83 FR 40772 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 159 (August 16, 2018)

Page Range		40772-40773
FR Document		2018-17702

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference.

Federal Register, Volume 83 Issue 159 (Thursday, August 16, 2018)

[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40772-40773]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2945]


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 40773]]

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Vaccines and 
Related Biological Products Advisory Committee (VRBPAC). The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. Members will participate via 
teleconference.

DATES: The meeting will be held on October 3, 2018, from 11 a.m. to 
3:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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/vrbpac1018. 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 FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-5771, 
[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 cannot always 
be published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's website 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On October 3, 2018, the VRBPAC will meet in an open session 
to discuss and make recommendations on the selection of strains to be 
included in an influenza virus vaccine for the 2019 southern hemisphere 
influenza season.
    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 website 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 website 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 
September 26, 2018. Oral presentations from the public will be 
scheduled between approximately 1:30 p.m. and 2:30 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 
September 18, 2018. 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 September 19, 
2018.
    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 Serina Hunter-Thomas at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website 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: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17702 Filed 8-15-18; 8:45 am]
 BILLING CODE 4164-01-P

40772 Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices

FOR FURTHER INFORMATION CONTACT: Ila the quality, utility, and clarity of the assessment, formal meetings are Type
S. Mizrachi, Office of Operations, Food information to be collected; and (4) A, B, B (End of Phase), and C meetings
and Drug Administration, Three White ways to minimize the burden of the during the IND phase of drug
Flint North, 10 a.m.–12 p.m., 11601 collection of information on development.
Landsdown St., North Bethesda, MD respondents, including through the use • For each active commercial IND in
20852, 301–796–7726, PRAStaff@ of automated collection techniques, the assessment, conduct an interview
fda.hhs.gov. when appropriate, and other forms of with the sponsor to obtain broader
SUPPLEMENTARY INFORMATION: Under the information technology. feedback about all communications with
PRA (44 U.S.C. 3501–3520), Federal Surveys and Interviews With FDA review staff during the study
Agencies must obtain approval from the Investigational New Drug (IND) period, including telephone and email
Office of Management and Budget Sponsors To Assess Current interactions in addition to meetings.
(OMB) for each collection of Communication Practices With FDA The purpose of this information
information they conduct or sponsor. Review Staff Under the Sixth collection is to understand active
‘‘Collection of information’’ is defined Authorization of the Prescription Drug commercial IND sponsor perspectives
in 44 U.S.C. 3502(3) and 5 CFR User Fee Act (PDUFA VI) on communication during drug
1320.3(c) and includes Agency requests development with a focus on what is
or requirements that members of the OMB Control Number 0910—NEW
working well, ongoing challenges and
public submit reports, keep records, or In Fiscal Year (FY) 2017, FDA pain points, lessons learned, and
provide information to a third party. published guidance on communications opportunities for improvement. The
Section 3506(c)(2)(A) of the PRA (44 between FDA review staff and drug contractor will develop anonymized
U.S.C. 3506(c)(2)(A)) requires Federal sponsors during the IND phase of drug aggregated summaries of survey and
Agencies to provide a 60-day notice in development. As part PDUFA VI, FDA interview responses, analyze this
the Federal Register concerning each committed to a third-party assessment information to identify common themes,
proposed collection of information of current IND-phase communication consider these results along with IND
before submitting the collection to OMB practices, which should reflect this data and feedback from FDA review
for approval. To comply with this guidance. The contractor for the staff to develop a set of findings and
requirement, FDA is publishing notice assessment of IND communication recommendations, and prepare a report
of the proposed collection of practices is Eastern Research Group, Inc. to be published on FDA’s website. The
information set forth in this document. (ERG). contractor will keep information
With respect to the following Therefore, in accordance with the collected private; ERG will not disclose
collection of information, FDA invites PDUFA VI Commitment Letter, FDA personally identifying information to
comments on these topics: (1) Whether proposes to have ERG conduct surveys FDA or any other party.
the proposed collection of information and interviews with sponsors of up to
is necessary for the proper performance 150 active commercial INDs as follows: The number of commercial INDs with
of FDA’s functions, including whether • For each formal meeting between activity is approximately 4,000 per year.
the information will have practical FDA review staff and active commercial ERG will interview 1 to 3 sponsor
utility; (2) the accuracy of FDA’s IND sponsors during the assessment representatives at a time for up to 150
estimate of the burden of the proposed period, send a survey to the sponsor to INDs during the annual assessment
collection of information, including the solicit specific feedback about period.
validity of the methodology and communication practices employed for Thus, FDA estimates the burden of
assumptions used; (3) ways to enhance that meeting. For the purpose of this this collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Type of respondent responses per Total hours
respondents responses per response
respondent

IND sponsors: Surveys ................................................ 150 1 150 0.17 (10 minutes) .. 25.50
IND sponsors: Interviews ............................................. 450 1 450 1.5 ......................... 675

Total ...................................................................... ........................ ........................ ........................ ............................... 700.50
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that it will take each collections for similar types of PDUFA- DEPARTMENT OF HEALTH AND
IND sponsor a maximum of 10 minutes related assessments. HUMAN SERVICES
to complete a survey. Up to 150 Dated: August 13, 2018.
respondents will take part in the survey, Food and Drug Administration
Leslie Kux,
yielding a maximum burden of 25.5
Associate Commissioner for Policy.
hours. FDA estimates that it will take [Docket No. FDA–2018–N–2945]
[FR Doc. 2018–17715 Filed 8–15–18; 8:45 am]
each IND sponsor up to 90 minutes to
sradovich on DSK3GMQ082PROD with NOTICES

respond to requests for interviews and BILLING CODE 4164–01–P Vaccines and Related Biological
participate in interviews. Up to 450 Products Advisory Committee; Notice
respondents will take part in interviews, of Meeting
yielding a maximum burden of 675 AGENCY: Food and Drug Administration,
hours. FDA’s burden estimates are based HHS.
on experience with information ACTION: Notice.

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Document Created: 2018-08-16 01:03:10
Document Modified: 2018-08-16 01:03:10

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.
Dates		The meeting will be held on October 3, 2018, from 11 a.m. to 3:30 p.m.
Contact		Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-5771, [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 cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's website 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.
FR Citation		83 FR 40772

83 FR 40772 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 159 (August 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration