Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 74113-74114 [2015-30121]

Download as PDF Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). mstockstill on DSK4VPTVN1PROD with NOTICES CMS–10066 Detailed Notice of Discharge (DND) and Supporting Regulations in 42 CFR 405.1206 and 422.622 Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Detailed Notice of Discharge (DND) and Supporting Regulations in 42 CFR 405.1206 and 422.622; Use: A beneficiary or enrollee who wishes to appeal a determination by a Medicare health plan (for a managed care enrollee) or hospital (for an original Medicare beneficiary) that inpatient care is no longer necessary may request Quality Improvement Organization (QIO) review of the determination. On the date the QIO receives the beneficiary’s/enrollee’s request, it must notify the plan and hospital that the beneficiary/enrollee has filed a request for an expedited determination. The plan or hospital, in turn, must deliver a DND to the enrollee/beneficiary. In this iteration the DND has been minimally changed to include language informing beneficiaries of their rights under the Rehabilitation Act of 1973 (section 504), by alerting the beneficiary to CMS’s VerDate Sep<11>2014 19:01 Nov 25, 2015 Jkt 238001 nondiscrimination practices and the availability of alternate forms of this notice if needed. There are no substantive changes to the DND form and instructions. Form Number: CMS– 10066 (OMB Control Number: 0938– 1019); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 6,164; Total Annual Responses: 17,000; Total Annual Hours: 17,000. (For policy questions regarding this collection contact Evelyn Blaemire at 410–786– 1803.) 2. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Reapplication Submission Requirement for Qualified Entities under ACA Section 10332; Use: Section 10332 of the Patient Protection and Affordable Care Act (ACA) requires the Secretary to make standardized extracts of Medicare claims data under Parts A, B, and D available to ‘‘qualified entities’’ for the evaluation of the performance of providers of services and suppliers. The statute provides the Secretary with discretion to establish criteria to determine whether an entity is qualified to use claims data to evaluate the performance of providers of services and suppliers. After consideration of comments from a wide variety of stakeholders during the public comment period, CMS established ‘‘Medicare Program; Availability of Medicare Data for Performance Measurement’’ (hereinafter called the Final Rule and referred to as the Medicare Data Sharing Program). It was published in the Federal Register on December 7, 2011 (42 CFR, Part 401, Subpart G). To implement the requirements outlined in the legislation, the Centers for Medicare and Medicaid Services (CMS) established the Qualified Entity Certification Program (QECP). The Qualified Entity Certification Program (QECP) was established to implement the Final Rule. One of the requirements in the Final Rule is that QEs must reapply for certification six months prior to the end of their 3-year certification period to remain in good standing. This form is the official reapplication that QEs must complete to reapply to the QECP. Form Number: CMS–10596 (OMB Control Number: 0938-New); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 1,200. (For policy questions regarding PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 74113 this collection contact Kari Gaare at 410–786–8612.) Dated: November 20, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015–30070 Filed 11–25–15; 8:45 am] BILLING CODE 4120–01–P 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. 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 https://www.fda.gov/Advisory Committees/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 E:\FR\FM\27NON1.SGM 27NON1 mstockstill on DSK4VPTVN1PROD with NOTICES 74114 Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices 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 https:// 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 https://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. VerDate Sep<11>2014 19:01 Nov 25, 2015 Jkt 238001 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 https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). Dates and Times: December 15, 2015 (9:30 a.m.–4:00 p.m.). Place: Conference Call/Webinar Format. Status: The meeting will be open to the public. Purpose: The ACICBL provides advice and recommendations to the Secretary of the Department of Health and Human Services (Secretary) concerning policy, program development, and other PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 matters of significance related to interdisciplinary, community-based training grant programs authorized under sections 750–759, Title VII, Part D of the Public Health Service Act, as amended by the Affordable Care Act. The following sections are included under this Part: 751—Area Health Education Centers; 752—Continuing Education Support for Health Professionals Serving in Underserved Communities; 753—Geriatrics Workforce Enhancement; 754—Quentin N. Burdick Program for Rural Interdisciplinary Training; 755—Allied Health and Other Disciplines; 756— Mental and Behavioral Health Education and Training, and 759— Program for Education and Training in Pain Care. The members of the ACICBL will select a topic for the legislatively mandated 16th report. They will also finalize their discussion of the legislatively mandated 15th Annual Report to the Secretary of Health and Human Services and Congress. In the 15th Annual Report they will make recommendations for Title VII, Part D programs, performance measures, and appropriation levels. Agenda: The ACICBL agenda will be available 2 days prior to the meeting on the HRSA Web site at https:// www.hrsa.gov/advisorycommittees/ bhpradvisory/acicbl/. SUPPLEMENTARY INFORMATION: Requests to make oral comments or provide written comments to the ACICBL should be sent to Dr. Joan Weiss, Designated Federal Official, using the address and phone number below. Individuals who plan to participate on the conference call and webinar should notify Dr. Weiss at least 3 days prior to the meeting, using the address and phone number below. Members of the public will have the opportunity to provide comments. Interested parties should refer to the meeting subject as the HRSA Advisory Committee on Interdisciplinary, Community-Based Linkages. • The conference call-in number is 1– 800–619–2521. The passcode is: 9271697. • The webinar link is https:// hrsa.connectsolutions.com/acicblmeeting/. Contact: Anyone requesting information regarding the ACICBL should contact Dr. Joan Weiss, Designated Federal Official within the Bureau of Health Workforce, Health Resources and Services Administration, in one of three ways: (1) Send a request to the following address: Dr. Joan Weiss, Designated Federal Official, Bureau of E:\FR\FM\27NON1.SGM 27NON1

Agencies

[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74113-74114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

    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 https://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 https://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 https://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 https://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

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