. 2. Form CMS–20017 with complete entry to the building. Food and Drug Administration contact information that includes name, • Security measures include address, phone number, and email inspection of vehicles, inside and out, at [Docket No. FDA–2016–N–0001] addresses for all presenters and the entrance to the grounds. commenters and a contact person that • All persons entering the building Advisory Committees; Filing of Closed can answer any questions and or must pass through a metal detector. Meeting Reports provide revisions that are requested for • All items brought into CMS AGENCY: Food and Drug Administration, the presentation. Presenters and including personal items, for example, HHS. commenters must clearly explain the laptops and cell phones are subject to ACTION: Notice. actions that they are requesting CMS to physical inspection. take in the appropriate section of the • The public may enter the building SUMMARY: The Food and Drug form. A presenter’s/commenter’s 30 to 45 minutes before the meeting Administration (FDA) is announcing relationship with the organization that convenes each day. that, as required by the Federal they represent must also be clearly • All visitors must be escorted in Advisory Committee Act, the Agency listed. areas other than the lower and first-floor has filed with the Library of Congress • The form is now available through levels in the Central Building. the annual reports of those FDA the CMS Forms Web site. The Uniform • The main-entrance guards will advisory committees that held closed Resource Locator (URL) for linking to issue parking permits and instructions meetings during fiscal year 2015. this form is as follows: http://www.cms. upon arrival at the building. ADDRESSES: Copies are available at the hhs.gov/cmsforms/downloads/ • Foreign nationals visiting any CMS facility require prior approval. If you are Dockets Management Branch (HFA– cms20017.pdf. 305), Food and Drug Administration, • We encourage presenters to make a foreign national and wish to attend the 5630 Fishers Lane, Rm. 1061, Rockville, efforts to ensure that their presentations meeting onsite, in addition to registering for the meeting, you must also send a MD 20852, 240–402–7500. You also and comments are 508 compliant. may access the docket at http:// separate email to V. Oral Comments APCPanel@cms.hhs.gov prior to the www.regulations.gov for the annual In addition to formal oral close of registration to request reports of those FDA advisory presentations, which are limited to 5 authorization to attend as a foreign committees that held closed meetings minutes total per presentation, there national. during fiscal year 2015. Insert the will be an opportunity during the docket number found in brackets in the VIII. Special Accommodations heading of this document at http:// meeting for public oral comments, which will be limited to 1 minute for Individuals requiring special www.regulations.gov into the ‘‘Search’’ each individual and a total of 3 minutes accommodations must include the box, clear filter under Document Type per organization. request for these services during (left side of screen), and check registration. ‘‘Supporting and Related Material,’’ VI. Meeting Attendance then Sort By Best Match (from the drop- The meeting is open to the public; IX. Panel Recommendations and down menu; top right side of screen), mstockstill on DSK3G9T082PROD with NOTICES however, attendance is limited to space Discussions ‘‘ID Number (Z–A)’’ or Sort By Best available. Priority will be given to those The Panel’s recommendations at any Match (from the drop-down menu) who pre-register and attendance may be Panel meeting generally are not final ‘‘Title (A–Z),’’ also found in the heading limited based on the number of until they have been reviewed and of this document. registrants and the space available. approved by the Panel on the last day FOR FURTHER INFORMATION CONTACT: Persons wishing to attend this of the meeting, before the final Michael Ortwerth, Director and meeting, which is located on Federal adjournment. These recommendations Committee Management Officer, VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1

31944 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices Advisory Committee and Oversight ACTION: Notice. 2016–M–0803, FDA–2016–M–0804, Management Staff, Food and Drug FDA–2016–M–0805, FDA–2016–M– Administration, 10903 New Hampshire SUMMARY: The Food and Drug 0806, FDA–2016–M–0807, FDA–2016– Avenue, Silver Spring, MD 20993–0002, Administration (FDA) is publishing a M–0926, FDA–2016–M–0928 for 301–796–8220. list of premarket approval applications ‘‘Medical Devices; Availability of Safety (PMAs) that have been approved. This and Effectiveness Summaries for SUPPLEMENTARY INFORMATION: Under list is intended to inform the public of Premarket Approval Applications.’’ section 10(d) of the Federal Advisory the availability of safety and Received comments will be placed in Committee Act (5 U.S.C. app.) and 21 effectiveness summaries of approved the docket and, except for those CFR 14.60(d), FDA has filed with the PMAs through the Internet and the submitted as ‘‘Confidential Library of Congress the annual reports Agency’s Division of Dockets Submissions,’’ publicly viewable at for the following FDA advisory Management. http://www.regulations.gov or at the committees that held closed meetings during the period October 1, 2014 ADDRESSES: You may submit comments Division of Dockets Management through September 30, 2015: as follows: between 9 a.m. and 4 p.m., Monday Center for Biologics Evaluation and Electronic Submissions through Friday. Research Submit electronic comments in the • Confidential Submissions—To Blood Products Advisory Committee submit a comment with confidential National Center for Toxicological following way: • Federal eRulemaking Portal: http:// information that you do not wish to be Research made publicly available, submit your Science Board to the National Center www.regulations.gov. Follow the instructions for submitting comments. comments only as a written/paper for Toxicological Research submission. You should submit two Center for Drug Evaluation and Comments submitted electronically, including attachments, to http:// copies total. One copy will include the Research information you claim to be confidential Bone, Reproductive Health Drugs www.regulations.gov will be posted to the docket unchanged. Because your with a heading or cover note that states Advisory Committee Joint Meetings of the Anesthetic and comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS Analgesic Drugs Advisory solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The Committee and the Drug Safety and comment does not include any Agency will review this copy, including Risk Management Advisory confidential information that you or a the claimed confidential information, in Committee third party may not wish to be posted, its consideration of comments. The such as medical information, your or second copy, which will have the Annual Reports are available for claimed confidential information public inspections between 9 a.m. and anyone else’s Social Security number, or confidential business information, such redacted/blacked out, will be available 4 p.m., Monday through Friday. for public viewing and posted on http:// 1. The Library of Congress, Madison as a manufacturing process. Please note that if you include your name, contact www.regulations.gov. Submit both Bldg., Newspaper and Current copies to the Division of Dockets Periodical Reading Room, 101 information, or other information that identifies you in the body of your Management. If you do not wish your Independence Ave. SE., Rm. 133, name and contact information to be Washington, DC; and comments, that information will be posted on http://www.regulations.gov. made publicly available, you can 2. The Dockets Management Branch provide this information on the cover (HFA–305), Food and Drug • If you want to submit a comment with confidential information that you sheet and not in the body of your Administration, 5630 Fishers Lane, Rm. comments and you must identify this 1061, Rockville, MD 20852. do not wish to be made available to the public, submit the comment as a information as ‘‘confidential.’’ Any Dated: May 16, 2016. information marked as ‘‘confidential’’ written/paper submission and in the Jill Hartzler Warner, manner detailed (see ‘‘Written/Paper will not be disclosed except in Associate Commissioner for Special Medical Submissions’’ and ‘‘Instructions’’). accordance with 21 CFR 10.20 and other Programs. applicable disclosure law. For more [FR Doc. 2016–11853 Filed 5–19–16; 8:45 am] Written/Paper Submissions information about FDA’s posting of BILLING CODE 4164–01–P Submit written/paper submissions as comments to public dockets, see 80 FR follows: 56469, September 18, 2015, or access • Mail/Hand delivery/Courier (for the information at: http://www.fda.gov/ DEPARTMENT OF HEALTH AND written/paper submissions): Division of regulatoryinformation/dockets/ HUMAN SERVICES Dockets Management (HFA–305), Food default.htm. and Drug Administration, 5630 Fishers Docket: For access to the docket to Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. read background documents or the [Docket Nos. FDA–2015–M–4948, FDA– • For written/paper comments electronic and written/paper comments 2015–M–4949, FDA–2015–M–4950, FDA– submitted to the Division of Dockets received, go to http:// 2016–M–0120, FDA–2016–M–0121, FDA– Management, FDA will post your www.regulations.gov and insert the 2016–M–0122, FDA–2016–M–0123, FDA– comment, as well as any attachments, docket number, found in brackets in the 2016–M–0803, FDA–2016–M–0804, FDA– except for information submitted, 2016–M–0805, FDA–2016–M–0806, FDA– heading of this document, into the marked and identified, as confidential, ‘‘Search’’ box and follow the prompts 2016–M–0807, FDA–2016–M–0926, FDA– if submitted as detailed in mstockstill on DSK3G9T082PROD with NOTICES 2016–M–0928] and/or go to the Division of Dockets ‘‘Instructions.’’ Management, 5630 Fishers Lane, Rm. Instructions: All submissions received Medical Devices; Availability of Safety 1061, Rockville, MD 20852. must include the Docket Nos. FDA– and Effectiveness Summaries for 2015–M–4948, FDA–2015–M–4949, FOR FURTHER INFORMATION CONTACT: Premarket Approval Applications FDA–2015–M–4950, FDA–2016–M– Joshua Nipper, Center for Devices and AGENCY: Food and Drug Administration, 0120, FDA–2016–M–0121, FDA–2016– Radiological Health, Food and Drug HHS. M–0122, FDA–2016–M–0123, FDA– Administration, 10903 New Hampshire VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1


Document Created: 2016-05-20 01:59:59
Document Modified: 2016-05-20 01:59:59
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.
ContactMichael Ortwerth, Director and Committee Management Officer, Advisory Committee and Oversight Management Staff, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993- 0002, 301-796-8220.
FR Citation81 FR 31943 
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