Agency Information Collection Activities: Proposed Collection: Comment Request, 30129-30131 [05-10430]

Download as PDF 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 VerDate jul<14>2003 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 http://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 http://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 http://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 http:// 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 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 .................................... VerDate jul<14>2003 17:52 May 24, 2005 Jkt 205001 16,703 4,062 PO 00000 Frm 00075 1 Fmt 4703 Sfmt 4703 4,062 E:\FR\FM\25MYN1.SGM 0.25 25MYN1 1,016 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 VerDate jul<14>2003 23,296 6,706 active and closing schools. 17:52 May 24, 2005 Jkt 205001 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 Sfmt 4703 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 25MYN1

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]


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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