Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 13866-13867 [2015-06116]

Download as PDF 13866 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices The Education and Community Involvement Branch (ECIB) designed the program to accomplish the following goals, which align with elements of both the NIH and NHGRI missions: • Expand NIH and NHGRI’s professional network to reach out to diverse communities, and to create new partnership opportunities. • Prepare the next generation of genomics professionals for an era of genomic medicine. • Train and diversify the pipeline of genome professionals in alignment with the NIH and US Department of Health and Human Services diversity efforts. The ECIB has systematically collected feedback annually after the program from participants since inception of the Short Course in 2003, and then used the data to tweak the program, but it has not conducted a long-term, cumulative and substantive outcome evaluation. NHGRI and the ECIB propose to conduct such an outcome evaluation, focusing on three main objectives: (1) To understand the degree of genetic and genomic curriculum integration by faculty participants; (2) To explore the barriers and supports faculty experience and changes when integrating curriculum; and (3) To investigate the influence of the program on the participants’ career path. Survey findings will provide valuable information about the various methods and pathways instructors use to disseminate new knowledge (and the associated timelines), the barriers and supports experienced by faculty as they integrate new knowledge into their teaching, and insights about additional avenues of support that NHGRI could provide teaching faculty from the types of institutions identified. Key indicators will also provide evidence about the degree to which the Short Course is meeting its goals. Collectively, the outcome evaluation will inform future program design and budget allocations. OMB approval is requested for 2 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 155. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Students ............................. Faculty ............................... 110 200 1 1 30/60 30/60 55 100 ............................................ 310 .................... .................... 155 Form name Type of respondents Short Course Survey—Students ..................................... Short Course Survey—Faculty ........................................ Totals ........................................................................ Dated: March 11, 2015. Gloria Butler, NHGRI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2015–06086 Filed 3–16–15; 8:45 am] BILLING CODE 4140–01–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. mstockstill on DSK4VPTVN1PROD with NOTICES 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: 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. VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 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: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/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 https:// www.fda.gov/AdvisoryCommittees/ PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Total annual burden hours 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 https://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 E:\FR\FM\17MRN1.SGM 17MRN1 13867 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 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 https://www.fda.gov/Advisory Committees/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 DEPARTMENT OF HEALTH AND HUMAN SERVCES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed project or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 1243. Comments are invited on: (a) Whether the proposed collection of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project Behavioral Health Information Technologies Survey— NEW The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) and Center for Behavioral Health Statistics and Quality (CBHSQ) are proposing a survey to assess health information technology (HIT) adoption among SAMHSA grantees. As part of its Strategic Initiative to advance the use of health information technologies to support integrated behavioral health care, SAMHSA has been working to develop a survey instrument that will examine Number of respondents mstockstill on DSK4VPTVN1PROD with NOTICES Type of grantee or respondent Screening, Brief Intervention, and Referral to Treatment (SBIRT) ............................................................................. Targeted Capacity Expansion-Targeted Assisted Care ...... Offender Re-entry Program ................................................. Primary Behavioral Health Care Integration (PBHCI) ......... National Child Traumatic Stress Initiative (NCTSI) ............. Suicide Lifeline Crisis Center Follow-up .............................. VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00046 Number of responses annually per respondent 18 17 13 89 56 12 Fmt 4703 Sfmt 4703 the status of and plans for HIT adoption by behavioral health service providers who are implementing SAMHSA grant programs. The selected programs are funded by the by the Center for Mental Health Services (CMHS), the Center for Substance Abuse Prevention (CSAP), and (CSAT). This project seeks to acquire baseline data necessary to inform the Agency’s strategic initiative that focuses on fostering the adoption of HIT in community behavioral health services. The survey of SAMHSA grantees regarding their access to and use of health information technology will provide valuable information that will inform the behavioral HIT literature. Approval of this data collection by the Office of Management and Budget (OMB) will allow SAMHSA to identify the current status of HIT adoption and use among a diverse group of grantees. Data from the survey will allow SAMHSA to enhance the HIT-related programmatic activities among its grantees by providing data on how HIT facilitates the implementation of different types of SAMHSA grants, thereby fostering the appropriate adoption of HIT within SAMSHAfunded programs. The survey will collect data once, providing a snapshot view of the current state of HIT adoption. The proposed participant pool is comprised of SAMHSA grantee program leadership who are willing to provide the assistance needed to ensure a high rate of response. Awardees from nine different SAMHSA programs drawn from CMHS, CSAT, and CSAP comprise the pool of survey participants. The survey mode for data collection will be web-based with embedded skip logic for respondents to avoid questions that are not applicable to them. The minimum amount of time for a respondent to complete the survey is 20 minutes, with respondents who do not skip items taking a maximum of 30 minutes for completion. The total estimated respondent burden is 149.6 hours. The following table summarizes the estimated response burden. Total responses 1 1 1 1 1 1 E:\FR\FM\17MRN1.SGM Average hours per response 18 17 13 89 56 12 17MRN1 .4 .4 .4 .4 .4 .4 Total burden hours 7.2 6.8 5.2 35.6 22.4 4.8

Agencies

[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13866-13867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06116]


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

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). 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: https://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 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 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 https://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 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: 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
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