Children's Hospitals Graduate Medical Education Payment Program (CHGME PP), 67622-67623 [E6-19688]
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Federal Register / Vol. 71, No. 225 / Wednesday, November 22, 2006 / Notices
regulations governing premarket
approval applications (21 CFR part 814,
OMB control number 0910–0231). The
labeling provisions addressed in the
guidance have been approved by OMB
under OMB control number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: October 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–9325 Filed 11–17–06; 4:30 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0463]
Draft Guidance for Industry on
Sinusitis: Designing Clinical
Development Programs of
Nonantimicrobial Drugs for Treatment;
Availability
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC61 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Sinusitis: Designing
Clinical Development Programs of
Nonantimicrobial Drugs for Treatment.’’
Sinusitis is a common disease affecting
an estimated 16 percent of the adult
U.S. population annually. At present,
other than antimicrobials, the treatment
options for sinusitis are limited. This
guidance is intended to assist the
pharmaceutical industry in designing
clinical development programs for
nonantimicrobial drug products for the
treatment of sinusitis.
DATES: Submit written or electronic
comments on the draft guidance by
January 22, 2007. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
VerDate Aug<31>2005
22:25 Nov 21, 2006
Jkt 211001
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Dr.
Badrul A. Chowdhury, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 3316,
Silver Spring, MD 20993–0002, 301–
796–2300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Sinusitis: Designing Clinical
Development Programs of
Nonantimicrobial Drugs for Treatment.’’
Sinusitis is a disease characterized by
inflammation of one or more of the
paranasal sinuses. It is one of the most
commonly diagnosed diseases in the
United States affecting an estimated 16
percent of the adult population
annually. At present, other than
antimicrobials, some of which have a
label indication of acute bacterial
sinusitis, the treatment options for
sinusitis are limited. There is an interest
within the pharmaceutical industry in
the development of new drugs,
including drugs other than
antimicrobials, for the treatment of
sinusitis.
This guidance focuses on the
development of nonantibiotic drugs for
the treatment of acute sinusitis as well
as the development of drugs for other
types of sinusitis. This guidance also
focuses on the assessment of efficacy in
phase 3 clinical studies of sinusitis. In
addition, this guidance addresses
chemistry, manufacturing, and controls
issues and pharmacology and toxicology
issues, because some of the products for
sinusitis are developed for nasal
delivery, and there are nuances to nasal
route of delivery that should be
considered for appropriate clinical
study design.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
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represent the agency’s current thinking
on designing clinical development
programs of nonantimicrobial drugs for
the treatment of sinusitis. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: November 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–19689 Filed 11–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Children’s Hospitals Graduate Medical
Education Payment Program (CHGME
PP)
Health Resources and Services
Administration, HHS.
ACTION: Notice of Children’s Hospitals
Graduate Medical Education Payment
Program (CHGME PP) Conference Call.
AGENCY:
SUMMARY: This document announces a
scheduled CHGME PP conference call
for Federal fiscal year (FY) 2007. The
purpose of this conference call is to
discuss new annual reporting
requirements as required under Public
Law (Pub. L.) 109–307 for children’s
hospitals participating in the CHGME
PP.
The conference call will be held
on Wednesday, December 6, 2006, from
2 p.m. to 4 p.m. EST.
DATES:
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Federal Register / Vol. 71, No. 225 / Wednesday, November 22, 2006 / Notices
FOR FURTHER INFORMATION CONTACT:
Ayah E. Johnson, Ph.D., telephone: (301)
443–1058; Division of Medicine and
Dentistry, Bureau of Health Professions,
Health Resources and Services
Administration, Parklawn Building,
5600 Fishers Lane, Room 9A–05,
Rockville, Maryland 20857; or by e-mail
at: ajohnson@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
CHGME PP, as authorized by section
340E of the Public Health Service Act
(the Act) (42 U.S.C. 256e), provides
funds to children’s hospitals to address
disparity in the level of Federal funding
for children’s hospitals that result from
Medicare funding for graduate medical
education. Pub. L. 109–307 amended
the CHGME statute to extend the
program through FY 2011.
The statute authorizes $330 million
for both direct and indirect medical
education payments for each of the FY
2007 through FY 2011. Congress
appropriated $300 million in FY 2006
for the CHGME PP. These funds have
supported over 4,000 residents receiving
training in children’s teaching hospitals
in 31 states.
The agenda for the conference call
will include but not be limited to: (1)
Welcome and opening comments and
(2) news releases/updates. Time will
also be available for a question and
answer period.
Interested parties must register, in
advance, but not later than 5 days prior
to the scheduled conference call.
Conference call registration forms and
information about the Program can be
found on the CHGME PP Web site. The
Web site address is: https://
bhpr.hrsa.gov/childrenshospitalgme.
Dated: November 15, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6–19688 Filed 11–21–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
Citizenship and Immigration Services
RIN 1615–ZA44
pwalker on PROD1PC61 with NOTICES
[DHS Docket No. USCIS–2006–0066]
Changes to the Regional, District and
Field Office Organizational Structure
Within U.S. Citizenship and
Immigration Services
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: Notice.
AGENCY:
VerDate Aug<31>2005
22:25 Nov 21, 2006
Jkt 211001
SUMMARY: This notice informs the public
of changes to U.S. Citizenship and
Immigration Services’ (USCIS’) regional,
district and field office organizational
structure due to a recent realignment of
the command and control
responsibilities within USCIS’ Domestic
Operations Directorate, Field Operations
Division. This action is necessary to
balance the workload and personnel
among USCIS field offices and improve
customer service. USCIS does not plan
to close any of its existing offices as a
result of this realignment.
DATES: This notice is effective
November 22, 2006.
FOR FURTHER INFORMATION CONTACT:
David Gulick, Chief of Staff, Domestic
Operations Directorate, U.S. Citizenship
and Immigration Services, Department
of Homeland Security, 20 Massachusetts
Avenue, NW., 3rd Floor, Washington,
DC 20529, telephone (202) 272–2700.
SUPPLEMENTARY INFORMATION:
I. Background.
Upon its establishment in 2003,
USCIS inherited legacy Immigration and
Naturalization Service’s (legacy INS’s)
domestic field office structure
consisting of 3 regions and 33 districts.
USCIS’ workload and workforce
distribution, however, varies greatly
from that of legacy INS. Consequently,
the continuation of the legacy INS field
office structure resulted in an
unbalanced USCIS field office chain of
command structure with one region
having a larger workforce than the other
two regions combined, and the largest
districts having workforces up to 50
times larger than other districts.
In addition, within the pre-existing
chain of command, in those districts
with multiple field offices, the district
director served as the office manager for
one of the field offices while also
managing the other field offices within
the district. This dual role has been an
obstacle to overall management of a
district.
Moreover, under the pre-existing
organizational structure, each regional
office, district office, field office or suboffice had an assigned geographic area
of responsibility. A field office manager
could not exercise any power or
authority over a matter that involved a
customer whose place of residence or
employment was located outside of his
or her geographical area of
responsibility, absent an express
delegation of such authority by the
appropriate USCIS official. In the
adjudications context, rigid
jurisdictional boundaries based on
geography have led to situations where
the USCIS office that is physically
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67623
located closer to a customer’s residence
or place of employment does not have
geographical jurisdiction to provide the
customer with the requested service.
In view of the aforementioned
considerations, USCIS has made a
determination to realign the domestic
operations field office command and
control structure. This realignment is
effective November 22, 2006.
II. Realignment
Under this realignment, the following
are the changes to the command and
control structure within USCIS
Domestic Operations Directorate, Field
Operations Division.
Field Offices, Districts, and Regions
The keystones of USCIS’ in-person
services are its local offices. USCIS field
offices exist based on the geographic
distribution of workload requiring inperson services. No USCIS field office
will be closed as a result of this
realignment, nor will this realignment
change the locations of any of the
existing USCIS local offices. For clarity,
USCIS will refer to each of these offices
as a ‘‘field office,’’ managed by a ‘‘field
office director,’’ rather than ‘‘district
office,’’ managed by a ‘‘district
director.’’ Field offices will continue to
be responsible for the administration
and enforcement of the Immigration and
Nationality Act and all other laws
relating to immigration and
naturalization.
Where USCIS determines that an
interview is necessary, it will schedule
the applicant’s interview at the
appropriate field office. While most
information and customer services are
provided through the USCIS Web-site
and toll-free customer service telephone
number, individuals who believe they
need in-person service can also use their
zip code to make an appointment online at the appropriate office.
Individuals without internet access can
contact any USCIS office in-person for
assistance in making an appointment.
Using zip codes, rather than the current
geographic jurisdictional alignment, to
determine service areas will allow
USCIS to shift interviews and other inperson services to the most convenient
field office.
While the realignment does not
change the locations of USCIS field
offices, it does change the command
structure for managing these field
offices. USCIS will maintain a district
management structure to lead a network
of field offices. Each field office will be
managed by a field office director who
reports to a District Director. In the
previous structure, the district director
was both the field office director as well
E:\FR\FM\22NON1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 225 (Wednesday, November 22, 2006)]
[Notices]
[Pages 67622-67623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19688]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Children's Hospitals Graduate Medical Education Payment Program
(CHGME PP)
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of Children's Hospitals Graduate Medical Education
Payment Program (CHGME PP) Conference Call.
-----------------------------------------------------------------------
SUMMARY: This document announces a scheduled CHGME PP conference call
for Federal fiscal year (FY) 2007. The purpose of this conference call
is to discuss new annual reporting requirements as required under
Public Law (Pub. L.) 109-307 for children's hospitals participating in
the CHGME PP.
DATES: The conference call will be held on Wednesday, December 6, 2006,
from 2 p.m. to 4 p.m. EST.
[[Page 67623]]
FOR FURTHER INFORMATION CONTACT: Ayah E. Johnson, Ph.D., telephone:
(301) 443-1058; Division of Medicine and Dentistry, Bureau of Health
Professions, Health Resources and Services Administration, Parklawn
Building, 5600 Fishers Lane, Room 9A-05, Rockville, Maryland 20857; or
by e-mail at: ajohnson@hrsa.gov.
SUPPLEMENTARY INFORMATION: The CHGME PP, as authorized by section 340E
of the Public Health Service Act (the Act) (42 U.S.C. 256e), provides
funds to children's hospitals to address disparity in the level of
Federal funding for children's hospitals that result from Medicare
funding for graduate medical education. Pub. L. 109-307 amended the
CHGME statute to extend the program through FY 2011.
The statute authorizes $330 million for both direct and indirect
medical education payments for each of the FY 2007 through FY 2011.
Congress appropriated $300 million in FY 2006 for the CHGME PP. These
funds have supported over 4,000 residents receiving training in
children's teaching hospitals in 31 states.
The agenda for the conference call will include but not be limited
to: (1) Welcome and opening comments and (2) news releases/updates.
Time will also be available for a question and answer period.
Interested parties must register, in advance, but not later than 5
days prior to the scheduled conference call. Conference call
registration forms and information about the Program can be found on
the CHGME PP Web site. The Web site address is: https://bhpr.hrsa.gov/
childrenshospitalgme.
Dated: November 15, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-19688 Filed 11-21-06; 8:45 am]
BILLING CODE 4165-15-P
