80_FR_13917 80 FR 13866 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

80 FR 13866 - 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 51 (March 17, 2015)

Page Range13866-13867
FR Document2015-06116

Federal Register, Volume 80 Issue 51 (Tuesday, March 17, 2015) 
[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13866-13867]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06116]


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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). The meeting will 
be open 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 May 12, 2015, from 8:30 
a.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. 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 Web cast and will 
be available at the following link: https://collaboration.fda.gov/vrbpac0515/.
    Contact Person: Sujata Vijh, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 6128, Silver Spring, MD 209930-0002, 240-402-7107; or Denise 
Royster, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6134, Silver 
Spring, MD 209930-0002, 240-402-8158; 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: On May 12, 2015, from 8:30 a.m. to 5 p.m., the committee 
will meet in open session to discuss the development and licensure of 
Ebola vaccines.
    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 May 
5, 2015. Oral presentations from the public will be scheduled between 
1:15 p.m. and 2:15 p.m. Those individuals interested in making formal 
oral presentations should

[[Page 13867]]

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 
April 27, 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 April 28, 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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Sujata Vijh (see 
Contact Person) 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: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06116 Filed 3-16-15; 8:45 am]
 BILLING CODE 4164-01-P

13866 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices The Education and Community Short Course in 2003, and then used the disseminate new knowledge (and the Involvement Branch (ECIB) designed the data to tweak the program, but it has not associated timelines), the barriers and program to accomplish the following conducted a long-term, cumulative and supports experienced by faculty as they goals, which align with elements of both substantive outcome evaluation. NHGRI integrate new knowledge into their the NIH and NHGRI missions: and the ECIB propose to conduct such teaching, and insights about additional • Expand NIH and NHGRI’s an outcome evaluation, focusing on avenues of support that NHGRI could professional network to reach out to three main objectives: provide teaching faculty from the types diverse communities, and to create new (1) To understand the degree of of institutions identified. Key indicators partnership opportunities. genetic and genomic curriculum will also provide evidence about the • Prepare the next generation of integration by faculty participants; degree to which the Short Course is genomics professionals for an era of (2) To explore the barriers and meeting its goals. Collectively, the genomic medicine. supports faculty experience and changes outcome evaluation will inform future • Train and diversify the pipeline of when integrating curriculum; and program design and budget allocations. genome professionals in alignment with (3) To investigate the influence of the the NIH and US Department of Health program on the participants’ career OMB approval is requested for 2 and Human Services diversity efforts. path. years. There are no costs to respondents The ECIB has systematically collected Survey findings will provide valuable other than their time. The total feedback annually after the program information about the various methods estimated annualized burden hours are from participants since inception of the and pathways instructors use to 155. ESTIMATED ANNUALIZED BURDEN HOURS Number of Average Total Type of Number of responses burden per annual Form name respondents respondents per response burden respondent (in hours) hours Short Course Survey—Students ..................................... Students ............................. 110 1 30/60 55 Short Course Survey—Faculty ........................................ Faculty ............................... 200 1 30/60 100 Totals ........................................................................ ............................................ 310 .................... .................... 155 Dated: March 11, 2015. Location: FDA White Oak Campus, default.htm and scroll down to the Gloria Butler, 10903 New Hampshire Ave., Building appropriate advisory committee meeting NHGRI Project Clearance Liaison, National 31 Conference Center, the Great Room link, or call the advisory committee Institutes of Health. (Rm. 1503), Silver Spring, MD 20993. information line to learn about possible [FR Doc. 2015–06086 Filed 3–16–15; 8:45 am] Answers to commonly asked questions modifications before coming to the BILLING CODE 4140–01–P including information regarding special meeting. accommodations due to a disability, Agenda: On May 12, 2015, from 8:30 visitor parking, and transportation may a.m. to 5 p.m., the committee will meet DEPARTMENT OF HEALTH AND be accessed at: http://www.fda.gov/ in open session to discuss the HUMAN SERVICES AdvisoryCommittees/AboutAdvisory development and licensure of Ebola Committees/ucm408555.htm. For those vaccines. Food and Drug Administration unable to attend in person, the meeting FDA intends to make background will also be Web cast and will be material available to the public no later [Docket No. FDA–2015–N–0001] available at the following link: https:// than 2 business days before the meeting. Vaccines and Related Biological collaboration.fda.gov/vrbpac0515/. If FDA is unable to post the background Products Advisory Committee; Notice Contact Person: Sujata Vijh, Center for material on its Web site prior to the of Meeting Biologics Evaluation and Research, meeting, the background material will Food and Drug Administration, 10903 be made publicly available at the AGENCY: Food and Drug Administration, New Hampshire Ave., Bldg. 71, Rm. location of the advisory committee HHS. 6128, Silver Spring, MD 209930–0002, meeting, and the background material ACTION: Notice. 240–402–7107; or Denise Royster, will be posted on FDA’s Web site after Center for Biologics Evaluation and the meeting. Background material is This notice announces a forthcoming Research, Food and Drug available at http://www.fda.gov/ meeting of a public advisory committee Administration, 10903 New Hampshire AdvisoryCommittees/Calendar/ of the Food and Drug Administration Ave., Bldg. 71, Rm. 6134, Silver Spring, default.htm. Scroll down to the (FDA). The meeting will be open to the MD 209930–0002, 240–402–8158; or appropriate advisory committee meeting public. FDA Advisory Committee Information link. Name of Committee: Vaccines and Line, 1–800–741–8138 (301–443–0572 Procedure: Interested persons may Related Biological Products Advisory in the Washington, DC area). A notice in present data, information, or views, mstockstill on DSK4VPTVN1PROD with NOTICES Committee. the Federal Register about last minute orally or in writing, on issues pending General Function of the Committee: modifications that impact a previously before the committee. Written To provide advice and announced advisory committee meeting submissions may be made to the contact recommendations to the Agency on cannot always be published quickly person on or before May 5, 2015. Oral FDA’s regulatory issues. enough to provide timely notice. presentations from the public will be Date and Time: The meeting will be Therefore, you should always check the scheduled between 1:15 p.m. and 2:15 held on May 12, 2015, from 8:30 a.m. to Agency’s Web site at http:// p.m. Those individuals interested in 5 p.m. www.fda.gov/AdvisoryCommittees/ making formal oral presentations should VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1

Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 13867 notify the contact person and submit a DEPARTMENT OF HEALTH AND the status of and plans for HIT adoption brief statement of the general nature of HUMAN SERVCES by behavioral health service providers the evidence or arguments they wish to who are implementing SAMHSA grant present, the names and addresses of Substance Abuse and Mental Health programs. The selected programs are proposed participants, and an Services Administration funded by the by the Center for Mental indication of the approximate time Health Services (CMHS), the Center for Agency Information Collection Substance Abuse Prevention (CSAP), requested to make their presentation on Activities: Proposed Collection; or before April 27, 2015. Time allotted and (CSAT). Comment Request for each presentation may be limited. If This project seeks to acquire baseline the number of registrants requesting to In compliance with Section data necessary to inform the Agency’s speak is greater than can be reasonably 3506(c)(2)(A) of the Paperwork strategic initiative that focuses on accommodated during the scheduled Reduction Act of 1995 concerning fostering the adoption of HIT in open public hearing session, FDA may opportunity for public comment on community behavioral health services. conduct a lottery to determine the proposed collections of information, the The survey of SAMHSA grantees Substance Abuse and Mental Health regarding their access to and use of speakers for the scheduled open public Services Administration (SAMHSA) health information technology will hearing session. The contact person will will publish periodic summaries of provide valuable information that will notify interested persons regarding their proposed projects. To request more inform the behavioral HIT literature. request to speak by April 28, 2015. information on the proposed project or Approval of this data collection by the Persons attending FDA’s advisory to obtain a copy of the information Office of Management and Budget committee meetings are advised that the collection plans, call the SAMHSA (OMB) will allow SAMHSA to identify Agency is not responsible for providing Reports Clearance Officer on (240) 276– the current status of HIT adoption and access to electrical outlets. 1243. use among a diverse group of grantees. Comments are invited on: (a) Whether Data from the survey will allow FDA welcomes the attendance of the the proposed collection of information SAMHSA to enhance the HIT-related public at its advisory committee are necessary for the proper meetings and will make every effort to programmatic activities among its performance of the functions of the grantees by providing data on how HIT accommodate persons with physical agency, including whether the disabilities or special needs. If you facilitates the implementation of information shall have practical utility; different types of SAMHSA grants, require special accommodations due to (b) the accuracy of the agency’s estimate thereby fostering the appropriate a disability, please contact Sujata Vijh of the burden of the proposed collection adoption of HIT within SAMSHA- (see Contact Person) at least 7 days in of information; (c) ways to enhance the funded programs. advance of the meeting. quality, utility, and clarity of the The survey will collect data once, FDA is committed to the orderly information to be collected; and (d) providing a snapshot view of the current conduct of its advisory committee ways to minimize the burden of the state of HIT adoption. The proposed meetings. Please visit our Web site at collection of information on participant pool is comprised of http://www.fda.gov/Advisory respondents, including through the use SAMHSA grantee program leadership of automated collection techniques or Committees/AboutAdvisoryCommittees/ who are willing to provide the other forms of information technology. ucm111462.htm for procedures on assistance needed to ensure a high rate public conduct during advisory Proposed Project Behavioral Health of response. Awardees from nine committee meetings. Information Technologies Survey— different SAMHSA programs drawn NEW from CMHS, CSAT, and CSAP comprise Notice of this meeting is given under the Federal Advisory Committee Act (5 The Substance Abuse and Mental the pool of survey participants. U.S.C. app. 2). Health Services Administration The survey mode for data collection (SAMHSA) Center for Substance Abuse will be web-based with embedded skip Dated: March 13, 2015. Treatment (CSAT) and Center for logic for respondents to avoid questions Leslie Kux, Behavioral Health Statistics and Quality that are not applicable to them. The Associate Commissioner for Policy. (CBHSQ) are proposing a survey to minimum amount of time for a [FR Doc. 2015–06116 Filed 3–16–15; 8:45 am] assess health information technology respondent to complete the survey is 20 BILLING CODE 4164–01–P (HIT) adoption among SAMHSA minutes, with respondents who do not grantees. As part of its Strategic skip items taking a maximum of 30 Initiative to advance the use of health minutes for completion. The total information technologies to support estimated respondent burden is 149.6 integrated behavioral health care, hours. SAMHSA has been working to develop The following table summarizes the a survey instrument that will examine estimated response burden. Number of Number of responses Total Average hours Total burden Type of grantee or respondent respondents annually per responses per response hours respondent mstockstill on DSK4VPTVN1PROD with NOTICES Screening, Brief Intervention, and Referral to Treatment (SBIRT) ............................................................................. 18 1 18 .4 7.2 Targeted Capacity Expansion-Targeted Assisted Care ...... 17 1 17 .4 6.8 Offender Re-entry Program ................................................. 13 1 13 .4 5.2 Primary Behavioral Health Care Integration (PBHCI) ......... 89 1 89 .4 35.6 National Child Traumatic Stress Initiative (NCTSI) ............. 56 1 56 .4 22.4 Suicide Lifeline Crisis Center Follow-up .............................. 12 1 12 .4 4.8 VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1


Document Created: 2015-12-18 12:01:37
Document Modified: 2015-12-18 12:01:37
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.
FR Citation80 FR 13866 
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