80 FR 69229 - Food Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 216 (November 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 216 (November 9, 2015)
| Page Range | 69229-69229 | |
| FR Document | 2015-28387 |
[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)] [Notices] [Page 69229] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28387] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Food Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Food Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on December 7 and 8, 2015, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503A), 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. Contact Person: Karen Strambler, Center for Food Safety and Applied Nutrition, HFS-024, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, 240-402-2589, 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. Agenda: The Food Advisory Committee will meet to discuss FDA's policies related to the presence of Listeria monocytogenes in foods. 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 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 November 20, 2015. Oral presentations from the public will be scheduled between approximately 11 a.m. to 12 p.m. on December 8, 2015. 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 November 30, 2015. 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 November 23, 2015. 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 Karen Strambler 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: November 3, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-28387 Filed 11-6-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices 69229
the Social Security Act and 42 CFR (FDA). The meeting will be open to the submissions may be made to the contact
424.100, allows payment of Medicare public. person on or before November 20, 2015.
benefits for a Medicare beneficiary to a Name of Committee: Food Advisory Oral presentations from the public will
nonparticipating hospital that does not Committee. be scheduled between approximately 11
have an agreement in effect with the General Function of the Committee: a.m. to 12 p.m. on December 8, 2015.
Centers for Medicare and Medicaid To provide advice and Those individuals interested in making
Services. These payments can be made recommendations to the Agency on formal oral presentations should notify
if such services were emergency FDA’s regulatory issues.
Date and Time: The meeting will be the contact person and submit a brief
services and if CMS would be required statement of the general nature of the
to make the payment if the hospital had held on December 7 and 8, 2015, from
8 a.m. to 5 p.m. evidence or arguments they wish to
an agreement in effect and met the
Location: FDA White Oak Campus, present, the names and addresses of
conditions of payment. This form is
used in connection with claims for 10903 New Hampshire Ave., Bldg. 31 proposed participants, and an
emergency hospital services provided Conference Center, the Great Room (rm. indication of the approximate time
by hospitals that do not have an 1503A), Silver Spring, MD 20993–0002. requested to make their presentation on
agreement in effect under section 1866 Answers to commonly asked questions or before November 30, 2015. Time
of the Social Security Act. As specified including information regarding special allotted for each presentation may be
in 42 CFR 424.103(b), before a non- accommodations due to a disability, limited. If the number of registrants
participating hospital may be paid for visitor parking, and transportation may requesting to speak is greater than can
emergency services rendered to a be accessed at: http://www.fda.gov/ be reasonably accommodated during the
Medicare beneficiary, a statement must AdvisoryCommittees/ scheduled open public hearing session,
be submitted that is sufficiently AboutAdvisoryCommittees/ FDA may conduct a lottery to determine
comprehensive to support that an ucm408555.htm. the speakers for the scheduled open
emergency existed. Form CMS–1771 Contact Person: Karen Strambler, public hearing session. The contact
contains a series of questions relating to Center for Food Safety and Applied
person will notify interested persons
the medical necessity of the emergency. Nutrition, HFS–024, Food and Drug
regarding their request to speak by
The attending physician must attest that Administration, 5100 Paint Branch
Parkway, College Park, MD 20740, 240– November 23, 2015.
the hospitalization was required under
the regulatory emergency definition and 402–2589, or FDA Advisory Committee Persons attending FDA’s advisory
give clinical documentation to support Information Line, 1–800–741–8138 committee meetings are advised that the
the claim. A photocopy of the (301–443–0572 in the Washington, DC Agency is not responsible for providing
beneficiary’s hospital records may be area). A notice in the Federal Register access to electrical outlets.
used in lieu of the CMS–1771 if the about last minute modifications that FDA welcomes the attendance of the
records contain all the information impact a previously announced public at its advisory committee
required by the form. Form Number: advisory committee meeting cannot meetings and will make every effort to
CMS–1771 (OMB control number: always be published quickly enough to accommodate persons with disabilities.
0938–0023); Frequency: Annually; provide timely notice. Therefore, you
If you require accommodations due to a
Affected Public: Private sector (Business should always check the Agency’s Web
disability, please contact Karen
or other for-profits and Not-for-profit site at http://www.fda.gov/
AdvisoryCommittees/default.htm and Strambler at least 7 days in advance of
institutions); Number of Respondents: the meeting.
100; Total Annual Responses: 200; Total scroll down to the appropriate advisory
Annual Hours: 50. (For policy questions committee meeting link, or call the FDA is committed to the orderly
regarding this collection contact advisory committee information line to conduct of its advisory committee
Shauntari Cheely at 410–786–1818.) learn about possible modifications meetings. Please visit our Web site at
before coming to the meeting. http://www.fda.gov/
Dated: November 4, 2015. Agenda: The Food Advisory AdvisoryCommittees/
William N. Parham, III Committee will meet to discuss FDA’s AboutAdvisoryCommittees/
Director, Paperwork Reduction Staff, Office policies related to the presence of
of Strategic Operations and Regulatory
ucm111462.htm for procedures on
Listeria monocytogenes in foods. public conduct during advisory
Affairs. FDA intends to make background
[FR Doc. 2015–28448 Filed 11–6–15; 8:45 am] committee meetings.
material available to the public no later
BILLING CODE 4120–01–P than 2 business days before the meeting. Notice of this meeting is given under
If FDA is unable to post the background the Federal Advisory Committee Act (5
material on its Web site prior to the U.S.C. app. 2).
DEPARTMENT OF HEALTH AND meeting, the background material will Dated: November 3, 2015.
HUMAN SERVICES be made publicly available at the Leslie Kux,
Food and Drug Administration location of the advisory committee
Associate Commissioner for Policy.
meeting, and the background material
[Docket No. FDA–2015–N–0001] [FR Doc. 2015–28387 Filed 11–6–15; 8:45 am]
will be posted on FDA’s Web site after
the meeting. Background material is BILLING CODE 4164–01–P
Food Advisory Committee; Notice of available at http://www.fda.gov/
Meeting AdvisoryCommittees/Calendar/
srobinson on DSK5SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration, default.htm. Scroll down to the
HHS. appropriate advisory committee meeting
ACTION: Notice. link.
Procedure: Interested persons may
This notice announces a forthcoming present data, information, or views,
meeting of a public advisory committee orally or in writing, on issues pending
of the Food and Drug Administration before the committee. Written
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Document Created: 2015-12-14 15:05:04
Document Modified: 2015-12-14 15:05:04
| 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. | |
| FR Citation | 80 FR 69229 |
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