80 FR 74113 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 228 (November 27, 2015)

Page Range		74113-74114
FR Document		2015-30121

Federal Register, Volume 80 Issue 228 (Friday, November 27, 2015)

[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74113-74114]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Vaccines and Related Biological 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological 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 14, 2016, from 1 
p.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
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 those unable to attend in person, the meeting will also be 
webcast and will be available at the following link https://collaboration.fda.gov/vrbpacsem1/.
    Contact Person: Sujata Vijh or Denise Royster, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, at 
240-402-7107 and 240-402-8158 respectively, 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

[[Page 74114]]

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: On January 14, 2016, the committee will meet by 
teleconference. In open session, the committee will hear updates of the 
research program in the Laboratory of Method Development, Division of 
Viral Products, Center for Biologics Evaluation and Research, FDA.
    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: On January 14, 2016, from 1 p.m. to 3:35 p.m., the 
meeting is open to the public. 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 7, 2016. Oral presentations from the public will be 
scheduled between approximately 2:35 p.m. and 3:35 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 30, 
2015.
    Closed Committee Deliberations: On January 14, 2016, from 3:35 p.m. 
to 5 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The Committee will discuss the report of 
the intramural research program and make recommendations regarding 
personnel staffing decisions.
    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 Sujata Vijh 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 20, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-30121 Filed 11-25-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices 74113

FOR FURTHER INFORMATION CONTACT: nondiscrimination practices and the this collection contact Kari Gaare at
Reports Clearance Office at (410) 786– availability of alternate forms of this 410–786–8612.)
1326. notice if needed. There are no Dated: November 20, 2015.
SUPPLEMENTARY INFORMATION: substantive changes to the DND form William N. Parham, III,
and instructions. Form Number: CMS– Director, Paperwork Reduction Staff, Office
Contents 10066 (OMB Control Number: 0938– of Strategic Operations and Regulatory
This notice sets out a summary of the 1019); Frequency: Occasionally; Affairs.
use and burden associated with the Affected Public: Private sector (Business [FR Doc. 2015–30070 Filed 11–25–15; 8:45 am]
following information collections. More or other for-profit and Not-for-profit BILLING CODE 4120–01–P
detailed information can be found in institutions); Number of Respondents:
each collection’s supporting statement 6,164; Total Annual Responses: 17,000;
and associated materials (see Total Annual Hours: 17,000. (For policy DEPARTMENT OF HEALTH AND
ADDRESSES). questions regarding this collection HUMAN SERVICES
CMS–10066 Detailed Notice of contact Evelyn Blaemire at 410–786–
Discharge (DND) and Supporting 1803.) Food and Drug Administration
Regulations in 42 CFR 405.1206 and 2. Type of Information Collection [Docket No. FDA–2015–N–0001]
422.622 Request: New collection (Request for a
Under the PRA (44 U.S.C. 3501– new OMB control number); Title of Vaccines and Related Biological
3520), federal agencies must obtain Information Collection: Reapplication Products Advisory Committee; Notice
approval from the Office of Management Submission Requirement for Qualified of Meeting
and Budget (OMB) for each collection of Entities under ACA Section 10332; Use: AGENCY: Food and Drug Administration,
information they conduct or sponsor. Section 10332 of the Patient Protection HHS.
The term ‘‘collection of information’’ is and Affordable Care Act (ACA) requires ACTION: Notice.
defined in 44 U.S.C. 3502(3) and 5 CFR the Secretary to make standardized
1320.3(c) and includes agency requests extracts of Medicare claims data under This notice announces a forthcoming
or requirements that members of the Parts A, B, and D available to ‘‘qualified meeting of a public advisory committee
public submit reports, keep records, or entities’’ for the evaluation of the of the Food and Drug Administration
provide information to a third party. performance of providers of services (FDA). At least one portion of the
Section 3506(c)(2)(A) of the PRA and suppliers. The statute provides the meeting will be closed to the public.
requires federal agencies to publish a Secretary with discretion to establish Name of Committee: Vaccines and
60-day notice in the Federal Register criteria to determine whether an entity Related Biological Products Advisory
concerning each proposed collection of is qualified to use claims data to Committee.
information, including each proposed evaluate the performance of providers of General Function of the Committee:
extension or reinstatement of an existing services and suppliers. After To provide advice and
collection of information, before consideration of comments from a wide recommendations to the Agency on
submitting the collection to OMB for variety of stakeholders during the public FDA’s regulatory issues.
approval. To comply with this Date and Time: The meeting will be
comment period, CMS established
requirement, CMS is publishing this held on January 14, 2016, from 1 p.m.
‘‘Medicare Program; Availability of
notice. to 5 p.m.
Medicare Data for Performance Location: FDA White Oak Campus,
Information Collection Measurement’’ (hereinafter called the 10903 New Hampshire Ave., Building
Final Rule and referred to as the 31 Conference Center, the Great Room
1. Type of Information Collection
Medicare Data Sharing Program). It was (Rm. 1503), Silver Spring, MD 20993–
Request: Extension of a currently
approved collection; Title of published in the Federal Register on 0002. Answers to commonly asked
Information Collection: Detailed Notice December 7, 2011 (42 CFR, Part 401, questions including information
of Discharge (DND) and Supporting Subpart G). To implement the regarding special accommodations due
Regulations in 42 CFR 405.1206 and requirements outlined in the legislation, to a disability, visitor parking, and
422.622; Use: A beneficiary or enrollee the Centers for Medicare and Medicaid transportation may be accessed at
who wishes to appeal a determination Services (CMS) established the http://www.fda.gov/Advisory
by a Medicare health plan (for a Qualified Entity Certification Program Committees/AboutAdvisoryCommittees/
managed care enrollee) or hospital (for (QECP). The Qualified Entity ucm408555.htm.
an original Medicare beneficiary) that Certification Program (QECP) was For those unable to attend in person,
inpatient care is no longer necessary established to implement the Final Rule. the meeting will also be webcast and
may request Quality Improvement One of the requirements in the Final will be available at the following link
Organization (QIO) review of the Rule is that QEs must reapply for https://collaboration.fda.gov/
determination. On the date the QIO certification six months prior to the end vrbpacsem1/.
receives the beneficiary’s/enrollee’s of their 3-year certification period to Contact Person: Sujata Vijh or Denise
request, it must notify the plan and remain in good standing. This form is Royster, Center for Biologics Evaluation
hospital that the beneficiary/enrollee the official reapplication that QEs must and Research, Food and Drug
has filed a request for an expedited complete to reapply to the QECP. Form Administration, 10903 New Hampshire
Number: CMS–10596 (OMB Control
mstockstill on DSK4VPTVN1PROD with NOTICES

determination. The plan or hospital, in Ave., Bldg. 71, Rm. 6128, Silver Spring,
turn, must deliver a DND to the Number: 0938-New); Frequency: MD 20993–0002, at 240–402–7107 and
enrollee/beneficiary. In this iteration the Occasionally; Affected Public: Private 240–402–8158 respectively, or FDA
DND has been minimally changed to sector (Business or other for-profit and Advisory Committee Information Line,
include language informing Not-for-profit institutions); Number of 1–800–741–8138 (301–443–0572 in the
beneficiaries of their rights under the Respondents: 10; Total Annual Washington, DC area). A notice in the
Rehabilitation Act of 1973 (section 504), Responses: 10; Total Annual Hours: Federal Register about last minute
by alerting the beneficiary to CMS’s 1,200. (For policy questions regarding modifications that impact a previously

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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 74113

80 FR 74113 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 228 (November 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration