Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 60884-60885 [2013-24025]
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60884
Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Federal Food, Drug, and Cosmetic Act or 21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
Section 412(d) of the FD&C Act ..........................................
21 CFR 106.120(b) ..............................................................
21 CFR 107.50(b)(3) and (b)(4) ..........................................
21 CFR 107.50(e)(2) ............................................................
5
1
3
1
13
1
2
1
65
1
6
1
10
4
4
4
650
4
24
4
Total ..............................................................................
........................
........................
........................
........................
682
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
106.100 ................................................................................
107.50(c)(3) ..........................................................................
5
3
10
10
50
30
400
300
20,000
9,000
Total ..............................................................................
........................
........................
........................
........................
29,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
21 CFR 107.10(a) and 107.20 .............................................
5
13
65
8
520
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, we
consulted our records of the number of
infant formula submissions received in
the past. All infant formula submissions
may be provided to us in electronic
format. The hours per response
reporting estimates are based on our
experience with similar programs and
information received from industry.
We estimate that we will receive 13
reports from 5 manufacturers annually
under section 412(d) of the FD&C Act,
for a total annual response of 65 reports.
Each report is estimated to take 10 hours
per response for a total of 650 hours. We
also estimate that we will receive one
notification under § 106.120(b). The
notification is expected to take four
hours per response, for a total of four
hours.
For exempt infant formula, we
estimate that we will receive 2 reports
from 3 manufacturers annually under
§§ 107.50(b)(3) and (b)(4), for a total
annual response of 6 reports. Each
report is estimated to take 4 hours per
response for a total of 24 hours. We also
estimate that we will receive one
notification annually under
§ 107.50(e)(2) and that the notification
will take 4 hours to prepare.
We estimate that 5 firms will expend
approximately 20,000 hours per year to
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17:48 Oct 01, 2013
Jkt 232001
fully satisfy the recordkeeping
requirements in § 106.100 and that 3
firms will expend approximately 9,000
hours per year to fully satisfy the
recordkeeping requirements in
§ 107.50(c)(3).
We estimate compliance with our
labeling requirements in §§ 107.10(a)
and 107.20 requires 520 hours annually
by 5 manufacturers.
Dated: September 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–24046 Filed 10–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–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
PO 00000
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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 November 13, 2013, between
approximately 12:30 p.m. and 3:45 p.m.
Location: Rockwall II, Conference
Room 1033, 5515 Security Lane,
Rockville, MD 20852. The public is
welcome to attend the meeting at the
specified location where a
speakerphone will be provided. Public
participation in the meeting is limited to
the use of the speakerphone in the
conference room.
Contact Person for More Information:
Donald W. Jehn or Denise Royster, Food
and Drug Administration, 1401
Rockville Pike (HFM–71), Rockville, MD
20852, 301–827–0314, 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
E:\FR\FM\02OCN1.SGM
02OCN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Notices
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 November 13, 2013, the
committee will meet in open session to
hear an overview of the research
programs in the Laboratory of
Retroviruses and Laboratory of
Immunoregulation, Division of Viral
Products, Office of Vaccines Research
and Review, Center for Biologics
Evaluation and Review, 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 November 13, 2013,
from 12:30 p.m. to approximately 3:10
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
November 6, 2013. Oral presentations
from the public will be scheduled
between approximately 2:10 p.m. and
approximately 3:10 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 October 29, 2013. 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
October 30, 2013.
VerDate Mar<15>2010
17:48 Oct 01, 2013
Jkt 232001
Closed Committee Deliberations: On
November 13, 2013, between
approximately 3:10 p.m. and
approximately 3:45 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 programs 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 physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Denise Royster 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: September 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–24025 Filed 10–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Notice
Request: Application Process for
Clinical Research Training and Medical
Education at the Clinical Center and Its
Impact on Course and Training
Program Enrollment and Effectiveness
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed application information
collection, the Clinical Center (CC), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
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60885
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
The quality, utility, and clarity of the
information to be collected; and (4)
Minimize the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Robert M. Lembo, MD,
Deputy Director, Office of Clinical
Research Training and Medical
Education, NIH Clinical Center, 10
Center Drive, MSC 1158, Bethesda, MD
20892–1352, or call non-toll-free
number (301)–594–4193, or Email your
request, including your address to:
lembor@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Application
Process for Clinical Research Training
and Medical Education at the Clinical
Center and its Impact on Course and
Training Program Enrollment and
Effectiveness, 0925–NEW, Clinical
Center, National Institutes of Health
(CC), National Institutes of Health (NIH).
Need and Use of Information
Collection: The primary objective of the
application process is to allow OCRTME
to evaluate applicants’ qualifications to
determine applicants’ eligibility for
courses and training programs managed
by the office. Applicants must provide
the required information requested in
the respective applications to be
considered a candidate for participation.
Information submitted by candidates for
training programs is reviewed initially
by OCRTME administrative staff to
establish eligibility for participation.
Eligible candidates are then referred to
the designated training program director
or training program selection committee
for review and decisions regarding
E:\FR\FM\02OCN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Notices]
[Pages 60884-60885]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-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 November 13, 2013,
between approximately 12:30 p.m. and 3:45 p.m.
Location: Rockwall II, Conference Room 1033, 5515 Security Lane,
Rockville, MD 20852. The public is welcome to attend the meeting at the
specified location where a speakerphone will be provided. Public
participation in the meeting is limited to the use of the speakerphone
in the conference room.
Contact Person for More Information: Donald W. Jehn or Denise
Royster, Food and Drug Administration, 1401 Rockville Pike (HFM-71),
Rockville, MD 20852, 301-827-0314, 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
[[Page 60885]]
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 November 13, 2013, the committee will meet in open
session to hear an overview of the research programs in the Laboratory
of Retroviruses and Laboratory of Immunoregulation, Division of Viral
Products, Office of Vaccines Research and Review, Center for Biologics
Evaluation and Review, 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 November 13, 2013, from 12:30 p.m. to approximately
3:10 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 November 6, 2013. Oral presentations from
the public will be scheduled between approximately 2:10 p.m. and
approximately 3:10 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 October 29, 2013. 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 October
30, 2013.
Closed Committee Deliberations: On November 13, 2013, between
approximately 3:10 p.m. and approximately 3:45 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
programs 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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Denise Royster 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: September 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-24025 Filed 10-1-13; 8:45 am]
BILLING CODE 4160-01-P
