Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting, 38188-38189 [2011-16234]
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38188
Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In May 2011, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q11 Development and
Manufacture of Drug Substances’’
should be made available for public
comment. The draft guidance is the
product of the Q11 Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
Q11 Expert Working Group.
The draft guidance describes
approaches to developing process and
drug substance understanding, and
provides guidance on what information
should be provided in sections 3.2.S.2.2
through 3.2.S.2.6 of the CTD. The draft
guidance provides further clarification
on the principles and concepts
described in ICH guidances ‘‘Q8
Pharmaceutical Development,’’ ‘‘Q9
Quality Risk Management,’’ and ‘‘Q10
Pharmaceutical Quality Systems’’ as
they pertain to the development and
manufacture of drug substance. The
guidance is applicable to drug
substances as defined in the ‘‘Scope’’
sections of ICH guidances ‘‘Q6A
Specifications: Test Procedures and
Acceptance Criteria for New Drug
Substances and New Drug Products:
Chemical Substances’’ and ‘‘Q6B
Specifications: Test Procedures and
Acceptance Criteria for
Biotechnological/Biological Products.’’
The draft guidance is intended to
harmonize the scientific and technical
principles relating to the description
and justification of the development and
manufacturing process (CTD sections
3.2.S.2.2. through 3.2.S.2.6) of drug
substances (both chemical entities and
biotechnological/biological entities) to
enable a consistent approach for
providing and evaluating this
information across the three regions.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
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17:48 Jun 28, 2011
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Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: June 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–16255 Filed 6–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
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 July 27, 2011, 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
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, e-mail:
ACPS–CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
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 and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On July 27, 2011, the
committee will discuss current
strategies for FDA’s Office of
Pharmaceutical Science implementation
of quality by design principles within
its review offices, incorporating an
update on the International Conference
on Harmonization of Technical
Requirements for Registration of
Pharmaceuticals for Human Use
Activities. The committee will also
receive awareness presentations on
FDA’s current partnering with the
United States Pharmacopeia, principally
to discuss the Monograph
Modernization Program.
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 20, 2011. Oral
presentations from the public will be
scheduled between approximately 10:45
a.m. to 11:15 a.m. and 3:30 p.m. to 4
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
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38189
Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices
indication of the approximate time
requested to make their presentation on
or before July 13, 2011. 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 14, 2011.
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: June 23, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–16234 Filed 6–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request; Environmental Science
Formative Research Methodology
Studies for the National Children’s
Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), 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. This proposed
information collection was previously
published in the Federal Register on
April 27, 2011, pages 23603–23605, and
allowed 60 days for public comment.
One written comment was received. The
comment questioned the cost and utility
of the study specifically and of federally
funded biomedical research in general.
The purpose of this notice is to allow an
additional 30 days for public comment.
Proposed Collection
Title: Environmental Science
Formative Research Methodology
Studies for the National Children’s
Study (NCS).
Type of Information Collection
Request: Generic Clearance.
Need and Use of Information
Collection: The Children’s Health Act of
2000 (Pub. L. 106–310) states:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) REQUIREMENT.—The study under
subsection (b) shall—
(1) incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of
environmental sample collection
procedures and technology, storage
procedures, accompanying
questionnaires, and assays, and thereby
inform data collection methodologies
for the National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain
OMB’s generic clearance to collect
environmental samples from homes and
child care settings, and conduct
accompanying short surveys related to
the physical and chemical environment.
The results from these formative
research projects will inform the
feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study
environmental sample and information
collection in a manner that minimizes
public information collection burden
compared to burden anticipated if these
projects were incorporated directly into
either the NCS Vanguard or Main Study.
Frequency of Response: Annual [As
needed on an on-going and concurrent
basis].
Affected Public: Members of the
public, researchers, practitioners, and
other health professionals.
Type of Respondents: Women of
child-bearing age, fathers, public health
and environmental science professional
organizations and practitioners, and
schools and child care organizations.
These include both persons enrolled in
the NCS Vanguard Study and their peers
who are not participating in the NCS
Vanguard Study.
Annual reporting burden: See Table 1.
The annualized cost to respondents is
estimated at: $780,000 (based on $10 per
hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE
Type of respondent
Home Air ........................................
NCS participants ..................
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Estimated
number of
responses per
respondent
Estimated
number of
respondents
Data collection activity
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4,000
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Average burden
hours per
response
Estimated total
annual burden
hours requested
1
4,000
1
29JNN1
]]>Agencies
[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38188-38189]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 July 27, 2011, 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, e-mail: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting. 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 and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On July 27, 2011, the committee will discuss current
strategies for FDA's Office of Pharmaceutical Science implementation of
quality by design principles within its review offices, incorporating
an update on the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use
Activities. The committee will also receive awareness presentations on
FDA's current partnering with the United States Pharmacopeia,
principally to discuss the Monograph Modernization Program.
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
20, 2011. Oral presentations from the public will be scheduled between
approximately 10:45 a.m. to 11:15 a.m. and 3:30 p.m. to 4 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
[[Page 38189]]
indication of the approximate time requested to make their presentation
on or before July 13, 2011. 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 14,
2011.
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: June 23, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16234 Filed 6-28-11; 8:45 am]
BILLING CODE 4160-01-P
