82 FR 36796 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

Page Range		36796-36797
FR Document		2017-16519

The Food and Drug Administration (FDA or the 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. The meeting will be open to the public.

Federal Register, Volume 82 Issue 150 (Monday, August 7, 2017)

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36796-36797]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the 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. The meeting will be open to the 
public.

DATES: The meeting will be held on September 13, 2017, from 8:30 a.m. 
to 5 p.m.

[[Page 36797]]


ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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 FURTHER INFORMATION CONTACT: Serina Hunter-Thomas or Rosanna 
Harvey, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver 
Spring, MD 20993-0002; 240-402-5771, [email protected] 
and 240-402-8072, [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 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On September 13, 2017, the VRBPAC will meet in an open 
session to discuss and make recommendations on the safety and 
effectiveness of Zoster Vaccine Recombinant, Adjuvanted, manufactured 
by GlaxoSmithKline Biologicals. 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 
September 6, 2017. 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 August 29, 2017. 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 August 30, 2017.
    Web cast: 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/vrbpac0917/.
    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 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: August 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16519 Filed 8-4-17; 8:45 am]
 BILLING CODE 4164-01-P

36796 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices

user fee provisions of the FD&C Act, and supporting documentation directly to requests for reconsideration annually,
the procedures for submitting requests SBA for evaluation and after completing and that the total average burden hours
for waivers or reductions. It also their review, SBA provided FDA with a for a reconsideration request will be 24
includes recommendations for determination whether a waiver hours. In addition, we estimate that we
submitting information for requests for applicant qualified as a small business will receive one request annually for an
reconsideration of denials of waiver or for purposes of evaluating user fee appeal of a user fee waiver
reduction requests, and for requests for waivers. The burden for submission of determination, and that the time needed
appeals. The guidance also provides this information to SBA is approved to prepare an appeal would be
clarification on related issues such as under OMB control number 3245–0101. approximately 12 hours. We have
user fee exemptions for orphan drugs. Beginning fiscal year 2015, the SBA included in this estimate both the time
Based on Agency records, we estimate declined to conduct further size needed to prepare the request for appeal
that the total annual number of waiver determinations for evaluation of small to the Chief Scientist, User Fee Appeals
requests submitted for all of these business user fee waivers and as a Officer, Office of the Commissioner, and
categories will be 150, submitted by 115 result, a processing change at FDA the time needed to create and send a
different applicants. We estimate that occurred. The new FDA process copy of the request for an appeal to the
the average burden hours for requires waiver applicants to submit Director, Division of User Fee
preparation of a submission will total 16 documentation directly to FDA. In Management, Office of Management,
hours. Because FDA may request addition, fewer supporting documents Center for Drug Evaluation and
additional information from the than previously requested by SBA are Research.
applicant during the review period, we required. As a result, we estimate that
The burden for completing and
have also included in this estimate time the 4 burden hours per small business
submitting Form FDA 3397
to prepare any additional information. waiver previously attributed to SBA and
(Prescription Drug User Fee Coversheet)
We have included in the burden approved under OMB control number
is not included in this analysis as the
estimate the preparation and submission 3245–0101, should now be attributed to
burden is included under OMB control
of application fee waivers for small FDA because SBA is no longer
number 0910–0297. The collections of
businesses, because small businesses conducting size determinations for FDA.
information associated with submission
requesting a waiver must submit Also, because FDA is asking that
of a new drug application or biologics
documentation to FDA on the number of applicants submit fewer supporting
license application are approved under
their employees and must include the documents, we estimate that these
OMB control numbers 0910–0001 and
information that the application is the burden hours should be reduced to 2
0910–0338, respectively.
first human drug application, within the hours instead of 4 hours. We understand
meaning of the FD&C Act, to be that SBA plans to submit a revised In the Federal Register of May 23,
submitted to the Agency for approval. burden estimate to OMB control number 2017 (82 FR 23581), FDA published a
Previously, after receipt of a small 3245–0101 to account for this 60-day notice requesting public
business waiver request, FDA would redistribution. comment on the proposed extension of
request a small business size The reconsideration and appeal this collection of information. No
determination from the Small Business requests are not addressed in the FD&C comments were received.
Administration (SBA). Waiver Act, but are discussed in the guidance. FDA estimates the burden of this
applicants would submit their We estimate that we will receive seven collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
User fee waivers, reductions, & refunds for Number of Total annual
responses per burden per Total hours
drug & biological products respondents responses
respondent response

FD&C Act sections 735 and 736 ....................................... 115 1.3 150 16 2,400
FD&C Act section 736(d)(1)(D)(4) ..................................... 25 1 25 2 50
Reconsideration requests .................................................. 7 1 7 24 168
Appeal requests ................................................................. 1 1 1 12 12

Total ................................................................................... ........................ .......................... ........................ ........................ 2,630
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: August 2, 2017. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Anna K. Abram, HUMAN SERVICES Administration (FDA or the Agency)
Deputy Commissioner for Policy, Planning, announces a forthcoming public
Legislation, and Analysis. Food and Drug Administration advisory committee meeting of the
[FR Doc. 2017–16580 Filed 8–4–17; 8:45 am] Vaccines and Related Biological
BILLING CODE 4164–01–P
[Docket No. FDA–2017–N–0001] Products Advisory Committee
(VRBPAC). The general function of the
Vaccines and Related Biological
mstockstill on DSK30JT082PROD with NOTICES

committee is to provide advice and
Products Advisory Committee; Notice recommendations to the Agency on
of Meeting FDA’s regulatory issues. The meeting
will be open to the public.
AGENCY: Food and Drug Administration,
HHS. DATES: The meeting will be held on
September 13, 2017, from 8:30 a.m. to
ACTION: Notice.
5 p.m.

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Document Created: 2017-08-05 03:00:18
Document Modified: 2017-08-05 03:00:18

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 September 13, 2017, from 8:30 a.m. to 5 p.m.
Contact		Serina Hunter-Thomas or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-0002; 240-402-5771, [email protected] and 240-402-8072, [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 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.
FR Citation		82 FR 36796

82 FR 36796 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 150 (August 7, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration