Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting, 41790-41791 [2012-17193]
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41790
Federal Register / Vol. 77, No. 136 / Monday, July 16, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC).
Centers for Disease Control and
Prevention
Background and Brief Description
The ART program reporting system is
used to comply with Section 2(a) of
Public Law 102–493 (known as the
Fertility Clinic Success Rate and
Certification Act of 1992 (FCSRCA)), 42
U.S.C. 263a–1(a)). FCSRCA requires
each ART program to annually report to
the Secretary through the CDC
pregnancy success rates achieved by
each ART program, the identity of each
embryo laboratory used by such ART
program, and whether the laboratory is
certified or has applied for certification
under the Act. The reporting system
allows CDC to publish an annual
success rate report to Congress as
specified by the FCSRCA.
CDC requests OMB approval to
continue information collection for
three years. This Revision request
includes an increase in the total
estimated burden hours due to an
increase in the estimated number of
responding clinics and an increase in
the estimated number of responses per
respondent. In addition, this Revision
request describes implementation of a
brief, one-time optional feedback survey
at the end of the data submission for
[30 Day–12–0556]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Assisted Reproductive Technology
(ART) Program Reporting System (0920–
0556, exp. 9/30/2012)—Revision—
National Center for Chronic Disease and
Public Health Promotion (NCDDPHP),
each reporting year. The feedback
survey will elicit information about
ART reporting system usability as well
as respondents’ perspectives on the
usefulness of the information collection.
Information is collected electronically
through the National ART Surveillance
System (NASS), a web-based interface,
or by electronic submission of NASScompatible files. The NASS includes
information about all ART cycles
initiated by any of the ART programs
practicing in the United States and its
territories. The system also collects
information about the pregnancy
outcome of each cycle as well as a
number of data items deemed important
to explain variability in success rates
across ART programs and individuals.
Respondents are the 484 ART
programs in the United States.
Approximately 440 ART programs are
expected to report an average of 339
ART cycles each. The burden estimate
includes the time for collecting,
validating, and reporting the requested
information. Information is collected on
an annual schedule.
There are no costs to the respondents
other than their time. The total
estimated annualized burden hours are
96,960.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Form name
ART Programs ................................................
NASS ..............................................................
Feedback Survey ...........................................
Kimberly S. Lane,
Deputy Director, Office of Science Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012–17292 Filed 7–13–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
srobinson on DSK4SPTVN1PROD with NOTICES
[Docket No. FDA–2012–N–0001]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
VerDate Mar<15>2010
16:32 Jul 13, 2012
Jkt 226001
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
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 August 9, 2012, from 8 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–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
440
176
Number of
responses per
respondent
339
1
Average
burden per
response (in
hours)
39/60
2/60
to the White Oak Campus must enter
through Building 1.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. 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
E:\FR\FM\16JYN1.SGM
16JYN1
41791
Federal Register / Vol. 77, No. 136 / Monday, July 16, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: During the morning session,
the committee will discuss FDA’s draft
guidance on tablet scoring. This topic
will include an overview of FDA’s
proposed plan to move forward and the
United States Pharmacopoeia’s
perspective on the topic. During the
afternoon session, the committee will
discuss: (1) The Center for Drug
Evaluation and Research (CDER)
Nanotechnology Risk Management
Working Group activities; (2)
nanotechnology-related research
conducted and published by CDER, to
include examples related to sunscreens;
and (3) the overview and preliminary
analysis of nanotechnology-related
information collected from drug
application submissions.
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 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 July 26, 2012. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11 a.m. for the morning session,
and 3:15 p.m. to 3:45 p.m. for the
afternoon session. 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 July 18,
2012. 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 July 19, 2012.
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 Yvette
Waples 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: July 10, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–17193 Filed 7–13–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial
(PLCO) (NCI)
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 data collection projects, the
National Cancer Institute (NCI), 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.
SUMMARY:
Proposed Collection: Title: Prostate,
Lung, Colorectal, and Ovarian Cancer
Screening Trial (PLCO) (NCI). Type of
Information Collection Request:
Revision (OMB #: 0925–0407, current
expiration date 9/30/2014). Need and
Use of Information Collection: This trial
was designed to determine if cancer
screening for prostate, lung, colorectal,
and ovarian cancer can reduce mortality
from these cancers which currently
cause an estimated 255,700 deaths
annually in the U.S. The design is a
two-armed randomized trial of men and
women aged 55 to 74 at entry. OMB first
approved this study in 1993 and has
approved it every 3 years since. The
main change to this submission is that
the Supplemental Questionnaire is
being replaced with the Medication Use
Questionnaire. As PLCO participants
now range from 74–94 years of age, the
focus is now on collecting additional
information regarding medications that
are particularly common among older
adults. Additionally, the contracts for 8
of the 10 Screening Centers (SCs) ended
in 2011 and the remaining two sites will
close in 2012 and 2014. NCI has
awarded a contract for continuation of
participant follow-up activities to one
data collection site named the PLCO
Central Data Collection Center (CDCC).
In 2011, participants were re-consented
for at least an additional five years of
follow-up. The current number of
respondents is limited to the
approximately 94,000 participants being
actively followed up. The reports on
cancer screening and prostate, lung,
colorectal, and ovarian cancer mortality
based on this trial have been published
in peer review medical journals. The
additional follow-up will provide data
that will clarify further the long term
effects of the screening on cancer
incidence and mortality for the four
targeted cancers. Further, demographic
and risk factor information may be used
to analyze the differential effectiveness
of cancer screening in high versus low
risk individuals. Frequency of Response:
Annually. Affected Public: Individuals.
Type of Respondents: Adult men and
women. The annual reporting burden is
provided for each study component as
shown in Table 1 below. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Type of respondents
Male and female participants.
VerDate Mar<15>2010
Survey instrument
Number of respondents
ASU ..................................
94,000 ...............................
16:32 Jul 13, 2012
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Fmt 4703
Sfmt 4703
Frequency of response
Average time per
response
(minutes/hour)
1.00
5/60
E:\FR\FM\16JYN1.SGM
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Annual burden
hours
7,833
Agencies
[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Notices]
[Pages 41790-41791]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; 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: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
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 August 9, 2012, from 8
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
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Yvette Waples, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, email: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find
out further information regarding FDA advisory committee information. 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
[[Page 41791]]
advisory committee information line to learn about possible
modifications before coming to the meeting.
Agenda: During the morning session, the committee will discuss
FDA's draft guidance on tablet scoring. This topic will include an
overview of FDA's proposed plan to move forward and the United States
Pharmacopoeia's perspective on the topic. During the afternoon session,
the committee will discuss: (1) The Center for Drug Evaluation and
Research (CDER) Nanotechnology Risk Management Working Group
activities; (2) nanotechnology-related research conducted and published
by CDER, to include examples related to sunscreens; and (3) the
overview and preliminary analysis of nanotechnology-related information
collected from drug application submissions.
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 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 July
26, 2012. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. for the morning session, and 3:15
p.m. to 3:45 p.m. for the afternoon session. 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 July 18, 2012. 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 July 19, 2012.
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 Yvette Waples 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: July 10, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-17193 Filed 7-13-12; 8:45 am]
BILLING CODE 4160-01-P