80 FR 79345 - Allergenic Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 244 (December 21, 2015)

Page Range		79345-79346
FR Document		2015-31894

Federal Register, Volume 80 Issue 244 (Monday, December 21, 2015)

[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79345-79346]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Allergenic Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Allergenic Products 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 January 21, 2016, from 
8:30 a.m. to 4 p.m.
    Location: 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.
    Contact Person: Janie Kim or Denise Royster, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301-796-9016 or 
240-402-8158, email: [email protected] or 
[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

[[Page 79346]]

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: On January 21, 2016, the Committee will meet in an open 
session to discuss safety and effectiveness data, including challenge 
study endpoints, for licensure of food allergy immunotherapy products, 
and the clinical development of aeroallergen immunotherapy products for 
the prevention of respiratory allergic disease.
    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 
January 6, 2016. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 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 December 29, 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 December 31, 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 Janie Kim 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: December 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-31894 Filed 12-18-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices 79345

additional fee/profit for exceptional (including education and outreach) with Federal Register documents, we are not
performance in areas critical to the providers? able to acknowledge or respond to them
success of the Medicare FFS program. Section 509(c) of MACRA directs us individually. We will consider all
For example, and specific to provider to make some MAC performance metrics comments we receive by the date and
satisfaction, we currently measure, available to the public, to the extent that time specified in the DATES section of
evaluate, and reward MACs for the doing so can be done in a manner that this preamble, and, when we issue a
quality (accuracy, completeness, does not compromise the competitive subsequent document, we will respond
customer skills, and adherence to the procurement process. Therefore, we are to the comments in the preamble to that
Privacy Act of 1974) of their customer requesting comment on the following document.
service representatives’ responses to questions regarding MAC performance Dated: November 23, 2015.
provider telephone calls and the transparency: Andrew M. Slavitt,
providers’ level of satisfaction with the • With regard to the MAC’s quality
and level of service and performance, Acting Administrator, Centers for Medicare
MAC’s Web site. The amount of award
& Medicaid Services.
fee earned by the MAC is based on our what types or kinds of information
[FR Doc. 2015–32027 Filed 12–18–15; 8:45 am]
comprehensive evaluation of the MAC’s should be published for public release?
performance against specific, written • If we were to publish the results of BILLING CODE 4120–01–P

quality measures and evaluation the evaluation of a MAC’s performance
criteria. on our Web site, which types of metrics
Prior to the enactment of MACRA, the or information should be made available DEPARTMENT OF HEALTH AND
law required that MAC contracts be for public release? HUMAN SERVICES
recompeted no less frequently than once We are also soliciting public comment Food and Drug Administration
every 5 years, which created the on potential MAC jurisdictional
potential for frequent turnover in these changes. Currently, there are 12 A/B [Docket No. FDA–2015–N–0001]
critical contracts and disruption for MAC jurisdictions; in 2010, we
Medicare providers and suppliers. With announced a plan to consolidate FFS Allergenic Products Advisory
the enactment of MACRA, we are now claims operations to 10 A/B MAC Committee; Notice of Meeting
able to renew a MAC contract for up to jurisdictions over the course of several AGENCY: Food and Drug Administration,
10 years and reduce the potential for years. However, in 2014, we announced HHS.
frequent turnover if the MAC meets or that we were postponing the ACTION: Notice.
exceeds our performance objectives; consolidation of Jurisdictions 8 (which
conversely, we may still utilize encompasses the states of Indiana and This notice announces a forthcoming
competitive procedures sooner than 10 Michigan) and 15 (which encompasses meeting of a public advisory committee
years in the event that a MAC does not Kentucky and Ohio) to form of the Food and Drug Administration
meet our performance objectives. In ‘‘Jurisdiction I’’ and the consolidation of (FDA). The meeting will be open to the
concert with or in (partial or full) Jurisdictions 5 (Iowa, Kansas, Missouri public.
replacement of our award fee process, and Nebraska) and 6 (Illinois, Name of Committee: Allergenic
we are considering incorporating an Minnesota, and Wisconsin) to form Products Advisory Committee.
‘‘award term’’ concept into MAC ‘‘Jurisdiction G.’’ For more information General Function of the Committee:
contracting, meaning that we may on our 2010 strategy for consolidating To provide advice and
incentivize and reward consistently, A/B MAC jurisdictions, as well as our recommendations to the Agency on
well-performing MACs with a longer- 2014 decision to postpone the final 2 FDA’s regulatory issues.
term contract (but not longer than 10 jurisdictional consolidations, see Date and Time: The meeting will be
years). For example, MACs that https://www.cms.gov/Medicare/ held on January 21, 2016, from 8:30 a.m.
consistently exceed our performance Medicare-Contracting/Medicare- to 4 p.m.
standards may be rewarded with a Administrative-Contractors/Downloads/ Location: FDA White Oak Campus,
longer-term contract (up to 10 years); RFI-Announcement-AB–MAC-March- 10903 New Hampshire Ave., Bldg. 31
whereas, MACs that do not consistently 2014.pdf Conference Center, the Great Room (rm.
exceed our performance standards may Accordingly, we are requesting 1503), Silver Spring, MD 20993–0002.
be limited to a shorter-term contract comment on the following question: Answers to commonly asked questions
(more or less than 5 years). Therefore, • What would the advantages and including information regarding special
we are soliciting public comment on the disadvantages be if CMS completed the accommodations due to a disability,
following questions regarding MAC last two MAC consolidations? visitor parking, and transportation may
incentives for exceptional performance: be accessed at: http://www.fda.gov/
• Do you have any concerns or III. Collection of Information AdvisoryCommittees/AboutAdvisory
suggestions related to development of a Requirements Committees/ucm408555.htm.
potential ‘‘award term’’ strategy and This request for information Contact Person: Janie Kim or Denise
plan? document does not impose any Royster, Center for Biologics Evaluation
• Do you have any other suggestions information collection requirements. In and Research, Food and Drug
for incentivizing and rewarding accordance with the implementing Administration, 10903 New Hampshire
exceptional MAC performance? regulations of the Paperwork Reduction Ave., Bldg. 71, Silver Spring, MD
• Are there any specific metrics or Act of 1995 (PRA) at 5 CFR 1320.3(h)(4), 20993–0002, 301–796–9016 or 240–
mstockstill on DSK4VPTVN1PROD with NOTICES

evaluation criteria that would be we believe it is a general solicitation of 402–8158, email: Janie.kim@fda.hhs.gov
valuable in measuring the level and comments from the public. Therefore, it or Denise.royster@fda.hhs.gov, or FDA
quality of the service provided by a is exempt from the requirements of the Advisory Committee Information Line,
MAC? PRA (44 U.S.C. 3501 et seq.). 1–800–741–8138 (301–443–0572 in the
• Are there any specific metrics or Washington, DC area). A notice in the
evaluation criteria that would be IV. Response to Comments Federal Register about last minute
valuable in measuring the level and Because of the large number of public modifications that impact a previously
quality of the MAC’s relationships comments we normally receive on announced advisory committee meeting

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Document Created: 2015-12-19 02:57:33
Document Modified: 2015-12-19 02:57:33

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 79345

80 FR 79345 - Allergenic Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 244 (December 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration