Submission for OMB Review; Comment Request; The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research, 19224-19225 [E9-9688]
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Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices
Board of Governors of the Federal Reserve
System, April 23, 2009.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E9–9627 Filed 4–27–09; 8:45 am]
BILLING CODE 6210–01–S
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR Part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than May 22, 2009.
A. Federal Reserve Bank of Atlanta
(Steve Foley, Vice President) 1000
Peachtree Street, N.E., Atlanta, Georgia
30309:
1. Piedmont Bancorp, Inc., Norcross,
Georgia; to become a bank holding
company by acquiring 100 percent of
the voting shares of Republic Bank of
Georgia, Lawrenceville, Georgia.
B. Federal Reserve Bank of St. Louis
(Glenda Wilson, Community Affairs
Officer) P.O. Box 442, St. Louis,
Missouri 63166–2034:
1. Southern Missouri Bancorp, Inc.,
Poplar Bluff, Missouri; to acquire 100
percent of the voting shares of Southern
Bank of Commerce, Paragould,
Arkansas.
Board of Governors of the Federal Reserve
System, April 23, 2009.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc.E9–9626 Filed 4–27–09; 8:45 am]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; The Impact of
Clinical Research Training and Medical
Education at the Clinical Center on
Physician Careers in Academia and
Clinical Research
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Clinical
Center, the National Institutes of Health
(NIH) has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Estimated
number of
respondents
Type of respondents
Register on January 2, 2009, page 112
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: The Impact
of Clinical Research Training and
Medical Education at the Clinical Center
on Physician Careers in Academia and
Clinical Research. Type of Information
Collection Request: New. Need and Use
of Information Collection: This study
will assess the value of the training
programs administered by the Office of
Clinical Research Training and Medical
Education. The primary objective of the
survey is to determine if training
programs have had an impact on
whether the trainees are performing
clinical research, hold an academic
appointment, have National Institutes of
Health funding sources as well as to
obtain information from the trainees as
to what part of the National Institutes of
Health medical education program they
feel could be improved upon, the
quality of the mentoring program, and
how their National Institutes of Health
training has contributed to their current
clinical competence. Frequency of
Response: On occasion. Affected Public:
Individuals and businesses. Type of
Respondents: Physicians, dentists,
medical students, dental students,
nurses, and Ph.D.s. The annual
reporting burden is as follows:
Estimated Number of Respondents: 825.
Estimated Number of Responses per
Respondent: 1; Average Burden Hours
per Response: 0.5; and Estimated Total
Annual Burden Hours Requested: 412.5.
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
625
100
100
1
1
1
0.5
0.5
0.5
312.5
50
50
Total ..........................................................................................................
erowe on PROD1PC64 with NOTICES
Doctoral Level ..................................................................................................
Students ...........................................................................................................
Nurses ..............................................................................................................
........................
........................
........................
412.5
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
VerDate Nov<24>2008
15:33 Apr 27, 2009
Jkt 217001
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
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Fmt 4703
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validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Linda
Wisniewski, Office of Clinical Research
Training and Medical Education,
Clinical Center, Building 10, Room:
1N252B, 9000 Rockville Pike, Bethesda,
MD 20892, or call 301–496–9425 or
E-mail your request, including your
address to: wisniewskil@cc.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: April 16, 2009.
Laura Lee,
Project Clearance Liaison, Warren Grant
Magnuson Clinical Center, National Institutes
of Health.
[FR Doc. E9–9688 Filed 4–27–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0565]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Formal Dispute
Resolution; Appeals Above the
Division Level
AGENCY:
Food and Drug Administration,
HHS.
erowe on PROD1PC64 with NOTICES
ACTION:
Notice.
SUMMARY: 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 May 28,
2009.
VerDate Nov<24>2008
15:33 Apr 27, 2009
Jkt 217001
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:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0396. 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 (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
Guidance for Industry on Formal
Dispute Resolution; Appeals Above the
Division Level—(OMB Control Number
0910–0396)—Extension
This information collection approval
request is for an FDA guidance on the
process for formally resolving scientific
and procedural disputes in the Center
for Drug Evaluation and Research
(CDER) and the Center for Biologics
Evaluation and Research (CBER) that
cannot be resolved at the division level.
The guidance describes procedures for
formally appealing such disputes to the
office or center level and for submitting
information to assist center officials in
resolving the issue(s) presented. The
guidance provides information on how
the agency will interpret and apply
provisions of the existing regulations
regarding internal agency review of
decisions (§ 10.75) and dispute
resolution during the investigational
new drug (IND) process (§ 312.48) and
the new drug application/abbreviated
new drug application (NDA/ANDA)
process (§ 314.103). In addition, the
guidance provides information on how
the agency will interpret and apply the
specific Prescription Drug User Fee Act
(PDUFA) goals for major dispute
resolution associated with the
development and review of PDUFA
products.
Existing regulations, which appear
primarily in parts 10, 312, and 314 (21
CFR parts 10, 312, and 314), establish
procedures for the resolution of
scientific and procedural disputes
between interested persons and the
agency, CDER, and CBER. All agency
decisions on such matters are based on
information in the administrative file
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19225
(§ 10.75(d)). In general, the information
in an administrative file is collected
under existing regulations in parts 312
(OMB Control No. 0910–0014), 314
(OMB Control No. 0910–0001), and part
601 (21 CFR part 601) (OMB Control No.
0910–0338), which specify the
information that manufacturers must
submit so that FDA may properly
evaluate the safety and effectiveness of
drugs and biological products. This
information is usually submitted as part
of an IND, NDA, or biologics license
application (BLA), or as a supplement to
an approved application. While FDA
already possesses in the administrative
file the information that would form the
basis of a decision on a matter in
dispute resolution, the submission of
particular information regarding the
request itself and the data and
information relied on by the requestor
in the appeal would facilitate timely
resolution of the dispute. The guidance
describes the following collection of
information not expressly specified
under existing regulations: The
submission of the request for dispute
resolution as an amendment to the
application for the underlying product,
including the submission of supporting
information with the request for dispute
resolution.
Agency regulations (§§ 312.23(11)(d),
314.50, 314.94, and 601.2) state that
information provided to the agency as
part of an IND, NDA, ANDA, or BLA is
to be submitted in triplicate and with an
appropriate cover form. Form FDA 1571
must accompany submissions under
INDs and Form FDA 356h must
accompany submissions under NDAs,
ANDAs, and BLAs. Both forms have
valid OMB control numbers as follows:
FDA Form 1571—OMB Control No.
0910–0014, and FDA Form 356h—OMB
Control No. 0910–0338.
In the guidance document, CDER and
CBER ask that a request for formal
dispute resolution be submitted as an
amendment to the application for the
underlying product and that it be
submitted to the agency in triplicate
with the appropriate form attached,
either Form FDA 1571 or Form FDA
356h. The agency recommends that a
request be submitted as an amendment
in this manner for two reasons: To
ensure that each request is kept in the
administrative file with the entire
underlying application and to ensure
that pertinent information about the
request is entered into the appropriate
tracking databases. Use of the
information in the agency’s tracking
databases enables the appropriate
agency official to monitor progress on
the resolution of the dispute and to
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19224-19225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9688]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; The Impact of
Clinical Research Training and Medical Education at the Clinical Center
on Physician Careers in Academia and Clinical Research
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the Clinical Center, the National
Institutes of Health (NIH) has submitted to the Office of Management
and Budget (OMB) a request for review and approval of the information
collection listed below. This proposed information collection was
previously published in the Federal Register on January 2, 2009, page
112 and allowed 60 days for public comment. No public comments were
received. The purpose of this notice is to allow an additional 30 days
for public comment. The National Institutes of Health may not conduct
or sponsor, and the respondent is not required to respond to, an
information collection that has been extended, revised, or implemented
on or after October 1, 1995, unless it displays a currently valid OMB
control number.
Proposed Collection: Title: The Impact of Clinical Research
Training and Medical Education at the Clinical Center on Physician
Careers in Academia and Clinical Research. Type of Information
Collection Request: New. Need and Use of Information Collection: This
study will assess the value of the training programs administered by
the Office of Clinical Research Training and Medical Education. The
primary objective of the survey is to determine if training programs
have had an impact on whether the trainees are performing clinical
research, hold an academic appointment, have National Institutes of
Health funding sources as well as to obtain information from the
trainees as to what part of the National Institutes of Health medical
education program they feel could be improved upon, the quality of the
mentoring program, and how their National Institutes of Health training
has contributed to their current clinical competence. Frequency of
Response: On occasion. Affected Public: Individuals and businesses.
Type of Respondents: Physicians, dentists, medical students, dental
students, nurses, and Ph.D.s. The annual reporting burden is as
follows: Estimated Number of Respondents: 825. Estimated Number of
Responses per Respondent: 1; Average Burden Hours per Response: 0.5;
and Estimated Total Annual Burden Hours Requested: 412.5.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Doctoral Level.................................. 625 1 0.5 312.5
Students........................................ 100 1 0.5 50
Nurses.......................................... 100 1 0.5 50
---------------------------------------------------------------
Total....................................... .............. .............. .............. 412.5
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who
[[Page 19225]]
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Linda Wisniewski, Office of Clinical Research
Training and Medical Education, Clinical Center, Building 10, Room:
1N252B, 9000 Rockville Pike, Bethesda, MD 20892, or call 301-496-9425
or E-mail your request, including your address to:
wisniewskil@cc.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: April 16, 2009.
Laura Lee,
Project Clearance Liaison, Warren Grant Magnuson Clinical Center,
National Institutes of Health.
[FR Doc. E9-9688 Filed 4-27-09; 8:45 am]
BILLING CODE 4140-01-P
