Advisory Council for the Elimination of Tuberculosis Meeting (ACET), 27327-27328 [2011-11526]
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Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Meeting
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Combining
Subjective and Objective Methods for
Quantifying Contact Rates and Mixing
Pattern in School-Aged Children,
Funding Opportunity Announcement,
CK11–006, Initial Review
Studies at the Animal-Human
Interface of Influenza and Other
Zoonotic Diseases in Vietnam, Funding
Opportunity Announcement (FOA)
IP11–005, The Incidence and Etiology of
Influenza-Associated CommunityAcquired Pneumonia in Hospitalized
Persons Study; FOA IP11–011,
Spectrum of Respiratory Pathogens in
Acute Respiratory Tract Infection
Among Children and Adults in India;
FOA IP11–012, Influenza Vaccine
Efficacy in Tropical and Developing
Countries; FOA IP11–013, Influenza and
Other Respiratory Diseases in Southern
Hemisphere; and FOA IP11–014, initial
review.
Correction: The notice was published
in the Federal Register on March 11,
2011, Volume 76, Number 48, Pages
13413–13414. The place should read as
follows:
Place: Holiday Inn Decatur Conference
Center, 130 Clairemont Avenue, Decatur,
Georgia 30030, Telephone: (404) 371–0204.
Contact Person For More Information:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road, NE., Mailstop E60,
Atlanta, Georgia 30333, Telephone:
(404) 498–2293.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 5, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
mstockstill on DSKH9S0YB1PROD with NOTICES
[FR Doc. 2011–11522 Filed 5–10–11; 8:45 am]
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Correction: The notice was published
in the Federal Register on March 22,
2011, Volume 76, Number 55, Page
15984. The time, date, and place should
read as follows:
Time And Date: 11 a.m.–2 p.m., May 3,
2011 (Closed).
Place: Teleconference.
Contact Person For More Information:
Gregory Anderson, M.S., M.P.H., Scientific
Review Officer, CDC, 1600 Clifton Road, NE.,
Mailstop E60, Atlanta, Georgia 30333,
Telephone: (404) 498–2293.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 5, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–11523 Filed 5–10–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Virologic
Evaluation of the Modes of Influenza
Virus Transmission Among Humans,
Funding Opportunity Announcement,
IP11–001
Correction: The notice was published
in the Federal Register on April 4, 2011,
Volume 76, Number 64, Page 18555.
The place should read as follows:
Place: Holiday Inn Decatur Conference
Plaza, 130 Clairemont Avenue, Decatur,
Georgia 30030, Telephone: (404) 371–0204.
Contact Person for More Information:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road, NE., Mailstop E60,
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27327
Atlanta, Georgia 30333, Telephone:
(404) 498–2293.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 5, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–11521 Filed 5–10–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Council for the Elimination of
Tuberculosis Meeting (ACET)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates
11 a.m.–5 p.m., June 7, 2011.
8:30 a.m.–2:30 p.m., June 8, 2011.
Place: Corporate Square, Building 8,
1st Floor Conference Room, Atlanta,
Georgia 30333, telephone (404) 639–
8317.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 100
people.
Purpose: This council advises and
makes recommendations to the
Secretary of Health and Human
Services, the Assistant Secretary for
Health, and the Director, CDC, regarding
the elimination of tuberculosis.
Specifically, the Council makes
recommendations regarding policies,
strategies, objectives, and priorities;
addresses the development and
application of new technologies; and
reviews the extent to which progress has
been made toward eliminating
tuberculosis.
Matters to be Discussed: Agenda items
include issues pertaining to TB
Surveillance/Epidemiology/Outbreaks;
Role of U.S. program in global TB
control; Federal role in TB clinical and
diagnostic research; Role of CDC in
development of evidence-based policies;
Forecasting the U.S. TB Trends and
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27328
Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Notices
Challenges; and other related
tuberculosis issues. Agenda items are
subject to change as priorities dictate.
Contact Person for More Information:
Margie Scott-Cseh, Centers for Disease
Control and Prevention, 1600 Clifton
Road, NE., M/S E–07, Atlanta, Georgia
30333, telephone: (404) 639–8317.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
Notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: May 5, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–11526 Filed 5–10–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0042]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
New Drug Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 10,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0014. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
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SUMMARY:
VerDate Mar<15>2010
17:18 May 10, 2011
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Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Investigational New Drug (IND)
Regulations—21 CFR Part 312—(OMB
Control Number 0910–0014)—Extension
FDA is requesting OMB approval for
the reporting and recordkeeping
requirements contained in the FDA
regulations ‘‘Investigational New Drug
Application’’ in part 312 (21 CFR part
312). Part 312 implements provisions of
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) to issue regulations under
which the clinical investigation of the
safety and effectiveness of unapproved
new drugs and biological products can
be conducted.
FDA is charged with implementing
statutory requirements that drug
products marketed in the United States
be shown to be safe and effective,
properly manufactured, and properly
labeled for their intended uses. Section
505(a) of the FD&C Act provides that a
new drug may not be introduced or
delivered for introduction into interstate
commerce in the United States unless
FDA has previously approved a new
drug application (NDA). FDA approves
an NDA only if the sponsor of the
application first demonstrates that the
drug is safe and effective for the
conditions prescribed, recommended, or
suggested in the product’s labeling.
Proof must consist, in part, of adequate
and well-controlled studies, including
studies in humans, that are conducted
by qualified experts. The IND
regulations establish reporting
requirements that include an initial
application as well as amendments to
that application, reports on significant
revisions of clinical investigation plans,
and information on a drug’s safety or
effectiveness. In addition, the sponsor is
required to give FDA an annual
summary of the previous year’s clinical
experience. Submissions are reviewed
by medical officers and other Agency
scientific reviewers assigned
responsibility for overseeing the specific
study. The IND regulations also contain
recordkeeping requirements that pertain
to the responsibilities of sponsors and
investigators. The detail and complexity
of these requirements are dictated by the
scientific procedures and human subject
safeguards that must be followed in the
clinical tests of INDs.
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The IND information collection
requirements provide the means by
which FDA can do the following: (1)
Monitor the safety of ongoing clinical
investigations; (2) determine whether
the clinical testing of a drug should be
authorized; (3) ensure production of
reliable data on the metabolism and
pharmacological action of the drug in
humans; (4) obtain timely information
on adverse reactions to the drug; (5)
obtain information on side effects
associated with increasing doses; (6)
obtain information on the drug’s
effectiveness; (7) ensure the design of
well-controlled, scientifically valid
studies; and (8) obtain other information
pertinent to determining whether
clinical testing should be continued and
information related to the protection of
human subjects. Without the
information provided by industry in
response to the IND regulations, FDA
cannot authorize or monitor the clinical
investigations which must be conducted
prior to authorizing the sale and general
use of new drugs. These reports enable
FDA to monitor a study’s progress, to
assure subject safety, to assure that a
study will be conducted ethically, and
to increase the likelihood that the
sponsor will conduct studies that will
be useful in determining whether the
drug should be marketed and available
for use in medical practice.
There are two forms that are required
under part 312:
Form FDA–1571—‘‘Investigational
New Drug Application’’—A person who
intends to conduct a clinical
investigation submits this form to FDA.
It includes the following information:
(1) A cover sheet containing background
information on the sponsor and
investigator; (2) a table of contents; (3)
an introductory statement and general
investigational plan; (4) an investigator’s
brochure describing the drug substance;
(5) a protocol for each planned study;
(6) chemistry, manufacturing, and
control information for each
investigation; (7) pharmacology and
toxicology information for each
investigation; and (8) previous human
experience with the investigational
drug.
Form FDA–1572—‘‘Investigator
Statement’’—Before permitting an
investigator to begin participation in an
investigation, the sponsor must obtain
and record this form. It includes
background information on the
investigator and the investigation, and a
general outline of the planned
investigation and the study protocol.
FDA is requesting OMB approval for
the following reporting and
recordkeeping requirements in part 312:
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]]>Agencies
[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27327-27328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Council for the Elimination of Tuberculosis Meeting
(ACET)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC), announces the following meeting of the aforementioned
committee:
Times and Dates
11 a.m.-5 p.m., June 7, 2011.
8:30 a.m.-2:30 p.m., June 8, 2011.
Place: Corporate Square, Building 8, 1st Floor Conference Room,
Atlanta, Georgia 30333, telephone (404) 639-8317.
Status: Open to the public, limited only by the space available.
The meeting room accommodates approximately 100 people.
Purpose: This council advises and makes recommendations to the
Secretary of Health and Human Services, the Assistant Secretary for
Health, and the Director, CDC, regarding the elimination of
tuberculosis. Specifically, the Council makes recommendations regarding
policies, strategies, objectives, and priorities; addresses the
development and application of new technologies; and reviews the extent
to which progress has been made toward eliminating tuberculosis.
Matters to be Discussed: Agenda items include issues pertaining to
TB Surveillance/Epidemiology/Outbreaks; Role of U.S. program in global
TB control; Federal role in TB clinical and diagnostic research; Role
of CDC in development of evidence-based policies; Forecasting the U.S.
TB Trends and
[[Page 27328]]
Challenges; and other related tuberculosis issues. Agenda items are
subject to change as priorities dictate.
Contact Person for More Information: Margie Scott-Cseh, Centers for
Disease Control and Prevention, 1600 Clifton Road, NE., M/S E-07,
Atlanta, Georgia 30333, telephone: (404) 639-8317.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register Notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Dated: May 5, 2011.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2011-11526 Filed 5-10-11; 8:45 am]
BILLING CODE 4163-18-P
