Agency Information Collection Activities: Proposed Collection: Comment Request, 30129-30131 [05-10430]
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Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices
children and the permission of their
parents or guardians, as set forth in 45
CFR 46.408 and 21 CFR 50.55.
HHS has received a request on behalf
of the Washington University Medical
Center IRB to review under 45 CFR
46.407 the protocol entitled ‘‘Precursor
Preference in Surfactant Synthesis of
Newborns.’’ The principal investigator
proposes to administer to preterm and
full-term newborns simultaneous 24hour infusions of palmitate and acetate
labeled with the stable (nonradioactive)
isotope carbon-13, then measure the
incorporation of each into surfactant,
collected by tracheal aspiration.
Subjects of the study would include
approximately 10 full-term, intubated
infants with normal lungs and 15 to 20
preterm (24 to 28 weeks gestational age),
intubated infants with respiratory
distress syndrome.
The overall goal of the proposed study
is to better understand the potential
differences in precursor preferences in
surfactant synthesis between preterm
infants with immature lungs (requiring
mechanical ventilation) and full-term
infants with normal lung function. The
three specific aims of the study are to:
(1) Determine the rate of surfactant
synthesis using de novo synthesized
fatty acids (acetate), (2) determine the
rate of surfactant synthesis using
preformed fatty acids (palmitate), and
(3) compare the rates of incorporation in
preterm infants versus full-term infants
with normal lungs.
The Washington University Medical
Center IRB determined that the protocol
was not approvable under 45 CFR
46.404, 46.405, or 46.406 because the
24-hour isotope infusion and extra
blood draws pose more than minimal
risks to the subjects, there is no prospect
of direct benefit to the individual
subjects, the interventions or procedures
do not present an experience to the
control group that are reasonably
commensurate with those inherent in
their expected medical situation, and
the control group does not have the
condition or disorder under study.
Accordingly, the Washington University
Medical Center IRB forwarded the
protocol to OHRP under 45 CFR 46.407
for consideration. Because this clinical
investigation is regulated by FDA,
FDA’s regulations in part 50, subpart D,
specifically § 50.54, apply as well.
In accordance with 45 CFR 46.407(b)
and 21 CFR 50.54(b), OHRP and FDA
are soliciting public review and
comment on this proposed clinical
investigation. In particular, comments
are solicited on the following questions:
(1) What are the potential benefits, if
any, to the subjects and to children in
general; (2) what are the types and
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17:52 May 24, 2005
Jkt 205001
degrees of risk that this research
presents to the subjects; (3) are the risks
to the subjects reasonable in relation to
the anticipated benefits, and is the
research likely to result in knowledge
that can be generalized about the
subjects’ disorder or condition; and (4)
does the research present a reasonable
opportunity to further the
understanding, prevention, or
alleviation of a serious problem
affecting the health or welfare of
children.
To facilitate the public review and
comment process, FDA has established
a public docket and placed in that
docket information relating to the
proposed clinical investigation,
including the following:
Correspondence from Washington
University Medical Center referring the
proposed research protocol to HHS for
consideration under 45 CFR 46.407;
correspondence from FDA and OHRP to
Washington University Medical Center
regarding the proposed protocol; the
research protocol; NIH’s grant funding
the protocol; IRB’s deliberations on the
proposed research; the drug preparation
protocol; certificate of analysis of the
test compounds; the data safety
monitoring plan; and the parental
permission documents. Electronic
copies of these documents can be
viewed at the Pediatric Advisory
Committee (PAC) Docket Web site at
https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm. (Click on the year 2005
and scroll down to Pediatric Ethics
Subcommittee meetings.) These
materials are also available on OHRP’s
website at https://www.hhs.gov/ohrp/
children/.
All written comments concerning this
proposed research should be submitted
to FDA’s Division of Dockets
Management under 21 CFR 10.20, no
later than 4:30 p.m. on June 17, 2005.
The background materials and received
comments may be viewed on FDA’s
Web site at https://www.fda.gov/ohrms/
dockets/dockets/05n0184/05n0184.htm
or may be seen in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
The background materials may also be
viewed on OHRP’s Web site at https://
www.hhs.gov/ohrp/children/.
Dated: May 19, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–10438 Filed 5–24–05; 8:45 am]
BILLING CODE 4160–01–S
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30129
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the Agency,
including whether the information shall
have practical utility; (b) the accuracy of
the Agency’s estimate of the burden of
the proposed collection of information;
(c) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including the use of
automated collection techniques or
other forms of information technology.
Proposed Project: Health Professions
Student Loan (HPSL) Program and
Nursing Student Loan (NSL) Program
Administrative Requirements
(Regulations and Policy)(OMB No.
0915–0047)—Extension
The regulations for the Health
Professions Student Loan (HPSL)
Program and Nursing Student Loan
(NSL) Program contain a number of
reporting and recordkeeping
requirements for schools and loan
applicants. The requirements are
essential for assuring that borrowers are
aware of rights and responsibilities that
schools know the history and staus of
each loan account that schools pursue
aggressive collection efforts to reduce
default rates, and that they maintain
adequate records for audit and
assessment purposes. Schools are free to
use improved information technology to
manage the information required by the
regulations.
E:\FR\FM\25MYN1.SGM
25MYN1
30130
Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices
The estimated total annual burden is
34,558 hours. The burden estimates are
as follows:
RECORDKEEPING REQUIREMENTS
Number of
recordkeepers
Regulatory/section requirements
HPSL Program:
57.206(b)(2), Documentation of Cost of Attendance .........................................
57.208(a), Promissory Note ...............................................................................
57.210((b)(1)(i), Documentation of Entrance Interview ......................................
57.210(b)(1)(ii), Documentation of Exit Interview ...............................................
57.215(a) & (d), Program Records .....................................................................
57.215(b), Student Records ...............................................................................
57.215(c), Repayment Records .........................................................................
Total burden
hours
Hours per year
547
547
547
*576
*576
*576
*576
1.17
1.25
1.25
0.33
10
10
18.75
640
684
684
190
5,760
5,760
10,800
HPSL Subtotal .............................................................................................
NSL Program:
57.306(b)(2)(ii), Documentation of Cost of Attendance .....................................
57.308(a), Promissory Note ...............................................................................
57.310(b)(1)(i), Documentation of Entrance Interview .......................................
57.310(b)(1)(ii), Documentation of Exit Interview ...............................................
57.315(a)(1) & (a)(4), Program Records ............................................................
57.315(a)(2), Student Records ...........................................................................
57.315(a)(3), Repayment Records .....................................................................
576
..............................
24,518
315
315
315
*502
*502
*502
*502
0.3
0.5
0.5
0.17
5
1
2.51
95
158
158
85
2,510
502
1,255
NSL Subtotal ...............................................................................................
502
4,763
*Includes active and closing schools.
HPSL data includes active and closing Loans for Disadvantaged Students (LDS) program schools.
REPORTING REQUIREMENTS
Regulatory/section requirements
Number of
respondents
Responses per
respondent
Total annual
responses
Hours per
response
Total hour
burden
HPSL Program:
57.205(a)(2), Excess Cash .............
Burden included under 0915–0044
57.206(a)(2), Student Financial Aid
Transcript ....................................
57.208(c), Loan Information Disclosure .............................................
4,679
1
4,679
.25
1,170
547
68.73
37,595
.0833
3,132
57.210(a)(3), Deferment Eligibility ..
Burden included under 0915–0044
57.210(b)(1)(i), Entrance Interview
57.210(b)(1)(ii), Exit Interview ........
57.210(b)(1)(iii), Notification of Repayment ......................................
57.210(b)(1)(iv), Notification During
Deferment ....................................
57.210(b)(1)(vi), Notification of Delinquent Accounts ........................
57.210(b)(1)(x), Credit Bureau Notification .........................................
57.210(b)(4)(i),
Write-off
of
Uncollectible Loans .....................
57.211(a) Disability Cancellation ....
547
*547
68.73
12
37,595
6,564
0.167
0.5
6,278
3,282
*547
30.83
16,864
0.167
2,816
*547
24.32
13,303
0.0833
1,108
*547
10.28
5,623
0.167
518
*547
8.03
4,392
0.6
2,635
20
8
1.00
1
20
8
3.0
.75
60
6
57.215(a) Reports ...........................
Burden included under 0915–0044
57.215(a)(2), Administrative Hearings ..............................................
57.215(a)(d), Administrative Hearings ..............................................
0
0
0
0
0
0
0
0
0
0
HPSL Subtotal .........................
NSL Program:
8,681
109,779
57.305(a)(2), Excess Cash .............
Burden included under 0915–0044
57.306(a)(2), Student Financial Aid
Transcript ....................................
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16,703
4,062
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1
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4,062
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0.25
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30131
Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices
REPORTING REQUIREMENTS—Continued
Number of
respondents
Regulatory/section requirements
57.310(b)(1)(i), Entrance Interview
57.310(b)(1)(ii), Exit Interview ........
57.301(b)(1)(iii), Notification of Repayment ......................................
57.310(b)(1)(iv), Notification During
Deferment ....................................
57.310(b)(1)(vi), Notification of Delinquent Accounts ........................
57.310(b)(1)(x), Credit Bureau Notification .........................................
57.310(b)(4)(i),
Write-off
of
Uncollectible Loans .....................
57.311(a), Disability Cancellation ...
Responses per
respondent
Total annual
responses
Hours per
response
Total hour
burden
315
*502
23.51
3.77
7,406
1,892
0.167
0.5
1,237
946
*502
6.18
3,102
0.167
518
*502
0.65
326
0.083
27
*502
4.61
2,314
0.167
386
*502
8.3
4,167
0.6
2,500
20
7
1.0
1.0
20
7
3.5
0.8
70
5.6
57.312(a)(3), Evidence of Educational Loans .............................
57.315(a)(1), Reports .....................
Inactive Provision
Burden included under 0915–0044
57.315(a)(1)(ii),
Administrative
Hearings ......................................
57.316(a)(d), Administrative Hearings ..............................................
0
0
0
0
0
0
0
0
0
0
NSL Subtotal ...........................
6,914
* Includes
Send comments to Susan G. Queen,
PhD, HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: May 18, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–10430 Filed 5–24–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
Dates and Times: July 7, 2005, 9 a.m.–
5 p.m., July 8, 2005, 8:30 a.m.–3 p.m.
Place: The Wyndham Washington
Hotel, 1400 M Street, NW., Washington,
DC 20005, (202) 429–1700.
Status: The meeting is open to the
public with attendance limited to space
availability.
Purpose: The Committee provides
advice and recommendations to the
Secretary of Health and Human Services
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23,296
6,706
active and closing schools.
17:52 May 24, 2005
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on the following: Department programs
that are directed at reducing infant
mortality and improving the health
status of pregnant women and infants;
factors affecting the continuum of care
with respect to maternal and child
health care, including outcomes
following childbirth; strategies to
coordinate the variety of Federal, State,
local and private programs and efforts
that are designed to deal with the health
and social problems impacting on infant
mortality; and the implementation of
the Healthy Start program and Healthy
People 2010 infant mortality objectives.
Agenda: Topics that will be discussed
include the following: Maternal and
Child Health (MCH) Services Financing,
Health Disparities in the MCH
Population, and Improving Data and
Public Health Practice. Substantial time
will be spent in Subcommittee and full
Committee discussions aimed at
formulating the ACIM issues agenda.
Proposed agenda items are subject to
change as priorities indicate.
Time will be provided for public
comments limited to five minutes each;
comments are to be submitted no later
than June 22, 2005.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the Committee should contact Peter C.
van Dyck, M.D., M.P.H., Executive
Secretary, ACIM, Health Resources and
Services Administration (HRSA), Room
18–05, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857, Telephone:
(301) 443–2170.
PO 00000
Frm 00076
Fmt 4703
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Individuals who are submitting public
comments or who have questions
regarding the meeting should contact
Ann M. Koontz, C.N.M., Dr.P.H., HRSA,
Maternal and Child Health Bureau,
telephone: (301) 443–6327, e-mail:
akoontz@hrsa.gov.
Dated: May 18, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–10429 Filed 5–24–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–21258]
National Boating Safety Advisory
Council; Vacancies
Coast Guard, DHS.
Request for applications.
AGENCY:
ACTION:
SUMMARY: The Coast Guard seeks
applications for membership on the
National Boating Safety Advisory
Council (NBSAC). NBSAC advises the
Coast Guard on matters related to
recreational boating safety.
DATES: Application forms should reach
us on or before September 8, 2005.
ADDRESSES: You may request an
application form by writing to
Commandant, Office of Boating Safety
E:\FR\FM\25MYN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 100 (Wednesday, May 25, 2005)]
[Notices]
[Pages 30129-30131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10430]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, call the HRSA Reports Clearance
Officer on (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information shall have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.
Proposed Project: Health Professions Student Loan (HPSL) Program and
Nursing Student Loan (NSL) Program Administrative Requirements
(Regulations and Policy)(OMB No. 0915-0047)--Extension
The regulations for the Health Professions Student Loan (HPSL)
Program and Nursing Student Loan (NSL) Program contain a number of
reporting and recordkeeping requirements for schools and loan
applicants. The requirements are essential for assuring that borrowers
are aware of rights and responsibilities that schools know the history
and staus of each loan account that schools pursue aggressive
collection efforts to reduce default rates, and that they maintain
adequate records for audit and assessment purposes. Schools are free to
use improved information technology to manage the information required
by the regulations.
[[Page 30130]]
The estimated total annual burden is 34,558 hours. The burden
estimates are as follows:
Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
Number of Total burden
Regulatory/section requirements recordkeepers Hours per year hours
----------------------------------------------------------------------------------------------------------------
HPSL Program:
57.206(b)(2), Documentation of Cost of Attendance.. 547 1.17 640
57.208(a), Promissory Note......................... 547 1.25 684
57.210((b)(1)(i), Documentation of Entrance 547 1.25 684
Interview.........................................
57.210(b)(1)(ii), Documentation of Exit Interview.. *576 0.33 190
57.215(a) & (d), Program Records................... *576 10 5,760
57.215(b), Student Records......................... *576 10 5,760
57.215(c), Repayment Records....................... *576 18.75 10,800
--------------------
HPSL Subtotal.................................. 576 ................. 24,518
NSL Program:
57.306(b)(2)(ii), Documentation of Cost of 315 0.3 95
Attendance........................................
57.308(a), Promissory Note......................... 315 0.5 158
57.310(b)(1)(i), Documentation of Entrance 315 0.5 158
Interview.........................................
57.310(b)(1)(ii), Documentation of Exit Interview.. *502 0.17 85
57.315(a)(1) & (a)(4), Program Records............. *502 5 2,510
57.315(a)(2), Student Records...................... *502 1 502
57.315(a)(3), Repayment Records.................... *502 2.51 1,255
--------------------
NSL Subtotal................................... 502 ................. 4,763
----------------------------------------------------------------------------------------------------------------
*Includes active and closing schools.
HPSL data includes active and closing Loans for Disadvantaged Students (LDS) program schools.
Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total annual Hours per Total hour
Regulatory/section requirements respondents respondent responses response burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
HPSL Program:
--------------------
57.205(a)(2), Excess Cash............................ Burden included under 0915-0044
--------------------
57.206(a)(2), Student Financial Aid Transcript....... 4,679 1 4,679 .25 1,170
57.208(c), Loan Information Disclosure............... 547 68.73 37,595 .0833 3,132
--------------------
57.210(a)(3), Deferment Eligibility.................. Burden included under 0915-0044
--------------------
57.210(b)(1)(i), Entrance Interview.................. 547 68.73 37,595 0.167 6,278
57.210(b)(1)(ii), Exit Interview..................... *547 12 6,564 0.5 3,282
57.210(b)(1)(iii), Notification of Repayment......... *547 30.83 16,864 0.167 2,816
57.210(b)(1)(iv), Notification During Deferment...... *547 24.32 13,303 0.0833 1,108
57.210(b)(1)(vi), Notification of Delinquent Accounts *547 10.28 5,623 0.167 518
57.210(b)(1)(x), Credit Bureau Notification.......... *547 8.03 4,392 0.6 2,635
57.210(b)(4)(i), Write-off of Uncollectible Loans.... 20 1.00 20 3.0 60
57.211(a) Disability Cancellation.................... 8 1 8 .75 6
--------------------
57.215(a) Reports.................................... Burden included under 0915-0044
--------------------
57.215(a)(2), Administrative Hearings................ 0 0 0 0 0
57.215(a)(d), Administrative Hearings................ 0 0 0 0 0
--------------------
HPSL Subtotal.................................... 8,681 ................. 109,779 ................. 16,703
NSL Program: ................. ................. ................. ................. .................
--------------------
57.305(a)(2), Excess Cash............................ Burden included under 0915-0044
--------------------
57.306(a)(2), Student Financial Aid Transcript....... 4,062 1 4,062 0.25 1,016
[[Page 30131]]
57.310(b)(1)(i), Entrance Interview.................. 315 23.51 7,406 0.167 1,237
57.310(b)(1)(ii), Exit Interview..................... *502 3.77 1,892 0.5 946
57.301(b)(1)(iii), Notification of Repayment......... *502 6.18 3,102 0.167 518
57.310(b)(1)(iv), Notification During Deferment...... *502 0.65 326 0.083 27
57.310(b)(1)(vi), Notification of Delinquent Accounts *502 4.61 2,314 0.167 386
57.310(b)(1)(x), Credit Bureau Notification.......... *502 8.3 4,167 0.6 2,500
57.310(b)(4)(i), Write-off of Uncollectible Loans.... 20 1.0 20 3.5 70
57.311(a), Disability Cancellation................... 7 1.0 7 0.8 5.6
--------------------
57.312(a)(3), Evidence of Educational Loans.......... Inactive Provision
57.315(a)(1), Reports................................ Burden included under 0915-0044
--------------------
57.315(a)(1)(ii), Administrative Hearings............ 0 0 0 0 0
57.316(a)(d), Administrative Hearings................ 0 0 0 0 0
--------------------
NSL Subtotal..................................... 6,914 ................. 23,296 ................. 6,706
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\ Includes active and closing schools.
Send comments to Susan G. Queen, PhD, HRSA Reports Clearance
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of this
notice.
Dated: May 18, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-10430 Filed 5-24-05; 8:45 am]
BILLING CODE 4165-15-P
