Agency Information Collection Activities: Proposed Collection: Comment Request, 58021-58023 [2011-23892]

Download as PDF Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2008–N–0352. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Alfred Kempski, Office of the PDUFA Business Program Manager, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1127, Silver Spring, MD 20993–0002, 301– 796–1999. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of an updated IT plan entitled ‘‘PDUFA IV Information Technology Plan.’’ This plan will meet one of the performance goals agreed to under the 2007 reauthorization of PDUFA IV (Title I of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110– 85)). Under section XIV of the PDUFA Performance Goals, FDA agreed to develop, periodically update, and publish for comment an IT plan for achieving the objectives defined in section XIV, Information Technology Goals, of the PDUFA Performance Goals (see http://www.fda.gov/ForIndustry/ UserFees/PrescriptionDrugUserFee/ ucm119243.htm). This plan is intended to provide regulated industry and other stakeholders with information on FDA’s vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications, to achieve the objectives defined in section XIV of the PDUFA Performance Goals. The objectives of the PDUFA IV IT Goals are to move FDA towards the long-term goal of an automated standards-based information technology environment for the exchange, review, and management VerDate Mar<15>2010 15:46 Sep 16, 2011 Jkt 223001 of information supporting the process for the review of human drug applications throughout the product life cycle. In the Federal Register of June 30, 2008 (73 FR 36880), FDA issued a notice announcing the availability of an earlier version of the IT plan entitled ‘‘Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan’’ (June 2008 plan). This updated plan revises the June 2008 plan; it communicates the progress and strategic changes for key initiatives that illustrate the accomplishment of near-term objectives and describes FDA’s strategy for meeting the long-term goal of a fully electronic submission and review environment. The sections that have been revised are identified in the Revision Index (after the Table of Contents) in the updated plan. FDA conducts an annual IT assessment to measure performance against the IT plan. The 2010 Annual IT Assessment is available at http:// www.fda.gov/ForIndustry/UserFees/ PrescriptionDrugUserFee/ ucm183308.htm. II. Electronic Access Persons with access to the Internet may obtain the updated plan at http:// www.regulations.gov. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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: September 12, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–23923 Filed 9–16–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration 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, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 0165. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the Agency; (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 through 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, know the history and status of each loan account in order to 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. The estimated total burden is 49,489 hours. The annualized burden estimates are as follows: Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 58021 E:\FR\FM\19SEN1.SGM 19SEN1 58022 Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices 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 ................................................................... Hours per year Total burden hours 435 435 435 * 477 * 477 *477 * 477 1.17 1.25 1.25 0.33 10 10 18.75 509 544 544 157 4,770 4,770 8,944 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 ..................................................................... 57.215(b)(3), Repayment Records ............................................................... ................................ ................................ 20,238 304 304 304 * 486 * 486 * 486 * 486 0.3 0.5 0.5 0.17 5 1 2.51 91 152 152 83 2,430 486 1,220 NSL Subtotal ......................................................................................... ................................ ................................ 4,614 * Includes active and closing schools. HPSL data include active and closing Loans for Disadvantaged Students (LDS) program schools. REPORTING REQUIREMENTS Number of respondents Regulatory/section requirements HPSL Program: 57.206(a)(2), Student Financial Aid Transcript ............ 57.208(c), Loan Information Disclosure ....................... 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 Uncollectable Loans ......... 57.211(a), Disability Cancellation ................................. 57.215(a)(2), Administrative Hearings .......................... 57.215(a)(d), Administrative Hearings .......................... Responses per respondent Total annual responses Hours per response Total burden hours 4,600 435 435 * 477 * 477 * 477 * 477 * 477 20 10 0 0 1 68.73 68.73 12 30.83 24.32 10.28 8.03 1 1 0 0 4,600 29,898 29,898 5,724 14,706 11,601 4,904 3,830 20 10 0 0 0.25 0.0833 0.167 0.5 0.167 0.0833 0.167 0.6 3 0.75 0 0 1,150 2,490 4,993 2,862 2,456 966 819 2,298 60 8 0 0 HPSL Subtotal ....................................................... NSL Program: 57.306(a)(2), Student Financial Aid Transcript ............ 57.310(b)(1)(i), Entrance Interview ............................... 57.310(b)(1)(ii), Exit Interview ...................................... 57.310(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 Uncollectable Loans ......... 57.311(a), Disability Cancellation ................................. 57.315(a)(1)(ii), Administrative Hearings ...................... 57.316(a)(d), Administrative Hearings .......................... ........................ ........................ ........................ ........................ 18,102 4,100 304 * 486 * 486 * 486 * 486 * 486 20 10 0 0 1 23.51 3.77 6.18 0.65 4.61 8.3 1 1 0 0 4,100 7,147 1,832 3,003 316 2,240 4,033 20 10 0 0 0.25 0.167 0.5 0.167 0.083 0.167 0.6 3.5 0.8 0 0 1,025 1,193 916 501 26 374 2,420 70 8 0 0 NSL Subtotal ......................................................... ........................ ........................ ........................ ........................ 6,535 mstockstill on DSK4VPTVN1PROD with NOTICES * Includes active and closing schools. VerDate Mar<15>2010 15:46 Sep 16, 2011 Jkt 223001 PO 00000 Frm 00076 Fmt 4703 Sfmt 9990 E:\FR\FM\19SEN1.SGM 19SEN1 Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices E-mail comments to paperwork@hrsa.gov or mail the 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: September 13, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–23892 Filed 9–16–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings mstockstill on DSK4VPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; P41 Site Visit (2012/ 01). Date: October 24–26, 2011. Time: 8 p.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: Springhill Suites by Marriott, Pittsburgh Southside Works, 2950 South Water Street, Pittsburgh, PA 15203. Contact Person: John K. Hayes, PhD, Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Boulevard, Room 959, Bethesda, MD 20892, 301–451–3398, hayesj@mail.nih.gov. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; Health Disparities SBIR 2012/01. Date: November 7, 2011. Time: 11 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health/NIBIB, DEM II, 6707 Democracy Blvd, 900, Bethesda, MD 20892. (Telephone Conference Call.) VerDate Mar<15>2010 15:46 Sep 16, 2011 Jkt 223001 Contact Person: Ruixia Zhou, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Democracy Two Building, Suite 957, Bethesda, MD 20892, 301–496–4773, zhour@mail.nih.gov. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; 2012–01 K-Award Review Meeting. Date: November 16, 2011. Time: 11 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: John K. Hayes, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Room 959, Bethesda, MD 20892, 301–451–3398, hayesj@mail.nih.gov. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; Development of Multiscale Models (U01). Date: November 17, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New Hampshire Avenue, NW., Washington, DC 20037. Contact Person: Manana Sukhareva, PhD, Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Boulevard, Suite 959, Bethesda, MD 20892, 301–451–3397, sukharem@mail.nih.gov. Dated: September 13, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–24031 Filed 9–16–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 58023 Name of Committee: National Human Genome Research Institute Initial Review Group; Genome Research Review Committee; Centers of Excellence in Genomic Science (CEGS). Date: November 3–4, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Ken D. Nakamura, PhD, Scientific Review Officer, Office of Scientific Review, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892, 301 402–0838. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: September 13, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–24026 Filed 9–16–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIDCD. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Deafness and Other Communication Disorders, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, NIDCD. Date: October 27–28, 2011. Closed: October 27, 2011, 10 a.m. to 10:30 a.m. E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58021-58023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23892]


-----------------------------------------------------------------------

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, e-mail paperwork@hrsa.gov or 
call the HRSA Reports Clearance Officer at (301) 443-0165.
    Comments are invited on: (a) The proposed collection of information 
for the proper performance of the functions of the Agency; (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 through 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, know the history and status 
of each loan account in order to 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.
    The estimated total burden is 49,489 hours. The annualized burden 
estimates are as follows:

[[Page 58022]]



                                           Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
                                                           Number of
           Regulatory/section requirements               recordkeepers      Hours per year    Total burden hours
----------------------------------------------------------------------------------------------------------------
HPSL Program:
    57.206(b)(2), Documentation of Cost of                           435                1.17                 509
     Attendance.....................................
    57.208(a), Promissory Note......................                 435                1.25                 544
    57.210(b)(1)(i), Documentation of Entrance                       435                1.25                 544
     Interview......................................
    57.210(b)(1)(ii), Documentation of Exit                        * 477                0.33                 157
     Interview......................................
    57.215(a) & (d), Program Records................               * 477                  10               4,770
    57.215(b), Student Records......................                *477                  10               4,770
    57.215(c), Repayment Records....................               * 477               18.75               8,944
                                                     -----------------------------------------------------------
        HPSL Subtotal...............................  ..................  ..................              20,238
NSL Program:
    57.306(b)(2)(ii), Documentation of Cost of                       304                 0.3                  91
     Attendance.....................................
    57.308(a), Promissory Note......................                 304                 0.5                 152
    57.310(b)(1)(i), Documentation of Entrance                       304                 0.5                 152
     Interview......................................
    57.310(b)(1)(ii), Documentation of Exit                        * 486                0.17                  83
     Interview......................................
    57.315(a)(1) & (a)(4), Program Records..........               * 486                   5               2,430
    57.315(a)(2), Student Records...................               * 486                   1                 486
    57.215(b)(3), Repayment Records.................               * 486                2.51               1,220
                                                     -----------------------------------------------------------
        NSL Subtotal................................  ..................  ..................               4,614
----------------------------------------------------------------------------------------------------------------
* Includes active and closing schools.
HPSL data include active and closing Loans for Disadvantaged Students (LDS) program schools.


                                             Reporting Requirements
----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per   Total annual      Hours per     Total burden
 Regulatory/section requirements    respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
HPSL Program:
    57.206(a)(2), Student                  4,600               1           4,600            0.25           1,150
     Financial Aid Transcript...
    57.208(c), Loan Information              435           68.73          29,898          0.0833           2,490
     Disclosure.................
    57.210(b)(1)(i), Entrance                435           68.73          29,898           0.167           4,993
     Interview..................
    57.210(b)(1)(ii), Exit                 * 477              12           5,724             0.5           2,862
     Interview..................
    57.210(b)(1)(iii),                     * 477           30.83          14,706           0.167           2,456
     Notification of Repayment..
    57.210(b)(1)(iv),                      * 477           24.32          11,601          0.0833             966
     Notification During
     Deferment..................
    57.210(b)(1)(vi),                      * 477           10.28           4,904           0.167             819
     Notification of Delinquent
     Accounts...................
    57.210(b)(1)(x), Credit                * 477            8.03           3,830             0.6           2,298
     Bureau Notification........
    57.210(b)(4)(i), Write-off                20               1              20               3              60
     of Uncollectable Loans.....
    57.211(a), Disability                     10               1              10            0.75               8
     Cancellation...............
    57.215(a)(2), Administrative               0               0               0               0               0
     Hearings...................
    57.215(a)(d), Administrative               0               0               0               0               0
     Hearings...................
                                 -------------------------------------------------------------------------------
        HPSL Subtotal...........  ..............  ..............  ..............  ..............          18,102
NSL Program:
    57.306(a)(2), Student                  4,100               1           4,100            0.25           1,025
     Financial Aid Transcript...
    57.310(b)(1)(i), Entrance                304           23.51           7,147           0.167           1,193
     Interview..................
    57.310(b)(1)(ii), Exit                 * 486            3.77           1,832             0.5             916
     Interview..................
    57.310(b)(1)(iii),                     * 486            6.18           3,003           0.167             501
     Notification of Repayment..
    57.310(b)(1)(iv),                      * 486            0.65             316           0.083              26
     Notification During
     Deferment..................
    57.310(b)(1)(vi),                      * 486            4.61           2,240           0.167             374
     Notification of Delinquent
     Accounts...................
    57.310(b)(1)(x), Credit                * 486             8.3           4,033             0.6           2,420
     Bureau Notification........
    57.310(b)(4)(i), Write-off                20               1              20             3.5              70
     of Uncollectable Loans.....
    57.311(a), Disability                     10               1              10             0.8               8
     Cancellation...............
    57.315(a)(1)(ii),                          0               0               0               0               0
     Administrative Hearings....
    57.316(a)(d), Administrative               0               0               0               0               0
     Hearings...................
                                 -------------------------------------------------------------------------------
        NSL Subtotal............  ..............  ..............  ..............  ..............           6,535
----------------------------------------------------------------------------------------------------------------
* Includes active and closing schools.


[[Page 58023]]

    E-mail comments to paperwork@hrsa.gov or mail the 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: September 13, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-23892 Filed 9-16-11; 8:45 am]
BILLING CODE 4165-15-P