Request for Nominations of Specific Drug/Biologic Product(s) That Could Be Brought Before the Food and Drug Administration's Pediatric Subcommittee of the Oncologic Drugs Advisory Committee, 47397 [2012-19330]
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Federal Register / Vol. 77, No. 153 / Wednesday, August 8, 2012 / Notices
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[FR Doc. 2012–19377 Filed 8–7–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2012–19453 Filed 8–7–12; 8:45 am]
[Docket No. FDA–2012–N–0793]
BILLING CODE 4154–01–P
Request for Nominations of Specific
Drug/Biologic Product(s) That Could
Be Brought Before the Food and Drug
Administration’s Pediatric
Subcommittee of the Oncologic Drugs
Advisory Committee
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0608]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
MedWatch: The Food and Drug
Administration Medical Products
Reporting Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘MedWatch: The Food and Drug
Administration Medical Products
Reporting Program’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On June
28, 2012, the Agency submitted a
proposed collection of information
entitled ‘‘MedWatch: The Food and
Drug Administration Medical Products
Reporting Program’’ to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
wreier-aviles on DSK7SPTVN1PROD with NOTICES
SUMMARY:
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AGENCY:
Food and Drug Administration,
HHS.
Notice; request for product
nominations.
ACTION:
The Food and Drug
Administration’s (FDA) Office of
Hematology and Oncology Products
invites the public to suggest one or more
specific drug or biologic products that
could be brought before the December 4,
2012, Pediatric Subcommittee of the
Oncologic Drugs Advisory Committee
(ODAC). The number of drugs studied
for use in pediatric patients is growing,
and we see a reduction in off-label use.
However, we would like to improve
current and future pediatric product
development by focusing on products
whose development would benefit the
most from the attention of an advisory
committee. The company developing a
product that is brought before the
committee will be given the unique
opportunity to present proposed
pediatric studies in the United States,
share their plans for global pediatric
development, and hear discussions by
the Pediatric Subcommittee on possible
directions for their current or future
pediatric oncology product
development.
SUMMARY:
Nominations must be received
by September 4, 2012, to receive
consideration for inclusion.
Nominations received after this date
will receive consideration for future
meetings of the Pediatric Subcommittee
of the ODAC.
DATES:
PO 00000
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47397
Email nominations to
Christine.Lincoln@fda.hhs.gov, and
please include the subject line
‘‘Suggested Product for 2012 Pediatric
Oncology Subcommittee of ODAC.’’
FOR FURTHER INFORMATION CONTACT:
Christine Lincoln, RN, MS, MBA, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2206,
Silver Spring, MD 20993, 301–796–
4117, Christine.Lincoln@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Food
and Drug Administration (FDA)
Advisory Committees are an important,
transparent interface that allows the
Agency to include the public in its
decision-making processes. Significant
public health and safety issues are
brought before these committees for
deliberation, and the meetings bring
together both experts with state-of-theart knowledge and members of the
public with relevant personal
experiences. This broad participation
gives FDA a unique perspective as it
seeks to assure the safety, efficacy, and
security of FDA-regulated products.
Additional information about the
prior November 2, 2011, Pediatric
Oncology Subcommittee of the
Oncologic Drugs Advisory Committee
may be found on FDA’s Web site at:
https://www.fda.gov/
AdvisoryCommittees/Calendar/
ucm274396.htm.
ADDRESSES:
Dated: August 2, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19330 Filed 8–7–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
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Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 77 FR 46098–46099
dated August 2, 2012).
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA).
Specifically, this notice updates the
functional statement for both the Office
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human resources function for HRSA;
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[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Notices]
[Page 47397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0793]
Request for Nominations of Specific Drug/Biologic Product(s) That
Could Be Brought Before the Food and Drug Administration's Pediatric
Subcommittee of the Oncologic Drugs Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for product nominations.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) Office of Hematology
and Oncology Products invites the public to suggest one or more
specific drug or biologic products that could be brought before the
December 4, 2012, Pediatric Subcommittee of the Oncologic Drugs
Advisory Committee (ODAC). The number of drugs studied for use in
pediatric patients is growing, and we see a reduction in off-label use.
However, we would like to improve current and future pediatric product
development by focusing on products whose development would benefit the
most from the attention of an advisory committee. The company
developing a product that is brought before the committee will be given
the unique opportunity to present proposed pediatric studies in the
United States, share their plans for global pediatric development, and
hear discussions by the Pediatric Subcommittee on possible directions
for their current or future pediatric oncology product development.
DATES: Nominations must be received by September 4, 2012, to receive
consideration for inclusion. Nominations received after this date will
receive consideration for future meetings of the Pediatric Subcommittee
of the ODAC.
ADDRESSES: Email nominations to Christine.Lincoln@fda.hhs.gov, and
please include the subject line ``Suggested Product for 2012 Pediatric
Oncology Subcommittee of ODAC.''
FOR FURTHER INFORMATION CONTACT: Christine Lincoln, RN, MS, MBA, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 2206, Silver Spring, MD 20993, 301-
796-4117, Christine.Lincoln@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA)
Advisory Committees are an important, transparent interface that allows
the Agency to include the public in its decision-making processes.
Significant public health and safety issues are brought before these
committees for deliberation, and the meetings bring together both
experts with state-of-the-art knowledge and members of the public with
relevant personal experiences. This broad participation gives FDA a
unique perspective as it seeks to assure the safety, efficacy, and
security of FDA-regulated products.
Additional information about the prior November 2, 2011, Pediatric
Oncology Subcommittee of the Oncologic Drugs Advisory Committee may be
found on FDA's Web site at: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm274396.htm.
Dated: August 2, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19330 Filed 8-7-12; 8:45 am]
BILLING CODE 4160-01-P
