Submission for OMB Review; Comment Request, 73665-73666 [2012-29905]
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Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices
tkelley on DSK3SPTVN1PROD with
Act and under authority delegated to
him by the Commissioner of Food and
Drugs, finds: (1) That Knott has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval of a drug
product or otherwise relating to the
regulation of a drug product under the
FD&C Act and (2) that the conduct
underlying the conviction undermines
the process for the regulation of drugs.
FDA has considered the relevant factors
listed in section 306(c)(3) of the FD&C
Act and determined that a debarment of
2 years is appropriate.
As a result of the foregoing findings,
Knott is debarred for 2 years from
providing services in any capacity to a
person with an approved or pending
drug product application under section
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see DATES)
(see 21 U.S.C. 335a(c)(1)(B),
(c)(2)(A)(iii), and 321(dd)). Any person
with an approved or pending drug
product application, who knowingly
uses the services of Knott, in any
capacity during her period of
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If
Knott, during her period of debarment,
provides services in any capacity to a
person with an approved or pending
drug product application, she will be
subject to civil money penalties (section
307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Knott during her period of debarment
(section 306(c)(1)(B) of the FD&C Act).
Any application by Knott for
termination of debarment under section
306(d) of the FD&C Act should be
identified with Docket No. FDA–2010–
N–0304 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the Internet may obtain
documents in the Docket at https://
www.regulations.gov/.
Dated: November 29, 2012.
Jesse L. Goodman,
Chief Scientist.
[FR Doc. 2012–29782 Filed 12–10–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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 65694–65698
dated October 30, 2012).
This notice reflects organizational
changes to the Health Resources and
Services Administration. This notice
updates the functional statement for the
Bureau of Clinician Recruitment and
Service (BCRS) (RU). Specifically, this
notice: (1) Updates the functional
statement for the Division of Program
Operations (RU9).
Chapter RU—Bureau of Clinician
Recruitment and Service
Section RU–20, Functions
Delete the functional statement for the
Division of Program Operations (RU9)
and replace in its entirety.
Division of Program Operations (RU9)
Serves as the organizational focal
point for the Bureau’s centralized,
comprehensive customer service
function to support program
participants and oversee participants’
compliance with all BCRS programs.
Provides regular and ongoing
communication, technical assistance,
and support to program participants
through the period of obligated service
and closeout. Specifically: (1) Initiates
contact with and monitors program
participants throughout their service; (2)
manages participants’ site transfers, inservice verifications, and similar service
change requests; (3) reviews program
cases and recommends participants for
suspensions, waivers, and defaults to
the appropriate BCRS Division; (4)
conducts closeout activities and issues
completion certificates to participants
that fulfill their service obligation; (5)
manages the 6-month verification
process; and, (6) maintains program
participants’ case files in the Bureau’s
management information system.
Section R–30, Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
consistent with this reorganization,
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73665
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
date of signature.
December 4, 2012.
Mary K. Wakefield,
Administrator.
[FR Doc. 2012–29862 Filed 12–10–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request
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 July 13, 2012, page 41431
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: Reinstatement with
Change; OMB Control Number: 0925–
0602; 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
SUMMARY:
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73666
Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices
Response: On occasion. Affected Public:
Individuals and businesses. Type of
Respondents: Physicians and dentists,
Ph.D. medical scientists, medical
students, dental students, postbaccalaureate students, graduate
students, post-doctoral students, and
other health care professionals. The
Estimated
number of
respondents
Type of respondents
estimated annualized burden hours are
as follows:
Number of
responses per
respondent
Average hours
per response
Total annual
burden hours
requested
354
403
28
1
1
1
20/60
20/60
20/60
118
134
9
Total ..........................................................................................................
tkelley on DSK3SPTVN1PROD with
Doctoral Level ..................................................................................................
Students ...........................................................................................................
Other ................................................................................................................
785
........................
........................
261
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
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: Robert
M. Lembo, MD, Office of Clinical
Research Training and Medical
Education, NIH Clinical Center, 10
Center Drive/1N252, Bethesda, MD
20892–1352, or call non-toll-free
number (301) 496–2636 or Email your
request, including your address to:
lembor@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.
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Dated: November 30, 2012.
Laura Lee,
Project Clearance Liaison, Warren Grant
Magnuson Clinical Center, National Institutes
of Health.
[FR Doc. 2012–29905 Filed 12–10–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cognition and Aging.
Date: January 7, 2013.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Weijia Ni, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 3184, MSC 7848, Bethesda, MD
20892, (301) 237–9918, niw@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Integrative,
Functional, and Cognitive Neuroscience
Member Conflicts: Hearing and Taste.
Date: January 8, 2013.
Time: 8:00 a.m. to 8:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: John Bishop, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 5, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–29861 Filed 12–10–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel; NEI Clinical Trial
Applications.
Date: January 30, 2013.
Time: 3:00 p.m. to 4:30 p.m.
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]]>Agencies
[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73665-73666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29905]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request
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 July 13, 2012, page 41431 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: Reinstatement with Change; OMB Control Number:
0925-0602; 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
[[Page 73666]]
Response: On occasion. Affected Public: Individuals and businesses.
Type of Respondents: Physicians and dentists, Ph.D. medical scientists,
medical students, dental students, post-baccalaureate students,
graduate students, post-doctoral students, and other health care
professionals. The estimated annualized burden hours are as follows:
----------------------------------------------------------------------------------------------------------------
Estimated Number of Total annual
Type of respondents number of responses per Average hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Doctoral Level.................................. 354 1 20/60 118
Students........................................ 403 1 20/60 134
Other........................................... 28 1 20/60 9
---------------------------------------------------------------
Total....................................... 785 .............. .............. 261
----------------------------------------------------------------------------------------------------------------
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 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: Robert M. Lembo, MD, Office of Clinical Research
Training and Medical Education, NIH Clinical Center, 10 Center Drive/
1N252, Bethesda, MD 20892-1352, or call non-toll-free number (301) 496-
2636 or Email your request, including your address to:
lembor@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: November 30, 2012.
Laura Lee,
Project Clearance Liaison, Warren Grant Magnuson Clinical Center,
National Institutes of Health.
[FR Doc. 2012-29905 Filed 12-10-12; 8:45 am]
BILLING CODE 4140-01-P
