Agency Information Collection Activities: Submission for OMB Review; Comment Request, 53779-53780 [E7-18561]
Download as PDF
<![CDATA[
53779
Federal Register / Vol. 72, No. 182 / Thursday, September 20, 2007 / Notices
Wanda Neal, Parenteral Drug
Association, 4350 East West Hwy.,
suite 200, Bethesda, MD 20814,
301–656–5900, FAX: 301–986–
0296, neal@pda.org.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Who Should Attend?
This announcement is directed
towards professionals involved in the
manufacture, control, and regulation of
pharmaceutical products who will
benefit from these workshops, including
process/production engineers,
manufacturing personnel, quality
assurance/quality control and regulatory
affairs professionals, consultants,
regulatory investigators, and CGMP
compliance officials. Other entities or
individuals may also be interested in
attending.
B. Where and When Will These
Workshops Be Held?
We have scheduled four workshops.
The locations and times are listed in
table 1 of this document.
TABLE 1.—WORKSHOP LOCATIONS AND SCHEDULES
Workshop Address
Dates and Local Times
Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814
November 1 and 2, 2007, from 9 a.m. to 5 p.m. each day
The Gresham Hotels, 23 Upper O’Connell St., Dublin 1, Ireland
December 10 and 11, 2007, from 9 a.m. to 5 p.m. each day
Peking University, Beijing, China 100871
April 21 and 22, 2008, from 9 a.m. to 5 p.m. each day
Grand Hyatt Shanghai, Jin Mao Tower, 88 Century Blvd., Pudong, Shanghai,
China 200121
April 24 and 25, 2008, from 9 a.m. to 5 p.m. each day
C. How Can I Participate?
You can participate in person.
Anyone interested in the GMP
workshops can register through the
contact person (see FOR FURTHER
INFORMATION CONTACT).
D. Is There a Registration Fee for This
Workshop?
Yes, a registration fee is required for
this workshop. The registration fee
includes workshop reference materials
and meals. Registration fees for the
Bethesda, MD and Dublin, Ireland
workshops are listed in table 2 of this
document. The registration fee for both
China locations (Beijing and Shanghai)
is $550 with no discounts. All fees are
given in U.S. dollars.
TABLE 2.—REGISTRATION FEES FOR THE BETHESDA, MD AND DUBLIN, IRELAND WORKSHOPS
Date of Registration
PDA Member
Government Employee
or Health Authority
Nonmember
Academic
Student
Through October 1, 2007
$1,295
$1,695
$350
$3501
$150
After October 1, 2007
$1,495
$1,895
$405
$4051
$180
1 Must
be PDA member to receive this rate.
E. How Can I Get Additional
Information?
The notice of participation form,
information about the workshops, and
other related documents are available
from the contact person (see FOR
FURTHER INFORMATION CONTACT) and on
the Internet at https://www.fda.gov/cder/
workshop.htm.
FDA and industry will provide a
regulatory and practical perspective on
the current relevant critical topics.
Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–18556 Filed 9–19–07; 8:45 am]
II. Background Information
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Why Is FDA Cosponsoring These
Workshops?
FDA is cosponsoring these 2-day
workshops to provide information and
training opportunities for industry as
well as CGMP compliance officials.
Health Resources and Services
Administration
jlentini on PROD1PC65 with NOTICES
B. What Will Be Covered?
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
The workshops will provide
information on specific topics designed
to educate and guide participants on
methodologies and implementation of
CGMP as applied to quality drug
manufacturing. Presentations by both
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
VerDate Aug<31>2005
17:50 Sep 19, 2007
Jkt 211001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
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: Children’s Hospital
Graduate Medical Education (CHGME)
Payment
Program Annual Report: NEW
The CHGME Payment Program was
enacted by Public Law 106–129 to
provide Federal support for graduate
medical education (GME) to
freestanding children’s hospitals,
similar to Medicare GME support
received by other non-children’s
hospitals. The legislation mandates that
eligible children’s hospitals will receive
payments for both direct and indirect
medical education. Direct payments are
E:\FR\FM\20SEN1.SGM
20SEN1
53780
Federal Register / Vol. 72, No. 182 / Thursday, September 20, 2007 / Notices
designed to offset the expenses
associated with operating approved
graduate medical residency training
programs and indirect payments are
designed to compensate hospitals for
expenses associated with the treatment
of more severely ill patients and the
additional costs relating to teaching
residents in such programs.
The CHGME Payment Program was
reauthorized for a period of five years in
October 2006 by Public Law 109–307.
The reauthorizing legislation requires
that children’s hospitals participating
and receiving funds from the CHGME
Payment Program provide information
about their residency training programs
in an annual report that will be an
addendum to the hospitals’ annual
applications for funds. Specifically, data
are required to be collected on: (1) The
types of training programs that the
hospital provided for residents such as
general pediatrics, internal medicine/
pediatrics, and pediatric subspecialties
including both American Board of
Pediatrics certified medical
subspecialties and non-medical
subspecialties approved by other
medical certification boards; (2) the
number of training positions for
residents, the number of such positions
recruited to fill, and the number of
positions filled; (3) the types of training
that the hospital provided for residents
related to the health care needs of
difference populations such as children
who are underserved for reasons of
family income or geographic location,
including rural and urban areas; (4)
changes in residency training the
hospital made during an academic year,
including changes in curricula, training
experiences, and types of training
programs, and benefits that have
resulted from such changes and changes
for purposed of training residents in the
measurement and improvement and the
quality and safety of patient care; and
(5) the numbers of residents
(disaggregated by specialty and
subspecialty) who completed training in
the academic year and provide care
within the borders of the service area of
the hospital or within the borders of the
State in which the children’s hospital is
located. For purposes of the annual
report data collection, ‘‘residents’’ are
Number of
respondents
Form name
Responses
per
respondent
those who are (1) in full-time equivalent
resident training positions in any
training program sponsored by the
hospital; or (2) in a training program
sponsored by an entity other than the
hospital who spend more than 75
percent of their time training at the
hospital.
The annual report data collection
instruments consist of Excel workbooks
with several pages (worksheets) each.
These data collection instruments for
the annual report were pre-tested by
nine participating CHGME Payment
Program hospitals. Each hospital
provided an estimate of the number of
hours required to complete each part of
the annual report. Following the pretest, the data collection instruments
were significantly reduced by collapsing
certain categories, shifting several
questions from the individual GME
training program level to the hospital
level instrument, and by omitting
several questions. As a result, the
estimated burden to each respondent
was significantly reduced.
The estimated annual burden is as
follows:
Total number
of responses
Hours per
response
Total burden
hours
Screening Instrument ...........................................................
Annual Report, Hospital and Program-Level Information ....
57
57
1
1
57
57
10.0
74.8
570.0
4263.6
Total ..............................................................................
57
........................
57
84.8
4833.6
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: September 14, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–18561 Filed 9–19–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jlentini on PROD1PC65 with NOTICES
Health Resources and Services
Administration
Notice of Availability of Final Policy
Guidance
Health Resources and Services
Administration, HHS.
AGENCY:
VerDate Aug<31>2005
17:50 Sep 19, 2007
Jkt 211001
Final Agency Guidance and
Response to Public Comments.
ACTION:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
publishing a final Agency Guidance
(‘‘Policy Information Notice’’ (PIN)
2007–16) to describe and clarify the
circumstances under which Federal Tort
Claims Act (FTCA)—deemed Health
Center Program grantees are covered
under the FTCA as they respond to
emergencies. The PIN, ‘‘Federal Tort
Claims Act Coverage for Health Center
Program Grantees Responding to
Emergencies,’’ and the Agency’s
‘‘Response to Public Comments’’ are
available on the Internet at https://
bphc.hrsa.gov/policy/pin0716.
DATES: The effective date of this final
Agency guidance is August 22, 2007.
BACKGROUND: HRSA administers the
Health Center Program, which supports
more than 3,800 health care delivery
sites, including community health
centers, migrant health centers, health
care for the homeless centers, and
public housing primary care centers.
Health centers serve clients that are
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
primarily low-income and minorities,
and deliver comprehensive, culturally
competent, quality primary health care
services to patients regardless of their
ability to pay. Charges for health care
services are set according to income.
On March 15, 2007, HRSA made the
draft PIN, ‘‘Federal Tort Claims Act
Coverage for Health Center Program
Grantees Responding to Emergencies,’’
available for public comment on
HRSA’s Web site. Comments were due
to HRSA by May 31, 2007.
Comments were received from 14
organizations and/or individuals. After
review and careful consideration of all
comments received, HRSA has amended
the PIN to incorporate certain
recommendations from the public. The
final PIN reflects these changes.
In addition to making the final PIN
available on HRSA’s Web site, HRSA is
also posting the Agency’s ‘‘Response to
Public Comments.’’ The purpose of that
document is to summarize the major
comments received and describe the
Agency’s response, including any
corresponding changes made to the PIN.
Where comments did not result in a
E:\FR\FM\20SEN1.SGM
20SEN1
]]>Agencies
[Federal Register Volume 72, Number 182 (Thursday, September 20, 2007)]
[Notices]
[Pages 53779-53780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18561]
-----------------------------------------------------------------------
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: Children's Hospital Graduate Medical Education
(CHGME) Payment
Program Annual Report: NEW
The CHGME Payment Program was enacted by Public Law 106-129 to
provide Federal support for graduate medical education (GME) to
freestanding children's hospitals, similar to Medicare GME support
received by other non-children's hospitals. The legislation mandates
that eligible children's hospitals will receive payments for both
direct and indirect medical education. Direct payments are
[[Page 53780]]
designed to offset the expenses associated with operating approved
graduate medical residency training programs and indirect payments are
designed to compensate hospitals for expenses associated with the
treatment of more severely ill patients and the additional costs
relating to teaching residents in such programs.
The CHGME Payment Program was reauthorized for a period of five
years in October 2006 by Public Law 109-307. The reauthorizing
legislation requires that children's hospitals participating and
receiving funds from the CHGME Payment Program provide information
about their residency training programs in an annual report that will
be an addendum to the hospitals' annual applications for funds.
Specifically, data are required to be collected on: (1) The types of
training programs that the hospital provided for residents such as
general pediatrics, internal medicine/pediatrics, and pediatric
subspecialties including both American Board of Pediatrics certified
medical subspecialties and non-medical subspecialties approved by other
medical certification boards; (2) the number of training positions for
residents, the number of such positions recruited to fill, and the
number of positions filled; (3) the types of training that the hospital
provided for residents related to the health care needs of difference
populations such as children who are underserved for reasons of family
income or geographic location, including rural and urban areas; (4)
changes in residency training the hospital made during an academic
year, including changes in curricula, training experiences, and types
of training programs, and benefits that have resulted from such changes
and changes for purposed of training residents in the measurement and
improvement and the quality and safety of patient care; and (5) the
numbers of residents (disaggregated by specialty and subspecialty) who
completed training in the academic year and provide care within the
borders of the service area of the hospital or within the borders of
the State in which the children's hospital is located. For purposes of
the annual report data collection, ``residents'' are those who are (1)
in full-time equivalent resident training positions in any training
program sponsored by the hospital; or (2) in a training program
sponsored by an entity other than the hospital who spend more than 75
percent of their time training at the hospital.
The annual report data collection instruments consist of Excel
workbooks with several pages (worksheets) each. These data collection
instruments for the annual report were pre-tested by nine participating
CHGME Payment Program hospitals. Each hospital provided an estimate of
the number of hours required to complete each part of the annual
report. Following the pre-test, the data collection instruments were
significantly reduced by collapsing certain categories, shifting
several questions from the individual GME training program level to the
hospital level instrument, and by omitting several questions. As a
result, the estimated burden to each respondent was significantly
reduced.
The estimated annual burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total number Hours per Total burden
Form name respondents respondent of responses response hours
----------------------------------------------------------------------------------------------------------------
Screening Instrument............ 57 1 57 10.0 570.0
Annual Report, Hospital and 57 1 57 74.8 4263.6
Program-Level Information......
-------------------------------------------------------------------------------
Total....................... 57 .............. 57 84.8 4833.6
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA_
submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: September 14, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review and Coordination.
[FR Doc. E7-18561 Filed 9-19-07; 8:45 am]
BILLING CODE 4165-15-P
