Agency Information Collection Activities: Submission for OMB Review; Comment Request, 61485 [E6-17318]
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61485
Federal Register / Vol. 71, No. 201 / Wednesday, October 18, 2006 / Notices
Submit written requests for
single copies of the summaries to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Please specify by
product name which summary or
summaries you are requesting. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
summaries.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm.
6460,Silver Spring, MD 20993–0002,
301–796–0700, e-mail:
grace.carmouze@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies conducted for ALTACE
(ramipril), GEMZAR (gemcitabine),
LESCOL (fluvastatin), SANDOSTATIN
LAR (octreotide), and SEREVENT
(salmeterol). The summaries are being
made available consistent with section 9
of the BPCA (Public Law 107–109).
Enacted on January 4, 2002, the BPCA
reauthorizes, with certain important
changes, the pediatric exclusivity
program described in section 505A of
the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 355a). Section
505A of the act permits certain
applications to obtain 6 months of
marketing exclusivity if, in accordance
with the requirements of the statute, the
sponsor submits requested information
relating to the use of the drug in the
pediatric population.
One of the provisions the BPCA
added to the pediatric exclusivity
program pertains to the dissemination of
pediatric information. Specifically, for
all pediatric supplements submitted
under the BPCA, the BPCA requires
FDA to make available to the public a
summary of the medical and clinical
pharmacology reviews of pediatric
studies conducted for the supplement
(21 U.S.C. 355a(m)(1)). The summaries
are to be made available not later than
180 days after the report on the
pediatric study is submitted to FDA (21
U.S.C. 355a(m)(1)). Consistent with this
provision of the BPCA, FDA has posted
on the Internet at https://www.fda.gov/
cder/pediatric/index.htm summaries of
medical and clinical pharmacology
reviews of pediatric studies submitted
in supplements for ALTACE (ramipril),
GEMZAR (gemcitabine), LESCOL
(fluvastatin), SANDOSTATIN LAR
(octreotide), and SEREVENT
(salmeterol). Copies are also available by
mail (see ADDRESSES).
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/pediatric/index.htm.
Dated: October 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–17284 Filed 10–17–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Proposed Project: National Health
Service Corps Travel Request
Worksheet (OMB No. 0915–0278):
Extension
Clinicians participating in the HRSA
National Health Service Corps (NHSC)
Scholarship Program use the Travel
Request Worksheet to receive travel
funds from the Federal Government to
perform pre-employment interviews at
sites on the Approved Practice List. The
travel approval process is initiated
when a scholar notifies the NHSC’s InService Support Branch of an
impending interview at one or more
NHSC approved practice sites.
The Travel Request Worksheet is also
used to initiate the relocation process
after a NHSC scholar has successfully
been matched to an approved practice
site. Upon receipt of the Travel Request
Worksheet, the NHSC will review and
approve or disapprove the request and
promptly notify the NHSC contractor
regarding authorization of the funding
for the relocation.
The burden estimate for the project is
as follows:
Periodically, the Health Resources
and Services Administration (HRSA)
Number of
respondents
Form
Responses
per respondent
250
2
Worksheet ................................................................................................
rmajette on PROD1PC67 with NOTICES1
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301)-443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
John Kraemer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: October 6, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–17318 Filed 10–17–06; 8:45 am]
BILLING CODE 4165–15–P
Total
responses
500
15:24 Oct 17, 2006
Jkt 211001
PO 00000
Total
burden
hours
.06
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Notice of Program Exclusions
AGENCY:
Office of Inspector General,
HHS.
ACTION:
VerDate Aug<31>2005
Hours
per response
Frm 00029
Fmt 4703
Sfmt 4703
E:\FR\FM\18OCN1.SGM
Notice of program exclusions.
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]]>Agencies
[Federal Register Volume 71, Number 201 (Wednesday, October 18, 2006)]
[Notices]
[Page 61485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17318]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, call the
HRSA Reports Clearance Office on (301)-443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: National Health Service Corps Travel Request
Worksheet (OMB No. 0915-0278): Extension
Clinicians participating in the HRSA National Health Service Corps
(NHSC) Scholarship Program use the Travel Request Worksheet to receive
travel funds from the Federal Government to perform pre-employment
interviews at sites on the Approved Practice List. The travel approval
process is initiated when a scholar notifies the NHSC's In-Service
Support Branch of an impending interview at one or more NHSC approved
practice sites.
The Travel Request Worksheet is also used to initiate the
relocation process after a NHSC scholar has successfully been matched
to an approved practice site. Upon receipt of the Travel Request
Worksheet, the NHSC will review and approve or disapprove the request
and promptly notify the NHSC contractor regarding authorization of the
funding for the relocation.
The burden estimate for the project is as follows:
----------------------------------------------------------------------------------------------------------------
Responses Total
Form Number of per Total Hours per burden
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Worksheet...................................... 250 2 500 .06 30
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
John Kraemer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503.
Dated: October 6, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-17318 Filed 10-17-06; 8:45 am]
BILLING CODE 4165-15-P
