Statement of Organization, Functions and Delegations of Authority, 73665 [2012-29862]
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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,
PO 00000
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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]
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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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]]>Agencies
[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Page 73665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29862]
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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, in-service 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 re-delegations of authority made
to HRSA officials that were in effect immediately prior to this
reorganization, and that are consistent with this reorganization, 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]
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